FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zostavax.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Zostavax.
English: Two further studies looked at Zostavax in over 1,000 patients aged 50 years or older, of whom 389 were between 50 and 59 years of age.
Croatian: Provedena su dva dodatna ispitivanja lijeka Zostavax u više od 1 000 bolesnika u dobi od 50 godina ili starijih, od kojih je 389 bilo u dobi od 50 do 59 godina.
English: Why has Zostavax been approved?
Croatian: Zašto je Zostavax odobren?
English: What is Zostavax?
Croatian: Što je Zostavax?
English: For more information about treatment with Zostavax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zostavax pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The vaccine must not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma, acquired immune deficiency syndrome (AIDS), or because they are taking medicines that affect the immune system.
Croatian: Cjepivo se ne smije primjenjivati u osoba koje imaju problema s imunološkim sustavom, bilo da boluju od leukemije, limfoma, sindroma stečene imunodeficijencije (AIDS) ili zbog toga što uzimaju lijekove koji utječu na imunološki sustav.
English: A risk management plan has been developed to ensure that Zostavax is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Zostavax.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zostavax, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Zostavax nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Zostavax shingles (herpes zoster) vaccine (live)
Croatian: Zostavax cjepivo protiv herpes zostera (živo)
English: The studies looked at the ability of the vaccine to stimulate the production of antibodies against varicella-zoster virus in the blood, four weeks after injection.
Croatian: Ispitivanja su bila usmjerena na sposobnost cjepiva da potakne proizvodnju protutijela protiv virusa varicella-zoster u krvi, četiri tjedna nakon primanja injekcije.
English: The risk of developing shingles increases with age and seems to be linked to a decline in immunity (protection) against varicella-zoster virus.
Croatian: Rizik od razvoja herpes zostera povećava se s godinama i čini se da je povezan sa smanjenjem imunosti na virus varicella-zoster.
English: Zostavax must not be used in people who are hypersensitive (allergic) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine such as neomycin (an antibiotic).
Croatian: Zostavax se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na neki od sastojaka cjepiva ili na neke od tvari koje su prisutne u cjepivu u tragovima (u vrlo malim količinama), kao što je neomicin (antibiotik).
English: Herpes zoster, or shingles, is a disease caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox.
Croatian: Herpes zoster bolest je koju uzrokuje ponovna aktivacija virusa varicella-zoster, istog virusa koji uzrokuje vodene kozice.
English: Fewer people developed shingles after vaccination with Zostavax than placebo: 315 of the 19,254 patients who received Zostavax had shingles during the study, compared with 642 of the 19,247 who received placebo.
Croatian: Broj osoba u kojih se razvio herpes zoster bio je manji u skupini koja je primila cjepivo Zostavax nego u skupini koja je primila placebo: 315 od 19 254 bolesnika koji su primili Zostavax imalo je herpes zoster tijekom ispitivanja, u usporedbi s 642 od 19 247 bolesnika koji su primili placebo.
English: The main study of Zostavax compared the vaccine with placebo (a dummy) vaccine in around 39,000 patients aged between 59 and 99 years.
Croatian: Tijekom glavnog ispitivanja cjepivo Zostavax uspoređeno je s placebom (lažnim cjepivom) u 39 000 bolesnika u dobi od 59 do 99 godina.
English: The active substance is the attenuated (weakened) varicella-zoster virus.
Croatian: Djelatna je tvar atenuirani (oslabljeni) virus varicella-zoster.
English: Zostavax is given as a single dose injected under the skin or into the muscle, preferably around the shoulder.
Croatian: Zostavax se daje kao jednokratna doza koju se ubrizgava pod kožu ili u mišić, po mogućnosti u nadlakticu.
English: The additional two studies showed that patients vaccinated with Zostavax had blood levels of antibodies against varicella-zoster virus that were about two to three times higher four weeks after vaccination.
Croatian: Ta dva dodatna ispitivanja pokazala su da su bolesnici koji su primili cjepivo Zostavax imali dva do tri puta više razine protutijela protiv virusa varicella-zoster u krvi četiri tjedna nakon cijepljenja.
