FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies, the most common side effects with Zostavax are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising), headache and pain in the arm or leg.
Maltese: FL-istudji, l-iktar effetti sekondarji komuni b'Zostavax huma reazzjonijiet fis-sit tal-injezzjoni (ħmura, uġigħ, nefħa, ħakk, sħana u tbenġil), uġigħ ta' ras u wġigħ fl-id u s-sieq.
English: What is Zostavax?
Maltese: Kif jintuża Zostavax?
English: What is the risk associated with Zostavax?
Maltese: X'inhu r-riskju assoċjat ma' 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.
Maltese: Minn dawn, 389 kellhom bejn 50 u 59 sena.
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.
Maltese: L-istudju ewlieni li sar dwar Zostavax qabbel lil dan il-vaċċin ma' plaċebo ( finta) f'madwar 39,000 pazjent ta' bejn id-59 u d-99 sena.
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).
Maltese: Zostavax ma għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal xi wieħed mill-komponenti talvaċċin, jew għal xi sustanzi li jisabu fil-vaċċin f'livelli ta' traċċi (baxxi ħafna) bħan-neomiċina (antibijotiku).
English: How has Zostavax been studied?
Maltese: Kif ġie studjat Zostavax?
English: How is Zostavax used?
Maltese: Kif jaħdem Zostavax?
English: The active substance is the attenuated (weakened) varicella-zoster virus.
Maltese: Is-sustanza attiva tiegħu huwa l-vajrus ħaj (imdgħajjef) tal-variċella-zoster.
English: Herpes zoster, or shingles, is a disease caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox.
Maltese: Il-ħruq ta' Sant'Antnin, jew shingles, hija marda kkawżata mill-virus tal-variċella-zoster, li huwa l-istess vajrus li jikkawża l-ġidri r-riħ.
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).
Maltese: Zostavax jintuża biex jingħata f'vaċċin lil persuni ta' ħamsin sena jew iżjed sabiex jiġi evitat l-iżvilupp tal-ħruq ta' Sant'Antnin (magħruf ukoll bħala zoster jew shingles) u l-uġigħ fin-nervituri fit-tul li s-soltu jsegwi ‘l din il-marda (nevralġija post-ħerpetika).
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.
Maltese: Dan il-vaċċin ma għandux jintuża minn persuni li jkollhom problemi fis-sistema immunitarja, kemm minħabba li jkunu jbatu minn xi marda bħal-lewkimja, il-linfoma jew is-sindromu mill-immunodefiċenza akkwiżita (AIDS), jew minħabba li jkunu qed jieħdu xi mediċini li jkollhom effett fuq is-sistema immunitarja.
English: The risk of developing shingles increases with age and seems to be linked to a decline in immunity (protection) against varicella-zoster virus.
Maltese: Ir-riskju tal-ħruġ tal-ħruq ta' Sant'Antnin huwa assoċjat ma' dgħajfien fid-difiża immunitarja (protezzjoni) kontra l-virus tal-variċella-zoster.
English: The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving.
Maltese: L-istudju sar f'għamad doppju (double-blind trial), li jfisser li la ttabib u lanqas il-pazjent ma kienu jafu liema trattament kienu qed jirċievu l-pazjenti.
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.
Maltese: Wara l-ħruġ tal-ġidri r-riħ, il-vajrus tal-variċellazoster jibqa' fil-ġisem, sewwasew fis-sistema nervuża, fi stat rieqed (inattiv).
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.
Maltese: L-istudji stħarrġu l-ħila tal-vaċċin li jistimula l-produzzjoni ta' antibijotiċi kontra l-virus tal-variċella-zoster fid-demm erba' ġimgħat wara l-għoti tat-titqiba.
English: 23 August 2012
Maltese: 23 ta' Awwissu 2012
English: What is Zinnat?
Maltese: X'inhu Zinnat?
English: It is also available under other trade names: Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos, Zoref.
Maltese: Jiġi wkoll b'ismijiet kummerċjali oħrajn: Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos, Zoref.
