1. Name Of The Medicinal Product

Salazopyrin Suppositories

2. Qualitative And Quantitative Composition

Sulfasalazine EP 0.5 g

3. Pharmaceutical Form

Suppository

4. Clinical Particulars 4.1 Therapeutic Indications

Ulcerative colitis or Crohn's Disease affecting the rectum.

4.2 Posology And Method Of Administration

The dose is adjusted according to the severity of the disease and the patient's tolerance of the drug.

Acute attack or relapse - Adults and the Elderly

Two suppositories are to be inserted in the morning and two at bedtime after defecation. After three weeks the dosage is gradually reduced as improvement occurs.

Adjustment to oral therapy - Adults and the Elderly

In severe generalised ulcerative colitis of the rectum or recto sigmoid, or in cases who are responding slowly to oral therapy, one or two suppositories may be given in the morning and at bedtime additional to oral therapy.

Children

The adult dose is reduced on the basis of body weight.

4.3 Contraindications

General

Because of lower absorption levels and shorter retention time in the body, Salazopyrin Suppositories give rise to fewer adverse events than equivalent treatment by mouth. However, because of the theoretical possibility that serious adverse events can arise from treatment from either route, the details below are based on adverse event reports to both oral and rectal treatment.

i) A known hypersensitivity to sulfasalazine, its metabolites or any of theexcipients as well as sulfonamides or salicylates.

ii) Use in infants under two years old.

iii) Porphyria.

4.4 Special Warnings And Precautions For Use

Complete blood counts (including differential white cell count), liver function tests and assessment of renal function (including urinalysis) should be performed in all patients before starting therapy with sulfasalazine, and frequently during the first 3 months of therapy. Thereafter, monitoring should be performed as clinically indicated. The patient should also be counselled to report immediately with any sore throat, fever, malaise, pallor, purpura, jaundice or unexpected non-specific illness during sulfasalazine treatment, this may indicate myelosuppression, haemolysis or hepatoxicity. Treatment should be stopped immediately while awaiting the results of blood tests. .

Sulfasalazine should not be given to patients with impaired hepatic or renal function or with blood dyscrasias, unless the potential benefit outweighs the risk.

Sulfasalazine should be given with caution to patients with severe allergy or bronchial asthma.

Use in children with the concomitant condition systemic onset juvenile rheumatoid arthritis may result in a serum sickness like reaction; therefore sulfasalazine is not recommended in these patients.

Since sulfasalazine may cause haemolytic anaemia, it should be used with caution in patients with G-6-PD deficiency.

Oral sulfasalazine inhibits the absorption and metabolism of folic acid and may cause folic acid deficiency potentially resulting in serious blood disorders (e.g., macrocytosis and pancytopenia), this can be normalised by administration of folic acid or folinic acid (leucovorin).

Because sulfasalazine causes crystalluria and kidney stone formation, adequate fluid intake should be ensured during treatment.

Oligospermia and infertility may occur in men treated with sulfasalazine. Discontinuation of the drug appears to reverse these effects within 2 to 3 months. As far as is know oligospermia has not occurred during therapy per rectum.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been no adverse interactions reported, due to the drug largely remaining confined to the rectum. However, there is a potential for interaction as follows:

Reduced absorption of digoxin , resulting in non-therapeutic serum levels, has been reported when used concomitantly with oral sulfasalazine.

Sulfonamides bear certain chemical similarities to some oral hypoglycemic agents. Hypoglycemia has occurred in patients receiving sulfonamides. Patients receiving sulfasalazine and hypoglycemic agents should be closely monitored.

Due to inhibition of thiopurine methyltransferase by salazopyrin, bone marrow suppression and leucopenia have been reported when the thiopurine 6-mercaptopurine or it's prodrug, azathioprine, and oral salazopyrin were used concomitantly.

Coadministration of oral sulfasalazine and methotrexate to rheumatoid arthritis patients did not alter the pharmacokinetic disposition of the drugs. However, an increased incidence of gastrointestinal adverse events, especially nausea, was reported.

4.6 Pregnancy And Lactation

Pregnancy

Reproduction studies in rats and rabbits have revealed no evidence of harm to the fetus. Published data regarding use of sulfasalazine in pregnant women have revealed no evidence of teratogenic hazards. If sulfasalazine is used during pregnancy, the possibility of fetal harm appears remote. Oral sulfasalazine inhibits the absorption and metabolism of folic acid and may cause folic acid deficiency. Because the possibility of harm cannot be completely ruled out, sulfasalazine should be used during pregnancy only if clearly needed.

Lactation

Sulfasalazine and sulfapyridine are found in low levels in breast milk. Caution should be used, particularly if breastfeeding premature infants or those deficient in G-6-PD.

