FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile in terms of hepatotoxicity and gastro intestinal toxicity for nimesulide is shown as worse than alternative NSAIDs such as diclofenac and naproxen.
Maltese: Il-profil ta' sigurtà f'termini ta' epatotossiċità u tossiċità gastrointestinali għal nimesulide huwa muri bħala agħar minn ta' NSAIDs alternattivi bħal diclofenac u naproxen.
English: In the context of this review, limited information on the gastrointestinal toxicity profile of nimesulide in comparison to other NSAIDs, and the possible consequences of switching to other NSAIDs with a higher gastrointestinal toxicity risk was considered.
Maltese: Fil-kuntest ta' din ir-reviżjoni, ġiet ikkunsidrata l-informazzjoni limitata dwar il-profil ta' tossiċità gastro-intestinali ta' nimesulide meta mqabbel ma' NSAIDs oħra, u l-konsegwenzi possibbli ta' bidla għal NSAIDs oħra b'riskju ogħla ta' tossiċità gastro-intestinali.
English: • Considering the maximum duration of 15 days of treatment to minimise the risk for hepatotoxicity and aiming a further minimisation of the risks associated with nimesulide, the Committee considered that nimesulide use should be restricted to acute conditions only i.e. treatment of acute pain and primary dysmenorrhoea.
Maltese: • Meta wieħed iqis it-tul massimu tal-kura ta' 15-il jum biex jiġi minimizzat ir-riskju għal epatotossiċità u bil-għan li jkompli jimminimizza r-riskji assoċjati ma' nimesulide, il-Kumitat ikkunsidra li l-użu ta' nimesulide għandu jiġi ristrett għal kundizzjonijiet akuti biss jiġifieri lkura tal-uġigħ akut u d-dismenorrea primarja.
English: The reported cases showed an association with non-A non-B non-paracetamol-related fulminant hepatic failure requiring liver transplantation in Ireland higher with nimesulide than with any other medicinal product.
Maltese: Il-każijiet irrapportati wrew li fl-Irlanda kien hemm assoċjazzjoni bejn insuffiċjenza epatika fulminanti mhux A, mhux B u mhux relatata mal-paracetamol li kienet teħtieġ trapjant tal-fwied ogħla b'nimesulide milli bi kwalunkwe prodott mediċinali ieħor.
English: Nimesulide efficacy is proven in short-term clinical studies which is consistent with the indication for short-term use (i.e. maximum 15 days of treatment) previously introduced to minimise the risks for hepatoxicity.
Maltese: L-effikaċja ta' Nimesulide hija pprovata fi studji kliniċi fuq perjodu qasir, ħaġa li hija konsistenti mal-indikazzjoni għall-użu għal perjodu qasir (jiġifieri massimu ta' 15-il jum ta' kura) preċedentement introdotta biex timminimizza r-riskji għal epatotossiċità.
English: It was concluded that the risk-benefit balance remained positive subject to amendments to the Marketing Authorisations, including introduction of restrictions for the safe use of the products.
Maltese: Ġie konkluż li l-bilanċ tar-riskju-benefiċċju jibqa' wieħed pożittiv soġġett għall-emendi għall-Awtorizzazzjonijiet għat-Tqegħid fis-Suq, inkluż l-introduzzjoni ta' restrizzjonijiet dwar l-użu sigur tal-prodotti.
English: The combined safety profile in terms of hepatotoxicity and gastro intestinal toxicity for nimesulide is shown as worse than some other alternative NSAIDs such as diclofenac and naproxen.
Maltese: Il-profil ta' sigurtà kkombinat f'termini ta' epatotossiċità u tossiċità gastro-intestinali għal nimesulide jidher bħala agħar minn dawk ta' xi wħud minn ta' NSAIDs alternattivi oħra bħal diclofenac u naproxen.
English: At that time the magnitude of the increased risk of severe hepatic adverse reactions with nimesulide compared to other NSAIDs seen in spontaneous reporting, clinical and epidemiological studies seemed slight, with the exception of the signal raised by Ireland.
