FrancophonIA/ELRC3.0 huggingface dataset:
English: The need for contraception prior to, during and after treatment with mycophenolate mofetil, including details of the duration of time for which contraception must be continued after cessation of therapy, will be clearly stated.
Slovenian: Opisane bodo zahteve za kontracepcijo za bolnike in bolnice v rodni dobi pred, med in po zdravljenju z mofetilmikofenolatom, zahteve za kontracepcijo za spolno aktivne bolnike (vključno z vazektomiziranimi) in bolnice v rodni dobi ter potrebo po kontracepciji pred, med in po zdravljenju z mofetilmikofenolatom, vključno s podrobnostmi o času, ko je treba kontracepcijo uporabljati še po zaključku zdravljenja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg mycophenolate mofetil. For the full list of excipients, see section 6.1.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka trda kapsula vsebuje 250 mg mofetilmikofenolata.
English: • You plan to become pregnant.
Slovenian: • nameravate zanositi;
English: Paediatric population No data are available for paediatric hepatic transplant patients.
Slovenian: Pediatrični bolniki Za otroke in mladostnike z jetrnim presadkom podatkov ni.
English: There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate mofetil, some of which have been fatal.
Slovenian: Pri bolnikih, ki so se zdravili z mofetilmikofenolatom, so poročali o primerih aplastične anemije in depresije kostnega mozga; nekateri od teh so bili smrtni.
English: Common Hypotension, hypertension, vasodilatation
Slovenian: Žilne bolezni zelo pogosti pogosti hipotenzija, hipertenzija, vazodilatacija
English: The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Slovenian: Priporočeni odmerek pri bolnikih s srčnim presadkom je 1,5 g dvakrat na dan (dnevni odmerek 3 g).
English: No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Slovenian: Za bolnike s srčnim ali jetrnim presadkom in hudo ledvično okvaro podatki niso znani.
English: There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with mycophenolate mofetil in combination with other immunosuppressants, some of which have been fatal.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pri bolnikih, ki so dobivali mofetilmikofenolat skupaj z drugimi imunosupresivi, so poročali o posameznih primerih intersticijske pljučne bolezni in pljučne fibroze; nekateri primeri so bili smrtni.
English: Skin problems such as • acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Slovenian: • akne, okužbe z virusom herpesa simpeksa, pasasti izpuščaj, rast kože, izguba las, izpuščaj,
English: • The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
Slovenian: • Dnevni odmerek so 6 tablet (3 g zdravila), ki se jemljejo v 2 posameznih odmerkih.
English: How to store Myclausen
Slovenian: Shranjevanje zdravila Myclausen
English: The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Slovenian: Priporočeni peroralni odmerek pri bolnikih z jetrnim presadkom je 1,5 g dvakrat na dan (dnevni odmerek 3 g).
English: • The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.
Slovenian: • Dnevni odmerek so 4 tablete (2 g zdravila), ki se jemlje v 2 posameznih odmerkih.
English: Take care not to let any powder from inside a broken capsule get into your eyes or mouth • If this happens, rinse with plenty of water.
Slovenian: Bodite previdni, da prašek, ki ga vsebujejo poškodovane kapsule, ne pride v oči ali usta.
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m mycophenolate mofetil orally twice daily.
Slovenian: Farmakokinetične parametre so opazovali pri 49 otrocih in mladostnikih z ledvičnim presadkom (starih od 2 do 18 let), ki so prejemali 600 mg/m mofetilmikofenolata peroralno dvakrat na dan. Ti odmerki so dali podobne vrednosti AUC mikofenolne kisline kot pri odraslih bolnikih z ledvičnim presadkom, ki so prejemali mofetilmikofenolat v odmerku 1 g dvakrat na dan v začetnem in poznejšem obdobju po presaditvi.
English: Common Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Slovenian: Neželeni učinki gastritis, ezofagitis, stomatitis, zaprtje, dispepsija, flatulenca, kolcanje
English: Posology
Slovenian: Novotvorbe
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti pogosti artralgija
English: • The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
Slovenian: • Dnevni odmerek so 12 kapsul (3 g zdravila), ki se jemljejo v 2 posameznih odmerkih.
English: The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/m mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate mofetil twice daily.
Slovenian: Vrsta in pogostnost neželenih učinkov v kliničnih študijah, ki so zajele 92 otrok in mladostnikov, starih od 2 do 18 let, ki so prejemali 600 mg/m mofetilmikofenolata peroralno dvakrat na dan, sta bila podobna neželenim učinkom, opaženim pri odraslih bolnikih, ki so prejemali 1 g mofetilmikofenolata dvakrat na dan. Naslednji neželeni učinki povezani z zdravljenjem pa so bili v primerjavi z odraslimi pogostejši pri otrocih in mladostnikih, zlasti pri otrocih, mlajših od 6 let: driska, sepsa, levkopenija, anemija in okužba.
