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SEBIVO Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Sebivo 600 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 600 mg telbivudine. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White to slightly yellowish, oval film-coated tablet, imprinted with LDT on one side.

Therapeutic indications

Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) ...

Posology and method of administration

Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection. Posology Adults The recommended dose of Sebivo is 600 mg (one tablet) once daily. Sebivo oral solution ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Combination of telbivudine with pegylated or standard interferon alfa (see sections 4.4 and 4.5).

Special warnings and precautions for use

Severe acute exacerbations of chronic hepatitis B are relatively frequent, and are characterised by transient elevation of serum ALT. Following initiation of antiviral treatment, serum ALT may rise in ...

Interaction with other medicinal products and other forms of interaction

Since telbivudine is eliminated primarily by renal excretion, co-administration of Sebivo with substances that affect renal function (such as aminoglycosides, loop diuretics, platinum compounds, vancomycin, ...

Fertility, pregnancy and lactation

Pregnancy Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Studies in pregnant rats ...

Effects on ability to drive and use machines

Sebivo has minor influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile Assessment of adverse reactions is mainly based on two studies, NV-02B-007 (GLOBE) and NV-02B-015, in which 1,699 patients with chronic hepatitis B received double-blind treatment ...

Overdose

There is no information on intentional overdose of telbivudine, but one subject was given an unintentional overdose which was asymptomatic. Tested doses up to 1,800 mg/day, three times greater than the ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF11 Mechanism of action Telbivudine is a synthetic thymidine nucleoside ...

Pharmacokinetic properties

The single- and multiple-dose pharmacokinetics of telbivudine were evaluated in healthy subjects and in patients with chronic hepatitis B. The pharmacokinetics of telbivudine were not evaluated with the ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Telbivudine did not show any carcinogenic potential. ...

List of excipients

Tablet core: Cellulose microcrystalline Povidone Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate Tablet film coat: Titanium dioxide (E171) Macrogol Talc Hypromellose

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

PVC/aluminium blisters. Pack sizes: 28 or 98 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

EU/1/07/388/001 EU/1/07/388/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 April 2007 Date of latest renewal: 16 December 2016

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