FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Maltese: Id-doża tista' tiżdied aktar f'intervalli ta' ġimgħatejn skont ir-rispons tal-pazjent, għal doża massima ta' 1,500 mg darbtejn kuljum.
English: 1 bottle + 1 oral syringe + 1 bottle adapter
Maltese: 1 flixkun + 1 siringi orali + 1 adapter talflixkun
English: Oral suspension Oral use bottle (glass)
Maltese: Suspensjoni orali fliexken (ħġieġ)
English: Further information on Emgality can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance galcanezumab.
Maltese: Fih is-sustanza attiva galcanezumab.
English: Other information about Emgality
Maltese: Informazzjoni oħra dwar Emgality
English: The active substance of Emgality, galcanezumab, is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size.
Maltese: Is-sustanza attiva ta' Emgality, il-galcanezumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex teħel ma' CGRP u timblokkaha, biex b'hekk tgħin lill-vażijiet jirritornaw għad-daqs normali tagħhom.
English: In two studies involving 1,784 patients who had migraines between 4 and 14 days a month, those treated with Emgality had 4 or 5 fewer days with migraines per month, compared with 2 to 3 fewer days for patients on a placebo injection.
Maltese: F'żewġ studji li fihom ħadu sehem 1,784 pazjent li kellhom emigranja bejn erbat ijiem u 14-il jum fixxahar, dawk ikkurati b'Emgality kellhom erbat ijiem jew ħamest ijiem inqas b'emigranja fix-xahar, meta mqabbla mal-jumejn jew tlett ijiem għall-pazjenti li ngħataw injezzjoni tal-plaċebo.
English: What are the risks associated with Emgality?
Maltese: X'inhuma r-riskji assoċjati ma' Emgality?
English: As for all medicines, data on the use of Emgality are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Emgality hija ssorveljata kontinwament.
English: The most common side effects with Emgality (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.
Maltese: L-effetti sekondarji l-aktar komuni b'Emgality (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni bħal uġigħ, ħmura, ħakk, tbenġil jew nefħa.
English: In a third study of 1,117 patients who had migraines for more than 15 days a month on average (chronic migraine), those treated with Emgality had on average around 5 fewer days with migraines per month compared with around 3 fewer days for patients on placebo.
Maltese: Fit-tielet studju ta' 1,117-il pazjent li kellhom emigranji għal aktar minn 15-il jum fix-xahar bħala medja (emigranja kronika), dawk ikkurati b'Emgality kellhom, bħala medja, madwar ħamest ijiem inqas b'emigranja fix-xahar meta mqabbla ma' madwar tlett ijiem inqas għall-pazjenti fuq plaċebo.
English: This will stop the symptoms of migraine.
Maltese: Dan iwaqqaf is-sintomi tal-emigranja.
English: How is Emgality used?
Maltese: Emgality?
English: Why is Emgality authorised in the EU?
Maltese: Għaliex Emgality huwa awtorizzat fl-UE?
English: Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Maltese: Emgality huwa mediċina użata biex tipprevjeni l-emigranja f'adulti li jkollhom emigranja minn talanqas erbat ijiem fix-xahar.
English: For the full list of side effects and restrictions of Emgality, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Emgality ara l-fuljett ta' tagħrif.
English: Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.
Maltese: Intwera li Emgality hu aktar effettiv mill-plaċebo biex inaqqas in-numru tal-jiem b'emigranja, għalkemm id-daqs tal-effett hu limitat b'mod partikolari għall-pazjenti b'emigranja kronika.
English: The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
Maltese: L-effetti sekondarji rrappurtati b'Emgality huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ml).
Maltese: Fih is-sustanza attiva 5-aminolevulinic acid hydrochloride (30 mg/ml).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GLIOLAN EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) GLIOLAN Sommarju ta' l-EPAR għall-pubbliku
English: After six months, 20.5% of the patients given Gliolan were still alive without progression, compared with 11.0% of those who did not receive the medicine.
Maltese: 5% tal-pazjenti li ngħataw Gliolan kienu għadhom ħajjin mingħajr progress, meta mqabbla ma' 11.0% ta' dawk li ma rċevewx il-mediċina.
English: The active substance in Gliolan, 5-aminolevulinic acid, is a ‘sensitiser used in photodynamic therapy'.
Maltese: Is-sustanza attiva fi Gliolan, 5-aminolevulinic acid, hija ‘sensitizzatur użat f'terapija fotodinamika'.
