FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAHs therefore stated their intention to repeat the study, with a study report expected to be available by 15th November 2012.
Maltese: Għaldaqstant, l-MAHs iddikjaraw l-intenzjoni tagħhom li jirrepetu listudju, b'rapport tal-istudju mistenni li jkun disponibbli sal-15 ta' Novembru 2012.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study 10540314, submitted in support of the marketing authorisations, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to their reference product, the CHMP was unable to conclude on the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy.
Maltese: Għalhekk, minħabba d-dubji serji rigward l-affidabbiltà u l-korrettezza tad-dejta mill-istudju pivotali kritiku ta' bijoekwivalenza 10540314, sottomessa b'appoġġ għall-awtorizzazzjonijiet għat-tqegħid fis-suq, u finnuqqas ta' studju affidabbli ta' bijoekwivalenza speċifikament imfassal biex jistabbilixxi l-bijoekwivalenza ta' Fenofibrato Pensa u Fenofibrato Ranbaxy mal-prodott ta' referenza tagħhom, is-CHMP ma setax jikkonkludi dwar il-bijoekwivalenza ta' Fenofibrato Pensa u Fenofibrato Ranbaxy.
English: Other Cetero Research sites were not affected.
Maltese: Siti oħra ta' Cetero Research ma kinux affettwati.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to its EU reference product, the benefit-risk balance of Fenofibrato Pensa and Fenofibrato Ranbaxy cannot be considered to be favourable.
Maltese: Għalhekk, u fin-nuqqas ta' studju affidabbli ta' bijoekwivalenza speċifikament imfassal biex jistabbilixxi l-bijoekwivalenza ta' Fenofibrato Pensa u Fenofibrato Ranbaxy mal-prodott ta' referenza tiegħu tal-UE, ilbilanċ tal-benefiċċju-riskju ta' Fenofibrato Pensa u Fenofibrato Ranbaxy ma jistax jiġi kkunsidrat bħala favorevoli.
English: Having assessed the available data, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisations.
Maltese: Wara li vvaluta d-dejta disponibbli, is-CHMP kien għad fadallu dubji serji minħabba s-sejbiet tal-ispezzjoni tal-faċilitajiet ta' Cetero Research fi Houston (Texas, USA), dwar l-affidabbiltà u l-korrettezza tad-dejta mill-istudju pivotali kritiku ta' bijoekwivalenza sottomessa b'appoġġ tal-awtorizzazzjonijiet għat-tqegħid fissuq.
English: It is used alone or in conjunction with statins in the treatment of hypercholesterolemia and hypertriglyceridemia.
Maltese: Tintuża waħidha jew flimkien ma' statini fil-kura ta' iperkolesterolemija u ipertrigliċeridemija.
English: The EMA, CMD(h) and CHMP initiated a process to identify and assess all medicinal product dossiers that include studies conducted at the above mentioned facility during the identified time period.
Maltese: L-EMA, is-CMD (h) u s-CHMP bdew proċess biex jidentifikaw u jevalwaw id-dossiers kollha tal-prodott mediċinali li jinkludu studji li kienu saru fil-faċilità msemmija hawn fuq matul il-perjodu ta' żmien identifikat.
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Maltese: • Il-Kumitat ikkunsidra li d-dejta disponibbli qajmet dubji serji dwar l-evidenza tal-bijoekwivalenza ta' Fenofibrato Pensa u Fenofibrato Ranbaxy mal-prodott ta' referenza tal-UE fid-dawl tat-tħassib dwar laffidabbiltà tad-dejta, minħabba s-sejbiet tal-ispezzjoni tal-faċilitajiet ta' Cetero Research.
English: Bayer Pharma AG Müllerstrasse 170-178 D-13353, Berlin Germany
Maltese: Bayer Pharma AG Müllerstrasse 170-178 D-13353, Berlin Il-Ġermanja
English: Portugal ethinylestradiol: 0.02 mg Drospirenone: 3 mg
Maltese: Il-Portugall ethinylestradiol: 0.02 mg Drospirenone: 3 mg
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mnejn jingħata, l-applikanti fl-istati membri
English: Crospovidone Sodium laurylsulfate Macrogol 400
Maltese: Crospovidone Sodium laurilsulfate Macrogol 400
English: The elimination half-life (t1/2) is 1.38 (± 0.24) hours.
