FrancophonIA/ELRC3.0 huggingface dataset:
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Maltese: F'din il-kategorija ta' annimali il-vaċċin għandu jintuża biss skont valutazzjoni tal-benefiċċju / riskju mill-veterinarju responsabbli u/jew l-awtoritajiet kompetenti nazzjonali fuq il-politika kurrenti dwar il-tilqim kontra l-virus talBluetongue (BTV).
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 veterinarju mediċinali tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1, 2, 4 and/or 8, and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of maximum 2 serotypes).
Maltese: Immunizzazzjoni attiva ta' baqar għall-prevenzjoni tal-viremija kkawżata mis-serotipi 1,2,4 u/jew 8, u għat-tnaqqis ta' sinjali kliniċi kkawżati minn serotipi tal-virus tal-bluetongue 1, 4 u/jew 8 (taħlita ta' massimu ta' 2 serotipi).
English: Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Maltese: Immunizzazzjoni attiva ta' nagħaġ għall-prevenzjoni tal-viremija* u għat-tnaqqis ta' sinjali kliniċi kkawżati mis-serotipi 1, 2, 4 u/jew 8 (taħlita ta' massimu 2 serotipi).tal-virus tal-bluetongue.
English: Inactivated bluetongue virus ........................................ strain specific pass level (log10 pixels) ** (*) maximum of two different inactivated bluetongue virus serotypes
Maltese: Virus tal-Buetongue inattivat ≥strain specific pass level log10 pixels** (*) massimu ta' żewġ serotipi differenti tal-virus inattivat tal-bluetongue.
English: Each dose of 1 ml contains: Active substances *:
Maltese: Kull doża ta' ml fiha : Sustanzi Attivi*:
English: Name and address of the manufacturers of the biological active substance
Maltese: Isem u indirizz tal-manufatturi tas-sustanza bijoloġika attiva:
English: nd injection: after 3-4 weeks
Maltese: - It-tieni injezzjoni: wara 3-4 ġimgħat
English: BTVPUR suspension for injection for sheep and cattle
Maltese: VETERINARJU BTVPUR suspensjoni għal injezzjoni għan-nagħaġ u l-baqar
English: Onset of immunity has been demonstrated 3 weeks (or 5 weeks in sheep for BTV2) after the primary vaccination course for BTV-1, BTV-2 (cattle), BTV-4 and BTV-8 serotypes.
Maltese: Il-bidu tal-immunità ġie muri 3 ġimgħat (jew 5 ġimgħat fin-nagħaġ għal BTV-2) wara l-ewwel kors ta' tilqim għas-serotipi ta' BTV-1, BTV-2 (baqar) BTV-4 u BTV-8.
English: Onset of immunity has been demonstrated 3 weeks (or 5 weeks in sheep for BTV2) after the primary vaccination course for BTV1, BTV2 (cattle), BTV-4 and BTV-8 serotypes.
Maltese: Il-bidu tal-immunità ġie muri 3 ġimgħat (jew 5 ġimgħat fin-nagħaġ għal BTV2) wara l-ewwel kors ta' tilqim għas-serotipi ta' BTV1, BTV2 (baqar) BTV-4 u BTV-8.
English: Bottle of 100 ml
Maltese: Kaxxa ta' flixkun ta' 100 ml
English: Disposal: read package leaflet
Maltese: DAQS TAL-PAKKETT
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' din it-tilqima meta tintuża flimkien ma' kwalunkwe prodott mediċinali veterinarju ieħor.
English: STATEMENT OF ACTIVE SUBSTANCES
Maltese: TAS-SUSTANZI ATTIVI
English: Box of 10 bottles of 50 ml,
Maltese: Kaxxa ta' 10 fliexken ta' 50 ml
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Maltese: b) il-marda li għaliha l-prodott huwa intiż li jagħti immunità hija ġeneralment assenti mit-territorju in kwestjoni.