English: Other information about Gliolan:
Maltese: Informazzjoni oħra dwar Gliolan:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gliolan to m e d a c Gesellschaft für klinische Spezialpräparate mbH on 7 September 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Gliolan lil m e d a c Gesellschaft für klinische Spezialpräparate mbH fis-7 ta' Settembru 2007.
English: The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase).
Maltese: L-effetti negattivi li huma l-iktar komuni (f'iktar minn pazjent 1 kull 10) huma l-anemija (livell baxx ta' ċelloli ħomor), tromboċitopenja (livell baxx ta' pjastrini), lukoċitożi (livell għoli ta' lukoċiti, tip ta' ċelloli bojod) u livelli għoljin ta' enzimi tal-fwied fid-demm (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase u amylase).
English: At 72 hours after the operation, 63.6% of the patients given Gliolan had no visible tumour on a brain scan, compared with 37.6% of those who did not receive Gliolan.
Maltese: 72 siegħa wara l-operazzjoni, 63.6% tal-pazjenti li ngħataw Gliolan ma kellhomx tumur viżibbli fuq l-immaġini skennjata tal-moħħ meta mqabbla ma' 37.6% ta' dawk li ma rċevewx Gliolan.
English: It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
Maltese: Hija assorbita miċ-ċelloli fil-ġisem, fejn din tiġi maqluba minn enzimi f'sostanzi kimiċi fluworexxenti, b'mod partikolari protoporphyrin IX (PPIX).
English: The summary of opinion of the Committee for Orphan Medicinal Products for Gliolan is available here.
Maltese: Is-sommarju ta' l-opinjoni tal-Kumitat għal Prodotti Mediċinali Orfni għal Gliolan huwa disponibbli minn hawnhekk.
English: This summary was last updated in 07-2007.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2007.
English: What is Gliolan?
Maltese: Gliolan.
English: Because the number of patients with malignant glioma is low, the disease is considered ‘rare', and Gliolan was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 November
Maltese: Minħabba li n-numru ta' pazjenti bi glijoma malinna huwa wieħed baxx, il-marda hija meqjusa ‘rari', u Gliolan ġie kklassifikat bħala ‘mediċina orfni' (mediċina wżata f'mard rari) fit-13 ta' Novembru
English: What is the risk associated with Gliolan?
Maltese: X'inhuma r-riskji assoċjati ma' Gliolan?
English: Gliolan is used in adult patients with malignant glioma (a type of brain tumour).
Maltese: Gliolan jintuża f'pazjenti adulti bi glijoma (tip ta' tumur tal-moħħ) malinna.
English: Why has Gliolan been approved?
Maltese: Għaliex ġie approvat Gliolan?
English: When illuminated under blue light of a specific wavelength, the PPIX in the tumour glows an intense red, while the normal brain tissue appears blue.
Maltese: Meta illuminat taħt dawl blu ta' wavelength speċifiku, il-PPIX fit-tumur jiddi b'kulur aħmar qawwi, filwaqt li t-tessut tal-moħħ normali jidher blu.
English: Gliolan has been studied in one main study involving 415 patients with malignant glioma who were about to undergo brain surgery to remove the tumour.
Maltese: Gliolan ġie studjat fi studju wieħed ewlieni li involva 415-il pazjent bi glijoma malinna li kienu ser jagħmlu operazzjoni fuq il-moħħ biex jitneħħielhom it-tumur.
English: Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Maltese: Gliolan m'għandux jintuża f'nies li huma sensittivi żżejjed (allerġiċi) għal 5-aminolevulinic acid jew għal hydrochloride jew porphyrins.
English: Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution.
Maltese: It-trab ta' Gliolan għandu jiddewweb f'50 ml ilma tal-vit mill-infermiera jew spiżjar qabel ma' l-pazjent jixrob is-soluzzjoni.
English: The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised.
Maltese: Id-doża rakkomandata ta' Gliolan hija 20 mg għal kull kilogramm tal-piż tal-ġisem, meħuda bejn sagħtejn jew erba' sigħat qabel ma' l-pazjent jingħata anesteżija.
English: The most common side effects seen with Gliolan are due to a combination of the medicine itself, as well as anaesthesia and the removal of the tumour.
Maltese: L-iktar effetti sekondarji komuni li jidhru bi Gliolan huma dovuti għall-kombinazzjoni tal-mediċina infisha, għall-anasteżija u għat-tneħħija tat-tumur.