Maltese: Il-half-life ta' eliminazzjoni (t1/2) hu ta' 1.38 (± 0.24) sigħat.
English: 8 tablets 32 tablets 144 tablets 45 tablets
Maltese: 8 pilloli 32 pillola 144 pillola 45 pillola
English: Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, ATCvet code: QM01AH93
Maltese: Grupp farakoterpewtiku: mediċina anti-infjammatorja mhux sterojdi, Kodiċi ATCvet: QM01AH93
English: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011
Maltese: EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010
English: EU/2/10/119/012
Maltese: EU/2/10/119/011 EU/2/10/119/012
English: Vétoquinol SA Magny Vernois 70200 Lure France
Maltese: Vétoquinol SA Magny Vernois 70200 Lure Franza
English: Pack sizes of 8, 32 or 144 tablets.
Maltese: Daqsijiet tal-pakkett ta' 8, 32 jew 144 pillola.
English: Pack sizes of 45 tablets.
Maltese: Daqs tal-pakkett ta' 45 pillola.
English: The peak concentration (Cmax) is 0.3918 (± 0.09021) µg/ml, area under the curve (AUC) is 1.676 (± 0.4735) µg.hr/ml, and oral bioavailability is 44.53 (± 10.26) percent.
Maltese: L-ogħla konċentrazzjoni (Cmax) hi ta' 0.3918 (± 0.09021) µg/ml, l-erja taħt il-kurva (AUC) hi 1.676 (± 0.4735) µg.hr/ml, u l-bijodisponibbilità orali hi ta' 44.53 (± 10.
English: Vétoquinol SA Magny-Vernois 70200 Lure France
Maltese: Vétoquinol SA Magny-Vernois 70200
English: Sodium stearyl fumarate Pork liver powder
Maltese: Sodium stearyl fumarate Trab tal-fwied tal-majjal
English: The cyclo-oxygenase enzyme (COX) is present in two isoforms.
Maltese: L-enzima cyclo-oxygenase (COX) hija preżenti f'żewġ isoformi.
English: COX-1 is usually a constitutive enzyme expressed in tissues, which synthesize products responsible for normal physiologic functions (e.g. in the gastro-intestinal tract and kidneys).
Maltese: COX-1 hija ġeneralment enzima kostituttiva li tesprimi ruha fir-tessuti, li jissensitizzaw prodotti responsabbli għal funzjonijiet fiżjoloġiċi normali (eż. fil-passaġġ gastrointestinali u l-kliewi).
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: DATA TA' SKADENZA EXP {xahar/sena}
English: COX-2 is involved in the production of mediators, including PGE2, that induce pain, exudation, inflammation and fever.
Maltese: COX-2 huwa involut fil-produzzjoni ta' medjaturi, li jinkludu PGE2, li jinduċu uġigħ, tnixxija, infjammazzjoni u deni.
English: Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.
Maltese: Terapija sintomatika u ta' appoġġ li tikkonsisti billi jingħataw sustanzi ta' protezzjoni gastrointestinali u infużjoni ta' salina isotonika hija rakkomandata.
English: Cimicoxib is a non-narcotic, non-steroidal anti-inflammatory drug (NSAID) drug.
Maltese: Cimicoxib hija mediċina li mhix narkotika, taġixxi kontra l-infjammazzjoni u mhix sterojdi (NSAID).
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Maltese: .8 Effetti fuq prodotti mediċinali oħra u effetti oħra
English: Refer also to section 4.8
Maltese: Ara wkoll sezzjoni 4.8
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Maltese: IN-NUMRU TAL-LOTT TAL-MANIFATTUR Lot {numru}
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/119/001-012
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/119/001-012
English: Cimalgex 80 mg cimicoxib 80 mg For the full list of excipients see section 6.1.
Maltese: Cimalgex 80 mg cimicoxib 80 mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Cimicoxib may cause skin sensitisation.
Maltese: Cimicoxib jista‘ jikkaġuna sensibilizzazzjoni tal-ġilda.
English: The other metabolite, glucuronide conjugate of the demethylated cimicoxib, is eliminated in urine.