English: Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Slovenian: Zdravilo Myclausen je indicirano pri odraslih, otrocih in mladostnikih, starih 2 do 18 let, v kombinaciji s ciklosporinom in kortikosteroidi za preprečevanje akutnih zavrnitvenih reakcij pri bolnikih z alogenim ledvičnim, srčnim ali jetrnim presadkom.
English: Neoplasms
Slovenian: Dojenje
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of Myclausen.
Slovenian: Pri sočasni uporabi holestiramina in zdravila Myclausen je potrebna previdnost, saj je lahko učinkovitost zdravila Myclausen zmanjšana.
English: Leucopenia, thrombocytopenia, anaemia Common Pancytopenia, leukocytosis
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti levkopenija, trombocitopenija, anemija pogosti pancitopenija, levkocitoza
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/647/001
English: Use in hepatic transplant
Slovenian: Uporaba pri presaditvi ledvic
English: Do not stop taking Myclausen unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Myclausen, ne da bi se prej posvetovali z zdravnikom.
English: No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Slovenian: Bolnikom z ledvičnim presadkom in hudo boleznijo jetrnega parenhima ni treba prilagajati odmerkov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/647/002
English: There is no basis for Myclausen dose adjustment following cardiac transplant rejection.
Slovenian: Pri zavrnitvi srčnega presadka prilagajanje odmerkov zdravila Myclausen ni potrebno.
English: However, the mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Slovenian: Pri bolnikih s hudo ledvično okvaro je bil srednji AUC mikofenolglukuronida po enkratnem odmerku od 3- do 6krat večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
English: (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with Myclausen.
Slovenian: Bolnice v rodni dobi se morajo zavedati tveganj in upoštevati priporočila iz poglavja 4.6 (npr. glede kontracepcijskih metod, preverjanja nosečnosti) pred, med in po zdravljenju z zdravilom Myclausen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 500 mg mycophenolate mofetil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 500 mg mofetilmikofenolata.
English: Antacids and proton pump inhibitors (PPIs)
Slovenian: Antacidi in zaviralci protonske črpalke
English: Neoplasms benign, malignant and unspecified (incl.
Slovenian: Benigne in maligne neoplazme (vključno s cistami in polipi)
English: The pharmacokinetics of oral contraceptives were unaffected by coadministration of mycophenolate mofetil (see also section 4.5).
Slovenian: Sočasno jemanje mofetilmikofenolata in peroralnih kontraceptivov ni vplivalo na farmakokinetiko peroralnih kontraceptivov (glejte tudi poglavje 4.5).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg mycophenolate mofetil.
Slovenian: Ena kapsula vsebuje 250 mg mofetilmikofenolata.
English: Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy (see section 4.3).
Slovenian: Zdravljenja ne smemo uvesti brez predložitve negativnega izvida testa nosečnosti.
English: Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Myclausen should be administered with caution in patients with active serious digestive system disease.
Slovenian: Pri bolnikih, ki so prejemali mofetilmikofenolat, so opazili povišano incidenco neželenih dogodkov v prebavilih, vključno z redkimi primeri razjed v prebavnem traktu, krvavitvami in perforacijami črevesa.
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94 % relative to IV mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal transplant patients.
Slovenian: Hrana na obseg absorpcije mofetilmikofenolata (AUC mikofenolne kisline), če ga dajemo v odmerkih 1,5 g dvakrat na dan bolnikom s presajeno ledvico, ne vpliva, zmanjša pa največjo plazemsko koncentracijo (Cmax) mikofenolne kisline za približno 40 %.
English: Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to Myclausen in combination with other immunosuppressants during pregnancy.
Slovenian: Pri otrocih bolnic, ki so se v času nosečnosti zdravile z zdravilom Myclausen v kombinaciji z drugimi imunosupresivi, so po prihodu zdravila na trg poročali o kongenitalnih malformacijah, vključno z večkratnimi malformacijami.
English: If you are not sure, talk to your doctor or pharmacist before taking Myclausen.
Slovenian: Če ste negotovi glede jemanja zdravila Myclausen, se pred tem pogovorite s svojim zdravnikom ali farmacevtom.
English: In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL•min
Slovenian: Ledvična okvara V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro
English: Adverse drug reactions Common Skin hypertrophy, rash, acne, alopecia
Slovenian: Bolezni kože in podkožja zelo pogosti pogosti hipertrofija kože, izpuščaj, akne, alopecija
English: No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Slovenian: Za bolnike s srčnim presadkom in hudo boleznijo jetrnega parenhima podatki niso znani.
English: Patient information pack
Slovenian: izobraževalno gradivo za bolnike.
English: OTHER
Slovenian: Prebavila
English: Always take Myclausen exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Myclausen natančno upoštevajte zdravnikova navodila.
