Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)

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Dossier: Ctd
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  • Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)
  • Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)
  • Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)
  • Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)
  • Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)
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Basic Info.

Model NO.
tablets
Specification
0.5mg
Trademark
Sinolead
Origin
China

Product Description

 
 

Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)
Basic Info.

 
Generic Name Entecavir Tablets 0.5mg
Strength 0.5mg
Packing 14tabs/blister,2blisters/box
Origin China

Component:
Entecavir

Character:

This product is a film coating, after removing the coating will appear white.


Indications:

This product is indicated for the treatment of chronic hepatitis B in adults with active viral replication, persistent elevated serum alanine aminotransferase (ALT) or active liver histology.

Also suitable for treatment from 2 years to < An 18-year-old child with chronic HBV compensatory liver disease who was initially treated with nucleoside had evidence of active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis. For details.

 

Usage and dosage:
Patients should take this product under the guidance of an experienced physician. The tablet and oral solution are bioequivalent in healthy subjects, so the two dosage forms can be used interchangeably. For more information about oral solutions, see the Oral Solutions manual. This product should be taken on an empty stomach (at least 2 hours before or after a meal).

Adults: Take 0.5mg orally once daily. Patients with viremia or lamivudine-resistant mutations on lamivudine therapy were given 1mg (0.5mg two tablets) once daily.

Children: suitable for ages 2 to < Entecavir oral solution and entecavir tablets in an 18-year-old child patient. Treatment decisions for pediatric patients should carefully consider the needs of the individual patient and refer to current pediatric treatment guidelines. In children with HBeAg-positive chronic hepatitis B compensatory liver disease, serum ALT should be elevated for at least 6 months before treatment; Hbeag-negative children were at least 12 months old. For patients weighing 32.6kg or more, the daily dose should be 0.5mg tablet or 10ml oral solution (0.5mg), with or without food. Patients weighing less than 32.6kg should be given an oral solution.

Liver dysfunction

Patients with hepatic insufficiency do not need to adjust the dosage.

Time of treatment

The optimal duration of treatment and the relationship with long-term treatment outcomes, such as cirrhosis and liver cancer, are not yet known.


Matters needing attention:

Patients should take entecavir under the guidance of their doctor and inform their doctor of any new symptoms and combinations of medications. Patients should be informed that liver disease can sometimes worsen if they stop taking the drug, so they should change their treatment under the guidance of their doctor.

Treatment with entecavir does not reduce the risk of HBV transmission through sexual contact or contaminated blood. Therefore, appropriate protective measures need to be taken.

Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)
Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)Entecavir Tablets 0.5mg (30tabs/bottle, 1bottle/box)

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