FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP acknowledged the advice of the Scientific Advisory Group (SAG) which was convened in September 2013 during which the experts discussed, based on their clinical experience, whether it is possible to define a population for which there is a therapeutic need for oral methysergide-containing products when standard treatment for these indications have been ineffective.
Slovenian: Odbor CHMP je upošteval nasvet znanstveno svetovalne skupine, ki se je septembra 2013 sestala na seji, med katero so strokovnjaki na podlagi svojih kliničnih izkušenj razpravljali o tem, ali je mogoče opredeliti populacijo, pri kateri obstaja terapevtska potreba po peroralnih zdravilih, ki vsebujejo metizergid, kadar standardno zdravljenje za te indikacije ni učinkovito.
English: However, in view of the demonstrated risk of fibrosis, adequate risk minimisation measures should be put in place.
Slovenian: Vendar pa je treba zaradi dokazanega tveganja za fibrozo sprejeti ustrezne ukrepe za zmanjšanje tveganja.
English: Methysergide is currently indicated in the prophylaxis of migraine headache, cluster headache and also in the treatment of diarrhoea caused by carcinoid disease (specific wording of the indication may vary from product to product).
Slovenian: Metizergid je trenutno indiciran za preprečevanje migrenskega glavobola in glavobola v rafalih ter tudi za zdravljenje driske, ki jo povzroča karcinoidna bolezen (točno besedilo indikacije se lahko med posameznimi zdravili razlikuje).
English: Patients should have failed at least 2 classes of drugs before starting methysergide.
Slovenian: Bolniki morajo prestati neuspešno zdravljenje z vsaj 2 vrstama zdravil, preden se uvede metizergid.
English: The CHMP also noted that methysergide is included in the latest recommendations of migraine preventive treatments of the European Federation of Neurological Societies (EFNS; 2009)9 as drug of third choice for migraine prophylaxis for short-term use only, and in the latest French recommendations of 2013 as Grade B or C (probably effective) for migraine prophylaxis10.
Slovenian: Odbor CHMP je upošteval tudi, da je metizergid vključen v najnovejša priporočila v zvezi s preventivnim zdravljenjem migrene Evropske zveze nevroloških združenj (EFNS, 2009)9 kot zdravilo tretje izbire za preprečevanje migrene, ki se lahko uporablja samo kratek čas, in v najnovejša francoska priporočila iz leta 2013 kot zdravilo za preprečevanje migrene razreda B ali C (verjetno, da je učinkovito)10.
English: J Neurol Neurosurg Psychiatry 1964; 27:463-9.
Slovenian: Neurosurg Psychiatry 1964; 27:463-9.
English: The CHMP further noted that methysergide is included as second choice treatment in the latest recommendations of cluster headache preventive treatments of the EFNS (2006)15 and is also included in the list of preventive therapies for cluster headache in recently published guidelines16,17,18.
Slovenian: Prav tako je odbor upošteval, da je metizergid kot zdravljenje druge izbire vključen v najnovejša priporočila v zvezi s preventivnim zdravljenjem glavobola v rafalih zveze EFNS (2006)15 ter tudi na seznam zdravil za preventivno zdravljenje glavobola v rafalih v nedavno objavljenih smernicah16,17,18.
English: • The Committee reviewed all available data on the efficacy and safety of methysergide containing medicinal products, in particular with regard to the risk of fibrotic reactions.
Slovenian: • odbor je pregledal vse razpoložljive podatke o učinkovitosti in varnosti zdravil, ki vsebujejo metizergid, zlasti podatke v zvezi s tveganjem za fibrozne reakcije;
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.
Slovenian: Posledično je odbor CHMP v skladu s členom 116 Direktive 2001/83/ES priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo metizergid in so navedena v Prilogi I.
English: For the indication “prophylaxis of migraine”, data were submitted from randomised, double-blind, placebo-controlled studies1,2,3,4.
Slovenian: Za indikacijo „preprečevanje migrene“ so bili predloženi podatki iz randomiziranih dvojno slepih študij, kontroliranih s placebom1,2,3,4.
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.