English: How is Gliolan used?
Maltese: X'inhu Gliolan?
English: The Committee decided that Gliolan's benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Maltese: Il-kumitat iddeċieda li l-benefiċċji ta' Gliolan jisbqu r-riskji tiegħu għall-viżwalizzazzjoni ta' tessut malinn waqt il-kirurġija ta' glijoma malinna.
English: Gliolan should only be used by experienced brain surgeons who are familiar with surgery of malignant glioma, who have an in-depth knowledge of the anatomy of the brain, and who have completed a training course in surgery guided by fluorescence.
Maltese: Għall-ewwel, l-effetti ta' Gliolan ġew ittestjati f'mudelli esperimentali qabel ma ġew studjati fuq ilbniedem.
English: How has Gliolan been studied?
Maltese: Kif ġie studjat Gliolan?
English: Gliolan is a powder to be made up into a solution to be taken by mouth.
Maltese: Huwa rakkomanda li Gliolan jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The full EPAR for Cancidas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • invasive candidiasis (an infection caused by Candida).
Maltese: • kandidjażi invażiva (infezzjoni kkawżata minn Candida).
English: The most common side effects with Cancidas in adults (which may affect up to 1 in 100 people) are reduced levels of haemoglobin or red blood cells, reduced white blood cell count, low levels of potassium in the blood, headache, inflammation of the veins, shortness of breath, nausea, diarrhoea, vomiting, raised levels of liver enzymes and bilirubin (which may indicate liver problems), rash, itching, redness of skin, excessive sweating, joint pain, fever, chills, itching at injection site, and reduced levels of albumin, a protein in the blood.
Maltese: L-effetti sekondarji l-aktar komuni b'Cancidas fl-adulti (li jistgħu jaffettwaw sa 1 minn kull 100 persuna) huma livelli mnaqqsa ta' emoglobina fiċ-ċelloli ħomor tad-demm, għadd imnaqqas ta' ċelloli bojod tad-demm, livelli baxxi ta' potassju fid-demm, uġigħ ta' ras, infjammazzjoni tal-vini, nuqqas ta' nifs, nawżja, dijarea, rimettar, żieda fil-livelli tal-enzimi tal-fwied u bilirubina (li tista' tindika problemi fil-fwied), raxx, ħakk, ħmura, għaraq eċċessiv, uġigħ fil-ġogi, deni, tertir, ħakk fuq il-post talinjezzjoni, u livelli mnaqqsa ta' albumina, proteina fid-demm.
English: This is a summary of the European public assessment report (EPAR) for Cancidas.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cancidas.
English: Other information about Cancidas
Maltese: Informazzjoni oħra dwar Cancidas
English: Cancidas contains the active substance caspofungin
Maltese: Cancidas jinkludi s-sustanza attiva l-caspofungin
English: Similar responses were seen in a study in 49 children and adolescents with either invasive candidiasis or invasive aspergillosis: 50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.
Maltese: Risponsi simili dehru fi studju fuq 49 tifel u tifla u adoloxxenti li kellhom jew kandidjażi invażiva jew asperiġillożi invażiva: 50% ta' dawk b'kandidjożi invażiva (5 minn 10) u 81% ta' dawk b'asperġillożi invażiva (30 minn 37) irrispondew għal Cancidas.
English: The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Maltese: Is-sustanza attiva f'Cancidas, il-caspofungin, tappartjeni għal grupp ta' mediċini antifungali magħrufin bħala ‘ekinokandini' (echinocandins).
English: Why is Cancidas approved?
Maltese: Għaliex ġie approvat Cancidas?
English: In a study of 239 adults with invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).
Maltese: Fi studju ta' 239 adult b'kandidjażi invażiva, 73% tal-adulti kkurati b'Cancidas li setgħu jiġu vvalutati kellhom rispons favorevoli (80 minn 109), meta mqabbla mat-62% tal-adulti kkurati b'amfoteriċina B (71 minn 115).
English: What are the risks associated with Cancidas?
Maltese: X'inhuma r-riskji assoċjati ma' Cancidas?
English: • invasive aspergillosis (an infection caused by Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines);
Maltese: • asperġillożi invażiva (infezzjoni kkawżati minn Aspergillus), meta l-pazjent ma jirrispondix għal jew ma jittollerax l-amfoteriċina B jew itraconazole (mediċini antifungali oħrajn);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Caspofungin MSD valida fl-Unjoni Ewropea kollha fl-24 ta' Ottubru 2001.
