Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
naltrexone (naltrexone hydrochloride)
Zambon S.P.A.
N07BB04
naltrexone (naltrexone hydrochloride)
50mg
capsules
(10/1x10/) blister
Prescription
Registered
2015-06-08
CCDS NALT201001 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Invented name strength pharmaceutical form Antaxone, 50mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Antaxone_ _50 mg hard capsule:_ _ Each hard capsule contains 50 mg of naltrexone hydrochloride equivalent to 45,17 mg of naltrexone base Excipient: Each hard capsule contains 96 mg of lactose monohydrate, see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Сapsules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Opioid addiction Antaxone is a pure opiate antagonist, it inhibits the pharmacological effects of opiates introduced from outside, and by this helps detoxicate those individuals that have been opiate- dependent previously and helps maintain the opiate-free state. 1 No such data exist that would unequivocally confirm the beneficial Antaxone effect during the detoxification of those individuals who have been opiate-dependent earlier with regard to the frequency of a relapse. Alcoholism: For use as part of a complete treatment programme for alcoholism with the aim of reducing the risk of relapse, maintaining abstinence and reducing the desire for alcohol during the initial recovery stages 2 . As naltrexone is not equally useful to all patients and the benefits that can be expected from naltrexone treatment is a moderate improvement of the results obtained with conventional therapy, its use in alcoholism should be combined with psychotherapeutic measures and conducted in centres specialised in the treatment of this disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Opioid addiction The treatment with Antaxone should be started in clinical centres specialized in the treatment of drug-addiction, and successively should be prosecuted under strict medical surveillance of the physicians of such centres. Dosage must be exclusively in accordance with the instructions of the specialist doctor. Start of therapy: 1.Treatment should not be initiated unless the patient has remained opio Прочитать полный документ