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SPC, UK: ZANTAC Injection (Aqueous solution) (2015)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zantac Injection 50 mg/2ml.

Qualitative and quantitative composition

Ranitidine Hydrochloride HSE 56.0 mg/2ml equivalent to Ranitidine 50.0 mg/2ml. Each ampoule contains 2.9 mg (0.09 mmol) of sodium and 0.6 mg (0.015 mmol) of potassium. For the full list of excipients, ...

Pharmaceutical form

Injection (Aqueous solution). A clear colourless to pale yellow liquid, practically free from particles.

Therapeutic indications

Adults Zantac Injection is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison Syndrome and the following conditions where ...

Posology and method of administration

(See section 5.2 Pharmacokinetic properties – Other special populations) Posology Adults (including elderly) / Adolescents (12 years and over) Zantac Injection may be given either as a slow (over 2 minutes) ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Malignancy The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer as treatment with ranitidine may mask symptoms of gastric carcinoma. Renal Disease ...

Interaction with other medicinal products and other forms of interaction

Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation ...

Fertility, pregnancy and lactation

Pregnancy Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or ...

Effects on ability to drive and use machines

None reported.

Undesirable effects

The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, ≤1/100), rare (≥1/10,000, ≤1/1000), very rare (≤1/10,000). ...

Overdose

Symptoms and signs Zantac is very specific in action and accordingly, no particular problems are expected following overdosage with the drug. Treatment Symptomatic and supportive therapy should be given ...

Pharmacodynamic properties

Pharmacotherapeutic group: H<sub>2</sub>-receptor antagonists ATC code: A02BA02 Mechanism of action Ranitidine is a specific, rapidly acting histamine H<sub>2</sub>-antagonist. It inhibits basal and stimulated ...

Pharmacokinetic properties

Absorption Absorption of ranitidine after intramuscular injection is rapid and peak plasma concentrations are usually achieved within 15 minutes of administration. Distribution Ranitidine is not extensively ...

Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and ...

List of excipients

Sodium chloride BP Potassium dihydrogen orthophosphate HSE Disodium hydrogen orthophosphate HSE Water for injection BP

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life: 36 months unopened.

Special precautions for storage

Store below 25°C, protect from light. Zantac Injection should not be autoclaved.

Nature and contents of container

2 ml colourless Type I glass ampoules. Pack size: 5 ampoules.

Special precautions for disposal and other handling

Zantac Injection has been shown to be compatible with the following intravenous infusion fluids: 0.9% Sodium Chloride BP 5% Dextrose BP 0.18% Sodium Chloride and 4% Dextrose BP 4.2% Sodium Bicarbonate ...

Marketing authorization holder

Glaxo Wellcome UK Ltd, T/A GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Marketing authorization number(s)

PL 10949/0109

Date of first authorization / renewal of the authorization

25 March 1998

Date of revision of the text

13 October 2015

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