Maltese: Dak iż-żmien, l-iskala taż-żieda fir-riskju ta' reazzjonijiet epatiċi avversi severi b'nimesulide meta mqabbla ma' NSAIDs oħra li dehru f'rapporti spontanji, fi studji kliniċi u epidemjoloġiċi dehret żgħira, bl-eċċezzjoni tas-sinjal imqajjem mill-Irlanda.
English: • The Committee considered that nimesulide overall gastrointestinal toxicity is comparable to other NSAIDs but that nimesulide is associated with an increased risk for hepatotoxicity.
Maltese: • Il-Kumitat ikkunsidra li t-tossiċità gastro-intestinali ġenerali b'nimesulide hija komparabbli ma' NSAIDs oħra iżda li nimesulide huwa assoċjat ma' żieda fir-riskju għal epatotossiċità.
English: On 19 January 2010, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC requesting the CHMP to give its opinion on whether the marketing authorisations for medicinal products containing nimesulide for systemic use should be maintained, varied, suspended or withdrawn.
Maltese: Fid-19 ta' Jannar 2010, il-Kummissjoni Ewropea tat bidu għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE li jitlob lis-CHMP biex jagħti l-opinjoni tiegħu dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali li fihom nimesulide għall-użu sistemiku għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati.
English: Poland, France and Greece.
Maltese: B'mod ġenerali l-ogħla espożizzjoni tidher fl-Italja, fil-Polonja, fi Franza u fil-Greċja.
English: As discussed throughout the assessment report, the SALT study presented several limitations such as small number of identified cases, all severe cases are of acute liver failure and very wide confidential intervals making the results not being robust.
Maltese: Kif diskuss matul ir-rapport ta' valutazzjoni, l-istudju SALT ippreżenta bosta limitazzjonijiet bħan-numru żgħir ta' każijiet identifikati, il-każijiet severi kollha huma ta' insuffiċjenza akuta tal-fwied u l-intervalli ta' fiduċja wiesgħin ħafna ma jagħmlux ir-riżultati robusti.
English: • The Committee considered that evidence of the clinically efficacy of nimesulide-containing products for systemic use in the indications for short-term treatment has been shown.
Maltese: • Il-Kumitat ikkunsidra li ntweriet evidenza tal-effikaċja klinika ta' prodotti li fihom nimesulide għall-użu sistemiku fl-indikazzjonijiet għall-kura fuq żmien qasir.
English: In the remaining Member States the exposure appears relatively stable over time.
Maltese: Fl-Istati Membri li fadal l-espożizzjoni tidher relattivament stabbli matul iż-żmien.
English: The hepatoxicity of nimesulide was previously assessed under the Article 107 procedure triggered by the new information regarding cases of fulminant hepatic failure associated with its use in Ireland and the consequent suspension of the marketing authorisations for nimesulide in that Member State.
Maltese: L-epatotossiċità ta' nimesulide kienet preċedentement evalwata taħt il-proċedura skont lArtikolu 107 minħabba informazzjoni ġdida fir-rigward ta' każijiet ta' insuffiċjenza epatika fulminanti assoċjati mal-użu tiegħu fl-Irlanda u s-sospensjoni konsegwenti tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal nimesulide f'dak l-Istat Membru.
English: Nimesulide is associated with an increased risk of hepatotoxicity versus no-use or past use.
Maltese: Nimesulide huwa assoċjat ma' żieda fir-riskju ta' epatotossiċità kontra l-ebda użu jew użu preċedenti.
English: Data suggests that that the renal safety for nimesulide is comparable to other NSAIDs and also comparable or slightly favourable with regards to skin, immunological and nervous system safety.
Maltese: Id-dejta tissuġġerixxi li s-sigurtà renali għal nimesulide hija komparabbli ma' ta' NSAIDs oħra u wkoll komparabbli jew ftit aqwa fir-rigward tal-ġilda, u ssigurtà immunoloġika u tas-sistema nervuża.
English: In view of the risk of chronic use in the treatment of osteoarthritis and aiming further minimisation of the risks associated with nimesulide, the CHMP concluded that nimesulide has no longer a positive risk- benefit in this indication.