4.7 Effects On Ability To Drive And Use Machines

No specific effects.

4.8 Undesirable Effects

The following have been reported to sulfasalazine given orally or rectally. The drug rectally is well tolerated. Overall, about 75% of adverse drug reactions occur within three months of starting therapy and over 90% by six months. Some undesirable effects are dose-dependent and symptoms can often be alleviated by reduction of the dose.

General

Sulfasalazine is split by intestinal bacteria to sulfapyridine and 5-amino salicylate so adverse drugs reactions to either sulfonamide or salicylate are possible. Patients with slow acetylator status are more likely to experience adverse drug reactions related to sulfapyridine. The most commonly encountered adverse drugs reactions are nausea, headache, rash, loss of appetite and raised temperature.

Specific

The adverse reactions observed during clinical studies conducted with Sulfasalazine have been provided in a single list below by class and frequency (very common (

Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in the list below.

Body System

Adverse drug reactions

Infections and infestations

 

Not known

Pseudomembranous colitis

Blood and Lymphatic System Disorders

 

Common

Leukopenia

Uncommon

Thrombocytopenia*

Not known

Agranulocytosis, aplastic anemia, haemolytic anemia, Heinz body anaemia, hypoprothrombinaemia, lymphadenopathy, macrocytosis, megaloblastic anemia, methaemoglobinaemina, neutropenia, pancytopenia

Immune System Disorders:

 

Not known

Anaphylaxis, polyarteritis nodosa, serum sickness

Metabolism and Nutrition Disorders:

 

Not known

Loss of appetite

Psychiatric Disorders:

 

Common

Insomnia

Uncommon

Depression

Not known

Hallucinations

Nervous System Disorders:

 

Common

Dizziness, headache, taste disorders

Uncommon

Convulsions

Not known

Aseptic meningitis, ataxia, encephalopathy, peripheral neuropathy, smell disorders

Ear and Labyrinth Disorders:

 

Common

Tinnitus

Uncommo

Vertigo

Eye Disorders:

 

Common

Conjuctivial and scleral injection

Cardiac Disorders:

 

Not known

Allergic myocarditis, cyanosis, pericarditis

vascular Disorders:

 

Uncommon

Vasculitis

Respiratory, Thoracic and Mediastinal Disorders:

 

Common

Cough

Uncommon

Dyspnoea

Not known

Fibrosing alveolitis, eosinophilic infiltration, interstitial lung disease

Gastrointestinal Disorders:

 

Very Common

Gastric distress, nausea

Common

Abdominal pain, diarrhoea, vomiting, stomatitis

Not known

Aggravation of ulcerative colitis, pancreatitis, parotitis

Hepato-biliary Disorders:

 

Not known

Hepatic failure, fulminant hepatitis, hepatitis*

Skin and Subcutaneous Tissue Disorders:

 

Common

Pruritus

Uncommon

Alopecia, urticaria

Not known

Epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), toxic pustuloderma, erythema, exanthema, exfoliative dermatitis, periorbital oedema, lichen planus, photosensitivity

Musculoskeletal and Connective Tissue Disorders:

 

Common

Arthralgia

Not known

Systemic lupus erythematosus

Renal and Urinary Disorders:

 

Common

Proteinuria

Not known

Nephrotic syndrome, interstitial nephritis, crystalluria*, haematuria

Reproductive System and Breast Disorders:

 

Not known

Reversible oligospermia*

General Disorders and Administration Site Conditions:

 

Common

Fever

Uncommon

Facial oedema

Not known

Yellow discoloration of skin and body fluids

Investigations:

 

Uncommon

Elevation of liver enzymes

Not known

Induction of autoantibodies

* See Section 4.4 for further information

4.9 Overdose

Overdose with suppositories is unlikely. In the event, evacuate the bowel and treat supportively. The toxicity of sulphasalazine is low in acute dosage. There is no specific antidote.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Therapeutic benefit of sulfasalazine in ulcerative colitis and Crohn's Disease appears to be due to a local action of the sulfasalazine and its split product 5-aminosalicylic acid on the mucous membrane and deeper colonic structures. Pharmacological actions noted for these compounds include inhibition of neutrophil activation, free radical scavenging, inhibition of superoxide production, inhibition of bacterial growth. Sulfasalazine inhibits 15-Prostaglandin dehydrogenase and slows prostaglandin metabolism. Lipoxygenase release in inflammatory cells is also depressed. NK cells and T cell proliferation are inhibited.

5.2 Pharmacokinetic Properties

There are considerable individual differences in the retention time of suppositories in volunteer studies. Consequently uptake values vary widely also. Given that the effect of the drug is almost certainly due to a local effect pharmacokinetics becomes less relevant to therapeutic action than to possible adverse effects related to systemic levels.

