FrancophonIA/ELRC3.0 huggingface dataset:
English: The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and -agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
Slovenian: Podatki kažejo, da ni rodilo in v 7 dneh po začetku zdravljenja ni potrebovalo alternativnega tokolitičnega zdravljenja 59,6 % (n = 201) žensk, ki so dobivale atosiban, in 47,7 % (n = 163) žensk, ki so dobivale -agonist (p = 0,0004).
English: Mean value of volume of distribution was 18.3 ± 6.8 litres.
Slovenian: Srednja vrednost očistka je bila 41,8 ± 8,2 litrov/uro, srednja vrednost volumna porazdelitve pa 18,3 ± 6,8 litrov.
English: Psychiatric disorder
Slovenian: Psihiatrične motnje nespečnost
English: Talk to your doctor, midwife or pharmacist before you are given Tractocile: - if you think your waters might have broken (premature rupture of your membranes).
Slovenian: Preden prejmete zdravilo Tractocile, se posvetujte s svojim zdravnikom, z babico ali s farmacevtom: - Če menite, da vam je odtekla voda (predčasni razpok plodovega mehurja).
English: - Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
Slovenian: - Nato boste prejeli kontinuirano (kapalno) infuzijo v odmerku 18 mg na uro.
English: To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/min.
Slovenian: Za natančno odmerjanje je priporočljivo uporabiti pripomoček za kontrolirano infundiranje, tako da je hitrost mogoče prilagajati v kapljicah na minuto.
English: In healthy non-pregnant subjects receiving atosiban infusions (10 to 300 micrograms/min over 12 hours), the steady state plasma concentrations increased proportionally to the dose.
Slovenian: Pri zdravih, nenosečih preiskovankah, ki so dobile infuzijo atosibana (od 10 do 300 mikrogamov/min v 12 urah), so se plazemske koncentracije v stanju dinamičnega ravnovesja povečevale sorazmerno z odmerkom.
English: Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Slovenian: Pri študijah toksičnosti na zarodek/plod niso odkrili škodljivih vplivov atosibana.
English: The side effects seen in the mother are generally of a mild severity.
Slovenian: Pri materi so neželeni učinki običajno blagi.
English: Up to 45 hours subsequent intravenous infusion
Slovenian: 3 Nadaljnja intravenska infuzija, ki traja do 45 ur
English: If you are not sure, talk to your doctor, midwife or pharmacist before you are given Tractocile.
Slovenian: Če ste kakorkoli negotovi, se posvetujte s svojim zdravnikom, z babico ali s farmacevtom, preden prejmete zdravilo Tractocile.
English: Rare (affects less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born.
Slovenian: Redki (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 1.000 bolnic) - Manjša sposobnost krčenja maternice po porodu, kar lahko povzroči krvavitev.
English: Do not use this medicine if you notice particulate matter and discoloration prior to administration.
Slovenian: Ne uporabljajte tega zdravila, če opazite trdne delce ali spremembo barve.
English: Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and betamimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Slovenian: V obdobju po prihodu zdravila na trg so poročali o respiratornih zapletih, kot so dispneja in pljučni edem, še posebej v povezavi s sočasno uporabo drugih zdravil s tokolitičnim delovanjem, kot so antagonisti kalcijevih kanalčkov in beta-mimetiki, in/ali pri ženskah z večplodno nosečnostjo.
English: Τηλ: +30 210 68 43 449
Slovenian: Ferring Ελλάς ΜΕΠΕ Τηλ: +30 210 68 43 449
English: Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours.
Slovenian: Zdravilo Tractocile se aplicira intravensko v treh zaporednih korakih: začetni bolusni odmerek (6,75 mg) zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje, ki mu takoj sledi kontinuirana visokoodmerna infuzija (polnilna infuzija 300 mikrogramov/min) zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje, ki traja tri ure, in nato še infuzija z manjšim odmerkom zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje (nadaljnja infuzija 100 mikrogramov/min), ki traja do 45 ur.