English: Questions and answers on Zinnat and associated names (cefuroxime axetil, 125, 250 and 500 mg tablets and 125, 250 and 500 mg granules for oral suspension) EMA/CHMP/339191/2012
Maltese: Mistoqsijiet u tweġibiet dwar Zinnat u ismijiet assoċjati (cefuroxime axetil, pilloli ta' 125, 250 u 500 mg u frak ta' 125, 250 u 500 mg għal sospensjoni orali) EMA/CHMP/339191/2012
English: On 24 May 2012, the European Medicines Agency completed a review of Zinnat.
Maltese: Fl-24 ta' Mejju 2012 l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Zinnat.
English: Zinnat is an antibiotic used to treat certain infections caused by bacteria, including respiratory tract infections such as tonsillitis and pharyngitis (infections of the throat), urinary tract infections (infections of the structures that carry urine), skin infections, soft-tissue infections (infections of tissues just below the skin) and Lyme disease (bacterial infection transmitted to humans by infected ticks).
Maltese: Zinnat huwa antibijotiku użat għall-kura ta' ċerti infezzjonijiet ikkawżati minn batterji, inklużi infezzjonijiet tal-apparat respiratorju bħalt-tonsillite u l-farinġite (infezzjonijiet tal-gerżuma), infezzjonijiet fl-apparat urinarju (infezzjonijiet tal-istrutturi li jġorru l-awrina), infezzjonijiet fil-ġilda, infezzjonijiet fit-tessuti rotob (infezzjonijiet fit-tessuti li jinsabu eżatt taħt il-ġilda) u l-marda Lyme (infezzjoni batterjali li tittieħed minn qurdien infettat).
English: The active substance, cefuroxime axetil, belongs to the group ‘cephalosporins'.
Maltese: Is-sustanza attiva, is-cefuroxime axetil, tappartieni lill-grupp taċ-‘ċefalosporini'.
English: Zinnat was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Ġie identifikat li Zinnat jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproki u Deċentralizzati - Umani (CMD(h)).
English: The CHMP also harmonised other sections of the SmPC including sections 4.3 (contra-indications) and 4.4 (special warnings and precautions for use).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħra tal-SmPC, inklużi s-sezzjonijiet 4.3 (Kontraindikazzjonijiet) u 4.4 (Twissijiet speċjali u prekawzjonijiet għall-użu).
English: Questions and answers on Zinnat and associated names (cefuroxime axetil, 125, 250 and 500 mg tablets and 125, 250 and 500 mg granules for oral suspension)
Maltese: Mistoqsijiet u tweġibiet dwar Zinnat u ismijiet assoċjati (cefuroxime axetil, pilloli ta' 125, 250 u 500 mg u frak ta' 125, 250 u 500 mg għal sospensjoni orali)
English: • Acute exacerbations (flares-up) of chronic bronchitis.
Maltese: • Taħrix akut (flares up) ta' bronkite kronika.
English: Zinnat is authorised in the EU via national procedures.
Maltese: Zinnat huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: • Pyelonephritis (kidney infection).
Maltese: • Pajelonefrite (infezzjoni tal-kliewi).
English: • Acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat).
Maltese: • Tonsillite u farinġite streptokokkali akuta (infezzjonijiet tat-tunsilli u tal-gerżuma).
English: • Treatment of early Lyme disease.
Maltese: • Kura fil-bidu tal-marda Lyme.
English: • Acute bacterial sinusitis (infection of the sinuses).
Maltese: • Sinużite batterjali akuta (infezzjoni tas-sinus).
English: On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Zinnat in the EU.
Maltese: Fl-20 ta' April 2010, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Zinnat fl-UE kollha.
English: • Cystitis (infection of the bladder).
Maltese: • Ċistite (infezzjoni tal-bużżieqa tal-awrina).
English: • Acute otitis media (infection of the middle ear).
Maltese: • Otite medja akuta (infezzjoni fil-widna tan-nofs).
English: Why was Zinnat reviewed?
Maltese: Għaliex ġie rivedut Zinnat?
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinnat in adults and children and in patients with reduced kidney and liver function.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar l-użu ta' Zinnat f'adulti u fi tfal u f'pazjenti b'funzjoni tal-kliewi u tal-fwied mnaqqsa.