English: Zostavax is a vaccine that is available as a powder and solvent to be made up into a solution for injection.
Croatian: Zostavax je cjepivo dostupno kao prašak i otapalo od kojih se priprema otopina za injekciju.
English: The CHMP decided that Zostavax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka Zostavax nadmašuju s njim povezane rizike te je za njega preporučio izdavanje odobrenja za stavljanje u promet.
English: Zostavax is a vaccine that was shown to ‘boost' this immunity, protecting against shingles and the pain associated with it.
Croatian: Zostavax je cjepivo za koje se pokazalo da pojačava tu imunost, štiteći osobu od herpes zostera i boli povezane s njim.
English: Zostavax was also more effective than placebo in preventing post-herpetic neuralgia: 27 of the Zostavax patients had post-herpetic neuralgia, compared with 80 in the placebo group.
Croatian: Zostavax je bio djelotvorniji od placeba u sprečavanju postherpetične neuralgije: postherpetična neuralgija zabilježena je u 27 bolesnika koji su primili Zostavax, u usporedbi s 80 bolesnika u skupini koja je primila placebo.
English: Zostavax is used to vaccinate people aged 50 years or older, to prevent herpes zoster (also known as zoster or shingles) and the long-lasting nerve pain that may follow the disease (post-herpetic neuralgia).
Croatian: Zostavax se koristi za cijepljenje osoba u dobi od 50 godina ili starijih radi sprečavanja herpes zostera (zostera) i dugotrajne neuropatske boli nakon herpes zostera (postherpetične neuralgije).
English: What is Zostavax used for?
Croatian: Za što se Zostavax koristi?
English: What benefit has Zostavax shown during the studies?
Croatian: Koje su koristi lijeka Zostavax utvrđene u ispitivanjima?
English: The rash takes usually several weeks to clear, and may be followed by severe long-lasting pain (post-herpetic neuralgia) in the area where the rash was.
Croatian: Osip može trajati nekoliko tjedana i može dovesti do jakih i dugotrajnih bolova (postherpetične neuralgije) na dijelovima zahvaćenima osipom.
English: Shingles develops in people who have had chickenpox earlier in life, generally as a child. After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘dormant' (inactive) state.
Croatian: Nakon što osoba preboli vodene kozice, virus varicella-zoster ostaje u tijelu, u živčanom sustavu, u stanju „mirovanja” (neaktivnom stanju).
English: How is Zostavax used?
Croatian: Kako se Zostavax koristi?
English: Sometimes, after many years, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful,
Croatian: Katkad se virus ponovno aktivira nakon mnogo godina i iz ne posve jasnih razloga te bolesnik razvije herpes zoster, bolan osip u obliku mjehurića koji obično nastaje na jednom dijelu tijela.
English: How does Zostavax work?
Croatian: Kako Zostavax djeluje?
English: For the full list of all side effects reported with Zostavax, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Zostavax potražite u uputi o lijeku.
English: 1 ed. Oxford: Oxford University Press; 1980.
Croatian: Oxford: Oxford University Press; 1980.
English: Methysergide containing products are currently authorised in the following EU countries: Belgium, France, the Netherlands and the United Kingdom.
Croatian: Lijekovi koji sadrže metizergid trenutno su odobreni u sljedećim državama EU-a: Belgija, Francuska, Nizozemska i Ujedinjena Kraljevina.
English: Such adverse effects may be serious and in some cases irreversible and potentially fatal.
Croatian: Takve nuspojave mogu biti ozbiljne i u nekim slučajevima ireverzibilne te potencijalno smrtonosne.
English: The CHMP highlighted that these results should be taken with caution as these studies are old and generally not carried out with the current upto-date methodology8.
Croatian: CHMP je istaknuo da te rezultate treba tumačiti s oprezom jer su ta ispitivanja stara i općenito nisu provedena u skladu s aktualnom, suvremenom metodologijom8.
