FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP further took note of third party interventions received from patients and healthcare professionals during the assessment, highlighting the importance of maintaining availability of this product to a population that, albeit small, has few or no therapeutic alternatives for a debilitating condition.
Croatian: CHMP je nadalje uzeo u obzir intervencije trećih strana zaprimljene od bolesnika i zdravstvenih djelatnika tijekom procjene u kojima se naglašava važnost daljnje dostupnosti ovog lijeka populaciji koja, iako mala, ima samo nekoliko terapijskih alternativa za onesposobljavajuće stanje ili ih uopće nema.
English: with caution as methods of detection of fibrosis used in these studies are not sensitive enough, in particular for valvular fibrosis.
Croatian: fibroze korištene u ovim ispitivanjima nisu dovoljno osjetljive, posebice za valvularnu fibrozu.
English: The CHMP also recommended that methysergide treatment should be initiated and supervised by specialised physicians with experience in the treatment of migraine and cluster headache.
Croatian: CHMP je također preporučio da liječenje metizergidom treba započeti i nadzirati liječnik specijalist s iskustvom u liječenju migrene i cluster glavobolja.
English: Kudrow L. Cluster Headache Mechanisms and management.
Croatian: Cluster Headache Mechanisms and management.
English: Methysergide is not effective for treating a migraine attack that is already present.
Croatian: Metizergid nije djelotvoran za liječenje napadaja migrene koji već traje.
English: The CHMP noted that the mechanistic basis for the fibrosis appears to be well-founded, and fits with the known association between methysergide use and fibrosis, which has been reported with respect of valvular heart disease since the mid-1960s.
Croatian: CHMP je napomenuo da se čini da je mehanicistička osnova fibroze dosta čvrsta i da odgovara poznatoj povezanosti između uporabe metizergida i fibroze koja je zabilježena u vezi s bolešću srčanih zalistaka od sredine šezdesetih godina prošlog stoljeća.
English: Based on this, France considered that the benefit risk balance of methysergide containing products should be reviewed and triggered a referral under Article 31 of Directive 2001/83/EC.
Croatian: Na temelju toga, Francuska je smatrala da omjer koristi i rizika za lijekove koji sadrže metizergid treba procijeniti te je pokrenula postupak upućivanja u skladu s člankom 31. Direktive 2001/83/EZ.
English: Am J Respir Crit Care Med 2006;174(7):810-6.
Croatian: Respir Crit Care Med 2006;174(7):810-6.
English: In addition, the CHMP noted that methysergide is recommended by experts as a rescue treatment, reserved for patients in whom other treatments have failed.
Croatian: Pored toga, CHMP je napomenuo da metizergid stručnjaci preporučuju kao terapiju spašavanja, rezerviranu za bolesnike kod kojih druge terapije ne djeluju.
English: 2013 Jan;169(1):14-29. doi: 10.1016/j.neurol.2012.07.022.
Croatian: 2013 Jan;169(1):14-29. doi: 10.1016/j.neurol.2012.07.022. Epub 2012 Dec 13. 11 Kudrow L.
English: Therefore, the potential causal association between fibrotic reactions and methysergide cannot be excluded.
Croatian: Stoga nije moguće isključiti potencijalnu uzročnu povezanost između fibrotičkih reakcija i metizergida.
English: The CHMP considered the view of the SAG which recommended some measures to be taken in order to minimise the risk of fibrotic reactions when prescribing methysergide.
Croatian: CHMP je razmatrao stajalište SAG-a u kojem se preporučuju neke mjere koje treba poduzeti kako bi se smanjio rizik od fibrotičkih reakcija prilikom propisivanja metizergida.
English: − Is not favourable for the treatment of diarrhoea caused by carcinoid disease.
Croatian: Nije povoljan za liječenje proljeva uzrokovanog karcinoidnom bolešću.
English: In a more recent review14, methysergide and verapamil were cited as the most useful treatments of the episodic form of cluster headache.
Croatian: U novijem pregledu14, metizergid i verapamil citirani su kao najkorisnije terapije u epizodnom obliku cluster glavobolje.
English: Based on the clinical experience of headache experts, the SAG considered that there is a small proportion of the populations suffering from migraine and from cluster headache that seems to benefit from treatment with methysergide, when previous treatments have failed.
Croatian: Na temelju kliničkog iskustva stručnjaka za glavobolju, SAG je smatrao da postoji mali dio populacije koji pati od migrene i cluster glavobolje, a za koji se čini da ima koristi od liječenja metizergidom kada prethodne terapije nisu djelovale.