English: The CHMP concluded that Zinnat should be used in adults and children from three months of age for the following conditions:
Maltese: Is-CHMP ikkonkluda li Zinnat għandu jintuża f'adulti u fi tfal minn tliet xhur 'il fuq għall-indikazzjonijiet li ġejjin:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Zinnat in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li kien jenħtieġ li linformazzjoni tal-preskrizzjoni għal Zinnat tiġi armonizzata fl-Unjoni Ewropea (UE) kollha.
English: The CHMP agreed that Zinnat should no longer be used to treat community acquired pneumonia (infection of the lungs acquired outside the hospital) and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae) because not enough clinical data are available to support these indications.
Maltese: Is-CHMP qabel li Zinnat m'għandux jintuża aktar għall-kura tal-pnewmonja li tittieħed mill-komunità (infezzjoni tal-pulmuni li tittieħed barra l-isptar) u tal-gonorroea (infezzjoni trażmessa sesswalment ikkawżata mill-batterji msejħa Neisseria gonorrhoeae) minħabba li għad m'hemmx biżżejjed dejta klinika li tappoġġja dawn l-indikazzjonijiet.
English: • Uncomplicated skin and soft tissue infections.
Maltese: • Infezzjonijiet mhux ikkumplikati tal-ġilda u tat-tessuti rotob.
English: The CHMP also decided that Zinnat should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.
Maltese: Is-CHMP iddeċieda wkoll li Zinnat m'għandux jintuża aktar fit-terapija sekwenzjali (meta l-pazjenti jinqalbu minn kura b'injezzjonijiet għal kura orali) minħabba tnaqqis kunsiderevoli fl-espożizzjoni għassustanza attiva meta l-pazjent jaqleb għall-formulazzjoni orali.
English: 1 ed. Oxford: Oxford University Press; 1980.
Maltese: Oxford: Oxford University Press; 1980.
English: Cephalalgia 1989;9 (SUPPL.
Maltese: A clinical experience. Cephalalgia 1989;9 (SUPPL.
English: Silberstein SD.
Maltese: Silberstein SD. Methysergide.
English: J Neurol Neurosurg Psychiatry 1964; 27:463-9.
Maltese: Neurosurg Psychiatry 1964; 27:463-9.
English: Lancet 1964 Jul 3;523-4.
Maltese: Jul 3;523-4.
English: Lovshin LL. Use of methysergide in the treatment of extracranial vascular headache.
Maltese: Use of methysergide in the treatment of extracranial vascular headache.
English: 14 Pradalier A, Baudesson G, Vincent D, Imberty-Campinos C. Treatment of the cluster headache.
Maltese: 14 Pradalier A, Baudesson G, Vincent D, Imberty-Campinos C.
English: Krabbe A. Limited efficacy of methysergide in cluster headache.
Maltese: Limited efficacy of methysergide in cluster headache.
English: 2006 Oct;13(10):1066-77.
Maltese: Eur J Neurol. 2006 Oct;13(10):1066-77.
English: Eur J Neurol.
Maltese: 1016/j.neurol.
English: Lance JW et al. An evaluation of methysergide in the prevention of migraine and other vascular headaches.
Maltese: An evaluation of methysergide in the prevention of migraine and other vascular headaches.
English: 7 Whewell J. Methysergide in prophylaxis of migraine: a clinical trial in general practice.
Maltese: Methysergide in prophylaxis of migraine: a clinical trial in general practice.
English: 2009 Sep;16(9):968-81.
Maltese: Eur J Neurol. 2009 Sep;16(9):968-81. 10
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for methysergide containing medicinal products.
Maltese: • Is-CHMP ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom methysergide.
English: The real incidence rate might be under-estimated and the risk of fibrosis is probably higher.
Maltese: Ir-rata ta' inċidenza reali jaf tkun sottovalutata u r-riskju ta' fibrożi huwa probabbilment ogħla.
English: In 2011, a French national pharmacovigilance review reported serious cases of valvulopathy, pulmonary, pleural and retroperitoneal fibrosis associated with methysergide containing medicinal products.
Maltese: Fl-2011, reviżjoni nazzjonali Franċiża tal-farmakoviġilanza rrapportat każijiet serji ta' valvulopatija, fibrożi pulmonari, plewrali u retroperitonali assoċjati ma' prodotti mediċinali li fihom methysergide.
