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BARACLUDE Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Baraclude 0.5 mg film-coated tablets. Baraclude 1 mg film-coated tablets.

Qualitative and quantitative composition

Baraclude 0.5 mg film-coated tablets: Each tablet contains 0.5 mg entecavir (as monohydrate). Baraclude 1 mg film-coated tablets: Each tablet contains 1 mg entecavir (as monohydrate). Excipients with known ...

Pharmaceutical form

Film-coated tablet (tablet). Baraclude 0.5 mg film-coated tablets: White to off-white and triangular-shaped tablet with BMS debossed on one side and 1611 on the other. Baraclude 1 mg film-coated tablets: ...

Therapeutic indications

Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: Compensated liver disease and evidence of active viral replication, persistently ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection. Posology Compensated liver disease Nucleoside naïve patients The recommended dose in adults is ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Renal impairment Dosage adjustment is recommended for patients with renal impairment (see section 4.2). The proposed dose modifications are based on extrapolation of limited data, and their safety and ...

Interaction with other medicinal products and other forms of interaction

Since entecavir is predominantly eliminated by the kidney (see section 5.2), coadministration with medicinal products that reduce renal function or compete for active tubular secretion may increase serum ...

Fertility, pregnancy and lactation

Women of childbearing potential Given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception. Pregnancy There are no adequate ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness, fatigue and somnolence are common side effects which may impair the ability to drive and use machines. ...

Undesirable effects

a. Summary of the safety profile In clinical studies in patients with compensated liver disease, the most common adverse reactions of any severity with at least a possible relation to entecavir were headache ...

Overdose

There is limited experience of entecavir overdose reported in patients. Healthy subjects who received up to 20 mg/day for up to 14 days, and single doses up to 40 mg had no unexpected adverse reactions. ...

Pharmacodynamic properties

Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF10 Mechanism of action Εntecavir, a guanosine nucleoside analogue with ...

Pharmacokinetic properties

Absorption Entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.5-1.5 hours. The absolute bioavailability has not been determined. Based on urinary excretion of unchanged drug, ...

Preclinical safety data

In repeat-dose toxicology studies in dogs, reversible perivascular inflammation was observed in the central nervous system, for which no-effect doses corresponded to exposures 19 and 10 times those in ...

List of excipients

Baraclude 0.5 mg film-coated tablets: Tablet core: Crospovidone Lactose monohydrate Magnesium stearate Cellulose, microcrystalline Povidone Tablet coating: Titanium dioxide Hypromellose Macrogol 400 Polysorbate ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Blisters: Do not store above 30°C. Store in the original carton. Bottles: Do not store above 25°C. Keep the bottle tightly closed.

Nature and contents of container

Each carton contains either: 30 1 film-coated tablet; 3 blister cards of 10 1 film-coated tablet each in Alu/Alu perforated unit dose blisters, or 90 1 film-coated tablet; 9 blister cards of 10 1 film-coated ...

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

BRISTOL-MYERS SQUIBB PHARMA EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

Marketing authorization number(s)

Baraclude 0.5 mg film-coated tablets: Blister packs: EU/1/06/343/003 EU/1/06/343/006 Bottle packs: EU/1/06/343/001 Baraclude 1 mg film-coated tablets: Blister packs: EU/1/06/343/004 EU/1/06/343/007 Bottle ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 June 2006 Date of latest renewal: 26 June 2011

Πηγαίο έγγραφο

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