English: Benefit-risk balance
Croatian: Procjena koristi i rizika
English: Serious intolerance or contra-indication to a first line drug is regarded as treatment failure.
Croatian: Ozbiljna intolerancija ili kontraindikacija na lijek prve linije liječenja smatra se neuspješnom terapijom.
English: Two studies, one observational and one prospective, reported less convincing evidence13 where around 26% patients had satisfactory, good or excellent outcomes.
Croatian: Dva ispitivanja, jedno opservacijsko i jedno perspektivno, zabilježila su manje uvjerljiv dokaz13 pri čemu je 26 % bolesnika imalo zadovoljavajuće, dobre ili izvrsne ishode.
English: This is provided that the recommended risk minimisation measures are implemented;
Croatian: To je pod uvjetom da su usvojene preporučene mjere smanjenja rizika;
English: Existing data seems to show that fibrosis development is not related to patient age.
Croatian: Čini se da aktualni podaci pokazuju da razvoj fibroze nije povezan s bolesnikovom dobi.
English: The majority of patients (92.4%) who developed fibrosis received daily doses of methysergide within the currently recommended (≤ 6 mg/day).
Croatian: Većina pacijenata koji su razvili fibrozu (92,4 %) primali su dnevne doze metizergida unutar trenutno preporučenih raspona doza (≤ 6 mg/dan).
English: The indication should be restricted to patients with functional disability in whom other treatments have failed.
Croatian: Indikaciju treba ograničiti na pacijente s funkcionalnom onesposobljenošću kod kojih druge terapije nisu bile djelotvorne.
English: This is subject to the agreed warnings, other changes to the product information and additional risk minimisation measures.
Croatian: Ovo je podložno dogovorenim upozorenjima, ostalim promjenama u informacijama o lijeku i dodatnim mjerama smanjenja rizika.
English: The incidence rates of valvular and pulmonary fibrosis in patients treated with methysergide was shown to be similar to those of the general population19,20,21,22.
Croatian: Stope incidencije valvularne i plućne fibroze u bolesnika liječenih metizergidom pokazale su se slične onima u općoj populaciji19,20,21,22.
English: Methysergide is an ergot alkaloid, first described in clinical practice in 1959.
Croatian: Metizergid je ergot alkaloid koji je prvo opisan u kliničkoj praksi 1959.
English: In addition, development of fibrosis appears to be correlated to treatment duration, as most patients developed fibrotic events after long-term therapy (at least one year).
Croatian: Pored toga, čini se da je razvoj fibroze povezan s trajanjem liječenja jer je većina bolesnika razvila fibrotičke događaje nakon dugoročne terapije (najmanje godinu dana trajanja).
English: The minimal duration of treatment before concluding failure is 2 months.
Croatian: Minimalno trajanje liječenja prije proglašenja terapije neuspješnom je 2 mjeseca.
English: In order to evaluate the safety of methysergide, the CHMP considered data from literature and safety database including spontaneous and literature reports.
Croatian: Za procjenu sigurnosti metizergida CHMP je razmatrao podatke iz literature i baze podataka o sigurnosti, uključujući spontana i literaturna izvješća.
English: However, cases have also been reported with treatment duration up to six months, so occurrence of fibrosis with short-term treatment cannot be excluded.
Croatian: Međutim, također su zabilježeni slučajevi s trajanjem terapije do 6 mjeseci pa se pojava fibroze s kratkoročnom terapijom ne može isključiti.
English: In this respect, the CHMP took note of the fact that one of the marketing authorisation holders of the products for which this indication is approved informed the CHMP of their intention to voluntarily withdraw the indication “diarrhoea caused by carcinoid syndrome”.
Croatian: U tom smislu CHMP je uzeo u obzir činjenicu da je jedan od nositelja odobrenja za lijekove za koje je indikacija odobrena obavijestio CHMP o svojoj namjeri da dobrovoljno povuče indikaciju „proljev uzrokovan karcinoidnom bolešću”.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for methysergide containing medicinal products.
Croatian: • Povjerenstvo je razmatralo postupak u skladu s člankom 31. Direktive 2001/83/EZ za lijekove koji sadrže metizergid.