English: 10 Lanteri-Minet M et al. Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
Maltese: Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
English: For the indication “prophylaxis of migraine”, data were submitted from randomised, double-blind, placebo-controlled studies1,2,3,4.
Maltese: Għall-indikazzjoni “profilassi tal-emigranja”, ġiet sottomessa dejta minn studji magħżula b'mod każwali, double-blind u kkontrollati bi plaċebo.1,2,3,4.
English: Raghu G, Weycker D, Edelsberg J, Bradford WZ, Oster G. Incidence and prevalence of idiopathic pulmonary fibrosis.
Maltese: Raghu G, Weycker D, Edelsberg J, Bradford WZ, Oster G.
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.
Maltese: Ir-rati ta' inċidenza tal-fibrożi valvulari u pulmonari f'pazjenti kkurati b'methysergide kienu jidhru simili għal dawk tal-popolazzjoni ġenerali19,20,21,22.
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.
Maltese: Fir-rigward tar-riskju ta' fibrożi retroperitonali, hemm evidenza ta' riskju akbar f'pazjenti kkurati b'methysergide (200 meta mqabbel ma' 1.3 għal kull 100 000 pazjent)23,24.
English: 15 May A, Leone M, Afra J et al. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias.
Maltese: EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias.
English: 2013 Jan;169(1):14-29. doi: 10.1016/j.neurol.2012.07.022.
Maltese: Neurol (Paris). 2013 Jan;169(1):14-29. doi: 10.
English: Benefit-risk balance
Maltese: Reference programme:
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.
Maltese: Is-CHMP innota wkoll li methysergide huwa inkluż bħala kura tat-tieni għażla fl-aħħar rakkomandazzjonijiet ta' kuri preventivi għal uġigħ ta' ras f'naħa waħda tar-ras tal-EFNS (2006)15 u huwa inkluż ukoll fil-lista ta' terapiji preventivi għal uġigħ ta' ras f'naħa waħda tar-ras f'linji gwida ppubblikati dan l-aħħar16,17,18.
English: In order to evaluate the safety of methysergide, the CHMP considered data from literature and safety database including spontaneous and literature reports.
Maltese: Sabiex tiġi evalwata s-sigurtà ta' methysergide, is-CHMP ikkunsidra d-dejta mid-dokumentazzjoni u ddatabase tas-sigurtà inkluż rapporti spontanji u ta' dokumentazzjoni.
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.
Maltese: Is-CHMP innota wkoll li methysergide huwa inkluż fl-aħħar rakkomandazzjonijiet ta' kuri preventivi talemigranja tal-Federazzjoni Ewropea tas-Soċjetajiet Newroloġiċi (EFNS; 2009)9 bħala mediċina tat-tielet għażla għall-profilassi tal-emigranja għal użu għal żmien qasir biss, u fl-aħħar rakkomandazzjonijiet Franċiżi tal-2013 bħala Grad B jew C (probabbilment effettiva) għall-profilassi tal-emigranja10.
English: 18 Bendtsen L, Birk S, Kasch H et al. Reference programme: Diagnosis and treatment of headache disorders and facial pain.
Maltese: 18 Bendtsen L, Birk S, Kasch H et al.
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.
Maltese: Steffensen C, Maegbaek ML, Laurberg P, Andersen M, Kistorp CMN, Norrelund H, et al.
English: Shekelle RB, Ostfeld AM. Methysergide in the migraine syndrome.
Maltese: Shekelle RB, Ostfeld AM.
English: Curran DA, Lance JW.
Maltese: Lance JW et al.
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.
Maltese: Xi reazzjonijiet fibrotiċi huma maħsuba li huma assoċjati ma' attivazzjoni persistenti tal-agonisti tar-riċettur 5-HT2B, kura fit-tul b'methysergide ser tesponi lill-pazjenti għallpotenzjal ta' fibrożi tat-tessut medjata mill-metabolit attiv prinċipali tagħha, methylergometrine.
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.
Maltese: EFNS guideline on the drug treatment of migraine - revised report of an EFNS task force.
English: 2 Pedersen E, Møller CE. Methysergide in migraine prophylaxis.
Maltese: Methysergide in migraine prophylaxis.
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.