English: In vivo, MPAG is converted back to free MPA via enterohepatic recirculation.
Slovenian: In vivo se v enterohepatičnem obtoku mikofenolglukuronid spremeni nazaj v prosto mikofenolno kislino.
English: Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Slovenian: Bolnice in bolniki med zdravljenjem z mofetilmikofenolatom in vsaj še 6 tednov po njegovi ukinitvi ne smejo darovati krvi.
English: You must not donate blood during treatment with Myclausen and for at least 6 weeks after stopping treatment.
Slovenian: Med zdravljenjem in vsaj še 6 tednov po končanem zdravljenju z zdravilom Myclausen ne smete darovati krvi.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Common Oedema, pyrexia, chills, pain, malaise, asthenia
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti pogosti edem, pireksija, mrzlica, bolečina, občutek neugodja, astenija
English: Common Convulsion, hypertonia, tremor, somnolence,
Slovenian: Bolezni živčevja zelo pogosti pogosti konvulzije, hipertonija, tremor, somnolenca, miastenijski sindrom, omotica, glavobol, parestezija, sprememba okusa
English: Men must not donate semen during treatment with Myclausen and for at least 90 days after stopping treatment.
Slovenian: Bolniki med zdravljenjem in vsaj še 90 dni po končanem zdravljenju z zdravilom Myclausen ne smete darovati sperme.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Trimetoprim/sulfametoksazol
English: The overall safety profile is considered acceptable.
Slovenian: Splošni varnostni profil se šteje za sprejemljivega.
English: What measures are being taken to ensure the safe and effective use of Lokelma?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lokelma?
English: The full EPAR for Lokelma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lokelma je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The powder is stirred into water to make a mixture to be drunk straight away.
Slovenian: Prašek pomešajte v vodi, da pripravite mešanico, ki jo je treba takoj popiti.
English: The recommended starting dose of Lokelma is 10 g three times a day.
Slovenian: Priporočeni začetni odmerek zdravila Lokelma je 10 g trikrat na dan.
English: This is a summary of the European public assessment report (EPAR) for Lokelma.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lokelma.
English: What benefits of Lokelma have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Lokelma izkazalo v študijah?
English: The European Medicines Agency decided that Lokelma's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Lokelma večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Once the blood levels of potassium return within the normal range (usually within 1-2 days), patients should take the lowest effective dose of Lokelma to prevent the return of hyperkalaemia, starting with 5 g once a day and not exceeding 10 g once a day.
Slovenian: Ko se koncentracija kalija v krvi vrne na normalno (običajno v enem do dveh dneh), mora bolnik jemati najmanjši še učinkoviti odmerek zdravila Lokelma, da se prepreči ponovitev hiperkaliemije, pri čemer začne z odmerkom 5 g enkrat dnevno in ne sme preseči odmerka 10 g enkrat dnevno.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lokelma have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lokelma upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What is Lokelma and what is it used for?
Slovenian: Kaj je zdravilo Lokelma in za kaj se uporablja?
English: Other information about Lokelma
Slovenian: Druge informacije o zdravilu Lokelma
English: It is not intended to provide practical advice on how to use Lokelma.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Lokelma is available as powder sachets (5 g and 10 g).
Slovenian: Zdravilo Lokelma je na voljo v obliki praška v vrečkah (po 5 g in 10 g).
English: What are the risks associated with Lokelma?
Slovenian: Kakšna tveganja so povezana z zdravilom Lokelma?
English: For more information about treatment with Lokelma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lokelma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The Agency considered that Lokelma is effective at controlling blood potassium levels, especially during initial (acute) treatment.
Slovenian: Agencija je menila, da je zdravilo Lokelma učinkovito pri nadzorovanju koncentracije kalija v krvi, še posebej med začetnim (akutnim) zdravljenjem.
English: Lokelma is a medicine used to treat hyperkalaemia (high levels of potassium in the blood) in adults.
Slovenian: Lokelma je zdravilo, ki se uporablja za zdravljenje hiperkaliemije (visoke koncentracije kalija v krvi) pri odraslih.
English: For practical information about using Lokelma, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Lokelma naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The most common side effects with Lokelma (which may affect up to 1 in 10 people) are oedema (fluid build-up with swelling in the ankles and feet) and hypokalaemia (low levels of potassium in the blood).
Slovenian: Najpogostejši neželeni učinki zdravila Lokelma (ki se lahko pojavijo pri največ 1 bolniku od 10) so edem (kopičenje tekočine in otekanje v gležnjih in stopalih) in hipokaliemija (nizka koncentracija kalija v krvi).
English: Another main study involved 258 patients who had normal potassium levels after Lokelma treatment.
Slovenian: V drugo glavno študijo je bilo vključenih 258 bolnikov, ki so imeli normalno koncentracijo kalija po zdravljenju z zdravilom Lokelma.