A study of five volunteers over three days following insertion of 2 x 0.5 g suppositories gave the following results:

Retention time: mean 8.9 hours (s.d. 5.2), serum concentration at 10 hours: sulfasalazine 1.7 mcg/ml (s.d. 0.46), sulfapyridine less than 1 mcg/ml. Percentage renal excretion: 10.2 (s.d. 4.3). Uptake as reflected by excretion is much below that of the oral rate and may explain the good tolerance of the dose form.

5.3 Preclinical Safety Data

In two-year carcinogenicity studies in rats and mice, sulfasalazine showed some evidence of carcinogenicity. In rats, there was a small increase in the incidence of transitional cell papillomas in the urinary bladder and kidney. The tumours were judged to be induced mechanically by calculi formed in the urine rather than through a direct genotoxic mechanism. In the mouse study, there was a significant increase in the incidence of hepatocellular adenoma or carcinoma. The mechanism of induction of hepatocellular neoplasia has been investigated and attributed to species-specific effects of sulfasalazine that are not relevant to humans.

Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) or in the L51784 mouse lymphoma cell assay at the HGPRT gene. It did not induce sister chromatid exchanges or chromosomal aberrations in cultured Chinese hamster ovary cells, and in vivo mouse bone marrow chromosomal aberration tests were negative. However, sulfasalazine showed positive or equivocal mutagenic responses in rat and mouse micronucleus assays, and in human lymphocyte sister chromatid exchange, chromosomal aberration and micronucleus assays. The ability of sulfasalazine to induce chromosome damage has been attributed to perturbation of folic acid levels rather than to a direct genotoxic mechanism.

Based on information from non-clinical studies, sulfasalazine is judged to pose no carcinogenic risk to humans. Sulfasalazine use has not been associated with the development of neoplasia in human epidemiology studies.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Povidone

Adepa Solidus

6.2 Incompatibilities

Certain types of extended wear soft contact lenses may be permanently stained during therapy.

6.3 Shelf Life

Five years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/Polyethylene laminate moulds

6.6 Special Precautions For Disposal And Other Handling

As the suppositories melt at body temperature they should be kept below 25°C and handled as little as possible before insertion so that they are firm.

Sulfasalazine is an orange dye, and care should thus be taken with clothing, bedding etc with regard to seepage or spillage.

Insertion

Empty the bowel if possible. Push the suppository through the anus with a finger, as far as possible. The urge to expel them will pass in a few minutes, once they have melted.

7. Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/1042

9. Date Of First Authorisation/Renewal Of The Authorisation

12 August 2010

10. Date Of Revision Of The Text

12 August 2010

11. LEGAL CATEGORY

POM.

Ref: SZ 6_0 Supp UK





Pronunciation: LAK-tase



Generic Name: testosterone buccal system (tes TOSS ter one)



Generic Name: hylan G-F 20 (HI lan G F 20)



1. Name Of The Medicinal Product

Sterile Dopamine Concentrate B.P. 800mg/5ml.

2. Qualitative And Quantitative Composition

Dopamine Hydrochloride U.S.P., 800mg in 5ml.

3. Pharmaceutical Form

Clear, colourless or pale yellow sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For the correction of haemodynamic imbalances in low-perfusion circulatory insufficiency associated with myocardial infarction, trauma, septicaemia, cardiac failure and open heart surgery.

4.2 Posology And Method Of Administration

The solution must be diluted before administration. Alkaline solutions such as 5% sodium bicarbonate should NOT be added to dopamine hydrochloride because the drug will be inactivated. The usual dilution is 1,600 micrograms per ml and this may be achieved by transfer, aseptically of 800mg of dopamine hydrochloride to one of the following sterile I.V. solutions: -

Sodium Chloride Injection

5% Dextrose Injection

5% Dextrose and 0.9% Sodium Chloride Injection

5% Dextrose and 0.45% Sodium Chloride Solution

5% Dextrose in Ringer Lactate Solution

Sodium Lactate 1/6 Molar Injection

Lactated Ringer's Injection

A suitable metering device is required in the infusion system to control the rate of flow, and this should be adjusted to the optimum patient response and monitored constantly in the light of the individual patient's response.

Adults: Use as large a vein as possible for infusion. The initial rate of infusion is 2 to 5 micrograms per kilogram bodyweight per minute and this may be increased gradually by increments of 5 to 10 micrograms/kg/minute until the optimum dose for the individual is achieved. Up to 50 micrograms/kg/minute may be required, and even higher doses have been used.

Children: The safety and efficacy of dopamine hydrochloride therapy in children have not been established.

4.3 Contraindications

Dopamine should not be used in patients with –

• Hypersensitivity to dopamine or any of the excipients.

• Phaeochromocytoma or hyperthyroidism

Dopamine should not be used in the presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation.

Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.

4.4 Special Warnings And Precautions For Use

The solution contains an antioxidant, sodium metabisulphite, a sulphite that may cause hypersensitivity reactions including bronchospasm, anaphylaxis and life-threatening episodes in certain susceptible individuals. The prevalence of sulphite-sensitivity in the general population is unknown and is probably low. Sulphite-sensitivity is seen more frequently in persons with a history of asthma or atopic allergy.

Each ampoule of this injection contains 2.42 mg sodium per ml.

Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses; the starting dose should be one tenth (1/10th) of the usual dose.

Excess administration of potassium-free solutions may result in significant hypokalaemia.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema.

Precautions:

Hypovolaemia should be corrected where necessary prior to dopamine infusion. Low doses should be used in shock due to acute myocardial infarction.

If a disproportionate rise in diastolic pressure (i.e. a marked decrease in pulse pressure) is observed, the infusion rate should be decreased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such an effect is desired.

Patients with a history of peripheral vascular disease should be closely monitored for any changes in colour or temperature of the skin of the extremities. If change of skin colour or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued dopamine infusion should be weighed against the risk of possible necrosis. These changes may be reversed by decreasing the rate or discontinuing the infusion. IV administration of phentolamine mesylate 5-10 mg may reverse the ischaemia.

Dopamine hydrochloride in 5% dextrose injection should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. Extravasation of dopamine hydrochloride during infusion may cause ischaemic necrosis and sloughing of surrounding tissue. Ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.

Administration of dopamine hydrochloride should always be under the direct supervision of a physician to whom facilities are available for monitoring cardiovascular and renal indices, including blood volume, cardiac output, blood pressure, electrocardiography and urine flow.

Dextrose solutions should be used with caution in patients with known subclinical or overt diabetes mellitus.

When dopamine is used in patients with a history of occlusive vascular disease, particular attention should be paid to the status of blood circulation in the extremities.

The occurrence of undesirable increases in blood pressure or vasoconstriction or decrease in urinary output requires a reduction in dosage of dopamine hydrochloride.

The routine use of low-dose dopamine hydrochloride in critically ill patients to prevent or treat acute renal failure is not recommended because this may cause adverse effects which could further compromise such patients.

As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised.

Dopamine infusion should be withdrawn gradually, to avoid unnecessary hypotension.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

i) Anaesthetics:

The myocardium is sensitised by the effect of dopamine, cyclopropane or halogenated hydrocarbon anaesthetics, and these should be avoided. This interaction applies both to pressor activity and cardiac beta adrenergic stimulation.

ii) Alpha and Beta Blockers:

The cardiac effects of dopamine are antagonised by ? -adrenergic blocking agents such as propanolol and metoprolol, and the peripheral vasoconstriction caused by high doses of dopamine is antagonised by ? adrenergic blocking agents. Dopamine induced renal and mesenteric vasodilation is not antagonised by either ? or ?- adrenergic blocking agents, but, in animals, is antagonised by haloperidol or other butrophenones, phenothiazines and opiates.

iii) Monoamine Oxidase (MAO) Inhibitors :

MAO inhibitors potentiate the effect of dopamine and its duration of action. Patients who have been treated with MAO inhibitors prior to administration of dopamine will therefore require a substantially reduced dosage. (The starting dose should be reduced to at least 1/10th of the usual dose).

iv) Phenytoin:

Administration of IV phenytoin to patients receiving dopamine has resulted in hypotension and bradycardia; some clinicians recommend that phenytoin be used with extreme caution, if at all, in patients receiving dopamine.

Dopamine may increase the effect of diuretic agents.

The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine.

4.6 Pregnancy And Lactation

Use in Pregnancy:

Animal studies have shown no evidence of teratogenic effects with dopamine.

However, the effect of dopamine on the human foetus is unknown. Therefore the drug should be used in pregnant women only when the expected benefits outweigh the potential risk to the foetus.

Use in Lactation:

It is not known if dopamine is excreted in breast milk, nor is the effect on the infant known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable in view of the indications for use and the short half-life of the drug.

4.8 Undesirable Effects

Adverse reactions to dopamine are related to its pharmacological action.

More common reactions include-

Cardiovascular: Ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction.

Gastrointestinal: Nausea, vomiting

Nervous System: Headache

Respiratory: Dyspnoea

Less common reactions include-

Biochemical Abnormalities- Azotaemia

Cardiovascular: Aberrant conduction, bradycardia, widened QRS complex, hypertension, gangrene, fatal ventricular arrhythmias have been reported on rare occasions.

Eye Disorders: Mydriasis

Nervous system- Piloerection

Serious or Life-threatening Reactions:

Gangrene of the feet has occurred following doses of 10-14 microgram/kg/min and higher in a few patients with pre-existing vascular disease.

