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Entecavir tablets (boludine)

This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum transaminase ALT or active liver histology. More role
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Common name:
Entecavir Tablets
Product No.:
C14202007047
Approval No.:
Gyzz h20052237 (inquired by the State Drug Administration)
Jianke price:
¥175.00
Product specification:
0.5mg*7s 0.5mg * 28 tablets
Manufacturer:
Sino American Shanghai Squibb Pharmaceutical Co., Ltd
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Product name Entecavir tablets (boludine)
Main raw materials The main component of this product is entecavir. Chemical name: 2-amino-9 - [(1s, 3R, 4S) - 4-hydroxy-3-hydroxymethyl-2-methylene cyclopentyl] - 1,9-dihydro-6h-purine-6-one monohydrate.
Main role This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum transaminase ALT or active liver histology.
Product specification 0.5mg*7s
Usage and dosage Patients should take bolutine under the guidance of an experienced doctor. 1. Recommended dose: adults and young people over 16 years old take boludine orally, once a day, 0.5mg each time. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1.0mg (0.5mg two tablets) once a day. Bolodine should be taken on an empty stomach (at least 2 hours before or after meals). 2. Renal insufficiency In patients with renal insufficiency, the apparent oral clearance of entecavir decreases with the decrease of creatinine clearance (see pharmacokinetics: special population). Creatinine clearance & lt; The dosage should be adjusted for patients with 50ml / min (including patients treated with hemodialysis or CAPD). Recommended dose of entecavir in patients with renal insufficiency Creatinine clearance (ml / min) normal dose (0.5mg) lamivudine treatment failure (1.0mg) ≥ 50 once a day, 0.5mg each time, once a day, 1.0mg each time 30 to & lt; 50 once a day, 0.25mg each time, once a day, 0.5mg each time 10 to & lt; 30 once a day, 0.15mg each time, once a day, 0.3mg each time Hemodialysis or CAPD once a day, 0.15mg once a day, 0.3mg once a day 3. Medication after hemodialysis Liver dysfunction Patients with liver dysfunction do not need to adjust the dosage.
manufacturing enterprise Sino American Shanghai Squibb Pharmaceutical Co., Ltd
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[drug name] Entecavir tablets (boludine)

[common name] Entecavir Tablets

[specification and model] 0.5mg*7s

[manufacturer] Sino American Shanghai Squibb Pharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20052237

[validity period] 36 months

[functional indications] This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum transaminase ALT or active liver histology.

[usage and dosage] Patients should take bolutine under the guidance of an experienced doctor. 1. Recommended dose: adults and young people over 16 years old take boludine orally, once a day, 0.5mg each time. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1.0mg (0.5mg two tablets) once a day. Bolodine should be taken on an empty stomach (at least 2 hours before or after meals). 2. Renal insufficiency In patients with renal insufficiency, the apparent oral clearance of entecavir decreases with the decrease of creatinine clearance (see pharmacokinetics: special population). Creatinine clearance & lt; The dosage should be adjusted for patients with 50ml / min (including patients treated with hemodialysis or CAPD). Recommended dose of entecavir in patients with renal insufficiency Creatinine clearance (ml / min) normal dose (0.5mg) lamivudine treatment failure (1.0mg) ≥ 50 once a day, 0.5mg each time, once a day, 1.0mg each time 30 to & lt; 50 once a day, 0.25mg each time, once a day, 0.5mg each time 10 to & lt; 30 once a day, 0.15mg each time, once a day, 0.3mg each time Hemodialysis or CAPD once a day, 0.15mg once a day, 0.3mg once a day 3. Medication after hemodialysis Liver dysfunction Patients with liver dysfunction do not need to adjust the dosage.

[adverse reactions] The evaluation of adverse reactions was based on four global clinical trials: ai463014, ai463022, ai463026, ai463027 and three clinical trials in China (ai463012, ai463023, ai463056). In these 7 studies, 2596 chronic hepatitis B patients were enrolled. In the control study with lamivudine, the adverse reactions and laboratory abnormalities of entecavir and lamivudine were similar. In studies conducted abroad, the most common adverse reactions of this product are headache, fatigue, dizziness and nausea. The common adverse reactions of patients treated with lamivudine are headache, fatigue and vertigo. In these four studies, 1% of patients treated with entecavir and 4% of patients treated with lamivudine withdrew from the study due to adverse reactions and abnormal laboratory test indicators. (see the inner packaging manual for details)

[precautions] Patients should take entecavir under the guidance of doctors, and inform doctors of any new symptoms and drug combinations. The patient should be informed that if the drug is stopped, sometimes the liver condition will worsen, so the treatment method should be changed under the guidance of the doctor. Entecavir treatment did not reduce the risk of HBV transmission through sexual contact or contaminated blood sources. Therefore, appropriate protective measures need to be taken. (see the inner packaging instructions for details) please read the instructions carefully and follow the doctor's instructions.

[taboo] It is prohibited for those who are allergic to entecavir or any component in the preparation.

[listing Permit Holder] Sino American Shanghai Squibb Pharmaceutical Co., Ltd

[packaging unit] box

[main ingredients] The main component of this product is entecavir. Chemical name: 2-amino-9 - [(1s, 3R, 4S) - 4-hydroxy-3-hydroxymethyl-2-methylene cyclopentyl] - 1,9-dihydro-6h-purine-6-one monohydrate.

[character] This product is a film coated tablet, which turns white after removing the coating.

[applicable population] adult

[medication for pregnant and lactating women] The effect of entecavir on pregnant women has not been fully studied. This product can only be used after fully weighing the potential risks and benefits of the fetus. At present, there is no data suggesting that this product can affect the mother to child transmission of HBV. Therefore, appropriate intervention measures should be taken to prevent neonatal infection with HBV. Entecavir can be secreted from rat milk. However, it is still unclear whether there is secretion in human milk, so mothers taking this product are not recommended to breastfeed.

[medication for children] Data on the safety and efficacy of this product for children under the age of 16 have not been established.

[medication for elderly patients] Since there are not enough elderly patients aged 65 and over to participate in the clinical study of this product, it is unclear how the response of elderly patients and young patients to this product is different. Other clinical trial reports also did not find the difference between elderly patients and young patients. Entecavir is mainly excreted by the kidney. In patients with renal function injury, the risk of toxic reaction may be higher. Because most of the elderly patients have decreased renal function, we should pay attention to the choice of drug dose and monitor renal function.

[storage] Seal and store in a dry place.

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    Entecavir tablets (boludine)

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