Slovenian: Odbor CHMP je upošteval, da je osnovni mehanizem za fibrozo dobro utemeljen in se ujema z znano povezavo med uporabo metizergida in fibrozo, o kateri so poročali v povezavi z boleznijo srčne zaklopke od sredine 60. let prejšnjega stoletja.
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.
Slovenian: V zvezi z indikacijo „zdravljenje driske, ki jo povzroča karcinoidna bolezen,“ je odbor CHMP zaključil, da je razmerje med tveganji in koristmi negativno, saj obstajajo nedvoumni dokazi o tveganju za fibrozo, dokazov o koristih pa ni.
English: Annex II Scientific conclusions and grounds for the variation of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo dovoljenj za promet z zdravili
English: In 2011, a French national pharmacovigilance review reported serious cases of valvulopathy, pulmonary, pleural and retroperitoneal fibrosis associated with methysergide containing medicinal products.
Slovenian: Nacionalni farmakovigilančni pregled, opravljen leta 2011 v Franciji, je razkril resne primere valvulopatije ter pljučne, plevralne in retroperitonealne fibroze, povezane z uporabo zdravil, ki vsebujejo metizergid.
English: Methysergide is not effective for treating a migraine attack that is already present.
Slovenian: Metizergid ni učinkovit pri zdravljenju migrenskega napada, ki se je že pojavil.
English: The SAG also considered that patients should be monitored at baseline and every six months while on treatment (heart ultrasound, abdominal magnetic resonance imaging (MRI), pulmonary function tests) in order to be able to identify all fibrosis before severe and potentially irreversible reactions have occurred.
Slovenian: Znanstveno svetovalna skupina je menila tudi, da je treba bolnike pregledati ob začetku zdravljenja in nato še vsakih šest mesecev zdravljenja (ultrazvok srca, magnetno resonančno slikanje (MRS) trebuha, preiskave delovanja pljuč), da se odkrijejo vsi primeri fibroze, preden se pojavijo hude in možne ireverzibilne reakcije.
English: The CHMP noted that fibrosis can be a life-threatening event and that some of the retroperitoneal fibrotic reactions reported are very severe (ureter fibrosis, bilateral uretic stenting, bilateral nephrostomy etc.).
Slovenian: Odbor CHMP je upošteval, da je fibroza lahko smrtno nevaren dogodek in da so nekatere retroperitonealne fibrozne reakcije, o katerih poročajo, zelo hude (uretrna fibroza, vstavitev uretrnega stenta na obeh straneh, bilateralna nefrostomija itd.).
English: The minimal duration of treatment before concluding failure is 2 months.
Slovenian: Preden se zaključi, da je zdravljenje neuspešno, mora trajati najmanj 2 meseca.
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.
Slovenian: Odbor CHMP je upošteval tudi pripombe tretjih oseb, tj. bolnikov in zdravstvenih delavcev, ki jih je prejel med postopkom ocenjevanja in ki so poudarili, da je pomembno zagotoviti, da bo to zdravilo še naprej na voljo populaciji, ki je sicer majhna, vendar ima malo drugih terapevtskih možnosti za izčrpavajočo bolezen ali pa sploh nobene.
English: • Therefore the CHMP was of the opinion that the benefit-risk balance of methysergide containing products:
Slovenian: • posledično je odbor CHMP menil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo metizergid:
English: The results of these studies are suggestive of the efficacy of methysergide compared to placebo in the prophylaxis of migraine.
Slovenian: Rezultati teh študij kažejo na učinkovitost metizergida v primerjavi s placebom pri preprečevanju migrene.
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.
Slovenian: Odbor CHMP je priporočil tudi, da naj zdravljenje z metizergidom uvedejo in nadzorujejo zdravniki specialisti, ki imajo izkušnje z zdravljenjem migrene in glavobola v rafalih.
English: The CHMP has considered the totality of the available data on the safety and efficacy of methysergide.
Slovenian: Odbor CHMP je proučil vse razpoložljive podatke o varnosti in učinkovitosti metizergida.
English: No data was submitted in support of efficacy of methysergide in the “treatment of diarrhoea caused by carcinoid disease”, and it is therefore considered that efficacy in this indication has not been demonstrated.
Slovenian: V podporo učinkovitosti metizergida pri indikaciji „zdravljenje driske, ki jo povzroča karcinoidna bolezen,“ niso bili predloženi nobeni podatki, zato se šteje, da učinkovitost pri tej indikaciji ni bila dokazana.
