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EDURANT Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

EDURANT 25 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. Excipient with known effect: Each film-coated tablet contains 56 mg lactose monohydrate. For the full list of ...

Pharmaceutical form

Film-coated tablet. White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with TMC on one side and 25 on the other side.

Therapeutic indications

EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology The recommended dose of EDURANT is one 25 mg tablet taken once daily. EDURANT must be taken with a meal ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine ...

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 rilpivirine exposure Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A. Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine ...

Fertility, pregnancy and lactation

Pregnancy There are limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2). Lower exposures of rilpivirine were observed ...

Effects on ability to drive and use machines

EDURANT has no or negligible influence on the ability to drive and use machines. However, fatigue, dizziness and somnolence have been reported in some patients taking EDURANT and should be considered when ...

Undesirable effects

Summary of the safety profile During the clinical development program (1,368 patients in the Phase III controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE)), 55.7% of subjects experienced at least ...

Overdose

There is no specific antidote for overdose with EDURANT. Human experience of overdose with rilpivirine is limited. Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams. Treatment ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors ATC code: J05AG05 Mechanism of action Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine ...

Pharmacokinetic properties

The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy subjects and in antiretroviral treatment-naïve HIV-1 infected patients 12 years of age and older. Exposure to rilpivirine ...

Preclinical safety data

Repeated dose toxicity Liver toxicity associated with liver enzyme induction was observed in rodents. In dogs, cholestasis-like effects were noted. Reproductive toxicology studies Studies in animals have ...

List of excipients

Tablet core: Lactose monohydrate Croscarmellose sodium Povidone K30 Polysorbate 20 Silicified microcrystalline cellulose Magnesium stearate Tablet coating: Lactose monohydrate Hypromellose 2910 6 mPa.s ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in the original bottle in order to protect from light.

Nature and contents of container

75 ml high density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant closure and induction seal liner. Each carton contains one bottle of 30 tablets.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization number(s)

EU/1/11/736/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 November 2011 Date of latest renewal: 22 July 2016

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