Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - saquinavir mesilate, quantity: 571.5 mg (equivalent: saquinavir, qty 500 mg) - 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 - 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).

United States - English - NLM (National Library of Medicine)

genentech, inc. - saquinavir mesylate (unii: uhb9z3841a) (saquinavir - unii:l3je09kz2f) - saquinavir 200 mg - invirase in combination with ritonavir and other antiretroviral agents is indicated for the treatment of hiv-1 infection in adults (over the age of 16 years). the following points should be considered when initiating therapy with invirase/ritonavir: invirase/ritonavir is contraindicated in patients with congenital long qt syndrome, those with refractory hypokalemia or hypomagnesemia, and in combination with drugs that both increase saquinavir plasma concentrations and prolong the qt interval [see warnings and precautions (5.4) and clinical pharmacology (12.2)] . invirase/ritonavir is contraindicated in patients with complete atrioventricular (av) block without implanted pacemakers, or patients who are at high risk of complete av block [see warnings and precautions (5.3)] . invirase/ritonavir is contraindicated in patients with clinically significant hypersensitivity (e.g., anaphylactic reaction, stevens-johnson syndrome) to saquinavir, saquinavir mesylate, or any of its ingredients. invirase/ ritonavir is con

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - saquinavir mesylate (unii: uhb9z3841a) (saquinavir - unii:l3je09kz2f) - saquinavir mesylate 500 mg - invirase in combination with ritonavir and other antiretroviral agents is indicated for the treatment of hiv infection. the twice daily administration of invirase in combination with ritonavir is supported by safety data from the maxcmin 1 study (see table 6 ) and pharmacokinetic data (see table 1 ). the efficacy of invirase with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care. in a randomized, double-blind clinical study (nv14256) in zidovudine-experienced, hiv-infected patients, invirase in combination with zalcitabine was shown to be superior to either invirase or zalcitabine monotherapy in decreasing the cumulative incidence of clinical disease progression to aids-defining events or death. furthermore, in a randomized study (actg229/nv14255), patients with advanced hiv infection with history of prolonged zidovudine treatment and who were given invirase 600 mg (three times daily) + zidovudine + zalcitabine experienced greater increases i

Bangladesh - English - DGDA (Directorate General of Drug Administration)

beximco pharmaceuticals ltd. - saquinavir - tablet - 500 mg

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - saquinavir - hiv infections - antivirals for systemic use - 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.

Canada - English - Health Canada

hoffmann-la roche limited - saquinavir (saquinavir mesylate) - capsule - 200mg - saquinavir (saquinavir mesylate) 200mg - hiv protease inhibitors

Canada - English - Health Canada

hoffmann-la roche limited - saquinavir (saquinavir mesylate) - tablet - 500mg - saquinavir (saquinavir mesylate) 500mg - hiv protease inhibitors

Canada - English - Health Canada

hoffmann-la roche limited - saquinavir - capsule - 200mg - saquinavir 200mg - hiv protease inhibitors

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - saquinavir mesilate - tablet - 500mg

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - saquinavir mesilate 228.7mg equivalent to 200 mg saquinavir free base - capsule - 200 mg - active: saquinavir mesilate 228.7mg equivalent to 200 mg saquinavir free base excipient: gelatin lactose magnesium stearate microcrystalline cellulose povidone purified talc sodium starch glycolate