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AUBAGIO Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

AUBAGIO 14 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 14 mg of teriflunomide. Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet (tablet). Pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (14) and engraved with a corporate logo on the other side.

Therapeutic indications

AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS). (please refer to section 5.1 for important information on the population for which efficacy has ...

Posology and method of administration

The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis. Posology The recommended dose of teriflunomide is 14 mg once daily. Special populations ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe hepatic impairment (Child-Pugh class C). Pregnant women, or women of childbearing potential ...

Special warnings and precautions for use

Monitoring Before treatment Before starting treatment with teriflunomide the following should be assessed: Blood pressure Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) Complete ...

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions of other substances on teriflunomide The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor pathway. Potent cytochrome P450 (CYP) ...

Fertility, pregnancy and lactation

Use in males The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see section 5.3). Pregnancy There are limited amount of data from the use of teriflunomide ...

Effects on ability to drive and use machines

AUBAGIO has no or negligible influence on the ability to drive and use machines. In the case of adverse reactions such as dizziness, which has been reported with leflunomide, the parent compound, the patient ...

Undesirable effects

Summary of the safety profile A total of 2267 patients were exposed to teriflunomide (1155 on teriflunomide 7 mg and 1112 on teriflunomide 14 mg) once daily for a median duration of about 672 days in four ...

Overdose

Symptoms There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily was administered up to 14 days in healthy subjects. The adverse reactions were consistent ...

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants ATC Code: L04AA31 Mechanism of action Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that selectively ...

Pharmacokinetic properties

Absorption Median time to reach maximum plasma concentrations occurs between 1 to 4 hours post-dose following repeated oral administration of teriflunomide, with high bioavailability (approximately 100%). ...

Preclinical safety data

Repeated oral administration of teriflunomide to mice, rats and dogs for up to 3, 6, and 12 months, respectively, revealed that the major targets of toxicity were the bone marrow, lymphoid organs, oral ...

List of excipients

Tablet core: Lactose monohydrate Maize starch Microcrystalline cellulose Sodium starch glycolate (Type A) Hydroxypropylcellulose Magnesium stearate Tablet coating: Hypromellose Titanium dioxide (E171) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Polyamide/aluminium/poly(vinyl chloride) - aluminium blisters inserted in wallets (14 and 28 film-coated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) ...

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

Sanofi-aventis groupe, 54, rue La Boétie, F-75008, Paris, France

Marketing authorization number(s)

EU/1/13/838/001 EU/1/13/838/002 EU/1/13/838/003 EU/1/13/838/004 EU/1/13/838/005

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 August 2013 Date of latest renewal: 28 May 2018

Πηγαίο έγγραφο

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