English: Instructions for use Before using Tractocile, the solution should be examined to ensure it is clear and free from particles.
Slovenian: Pred uporabo zdravila Tractocile morate raztopino pregledati in se prepričati, da je bistra in ne vsebuje trdnih delcev.
English: How to store Tractocile
Slovenian: Shranjevanje zdravila Tractocile
English: It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
Slovenian: Zdravilo zavira učinek naravnega hormona oksitocina, ki povzroča krčenje maternice (uterusa).
English: - A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
Slovenian: - Kontinuirana infuzija v odmerku 24 ml/uro.
English: 3 hours intravenous loading infusion
Slovenian: 2 Intravenska polnilna infuzija, ki traja 3 ure
English: - If you have any further questions, ask your doctor, midwife or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, z babico (pomočnico pri porodu) ali s farmacevtom.
English: In the CAP-001 studies the probability of remaining undelivered and not requiring alternative tocolytics within 7 days of treatment initiation was similar for atosiban and beta-mimetics treated women at gestational age of 24-28 weeks.
Slovenian: Verjetnost, da ne pride do poroda in da v 7 dneh od začetka zdravljenja niso potrebni alternativni tokolitiki, je bila v študijah CAP-001 pri ženskah, zdravljenih v obdobju od 24. do 28. tedna gestacije pri uporabi atosibana podobna, kot pri uporabi beta-mimetikov.
English: 0.9 ml intravenous bolus injection given over 1 minute
Slovenian: 1 0,9 ml intravenska injekcija v obliki enominutnega bolusa
English: Tractocile can be used to delay the premature birth of your baby.
Slovenian: Zdravilo Tractocile se lahko uporabi za preprečitev prezgodnjega poroda.
English: Withdraw 0.9 ml of a 0.9 ml labelled vial of Tractocile 6.75 mg/0.9 ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit.
Slovenian: Izvlecite 0,9 ml iz 0,9-ml označene viale zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje in aplicirajte počasi v intravenskem bolusu eno minuto pod ustreznim zdravniškim nadzorom na porodnem oddelku.
English: It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Slovenian: Verjetnost, da bi atosiban pri človeku zaviral izoencime jetrnega citokroma P450, je majhna (glejte poglavje 4.5).
English: The reconstituted product is a clear, colourless solution without particles.
Slovenian: Zdravilo, pripravljeno za uporabo, je bistra, brezbarvna raztopina brez delcev.
English: Solution for injection (6.75 mg/0.9 ml) 1 vial
Slovenian: raztopina za injiciranje (6,75 mg/0,9 ml) 1 viala
English: In atosiban clinical trials no effects were observed on breast-feeding.
Slovenian: V kliničnih preskušanjih atosibana učinkov na dojenje niso opazili.
English: (accumulation of fluid in the lungs).
Slovenian: To lahko poveča tveganje za pljučni edem (nabiranje tekočine v pljučih).
English: In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Slovenian: Med kliničnimi preskušanji so se neželeni učinki pojavili pri 48 % vseh bolnic, ki so se zdravile z atosibanom.
English: In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection followed by infusion with Tractocile 37.5 mg/5 ml, concentrate for solution for infusion.
Slovenian: Če je potrebno ponovno zdravljenje z atosibanom, ga je treba zopet začeti z bolusno injekcijo zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje, ki ji sledi infuzija zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje.
English: During treatment with Tractocile, your contractions and your unborn baby's heart rate may be monitored.
Slovenian: Med zdravljenjem z zdravilom Tractocile bodo po potrebi nadzirali kontrakcije vaše maternice in srčno frekvenco ploda.
English: For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban.
Slovenian: Pri novorojenčkih klinična preskušanja niso pokazala nobenih specifičnih neželenih učinkov atosibana.
English: Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials.