English: In addition, risk minimisation measures can be put in place to minimise the risk of fibrosis.
Slovenian: Poleg tega se lahko sprejmejo ukrepi za zmanjšanje tveganja za fibrozo;
English: In particular, it binds to and is an antagonist of the 5HT2B receptor.
Slovenian: Še zlasti se veže na receptor 5-HT2B in je tudi njegov antagonist.
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.
Slovenian: Ob upoštevanju vseh razpoložljivih podatkov je odbor CHMP menil, da obstaja nekaj dokazov o klinično pomembni učinkovitosti metizergida pri profilaktičnem zdravljenju hude in izčrpavajoče migrene.
English: The real incidence rate might be under-estimated and the risk of fibrosis is probably higher.
Slovenian: Mogoče je, da je bila incidenca v resnici višja, tako da je tveganje za fibrozo verjetno večje.
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.
Slovenian: Poleg tega je odbor CHMP upošteval, da strokovnjaki metizergid priporočajo za reševalno zdravljenje, ki se uporablja pri bolnikih, pri katerih druga zdravila niso bila učinkovita.
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:
Slovenian: Potem ko je proučil vse podatke, ki jih je v pisni obliki predložil imetnik dovoljenja za promet z zdravilom, je odbor CHMP zaključil, da je razmerje med tveganji in koristmi metizergida ugodno pri indikacijah:
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.
Slovenian: • odbor je upošteval, da ni dokazov o učinkovitosti metizergida pri zdravljenju driske, ki jo povzroča karcinoidna bolezen, zaradi česar je ugotovljeno tveganje večje od možne koristi za bolnike pri tej indikaciji;
English: Overall, the CHMP considered that methysergide seems to benefit a small patient population of migraine and cluster headache patients.
Slovenian: Na splošno je odbor CHMP menil, da je metizergid koristen za majhno populacijo bolnikov z migreno in glavobolom v rafalih.
English: Kudrow L. Cluster Headache Mechanisms and management.
Slovenian: Epub 2012 Dec 13. 11 Kudrow L. Cluster Headache Mechanisms and management.
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.
Slovenian: Na podlagi kliničnih izkušenj strokovnjakov za glavobole je znanstveno svetovalna skupina presodila, da obstaja majhen delež bolnikov, ki trpijo za migreno in glavobolom v rafalih, ki ima koristi od zdravljenja z metizergidom, potem ko predhodna zdravljenja niso bila uspešna.
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.
Slovenian: Odbor CHMP je proučil mnenje znanstveno svetovalne skupine, ki je priporočila sprejetje nekaterih ukrepov za zmanjšanje tveganja za fibrozne reakcije, kadar se bolniku predpiše metizergid.
English: In a more recent review14, methysergide and verapamil were cited as the most useful treatments of the episodic form of cluster headache.
Slovenian: V enem od novejših pregledov14 so metizergid in verapamil navedli kot najučinkovitejši zdravili za epizodni glavobol v rafalih.
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.
Slovenian: Odbor CHMP je upošteval, da dokazi o učinkovitosti metizergida pri profilaktičnem zdravljenju glavobola v rafalih, ki so jih pridobili v kliničnih preskušanjih, niso tako zanesljivi kot dokazi, povezani s preprečevanjem migrene, in da je večina študij imela številne pomanjkljivosti.
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.
Slovenian: • odbor je menil, da obstaja nekaj dokazov o klinično pomembni učinkovitosti metizergida pri profilaktičnem zdravljenju hude izčrpavajoče migrene in glavobola v rafalih, za zdravljenje katerih obstaja malo drugih možnosti.
English: Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
Slovenian: Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
English: • the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Slovenian: • profilaktično zdravljenje hude trdovratne migrene (z avro ali brez nje) s funkcionalno nezmožnostjo pri odraslih.
English: Clin Pharmacol Ther 19645:201-204
Slovenian: Clin Pharmacol Ther 19645:201-204 5 Curran DA, Lance JW.
English: − Is favourable for the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Slovenian: − je ugodno za profilaktično zdravljenje hude trdovratne migrene (z avro ali brez nje) s funkcionalno nezmožnostjo pri odraslih.