Maltese: Fid-dawl tar-riskju ta' użu kroniku fil-kura tal-osteoartrite u bil-għan li jkompli jimminimizza r-riskji assoċjati ma' nimesulide, is-CHMP ikkonkluda li nimesulide ma għadx għandu riskju-benefiċċju pożittiv għal din l-indikazzjoni.
English: The recommended dosage is 100 mg twice daily and the maximum duration of treatment is 15 days with the shortest duration of treatment recommended to minimise the occurrence of side effects.
Maltese: Id-dożaġġ irrakkomandat huwa ta' 100 mg darbtejn kuljum u t-tul massimu tal-kura huwa ta' 15-il jum u huwa rrakkomandat l-iqsar tul ta' kura biex tiġi mminimizzata l-okkorrenza ta' effetti sekondarji.
English: Although there are some results of clinical studies that may suggest rapid onset of analgesic action associated with the use of nimesulide compared with other NSAIDs, the clinical relevance of the measured differences in onset of pain relief is doubtful.
Maltese: Minkejja li xi riżultati ta' studji kliniċi jistgħu jissuġġerixxu bidu rapidu ta' azzjoni analġeżika assoċjata malużu ta' nimesulide meta mqabbel ma' NSAIDs oħra, ir-rilevanza klinika tad-differenzi mkejla fil-bidu tas-serħan mill-uġigħ huma dubjużi.
English: • The Committee considered all the available data submitted on the safety and the efficacy of nimesulide-containing products for systemic use.
Maltese: • Il-Kumitat ikkunsidra d-dejta kollha disponibbli sottomessa dwar is-sigurtà u l-effikaċja ta' prodotti li fihom nimesulide għall-użu sistemiku.
English: No unequivocal and clinically meaningful advantage over other NSAIDs has been demonstrated and, therefore the Committee considered the efficacy of nimesulide to be similar to other NSAIDs available.
Maltese: Ma ntwera l-ebda vantaġġ ċar u klinikament sinifikanti fuq NSAIDs oħra u, għalhekk il-Kumitat ikkunsidra li l-effikaċja ta' nimesulide hija simili għal dik ta' NSAIDs oħra disponibbli.
English: In view of the uncertainties regarding the magnitude and the determinants of possible nimesulide-induced harm, the riskbenefit balance was considered positive subject to amendments to the product information and conditions to the Marketing Authorisations for all products containing nimesulide for systemic use.
Maltese: Fid-dawl tal-inċertezzi dwar l-iskala u d-determinanti ta' ħsara possibbilment indotta minn nimesulide, il-bilanċ tar-riskju-benefiċċju kien ikkunsidrat bħala wieħed pożittiv soġġett għall-emendi għall-informazzjoni dwar il-prodott u lkundizzjonijiet għall-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għall-prodotti kollha li fihom nimesulide għal użu sistemiku.
English: - That the product should be used immediately after opening the ampoule and unused portions left in the ampoule should be discarded - That baseline plasma levels may need measuring because of an increased risk of toxicity if o The neonate has been previously treated with theophylline o The mother has been consuming large amounts of caffeine prior to delivery or breast feeding - That caffeine and theophylline should not be used concurrently - That if caffeine and doxapram are used concurrently, the patient should be closely monitored - That additional plasma caffeine monitoring and dosage adjustment may be necessary in at risk situations such as preterm infants: o With cholestatic hepatitis o With significant renal impairment o With seizure disorders o With cardiac disease o less than 28 weeks gestational age and/or body weight <1000g particularly when receiving parenteral nutrition o with co-administration of medicinal products known to interfere with caffeine metabolism - That cardiac disorders (including arrhythmias) may arise in neonates with pre-existing cardiac disease - That all suspected adverse reactions should be reported in accordance with national reporting requirements - In particular, if convulsions, seizures, necrotising enterocolitis, symptoms and signs of caffeine withdrawal, medically abnormal decrease in infant weight gain or interactions with other medicines are suspected as being associated with the use of caffeine citrate, these should be reported to <insert local name and address of Chiesi Farmaceutici S.p.A.