Maltese: Il-metabolit lieħor, konjugat ta' glucuronide ta' demethylated cimicoxib, huwa eliminat fl-awrina.
English: Metabolism of cimicoxib is extensive.
Maltese: Il-metaboliżmu ta' cimicoxib hu estensiv.
English: 4.11 Withdrawal period Not applicable.
Maltese: 4.11 Perjodu ta' Tiżmin
English: Treatment duration:
Maltese: Tqala u treddigħ:
English: • Management of peri-operative pain due to orthopaedic or soft tissue surgeries: one dose 2 hours prior to surgery, followed by 3 to 7 days of treatment, based on the judgment of the attending veterinarian.
Maltese: • Kontroll ta' uġigħ matul iż-żmien tal-operazzjoni waqt interventi kirurġiċi ortopediċi jew tat-tessut artab: doża waħda sagħtejn qabel il-kirurġija, segwita bi 3 sa 7 ijiem ta' kura, bażata fuq il-fehma tal-veterinarju tiegħek.
English: Cimicoxib is a non-steroidal anti-inflammatory drug belonging to the coxib group and acting by selective inhibition of the enzyme cyclo-oxygenase 2.
Maltese: Cimicoxib huwa mediċina anti-infjammatorja mhux sterojdi li jappartjeni għal grupp coxib u jaġixxi billi jimpedixxi l-enzima cyclo-oxygenase 2 b'mod silettiv.
English: In an overdose study where 3 times (5.8 to 11.8 mg/kg body weight) and 5 times (9.7 to 19.5 mg/kg body weight) the recommended dose was administered to dogs for a period of 6 months, a dose related increase in gastrointestinal disturbances, which affected all dogs in the highest dose group, was noted.
Maltese: Fi studju ta' doża eċċessiva fejn klieb ingħataw 3 darbiet (5.8 sa 11.8 mg/kg piż tal-ġisem) u 5 darbiet (9.7 sa 19.5 mg/kg piż tal-ġisem) id-doża rakkomandata għal perjodu ta' 6 xhur, ġie osservat li kien hemm żieda marbuta ma' disturbi gastrointestinali li affettwat il-klieb kollha fil-grupp li ngħata logħla doża.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/
English: The major metabolite, demethylated cimicoxib is mainly eliminated in faeces by the biliary route and, to a lesser extent, in urine.
Maltese: Il-metabolit ewlieni, demethylated cimicoxib huwa eliminat prinċipalment mal-ippurgar permezz tar-rotta biljarja u, bil-wisq inqas, mal-awrina.
English: STATEMENT OF MRLs
Maltese: DIKJARAZZJONI TAL- MRLs
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 8 mg cimicoxib
Maltese: ATTIVA(I) 8 mg cimicoxib
English: Each tablet contains: Cimicoxib 8 mg Cimicoxib 30 mg Cimicoxib 80 mg
Maltese: Cimicoxib 8 mg Cimicoxib 30 mg Cimicoxib 80 mg
English: Bodyweight kg
Maltese: Piż tal‐ ġisem kg
English: COX-2 on the other hand, is mainly inducible and synthesized by macrophages and inflammatory cells after stimulation by cytokines and other mediators of inflammation.
Maltese: COX-2 min-naħa l-oħra tiġi indotta u sintettizzata prinċipalment minn makrofaġi u ċelluli infjammatorji wara stimulazzjoni minn cytokines u medjaturi oħra talinfjammazzjoni.
English: The oral administration of cimicoxib with food did not significantly influence the bioavailability but decreased significantly the observed Tmax.
Maltese: It-teħid orali ta' cimicoxib mal-ikel ma influwenzax b'mod sinifikanti l-bijodisponibilità, imma naqqas b'mod sinifikanti t-Tmax osservata.
English: Cimalgex 8 mg tablets for dogs Cimalgex 30 mg tablets for dogs Cimalgex 80 mg tablets for dogs cimicoxib
Maltese: Cimalgex 8 mg pilloli għall-klieb Cimalgex 30 mg pilloli għall-klieb Cimalgex 80 mg pilloli għall-klieb cimicoxib
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 45 tablets
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 45 pillola
English: Furthermore, in very rare cases, renal failure has been reported.
