SEBIVO Film-coated tablet (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: