Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diazepam
Alkaloid AD Skopje
N05BA01
diazepam
10mg/2ml
solution for injection
(10) ampoules 2ml
Prescription
Registered
2021-06-29
Diazepam Alkaloid 10 mg/2 ml solution for injection _ _ Summary of Product Characteristics _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diazepam Alkaloid 10 mg/2 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2 ml solution for injection (1 ampoule) contains 10 mg diazepam. Excipients with known effect: Each ampoule contains 4.80 mg benzoic acid; 40 mg sodium benzoate; 100 mg benzyl alcohol; 200 mg ethanol, anhydrous; 900 mg propylene glycol and 6.384 mg sodium . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM * solution for injection Clear light yellow to greenish solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute anxiety and agitation, abstinence syndrome (delirium tremens), status epilepticus, tetanus, acute central and peripheral muscle spasms. Anesthesia: pre-medication, introduction of anesthesia, cardioversia, minor surgical procedures, endoscopy. Obstetrics: for relief of pre-natal pains, in placenta previa, delayed eclampsia, and pre- eclampsia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY In case of acute conditions, the dosage may be repeated after an hour, whereas the usual time interval between the doses is 4 hours. In case of elderly and exhausted patients, as well as in case of concomitant use of other sedatives, smaller doses, with gradual increase are recommended (2 – 5 mg). Acute anxiety or agitation: _Adults:_ 5 – 10 mg i.v. or i.m. If necessary, the administration could be repeated after 4 hours. Delirium tremens: _Adults: _ 10 – 20 mg i.v. or i.m. If necessary, the dose of 5-10 mg should be repeated after 4 hours. Status epilepticus: Diazepam Alkaloid 10 mg/2 ml solution for injection _ _ Summary of Product Characteristics _ _ _Adults: _ 0.15 – 0.25 mg/kg body weight at a slow rate i.v. or i.m. After 30 – 60 minutes, if necessary, the dose should be repeated or, administered in form of an infusion that should run at a very slow rate, drop by drop. The largest dose is 3 mg/kg body weight d Прочитать полный документ