INTELENCE Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
INTELENCE 25 mg tablets. INTELENCE 100 mg tablets. INTELENCE 200 mg tablets.
Qualitative and quantitative composition
INTELENCE 25 mg tablets: Each tablet contains 25 mg of etravirine. Excipient with known effect: Each tablet contains 40 mg lactose (as monohydrate). Each tablet contains less than 1 mmol sodium (23 mg), ...
Pharmaceutical form
INTELENCE 25 mg tablets Tablet. White to off-white, oval, scored tablet, debossed with TMC on one side. The tablet can be divided into two equal doses. INTELENCE 100 mg tablets Tablet. White to off-white, ...
Therapeutic indications
INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral ...
Posology and method of administration
Therapy should be initiated by a physician experienced in the management of HIV infection. Posology INTELENCE must always be given in combination with other antiretroviral medicinal products. Adults The ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with elbasvir/grazoprevir (see section 4.5).
Special warnings and precautions for use
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission ...
Interaction with other medicinal products and other forms of interaction
Medicinal products that affect etravirine exposure Etravirine is metabolised by CYP3A4, CYP2C9 and CYP2C19 followed by glucuronidation of the metabolites by uridine diphosphate glucuronosyl transferase ...
Fertility, pregnancy and lactation
Pregnancy As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women, and consequently for reducing the risk of HIV vertical transmission to the ...
Effects on ability to drive and use machines
INTELENCE has minor influence on the ability to drive and use machines. No studies on the effects of INTELENCE on the ability to drive or operate machines have been performed. Adverse reactions such as ...
Undesirable effects
Summary of the safety profile The most frequent (incidence ≥10%) adverse reactions of all intensities reported for etravirine were rash, diarrhoea, nausea and headache. In the Phase III studies, the rates ...
Overdose
There are no data with regard to symptomatic overdose with etravirine, but it is possible that the most frequent adverse reactions of etravirine, i.e. rash, diarrhoea, nausea, and headache would be the ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors ATC code: J05AG04 Mechanism of action Etravirine is an NNRTI of human immunodeficiency virus type ...
Pharmacokinetic properties
The pharmacokinetic properties of etravirine have been evaluated in adult healthy subjects and in adult and paediatric treatment-experienced HIV-1 infected patients. Exposure to etravirine was lower (35-50%) ...
Preclinical safety data
Animal toxicology studies have been conducted with etravirine in mice, rats, rabbits and dogs. In mice, the key target organs identified were the liver and the coagulation system. Haemorrhagic cardiomyopathy ...
List of excipients
INTELENCE 25 mg tablets: Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate Lactose monohydrate INTELENCE 100 mg tablets: Hypromellose Microcrystalline ...
Incompatibilities
Not applicable.
Shelf life
Shelf life INTELENCE 25 mg tablets: 2 years. 8 weeks after opening the bottle. INTELENCE 100 mg tablets: 2 years. INTELENCE 200 mg tablets: 2 years. 6 weeks after opening the bottle.
Special precautions for storage
Store in the original bottle and keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant pouches.
Nature and contents of container
INTELENCE 25 mg tablets: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 2 desiccant pouches, fitted with a polypropylene (PP) child resistant closure. Each carton ...
Special precautions for disposal and other handling
Patients who are unable to swallow the tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following: place the tablet(s) in 5 ml (1 teaspoon) of ...
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Marketing authorization number(s)
25 mg: EU/1/08/468/003 100 mg: EU/1/08/468/001 200 mg: EU/1/08/468/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 August 2008 Date of latest renewal: 23 August 2018
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