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Entecavir Dispersible Tablets

 

Please peruse the instructions carefully before using and following the advice of a physician.

 

[Product Name]

Generic name: Entecavir Dispersible Tablets

Brand name:Run Zhong

 

[Ingredients]

The active ingredient of this product is entecavir. It is chemically described as 2-amino-9- -[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one, monohydrate.

Structural formula: 

 

Molecular formula: C12H15N5O3·H2O

Molecular weight: 295.3

 

[Description]

It is a white or whitish tablet.

[Indication] It is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

 

[Strength]

Each tablet contains 0.5mg or 1mg of entecavir.

 

[Storage]

Preserve in well-closed containers, and store at dried places below 25℃.

 

[Package]

It is packed by PTP and PVC/PVDC mixture plates.

7 tablets/blister, ① 1 blister/box ② 2 blisters/box

12 tablets/blister, ① 1 blister/box ② 2 blisters/box

 

[Expiration date]

18 months

 

[Executive standard]

SFDA criteria: YBH00452010

 

[Approval registered no.]

GuoyaozhunziH20100019 for 0.5mg per tablet

GuoyaozhunziH20100018 for 1.0mg per tablet