FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP recommended that Kytril tablets and solution for injection can be used in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy, and also for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Slovenian: CHMP je priporočil, da se lahko tablete in raztopina za injiciranje Kytril uporabljajo pri odraslih za preprečevanje in zdravljenje akutne slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo, ter tudi za preprečevanje zakasnele slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.
English: On 3 June 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Kytril in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Kytril v EU, je dne 3. junija 2010 zadevo napotila na CHMP.
English: The solution for injection can also be used in children aged two years above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.
Slovenian: Raztopina za injiciranje se lahko uporablja tudi pri otrocih, starih 2 leti in več, za preprečevanje in zdravljenje akutne slabosti in bruhanja, povezanih s kemoterapijo.
English: In addition, the solution for injection can be used in adults for the prevention and treatment of nausea and vomiting following surgery.
Slovenian: Raztopina za injiciranje se lahko pri odraslih uporablja tudi za preprečevanje in zdravljenje slabosti in bruhanja po operaciji.
English: Granisetron prevents the nausea and vomiting by blocking these receptors.
Slovenian: Granisetron zavira te receptorje ter tako preprečuje slabost in bruhanje.
English: Kytril was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Kytril potrebno usklajevanje.
English: 5 (5 x 1) vials (multipack)
Slovenian: 5 (5 x 1) vial (skupno pakiranje)
English: 10 (2 x 5) prefilled pens (multipack)
Slovenian: 10 (2 x 5) napolnjenih injekcijskih peresnikov (skupno pakiranje)
English: 25 (5 x 5) cartridges (multipack)
Slovenian: 25 (5 x 5) injekcijskih vložkov (skupno pakiranje)
English: Annex
Slovenian: Priloga
English: The patient safety card should contain:
Slovenian: Varnostna kartica za bolnike mora vsebovati:
English: • All patients must be monitored for signs of meningitidis
Slovenian: • vse bolnike je treba spremljati za znake meningitisa,
English: Eculizumab should be given to a pregnant woman only if clearly needed.
Slovenian: Ekulizumab dajemo nosečnicam samo v primeru nujne potrebe.
English: • Warning to seek immediate medical care if above are present
Slovenian: • opozorilo, naj nemudoma poišče zdravniško pomoč, če se zgoraj našteto pojavi,
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Slovenian: Pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih morajo upoštevati države članice
English: • No clinical data on exposed pregnancies is available.
Slovenian: • za ekulizumab ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
English: • Signs and symptoms of severe infection and the need to obtain urgent medical care
Slovenian: • znaki in simptomi resne okužbe in potreba po urgentni medicinski pomoči,
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented
Slovenian: Države članice morajo zagotoviti, da bodo pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, ki so opisane spodaj, upoštevane.
English: The educational material should be agreed with the National Competent Authority and should contain the following:
Slovenian: Izobraževalno gradivo mora biti skladno z dogovorom s pristojnim nacionalnim organom in mora vsebovati naslednje:
English: All healthcare practitioners who may prescribe eculizumab receive the appropriate educational material.
Slovenian: 1. bodo vsi tisti zdravstveni delavci, ki smejo predpisovati ekulizumab, prejeli ustrezno izobraževalno gradivo;
English: • Contact details where a health care practitioner can receive further information
Slovenian: • kontaktne podatke, kamor se lahko zdravstveni delavec obrne za dodatne informacije.
English: • Details of the PNH and aHUS registries and how to enter patients
Slovenian: • podrobnosti registrov bolnikov s PNH in aHUS in kako vanje vključiti bolnike.
English: • Patient safety card
Slovenian: • varnostno kartico za bolnike.
English: • Statement that the patient is receiving eculizumab
Slovenian: • izjavo, da bolnik prejema ekulizumab,
English: All patients being treated with eculizumab receive a patient safety card
Slovenian: 2. bodo vsi bolniki, ki se zdravijo z ekulizumabom, prejeli varnostno kartico za bolnike;
English: • Summary of product characteristics
Slovenian: • povzetek glavnih značilnosti zdravila,
English: The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National CompetentAuthority and must implement such programmes nationally to ensure that:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora s pristojnimi nacionalnimi organi uskladiti podrobnosti nadzorovanega distribucijskega sistema zdravila in izobraževalnega gradiva, vključno z varnostnimi karticami za bolnike, ter na nacionalni ravni izvesti programe, ki bodo zagotovili, da:
English: The patient's/carer's guides should be indication specific and contain the following key messages:
Slovenian: Smernice za bolnike/negovalce morajo biti specifične za indikacije in morajo vsebovati naslednja ključna sporočila:
English: • The patient safety card and the need to carry it on their person and tell any treating healthcare professional that they are being treated with eculizumab
Slovenian: • varnostno kartico za bolnike in potrebo po tem, da jo bolnik ves čas nosi pri sebi ter opozori vsakega zdravstvenega delavca, s katerim pride v stik, da prejema zdravljenje z ekulizumabom;
English: Drug distribution will only be possible after written confirmation that the patient has effectively received meningococcal vaccination and/or antibiotic prophylaxis.