4.9 Overdose

Excessive elevation of blood pressure and vasoconstriction can occur due to the alpha adrenergic actions of dopamine, especially in patients with a history of occlusive vascular disease. If desired, this condition can be rapidly reversed by dose reduction or discontinuing the infusion, since dopamine has a half-life of less than 2 minutes in the body.

Should these measures fail, an infusion of an alpha adrenergic blocking agent, e.g., phentolamine mesylate, should be considered.

Dopamine at the infusion site can cause local vasoconstriction hence the desirability of infusing into a large vein. The resulting ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 mg to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.

Accidental Overdosage:

Accidental overdosage as evidenced by excessive blood pressure elevation can be controlled by dose reduction or discontinuing the dopamine infusion for a short period, since the duration of action of dopamine is short.

Should these measures fail, an infusion of phentolamine mesylate should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Dopamine (3,4-dihydroxyphenylethylamine) is the third naturally-occurring catecholamine and is a metabolic precursor of noradrenaline and adrenaline. Dopamine is used therapeutically as the hydrochloride and its main effects are seen in the cardiovascular system and the kidneys.

Heart

Dopamine exerts positive inotropic and chronotropic effects on the myocardium, acting as an agonist at beta-adrenergic receptors. In addition to its direct action on beta-adrenergic receptors, dopamine acts indirectly by releasing noradrenaline from sympathetic storage sites.

Blood Vessesls

Depending on the vascular bed being studied and the dose administered, Dopamine can cause relaxation or contraction of vascular smooth muscle.

Dopamine Receptors

Unlike other endogenous catecholamines or sympathomimetic amines, Dopamine caused vasodilatation in renal, coronary, mesenteric and intracerebral arterial vascular beds in anaesthetised dogs. This vasodilator effect is not antagonised by beta-adrenergic blockers, atropine or antihistamines. However, butyrophenones, phenothiazines, apomorphine and bulbocapnine selectively attenuate dopamine-induced vasodilatation, thus suggesting the existence of specific dopamine vascular receptors similar to those in the basal ganglia and other areas in the central nervous system.

Alpha-adrenergic Receptors

Dose response studies indicate that with a sufficiently large dose, the vasoconstrictor effect of dopamine predominates over its vasodilator effect. This dopamine-induced vasoconstrictor effect is antagonised by alpha-adrenoreceptor blocking agents such as phentolamine and phenoxybenzamine, indicating that vasoconstriction results from the action of dopamine on alpha-adrenergic receptors.

Kidney

Intravenous infusions of dopamine (2.6 to 7.1µg/kg/min.) to seven normal subjects increased estimated average renal plasma flow from 507 to 798ml/min., insulin clearance from 109 to 136ml/min. and average sodium excretion from 171 to 571µEq./min. Although the diuretic and natriuretic effects of dopamine may result from vasodilatation in renal vascular bed (vide supra), disassociation between natriuresis and increments in renal blood flow has been observed, suggesting that other mechanisms such as redistribution of intrarenal blood flow may be involved.

5.2 Pharmacokinetic properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration by subcutaneous or intramuscular injection. Dopamine hydrochloride is administered by intravenous infusion.

Dopamine is a metabolic precursor of nor-adrenaline and, whereas a proportion is excreted as the metabolic products of nor-adrenaline, the majority is mainly metabolised into 3,4,-Dihydroxyphenylacetic Acid (DOPAC) and 3-methoxy-4-hydroxyphenylacetic (HVA) which are rapidly excreted in the urine.

The plasma half-life of dopamine is approximately two minutes.

5.2 Pharmacokinetic Properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration by subcutaneous or intramuscular injection. Dopamine hydrochloride is administered by intravenous infusion.

Dopamine is a metabolic precursor of nor-adrenaline and, whereas a proportion is excreted as the metabolic products of nor-adrenaline, the majority is mainly metabolised into 3,4,-Dihydroxyphenylacetic Acid (DOPAC) and 3-methoxy-4-hydroxyphenylacetic (HVA) which are rapidly excreted in the urine.

The plasma half-life of dopamine is approximately two minutes.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Metabisulphite B.P.

Water for Injections B.P.

6.2 Incompatibilities

Iron salts, alkalis or oxidising agents.

6.3 Shelf Life

3 years (36 months)

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

5ml Clear glass one point-cut (OPC) ampoules, glass type I Ph Eur. with white ring packed in cardboard cartons to contain 10 x 5ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

This solution must be diluted before use.

Do not dilute with alkaline solution.

Do not use the injection if it is darker than slightly yellow or discoloured in any other way.

For the preparation of Dopamine Hydrochloride Intravenous Infusion.

Use as directed by the physician.