Maltese: Meta wieħed iqis in-numru ta' każijiet ta' fibrożi rrapportati u s-sottorapportar probabbli, ir-riskju ta' reazzjonijiet fibrotiċi assoċjati ma' methysergide ma jistax jiġi eskluż.
English: • The Committee considered that a causal association between methysergide and fibrotic reactions is likely based on available data (mainly relating to retroperitoneal fibrosis).
Maltese: • Il-Kumitat ikkunsidra li assoċjazzjoni kawżali bejn methysergide u r-reazzjonijiet fibrotiċi x'aktarx li hija bbażata fuq id-dejta disponibbli (prinċipalment relatata ma' fibrożi retroperitonali).
English: Overall summary of the scientific evaluation of methysergide containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom methysergide (ara Anness I)
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.
Maltese: L-SAG ikkunsidra wkoll li l-pazjenti għandhom jiġu sorveljati fil-linja bażi u kull sitt xhur waqt il-kura (ultrasound tal-qalb, immaġni b'riżonanza manjetika tal-addome (MRI), testijiet tal-funzjoni pulmonari) sabiex ikunu jistgħu jiġu identifikati l-fibrożi kollha qabel ma jkunu seħħew reazzjonijiet severi u potenzjalment irriversibbli.
English: Such adverse effects may be serious and in some cases irreversible and potentially fatal.
Maltese: Tali effetti avversi jistgħu jkunu serji u f'xi każijiet irriversibbli u potenzjalment fatali.
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.
Maltese: Double-blind crossover comparison of BC-105, methysergide, and placebo in the prophylaxis of migraine headache.
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.).
Maltese: Is-CHMP innota li l-fibrożi tista' tkun avveniment ta' periklu għall-ħajja u li xi wħud mir-reazzjonijiet fibrotiċi retroperitonali rrapportati huma severi ħafna (fibrożi tal-ureteru, stenting uretiku bilaterali, nefrostomija bilaterali, eċċ.).
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.
Maltese: Fid-dawl tad-dejta ġenerali disponibbli, is-CHMP huwa tal-opinjoni li hemm xi evidenza ta' effikaċja klinikament sinifikanti ta' methysergide fil-kura profilattika ta' emigranja severa u debilitanti.
English: − Is favourable for the prophylactic treatment of episodic and chronic cluster headache in adults.
Maltese: − Huwa favorevoli għall-kura profilattika ta' uġigħ ta' ras episodiku u kroniku f'naħa waħda tarras (cluster headache) fl-adulti.
English: • the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Maltese: • il-kura profilattika ta' emigranja intrattabbli severa (bi jew mingħajr awra) b'diżabilità funzjonali fl-adulti.
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.
Maltese: Fir-rigward tal-indikazzjoni “uġigħ ta' ras f'naħa waħda tar-ras”, l-applikant irrefera għal reviżjoni11 li indikat l-effikaċja profilattika ta' methysergide, b'mod partikolari għall-forma episodika ta' uġigħ ta' ras f'naħa waħda tar-ras u għal studju12 fejn 69 % tal-pazjenti li jsofru minn uġigħ ta' ras f'naħa waħda tarras irrapportaw li kellhom riżultati tajbin sa eċċellenti.
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.
Maltese: Hemm numru ta' passaġġi farmakoloġiċi li permezz tagħhom methysergide jista' jkun effikaċi biex jipprevjeni l-emigranja, pereżempju xi dejta tappoġġja r-rwol tal-antagoniżmu tar-riċettur 5-HT2B fil-profilassi tal-emigranja.
English: Methysergide is an ergot alkaloid, first described in clinical practice in 1959.
Maltese: Methysergide huwa ergot alkaloid, li ġie deskritt għall-ewwel darba fil-prattika klinika fl-1959.
English: − Is favourable for the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Maltese: − Huwa wieħed favorevoli għall-kura profilattika ta' emigranja intrattabbli severa (bi jew mingħajr awra) b'diżabilità funzjonali fl-adulti.
English: • Therefore the CHMP was of the opinion that the benefit-risk balance of methysergide containing products:
Maltese: • Għaldaqstant, is-CHMP kien tal-opinjoni li l-bilanċ tal-benefiċċju-riskju ta' prodotti li fihom methysergide: