Antaxone 50mg capsules

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

naltrexone (naltrexone hydrochloride)

Beschikbaar vanaf:

Zambon S.P.A.

ATC-code:

N07BB04

INN (Algemene Internationale Benaming):

naltrexone (naltrexone hydrochloride)

Dosering:

50mg

farmaceutische vorm:

capsules

Eenheden in pakket:

(10/1x10/) blister

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2015-06-08

Productkenmerken

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