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

boehringer ingelheim pharmaceuticals, inc. - tipranavir (unii: zzt404xd09) (tipranavir - unii:zzt404xd09) - tipranavir 250 mg - aptivus, co-administered with ritonavir, is indicated for combination antiretroviral treatment of hiv-1 infected patients who are treatment-experienced and infected with hiv-1 strains resistant to more than one protease inhibitor (pi). this indication is based on analyses of plasma hiv-1 rna levels in two controlled studies of aptivus/ritonavir of 48 weeks duration in treatment-experienced adults and one open-label 48-week study in pediatric patients age 2 to 18 years. the adult studies were conducted in clinically advanced, 3-class antiretroviral (nrti, nnrti, pi) treatment-experienced adults with evidence of hiv-1 replication despite ongoing antiretroviral therapy. the following points should be considered when initiating therapy with aptivus/ritonavir: - the use of aptivus/ritonavir in treatment-naïve patients is not recommended [see warnings and precautions (5.1) ]. - the use of other active agents with aptivus/ritonavir is associated with a greater likelihood of treatment response [see microbiology (12.

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

boehringer ingelheim pty ltd - tipranavir -

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tipranavir - hiv infections - antivirals for systemic use - aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of hiv-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.this indication is based on the results of two phase-iii studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-ii study investigating pharmacokinetics, safety and efficacy of aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.in deciding to initiate treatment with aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of aptivus. initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to aptivus, co-administered with low-dose ritonavir.

Canada - English - Health Canada

boehringer ingelheim (canada) ltd ltee - tipranavir - capsule - 250mg - tipranavir 250mg - hiv protease inhibitors

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

boehringer ingelheim ltd - tipranavir - capsule - 250mg

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

boehringer ingelheim ltd - tipranavir - oral solution - 100mg/1ml

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

boehringer ingelheim pty ltd - tipranavir -

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

boehringer ingelheim pty ltd - tipranavir -

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - tipranavir 250mg - soft gelatin capsule - 250 mg - active: tipranavir 250mg excipient: decanoic acid ethanol gelatin iron oxide red macrogol glycerol ricinoleate propyl gallate propylene glycol   purified water sorbitol titanium dioxide trometamol

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxo wellcome s.a. - dolutegravir (dolutegravir sodium), abacavir (abacavir sulfate), lamivudine - tablets film-coated - 50mg+ 600mg+ 300mg