English: Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).
Maltese: Minn dawk li ma ttollerawx kuri oħrajn, 70% rrispondew għal Cancidas (7 minn
English: The list of fungi against which Cancidas is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Il-lista ta' fungi li Cancidas huwa attiv kontrihom tinstab fis-Sommarju tal-Karatteristiċi tal-Prodott (parti wkoll mill-EPAR).
English: Cancidas is an antifungal medicine used to treat the following fungal infections in adults and children:
Maltese: Cancidas huwa mediċina antifungali li tintuża biex tikkura l-infezzjonijiet fungali li ġejjin f'adulti u tfal:
English: The CHMP decided that evidence form the studies with Cancidas show that the medicines benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and for empirical therapy for presumed fungal infections, in adults or children.
Maltese: Is-CHMP iddeċieda li l-evidenza mill-istudji li saru b'Cancidas juru li l-benefiċċji tal-mediċina huma akbar mir-riskji tagħha għall-kura ta' kandidjażi jew asperġillożi invażiva, u għall-kura empirika għal infezzjonijiet fungali preżunti, fl-adulti u fit-tfal.
English: In adults, treatment starts with a 70 mg on the first day, followed by a daily dose of 50 mg, or 70 mg if the patient weighs more than 80 kg. A lower dose may be necessary in adults who have moderate problems with their liver.
Maltese: Fl-adulti, il-kura tinbeda b'doża ta' 70 mg fl-ewwel ġurnata, segwita b'doża ta' 50 mg kuljum, jew 70 mg jekk il-pazjent ikun jiżen iktar minn 80 kg.
English: It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to continue living and growing.
Maltese: Taħdem billi tinterferixxi mal-produzzjoni ta' komponent tal-ħajt taċ-ċellola fungali ‘glukan polisakkaride' (glucan polysaccharide), li hija meħtieġa biex il-fungu jkompli jgħix u jikber.
English: The name of the medicine was changed to Cancidas on 9 April
Maltese: L-isem tal-mediċina nbidel f'Cancidas fid-9 ta' April 2003.
English: Finally, in 2 studies of patients with suspected fungal infection who were treated empirically, Cancidas was as effective as amphotericin B. In one of studies involving around 1,000 adults, 34% of patients had a favourable response with either Cancidas or amphotericin B Similar results were seen in the second study, which involved 82 children aged between two and 17 years.
Maltese: F'wieħed mill-istudji li involva madwar 1,000 adult, 34% tal-pazjenti kellhom rispons favorevoli jew b'Cancidas jew b'amfoteriċina B.
English: Cancidas is a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Cancidas huwa trab li jitħallat biex isir soluzzjoni għall-infużjoni (dripp) fil-vina.
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is feverish and has low white blood cell counts.
Maltese: • suspett ta' infezzjonijiet fungali (bħal dawk dovuti għal Candida jew Aspergillus) meta l-pazjent ikollu d-deni u jkollu għadd baxx taċ-ċelloli bojod tad-demm.
English: In an invasive aspergillosis study involving 69 adults, 41% had a favourable response to Cancidas at the end of the study (26 out of 63).
Maltese: Fl-istudju ta' asperġillożi invażiva li involva 69 adult, 41% kellhom rispons favorevoli għal Cancidas fi tmiem l-istudju (26 minn 63). Mill-adulti li ma wrewx rispons għal kuri oħrajn, 36% rrispondew għal Cancidas (19 minn 53).
English: What measures are being taken to ensure the safe and effective use of Cancidas?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effikaċi ta' Cancidas?
English: It is not intended to provide practical advice on how to use Cancidas.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Cancidas.
English: Do not take for more than 3 days.
Maltese: Tiħux għal aktar minn 3 ijiem.
English: B. Labelling Carton
Maltese: B. Tikkettar Kartuna
English: Section 6.1 List of excipients [The following phrase is amended]
Maltese: Sezzjoni 6.1 Lista ta' eċċipjenti [Il-frażi li ġejja qed tiġi emendata]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti talIstati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, b'konformità mal-proċeduri stabbiliti f'Kapitlu 4 ta' Titolu III ta' Direttiva 2001/83/KE.
English: How to take {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets}
Maltese: X'fih {Paracetamol/Ibuprofen 500 mg/150 mg pilloli miksija b'rita}{Novogesic 500 mg/150 mg pilloli miksija b'rita}
English: The active substance ibuprofen shows an environmental risk for the aquatic environment especially to fish.