Slovenian: 3. bo distribucija zdravila možna samo po pisnem zagotovilu, da je bil bolnik uspešno cepljen proti meningokoku in/ali je prejel antibiotično zaščito;
English: The physician's guides to prescribing should be indication specific and contain the following key messages:
Slovenian: Smernice za predpisovanje za zdravnike morajo biti specifične za indikacije in morajo vsebovati naslednja ključna sporočila:
English: Breast-feeding should be discontinued during and up to five months after treatment.
Slovenian: Dojenje je treba med zdravljenjem in do pet mesecev po njem prekiniti;
English: • That eculizumab may be teratogenic and the need for effective contraception in women of childbearing potential during and up to five months after treatment, and that breast-feeding should be discontinued during and up to five months after treatment.
Slovenian: • ekulizumab je lahko teratogen, potrebna je učinkovita kontracepcija pri ženskah v rodni dobi med zdravljenjem in do pet mesecev po njem in dojenje je treba med zdravljenjem in do pet mesecev po njem prekiniti;
English: • Enrolment in the PNH and aHUS registries
Slovenian: • vpis v register bolnikov s PNH in z aHUS,
English: • Physician's guides to prescribing
Slovenian: • smernice za predpisovanje za zdravnike,
English: • Patient's/carer's information brochures
Slovenian: • brošure z informacijami za bolnike,
English: The MAH shall send annually to prescribers and pharmacists who prescribe/dispense eculizumab, a reminder about the need for (re)-vaccination against Neisseria meningitidis for patients on eculizumab.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zdravnikom, ki predpisujejo zdravilo, in farmacevtom, ki predpisujejo/izdajajo ekulizumab, poslati letne opomnike glede potrebe po cepljenju/ponovnem cepljenju proti bakteriji Neisseria meningitidis bolnikov, ki se zdravijo z ekulizumabom.
English: • The need for patients to be vaccinated against Neisseria meningitidis two weeks prior to receiving eculizumab and/or to receive antibiotic prophylaxis
Slovenian: • bolnike je treba dva tedna preden prejmejo ekulizumab cepiti proti bakteriji Neisseria meningitidis in/ali morajo prejeti antibiotično zaščito,
English: • Treatment with eculizumab increases the risk of severe infection and sepsis, especially of Neisseria meningitidis
Slovenian: • zdravljenje z ekulizumabom zveča tveganje za resne okužbe in sepso, zlasti z bakterijo Neisseria meningitides,
English: • Signs and symptoms of infection and sepsis
Slovenian: • znake in simptome okužbe in sepse,
English: • Treatment with eculizumab increases the risk of severe infection, especially Neisseria meningitidis
Slovenian: • zdravljenje z ekulizumabom zveča tveganje za resne okužbe, zlasti z bakterijo Neisseria meningitides;
English: • The importance of meningococcal vaccination prior to treatment and/or to receive antibiotic prophylaxis
Slovenian: • pomen cepljenja proti meningokokom pred zdravljenjem in/ali antibiotične zaščite,
English: • The risk of developing antibodies to eculizumab
Slovenian: • obstaja tveganje za nastanek protiteles proti ekulizumabu,
English: • The need to explain to and ensure understanding of by patients/carers: o the risks of treatment with eculizumab o the signs and symptoms of sepsis/severe infection and what action to take o the patient's/carer's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with eculizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the registries
Slovenian: • bolnikom/negovalcem je treba razložiti in se prepričati, da razumejo naslednje: o tveganja zdravljenja z ekulizumabom, o znake in simptome sepse/resne okužbe in kaj morajo storiti v takem primeru, o smernice za bolnike/negovalce in njihovo vsebino,
English: • Risk of serious haemolysis following eculizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management (PNH only)
Slovenian: • tveganje za resno hemolizo po prekinitvi jemanja ekulizumaba in odlogu dajanja zdravila, kriterije zanjo, potrebno spremljanje po zdravljenju in predlagana terapija (samo za bolnike s PNH);
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only)
Slovenian: • tveganje za resno trombotično mikroangiopatijo po prekinitvi zdravljenja z ekulizumabom in odlogu dajanja zdravila, znake in simptome zapleta, spremljanje in zdravljenje (samo za bolnike z aHUS);
English: The need for effective contraception in women of childbearing potential during and up to five months after treatment.