English: Regarding the indication “treatment of diarrhoea caused by carcinoid disease”, the CHMP concluded that the benefit-risk balance is negative as there is a clearly demonstrated risk of fibrosis but no evidence of benefit.
Croatian: Što se tiče indikacije „liječenje proljeva uzrokovanog karcinoidnom bolešću”, CHMP je zaključio da je omjer koristi i rizika nepovoljan te da postoji jasno dokazan rizik od fibroze, ali ne i dokaz koristi lijeka.
English: • The Committee considered that there is some evidence for clinically significant efficacy of methysergide in the prophylactic treatment of severe, debilitating migraine and cluster headache for which therapeutic alternatives are limited.
Croatian: • Povjerenstvo je smatralo da postoje određeni dokazi za klinički značajnu djelotvornost metizergida u profilaktičkom liječenju teške, onesposobljavajuće migrene i cluster glavobolje za koje su alternativne terapije ograničene.
English: The CHMP noted that the clinical trial evidence for the efficacy of methysergide as a prophylactic treatment for cluster headache is less robust compared to the evidence for migraine prophylaxis and that the majority of studies have a number of limitations.
Croatian: CHMP je zabilježio da su dokazi iz kliničkih ispitivanja o djelotvornosti metizergida u profilaktičkom liječenju cluster glavobolje manje čvrsti u usporedbi s dokazima za profilaksu migrene i da je većina ispitivanja imala brojna ograničenja.
English: • The Committee noted that there is no evidence of efficacy of methysergide in the treatment of diarrhoea caused by carcinoid disease, and therefore the potential benefit for patients in this indication is outweighed by the identified risk.
Croatian: • Povjerenstvo je zabilježilo da nema dokaza o djelotvornosti metizergida u liječenju proljeva uzrokovanog karcinoidnom bolešću i da je stoga potencijalna korist za bolesnike u ovoj indikaciji manja od identificiranog rizika.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends the variation to the terms of the marketing authorisation for methysergide containing medicinal products referred to in Annex I.
Croatian: Direktive 2001/83/EZ, CHMP preporučuje izmjenu uvjeta odobrenja za stavljanje lijeka u promet za sve lijekove koji sadrže metizergid i koji su navedeni u Prilogu I.
English: Annex II Scientific conclusions and grounds for the variation of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za izmjenu odobrenja za stavljanje lijeka u promet
English: The CHMP has considered the totality of the available data on the safety and efficacy of methysergide.
Croatian: CHMP je uzeo u obzir ukupne dostupne podatke o sigurnosti i djelotvornosti metizergida.
English: • Therefore the CHMP was of the opinion that the benefit-risk balance of methysergide containing products:
Croatian: • Stoga je CHMP smatrao da je omjer koristi i rizika za lijekove koji sadrže metizergid:
English: The results of these studies are suggestive of the efficacy of methysergide compared to placebo in the prophylaxis of migraine.
Croatian: Rezultati ovih ispitivanja ukazuju na djelotvornost metizergida u usporedbi s placebom u profilaksi migrene.
English: Considering the overall data available, the CHMP is of the opinion that there is some evidence of clinically significant efficacy of methysergide in the prophylactic treatment of severe and debilitating migraine.
Croatian: Uzimajući u obzir ukupne dostupne podatke, CHMP je smatrao da postoje određeni dokazi klinički značajne djelotvornosti metizergida u profilaktičkom liječenju teške i onesposobljavajuće migrene.
English: Overall summary of the scientific evaluation of methysergide containing medicinal products (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene lijekova koji sadrže metizergid (vidjeti Prilog I.)
English: Having considered the overall data provided by the MAH in writing, the CHMP concluded that the benefit-risk balance of methysergide is favourable in:
Croatian: Imajući u vidu ukupne podatke koje je u pismenom obliku predao nositelj odobrenja, CHMP je zaključio da je omjer koristi i rizika metizergida povoljan u:
English: Lovshin LL. Use of methysergide in the treatment of extracranial vascular headache.
Croatian: Use of methysergide in the treatment of extracranial vascular headache.
English: Overall, the CHMP considered that methysergide seems to benefit a small patient population of migraine and cluster headache patients.
Croatian: Ukupno gledano, CHMP je smatrao da se čini da metizergid pomaže maloj populaciji bolesnika s migrenom i cluster glavoboljama.
English: Silberstein SD.
Croatian: 21 Silberstein SD. Methysergide.
English: 14 Pradalier A, Baudesson G, Vincent D, Imberty-Campinos C. Treatment of the cluster headache.
Croatian: Pradalier A, Baudesson G, Vincent D, Imberty-Campinos C.