English: − Is favourable for the prophylactic treatment of episodic and chronic cluster headache in adults.
Slovenian: − je ugodno za profilaktično zdravljenje epizodnega in kroničnega glavobola v rafalih pri odraslih.
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.
Slovenian: Pri indikaciji „glavobol v rafalih“ se je predlagatelj skliceval na pregled11, ki je pokazal, da je metizergid učinkovit pri preprečevanju glavobola v rafalih, še zlasti epizodnega, in na študijo12, v kateri so pri
English: • The Committee considered that a causal association between methysergide and fibrotic reactions is likely based on available data (mainly relating to retroperitoneal fibrosis).
Slovenian: • odbor je menil, da razpoložljivi podatki (ki se v glavnem nanašajo na retroperitonealno fibrozo) kažejo, da verjetno obstaja vzročna povezava med metizergidom in fibroznimi reakcijami.
English: Grounds for variation to the terms of the marketing authorisations Whereas
Slovenian: Podlaga za spremembo pogojev dovoljenj za promet z zdravilom
English: • the prophylactic treatment of episodic and chronic cluster headache in adults.
Slovenian: • profilaktično zdravljenje epizodnega in kroničnega glavobola v rafalih pri odraslih.
English: There are a number of pharmacological pathways by which methysergide may be effective in preventing migraine, for instance some data support the role of antagonism of the 5-HT2B receptor in the prophylaxis of migraine.
Slovenian: Nekateri podatki na primer kažejo, da ima pri preprečevanju migrene vlogo antagonistično delovanje na receptor 5-HT2B.
English: 23 Graham JR, Suby HI, LeCompte PR, Sadowsky NL. Fibrotic disorders associated with methysergide therapy for headache.
Slovenian: Respir Crit Care Med 2006;174(7):810-6. 23 Graham JR, Suby HI, LeCompte PR, Sadowsky NL. Fibrotic disorders associated with methysergide therapy for headache.
English: 24 van Bommel EFH, Jansen I, Hendriksz TR, Aarnoudse ALHJ.
Slovenian: N Engl J Med 1966;274(7):359-68. 24 van Bommel EFH, Jansen I, Hendriksz TR, Aarnoudse ALHJ.
English: 10 Lanteri-Minet M et al. Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
Slovenian: 2009 Sep;16(9):968-81. 10 Lanteri-Minet M et al. Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
English: This should be taken into consideration.
Slovenian: To je treba upoštevati.
English: Date of first authorisation: 16 August 2016.
Slovenian: Datum prve odobritve: 16. avgust 2016
English: An updated RMP should be submitted: ● At the request of the European Medicines Agency;
Slovenian: Posodobljen RMP je treba predložiti: ● na zahtevo Evropske agencije za zdravila;
English: In this short period, a risk to the suckling child cannot be excluded.
Slovenian: V tem kratkem obdobju tveganja za dojenega otroka ni možno izključiti.
English: % reduction
Slovenian: % zmanjšanja
English: *** Patients weighing more than 188 kg were not studied.
Slovenian: *** Bolnikov, ki tehtajo več kot 188 kg, niso preučili.
English: Results were supported by the secondary efficacy endpoints and were in line with the overall population.
Slovenian: Rezultate so podprli sekundarni opazovani dogodki učinkovitosti in so bili skladni s celotno populacijo.
English: • Serious allergic reactions
Slovenian: • Resne alergijske reakcije
English: b CI = Confidence interval.
Slovenian: b IZ = interval zaupanja.
English: These cases resulted in the discontinuation of treatment.
Slovenian: V teh primerih je prišlo do prenehanja zdravljenja.
English: LT-08409 Vilnius Lithuania
Slovenian: LT-08409 Vilnius Litva
English: Patients should be instructed on how to recognise symptoms of serious allergic reactions.
Slovenian: Bolnikom je treba dati navodila za prepoznavanje simptomov resnih alergijskih reakcij.
English: A decision to continue the therapy should be made at least annually based on disease severity and level of exacerbation control.
Slovenian: Odločitev o nadaljevanju zdravljenja je treba sprejeti vsaj enkrat letno na podlagi resnosti bolezni in ravni nadzora poslabšanja.