Slovenian: V kliničnih preskušanjih so bili med uporabo atosibana opisani možni neželeni učinki atosibana pri materi.
English: One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Slovenian: Ena viala z raztopino za injiciranje vsebuje 0,9 ml raztopine, kar ustreza 6,75 mg atosibana.
English: Hypotension, Hot flush
Slovenian: Žilne bolezni hipotenzija, navali vročine
English: - if you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be delivered straight away.
Slovenian: - Če imate hudo preeklampsijo in zdravnik meni, da je treba porod opraviti takoj.
English: However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Slovenian: Vendar med kliničnimi preskušanji niso poročali o nezadostnih kontrakcijah maternice po porodu.
English: Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
Slovenian: Med uporabo atosibana in v primeru trajnih kontrakcij maternice je treba razmisliti o nadziranju kontrakcij in spremljanju plodovega srčnega utripa.
English: In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.
Slovenian: Pri prezgodnjem porodu pri človeku atosiban v priporočenem odmerjanju zavira kontrakcije maternice in maternico umiri.
English: The intravenous infusion is prepared by diluting Tractocile 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's lactate solution or 5% w/v glucose solution.
Slovenian: Raztopino zdravila za intravensko infuzijo se pripravi tako, da se zdravilo Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje razredči v 9 mg/ml (0,9 %) raztopini natrijevega klorida za injiciranje, raztopini Ringerjevega laktata ali 5 % (w/v) raztopini glukoze.
English: Replace it by 10 ml Tractocile 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Slovenian: Nadomestite jo z 10 ml zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje, ki jih dobite iz dveh 5 ml vial, tako da bo končna koncentracija 75 mg atosibana v 100 ml.
English: One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
Slovenian: Ena viala s koncentratom za raztopino za infundiranje vsebuje 5 ml raztopine, kar ustreza 37,5 mg atosibana.
English: Very common (affects more than 1 in 10 people) - feeling sick (nausea)
Slovenian: Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnic) - Siljenje na bruhanje (navzea).
English: Tractocile is given intravenously in three successive stages: - The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
Slovenian: Zdravilo Tractocile aplicirajte intravensko v treh zaporednih korakih: - Začetna intravenska injekcija 6,75 mg v 0,9 ml. Injicirajte počasi (tj. eno minuto) v veno.
English: Tractocile will be given into a vein (intravenously) in three stages: - The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.
Slovenian: Zdravilo Tractocile boste prejeli v veno (intravensko) v treh korakih: - Najprej boste v veno prejeli počasno injekcijo s 6,75 mg v 0,9 ml. Injiciranje zdravila bo trajalo eno minuto.
English: 12 hours.
Slovenian: ure.
English: - if your unborn baby has died.
Slovenian: - Če je plod odmrl.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja srbenje, kožni izpuščaj
English: Each ml of solution contains 7.5 mg atosiban.
Slovenian: En ml raztopine vsebuje 7,5 mg atosibana.
English: Atosiban passes the placenta.
Slovenian: Atosiban prehaja skozi placento.
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi manitol
English: This will mean your unborn baby needs to be delivered straight away.
Slovenian: V tem primeru je treba porod opraviti takoj.
English: - A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
Slovenian: Infundiranje traja do 45 ur ali dokler kontrakcije uterusa ne popustijo.
English: The Tractocile 6.75 mg/0.9 ml, solution for injection should be used immediately.
Slovenian: Zdravilo Tractocile 6,75 mg/0,9 ml raztopina za injiciranje morate uporabiti takoj.
English: What Tractocile looks like and contents of the pack Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles.
Slovenian: Zdravilo Tractocile 6,75 mg/0,9 ml raztopina za injiciranje je bistra, brezbarvna raztopina brez delcev.
English: Tractocile works by making the contractions in your womb (uterus) less strong.
Slovenian: Zdravilo Tractocile ublaži in zmanjša pogostnost materničnih kontrakcij (popadkov).
