Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
saquinavir mesilate, Quantity: 571.5 mg (Equivalent: saquinavir, Qty 500 mg)
Roche Products Pty Ltd
saquinavir mesilate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; povidone; triacetin; croscarmellose sodium; titanium dioxide; hypromellose; purified talc; iron oxide red; lactose monohydrate; iron oxide yellow; magnesium stearate
Oral
120 film coated tablets in white HDPE bottle with plastic screw cap
(S4) Prescription Only Medicine
INVIRASE (saquinavir) is indicated for the treatment of HIV/AIDS in adults and children 12 years of age or older. Clinical studies indicate that saquinavir should only be used in combination with ritonavir and other anti-retroviral therapies (see CLINICAL TRIALS). This indication is based on changes in surrogate markers. At present there are no results from controlled clinical trials evaluating the effect of regimens containing saquinavir on HIV disease progression or survival (see CLINICAL TRIALS).
Visual Identification: Light orange to greyish-brown orange, oval, cylindrical, biconvex flim-coated tablet, with 'SQV 500' on one side and 'Roche' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2006-07-07
INVIRASE ® pronounced "In-vir-ase" _contains the active ingredient saquinavir_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Invirase tablets. 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 Invirase 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 INVIRASE IS USED FOR Invirase belongs to a group of medicines called anti-HIV drugs. Within this group, Invirase belongs to a class of drugs called HIV protease inhibitors. Invirase is used for the treatment of HIV (Human Immunodeficiency Virus). It works by interfering with the viral reproductive cycle. Invirase must be used only in combination with ritonavir (Norvir ® ) and other medicines to treat the HIV virus. Please note that you should always report any changes in your condition to your doctor to ensure that any infections which occur due to your low immunity (called opportunistic infections) are treated promptly. Your doctor may have prescribed Invirase for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY INVIRASE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Invirase is not a cure for HIV infection and you may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections. Invirase does not reduce the risk of transmitting HIV to others through sexual contact or contamination through blood. BEFORE YOU TAKE INVIRASE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE INVIRASE IF: 1. YOU HAVE ALLERGIES TO SAQUINAVIR OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET 2. YOU HAVE SEVERE LIVER DISEASE 3. IF YOU WERE BORN WITH OR HAVE: • any condition with abnormal electrocardiograms (ECG- electrical re Aqra d-dokument sħiħ
AUSTRALIAN PRODUCT INFORMATION INVIRASE ® (SAQUINAVIR MESILATE) Invirase 180906 1 1. NAME OF THE MEDICINE Saquinavir mesilate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Invirase film-coated tablets contain 571.5 mg of saquinavir mesilate equivalent to 500 mg saquinavir free base. Excipients with known effect Lactose monohydrate For the full list of excipients, see section 6.1. Note: Saquinavir soft gel capsules (Fortovase) are no longer marketed in Australia. 3. PHARMACEUTICAL FORM Invirase 500 mg film-coated tablets are light orange to brownish orange, oval, cylindrical and biconvex. The tablets are marked “SQV 500” on one side and “ROCHE” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Invirase (saquinavir) is indicated for the treatment of HIV/AIDS in adults. Saquinavir must be used only in combination with ritonavir and other antiretroviral therapies (see section 5.1). This indication is based on changes in surrogate markers. At present there are no results from controlled clinical trials evaluating the effect of regimens containing saquinavir on HIV disease progression or survival (see section 5.1). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Invirase must be given in combination with ritonavir (ritonavir-boosted Invirase). Please also see the complete product information for ritonavir. The recommended dose of Invirase is 1000 mg twice daily (2000 mg total daily dose) with ritonavir 100 mg twice daily in combination with other antiretroviral agents. For treatment-naïve patients initiating treatment with Invirase, the recommended starting dose of Invirase is 500 mg twice daily with ritonavir 100 mg twice daily for the first 7 days of treatment. After 7 days, the recommended dose of Invirase is 1000 mg twice daily with ritonavir 100 mg twice daily. Patients switching immediately from treatment with another protease inhibitor (PI) taken with ritonavir or from a non-nucleoside reverse transcriptase inhibitor (NNRTI) based regimen, Invirase 180906 2 except rilpivirine (see section Aqra d-dokument sħiħ