Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Telbivudine 600mg;
Novartis New Zealand Ltd
Telbivudine 600 mg
600 mg
Film coated tablet
Active: Telbivudine 600mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 4000 Magnesium stearate Microcrystalline cellulose Povidone Purified talc Sodium starch glycolate Titanium dioxide
Blister pack, PVC/Al x 28 tablets, 28 tablets
Prescription
Prescription
Novartis Pharma Stein AG
Sebivo® is indicated for the treatment of chronic hepatitis B in patients with evidence of viral replication and active liver inflammation. This indication is based on virological, serological, biochemical and histological responses in adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B. The following points should be considered when initiating therapy with Sebivo: 1. For HBeAg-positive patients, Sebivo treatment should only be initiated in patients with baseline HBV DNA 2 x ULN. 2. For HBeAg-negative patients, Sebivo treatment should only be initiated in patients with baseline HBV DNA < 7 log 10 copies/mL
Package - Contents - Shelf Life: Blister pack, PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C
2006-02-20
SEBIVO ® 1 SEBIVO ® _Telbivudine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sebivo. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. Some more recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SEBIVO IS USED FOR Sebivo belongs to a group of medicines called antivirals. Sebivo is used to treat chronic hepatitis B in patients. Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage. Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its multiplication, resulting in less liver damage and improvement in liver function. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is only available with a doctor's prescription. It is not addictive. Sebivo does not reduce the risk of infecting others with hepatitis B virus (HBV) through sexual contact or exposure to contaminated blood or other body fluids. You should use appropriate precautions. BEFORE YOU TAKE SEBIVO _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SEBIVO IF: YOU ARE ALLERGIC (HYPERSENSITIVE) TO TELBIVUDINE (ACTIVE INGREDIENT) OR TO ANY OF THE O Preberite celoten dokument
NEW ZEALAND DATA SHEET New Zealand Data Sheet Template v 1.0 January 2017 Page 1 of 22 1 PRODUCT NAME SEBIVO ® (TELBIVUDINE) 600 mg Film-Coated Tablets 20 mg/mL Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Telbivudine Each film-coated tablet contains 600 mg telbivudine. Each mL of oral solution contains 20 mg telbivudine. 3 PHARMACEUTICAL FORM FILM-COATED TABLET White to slightly yellowish, ovaloid, slightly curved film-coated tablet with beveled edges, imprinted with “LDT” on one side. ORAL SOLUTION Clear, colourless to pale yellow, liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sebivo ® is indicated for the treatment of chronic hepatitis B in patients with evidence of viral replication and active liver inflammation. This indication is based on virological, serological, biochemical and histological responses in adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B. The following points should be considered when initiating therapy with Sebivo: • For HBeAg-positive patients, Sebivo treatment should only be initiated in patients with baseline HBV DNA < 9 log 10 copies/mL and baseline ALT ≥ 2x ULN. • For HBeAg-negative patients, Sebivo treatment should only be initiated in patients with baseline HBV DNA < 7 log 10 copies/mL. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The recommended dose of Sebivo for the treatment of chronic hepatitis B is 600 mg once daily. Sebivo oral solution may be considered for patients who have difficulties in swallowing tablets. Due to risk of higher rates of resistance that may develop with longer term treatment among patients with incomplete viral suppression, treatment should only be initiated after baseline HBV DNA criteria are met (see section 4.1 Therapeutic indications). NEW ZEALAND DATA SHEET New Zealand Data Sheet Template v 1.0 January 2017 Page 2 of 22 MONITORING AND DURATION OF TREATMENT On-treatment response at week 24 has been shown to be predictive of longer-term response (see Pharmacodynamic properties). HBV DNA level Preberite celoten dokument