natgillin/translations-raw huggingface dataset:
amphetamine or amphetamine derivatives; antibiotics (e.g. erythromycin, clarithromycin); anticancer treatments (e.g. abemaciclib, afatinib, ceritinib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine); anticoagulants (e.g. rivaroxaban, vorapaxar, warfarin); antidepressants (e.g. amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone); antifungals (e.g. ketoconazole, itraconazole); antihistamines (e.g. loratadine, fexofenadine); antiretroviral medicines including HIV-protease inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir) non-nucleoside reverse transcriptase inhibitors (NNRTI) (delavirdine, efavirenz, nevirapine), and others (didanosine, maraviroc, raltegravir, zidovudine); anti-tuberculosis medicine (bedaquiline and delamanid); antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir and simeprevir); anxiety medicine, buspirone; asthma medicine, theophylline, salmeterol; atovaquone, a medicine used to treat a certain type of pneumonia and malaria; buprenorphine, a medicine used for the treatment of chronic pain; bupropion, a medicine used to help you stop smoking; epilepsy medicines (e.g. carbamazepine, divalproex, lamotrigine, phenytoin); heart medicines (e.g. disopyramide, mexiletine and calcium channel antagonists such as amlodipine, diltiazem and nifedipine); immune system (e.g. cyclosporine, tacrolimus, everolimus); levothyroxine (used to treat thyroid problems)
glecaprevir/pibrentasvir i simeprevir); - lijek za tjeskobu, buspiron; - lijekove za astmu, teofilin, salmeterol; - atovakon, lijek koji se koristi za liječenje određenih vrsta upale pluća i malarije; - buprenorfin, koji se koristi za liječenje kronične boli; - bupropion, koji se koristi za odvikavanje od pušenja; - lijekove za epilepsiju (npr. karbamazepin, divalproeks, lamotrigin, fenitoin); - lijekove za srce (npr. dizopiramid, meksiletin i antagonisti kalcijevih kanala, poput amlodipina,
Hepatic transaminase elevations exceeding five times the upper limit or normal, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir alone or in combination with other antiretrovirals.
U bolesnika koji su uzimali ritonavir sam ili u kombinaciji s drugim antiretroviroticima, zabilježena su povišenja vrijednosti jetrenih transaminaza više nego peterostruko od gornje granice normale, hepatitis i žutica.
Serum concentrations may be increased due to CYP3A4 inhibition by ritonavir.
Serumske se koncentracije mogu povećati zbog inhibicijskog učinka ritonavira na CYP3A4.
↑ 2 fold
Gospina trava
Desipramine
Apsorpcija
Pharyngitis, oropharyngeal pain, cough
Vrlo često Faringitis, orofaringalna bol, kašalj
600 q12 h Delavirdine1
400 svakih 8 h 600 svakih 12 h Delavirdin
HMG Co-A reductase inhibitors
Lijekovi koji modificiraju lipide Inhibitori HMG Co-A reduktaze
Due to CYP3A inhibition by ritonavir, concentrations of lurasidone are expected to increase.
Zbog inhibicije CYP3A ritonavirom, očekuje se povećanje koncentracija lurasidona.
A history of liver disease.
- Preboljelu bolest jetre.
4.4 Special warnings and precautions for use Ritonavir is not a cure for HIV-1 infection or AIDS.
Ritonavir nije lijek za izlječenje infekcije virusom HIV-1 ni AIDS-a.
↑ 11 fold
↑ 13 puta
Ritonavir increases the serum levels of tipranavir as a result of CYP3A inhibition.
Ritonavir povisuje serumske razine tipranavira zbog inhibicije CYP3A.
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
CART, combination antiretroviral therapy) javiti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with ritonavir.
Preporučuje se pažljivo praćenje terapijskih učinaka i mogućih nuspojava kada se fentanil daje istodobno s ritonavirom.
Thereby, increasing the risk of serious arrhythmias from these agents.
Time se povećava rizik od ozbiljnih aritmija izazvanih tim lijekovima.
Important information regarding medicinal product interactions when ritonavir is used a pharmacokinetic enhancer is also contained in the Summary of Product Characteristics of the co-administered protease inhibitor.
Važne informacije o interakcijama s drugim lijekovima kada se ritonavir daje kao farmakokinetički pojačivač nalaze se i u Sažetku opisa svojstava lijeka za određeni inhibitor proteaza u kombinaciji s kojim se ritonavir daje.
