Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Lopinavir 100mg; Ritonavir 25mg;
Viatris Limited
Lopinavir 100 mg
100mg/25mg
Film coated tablet
Active: Lopinavir 100mg Ritonavir 25mg Excipient: Colloidal silicon dioxide Copovidone Opadry white 20C580015 Sodium stearyl fumarate Sorbitan laurate
Prescription
Mylan Laboratories Limited
Lopinavir/Ritonavir Mylan is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.
Package - Contents - Shelf Life: Blister pack, Cold form blister OPA/Al/PVC with hard tempered Aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Cold form blister OPA/Al/PVC with hard tempered Aluminium foil - 120 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE bottle with PP screw cap and aluminium induction sealing liner wad - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE bottle with PP screw cap and aluminium induction sealing liner wad - 120 tablets - 36 months from date of manufacture stored at or below 25°C
2015-01-08
Page 1 of 5 INEW ZEALAND CONSUMER MEDICINE INFORMATION LOPINAVIR/RITONAVIR MYLAN _LOPINAVIR/RITONAVIR FILM COATED TABLET 100/25MG, 200/50MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Lopinavir/Ritonavir Mylan. This leaflet answers some common questions about Lopinavir/Ritonavir Mylan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Lopinavir/Ritonavir Mylan against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LOPINAVIR/RITONAVIR MYLAN IS USED FOR Lopinavir/Ritonavir Mylan is used to treat HIV-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older Lopinavir/Ritonavir Mylan contains the active ingredients lopinavir and ritonavir. It belongs to a group of medicines called protease inhibitors. It works by producing an immature, non-infectious virus and slows down the spread of the infection in your body. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE LOPINAVIR/RITONAVIR MYLAN _WHEN YOU MUST NOT TAKE_ _IT_ DO NOT TAKE LOPINAVIR/RITONAVIR MYLAN IF YOU HAVE AN ALLERGY TO: any medicine containing lopinavir or ritonavir. any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE LOPINAVIR/RITONAVIR MYLAN IF YOU HAVE SEVERE LIVER PROBLEMS. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT. It may aff read_full_document
NEW ZEALAND DATA SHEET LOPINAVIR/RITONAVIR MYLAN 1. PRODUCT NAME Lopinavir/Ritonavir Mylan, 100mg/25mg & 200mg/50mg, film coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 100mg/25mg or 200mg/50mg of lopinavir/ritonavir. 3. PHARMACEUTICAL FORM 100 mg/25 mg: White, film coated, ovaloid, biconvex bevelled edge tablet debossed with ‘MLR4’ on one side of the tablet and plain on the other side. 200 mg/50 mg: White, film coated, ovaloid, biconvex bevelled edge tablet debossed with ‘MLR3’ on one side of the tablet and plain on the other side. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ Lopinavir/Ritonavir Mylan is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ DOSE ADULTS The recommended dosage of Lopinavir/Ritonavir Mylan tablets is 400/100 mg (two 200/50 mg tablets) twice daily. Lopinavir/Ritonavir Mylan tablets may also be administered as 800/200 mg (four 200/50 mg tablets) once daily, in patients with less than three lopinavir-associated mutations. There are insufficient data to support the use of once daily administration of Lopinavir/Ritonavir Mylan for adult patients with three or more lopinavir-associated mutations (see section 5.1). _CONCOMITANT THERAPY: EFAVIRENZ, NEVIRAPINE, AMPRENAVIR OR NELFINAVIR _ A dose increase of lopinavir/ritonavir to 500/125 mg twice daily (such as two 200/50 mg tablets and one 100/25 mg tablet) should be considered when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir in treatment experienced patients where reduced susceptibility to lopinavir is clinically suspected (by treatment history or laboratory evidence) (see section 4.5). PAEDIATRIC PATIENTS The adult dose of Lopinavir/Ritonavir Mylan tablets (400/100 mg twice daily) may be used in children 35 kg or greater. For children weighing less than 35 kg and ABLE TO SWALLOW TABLETS, refer to the dosing guideli read_full_document