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

boehringer ingelheim pharmaceuticals inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 50 mg in 5 ml - viramune is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, viramune is not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)] . viramune is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] . - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that mon

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

state of florida doh central pharmacy - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - viramune is indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection. this indication is based on one principal clinical trial (bi 1090) that demonstrated prolonged suppression of hiv-1 rna and two smaller supportive studies, one of which (bi 1046) is described below. additional important information regarding the use of viramune for the treatment of hiv-1 infection: - based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, viramune should not be initiated in adult females with cd4+ cell counts greater than 250 cells/mm3 or in adult males with cd4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see boxed warning and warnings and precautions (5.1) ]. - the 14-day lead-in period with viramune 200 mg daily dosing has been demonstrated to reduce the frequency of rash [see dosage and administration (2.4) and warnings and precautions (5.2) ]. - if rash persists beyond the 14-d

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nevirapine - hiv infections - antivirals for systemic use - tablets and oral suspensionviramune is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1-infected adults, adolescents, and children of any age.most of the experience with viramune is in combination with nucleoside reverse-transcriptase inhibitors (nrtis). the choice of a subsequent therapy after viramune should be based on clinical experience and resistance testing.50- and 100-mg prolonged-release tabletsviramune is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1-infected adolescents and children three years and above and able to swallow tablets.prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.most of the experience with viramune is in combination with nucleoside reverse-transcriptase inhibitors (nrtis). the choice of a subsequent therapy after viramune should be based on clinical experience and resistance testing.400-mg prolonged-release tabletsviramune is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1-infected adults, adolescents and children three years and above and able to swallow tablets.prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.most of the experience with viramune is in combination with nucleoside reverse-transcriptase inhibitors (nrtis). the choice of a subsequent therapy after viramune should be based on clinical experience and resistance testing.

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

physicians total care, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 400 mg - viramune xr is indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and in children 6 to less than 18 years of age [see clinical studies (14.1, 14.2) ]. additional important information regarding the use of viramune xr for the treatment of hiv-1 infection: - based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with cd4+ cell counts greater than 250 cells/mm3 or in adult males with cd4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see boxed warning and warnings and precautions (5.1) ]. - the 14-day lead-in period with immediate-release viramune dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see dosage and administration (2.5) and warnings and precautions (5.2) ]. - if rash persists beyond the 14-day lead-in period with immediate-release viramune, do not begin dosing with

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

boehringer ingelheim pty ltd - nevirapine, quantity: 400 mg - tablet, modified release - excipient ingredients: lactose monohydrate; hypromellose; iron oxide yellow; magnesium stearate - viramune (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of 2 months. viramune xr (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of three years. extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. resistant virus emerges rapidly when viramune is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, viramune should always be administered in combination with at least two additional antiretroviral agents.

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

boehringer ingelheim pty ltd - nevirapine hemihydrate, quantity: 10.35 mg/ml (equivalent: nevirapine, qty 10 mg/ml) - oral liquid, suspension - excipient ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); propyl hydroxybenzoate; sodium hydroxide; carbomer 934p; polysorbate 80; sucrose; methyl hydroxybenzoate - viramune (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of 2 months. viramune xr (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of three years. extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. resistant virus emerges rapidly when viramune is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, viramune should always be administered in combination with at least two additional antiretroviral agents.

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

boehringer ingelheim pharmaceuticals, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 400 mg - viramune xr is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (bsa) of 1.17 m2 or greater [see clinical studies (14.1, 14.2)] . limitations of use: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. viramune xr is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] . - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register pat

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

boehringer ingelheim pty ltd - nevirapine -

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - nevirapine hemihydrate 10.35 mg/ml equivalent 10 mg/ml nevirapine;   - oral suspension - 10 mg/ml - active: nevirapine hemihydrate 10.35 mg/ml equivalent 10 mg/ml nevirapine   excipient: carbomer methyl hydroxybenzoate polysorbate 80 propyl hydroxybenzoate purified water sodium hydroxide sorbitol as 231.3 mg/ml sorbitol 70% solution sucrose - viramune is indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and children over the age of 2 months.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - nevirapine 200mg - tablet - 200 mg - active: nevirapine 200mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate microcrystalline cellulose povidone purified water sodium starch glycolate - viramune is indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and children over the age of 2 months.