English: Regarding the risk of retroperitoneal fibrosis, there is evidence of increased risk in patients treated with methysergide (200 versus 1.3 per 100 000 patients)23,24.
Croatian: U vezi s rizikom od retroperitonealne fibroze, postoji dokaz povećanog rizika u bolesnika liječenih metizergidom (200 naspram 1,3 na 100 000 bolesnika)23,24.
English: The real incidence rate might be under-estimated and the risk of fibrosis is probably higher.
Croatian: Stvarna stopa incidencije možda je i podcijenjena, a rizik od fibroze vjerojatno je veći.
English: For the indication “prophylaxis of migraine”, data were submitted from randomised, double-blind, placebo-controlled studies1,2,3,4.
Croatian: Za indikaciju „profilaksa migrene” podaci su predani iz randomiziranih, dvostruko slijepih, placebom kontroliranih ispitivanja1,2,3,4.
English: In 2011, a French national pharmacovigilance review reported serious cases of valvulopathy, pulmonary, pleural and retroperitoneal fibrosis associated with methysergide containing medicinal products.
Croatian: Tijekom nacionalnog pregleda farmakovigilancijskih podataka u Francuskoj 2011. prijavljeni su ozbiljni slučajevi valvulopatije, plućne, pleuralne i retroperitonealne fibroze povezani s lijekovima koji sadrže metizergid.
English: Since fibrotic reactions are believed to be associated with persistent agonist activation of the 5-HT2B receptor, long-term treatment with methysergide will expose patients to the potential for tissue fibrosis mediated by its principal active metabolite, methylergometrine.
Croatian: S obzirom da se vjeruje da su fibrotičke reakcije povezane s perzistentnom aktivacijom agonista receptora 5-HT2B, dugoročno liječenje metizergidom izložit će bolesnike potencijalnoj fibrozi tkiva koja je posredovana njegovim glavnim aktivnim metabolita, metilergometrina.
English: • The Committee considered that a causal association between methysergide and fibrotic reactions is likely based on available data (mainly relating to retroperitoneal fibrosis).
Croatian: • Povjerenstvo je smatralo da se uzročna povezanost između metizergida i fibrotičkih reakcija vjerojatno temelji na dostupnim podacima (koji se uglavnom odnose na retroperitonealnu fibrozu).
English: In addition, further trials comparing methysergide with placebo or comparators were also presented, some of which also showed efficacy of methysergide compared to placebo in this indication5,6,7.
Croatian: Pored toga, prikazana su i daljnja ispitivanja kojima se metizergid uspoređivao s placebom, od kojih su neka također dokazala djelotvornost metizergida u usporedbi s placebom u ovoj indikaciji5,6,7.
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.
Croatian: CHMP je potvrdio savjet Znanstvene savjetodavne skupine (SAG) koja se sastala u rujnu 2013., a kojom prilikom su stručnjaci na temelju svog kliničkog iskustva raspravljali je li moguće definirati populaciju za koju postoji terapijska potreba za peroralnim lijekovima koji sadrže metizergid kada je standardna terapija za te indikacije neučinkovita.
English: These included restricted duration of treatment, optimal dose of treatment, specialist supervision and information for prescribing physicians and patients' organisation.
Croatian: To uključuje ograničeno trajanje liječenja, optimalnu dozu lijeka, nadzor liječnika specijalista i informacije za liječnike propisivače i udruženja bolesnika.
English: Warnings on the risk of fibrosis should be included in the product information, alongside measures to monitor patients for development of fibrosis, and these should also be communicated to prescribers and patients using educational material.
Croatian: Upozorenja o riziku od fibroze treba uključiti u informacije o lijeku zajedno s mjerama za nadzor bolesnika u slučaju razvoja fibroze, a iste također treba priopćiti propisivačima i bolesnicima u edukativnim materijalima.
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.