Keep out of reach of children.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 02848/0131.

9. Date Of First Authorisation/Renewal Of The Authorisation

14 September 1989 / 25 July 1997

10. Date Of Revision Of The Text

18/03/2010



1. Name Of The Medicinal Product

Strong Pholcodine Linctus BP

2. Qualitative And Quantitative Composition

Each 5ml contains Pholcodine BP 10mg

3. Pharmaceutical Form

Oral solution: Clear, colourless, raspberry and cola flavoured syrup.

4. Clinical Particulars 4.1 Therapeutic Indications

Suppression of non-productive cough.

4.2 Posology And Method Of Administration

Adults:

5ml spoonful 3-4 times daily

Children:

Not recommended.

4.3 Contraindications

Liver disease, ventilatory failure, asthma, bronchitis, bronchiectasis. Use in patients with hypersensitivity or idiosyncratic response to the active ingredient, use in children.

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Depressant effects may occur with concurrent alcohol ingestion; concurrent (or within 2 weeks) use of MAOIs may lead to excitation; the depressant effects might be increased by phenothiazines, MAOIs and tricyclic anti-depressants.

4.6 Pregnancy And Lactation

This product should not be used during pregnancy or lactation unless it is considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Pholcodine may induce drowsiness. Patients receiving this medication should not drive or operate machinery unless it has been shown not to affect mental or physical ability.

4.8 Undesirable Effects

Constipation, nausea and drowsiness occasionally occur.

Immune system disorders: hypersensitivity reactions, anaphylaxis.

4.9 Overdose

Restlessness, excitement and ataxia may occur after large doses. A toxic dose in children is reported to be about 200mg.

Treatment: Gastric lavage with supportive and symptomatic measures. In severe cases, and where respiratory depression occurs an opioid antagonist such as Naloxone – should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Morphine or codeine derivatives. By tradition used mainly as an antitussive. It suppresses the cough reflex by a direct central action, probably in the medulla or pons. It has little or no analgesic or euphorigenic activity.

5.2 Pharmacokinetic Properties

Metabolised in the liver.

5.3 Preclinical Safety Data

Not stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric Acid BP

Sodium Carboxymethylcellulose 7HOF BP

Glycerol BP

Sodium Benzoate BP

Saccharin Sodium BP

Lycasin 80/55 HSE

Ethanol 96% BP

Raspberry/Cola flavour

Purified Water BP to volume

6.2 Incompatibilities

None known

6.3 Shelf Life

Amber glass bottles – 2 years

High density polyethylene bottles – 2 years

6.4 Special Precautions For Storage

Store below 20°C. Protect from light.

6.5 Nature And Contents Of Container

Amber Grade III glass bottle with pilfer proof screw cap, 100ml, 125ml, 200ml and 500ml.

Virgin HDPE bottle with tamper evident screw cap, 500ml, 1 Litre, 2 Litres.

6.6 Special Precautions For Disposal And Other Handling

As for all medicines – no special requirements.

Administrative Data 7. Marketing Authorisation Holder

Pinewood Laboratories Ltd.,

Ballymacarbry, Clonmel,

Co. Tipperary, Ireland

8. Marketing Authorisation Number(S)

PL 04917/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

15 August 1991

10. Date Of Revision Of The Text

February 2008



Generic Name: desflurane (Inhalation route)

des-FLOO-rane

Commonly used brand name(s)

In the U.S.

Suprane

Available Dosage Forms:

Liquid Solution

Therapeutic Class: Volatile Liquid

Chemical Class: Haloalkane

Uses For Suprane

Desflurane belongs to the group of medicines known as general anesthetics. Desflurane is used to cause general anesthesia (loss of consciousness) before and during surgery. It is breathed in (inhaled). Although desflurane can be used by itself, combinations of anesthetics are often used together. This helps produce more effective anesthesia in some patients.

General anesthetics are given only by or under the immediate supervision of a medical doctor trained to use them. If you will be receiving a general anesthetic during surgery, your doctor will give you the medicine and closely follow your progress.

Before Using Suprane

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Desflurane has been tested in children. It is not used to start anesthesia in children who are awake because it causes irritation and other unwanted effects. However, when it is used to continue general anesthesia that has been started with another anesthetic, desflurane does not cause different side effects or problems in children than it does in adults.