Maltese: - Li l-prodott għandu jintuża immedjatament wara li tinfetaħ l-ampulla u li l-porzjonijiet mhux użati li jibqa' fl-ampulla għandhom jintremew - Li l-livelli fil-plażma fil-linja bażi jista' jkollhom bżonn jitkejlu minħabba żieda fir-riskju ta' tossiċità jekk o It-tarbija tat-twelid qabel kienet ikkurata b'theophylline o L-omm kienet tieħu ammonti kbar ta' kaffeina qabel il-ħlas jew it-treddigħ - Li l-kaffeina u theophylline m'għandhomx jintużaw fl-istess ħin - Li jekk il-kaffeina u doxapram jintużaw fl-istess ħin, il-pazjent għandu jkun immonitorjat mill-qrib - Li monitoraġġ addizzjonali għall-kaffeina fil-plażma u aġġustament fid-dożaġġ jistgħu jkunu meħtieġa f'sitwazzjonijiet ta' riskju, bħal fil-każ ta' trabi li jitwieldu qabel iżżmien: o B'epatite kolestatika o B'indeboliment sinifikanti tal-kliewi o B'disturbi ta' attakki ta' puplesija o B'mard kardijaku o ta' inqas minn 28 ġimgħa tqala u/jew piż tal-ġisem ta' <1000g partikularment meta t-tarbija tkun qed tirċievi nutrizzjoni parenterali o bl-għoti flimkien ta' prodotti mediċinali magħrufa li jinterferixxu malmetaboliżmu tal-kaffeina - Li disturbi kardijaċi (li jinkludu arritmiji) jistgħu jinħolqu fi trabi tat-twelid b'mard kardijaku li kien jeżisti minn qabel
English: - That the dose of caffeine expressed as caffeine base is one half the dose of caffeine expressed as caffeine citrate (20mg caffeine citrate is equivalent to 10mg caffeine base) and that prescriptions should clearly indicate that caffeine citrate is to be administered.
Maltese: - Li d-doża tal-kaffeina espressa bħala bażi tal-kaffeina hi nofs id-doża tal-kaffeina espressa bħala caffeine citrate (20mg ta' caffeine citrate hu ekwivalenti għal 10mg ta' bażi tal-kaffeina) u li r-riċetti għall-mediċina għandhom jindikaw b'mod ċar li caffeine citrate ser jingħata.
English: The Member States shall ensure that the card contains the following key elements and is provided by the Marketing Authorisation Holder to all neonatal intensive care units where the product is likely to be used at launch of the product: - That Peyona is for the treatment of primary apnoea - That treatment with Peyona must be provided in a neonatal intensive care unit and initiated and supervised by a physician experienced in neonatal intensive care - Details of the loading and maintenance dosages and that caffeine may accumulate in premature neonates because of its long half-life.
Maltese: - Li Peyona hu għall-kura ta' apnea primarja - Li l-kura b'Peyona trid tkun ipprovduta f'taqsima tal-kura intensiva għal trabi tat-twelid u tinbeda u tiġi ssorveljata minn tabib b'esperjenza fil-kura intensiva ta' trabi tat-twelid - Dettalji tad-dożaġġi loading u tal-manteniment u li l-kaffeina tista' takkumula fi trabi tattwelid prematuri minħabba l-half-life twila tagħha.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES The Member States shall agree with the Marketing Authorisation Holder the final text of a card suitable for display in neonatal intensive care units.
Maltese: MEMBRI Il-Membri Stati għandhom jaqblu mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq dwar il-kliem finali ta' kard adattata biex tintwera fit-taqsimiet tal-kura intensiva għal trabi tat-twelid.
English: Annex III Summary of product characteristics, labelling and package leaflet
Maltese: ANNESS III SOMMARJU TAL-KARATTERISTIĊI
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif validi huma l-verżjonijiet finali miksuba waqt il-proċedura tal-Grupp ta' Koordinazzjoni
English: Further information on Credelio can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Credelio received a marketing authorisation valid throughout the EU on 25 April 2017.
