ETHYLEX Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Ethylex 50 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 50 mg naltrexone hydrochloride. Contains lactose monohydrate. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. Capsule shaped, beige film-coated tablets with a break-score on each side. The tablet can be divided into equal doses.
4.1. Therapeutic indications
For use as an additional therapy within a comprehensive treatment program including psychological guidance for alcohol dependence to support abstinence.
4.2. Posology and method of administration
Ethylex treatment should be initiated and supervised by suitably qualified persons. Administration of Ethylex should not be started before a naloxone challenge test is performed and a negative result obtained ...
4.3. Contraindications
Ethylex is contraindicated: in patients with acute hepatitis or liver failure. in patients currently dependent on opioids since an acute withdrawal syndrome may ensue. in any patient who has a positive ...
4.4. Special warnings and precautions for use
In accordance to national guidance the therapy should be initiated and supervised by a physician experienced in treatment of alcohol-addicted patients. Since Ethylex is extensively metabolised by the liver ...
4.5. Interaction with other medicinal products and other forms of interaction
Presently, clinical experience and experimental data on the effect of naltrexone on the pharmacokinetics of other substances are limited. Concomitant treatment with naltrexone and other medicinal products ...
4.6. 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 ...
4.7. Effects on ability to drive and use machines
Ethylex may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery.
4.8. Undesirable effects
The following adverse reactions have been reported before and during naltrexone medication: Frequency is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon ...
4.9. Overdose
There is limited clinical experience with Ethylex overdose in patients. There was no evidence of toxicity in volunteers receiving 800 mg/day for seven days, however, in case of overdose, patients should ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in alcohol dependence <b>ATC code:</b> N07BB04 Naltrexone is a specific opioid antagonist with only minimal agonistic activity. It acts by stereospecific competition ...
5.2. Pharmacokinetic properties
Naltrexone is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration. It undergoes a liver first-pass effect and peak plasma concentration is reached within approximately ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology,repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. However, ...
6.1. List of excipients
<u>Tablet core:</u> Lactose monohydrate Powered cellulose Microcrystalline cellulose Silica, colloidal anhydrous Crospovidone Magnesium stearate <u>Film-coat:</u> Opadry 31 F27245 Beige Lactose monohydrate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
<u>Pack sizes:</u> 7, 14, 28, 30 and 56 tablets in PVC/PVDC/Aluminium blister. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
AOP Orphan Pharmaceuticals Gmbh, Leopold-Ungar-Platz 2, A-1190 Vienna, Austria
8. Marketing authorization number(s)
PA0934/002/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 20 April 2004 Date of last renewal: 19 April 2009
10. Date of revision of the text
February 2022
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