Geriatric

Desflurane has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older people usually need smaller amounts of an anesthetic than younger people. Your doctor will take your age into account when deciding on the right amount of desflurane for you.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cisatracurium Hydromorphone Oxycodone St John's Wort Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

The presence of other medical problems may affect the use of desflurane. Make sure you tell your doctor if you have any other medical problems, especially:

Diseases that can cause muscle weakness, such as familial periodic paralysis, muscular dystrophy, myasthenia gravis, or Eaton-Lambert syndrome, or Heart or blood vessel disease—The chance of side effects may be increased, but serious problems can be prevented if your doctor knows that these conditions are present before giving you an anesthetic Malignant hyperthermia, during or shortly after receiving an anesthetic (history of, or family history of). Signs of malignant hyperthermia include very high fever, fast and irregular heartbeat, muscle spasms or tightness, and breathing problems—This side effect may occur again Proper Use of Suprane Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your age. Your general physical condition. The kind of surgery being performed. Other medicines you are taking or will receive before and during surgery. Precautions While Using Suprane

For patients going home within 24 hours after receiving a general anesthetic:

General anesthetics may cause some people to feel drowsy, tired, or weak for a while after they have been given. They may also cause problems with coordination and one's ability to think. Therefore, for about 24 hours (or longer if necessary) after receiving a general anesthetic, do not drive, use machines, or do anything else that could be dangerous if you are not alert. Unless otherwise directed by your doctor or dentist, do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received a general anesthetic. To do so may add to the effects of the anesthetic. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; other sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; and muscle relaxants. Suprane Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Coughing nausea or vomiting Less common or rare Dizziness headache irritated or red eyes nervousness and restlessness sore throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Suprane side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Suprane resources Suprane Side Effects (in more detail) Suprane Use in Pregnancy & Breastfeeding Suprane Drug Interactions Suprane Support Group 0 Reviews for Suprane - Add your own review/rating Suprane Prescribing Information (FDA) Desflurane Compare Suprane with other medications Anesthesia



Generic Name: Trospium Chloride



Generic Name: mazindol (MA zin doll)





Pronunciation: DOCK-yoo-sate/SEN-oh-sides





Pronunciation: SOE-li-FEN-a-sin



Generic Name: trimethobenzamide (Intramuscular route)

trye-meth-oh-BENZ-a-mide

Commonly used brand name(s)

In the U.S.

Arrestin Benzacot Stemetic Ticon Tigan Tribenzagan

Available Dosage Forms:

Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Anticholinergic

Uses For Stemetic

Trimethobenzamide is used to treat nausea and vomiting .

This medicine is available only with your doctor's prescription .

Before Using Stemetic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No information is available on the relationship of age to the effects of intramuscular trimethobenzamide in the pediatric population. However, because of this medication's toxicity, use in children is contraindicated. Intramuscular trimethobenzamide should never be used in children .

Geriatric

No information is available on whether the risk of trimethobenzamide-induced adverse effects is increased in the elderly. However, because of this medication's toxicity, it should be used with caution, after less toxic alternatives have been considered and/or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy .

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Metoclopramide Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Dehydration or Electrolyte imbalance (high or low levels of minerals in the blood) or High fever or Intestinal infection, severe—May cause side effects to become worse . Proper Use of trimethobenzamide

This section provides information on the proper use of a number of products that contain trimethobenzamide. It may not be specific to Stemetic. Please read with care.

Trimethobenzamide is only used to relieve or prevent nausea and vomiting. A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles .

Your doctor may only give you a few doses of this medicine until your condition improves, and then may switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor .

Precautions While Using Stemetic

Trimethobenzamide will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using trimethobenzamide .

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert .

Stemetic Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Body spasm, with head and heels bent backward and body bowed forward convulsions (seizures) depression shakiness or tremors skin rash sore throat or fever unusual tiredness vomiting (severe or continuing) yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Drowsiness Less common Blurred vision diarrhea dizziness headache muscle cramps

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Stemetic side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Stemetic resources Stemetic Side Effects (in more detail) Stemetic Use in Pregnancy & Breastfeeding Drug Images Stemetic Drug Interactions Stemetic Support Group 3 Reviews for Stemetic - Add your own review/rating Compare Stemetic with other medications Nausea/Vomiting



Definition of Secondary Hyperparathyroidism: The parathyroids are four glands in the neck that produce parathyroid hormone to help control calcium metabolism. Excessive production of this hormone caused by increased activity of these glands is known as hyperparathyroidism. When this occurs in response to low blood calcium caused by another condition, the condition is called secondary hyperparathyroidism.

Drugs associated with Secondary Hyperparathyroidism

The following drugs and medications are in some way related to, or used in the treatment of Secondary Hyperparathyroidism. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Secondary Hyperparathyroidism

Medical Encyclopedia:

Secondary hyperparathyroidism



Serc-8

Serc-16

Betahistine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Serc is and what it is used for 2. Before you take Serc 3. How to take Serc 4. Possible side effects 5. How to store Serc 6. Further information What Serc is and what it is used for

Serc contains betahistine. This medicine is called a histamine analogue. It is used to treat:

dizziness (vertigo) ringing in the ears (tinnitus) hearing loss suffered by people with M?ni?re's disease

This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.