English: EU/1/09/549/001 EU/1/09/549/002 EU/1/09/549/003 EU/1/09/549/004 EU/1/09/549/005 EU/1/09/549/006 EU/1/09/549/007
Maltese: EU/1/09/549/001 EU/1/09/549/002 EU/1/09/549/003 EU/1/09/549/004
English: -Very rare side effects:
Maltese: -Effetti sekondarji rari:
English: 83714 Miesbach Germany
Maltese: 83714 Miesbach Il-Ġermanja
English: Their frequency is defined using the following conventions: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: Il-frekwenza tagħhom hija definita skond dawn ilkonvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Acino Pharma GmbH Am Windfeld 35
Maltese: Acino Pharma GmbH Am
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Maltese: Dermatite bulloża (nekroliżi tossika ta' lepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), anġjoedima, raxx eritematika, urtikarja, ekżema, lichen planus
English: System Organ Class
Maltese: Sistema tal-klassifika ta' l-organi
English: -Uncommon side effects:
Maltese: -Effetti sekondarji komuni:
English: Acino AG Am Windfeld 35 83714 Miesbach Germany
Maltese: Windfeld 35 83714 Miesbach Il-Ġermanja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/549/001-007
Maltese: EU/1/09/549/006 EU/1/09/549/007
English: INFORMATION IN BRAILLE Clopidogrel Acino Pharma 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel Acino Pharma 75 mg
English: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
Maltese: Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta' avvenimenti aterotrombotiċi f':
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Fsada muskolu-skeltrali (emartrożi), artrite, artralġja, majalġja
English: Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Maltese: L-analiżi tal-mortalita` totali bħala punt sekondarju ta' tmiem m'urietx xi differenza sinifikanti bejn clopidogrel (5.8 %) u ASA (6.0 %).
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Maltese: Emorraġija gastrointestinali u tarretroperitonew b'eżitu fatali, pankreatite, kolite (inklużi kolite ulċerattiva jew limfoċitika), stomatite
English: Alu/Alu blisters containing 14, 28, 30, 50, 84, 90 and 100 film-coated tablets packed in cardboard cartons.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji Alu/Alu li fihom 14, 28, 30, 50, 84, 90 u 100 pillola miksija b'rita, ippakkjati f'kaxxi tal-kartun.
English: After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers.
Maltese: Wara s-sistema ta' dożaġġ ta' 300 mg/75 mg, ir-risponsi kontra l-plejtlits tnaqqsu fil-metabolizzaturi dgħajfa b'IPA medja (5 μM ADP) ta' 24% (24 siegħa) u 37% (Jum 5) meta mqabbel ma' IPA ta' 39% (24 siegħa) u 58% (Jum 5) fil-metabolizzaturi estensivi u 37% (24 siegħa) u 60% (Jum 5) filmetabolizzaturi intermedji.
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Maltese: L-assorbiment huwa millinqas ta' 50%, skond l-eskrezzjoni fl-urina ta' metaboliti ta' clopidogrel.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Maltese: Kategorija farmakoterapewtika: inibituri ta' l-aggregazzjoni tal-plejtlets eskl. heparin, Kodiċi ATC:
English: There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2).
Maltese: Ma kien hemm ebda differenza sinifikanti bejn il-gruppi fil-varjetà ta' riżultati finali primarji ta' mewt, trombożi taddevjazzjoni kirurġika jew intervent tat-tip kardijaku sa qabel l-età ta' 120 ġurnata wara avveniment li kien ikkunsidrat ta' natura trombotika (89 [19.1%] għall-grupp ta' clopidogrel u 90 [20.5%] għallgrupp tal-plaċebo) (ara sezzjoni 4.2).
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: Fl-analiżi ta' lintenzjoni tal-kura, ġew osservati 939 avveniment fil-grupp ta' clopidogrel u 1,020 avveniment b'ASA (tnaqqis tar-riskju relattiv (RRR) ta' 8.7 %, [95 % CI: minn 0.2 għal 16.4]; p=0.045), li jikkorrispondi, għal kull 1,000 pazjent ttrattati għal sentejn, ma' 10 [CI: minn 0 sa 20] pazjenti oħra li evitaw avveniment iskemiku ġdid.
English: In vitro and in vivo, clopidogrel is metabolised according to two main metabolic pathways: one mediated by esterases and leading to hydrolysis into its inactive carboxylic acid derivative (85% of circulating metabolites), and one mediated by multiple cytochromes P450.
Maltese: In vitro u in vivo, clopidogrel jiġi mmetabolizzat permezz ta' żewġ sensiliet ta' reazzjonijiet metaboliċi: waħda bl-intervent ta' esterases u li twassal għall-idroliżi fid-derivattiv inattiv tiegħu carboxylic acid (85% tal-metaboliti fiċċirkulazzjoni), u waħda bl-intervent ta' ċitokromi P450 multipli. Clopidogrel jiġi mmetabolizzat l ewwel f'metabolit intermedjarju 2-oxo-clopidogrel.