English: For intravenous infusion, following the bolus dose, Tractocile 37.5 mg/5 ml, concentrate for solution for infusion should be diluted in one of the following solutions: sodium chloride 9 mg/ml (0.9%) solution for injection Ringer's lactate solution
Slovenian: Za pripravo intravenske infuzije, ki sledi bolusnemu odmerku, je treba zdravilo Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje razredčiti z eno od naslednjih raztopin: - 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida, - raztopino Ringerjevega laktata, - 5-odstotno (w/v) raztopino glukoze.
English: Preparation of the intravenous infusion solution:
Slovenian: Priprava raztopine za intravensko infundiranje:
English: There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Slovenian: Pri bolnicah z okvaro delovanja jeter ali ledvic ni izkušenj z uporabo atosibana.
English: Clear, colourless solution without particles.
Slovenian: raztopina za injiciranje (injekcija) Bistra, brezbarvna raztopina brez delcev.
English: One vial of 5 ml contains 37.5 mg of atosiban (as acetate).
Slovenian: Ena viala s 5 ml vsebuje 37,5 mg atosibana (v obliki acetata).
English: This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Tractocile 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Slovenian: Iz 100 ml infuzijske vrečke odstranite 10 ml raztopine in jo nadomestite z 10 ml zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje iz dveh 5 ml vial.
English: If you get any side effects, talk to your doctor, midwife or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, babico ali farmacevtom.
English: Once the vial has been opened, the dilution must be performed immediately.
Slovenian: Raztopino je treba uporabiti takoj po odprtju viale.
English: One vial of 0.9 ml contains 6.75 mg of atosiban (as acetate).
Slovenian: Ena viala z 0,9 ml vsebuje 6,75 mg atosibana (v obliki acetata).
English: Preparation of the intravenous infusion
Slovenian: Priprava raztopine za intravensko infundiranje
English: Österreich Ferring Arzneimittel Ges.m.b.H
Slovenian: Deutschland Ferring Arzneimittel GmbH
English: Reproductive system and breast disorder
Slovenian: Motnje reprodukcije in dojk maternična krvavitev, atonija maternice
English: - if you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions).
Slovenian: Bolezenski znaki eklampsije so podobni kot pri hudi preeklampsiji,
English: Nausea Vomiting
Slovenian: Bolezni prebavil navzea bruhanje
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra, brezbarvna raztopina brez delcev.
English: Do not use Tractocile if any of the above apply to you.
Slovenian: Če se karkoli od navedenega nanaša na vas, zdravila Tractocile ne smete prejeti.
English: Uterine haemorrhage, uterine atony
Slovenian: Hitrost infundiranja Odmerek atosibana
English: Tel: +36 1 236 3800 ferring@ferring.hu
Slovenian: Ferring Magyarország Gyógyszerkereskedelmi Kft. Tel: +36 1 236 3800 ferring@ferring.hu
English: Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Slovenian: Ena viala z 0,9 ml raztopine vsebuje 6,75 mg atosibana (v obliki acetata).
English: Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Slovenian: Ena viala s 5 ml raztopine vsebuje 37,5 mg atosibana (v obliki acetata).
English: Uncommon (affects less than 1 in 100 people) - high temperature (fever) - difficulty sleeping (insomnia) - itching - rash
Slovenian: Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 100 bolnic) - Zvišana telesna temperatura (vročina).
English: Tractocile 37.5 mg/5 ml sterile concentrate atosiban
Slovenian: Tractocile 37,5 mg/5 ml sterilni koncentrat atosiban i.v.
English: The vials should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Viale je treba pred uporabo pregledati, da ne vsebujejo delcev oziroma, da vsebina ni spremenila barve.
English: Tractocile 6.75 mg/0.9 ml injection atosiban
Slovenian: Tractocile 6,75 mg/0,9 ml injekcija atosiban i.v.