Slovenian: Med zdravljenjem in do pet mesecev po njem je pri ženskah v rodni dobi potrebna učinkovita kontracepcija.
English: Vaccination reminders are sent to the prescribers.
Slovenian: 4. bodo zdravniki, ki predpisujejo zdravilo, prejeli opomnik za cepljenje.
English: • Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Slovenian: • tveganje za resno trombotično mikroangiopatijo (pri bolnikih z aHUS) po prekinitvi/odlogu dajanja ekulizumaba, znake in simptome zapleta in priporočilo, naj se pred prekinitvi jemanja/odlogu zdravljenja z ekulizumabom posvetujejo z zdravnikom, ki je zdravilo predpisal;
English: • Risk of severe haemolysis (in PNH) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Slovenian: • tveganje za resno hemolizo (pri bolnikih s PNH) po prekinitvi/odlogu dajanja ekulizumaba, znake in simptome zapleta in priporočilo, naj se pred prekinitvi jemanja/odlogu zdravljenja z ekulizumabom posvetujejo z zdravnikom, ki je zdravilo predpisal;
English: It was to be available as tablets (15, 30 and 45 mg).
Slovenian: Na voljo naj bi bilo v obliki tablet (15, 30 in 45 mg).
English: The company withdrew before the European Commission had issued a decision on this opinion.
Slovenian: Družba je vlogo umaknila, preden je Evropska komisija izdala odločbo v zvezi s tem mnenjem.
English: It was to be used in addition to diet and exercise.
Slovenian: Uporabljalo naj bi se kot dodatek k dieti in telesni vadbi.
English: As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Slovenian: Posledično se raven glukoze v krvi zniža, kar pripomore k nadzoru nad sladkorno boleznijo tipa 2.
English: The active substance in Pioglitazone ratiopharm, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Slovenian: Zdravilna učinkovina zdravila Pioglitazone ratiopharm, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
English: This means that Pioglitazone ratiopharm 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.
English: The withdrawal letter is available here.
Slovenian: Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo tukaj.
English: On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm, for the treatment of type 2 diabetes.
Slovenian: Družba ratiopharm GmbH je dne 3. februarja 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Pioglitazone ratiopharm, namenjenim zdravljenju sladkorne bolezni tipa 2.
English: Because Pioglitazone ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Slovenian: Ker je zdravilo Pioglitazone ratiopharm generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm had been shown to have comparable quality and to be bioequivalent to Actos.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone ratiopharm primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
English: Pioglitazone ratiopharm was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Slovenian: Zdravilo Pioglitazone ratiopharm naj bi se uporabljalo za zdravljenje sladkorne bolezni tipa 2 pri odraslih, zlasti tistih s prekomerno telesno maso.
English: Pioglitazone ratiopharm was developed as a ‘generic medicine'.
Slovenian: Zdravilo Pioglitazone ratiopharm je bilo razvito kot „generično zdravilo“.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za vzdrževanje primerne ravni glukoze v krvi ali pri kateri telo insulina ne more učinkovito izrabiti.
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm for the treatment of type 2 diabetes.
Slovenian: Odbor je zato v času umika vloge izrazil pozitivno mnenje in priporočil odobritev vloge za pridobitev dovoljenja za promet z zdravilom Pioglitazone ratiopharm za zdravljenje sladkorne bolezni tipa 2.
English: Pioglitazone ratiopharm is a medicine that contains the active substance pioglitazone.
Slovenian: Pioglitazone ratiopharm je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
English: What is Pioglitazone ratiopharm?
Slovenian: Kaj je zdravilo Pioglitazone ratiopharm?
English: Pioglitazone ratiopharm was also to be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Slovenian: Zdravilo Pioglitazone ratiopharm naj bi se uporabljalo tudi skupaj z metforminom in sulfonilsečnino pri bolnikih, pri katerih bolezen ni zadostno nadzorovana kljub dvojnemu peroralnemu zdravljenju (zdravljenje s tremi zdravili).
English: Pioglitazone ratiopharm was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Slovenian: Uporabljalo naj bi se tudi v kombinaciji z metforminom pri bolnikih, pri katerih bolezni zgolj z metforminom ni mogoče zadostno nadzorovati, ali v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni), če metformin ni primeren (zdravljenje z dvema zdraviloma).
English: Pioglitazone ratiopharm was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Slovenian: Uporabljalo naj bi se tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z insulinom samim in za katere metformin ni primeren.