Maltese: Barra minn hekk, f'każijiet rari ħafna ġie rrapurtat falliment tas-sistema renali.
English: • Management of peri-operative pain due to orthopaedic or soft tissue surgeries: one dose 2 hours prior to surgery, followed by 3 to 7 days of treatment, based on the judgment of your veterinary surgeon.
Maltese: • Kontroll ta' uġigħ matul iż-żmien tal-operazzjoni waqt interventi kirurġiċi ortopediċi jew tat-tessut artab: doża waħda sagħtejn qabel il-kirurġija, segwita bi 3 sa 7 ijiem ta' kura, bażati fuq il-fehma tal-veterinarju li qed jinvista.
English: • Plastic (HDPE) bottle with child resistant plastic (PP) closure packaged into an outer cardboard box.
Maltese: • Flixkun tal-plastik (HDPE) b'għatu tal-plastik reżistenti għal ftuħ mit-tfal (PP) li hu ppakkettat ġo kaxxa tal-kartun.
English: • Aluminium blisters (each strip containing 8 tablets) packaged into an outer cardboard box.
Maltese: • Folji tal-aluminju (kull strixxa fiha 8 pilloli) ippakkjata ġo kaxxa tal-kartun.
English: On rare occasions, serious gastrointestinal problems such as bleeding and ulcer formation have occurred.
Maltese: F'okkażjonijiet rari, seħħew problemi gastrointestinali serji bħal emorraġiji u formazzjoni ta' ulċeri.
English: The cyclooxygenase 1 enzyme (COX-1) which has protective functions, for example, in the digestive tract and kidneys, is not inhibited by cimicoxib.
Maltese: L-enzima cyclooxygenase 1 (COX-1) li għandha funzjonijiet protettivi, pereżempju fil-passaġġ diġestiv u l-kliewi, mhix imxekkla b'cimicoxib.
English: Disposal: Read Package Leaflet.
Maltese: Mhux id-daqsijiet tal-pakkett jistgħu qegħdin fis-suq.
English: In very rare cases, increases in renal biochemistry parameters were noted.
Maltese: F'każijiet rari ħafna, kienu nnotati żidiet fil-parametri bijokemkali tal-kliewi.
English: If adverse reactions such as persistent vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy or worsening of renal or hepatic biochemistry parameters occur, use of the product should be discontinued and appropriate monitoring and/or treatment should be put in place.
Maltese: Jekk reazzjonijiet avversi bħal remettar persistenti, dijarea ripetuta, demm li ma jidhirx fl-ippurgar, telf f'daqqa fil-piż, anoreksja, għeja kbira jew il-parametri bijokimiċi tal-kliewi jew tal-fwied jaqilbu għall-agħar, il-prodott għandu jitwaqqaf u monitoraġġ xieraq u/jew kura għandha tkun lesta biex tintuża.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Tużax fl-istess waqt ma' kortikoseterojdi jew mediċini anti-infjammatorji mhux sterojdi (NSAIDs) oħra.
English: In an in vivo inflammatory acute pain model, it was shown that the simulated effect of cimicoxib lasted for approximately 10-14 hours.
Maltese: F'mudell in vivo dwar uġigħ infjammatorju akut, intwera li l-effett ssimulat ta' cimicoxib baqa' sejjer għal madwar 10-14-il siegħa.
English: If adverse reactions such as persistent vomiting, repeated diarrhoea, blood in the stools, sudden weight loss, loss of appetite, lethargy or worsening of liver or kidney function results occur, use of the product should be discontinued and the advice of your veterinary surgeon should be sought immediately.
Maltese: Jekk reazzjonijiet avversi bħal remettar persistenti, dijarea ripetuta, demm li ma jidhirx fl-ippurgar, telf f'daqqa fil-piż, anoreksja, għeja kbira jew il-parametri bijokimiċi tal-kliewi jew tal-fwied imorru għall-agħar, il-prodott għandu jitwaqqaf u għandek fittex il-parir tat-tabib veterinarju tiegħek minnufih.
English: People with a known hypersensitivity to cimicoxib should avoid contact with the veterinary medicinal product.
Maltese: Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: PARIR BIEX TAMMINISTRA B'MOD KORRETT
English: Mild and transient gastro-intestinal disorders (vomiting and/or diarrhoea) were very commonly reported.