English: • the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Croatian: • profilaktičkom liječenju teške, perzistentne migrene (s aurom ili bez nje) s funkcionalnom onesposobljenošću u odraslih osoba.
English: Lance JW et al. An evaluation of methysergide in the prevention of migraine and other vascular headaches.
Croatian: An evaluation of methysergide in the prevention of migraine and other vascular headaches.
English: 10 Lanteri-Minet M et al. Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
Croatian: Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
English: • the prophylactic treatment of episodic and chronic cluster headache in adults.
Croatian: • profilaktičkom liječenju epizodnih i kroničnih cluster glavobolja u odraslih osoba.
English: − Is favourable for the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Croatian: Povoljan za profilaktičko liječenje teške, perzistentne migrene (s aurom ili bez nje) s funkcionalnom onesposobljenošću u odraslih osoba.
English: Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
Croatian: Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
English: Grounds for variation to the terms of the marketing authorisations Whereas
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: − Is favourable for the prophylactic treatment of episodic and chronic cluster headache in adults.
Croatian: Povoljan je za profilaktičko liječenje epizodnih i kroničnih cluster glavobolja u odraslih osoba.
English: 2009 Sep;16(9):968-81.
Croatian: 2009 Sep;16(9):968-81. 10 Lanteri-Minet
English: Clin Pharmacol Ther 19645:201-204
Croatian: Clin Pharmacol Ther 19645:201-204 5 Curran DA, Lance JW.
English: 15 May A, Leone M, Afra J et al. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias.
Croatian: EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias.
English: 20 Steffensen C, Maegbaek ML, Laurberg P, Andersen M, Kistorp CMN, Norrelund H, et al. Heart valve disease among patients with hyperprolactinemia: A nationwide population-based cohort study.
Croatian: 20 Steffensen C, Maegbaek ML, Laurberg P, Andersen M, Kistorp CMN, Norrelund H, et al.
English: Patients should have failed at least 2 classes of drugs before starting methysergide.
Croatian: Prije početka liječenja metizergidom bolesnici trebaju imati neuspjeh s barem 2 razreda lijekova.
English: With regard to the indication “cluster headache”, the applicant referred to a review11 which suggested the prophylactic efficacy of methysergide, particularly for the episodic form of cluster headache and to a study12 where 69% of cluster headache patients reported to have good to excellent results.
Croatian: S obzirom na indikaciju „cluster glavobolje”, podnositelj zahtjeva pozvao se na procjenu11 koja je ukazala na profilaktičku djelotvornost metizergida, posebice za epizodni oblik cluster glavobolje i na
English: 23 Graham JR, Suby HI, LeCompte PR, Sadowsky NL. Fibrotic disorders associated with methysergide therapy for headache.
Croatian: 23 Graham JR, Suby HI, LeCompte PR, Sadowsky NL.
English: 19 Bana DS, MacNeal PS, LeCompte PM. Cardiac murmurs and endocardial fibrosis associated with methysergide therapy.
Croatian: Cardiac murmurs and endocardial fibrosis associated with methysergide therapy.
English: However, these results should be taken
Croatian: Međutim, te rezultate treba uzeti s oprezom jer metode detekcije
English: CPMP/EWP/788/01 Rev. 1 (2007) 9 Evers S, Afra J, Frese A et al. EFNS guideline on the drug treatment of migraine - revised report of an EFNS task force.
Croatian: EFNS guideline on the drug treatment of migraine - revised report of an EFNS task force.
English: Southwell N, Williams J, Mackenzie I. Methysergide In The Prophylaxis Of Migraine.
Croatian: Southwell N, Williams J, Mackenzie I.
English: Curran DA, Lance JW.
Croatian: Lance JW et al.
English: Shekelle RB, Ostfeld AM. Methysergide in the migraine syndrome.
Croatian: 4 Shekelle RB, Ostfeld AM.
English: 2 Pedersen E, Møller CE. Methysergide in migraine prophylaxis.
Croatian: Methysergide in migraine prophylaxis.
English: 18 Bendtsen L, Birk S, Kasch H et al. Reference programme: Diagnosis and treatment of headache disorders and facial pain.
Croatian: Bendtsen L, Birk S, Kasch H et al.
English: Clin Pharmacol Ther 19667(4):520-526 3 Ryan RE. Double-blind crossover comparison of BC-105, methysergide, and placebo in the prophylaxis of migraine headache.
Croatian: Double-blind crossover comparison of BC-105, methysergide, and placebo in the prophylaxis of migraine headache.
English: N Engl J Med 1966;274(7):359-68.