Maltese: Is-sustanza attiva ibuprofen turi riskju ambjentali għall-ambjent akwatiku, speċjalment għall-ħut.
English: [The following AEs are described as follows:] ‘Paraesthesia' to frequency Rare (moved from Very Rare) ‘Oedema' to frequency Common (moved from Very Rare)
Maltese: [L-AEs (Adverse Events - avvenimenti avversi) li ġejjin huma deskritti kif ġej:] ‘Parestesija' għal frekwenza Rari (iċaqilqet minn Rari Ħafna) ‘Edema' għal frekwenza Komuni (iċaqilqet minn Rari
English: [The following wording should be amended as follows] This medicinal product should not be taken with other medicinal products containing paracetamol, ibuprofen, acetylsalicylic acid, salicylates or with any other anti-inflammatory drugs (NSAIDs) unless under a doctor's instruction.
Maltese: [Il-frażi t'hawn taħt għandha tiġi emendata kif ġej] Dan il-prodott mediċinali m'għandux jittieħed ma' prodotti mediċinali oħra li jkun fihom paracetamol, ibuprofen, acetylsalicylic acid, salicylates jew ma' kwalunkwe mediċini antiinfjammatorji oħrajn (NSAIDs) ħlief jekk dan isir skont l-istruzzjonijiet ta' tabib.
English: Section 5.3 Preclinical data
Maltese: Sezzjoni 4.5
English: Annex III
Maltese: Sezzjoni 5
English: [The following phrase is deleted as it was duplication]
Maltese: [Il-frażi li ġejja qed titħassar għax hi ripetuta]
English: Renal Impairment
Maltese: ISTRUZZJONIJIET DWAR LUŻU
English: [The wording below should be inserted in this section] Treatment should be stopped in those patients who develop severe renal failure (see section 4.3).
Maltese: [Il-kitba t'hawn taħt għandha tiddaħħal f'din is-sezzjoni] Il-kura għandha titwaqqaf f'dawk il-pazjenti li jiżviluppaw insuffiċjenza severa tal-kliewi (ara sezzjoni 4.3).
English: Dose reduction is recommended in patients showing signs of worsening hepatic function.
Maltese: Tnaqqis fid-doża hu rakkomandat f'pazjenti li juru sinjali ta' aggravament tal-funzjoni tal-fwied.
English: The exact mechanism of action of ibuprofen is thought to be through peripheral inhibition of cyclooxygenases and subsequent prostaglandin synthesise inhibition.
Maltese: Hu maħsub li l-mekkaniżmu eżatt tal-azzjoni ta' ibuprofen hu permezz ta' inibizzjoni periferali ta' cyclooxygenases u inibizzjoni sussegwenti ta' prostaglandin synthesise.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: TWISSIJA(IET) SPEĊJALI
English: What {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets}contain macrogol/PEG 4000
Maltese: L-informazzjoni valida tal-prodott hi l-verżjoni finali miksuba matul il-proċedura tal-Grupp ta' Koordinazzjoni bl-emendi li ġejjin (inserzjoni, sostituzzjoni jew tħassir tal-kitba, kif xieraq) li jirriflettu l-kitba maqbula kif muri hawn taħt:
English: [The phrase below should be inserted] This medicine is for short term use and is not recommended for use beyond 3 days.
Maltese: [Il-kitba t'hawn taħt għandha tiddaħħal f'din is-sezzjoni] Tiħux għal aktar minn 3 ijiem.
English: Zero days
Maltese: Ġranet 0
English: EMEA/V/C/123
Maltese: EMEA/V/C/123 RAPPORT TA' VALUTAZZJONI
English: The vaccine contains a mineral oil.
Maltese: Il-vaċċin fih żejt minerali.
English: The virus used for the vaccine carries the H7 (haemagglutinin 7) and N1 (neuramidase 1) antigens.
Maltese: Il-vajrus użat fil-vaċċin iġorr l-antiġeni H7 (haemagglutinin 7) u n-N1 (neuramidase 1).
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tarrakkomandazzjonijiet ta' CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Vaccinated birds can be differentiated identified from infected birds by a diagnostic test for antibodies against the N1 component.
Maltese: Għasafar vaċċinati jistgħu jiġu differenzjati b'identifikazzjoni minn għasafar infettati permezz ta' test dijanjostiku għal antikorpi kontra l-komponent N1.