欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tipranaviir - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - aptivus, co-manustatakse koos väikeses annuses ritonaviiri, mis on näidustatud kombineeritud retroviirusevastast ravi hiv-1 nakkus väga pretreated täiskasvanud ja noorukid, 12-aastased või vanemad viiruse resistentseks mitme proteaasi inhibiitorid. aptivus tuleks kasutada üksnes ühe osana aktiivne kombineeritud retroviirusevastase raviskeemi patsientidel, kellel puuduvad muud ravivõimalused. see märge on tulemuste põhjal kahte etapp-iii uuringuid, mis viiakse läbi väga pretreated täiskasvanud patsientidel (keskmine arv 12 eelnevat retroviirusevastast ained) viiruse resistentsed proteaasi inhibiitorid ja üks faas-ii uuring uurimise farmakokineetika, ohutuse ja tõhususe aptivus valdavalt ravi-kogenud noorukieas patsientidele vanuses 12 kuni 18 aastat. otsustades ravi alustada aptivus, co-manustatakse koos väikeses annuses ritonaviiri, tuleks hoolikalt kaaluda ravi ajalugu konkreetse patsiendi ja mustreid mutatsioonid on seotud erinevate mõjurite. genotypic või fenotüübiline testimine (kui on saadaval) ja ravi ajalugu peaks juhend kasutada aptivus. algatamise ravi tuleks arvesse võtta mutatsioonide kombinatsioone, mis võivad negatiivselt viroloogiline vastus, et aptivus, co-manustatakse koos väikeses annuses ritonaviiri.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - atasanavir mylan koos ritonaviiri väikeste annustega on näidustatud hiv-1 nakkusega täiskasvanute ja 6-aastaste ja vanemate laste raviks kombinatsioonis teiste retroviirusevastaste ravimitega. põhjal kättesaadavad viroloogiliste ja kliiniliste andmete täiskasvanud patsientidel, mingit kasu on oodatud patsiendid, kellel on resistentsed tüved, et mitme proteaasi inhibiitorid (≥ 4 pi mutatsioonid). laste vanuses 6 kuni alla 18 aasta andmed on väga piiratud. valik atazanavir mylan kohtlemist kogenud täiskasvanud ja pediaatriliste patsientide peaks põhinema individuaalsel viiruse resistentsuse testimise ja patsiendi ravi ajalugu.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

merck sharp & dohme b.v. - indinavir sulfate ethanolate - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - hiv-1 nakatunud täiskasvanute raviks on crixivan näidustatud kombinatsioonis retroviirusevastaste nukleosiidi analoogidega.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunaviiri - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - darunavir, 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 (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):ravi hiv-1 nakkuse retroviirusevastast ravi (art)-kogenud täiskasvanud patsientidele, sealhulgas neid, mis on väga eeltöödeldud. ravi hiv-1 nakkuse pediaatrilised patsiendid alates vanusest 3 aastat ja vähemalt 15 kg kehakaalu kohta. otsustades ravi alustada darunavir co-manustatakse koos väikeses annuses ritonaviiri, tuleks hoolikalt kaaluda ravi ajalugu konkreetse patsiendi ja mustreid mutatsioonid on seotud erinevate mõjurite. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 ja 5. darunavir co-manustatakse koos väikeses annuses ritonaviir on näidustatud kombinatsioonis teiste viirusevastase ravimitega ravi patsientidel, kellel on inimese immuunpuudulikkuse viiruse (hiv-1) nakkus.  darunavir 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) (see section 4.  darunavir mylan 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 (see section 4.  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. otsustades ravi alustada darunavir sellisel kunsti-kogenud patsientidel, genotypic katsetamine peaks juhendi kasutamine darunavir (vt lõigud 4. 2, 4. 3, 4. 4 ja 5.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 ja 5.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonasool - cushingi sündroom - antimükoosid süsteemseks kasutamiseks - ketoconazole hra on näidustatud täiskasvanutel ja noorukitel alates 12 aasta vanusest endogeense cushingi sündroomiga.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

aziende chimiche riunite angelini francesco s.p.a. - lurasidoon - skisofreenia - psühhoeptikumid - skisofreenia ravi 18-aastastel ja vanematel täiskasvanutel.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

astrazeneca ab - olaparib - munasarjade kasvajad - antineoplastilised ained - munasarja cancerlynparza on näidustatud monotherapy eest:hooldus ravi täiskasvanud patsientidel, kellel on arenenud (figo etapid iii ja iv) brca1/2-muteerunud (germline ja/või somaatilise) kõrge-klassi epiteeli munasarja -, munajuha-või esmase peritoneaaldialüüsi vähi, kes on vastuseks (täielik või osaline) pärast lõpetamist esimese-line platinum põhineva keemiaravi. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 ja 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. patsientidel peaks olema varem ravitud mõne anthracycline ja taxane aastal (neo)abiaine või metastaatilise seade välja arvatud juhul, kui patsientidele ei sobi nende ravi (vt lõik 5. patsiendid, kellel on hormooni retseptori (hr)-positiivse rinnavähi peaks ka jõudnud või pärast eelneva endokriinse ravi, või pidada sobi endokriinse ravi. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviiri - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - 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.

欧盟 - 爱沙尼亚文 - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv-nakkused - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta on näidustatud koos teiste retroviirusevastaste ravimitega inimese immuunpuudulikkuse viiruse 1 (hiv 1) nakkuse raviks 18-aastastel ja vanematel täiskasvanutel. genotypic katsetamine peaks juhendi kasutamine rezolsta.