Ritonavir increases the serum levels of darunavir as a result of CYP3A inhibition.
Ritonavir povisuje serumske razine darunavira zbog inhibicije CYP3A.
600 q12 h 2 h later
200 svakih 12 h 600 svakih 12 h 2 h kasnije
Ritonavir co-administration is likely to result in increased plasma concentrations of clozapine or pimozide and is therefore contraindicated (see section 4.3).
Istodobno primijenjeni ritonavir vjerojatno povećava koncentracije klozapina ili pimozida u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
Due to CYP3A inhibition by ritonavir, concentrations of ranolazine are expected to increase.
Zbog inhibicije CYP3A ritonavirom očekuje se povećanje koncentracija ranolazina.
In a healthy volunteer drug interaction study of delamanid 100 mg twice daily and lopinavir/ritonavir 400/100 mg twice daily for 14 days, the
U ispitivanju interakcija delamanida u dozi od 100 mg dva puta na dan i lopinavira/ritonavira u dozi od 400/100 mg dva puta na dan tijekom 14 dana kod zdravih dobrovoljaca, izloženost metabolitu delamanida DM-6705 je bila povišena za 30%.
Ritonavir may modify P-glycoprotein mediated fexofenadine efflux when dosed as an antiretroviral agent or as a pharmacokinetic enhancer resulting in increased concentrations of fexofenadine.
Ritonavir doziran kao antiretrovirusni lijek ili kao farmakokinetički pojačivač može modificirati istjecanje feksofenadina posredovan P-glikoproteinom, zbog čega će se povećati koncentracije feksofenadina.
Also read the list of medicines under ‘Other medicines and Ritonavir Mylan' for use with certain other medicines which require special care.
Za informacije o uzimanju određenih drugih lijekova zbog kojih je nužan poseban oprez, molimo pogledajte i popis lijekova u dijelu „Drugi lijekovi i Ritonavir Mylan”.
Ritonavir co-administration is likely to result in increased plasma concentrations of alfuzosin and is therefore contraindicated (see section 4.3).
Istodobno primijenjeni ritonavir vjerojatno bi povećao plazmatske koncentracije alfuzosina te je stoga kontraindiciran (vidjeti dio 4.3).
Ritonavir dosed as an antiretroviral agent is likely to inhibit CYP2D6 and as a result is expected to increase concentrations of haloperidol, risperidone and thioridazine.
Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek vjerojatno inhibira CYP2D6, zbog čega se očekuje povećanje koncentracije haloperidola, risperidona i tioridazina.
100 q12 h 500 q12 h
500 svakih 12 h 200 svakih 12 h Tipranavir
Due to CYP3A inhibition by ritonavir, concentrations of quetiapine are expected to increase.
Zbog inhibicije CYP3A ritonavirom, očekuje se povećanje koncentracija kvetiapina.
For further information, refer to the Summary of Product Characteristics for darunavir.
Daljnje informacije liječnik treba potražiti u Sažetku opisa svojstava lijeka za darunavir.
300 q24 h
300 svakih 24 h 100 svakih 24h Atazanavir
Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200 mg once daily could be considered.
Povećanje doze ritonavira na 200 mg jedanput na dan može se razmotriti samo ako se uz atazanavir i ritonavir istodobno daje i efavirenz.
Ritonavir co-administration is likely to result in increased plasma concentrations of both fusidic acid and ritonavir and is therefore contraindicated (see section 4.3).
Istodobno primijenjeni ritonavir vjerojatno povećava koncentracije i fuzidične kiseline i ritonavira u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
Please also review the Summary of Product Characteristics for the particular boosted PI.
Molimo također pročitati Sažetak opisa svojstava lijeka za određeni IP čija se farmakokinetika pospješuje.
For further information, physicians should refer to the Summary of Product Characteristics for fosamprenavir.
Daljnje informacije liječnik treba potražiti u Sažetku opisa svojstava lijeka za fosamprenavir.
200 q12 h
200 svakih 12 h
In intent to treat analyses, 50% and 57% of patients in the 350 and 450 mg/m2 dose groups, respectively, achieved reduction in plasma HIV-1 RNA to ≤ 400 copies/ml at Week 48.
ITT analiza je pokazala da se broj kopija HIV-1 RNA nakon 48 tjedana smanjio na ≤ 400/ml u, redom, 50% i 57% bolesnika koji su primali 350 odnosno 450 mg/m² ritonavira.