English: Tractocile 37.5 mg/5 ml concentrate for solution for infusion Atosiban
Slovenian: Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje atosiban
English: Atosiban dose
Slovenian: Odmerjanje
English: Further treatment with Tractocile can be used if your contractions start again.
Slovenian: Če se kontrakcije maternice zopet začnejo, se lahko zdravljenje z zdravilom Tractocile ponovi.
English: Tractocile 6.75 mg/0.9 ml solution for injection
Slovenian: Tractocile 6,75 mg/0,9 ml raztopina za injiciranje
English: Tractocile 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles.
Slovenian: Izgled zdravila Tractocile in vsebina pakiranja Zdravilo Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje je bistra, brezbarvna raztopina brez delcev.
English: Tractocile 37.5 mg/5 ml concentrate for solution for infusion
Slovenian: Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje
English: Further treatment cycles of Tractocile can be used should contractions recur.
Slovenian: Če se kontrakcije uterusa ponovijo, se lahko cikel zdravljenja z zdravilom Tractocile ponovi.
English: Provides 0.75 mg/ml when diluted as recommended.
Slovenian: Po priporočenem redčenju vsebuje 0,75 mg/ml.
English: - Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or until your contractions have stopped.
Slovenian: - Nato boste prejeli še drugo kontinuirano (kapalno) infuzijo v odmerku 6 mg na uro.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema alergijska reakcija
English: - Each vial of Tractocile 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Slovenian: - Ena viala zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje vsebuje atosibanijev acetat, ki ustreza 37,5 mg atosibana v 5 ml. - Pomožne snovi so manitol, klorovodikova kislina in voda za injekcije.
English: Tractocile contains atosiban.
Slovenian: Zdravilna učinkovina zdravila Tractocile je atosiban.
English: MedDRA System Organ Class (SOC)
Slovenian: Razvrstitev organskih sistemov po MedDRA
English: Gestational age below 24 or over 33 completed weeks Premature rupture of the membranes >30 weeks of gestation Abnormal foetal heart rate
Slovenian: - gestacijska starost pod 24 ali nad 33 dopolnjenih tednov, - prezgoden razpok plodnega mehurja > 30 tednov gestacije, - nenormalna srčna frekvenca ploda, - predporodna maternična krvavitev, ki zahteva takojšen porod, - eklampsija ali huda preeklampsija, ki zahtevata porod, - intrauterino odmrtje ploda, - sum na intrauterino okužbo, - placenta praevia, - abruptio placentae, - katerokoli drugo stanje pri materi ali plodu, zaradi katerega je nadaljevanje nosečnosti tvegano, - preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: The following side effects may happen with this medicine: Very common (affects more than 1 in 10 people) - feeling sick (nausea)
Slovenian: Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10 bolnic) - Glavobol.
English: Nervous system disorders
Slovenian: Bolezni živčevja glavobol, omotica
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Slovenian: Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je potreben boljši nadzor glukoze (sladkorja) v krvi.
English: The recommended starting dose of Pioglitazone Krka is 15 or 30 mg once a day.
Slovenian: Priporočeni začetni odmerek zdravila Pioglitazone Krka je 15 ali 30 mg enkrat dnevno.
English: The full EPAR for Pioglitazone Krka 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 Pioglitazone Krka je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Krka on 21 March 2012.
Slovenian: Evropska Komisija je dovoljenje za promet z zdravilom Pioglitazone Krka, veljavno po vsej Evropski uniji, odobrila dne 21. marca 2012.
English: At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Slovenian: Pri nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali se koristi za bolnike ohranjajo.
English: Treatment with Pioglitazone Krka should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Slovenian: Zdravljenje z zdravilom Pioglitazone Krka je treba po treh do šestih mesecih proučiti in prekiniti pri bolnikih, pri katerih ni zadostne koristi.
English: For more information about treatment with Pioglitazone Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pioglitazone Krka preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: This means that Pioglitazone Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.