Maltese: Credelio rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-25 ta' April 2017.
English: This overview was last updated in April 2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'April 2018.
English: It contains the active substance lotilaner.
Maltese: Fih is-sustanza attiva lotilaner.
English: The active substance in Credelio, lotilaner, acts as an ‘ectoparasiticide'.
Maltese: Is-sustanza attiva fi Credelio, il-lotilaner, taġixxi bħala ‘ektoparassitiċida'.
English: Other information about Credelio
Maltese: Informazzjoni oħra dwar Credelio
English: What are the risks associated with Credelio?
Maltese: X'inhuma r-riskji assoċjati ma' Credelio?
English: It blocks the normal movement of charged particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Maltese: Timblokka l-moviment normali ta' partikuli ċċarġjati ġewwa u barra ċ-ċelloli tan-nervituri, speċjalment dawk assoċjati mal-aċidu gamma-aminobutirriku (GABA) u glutamat, żewġ sustanzi li jgħaddu l-messaġġi bejn in-nervituri (newrotrażmettituri).
English: Credelio can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Maltese: Credelio jista' jintuża bħala parti mill-ġestjoni ta' dermatite allerġika mill-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: In a one month study involving cats with fleas, 121 cats were treated with Credelio and 61 cats with a spot-on medicine containing fipronil and (s)-methoprene.
Maltese: Fi studju ta' xahar li involva qtates bi briegħed, 121 qattus ġew ikkurati b'Clerelio u 61 qattus b'mediċina lokalizzata li fiha fipronil u (s)-methoprene.
English: In all studies below animals had natural infestations.
Maltese: Fl-istudji kollha ta' hawn taħt l-annimali kellhom infestazzjonijiet naturali.
English: In a small field study involving dogs with ticks, 47 dogs were treated once with Credelio and 35 dogs were treated with a spot-on medicine containing fipronil and another active substance, (s)-methoprene.
Maltese: Fi studju żgħir fuq il-post li fih ħadu sehem klieb bil-qurdien, 47 kelb ingħataw kura ta' darba bi Credelio u 35 kelb ingħataw kura b'mediċina lokalizzata li kien fiha fipronil u sustanza attiva oħra, (s)-methoprene.
English: In a 12-week field study involving dogs with fleas, 128 dogs were treated with Credelio every four weeks and 64 dogs with a spot-on medicine containing fipronil, another medicine to treat flea infestation.
Maltese: Fi studju fuq il-post ta' 12-il ġimgħa li fih ħadu sehem klieb infestati bil-briegħed, 128 kelb ingħataw kura bi Credelio kull erba' ġimgħat u 64 kelb ingħataw kura b'mediċina lokalizzata li kien fiha fipronil, mediċina oħra għall-kura ta' infestazzjoni tal-briegħed.
English: Credelio was as effective as the other medicine in reducing tick counts and reduced tick counts by 99% during the study.
Maltese: Credelio kien effettiv daqs il-mediċina l-oħra fit-tnaqqis tal-għadd ta' qurdien u naqqas l-ammont ta' qurdien b'99% matul l-istudju.
English: Credelio is a veterinary medicine used to treat flea and tick infestations in dogs and cats.
Maltese: Credelio huwa mediċina veterinarja użata biex tikkura infestazzjonijiet tal-briegħed u l-qurdien fil-klieb u l-qtates.
English: Credelio reduced flea counts by 97% over one month and was as effective as the other medicine.
Maltese: Credelio naqqas l-għadd tal-briegħed b'97% fuq xahar u kien effettiv daqs il-mediċina l-oħra.
English: A second larger field study of dogs with ticks involved 127 dogs treated with Credelio monthly for 3 months whilst 68 dogs were treated with a spot-on medicine containing fipronil and (s)-methoprene.
Maltese: Fit-tieni studju akbar fuq il-post li fih ħadu sehem klieb bil-qurdien 127 kelb ingħataw kura bi Credelio darba fix-xahar għal tliet xhur filwaqt li 68 kelb ingħataw kura b'mediċina lokalizzata li kien fiha fipronil u (s)-methoprene.
