Kraj: Republika Południowej Afryki
Język: angielski
Źródło: South African Health Products Regulatory Authority (SAHPRA)
Novagen Pharma (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg
Renewal -In Progress
2020-07-08
PAGE 1 OF 10 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM DIVTRIDA (film-coated tablet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DIVTRIDA. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - DIVTRIDA HAS been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 1. WHAT DIVTRIDA CONTAINS The active substances are dolutegravir, lamivudine and tenofovir disoproxil fumarate. Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir, lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg which is equivalent to 245 mg of tenofovir disoproxil. The other ingredients of DIVTRIDA ARE colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, opadry II pink 85F94172, povidone, sodium starch glycolate and sodium stearyl fumarate. In addition opadry II pink 85F94172 contains iron oxide red (C.I. No: 77491), oxide black (C.I. No: 77499), polyethylene glycol, talc and titanium dioxide (C.I. No: 77891). Contains sugar: 145,37 mg mannitol. WARNING PAGE 2 OF 10 LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS. DIVTRIDA IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION. THE SAFETY AND EFFICACY OF DIVTRIDA HAS NOT BEEN ESTABLISHED IN PATIENTS CO-INFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE CO- INFECTED WITH HBV AND HIV AND HAVE DISCONTINUED THE COMBINATION TABLET. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE DIVTRIDA AND ARE CO-INFECTED WITH HIV AND HBV. IF APPROP Przeczytaj cały dokument
PAGE 1 OF 40 PROFESSIONAL INFORMATION SCHEDULING STATUS: S4 PROPRIETARY NAME AND DOSAGE FORM: DIVTRIDA (film-coated tablet) COMPOSITION: Each DIVTRIDA contains dolutegravir sodium equivalent to 50 mg of dolutegravir, lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg which is equivalent to 245 mg of tenofovir disoproxil. The other ingredients of DIVTRIDA are colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, opadry II pink 85F94172, povidone, sodium starch glycolate and sodium stearyl fumarate. In addition opadry II pink 85F94172 contains iron oxide red (C.I. No: 77491), oxide black (C.I. No: 77499), polyethylene glycol, talc and titanium dioxide (C.I. No: 77891) Contains sugar: 145,37 mg mannitol. WARNING LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE WARNINGS AND SPECIAL PRECAUTIONS). DIVTRIDA IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION. THE SAFETY AND EFFICACY OF DIVTRIDA HAS NOT BEEN ESTABLISHED IN PATIENTS CO-INFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE CO-INFECTED WITH HBV AND HIV AND HAVE DISCONTINUED THE COMBINATION TABLET. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL PAGE 2 OF 40 MONTHS IN PATIENTS WHO DISCONTINUE DIVTRIDA AND ARE CO-INFECTED WITH HIV AND HBV. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE WARNINGS AND SPECIAL PRECAUTIONS). PHARMACOLOGICAL CLASSIFICATION: A 20.2.8 Antimicrobial (Chemotherapeutic) Medicines. Antiviral Medicines. PHARMACOLOGICAL ACTION: PHARMACODYNAMIC PROPERTIES: LAMIVUDINE Lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), is a selective inhibitor of HIV-1 and HIV-2 replication _in vitro. _ Lamivudine is metabolised intracellularly to the activ Przeczytaj cały dokument