Quamatel powder lyophilized for solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

famotidine

Available from:

Gedeon Richter PLC

ATC code:

A02BA03

INN (International Name):

famotidine

Dosage:

20mg

Pharmaceutical form:

powder lyophilized for solution for injection

Units in package:

(5) glass vials and (5) solvent in ampoules 5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-12

Summary of Product characteristics

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