English: How does Credelio work?
Maltese: Kif jintuża Credelio?
English: The study showed Credelio to be as effective as the other medicine in reducing tick counts over four weeks and tick counts were reduced by 100% for Credelio treated dogs.
Maltese: L-istudju wera li Credelio kien effettiv daqs il-mediċina l-oħra fit-tnaqqis tal-għadd tal-qurdien tul l-erba' ġimgħat u l-klieb li ngħataw kura bi Credelio kellhom tnaqqis ta' 100% fl-għadd ta' qurdien.
English: In a further three month study involving cats with ticks, 112 cats were treated with Credelio every month and 57 cats with a spot-on medicine containing fipronil.
Maltese: Fi studju ieħor ta' tliet xhur li kien jinvolvi qtates bil-qurdien, 112-il qattus ġew ikkurati bi Credelio kull xahar u 57 qattus b'mediċina lokalizzata li fiha fipronil.
English: Credelio is available as chewable tablets in seven different strengths (the lowest two strengths for cats, the rest for dogs) which are given to the animals with food or within 30 minutes after feeding.
Maltese: Credelio jiġi bħala pilloli li tomgħodhom f'seba' qawwiet differenti (l-inqas żewġ qawwiet għall-qtates, il-bqija għall-klieb) li jingħataw lill-annimali bl-ikel jew fi żmien 30 minuta wara l-għalf.
English: Pack size blister (alu/alu) 30 tablets blister (alu/alu) 90 (3 x 30) tablets (multipack)
Maltese: 90 (3 x 30) pillola (pakkett multiplu)
English: MA (EU) Numbers
Maltese: <Numru ta' lEU> <Numru talMA>
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
Maltese: België/Belgique/Belgien Teva Pharma Belgium N.V./S.
English: TEVA Santé SA Rue Bellocier 89107 Sens France
Maltese: TEVA Santé SA Rue Bellocier 89107 Sens Franza
English: TEVA Santé SA, Rue Bellocier, 89107 Sens, France
Maltese: TEVA Santé SA, Rue Bellocier, 89107 Sens, Franza
English: The active substance is clopidogrel.
Maltese: • Is-sustanza attiva hi clopidogrel.
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (type A) Hydrogenated castor oil Sodium laurilsulfate
Maltese: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (tip A) Żejt ir-riġnu idroġenat Sodium laurilsulfate
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/649/001-016
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/649/001-016
English: Each tablet contains 62.16 mg lactose monohydrate and 10 mg hydrogenated castor oil.
Maltese: Kull pillola miksija b'rita fiha 62.16 mg lactose monohydrate u 10 mg hydrogenated castor oil.
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Maltese: Każijiet kardjovaskulari ġodda (punt aħħari ta' riferiment primarju) kienu evitati, bi tnaqqis fir-riskju relattiv ta' 22% (CI: 8.6, 33.4), 32 % (CI: 12.8, 46.4), 4 % (CI: -26.9, 26.7), 6 % (CI: -33.5, 34.3) u 14 % (CI: -31.6, 44.2), waqt l-intervalli ta' studju ta' 0-1, 1-3, 3-6, 6-9 u 9-12 xhur, rispettivament.
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Maltese: F'CURE, 823 (6.6 %) pazjent ingħataw terapija ta' antagonista għar-riċettatur GPIIb/IIIa fl-istess ħin.
English: • 100 tablets bottle: 100 days
Maltese: • flixkun ta' 100 pillola: 100 jum
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Maltese: Clopidogrel u l-metabolit (mhux attiv) ċirkolanti prinċipali jintrabtu b'mod riversibbli in vitro malproteini umani tal-plażma (98% u 94% rispettivament).
English: Medicinal products that inhibit CYP2C19 include omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol.
Maltese: Mediċini li jimpedixxu CYP2C19 jinkludu omeprazole u esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine u chloramphenicol.
English: Retroperitoneal haemorrhage
Maltese: Emorraġija retroperitoneal i
English: Computerweg 10, 3542 DR Utrecht, The Netherlands
Maltese: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, L-Olanda