ADEPEND Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Adepend 50 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 50 mg naltrexone hydrochloride. <u>Excipients with known effect:</u> contains 126,755 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablets. Capsule shaped, beige film-coated tablets with a break-score on each side. The tablet can be divided into equal doses.
Therapeutic indications
Adepend is used as part of a comprehensive programme of treatment against alcoholism to reduce the risk of relapse, as support treatment in abstinence and to reduce the craving for alcohol.
Posology and method of administration
Before treatment, it has to be assured that the patient is free of opioids (see section 4.4). Treatment with naltrexone should according to national guidelines only be initiated and monitored by physicians ...
Contraindications
Hypersensitivity to naltrexone hydrochloride or to any of the excipients listed in section 6.1. Acute hepatitis or liver failure. Severe or acute liver impairment. Severe renal impairment. Patients taking ...
Special warnings and precautions for use
In accordance with national guidance the therapy should be initiated and supervised by a physician experienced in the treatment of alcohol-addicted patients. During the treatment, painful conditions should ...
Interaction with other medicinal products and other forms of interaction
At the moment, there is only limited clinical experience and experimental data on the effect of naltrexone on the pharmacokinetics of other substances. Concomitant treatment with naltrexone and other medicinal ...
Pregnancy and lactation
Pregnancy There are no clinical data on naltrexone hydrochloride use in pregnancy. Data from animal studies have shown reproductive toxicity (see section 5.3). The data are insufficient to establish clinical ...
Effects on ability to drive and use machines
Adepend 50 mg film-coated tablets may influence psychological and physical abilities and, therefore, conduction of potentially dangerous tasks like driving vehicles or using machines should be avoided. ...
Undesirable effects
The following undesirable effects are classified according to system organ class and frequency: Very Common (1/10), Common (1/100 to 1/10), Uncommon (1/1000 to 1/100), Rare (1/10000 to 1/1000), Very Rare ...
Overdose
Symptoms There is limited experience with overdose of naltrexone hydrochloride. There was no evidence of toxicity in volunteers receiving 800 mg naltrexone hydrochloride per day for one week. Treatment ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in alcohol dependence <b>ATC code:</b> N07BB04 Naltrexone hydrochloride is an orally used, long acting specific opioid antagonist. Naltrexone hydrochloride ...
Pharmacokinetic properties
Absorption After oral administration naltrexone hydrochloride is rapidly and completely absorbed from the gastrointestinal tract. Peak plasma concentration is reached within one hour. Distribution Plasmaprotein-binding ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. However, there is some evidence ...
List of excipients
<u>Tablet core:</u> Lactose monohydrate Powered cellulose Crospovidone Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate <u>Film-coat:</u> Lactose monohydrate Hypromellose Titanium ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
7, 10, 14, 28, 30 or 100 tablets in PVC/PVDC/Aluminium blister packed in a carton. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002, Purkersdorf, Austria
Marketing authorization number(s)
PL 30414/0013
Date of first authorization / renewal of the authorization
22/12/2011 / 08/05/2015
Date of revision of the text
07/11/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