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of fentanyl.
Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4 te se stoga očekuje da će povećati koncentracije fentanila u plazmi.
Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported in patients taking ritonavir.
U bolesnika koji su uzimali ritonavir bilo je prijava poremećenih nalaza jetrene funkcije, hepatitisa (upala jetre) i rijetko žutice.
Concomitant use of avanafil or vardenafil with ritonavir is contraindicated (see section 4.3).
Istodobna primjena avanafila sa ritonavirom je kontraindicirana (vidjeti dio 4.3)
Paediatric Use
Pedijatrijska primjena
For specific dosing information in patients with renal impairment, refer to the Summary of Product Characteristics (SPC) of the co-administered protease inhibitor.
Za specifične informacije o doziranju bolesnicima s oslabljenom funkcijom bubrega vidjeti Sažetak opisa svojstava lijeka (SPC, engl.
For further information, physicians should refer to the Summary of Product Characteristics for amprenavir.
Daljnje informacije liječnik treba potražiti u Sažetku opisa svojstava lijeka za amprenavir.
Refer to the darunavir Summary of Product Characteristics for further information on once daily dosing in ART experienced patients.
Za više informacija o doziranju jedanput na dan kod bolesnika koji su prethodno primali ART treba pročitati Sažetak opisa svojstava lijeka za darunavir.
200 q12 h, 2 days
1, jednokratna doza 200 svakih 12 h, 2 dana
Due to CYP3A inhibition by ritonavir, concentrations of lomitapide are expected to increase.
Zbog inhibicije CYP3A ritonavirom, očekuje se povećanje koncentracije lomitapida.
Methadone1
Atazanavir1
Ritonavir increases the serum levels of atazanavir as a result of CYP3A4 inhibition.
Ritonavir povisuje serumske razine atazanavira zbog inhibicije CYP3A4.
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of loratadine.
Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A, zbog čega se očekuje povećanjekoncentracije loratadina u plazmi.
Refer to the Summary of Product Characteristics for atazanavir for further details.
Za ostale detalje molimo pročitati Sažetak opisa svojstava lijeka za atazanavir.
Ritonavir co-administration is likely to result in increased plasma concentrations of cisapride and is therefore contraindicated (see section 4.3).
Istodobno primijenjeni ritonavir vjerojatno bi povećao koncentracije cisaprida u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
• muscle aches (pain), tenderness or weakness
• bol, osjetljivost ili slabost mišića
Hyperplasia of the retinal pigment epithelium (RPE) and retinal degeneration have been seen in all of the rodent studies conducted with ritonavir, but have not been seen in dogs.
U svim ispitivanjima ritonavira u glodavaca, ali ne i u pasa, zamijećene su hiperplazija pigmentnog epitela mrežnice i degeneracija mrežnice.
• joint pain and back pain
Vrlo često Artralgija i bol u leđima Često
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of carbamazepine.
Ritonavir doziran kao antiretrovirusni lijek ili kao farmakokinetički pojačivač inhibira CYP3A4 te se zbog toga može očekivati povećanje koncentracija karbamazepina u plazmi.
↑ 2.4fold ↑ 11 fold
↑ 11 puta ↑ 29 puta
500q12h ↑ 3.4-fold ↑ 55% Ritonavir inhibits CYP3A-mediated metabolism of ketoconazole.
Ritonavir inhibira metabolizam ketokonazola posredovan enzimom CYP3A.
600 q24 h
200, 4 doze
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of erythromycin and itraconazole.
Eritromicin, itrakonazol Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4, zbog čega se očekuje povećanje koncentracije eritromicina i itrakonazola u plazmi.
Ritonavir increases the serum levels of indinavir as a result of CYP3A4 inhibition.
Ritonavir povisuje serumske razine indinavira zbog inhibicije CYP3A4.
Tipranavir must be given with low dose ritonavir to ensure its therapeutic effect.
Da bi se osigurao terapijski učinak, tipranavir se mora davati s malim dozama ritonavira.
Ritonavir increases the serum levels of nelfinavir as a result of CYP3A4 inhibition.
Ritonavir povisuje serumske razine nelfinavira zbog inhibicije CYP3A4.
Extra monitoring is recommended when diarrhoea occurs.
Pojavi li se proljev, preporučuje se osobito pažljivo praćenje.