Maltese: Disturbi gastrointestinali ħfief u għaddiena (remettar u/jew dijarea) kienu rapportati b'mod komuni ħafna.
English: In very rare cases, increases in kidney function results (renal biochemistry parameters) were noted.
Maltese: F'każijiet rari ħafna, kienu nnotati li r-riżultati tal-funzjoni tal-kliewi (żidiet fil-parametri bijokimiċi tal-kliewi) kienu ogħla.
English: None known.
Maltese: 26) perċentwali.
English: It selectively inhibits the cyclooxygenase 2 enzyme (COX-2), which is responsible for pain, inflammation or fever.
Maltese: Huwa jimpedixxi b'mod silettiv l-enzima cyclooxygenase 2 (COX-2), li hi responsabbli għal uġigħ, infjammazzjoni jew deni.
English: After oral administration in dogs at the recommended dose of 2 mg/kg without food, cimicoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 2.25 (± 1.24) hours.
Maltese: Wara li jingħata mill-ħalq fil-klieb fid-doża rakkomandata ta' 2 mg/kg mingħajr ikel, cimicoxib jiġi assorbit malajr u l-ħin li jieħu sabiex jilħaq il-konċentrazzjoni massima (Tmax) hi ta' 2.25 (± 1.24) sigħat.
English: ROUTES OF ADMINISTRATION Oral use
Maltese: U METODU TA' AMMINISTRAZZJONI Użu orali.
English: Cimalgex 80 mg, tablets: oblong, white to pale brown, chewable tablets with 3 break-lines on both sides.
Maltese: Cimalgex 80 mg, pilloli: pilloli oblongi ta' lewn bajdani bojod għal kannella ċari, li jintmagħdu bi 3 ifruq fuq iż-żewġ naħat.
English: • Relief of pain and inflammation associated with osteoarthritis: 6 months.
Maltese: • Sabiex jittaffa l-uġigħ u l-infjammazzjoni marbuta ma' osteoartrite: 6 xhur.
English: SPECIAL STORAGE CONDITIONS
Maltese: KOMPOŻIZZJONI KWALITTATIVA
English: Do not use in breeding, pregnant or lactating animals (see Section 12 “Special precautions for dogs”).
Maltese: (ara sezzjoni 12 “Prekawzjonijiet speċjali għal klieb”).
English: Other adverse reactions including anorexia or lethargy may also be observed on rare occasions.
Maltese: Reazzjonijiet avversi oħra li jinkludu anoreksja jew għeja jistgħu jkunu osservati f'okkażjonijiet rari.
English: All strengths of Cimalgex tablets are available in the following pack sizes and types:
Maltese: Il-qawwiet kollha huma disponibbli fid-daqsijiet tal-pakkett u l-għamli li ġejjin:
English: Other adverse reactions including loss of appetite or lethargy may also be observed on rare occasions.
Maltese: Reazzjonijiet avversi oħra li jinkludu nuqqas t'aptit jew għeja jistgħu jkunu osservati f'okkażjonijiet rari.
English: For the treatment of pain and inflammation associated with osteoarthritis, and the management of perioperative pain due to orthopaedic or soft tissue surgery, in dogs.
Maltese: Għall-kura mill-uġigħ u l-infjammazzjoni marbuta ma' osteoartrite, u l-kontroll ta' uġigħ waqt interventi kirurġiċi minħabba kirurġija ortopedika jew kirurġija dovuta għal tessut artab, fil-klieb.
English: Cimalgex 30 mg, tablets: oblong, white to pale brown, chewable tablets with 2 break-lines on both sides.
Maltese: Cimalgex 30 mg, pilloli: pilloli oblongi ta' lewn bajdani bojod għal kannella ċari, li jintmagħdu b'2 ifruq fuq iż-żewġ naħat.
English: 22 May 2015 EMA/325007/2015
Maltese: EMA/325007/2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Mejju 2015
English: Salvo F, Fourrier-Reglat A, Bazin F, et al. Cardiovascular and gastrointestinal safety of NSAIDs: a systematic review of meta-analyses of randomized clinical trials.
Maltese: Salvo F, Fourrier-Reglat A, Bazin F, et al. Cardiovascular and gastrointestinal safety of NSAIDs: a systematic review of meta-analyses of randomized clinical trials. Clinical pharmacology and therapeutics 2011;89:855-66.
English: A dose of 2,400 mg per day of ibuprofen is equivalent to 1,200 mg per day of dexibuprofen.
Maltese: Doża ta' 2 400 mg kuljum ta' ibuprofen hija ekwivalenti għal 1 200 mg kuljum ta' dexibuprofen.
English: The review looked at data from several studies including:
Maltese: Ir-reviżjoni eżaminat dejta minn diversi studji inkluż:
English: Ibuprofen and dexibuprofen are currently available in the European Union (EU) in a number of different formulations.
Maltese: Ibuprofen u dexibuprofen huma attwalment disponibbli fl-Unjoni Ewropea (UE) f'numru ta' formulazzjonijiet differenti.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Maltese: 1 Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE), lill-Iżlanda, lilLiechtenstein u lin-Norveġja.
English: The usual dose for adults and children over 12 years of age is 200 to 400 mg, 3 or 4 times a day as needed.
Maltese: Id-doża tas-soltu għall-adulti u t-tfal li għandhom aktar minn 12-il sena hija 200 sa 400 mg, 3 jew 4 darbiet kuljum kif meħtieġ.
English: Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of nonsteroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
Maltese: Vascular and upper gastrointestinal effects of nonsteroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
English: The review of ibuprofen was initiated on 9 June 2014 at the request of the UK's medicines agency (MHRA), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' ibuprofen inbdiet fid-9 ta' Ġunju 2014 fuq talba tal-aġenzija tal-mediċini tar-Renju Unit (MHRA), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Olsen AM, Fosbol EL, Lindhardsen J, et al. Cause-specific cardiovascular risk associated with nonsteroidal anti-inflammatory drugs among myocardial infarction patients--a nationwide study.
Maltese: Cause-specific cardiovascular risk associated with nonsteroidal anti-inflammatory drugs among myocardial infarction patients--a nationwide study.
English: • Experimental data suggest long-term use of ibuprofen/dexibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid (typically 75 mg per day).
Maltese: • Dejta sperimentali tissuġġerixxi li l-użu fit-tul ta' ibuprofen/dexibuprofen jista' jnaqqas l-effett kardjoprotettiv ta' aċidu aċetilsaliċiliku f'doża baxxa (ġeneralment 75 mg kuljum).
English: The safety of NSAIDs, including ibuprofen, has been reviewed regularly by authorities in the EU over the past few years.
Maltese: Is-sigurtà tal-NSAIDs, inkluż ibuprofen, ġiet irriveduta b'mod regolari mill-awtoritajiet fl-UE tul l-aħħar ftit snin.
English: • The risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal antiinflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.
Maltese: • Ir-riskju b'ibuprofen f'dożi għoljin huwa simili għar-riskju osservat b'xi mediċini antinfjammatorji nonsterojdali (NSAIDs) oħra, inkluż inibituri COX-2 u diclofenac.
English: • Data from meta-analyses and epidemiological studies indicate that there is an increased risk of cardiovascular events (such as myocardial infarction or stroke) associated with the use of highdose ibuprofen (at or above 2,400 mg per day).1-4
Maltese: • Id-dejta mill-metaanaliżijiet u l-istudji epidemjoloġiċi jindikaw li hemm riskju akbar ta' avvenimenti kardjovaskulari (bħal infart mijokardijaku jew puplesija) assoċjati mal-użu ta' ibuprofen f'dożi għoljin (f'2,400 mg jew aktar kuljum).1-4
English: Ibuprofen is present in medicines as a mixture of two molecules that are enantiomers (mirror images of each other).
Maltese: Ibuprofen huwa preżenti f'mediċini bħala taħlita ta' żewġ molekuli li huma enantjomeri (immaġnijiet riflessi ta' xulxin).
English: For diclofenac, the risk was estimated at around three additional major vascular events per 1,000 participants per year.
Maltese: Għal diclofenac, ir-riskju kien stmat f'madwar tliet avvenimenti vaskulari ewlenin oħrajn għal kull 1,000 parteċipant fis-sena.