Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
saquinavir
Roche Registration GmbH
J05AE01
saquinavir
Antivirals for systemic use
HIV Infections
Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.
Revision: 50
Withdrawn
1996-10-03
43 B. PACKAGE LEAFLET Medicinal product no longer authorised 44 PACKAGE LEAFLET: INFORMATION FOR THE USER INVIRASE 500 MG FILM-COATED TABLETS SAQUINAVIR READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Invirase is and what it is used for 2. What you need to know before you take Invirase 3. How to take Invirase 4. Possible side effects 5. How to store Invirase 6. Contents of the pack and other information 1. WHAT INVIRASE IS AND WHAT IT IS USED FOR Invirase contains the active substance saquinavir which is an antiviral agent. It is a member of a class of medicines called protease inhibitors. It is for the treatment of infection with the human immunodeficiency virus (HIV). Invirase is used by HIV-1-infected adults. Invirase is prescribed for use in combination with ritonavir (Norvir) and other antiretroviral medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INVIRASE DO NOT TAKE INVIRASE IF YOU HAVE: • an allergy to saquinavir, ritonavir or any of the other ingredients (see “Invirase contains lactose” later in this section and “What Invirase contains” in Section 6) • any heart problems that show on an electrocardiogram (ECG, electrical recording of the heart) - you may have been born with that • a very slow heart rate (bradycardia) • a weak heart (heart failure) • a history of an irregular heart beat (arrhythmias) • a salt imbalance in your blood, especially low blood concentrations of potassium (hypokalaemia), which is not currently controlled by treatment • severe Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT INVIRASE 500 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate. Excipient with known effect: Lactose monohydrate: 38.5 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light orange to greyish or brownish orange film-coated tablet of oval cylindrical biconvex shape with the marking "SQV 500" on the one side and "ROCHE" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Invirase is indicated for the treatment of HIV-1 infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Therapy with Invirase should be initiated by a physician experienced in the management of HIV infection. _In combination with ritonavir _ The recommended dose of Invirase is 1000 mg (2 x 500 mg film-coated tablets) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents. For treatment-naive patients initiating treatment with Invirase/ritonavir, the starting recommended dose of Invirase is 500 mg (1 x 500 mg film-coated tablet) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents for the first 7 days of treatment. After 7 days, the recommended dose of Invirase is 1000 mg two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents. Patients switching immediately from treatment with another protease inhibitor taken with ritonavir or from a non-nucleoside reverse transcriptase inhibitor based regimen, except rilpivirine (see section 4.5), without a wash-out period, should however initiate and continue Invirase at the standard recommended dose of 1000 mg two times daily with ritonavir 100 mg two t Pročitajte cijeli dokument