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Entecavir dispersible tablets (Betadine)

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 dispersible tablets
Product No.:
S14200229021
Approval No.:
Gyzz h20140037 (inquired by the State Drug Administration)
Jianke price:
¥130.00
Product specification:
0.5mg * 14 pieces / plate 0.5mg*28s 0.5mg*7s
Manufacturer:
Anhui Baker biopharmaceutical Co., Ltd
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Product name Entecavir dispersible tablets (Betadine)
Main raw materials 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 Adults and adolescents aged 16 and over take this product orally, once a day, 0.5mg (1 tablet) each time. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1mg (0.5mg two tablets) once a day. This product should be taken on an empty stomach (at least 2 hours before or after meals). See the inner packaging instructions for details.
manufacturing enterprise Anhui Baker biopharmaceutical Co., Ltd
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[drug name] Entecavir dispersible tablets (Betadine)

[common name] Entecavir dispersible tablets

[specification and model] 0.5mg*7s

[manufacturer] Anhui Baker biopharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20140037

[validity period] 24 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] Adults and adolescents aged 16 and over take this product orally, once a day, 0.5mg (1 tablet) each time. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1mg (0.5mg two tablets) once a day. This product should be taken on an empty stomach (at least 2 hours before or after meals). See the inner packaging instructions for details.

[adverse reactions] 1. The evaluation of adverse reactions is based on four global clinical trials: ai463014, ai463022, ai463026, ai463027 and three clinical trials conducted in China (ai463012, ai463023, ai463056). In these 7 studies, 2596 chronic hepatitis B patients were enrolled. In the study compared with lamivudine, the adverse events and laboratory abnormalities of entecavir and lamivudine were similar. 2. In studies conducted abroad, the most common adverse events of this product are headache, fatigue, dizziness and nausea. The common adverse events of patients treated with lamivudine were 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 events and abnormal laboratory test indicators, respectively. See the inner packaging instructions for details.

[precautions] 1. For patients with creatinine clearance < 50ml / min, including hemodialysis or CAPD, it is recommended to adjust the dosage of entecavir. 2. The safety and efficacy of entecavir in liver transplant recipients are unclear. If it is considered that the liver transplant recipient needs to be treated with entecavir and has received or is receiving immunosuppression that may affect renal function, such as cyclosporin or tacrolimus, renal function should be closely monitored before and during the administration of entecavir. 3. The patient should take entecavir under the guidance of the doctor, and inform the doctor of any new symptoms and drug combination. 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. 4. The patient needs to be tested for HIV antibody before starting entecavir treatment. Patients should be informed that if they are infected with HIV and do not receive effective HIV drug treatment, entecavir may increase the chance of resistance to HIV drug treatment. See the inner packaging instructions for details. Please read the instructions carefully and follow the doctor's advice.

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

[listing Permit Holder] Anhui Baker biopharmaceutical Co., Ltd

[packaging unit] box

[main ingredients] 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 white or off white.

[applicable population] unlimited

[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.

[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 up.

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    Entecavir dispersible tablets (Betadine)

    ¥130.00

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