Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

teva b.v. - darunavirethanolat - filmovertrukne tabletter - 600 mg

Den Europæiske Union - dansk - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberkulose, multidrugt-resistent - antimyco-bakterielle midler - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 og 5. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Den Europæiske Union - dansk - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv infektioner - antivirale midler til systemisk anvendelse - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or 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 prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista 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 prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

sandoz a/s - darunavir - filmovertrukne tabletter - 800 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - darunavir - filmovertrukne tabletter - 400 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

teva b.v. - darunavir - filmovertrukne tabletter - 800 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

pharmathen s.a. - darunavirpropylenglycolat - filmovertrukne tabletter - 400 mg

Den Europæiske Union - dansk - EMA (European Medicines Agency)

krka, d.d., novo mesto - darunavir - hiv infektioner - antivirale midler til systemisk anvendelse - 400 mg og 800 mg filmovertrukne tabletsdarunavir krka d. , co-administreres med en lav dosis ritonavir er indiceret i kombination med andre antiretrovirale lægemidler til behandling af patienter med human immundefekt virus (hiv-1) infektion. darunavir krka d. , co-administreres med cobicistat er indiceret i kombination med andre antiretrovirale lægemidler til behandling af patienter med human immundefekt virus (hiv-1) infektion hos voksne patienter (se afsnit 4. darunavir krka d. 400 mg og 800 mg tabletter kan anvendes til at tilvejebringe passende dosis regimer til behandling af hiv-1 infektion hos voksne og pædiatriske patienter fra en alder af 3 år, og mindst 40 kg kropsvægt, der er:antiretroviral behandling (art)-naive (se afsnit 4. kunst-erfarne med ingen darunavir modstand associerede mutationer (drv-rams), og som har plasma-hiv-1 rna - < 100.000 kopier/ml og cd4 celletal (≥ 100 x 106 celler/l. i beslutter at indlede behandling med darunavir i en sådan kunst-erfarne patienter, genotypiske test bør vejlede i brugen af darunavir (se afsnit 4. 2, 4. 3, 4. 4 og 5. 600 mg filmovertrukne tabletsdarunavir krka d. , co-administreres med en lav dosis ritonavir er indiceret i kombination med andre antiretrovirale lægemidler til behandling af patienter med human immundefekt virus (hiv-1) infektion. darunavir krka d. 600 mg tabletter kan anvendes til at tilvejebringe passende dosis regimer (se afsnit 4. 2):til behandling af hiv-1 infektion i antiretroviral behandling (art)-erfarne voksne patienter, herunder dem, der har været meget forbehandlet. til behandling af hiv-1 infektion hos pædiatriske patienter fra en alder af 3 år og mindst 15 kg kropsvægt. i beslutter at indlede behandling med darunavir co-administreres med en lav dosis ritonavir, forsigtig, bør det overvejes, om den historie behandling af den enkelte patient og de mønstre af mutationer, der er forbundet med forskellige agenter. genotypiske eller fænotypiske test (når de er tilgængelige) og behandling, historie bør vejlede i brugen af darunavir.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

glenmark arzneimittel gmbh - darunavirpropylenglycolat - filmovertrukne tabletter - 400 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

medical valley invest ab - darunavirpropylenglycolat - filmovertrukne tabletter - 400 mg