Croatian: CHMP je također napomenuo da je metizergid uključen u najnovije preporuke za prevenciju migrene Europske federacije neuroloških udruženja (EFNS; 2009.)9 kao lijek trećeg izbora za profilaksu migrene samo za kratkoročnu uporabu te u najnovijim francuskim preporukama iz 2013. kao lijek razreda B ili C (vjerojatno djelotvoran) za profilaksu migrene10.
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.
Croatian: • Povjerenstvo je pregledalo sve dostupne podatke o djelotvornosti i sigurnosti lijekova koji sadrže metizergid, posebice s obzirom na rizik od fibrotičkih reakcija.
English: Methysergide binds with varying affinities to a range of serotonergic receptors (5-HT receptors).
Croatian: Metizergid se veže s promjenjivim afinitetom na niz serotoninergičnih receptora (5-HT receptori).
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.
Croatian: Postoje brojni farmakološki putevi kojima metizergid može uspješno djelovati u sprječavanju migrene pa tako primjerice neki podaci podržavaju ulogu antagonizma receptora 5-HT2B u profilaksi migrene.
English: Taking into account the number of fibrosis cases reported and the probable under reporting, the risk of fibrotic reactions associated with methysergide cannot be excluded.
Croatian: Uzimajući u obzir broj prijavljenih slučajeva fibroze i vjerojatno nepotpuno prijavljivanje, rizik od fibrotičkih reakcija povezanih s metizergidom ne može se isključiti.
English: However, in view of the demonstrated risk of fibrosis, adequate risk minimisation measures should be put in place.
Croatian: Međutim, u smislu dokazanog rizika od fibroze, treba postaviti odgovarajuće mjere smanjenja rizika.
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.
Croatian: CHMP je nadalje napomenuo da je metizergid uključen kao lijek drugog izbora u najnovije preporuke za preventivne terapije cluster glavobolje EFNS-a (2006.)15 te je također uključen u popis preventivnih terapija za cluster glavobolju u nedavno objavljenim smjernicama16,17,18.
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.
Croatian: Nisu predočeni nikakvi podaci koji bi podržali djelotvornost metizergida u „liječenju proljeva uzrokovanog karcinoidnom bolešću” te se stoga smatra da djelotvornost u ovoj indikaciji nije dokazana.
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).
Croatian: Metizergid je trenutno indiciran u profilaksi migrenske glavobolje, cluster glavobolje i također u liječenju proljeva uzrokovanog karcinoidnom bolešću (specifični tekst indikacije može se razlikovati od lijeka do lijeka).
English: In particular, it binds to and is an antagonist of the 5HT2B receptor.
Croatian: Posebice se veže na receptor 5HT2B te je antagonist receptora 5HT2B.
English: Methysergide is to be used only following unsuccessful treatment with other standard classes of drugs after sufficient treatment duration (at least 4 months) at the maximal tolerated dose.
Croatian: Metizergid treba koristiti samo nakon neuspješnih terapija drugim standardnim razredima lijekova nakon dostatnog trajanja liječenja (najmanje 4 mjeseca) pri najvećoj toleriranoj dozi.
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.).
Croatian: CHMP je napomenuo da fibroza može biti po život opasan događaj i da je zabilježeno nekoliko vrlo teških retroperitonealnih fibrotičkih reakcija (fibroza mokraćne cijevi, bilateralno suženje mokraćne cijevi, bilateralna nefrostomija itd.).
English: J Neurol Neurosurg Psychiatry 1964; 27:463-9.
Croatian: Neurosurg Psychiatry 1964; 27:463-9.
English: In addition, risk minimisation measures can be put in place to minimise the risk of fibrosis.
Croatian: Pored toga, mogu se implementirati mjere smanjenja rizika kako bi se smanjio rizik od fibroze.
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.
Croatian: SAG je također smatrao da bolesnike treba nadzirati na početku liječenja te potom svakih 6 mjeseci (ultrazvuk srca, snimanje abdomena magnetskom rezonancijom (NMR), testiranje funkcije pluća) kako bi se moglo identificirati sve fibrotičke reakcije prije nego se pojave ozbiljne i potencijalno ireverzibilne reakcije.