Active ingredients: Entecavir
Baraclude 0.5 mg film-coated tablets.
Baraclude 1 mg film-coated tablets.
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: Pink and triangular-shaped tablet with “BMS” debossed on one side and “1612” on the other.
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 effect:
Each 0.5 mg film-coated tablet contains 120.5 mg lactose.
Each 1 mg film-coated tablet contains 241 mg lactose.
For the full list of excipients, see section 6.1.
Εntecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
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 80 (E433)
Baraclude 1 mg film-coated tablets:
Tablet core:
Crospovidone
Lactose monohydrate
Magnesium stearate
Cellulose, microcrystalline
Povidone
Tablet coating:
Titanium dioxide
Hypromellose
Macrogol 400
Iron oxide red
Each carton contains either:
High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets. Each carton contains one bottle.
Not all pack sizes and container types may be marketed.
BRISTOL-MYERS SQUIBB PHARMA EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
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 packs:
EU/1/06/343/002
Date of first authorisation: 26 June 2006
Date of latest renewal: 26 June 2011