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Tenofovir Disoproxil Fumarate Tablets(30 tablets)
简 介


【药品名称】

通用名:富马酸替诺福韦二吡呋酯片;

英文名:Tenofovir Disoproxil Fumarate Tablets

汉语拼音:Fumasuan Tinuofuwei Erbifuzhi Pian

QUALITATIVE AND QUANTITATIVE COMPOSITION:Each film-coated tablet contains 300mg of tenofovir disoproxil fumarate.

PHARMACEUTICAL FORM:White or off-white film-coated tablet

THERAPEUTIC INDICATIONS:Tenofovir Disoproxil Fumarate Tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in adults and paediatric patients.

Tenofovir Disoproxil Fumarate Tablets are indicated for the treatment of chronic hepatitis B in adults and paediatric patients 12 years of age and older.

【规格】300mg。

POSOLOGY AND METHOD OF ADMINISTRATION:The recommended dose is one tablet once daily taken orally without regard to food.

Please refer to Pateinet information leaflet for details. 

ADVERSE REACTIONS:Most common adverse reactions based on clinical study are gastrointestinal events, headache, dizziness, asthenia, nasopharyngitis, pain, rash, depression, insomnia, increased amylase, increased liver enzymes, increased creatinine and etc.

Please refer to Pateinet information leaflet for details.

CONTRAINDICATIONS:Tenofovir Disoproxil Fumarate Tablets are contraindicated in patients with previously hypersensitivity to any of the components of the products.

【注意事项】

1. 如果实验室或临床检验发现乳酸血症或明确的肝毒性存在,应停止本药物的治疗。

2. HBV感染患者停用本品后至少数个月里,应密切监控临床和实验室指标。

3. 建议在治疗开始时和在治疗过程中对患者进行肌酐清除率测定。对于有肾功能损害风险的患者,应进行常规的肌酐清除率测定和血磷检查。避免与有肾毒性的制剂合用。

4.不能和固定比例的复方制剂TRUVADA同用。不能和阿德福韦酯同用。5.阿扎那韦可以增加替诺福韦的血药浓度。与本品联用时,建议同时服用阿扎那韦300mg和利托那韦100mg。没有利托那韦时不要将阿扎那韦与本品同服。

6.对于有病理性骨折史或骨质疏松风险的患者应考虑进行骨骼矿物质密度(BMD)监控。

7. 目前无法确定老年人的用药反应与年轻人有何不同。

8. 年龄小于18岁儿童的本品用药安全性和有效性尚不明确。

USE IN SPECIFIC POPULATIONS

Pregnancy and Nursing Mothers

US Pregnancy Category B;

The Centers for Disease Control and Prevention in US recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1.

Pediatric Use

The safety of Tenofovir Disoproxil Fumarate Tablets in pediatric patients aged 2 to less than 18 years with HIV-1 infection is supported by data from the clinical study abroad. In addition, the pharmacokinetic profile of tenofovir in patients 2 to less than 18 years of age at the recommended doses was similar to that found to be safe and effective in adult clinical trials. Safety and effectiveness of Tenofovir Disoproxil Fumarate Tablets in pediatric patients younger than 2 years of age have not been established.

Geriatric Use

Clinical trials of Tenofovir Disoproxil Fumarate Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

SPECIAL PRECATIONS FOR STORAGE

Keep the bottle tightly colsed, do not store above 30°C.


NATURE AND CONTENTS OF CONTAINER

High density polyethylene (HDPE) bottle containing 10, 14, 20, 30 or 60 tablets.

SHELF LIFE

24 months

MANUFACTURER

Anhui Biochem Bio-Pharmaceutical Co., Ltd

No. 30 Hongfeng Road, Hi-Tech Development Zone, Hefei 230088, China

Tel.: 0086 551 65355222/65355777

Fax: 0086 551 65369760

www.bcpharm.com