English: Pioglitazone ratiopharm was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Slovenian: Prav tako naj bi se uporabljalo samostojno pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primeren.
English: How is Pioglitazone ratiopharm expected to work?
Slovenian: Kako naj bi zdravilo Pioglitazone ratiopharm delovalo?
English: What was Pioglitazone ratiopharm expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Pioglitazone ratiopharm uporabljalo?
English: The study lasted for up to 18 months.
Slovenian: Ta študija je trajala do 18 mesecev.
English: The effect of these antibodies on the safety and effectiveness of Myozyme is not yet clear.
Slovenian: Učinek teh protiteles na varnost in učinkovitost zdravila Myozyme še ni razjasnjen.
English: The results were confirmed in the other study, which involved children aged between six months and three and a half years.
Slovenian: Rezultati so bili potrjeni z drugo študijo, ki je vključevala otroke, stare od šest mesecev do treh let in pol.
English: Myozyme alglucosidase alfa
Slovenian: Myozyme alglukozidaza alfa
English: Myozyme is given as an infusion of 20 mg per kilogram body weight given once every two weeks.
Slovenian: Zdravilo Myozyme se daje z infuzijo v odmerku 20 mg na kilogram telesne mase enkrat vsaka dva tedna.
English: The disease can appear at birth (the ‘infantile-onset' form) but also later in life (the ‘late-onset' form).
Slovenian: Bolezen se lahko pojavi ob rojstvu („zgodnji nastop“ bolezni), pa tudi kasneje v življenju („pozni nastop“ bolezni).
English: The main measures of effectiveness were the improvement in the distance the patients could walk in six minutes and in their ‘forced vital capacity' (a measure of how well their lungs were working).
Slovenian: Glavni merili učinkovitosti sta bili povečanje razdalje, ki jo je bolnik lahko prehodil v šestih minutah, in njihova „forsirana vitalna kapaciteta“ (kako dobro delujejo pljuča).
English: What measures are being taken to ensure the safe use of Myozyme?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Myozyme?
English: In contrast, only one of the 42 patients in the historical comparison group was alive at 18 months of age.
Slovenian: Nasprotno pa je v historični primerjalni skupini od 42 bolnikov preživel samo en bolnik do starosti 18 mesecev.
English: This is a summary of the European public assessment report (EPAR) for Myozyme.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Myozyme.
English: These patients were compared with a ‘historical comparison group' of babies and young children with Pompe disease who had not received treatment and did not take part in the studies.
Slovenian: Te bolnike so primerjali s historično primerjalno skupino dojenčkov in otrok s Pompejevo boleznijo, ki niso bili zdravljeni in niso sodelovali v študijah.
English: For more information about treatment with Myozyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Myozyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The infusion should start slowly and then be gradually sped up as long as there are no signs of side effects caused by the infusion.
Slovenian: Infundiranje je treba začeti počasi in ga počasi pospeševati do hitrosti, ko še ni znakov neželenih učinkov, ki bi jih to lahko povzročilo.
English: In the first main study, which involved babies less than six months old, all 18 patients treated with Myozyme were alive at 18 months of age, and 15 of these did not need a ventilator to help them breathe.
Slovenian: V prvi glavni študiji z dojenčki, mlajšimi od šest mesecev, je vseh 18 bolnikov, ki so prejemali zdravilo Myozyme, pri starosti 18 mesecev še živelo, 15 od teh bolnikov za lažje dihanje ni potrebovalo predihavanja.
English: Myozyme is an enzyme replacement therapy.
Slovenian: Zdravilo Myozyme je encimska nadomestna terapija.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Myozyme je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The main measures of effectiveness were the number of patients who survived and the number who did not need a ventilator to help them breathe.
Slovenian: Glavni merili učinkovitosti sta bili število bolnikov, ki so preživeli, in število bolnikov, ki niso potrebovali predihavanja za lažje dihanje.
English: This enzyme normally breaks down sugar stored as glycogen into glucose that can be used for energy by the body's cells.
Slovenian: Ta encim navadno pretvarja sladkor, ki je shranjen kot glikogen, v glukozo, ki jo telesne celice uporabljajo za energijo.
English: Because the number of patients with Pompe disease is low, the disease is considered ‘rare', and Myozyme was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 14 February
Slovenian: Ker je bolnikov s Pompejevo boleznijo malo, velja ta bolezen za redko, zato je bilo zdravilo Myozyme dne 14. februarja 2001 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: What benefit has Myozyme shown during the studies?
Slovenian: Kakšne koristi je zdravilo Myozyme izkazalo med študijami?