English: The infusion will take about 20 to 50 minutes.
Slovenian: Infuzija bo trajala približno 20 do 50 minut.
English: Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better.
Slovenian: NE prenehajte zdravljenja z zdravilom CINQAERO, razen če vam tako naroči zdravnik, tudi če se počutite boljše.
English: This medicine is NOT intended for use in children and adolescents below the age of 18 years.
Slovenian: To zdravilo NI namenjeno za uporabo pri otrocih in mladostnikih, stari manj kot 18 let.
English: Patients below 35 kg or above 199 kg
Slovenian: Bolniki pod 35 kg ali nad 199 kg
English: Subgroup GINA 4 and 5
Slovenian: Podskupina GINA 4 in 5
English: Any concentrate remaining in the vial must be discarded.
Slovenian: Preostali koncentrat v viali je treba zavreči.
English: The concentrate does not contain any preservatives.
Slovenian: Koncentrat ne vsebuje konzervansov.
English: Your doctor will work out the right dose for you.
Slovenian: Zdravnik bo določil za vas primeren odmerek.
English: The recommended dose is based on patient body weight and should only be adjusted for significant changes in body weight.
Slovenian: Priporočeni odmerek temelji na bolnikovi telesni masi in ga je treba prilagoditi samo za znatne spremembe v telesni masi.
English: Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Slovenian: Anafilaktična reakcija (glejte poglavje 4.4) se je pojavila pri manj kot 1 % bolnikov.
English: CINQAERO will be given every 4 weeks.
Slovenian: Zdravilo CINQAERO vam bo dano na vsake 4 tedne.
English: Over 52 weeks
Slovenian: 52. tednu.
English: Elimination Reslizumab clearance is approximately 7 mL/hour.
Slovenian: Izločanje Očistek reslizumaba je približno 7 ml/uro.
English: Always follow the instructions exactly as your doctor has told you.
Slovenian: Vedno natančno upoštevajte navodila zdravnika.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste dobili to zdravilo.
English: Possible side effects”).
Slovenian: Možni neželeni učinki").
English: Maintenance OCS was not allowed.
Slovenian: Vzdrževalni PKS ni bil dovoljen.
English: The active substance in this medicine may pass into breast milk but only during the first few days after birth.
Slovenian: Učinkovina v tem zdravilu lahko prehaja v materino mleko, vendar le prvih nekaj dni po porodu.
English: Mean number of exacerbations in previous year
Slovenian: Povprečno število poslabšanj v preteklem letu
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.
Slovenian: Zaradi majhne velikosti vzorca in izhodiščnega neravnovesja, ki je bilo posledica analize podskupine, ni mogoče izpeljati zaključkov glede učinkovitosti pri astmi pri pediatrični populaciji.
English: cohort of 763 patients within Studies I and II met this criterion; the primary efficacy outcome is presented in Table 4.
Slovenian: Kohorta 763 bolnikov v študijah I in II je ta kriterije izpolnjevala in primarni izidi učinkovitosti so predstavljeni v preglednici 4.
English: There are limited safety data in non-white ethnic populations.
Slovenian: V nebelskih etničnih skupinah so varnostni podatki omejeni.
English: - if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na reslizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Inter-individual variability in peak and overall exposure is approximately 20-30%
Slovenian: Med posamezniki so razlike največje in celokupne izpostavljenosti približno 20 do 30 %.
English: Interrupting or stopping treatment with this medicine may cause your asthma symptoms to come back.
Slovenian: Prekinitev ali ustavitev zdravljenja s tem zdravilom lahko povzroči, da se simptomi astme ponovijo.
English: Overall, 2,195 subjects received at least one dose of reslizumab.
Slovenian: Skupaj je 2.195 oseb prejelo vsaj en odmerek reslizumaba.
English: In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity.
Slovenian: Podatki in vitro kažejo, da ni verjetno, da bi IL-5 in reslizumab vplivala na aktivnost CYP1A2, 3A4 ali 2B6.
English: The concentrate must not be used if coloured (except slightly yellow) or if foreign particles are present.
Slovenian: Koncentrata se ne sme uporabiti, če je obarvan (razen rahlo rumen) ali so v njem tujki.