Pajjiż: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Lopinavir 100mg; Ritonavir 25mg ((pharmacokinetic enhancer))
AbbVie Limited
Lopinavir 100 mg
100mg/25mg
Film coated tablet
Active: Lopinavir 100mg Ritonavir 25mg ((pharmacokinetic enhancer)) Excipient: Colloidal silicon dioxide Copovidone Opadry yellow 85F32450 Sodium stearyl fumarate Sorbitan laurate
Bottle, HDPE with polypropylene cap, 60 tablets
Prescription
Prescription
AbbVie S.r.l
Kaletra 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: Bottle, HDPE with polypropylene cap - 60 tablets - 3 years from date of manufacture stored at or below 30°C
2007-05-17
KALETRA Version 23 KALETRA _TABLETS AND ORAL SOLUTION _ _lopinavir and ritonavir _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Kaletra. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Kaletra against the benefits they expect it will have on 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 KALETRA IS USED FOR Kaletra is used to control Human Immunodeficiency Virus (HIV) infection in adults and children 2 years of age and older. Kaletra does this by slowing down the spread of the infection in your body. Kaletra is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors. Kaletra is prescribed for use in combination with other antiviral medicines. Your doctor will determine which medicines are best for you. Kaletra is available only with a doctor's prescription. Kaletra is not addictive. BEFORE YOU TAKE KALETRA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE KALETRA IF YOU HAVE AN ALLERGY TO: − any medicine containing lopinavir or ritonavir; − any of the ingredients listed at the end of this leaflet. Some 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; ˗ hives, rash or itching of the skin. DO NOT TAKE KALETRA IF YOU HAVE SEVERE LIVER PROBLEMS. DO NOT TAKE KALETRA IF YOU ARE PREGNANT. If may affect your developing baby if you take it during pregnancy. DO NOT BREASTFEED IF YOU ARE TAKING THIS MEDICINE. The active ingredient in Kaletra passes into breast milk and there is a possibility your baby may be affected. DO NOT GIVE KALETRA TO A CHILD UNDER THE AGE OF 2 YEARS. DO NOT TAKE KALETRA WITH ANY OF THE FOLLOWING MEDICINES: − alfuz Aqra d-dokument sħiħ
Kaletra Tablets and Oral Solution Version 30 6 May 2020 Page 1 of 57 NEW ZEALAND DATA SHEET 1. PRODUCT NAME KALETRA 100 mg/25 mg film-coated tablets KALETRA 200 mg/50 mg film-coated tablets KALETRA 80 mg/20 mg per mL oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FILM-COATED TABLETS Kaletra 100/25 mg: Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer. Kaletra 200/50 mg: Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer. ORAL SOLUTION Kaletra 80/20 mg: Each 1 mL of oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer. EXCIPIENTS WITH KNOWN EFFECT Kaletra oral solution contains alcohol (42.4% v/v), high fructose maize syrup, propylene glycol (15.3% w/v) (see section 4.3), Castor oil – PEG 40 hydrogenated and acesulfame potassium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM FILM-COATED TABLETS Kaletra 100/25 mg film-coated tablets are pale yellow, debossed with the Abbott logo and ‘KC’. Kaletra 200/50 mg tablets are yellow, ovaloid, film-coated tablets debossed with the Abbott logo and ‘KA’. ORAL SOLUTION Kaletra oral solution is a light yellow to golden coloured liquid, supplied in 60 mL amber-coloured multiple- dose bottle containing 400 mg lopinavir and 100 mg ritonavir per 5 mL marked dosing syringe, equivalent to 80 mg lopinavir and 20 mg ritonavir per 1 mL of oral solution. Kaletra Tablets and Oral Solution Version 30 6 May 2020 Page 2 of 57 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kaletra is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. This indication is based on analyses of plasma HIV RNA levels and CD4 cell counts from controlled clinical studies (see section 5.1 - Clinical Efficacy and Safety Results). 4.2 DOSE AND METHOD OF ADMINISTRATION FIL Aqra d-dokument sħiħ