Before you take Serc Do not take Serc if: You are allergic to any of the ingredients in the tablets (see section 6 for further details). You have high blood pressure due to an adrenal tumour (phaeochromocytoma).

If any of the above applies to you, do not take this medicine and talk to your doctor.

Take special care and tell your doctor if: you have a stomach ulcer you have asthma you are pregnant or planning to become pregnant you are breast-feeding

If any of the above applies to you, talk to your doctor before taking this medicine. Your doctor will tell you whether it is safe for you to start taking this medicine. Your doctor may also want to monitor your asthma while you take Serc.

Taking other medicines

No interaction between Serc and other medicines are known. If you notice any unwanted effects tell your doctor or pharmacist.

Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Taking Serc with food and drink

You can drink alcohol while taking Serc.

You can take Serc with or without food.

Pregnancy and breast-feeding

Do not take Serc if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice.

Do not breast-feed while using Serc unless instructed by your doctor. It is not known if Serc passes into breast milk.

Driving and using machines

You can drive and use machines while you are taking this treatment, so long as this medicine does not make you sleepy. Make sure you know how this medicine affects you before you drive or use machines.

How to take Serc How to take Serc Swallow the tablets with water. Take the tablet with or after a meal. How much Serc to take

Always follow your doctor’s instructions because your doctor might adjust your dose.

Serc is available in two strengths, an 8 mg tablet and a 16 mg tablet. The usual starting dose is 16 mg three times a day (48 mg). Your doctor may lower your dose to 8 mg three times a day (24 mg).

Keep taking your tablets. The tablets can take a while to start to work.

Serc is not recommended for use in children.

How to stop taking Serc

Keep taking your tablets until your doctor tells you to stop.

Even when you start feeling better, your doctor may want you to carry on taking the tablets for some time to make sure that the medicine has worked completely.

If you take more Serc than you should

If you or someone else takes too much Serc (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Serc

If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Serc Side Effects

Like all medicines Serc can cause side effects (unwanted effects or reactions), but not everyone gets them.

The following serious side effects may occur during treatment with Serc: Allergic reactions such as: swelling of your face, lips, tongue or neck.



1. Name Of The Medicinal Product

Simple Linctus Sugar Free

2. Qualitative And Quantitative Composition

Simple Linctus Sugar Free: Citric Acid Monohydrate 125 mg/5 ml equivalent to 114.29mg/5ml Anhydrous Citric Acid.

3. Pharmaceutical Form

Clear Pink Sugar Free Syrup

4. Clinical Particulars 4.1 Therapeutic Indications

For the management of a mild non-specific cough.

4.2 Posology And Method Of Administration

Adults: One 5 ml spoonful orally 3-4 times daily.

Children: Not appropriate

4.3 Contraindications

Not known

4.4 Special Warnings And Precautions For Use

This medicine contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None Known

4.6 Pregnancy And Lactation

No data available

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Not Applicable

4.9 Overdose

Sufficient prolonged overdose of citric acid may cause erosion of the teeth and have a local irritant action.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Absorption: Citric Acid Monohydrate is absorbed after oral administration.

Distribution: Citric Acid is found naturally in the body and is widely distributed, about 70% of the citric acid in the body is in hard bone and this accounts for 1.5% of bone content.

Metabolic Reactions: It is an important intermediate in carbohydrate metabolism and its major role is in the tricarboxylic acid cycle (Krebs citric acid cycle); it is metabolised to carbon dioxide and water.

Excretion: Citric acid is normally excreted in the urine in amounts ranging from 0.4 to 1.5g daily and this amount is not increased unless very large doses are administered. The urinary excretion of citric acid is increased in alkaline urine

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol (E422)

Sodium Carboxymethylcellulose

Sodium Benzoate (E211)

Saccharin Sodium (E954)

Lycasin 80/55 (E965)

Ethanol (96%)

Anise Oil

Chloroform

Natural Red DI (E163)

Purified Water

6.2 Incompatibilities

Not appropriate

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Do not Store above 25°C.

6.5 Nature And Contents Of Container

Amber glass bottles with pilfer screw closure

High density Polyethylene with screw on closure

Pack sizes of 100ml, 125ml, and 200ml for Amber Glass Bottles

Pack size of 2000ml for High Density Polyethylene dispensary pack.

6.6 Special Precautions For Disposal And Other Handling

As with all medicines.

7. Marketing Authorisation Holder

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co Tipperary

8. Marketing Authorisation Number(S)

PL 04917/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

28 August 1991

10. Date Of Revision Of The Text

November 2008



Generic Name: pramoxine topical (pra MOX een TOP i kal)



Generic Name: sumatriptan (oral/nasal) (soo ma TRIP tan)



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