English: Each tablet contains 75 mg of clopidogrel (as besilate).
Maltese: Kull pillola fiha 75 mg ta'Clopidogrel (bħala besilate).
English: Excipients: each film-coatedtablet contains 3.80 mg of hydrogenated castor oil.
Maltese: Sustanzi mhux attivi: kull pillola miksija b'rita fiha 3.80 mg ta' castor oil idroġenat.
English: Do not take Clopidogrel Acino Pharma:
Maltese: Tiħux Clopidogrel Acino Pharma:
English: Acute liver failure, hepatitis, abnormal liver function test
Maltese: Insuffiċjenza akuta talfwied, epatite, test talfunzjoni tal-fwied anormali
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (< 35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Maltese: L-istudju CAPRIE kien jinkludi 19,185 pazjent bi trombożi fil-vini li ntweriet permezz ta' infart mijokardijaku reċenti (<35 jum), puplesija iskemika reċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit ta' l-arterji periferali (PAD).
English: In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
Maltese: F'studju magħmul b'mod arbitrarju, b'grupp parallel u double-blind (CLARINET), 906 pazjenti pedjatriċi (trabi tat-twelid u tfal ċkejknin) b'mard tal-qalb konġenitali ċjanotiku u megħjuna b'devjazzjoni kirurġika ta' arterja sistemika għal dik pulmonarja, ġew mogħtija b'mod arbitrarju clopidogrel 0.2 mg/kg (n=467) jew plaċebo (n=439) flimkien ma' terapija konkomitanti ta' rutina sakemm kien hemm il-bżonn ta' kirurġija tat-tieni fażi.
English: Film-coating:
Maltese: Farmakoġenetika:
English: Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Maltese: Konsistenti ma' dawn ir-riżultati, f'meta-analiżi li inkludiet 6 studji ta' 335 suġġett ikkurat b'clopidogrel f'livell fiss, ġie muri li l-espożizzjoni tal-metabolit attiv tnaqqas b'28% għallmetabolizzaturi intermedji, u 72% għall-metabolizzaturi dgħajfa filwaqt li l-inibizzjoni talaggregazzjoni tal-plejtlits (5 μM ADP) tnaqqset b'differenzi fl-IPA ta' 5.9% u 21.4% rispettivament, meta mqabbel ma' metabolizzaturi estensivi.
English: However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Maltese: Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogrel ngħataw varjeta` ta' prodotti mediċinali fl-istess ħin u dawn kienu jinkludu dijuretiċi, beta blockers ACEI, antagonisti tal-kalċju, sustanzi li jbaxxu l-kolesterol, vasodilataturi koronarji, sustanzi kontra d-dijabete (inkluża l-insulina), sustanzi antiepilettiċi, u antagonisti GPIIb/IIIa mingħajr ma kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Maltese: Fil-metabolizzaturi dgħajfa, lespożizzjoni tal-metabolit attiv tnaqqset b'63-71% meta mqabbla ma' metabolizzaturi estensivi.
English: Clopidogrel Acino Pharma contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel Acino Pharma fih is-sustanza attiva Clopidogrel li tifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' antiplejtlets.
English: You should specifically tell your doctor if you take - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints - heparin or any other injectable medicine used to reduce blood clotting - omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy - ticlopidine, other antiplatelet agent.
Maltese: Għandek speċifikament tgħid lit-tabib tiegħek jekk qiegħed tieħu - sustanzi kontra l-koagulazzjoni tad-demm li jittieħdu mill-ħalq, mediċini li jraqqu d-demm, - mediċina li hija anti-infjammatorju li mhux sterojde, normalment użat biex jiġi ittrattat l-uġigħ u/jew kundizzjonijiet infjammatorji tal- muskoli jew tal-ġogi, - heparin jew xi mediċina oħra li tinjetta biex traqqaq id-demm, - omeprazole, esomeprazole jew cimetidine, mediċini għat-taqlib tal-istonku - fluconazole, voriconazole, ciprofloxacin, jew chloramphenicol, mediċini li jittrattaw infezzjonijiet tal-batterja u tal-fungu, - fluoxetine, fluvoxamine, jew moclobemide, mediċinii li jittrattaw d-dipressjoni, - carbamazepine, jew oxcarbazepine, mediċini li jittrattaw xi tip ta' epilessija, - ticlopidine, sustanza oħra kontra l-plejtlets.