Ritonavir co-administration is likely to result in increased plasma concentrations of astemizole and terfenadine and is therefore contraindicated (see section 4.3).
Antihistaminici Astemizol, terfenadin Istodobno primijenjeni ritonavir vjerojatno bi povećao koncentracije astemizola i terfenadina u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
Pethidine, piroxicam, propoxyphene Ritonavir co-administration is likely to result in increased plasma concentrations of pethidine, piroxicam, and propoxyphene and is therefore contraindicated (see section 4.3).
Istodobno primijenjeni ritonavir vjerojatno bi povećao plazmatske koncentracije petidina, piroksikama i propoksifena te je stoga kontraindiciran (vidjeti dio 4.3).
Ritonavir co-administration is likely to result in increased plasma concentrations of ergot derivatives and is therefore contraindicated (see section 4.3).
Istodobno primijenjeni ritonavir vjerojatno povećava koncentracije derivata ergota u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
For further information, physicians should refer to the Summary of Product Characteristics for saquinavir.
Daljnje informacije liječnik treba potražiti u Sažetku opisa svojstava lijeka za sakvinavir.
1,250 q12 h 750, single
750, jednokratno 500 svakih 12 h Nelfinavir
Antimycobacterial
Antimikotici
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of buspirone.
Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A te se zbog toga može očekivati povećanje koncentracija buspirona u plazmi.
500 q12 h ↑ 4-fold
5, jednokratna doza 600 svakih 12h ↑49puta
Zidovudine
Prednizolon
Co-administration of ritonavir and raltegravir results in a minor reduction in raltegravir levels.
400 jednokratno 100 svakih 12h Raltegravir Istodobna primjena ritonavira i raltegravira dovodi do blagog sniženja razina raltegravira.
GI motility agent
• učestalije mokrenje
Taking Ritonavir Mylan with food and drink
Uzimanje hrane i pića s lijekom Ritonavir Mylan
100 q12 h Indinavir3 Ritonavir
800 svakih 12 h 100 svakih 12 h Indinavir3
The reduction of the rifabutin dose to 150 mg 3 times per week may be indicated for select PIs when co-administered with ritonavir as a pharmacokinetic enhancer.
Pri primjeni ritonavira kao farmakokinetičkog pojačivača istodobno s određenim IP može biti indicirano smanjenje doze rifabutina na 150 mg triput na tjedan.
Ritonavir increases the serum levels of saquinavir as a result of CYP3A4 inhibition.
Ritonavir povisuje serumske razine sakvinavira zbog inhibicije CYP3A4.
See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction.
Za istodobnu primjenu sildenafila bolesnicima s erektilnom disfunkcijom vidjeti dio 4.4 i dio 4.5.
Cmax recommended when these medicines are concomitantly administered with antiretroviral doses of ritonavir (see section 4.4).
Preporučuje se pažljivo praćenje njihovih serumskih razina i terapijskih učinaka kada se ti lijekovi primjenjuju istodobno s ritonavirom doziranim kao antiretrovirusnim lijekom (vidjeti dio 4.4).
Haemophilia
Hiperglikemija
Hepatic impairment
Bolest bubrega
When ritonavir is used as a pharmacokinetic enhancer at the 100 mg and 200 mg level it cannot be assumed that the following warnings and precautions will also apply.
Ta upozorenja i mjere opreza ne moraju vrijediti ako se ritonavir daje kao farmakokinetički pojačivač u dozama od 100 mg i 200 mg.
400 q8 h
↑ 2.4 puta
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of dexamethasone.
Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A te se zbog toga može očekivati povećanje koncentracija deksametazona u plazmi.
Generics UK Limited Station Close Potters Bar Hertfordshire EN6 1TL
Generics UK Limited Station Close
In intent to treat analyses, 72% and 36% of patients achieved reduction in plasma HIV-1 RNA of ≤ 400 copies/ml at Week 16 and 104, respectively.
≤ 400/ml u 73% bolesnika nakon 16 tjedana, a u 36% bolesnika nakon 104 tjedna.
Fatigue including asthenia, flushing, feeling hot
Vrlo često Umor uključujući asteniju, crvenilo uz osjećaj vrućine Često
ND: Not determined 1 Based on a parallel group comparison 2 Sulfamethoxazole was co-administered with trimethoprim
2 Sulfametoksazol se davao istodobno s trimetoprimom.
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors.
A i B liječenih inhibitorima proteaza bilo je prijava pojačanog krvarenja, uključujući spontane kožne hematome i hemartroze.
