Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
famotidine
Gedeon Richter PLC
A02BA03
famotidine
20mg
powder lyophilized for solution for injection
(5) glass vials and (5) solvent in ampoules 5ml
Prescription
Registered
2019-12-12
OGYÉI/34747/2017 1. NAME OF THE MEDICINAL PRODUCT Quamatel 20 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20.0 mg famotidine. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder for injection: white, sterile lyophilisate. Solvent for injection: clear, colourless, sterile solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quamatel injection is indicated in: - Duodenal ulcer. - Benign gastric ulcer. - Gastro-oesophageal reflux disease. - Other hypersecretory conditions (e.g. Zollinger-Ellison syndrome). - Prevention of acid aspiration in general anaesthesia (Mendelson syndrome). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Quamatel injection is for hospital use only, and in patients who may not take oral medications. Quamatel tablets should be administered instead of the injection as soon as possible. The recommended dose of Quamatel injection is 20 mg IV twice daily (every 12 hours). In Zollinger-Ellison syndrome: The initial dose is 20 mg IV, every 6 hours, which may be increased depending on the amount of secreted gastric acid and the clinical condition of the patient. In general anaesthesia for the prevention of acid aspiration: 20 mg IV in the morning of the day of the surgery, or at least 2 hours before the surgery. The single IV dose cannot be higher than 20 mg. In renal insufficiency: Since famotidine is excreted primarily via the kidneys, caution should be observed in patients with severe renal impairment. If creatinine clearance is < 30 mL/min and serum creatinine is >3 mg/100 mL, the daily dose should be reduced to 20 mg or the intervals between doses should be increased to 36-48 hours. _ _ Paediatric population: Safety and efficacy of the medicinal product in children have not been established. The use of Quamatel solution for injection in children and adolescents is not recommended (see section 4.3). 2/6 Use in elderly patients: No dosage adjustm Prečítajte si celý dokument