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CN | EN
Tenofovir Disoproxil Fumarate Tablets(30 tablets)
簡 介


【藥品名稱】

通用名:富馬酸替諾福韋二吡呋酯片;

英文名:Tenofovir Disoproxil Fumarate Tablets

漢語拼音: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.

【規格】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.

【注意事項】

1. 如果實驗室或臨床檢驗發現乳酸血癥或明確的肝毒性存在,應停止本藥物的治療。

2. HBV感染患者停用本品后至少數個月里,應密切監控臨床和實驗室指標。

3. 建議在治療開始時和在治療過程中對患者進行肌酐清除率測定。對于有腎功能損害風險的患者,應進行常規的肌酐清除率測定和血磷檢查。避免與有腎毒性的制劑合用。

4.不能和固定比例的復方制劑TRUVADA同用。不能和阿德福韋酯同用。5.阿扎那韋可以增加替諾福韋的血藥濃度。與本品聯用時,建議同時服用阿扎那韋300mg和利托那韋100mg。沒有利托那韋時不要將阿扎那韋與本品同服。

6.對于有病理性骨折史或骨質疏松風險的患者應考慮進行骨骼礦物質密度(BMD)監控。

7. 目前無法確定老年人的用藥反應與年輕人有何不同。

8. 年齡小于18歲兒童的本品用藥安全性和有效性尚不明確。

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.www.the3dtechnologies.com

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