175 mg (2.2 ml) twice daily 200mg in the morning and 200mg in the evening 350 mg (4.4 ml) twice daily 400mg in the morning and 300mg in the evening 437.5 mg (5.5 ml) twice daily 500mg in the morning and 400mg in the evening 525 mg (6.6 ml) twice daily 500mg in the morning and 500mg in the evening
437,5 mg (5,5 ml) dva puta na dan
Amlodipine, diltiazem, nifedipine Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of calcium channel antagonists.
Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4, zbog čega se očekuje povećanje koncentracije antagonista kalcijevih kanala u plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole is used concomitantly administered with ritonavir.
Kada se eritromicin ili itrakonazol daju istodobno s ritonavirom, preporučuje se pažljivo praćenje terapijskih učinaka i mogućih nuspojava.
What is Dutrebis and what is it used for?
Što je Dutrebis i za što se koristi?
Other information about Dutrebis
Ostale informacije o lijeku Dutrebis
The full EPAR and risk management plan summary for Dutrebis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Dutrebis nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The effectiveness and safety are taken to be the same as that for the two individual active substances, which are well characterised and do not raise any particular concern.
Pretpostavka je da su djelotvornost i sigurnost podjednaki kao i u slučaju dvije individualne aktivne tvari, koje su dobro okarakterizirane i ne predstavljaju nikakav poseban razlog za zabrinutost.
The main measure of effectiveness was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml, which was 68.8%.
Glavna mjera djelotvornosti bio je omjer bolesnika sa smanjenim koncentracijama virusa u krvi (viralno opterećenje) na manje od 50 HIV-RNK kopija po ml, što iznosi 68,8%.
Dutrebis is a medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Dutrebis je lijek koji se koristi za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
Dutrebis is available as tablets containing 150 mg of lamivudine and 300 mg of raltegravir, and the recommended dose is one tablet twice a day.
Dutrebis je dostupan kao tablete koje sadrže 150 mg lavudina i 300 mg retegravira, a preporučena doza je jedna tableta dva puta na dan.
The Committee noted that the two active substances in Dutrebis are frequently taken together in clinical practice.
Odbor je zaključio kako se dvije djelatne tvari lijeka Dutrebis često uzimaju zajedno u kliničkoj praksi.
The active substances in Dutrebis are already available in the European Union (EU) as singlecomponent medicines: lamivudine as Epivir since 1996, and raltegravir as Isentress since 2007.
Djelatne tvari lijeka Dutrebis već su dostupne u Europskoj uniji (EU) kao lijekovi s jednom komponentom: lamivudin kao Epivir od 1996. i raltegravir kao Isentress od 2007.
It is used together with other HIV medicines and can be used in patients from 6 years of age and weighing at least 30 kg.
Koristi se zajedno s drugim lijekovima za terapiju protiv HIV-a te se može primjenjivati u bolesnika od 6 godina starosti i tjelesne težine od najmanje 30 kg.
Because lamivudine and raltegravir are already approved individually to treat HIV infection, the company presented data from the studies used to approve these medicines, including a study involving 160 patients given raltegravir with lamivudine (plus another HIV medicine, tenofovir) for a total of 240 weeks.
Budući da su lamivudin i raltegravir već pojedinačno odobreni za liječenje infekcije HIV-om, tvrtka je dostavila podatke iz ispitivanja korištenih za odobravanje ovih lijekova, uključujući ispitivanje koje je obuhvatilo 160 bolesnika koji su primili raltegravir s lamivudinom (plus drugi lijek protiv HIV-a, tenofovir) tijekom ukupno 240 tjedana.
Dutrebis reduces the amount of HIV in the blood and keeps it at a low level.
Dutrebis smanjuje količinu HIV-a u krvi i održava ga u malim koncentracijama.
The European Commission granted a marketing authorisation valid throughout the European Union for Dutrebis on 26 March 2015.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Dutrebis na snazi u Europskoj uniji od 26. ožujka 2015.
It is not intended to provide practical advice on how to use Dutrebis.
Svrha sažetka nije davati praktične savjete o korištenju lijeka Dutrebis.
It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Djeluje inhibirajući djelovanje reverzne transkriptaze, enzima koji je potreban HIV-u da proizvede genetske upute za stvaranje više virusa nakon što je stanica zaražena.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Dutrebis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Dutrebis nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.