Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; Dolutegravir Sodium
CAMBER LABORATORIES SDN. BHD.
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; Dolutegravir Sodium
30 Tablets
Hetero Labs Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ TELDY _ _ Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Film-Coated Tablets 50 mg/300 mg/300 mg Page. 1 WHAT IS IN THIS LEAFLET 1. What TELDY is used for 2. How TELDY works 3. Before you use TELDY 4. How to use TELDY 5. While you are using it 6. Side effects 7. Storage and Disposal of TELDY 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number Read this Patient Information before you start taking TELDY and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. 1. WHAT TELDY IS USED FOR TELDY is a prescription medicine that is used alone as a complete regimen to treat Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescent above 12 years of age weighing 40 kg or or more. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). TELDY contain 3 prescription medicines, dolutegravir, lamivudine and tenofovir disoproxil fumarate. • TELDY is not for use by itself in people who have or have had resistance to dolutegravir, lamivudine, or tenofovir disoproxil fumarate. 2. HOW TELDY WORKS TELDY may reduce the amount of HIV in your blood (called “viral load”). TELDY may also help to increase the number of CD4 (T) cells in your blood which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections). TELDY DO NOT CURE HIV INFECTION OR AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. Avoid doing things that can spread HIV- 1 infection to others. • Do not share or re-use needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, Baca dokumen lengkap
TELDY (Dolutegravir 50mg/Lamivudine 300mg/Tenofovir Disoproxil Fumarate 300mg) Film-Coated Tablets Font: Times New Roman, size 8 WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS AND POST TREATMENT EXACERBATIONS OF HEPATITIS B LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES. DISCONTINUE DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS IF CLINICAL OR LABORATORY FINDINGS SUGGESTIVE OF LACTIC ACIDOSIS OR PRONOUNCED HEPATOTOXICITY OCCUR _[SEE WARNINGS AND PRECAUTIONS _ _(5.1)]_. EXACERBATIONS OF HEPATITIS B: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE COINFECTED WITH HBV AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) AND HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY, INCLUDING LAMIVUDINE OR TENOFOVIR DISOPROXIL FUMARATE. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS AND ARE CO-INFECTED WITH HIV- 1 AND HBV. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED _[SEE WARNINGS AND PRECAUTIONS (5.2)]_. 1 INDICATIONS AND USAGE Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets are indicated for use alone as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing 40 kg or greater. Limitation of Use: • Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets alone are not recommended in patients with resistance associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir in dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets is insufficient in these subpopulations. See the dolutegravir prescribing information. 2 DOSAGE AND ADMINISTR Baca dokumen lengkap