Croatian: N Engl J Med 1966;274(7):359-68. 24 van Bommel EFH, Jansen I, Hendriksz TR, Aarnoudse ALHJ.
English: This should be taken into consideration.
Croatian: To treba uzeti u obzir.
English: Always follow the instructions exactly as your doctor has told you.
Croatian: Uvijek slijedite upute točno onako kako Vam je rekao liječnik.
English: The overall reduction was 54%.
Croatian: Ukupno smanjenje iznosilo je 54 %.
English: Date of first authorisation: 16 August 2016.
Croatian: Datum prvog odobrenja: 16. kolovoza 2016.
English: % reduction
Croatian: % smanjenja
English: Your doctor will work out the right dose for you.
Croatian: Liječnik će izračunati pravu dozu za Vas.
English: In this short period, a risk to the suckling child cannot be excluded.
Croatian: U tom se kratkom razdoblju ne može isključiti rizik za dojeno dijete.
English: Over 52 weeks
Croatian: Tijekom 52 tjedna
English: Remove CINQAERO from the refrigerator.
Croatian: Izvadite CINQAERO iz hladnjaka.
English: CINQAERO will be given every 4 weeks.
Croatian: CINQAERO će se davati svaka 4 tjedna.
English: Possible side effects”).
Croatian: Moguće nuspojave").
English: • Serious allergic reactions
Croatian: • Ozbiljne alergijske reakcije
English: Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better.
Croatian: NEMOJTE prestati s liječenjem lijekom CINQAERO osim ako Vam to ne kaže liječnik, čak i ako se osjećate bolje.
English: Over 16 weeks
Croatian: Tijekom 16 tjedana
English: LT-08409 Vilnius Lithuania
Croatian: LT-08409 Vilnius Litva
English: These cases resulted in the discontinuation of treatment.
Croatian: Ovi su slučajevi doveli do prekida liječenja.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog gledišta, lijek treba primijeniti odmah.
English: The concentrate does not contain any preservatives.
Croatian: Koncentrat ne sadrži konzervanse.
English: Patients should be instructed on how to recognise symptoms of serious allergic reactions.
Croatian: Bolesnike treba uputiti u to kako prepoznati simptome ozbiljne alergijske reakcije.
English: This is not unusual for proteinaceous solutions.
Croatian: To nije neobično za proteinske otopine.
English: No data are available for children aged up to 11 years.
Croatian: Nema dostupnih podataka za djecu u dobi do 11 godina.
English: This medicine is NOT intended for use in children and adolescents below the age of 18 years.
Croatian: Ovaj lijek NIJE namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: The recommended dose is based on patient body weight and should only be adjusted for significant changes in body weight.
Croatian: Preporučena doza temelji se na tjelesnoj težini bolesnika i smije se prilagoditi samo u slučaju značajnih promjena u tjelesnoj težini.
English: Infusion time may vary depending on the total volume to be infused.
Croatian: Trajanje infuzije može varirati ovisno o ukupnom volumenu koji se daje infuzijom.
English: It may take more than one dose before your asthma symptoms improve.
Croatian: Možda ćete trebati primiti više od jedne doze prije nego što Vam se poboljšaju simptomi astme.
English: The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established for the indication of CINQAERO.
Croatian: Sigurnost i djelotvornost lijeka CINQAERO u djece i adolescenata u dobi do 17 godina nisu ustanovljene za indikaciju lijeka CINQAERO.
English: ● Risk management plan (RMP)
Croatian: LIJEKA ● Plan upravljanja rizikom (RMP)
English: Subgroup GINA 4 and 5
Croatian: Podskupina GINA 4 i 5
English: Currently available data in adolescents from 12 to 17 years are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci za adolescente u dobi od 12 do 17 godina opisani su u dijelovima 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: They were fully resolved with standard treatment with no residual effect.
Croatian: Potpuno su se povukle uz standardno liječenje bez rezidualnog učinka.
English: - if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na reslizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Croatian: Anafilaktička reakcija (vidjeti dio 4.4) nastala je u manje od 1 % bolesnika.
English: As a precautionary measure, it is preferable to avoid the use of CINQAERO during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka CINQAERO tijekom trudnoće.
English: The most frequently reported adverse reaction during treatment was increased blood creatine phosphokinase, which occurred in approximately 2% of patients.
Croatian: Najčešće prijavljena nuspojava tijekom liječenja bila je povišena kreatin fosfokinaza u krvi, što se dogodilo u približno 2 % bolesnika.
English: Other medicines and CINQAERO
Croatian: Drugi lijekovi i CINQAERO
English: Results were supported by the secondary efficacy endpoints and were in line with the overall population.
