Nhà máy Stada
Stada
stada
stada
Antifungals & Antivirals

Tenofovir STADA® 300 mg

 

Pack szie:    

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains tenofovir disoproxil fumarate 300 mg.

 

Shelf-life:

36 months from the date of manufacturing. 

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

Tên thuốc: Calcium Stada ® 500mg
Mã thuốc: 500
Quy cách: Viên sủi bọt.Ống 20 viên. Hộp 1 ống.
Thành phần: Mỗi viên sủi bọt chứa:
Calci ................................... 500 mg
(Bao gồm calci carbonat và calci gluconolactat).
Tá dược vừa đủ ...................... 1 viên.

Chỉ định: - Loãng xương có nguồn gốc khác nhau (mãn kinh, người lớn tuổi, điều trị bằng Corticosteroid, cắt dạ dày hoặc bất động).
- Phòng ngừa tình trạng giảm sự khoáng hóa xương ở giai đoạn tiền và hậu mãn kinh.
- Điều trị hỗ trợ trong còi xương và nhuyễn xương.
- Tetani tiềm ẩn.
- Tăng nhu cầu calci ở phụ nữ có thai và cho con bú và trẻ em đang tăng trưởng.
- Tình trạng dị ứng (điều trị hỗ trợ).

Chống chỉ định: Tăng calci huyết ( như cường cận giáp, rối loạn thừa vitamin D, khối u do mất xương, suy thận nặng, ung thư xương di căn), sỏi calci do tăng calci niệu nặng và sỏi thận. Bất động lâu ngày kèm với tăng calci niệu và / hoặc tăng calci huyết. Quá mẫn với bất kỳ thành phần nào của thuốc.
Liều dùng: Calcium STADA® 500 mg được dùng uống. Hòa tan viên sủi trong 1 ly nước.
Liều dùng thường ngày: 500 - 1000 mg calci nguyên tố (1-2 viên) để bổ sung tối thiểu khoảng 70% nhu cầu khuyến cáo mỗi ngày. Trong trường hợp nặng có thể dùng đến 2000 mg (4 viên) trong những tuần lễ đầu điều trị.
Hạn sử dụng: 24 tháng kể từ ngày sản xuất
Đơn giá:

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Tenofovir disoproxil fumarate is used in conjunction with other antiretroviral agents (but should not be used alone) in the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.
  • Tenofovir disoproxil fumarate is used in conjunction with other antiretroviral agents for postexposure prophylaxis of HIV infection (occupational exposure or nonoccupational exposure) in individuals associated with a risk for transmission of the virus.
  • Tenofovir disoproxil fumarate is also used in the treatment of chronic hepatitis B in adults. Like adefovir, tenofovir is also active against lamivudine-resistant mutant HBV.
  • Tenofovir STADA® 300 mg is administered orally once daily without regard to meals.
     
  • Adults
    Treatment of HIV infection: 1 tablet once daily, in conjunction with other antiretrovirals.
    Postexposure prophylaxis following occupational exposure to HIV: 1 tablet once daily in conjunction with other antiretrovirals (usually in conjunction with lamivudine or emtricitabine). Postexposure prophylaxis should be started as soon as possible following occupational exposure (preferably within hours rather than days) and continued for 4 weeks, if tolerated.
    Postexposure prophylaxis following nonoccupational exposure to HIV: 1 tablet once daily in conjunction with at least 2 other antiretrovirals. Postexposure prophylaxis should be initiated as soon as possible following nonoccupational exposure (preferably within 72 hours) and continued for 28 days.
    Treatment of chronic hepatitis B: The recommended dosage is 1 tablet once daily past 48 weeks.
  • Renal impairment patients
    Doses of tenofovir disoproxil fumarate should be modified by adjustment of the dosing interval in patients with renal impairment according to their creatinine clearance (Clcr):
    Clcr 50 mL or more per minute: Usual once-daily dosage.
    Clcr 30 to 49 mL/minute: Every 48 hours.
    Clcr 10 to 29 mL/minute: Every 72 to 96 hours.
    Haemodialysis patients:
    A dose every 7 days or after a cumulative total of 12 hours of dialysis.
    Because safety and efficacy of these dosages have not been evaluated in clinical studies, clinical response to treatment and renal function should be closely monitored.
  • Dosage adjustment is not necessary in patients with hepatic impairment.

 

Or as prescribed by physicians.

 

  • Known hypersensitivity to tenofovir disoproxil fumarate or to any ingredient of the drug.

     

  • The most common adverse effects reported from the use of tenofovir disoproxil fumarate are mild gastrointestinal effects, particularly diarrhoea, nausea and vomiting, abdominal pain, flatulence, dyspepsia, and anorexia.
  • Serum-amylase concentrations may be raised and pancreatitis has been reported.
  • Hypophosphataemia occurs commonly.
  • Skin rashes may occur.
  • Other adverse effects occurring commonly include peripheral neuropathy, headache, dizziness, insomnia, depression, asthenia, sweating, and myalgia.
  • Raised liver enzymes, hypertriglyceridaemia, hyperglycaemia, and neutropenia.
  • Renal impairment, acute renal failure, and effects on the renal proximal tubules, including Fanconi syndrome.
  • Lactic acidosis, usually associated with severe hepatomegaly and steatosis, has been associated with treatment with nucleoside reverse transcriptase inhibitors.

     

  • Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) have been reported rarely in patients receiving nucleoside reverse transcriptase inhibitors alone or in conjunction with other antiretroviral agents (tenofovir).
  • Adipogenic effects: Redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general Cushingoid appearance, has been reported with antiretroviral therapy.
  • Bone effects: Decreases in bone mineral density at the lumbar spine, increases in levels of 4 biochemical markers of bone metabolism, and increased serum parathyroid hormone levels were reported in HIV infected patients receiving tenofovir concomitantly with lamivudine and efavirenz.
  • Bone monitoring should be considered for HIV-infected patients who have a history of pathologic bone fracture or are at substantial risk for osteopenia. Although the effect of supplementation with calcium and vitamin D was not studied, such supplementation may be beneficial for all patients. If bone abnormalities are suspected, appropriate consultation should be obtained.
  • Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
  • Severe acute exacerbations of HBV infection have been reported in HIV-infected patients following discontinuance of tenofovir. Hepatic function should be closely monitored with clinical and laboratory follow up for at least several months after tenofovir is discontinued in patients with HBV and HIV coinfection. If appropriate, initiation of treatment for HBV infection may be warranted.
  • The clinical activity of tenofovir disoproxil fumarate has not been determined against hepatitis B virus (HBV) in humans. It is unknown whether treatment of patients co-infected with HIV-1 and HBV will result in the development of HBV resistance to tenofovir disoproxil fumarate or other medicinal products.
  • Immune reactivation syndrome: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
  • No clinical data on exposed pregnancies are available for tenofovir disoproxil fumarate. Tenofovir disoproxil fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
    However, given that the potential risks to developing human foetuses are unknown, the use of tenofovir disoproxil fumarate in women of childbearing potential must be accompanied by the use of effective contraception.
  • It is not known whether tenofovir is excreted in human milk. It is recommended that mothers being treated with tenofovir disoproxil fumarate do not breast-feed their infants. As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.
  • No studies on the effects on the ability to drive or use machines have been performed. However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil fumarate.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



Visitors Counter

Online
25
Total