English: Why is Lokelma approved?
Slovenian: Zakaj je bilo zdravilo Lokelma odobreno?
English: Lokelma sodium zirconium cyclosilicate
Slovenian: Lokelma natrijev cirkonijev ciklosilikat
English: In a main study of 754 patients with hyperkalaemia, 86% of patients taking Lokelma 10 g had normal potassium levels after 2 days compared with 48% of those taking placebo (a dummy treatment).
Slovenian: V glavni študiji s 754 bolniki s hiperkaliemijo je imelo po dveh dneh normalno koncentracijo kalija 86 % bolnikov, ki so jemali zdravilo Lokelma v odmerku 10 g, in 48 % bolnikov, ki so jemali placebo (zdravilo brez zdravilne učinkovine).
English: This action removes potassium from the body overall, thus helping to lower the potassium levels in the blood.
Slovenian: S tem se kalij popolnoma odstrani iz telesa, kar pomaga znižati koncentracijo kalija v krvi.
English: For the full list of all side effects and restrictions with Lokelma, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lokelma glejte navodilo za uporabo.
English: In this 4-week study, patients receiving further treatment with Lokelma had lower potassium levels from the second week of treatment than patients taking placebo.
Slovenian: V tej štiritedenski študiji so bolniki, ki so prejemali nadaljnje zdravljenje z zdravilom Lokelma, od drugega tedna zdravljenja imeli nižjo koncentracijo kalija kot bolniki, ki so prejemali placebo.
English: When taken by mouth, Lokelma attaches to potassium from food and body fluids in the gut, forming a compound that
Slovenian: Pri peroralnem jemanju se zdravilo Lokelma veže na kalij iz hrane in telesnih tekočin v črevesu ter tako ustvari
English: Lokelma is effective at lowering blood potassium levels and keeping levels of potassium within the normal range.
Slovenian: Zdravilo Lokelma je učinkovito pri zniževanju koncentracije kalija v krvi in ohranjanju njegove koncentracije v okviru normalnih vrednosti.
English: How is Lokelma used?
Slovenian: Kako se zdravilo Lokelma uporablja?
English: In addition, when patients who had normal potassium levels after Lokelma treatment were given further treatment with either Lokelma or placebo, potassium levels stayed normal for longer with Lokelma than with placebo.
Slovenian: Poleg tega so bolniki, ki so imeli po zdravljenju z zdravilom Lokelma normalno koncentracijo kalija in so nato prejemali nadaljnje zdravljenje s tem zdravilom, ohranili normalno koncentracijo kalija dlje časa kot bolniki, ki so po zdravljenju z zdravilom Lokelma prejemali placebo.
English: It contains the active substance sodium zirconium cyclosilicate.
Slovenian: Vsebuje zdravilno učinkovino natrijev cirkonijev ciklosilikat.
English: The active substance in Lokelma, sodium zirconium cyclosilicate, is a potassium binder.
Slovenian: Zdravilna učinkovina v zdravilu Lokelma je natrijev cirkonijev ciklosilikat, vezalec kalija.
English: How does Lokelma work?
Slovenian: Kako zdravilo Lokelma deluje?
English: is then eliminated in the stools.
Slovenian: spojino, ki se izloči z blatom.
English: Treatment should start with a low dose that is gradually increased over the first 14 days of treatment.
Slovenian: Zdravljenje se začne z nizkim odmerkom, ki ga zdravnik v prvih 14 dneh zdravljenja postopoma povečuje.
English: It is available as tablets (100 mg) and should be taken with food.
Slovenian: Na voljo je v obliki tablet (100 mg) in ga je treba jemati skupaj s hrano.
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Slovenian: Priporočeni odmerek zdravila za odrasle (stare 18 let ali več) je 600 mg dvakrat na dan.
English: This increases the levels of these protease inhibitors in the blood and enhances their antiviral effect.
Slovenian: To poveča ravni teh zaviralcev proteaz v krvi in okrepi njihov protivirusni učinek.
English: For younger patients, the recommended dose depends on the patient's height and weight.
Slovenian: Pri mlajših bolnikih je priporočeni odmerek odvisen od bolnikove telesne višine in mase.
English: When the enzyme is blocked, the virus can no longer multiply normally, slowing down its spread.
Slovenian: Ko je encim zavrt, se virus ne more več normalno razmnoževati, kar zmanjša hitrost njegovega širjenja.
English: The full EPAR for Ritonavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ritonavir Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Ritonavir Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ritonavir Mylan.
English: This means that it blocks a viral enzyme called protease, which is involved in the multiplication of HIV.
Slovenian: To pomeni, da zavira virusni encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
English: As for every medicine, the company provided studies on the quality of Ritonavir Mylan.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Ritonavir Mylan.