Croatian: Rezultati su bili poduprti sekundarnim ishodima djelotvornosti i sukladni onima u ukupnoj populaciji.
English: If a reslizumab infusion is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen.
Croatian: Ako se propusti primjena infuzije reslizumaba na planirani datum, doziranje treba nastaviti čim prije u indiciranoj dozi i režimu.
English: b CI = Confidence interval.
Croatian: b CI = interval pouzdanosti
English: Interrupting or stopping treatment with this medicine may cause your asthma symptoms to come back.
Croatian: Prekid ili prestanak liječenja ovim lijekom može dovesti do povratka simptoma astme.
English: It must not be administered by the subcutaneous, oral or intramuscular route.
Croatian: Ne smije se primijeniti supkutanim, peroralnim ili intramuskularnim putem.
English: The solution for infusion is intended only for intravenous use after dilution and should be prepared using aseptic technique as follows:
Croatian: Otopina za infuziju namijenjena je samo za intravensku primjenu nakon razrjeđivanja i treba biti pripremljena pomoću aseptične tehnike na sljedeći način:
English: The active substance in this medicine may pass into breast milk but only during the first few days after birth.
Croatian: Djelatna tvar u ovom lijeku može prijeći u majčino mlijeko, ali samo tijekom prvih nekoliko dana nakon rođenja.
English: Any concentrate remaining in the vial must be discarded.
Croatian: Sav koncentrat preostao u bočici mora se baciti.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving reslizumab or the response to new immunisations in patients receiving reslizumab.
Croatian: Nema dostupnih podataka o sekundarnom prijenosu infekcije s osoba koje su primile živo cjepivo na bolesnike koji primaju reslizumab ili o odgovoru bolesnika koji primaju reslizumab na novu imunizaciju.
English: Proteinaceous particles might be present.
Croatian: Mogu biti prisutne proteinske čestice.
English: Available non-clinical data do not suggest an effect on fertility.
Croatian: Dostupni neklinički podaci ne ukazuju na utjecaj na plodnost.
English: In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity.
Croatian: In vitro podaci pokazuju da IL-5 i reslizumab najvjerojatnije neće utjecati na aktivnost CYP1A2, 3A4 ili 2B6.
English: Contents of the pack and other information What CINQAERO contains
Croatian: Sadržaj pakiranja i druge informacije Što CINQAERO sadrži
English: The solution for infusion should not be infused concomitantly in the same intravenous line with other medicinal products.
Croatian: Otopina za infuziju ne smije se davati istovremeno kroz istu intravensku liniju s drugim lijekovima.
English: Parasitic (helminth) infections
Croatian: Parazitarne infekcije (helminti)
English: *** Patients weighing more than 188 kg were not studied.
Croatian: *** Bolesnici tjelesne težine veće od 188 kg nisu ispitani.
English: *See subsection “Description of selected adverse reactions” below
Croatian: *Vidjeti odlomak "Opis odabranih nuspojava" niže Opis odabranih nuspojava
English: Given the small sample size and baseline imbalances resulting from subgroup analysis, no conclusion can be drawn regarding asthma efficacy in the paediatric population.
Croatian: S obzirom na mali uzorak i početne razlike proizašle iz analize podskupina, ne može se izvući nikakav zaključak u pogledu djelotvornosti kod astme u pedijatrijskoj populaciji.
English: * This dosing scheme is based on a maximum dose of 3 mg/kg.
Croatian: * Ova shema doziranja temelji se na maksimalnoj dozi od 3 mg/kg.
English: Reslizumab has a half-life of about 24 days.
Croatian: Reslizumab ima poluvijek od približno 24 dana.
English: Reslizumab has a long half-life (see section 5.2).
Croatian: Reslizumab ima dugi poluvijek (vidjeti dio 5.2).
English: If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (15 °C-25 °C).
Croatian: Ako se otopina za infuziju čuvala u hladnjaku, dopustite da postigne sobnu temperaturu (15 °C-25 °C).
English: Treatment duration CINQAERO is intended for long-term treatment.
Croatian: CINQAERO je namijenjen za dugotrajno liječenje.
English: If you miss a scheduled dose of CINQAERO, ask your doctor when to schedule your next treatment.
Croatian: Ako propustite primiti planiranu dozu lijeka CINQAERO, upitajte svog liječnika kada biste mogli planirati sljedeću dozu.
English: The concentrate must not be used if coloured (except slightly yellow) or if foreign particles are present.
Croatian: Koncentrat se ne smije primijeniti ako je obojen (osim ako je blago žut) ili ako su prisutne strane čestice.