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
Maltese: F'analiżi tas-sottogrupp permezz ta' kondizzjoni qwalifikanti (infart mijokardijaku, puplesija iskemika, u PAD) il-benefiċċju jidher li kien l-ikbar (b'relevanza statistika ta' p=0.003) f'pazjenti li ddaħħlu minħabba PAD (speċjalment dawk li kellhom ukoll storja medika ta' infart mijokardijaku) (RRR = 23.7 %; CI: minn 8.9 sa 36.2) u inqas (mhux differenti b'mod sinifikanti minn ASA)
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Maltese: Fi stat fiss, il-livell medju ta' inibizzjoni osservat b'doża ta' 75 mg kuljum kien bejn 40 % u 60 %.
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation Esomeprazole is expected to give a similar interaction with clopidogrel.
Maltese: It-tnaqqis kien assoċjat ma' tnaqqis ta' 39 % (id-doża ta' kkargar) u ta' 21 % (id-doża ta' manteniment) fl-inibizzjoni tal-aggregazzjoni tal-plejtlits.
English: Pregnancy and breast-feeding It is preferable not to take this product during pregnancy.
Maltese: Tqala u treddigħ Huwa preferibbli li ma tiħux dan il-prodott waqt it-tqala.
English: The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Maltese: L-alleli CYP2C19*2 u CYP2C19*3 jgħoddu għallmaġġoranza tal-alleli b'funzjoni mnaqqsa fil-Kawkasi u 99% f'metabolizzaturi dgħajfa Asjatiċi.
English: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Acino Pharma;
Maltese: • Jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għall-clopidogrel jew sustanzi oħra ta' Clopidogrel Acino Pharma;
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of clopidogrel.
Maltese: M'hemm ebda evidenza li prodotti mediċinali oħra li jnaqqsu l-aċtu fl-istonku bħall-imblokkaturi ta' H2 (ħlief cimetidine li huwa inibitur ta' CYP2C19) jew l-antaċidi jaffettwaw l-attività kontra lplejtlits ta' clopidogrel.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilmediċini: http://www.ema.europa.eu/
English: Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Maltese: Madwar 88 % talpazjenti rċevew fl-istess ħin ASA (b'varjazzjoni minn 1 sa 23 mg/kg/jum).
English: In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
Maltese: F'studju b'dożi li jibqgħu jogħlew u li sar f'86 tarbija tat-twelid jew tfal ċkejknin sa 24 xahar ta' età f'riskju ta' trombożi (PICOLO), clopidogrel ġie evalwat f'dożi konsekuttivi ta' 0.01, 0.1 u 0.2 mg/kg fit-trabi tat-twelid u fit-tfal ċkejknin u 0.15 mg/kg fit-trabi tat-twelid biss.
English: Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Maltese: Il-pazjenti kienu randomised għal clopidogrel 75 mg/jum jew ASA 325 mg/jum, u ġew osservati għal bejn sena u 3 snin.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Maltese: Fi CURE, CLARITY, ACTIVE-A u wieħed mill-istudji ko-orti (Trenk), ma ġiet osservata l-ebda żieda fir-rata ta' avvenimenti bbażata fuq l-istatus tal-metaboliżżatur.
English: In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
Maltese: Barra minn hekk, IPA kienet ta' 32% (24 siegħa) u 61% (Jum 5), u dawn kienu akbar milli fil-metabolizzaturi dgħajfa li rċevew is-sistema ta' dożaġġ ta' 300 mg/75 mg, u simili għallgruppi ta' metabolizzaturi l-oħra ta' CYP2C19 li rċevew is-sistema ta' dożaġġ ta' 300 mg/75 mg.
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Maltese: Ma ġew osservati l-ebda differenzi sostanzjali fl-espożizzjoni tal-metabolit attiv u l-inibizzjoni medja tal-aggregazzjoni tal-plejtlits (IPA) bejn metabolizzaturi estremament mgħaġġla, estensivi u intermedji.
English: The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Maltese: Il-metabolit attiv ta' clopidogrel jimpedixxi b'mod selettiv l-irbit ta' adenosine diphosphate (ADP) mar-riċettur tal-plejtlits P2Y12 u l-attivazzjoni suċċessiva talkumpless ta' glikoproteina GPIIb/IIIa bl-intervent ta' ADP, u b'hekk jimpedixxi l-aggregazzjoni talplejtlits.
English: Clopidogrel Acino Pharma 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel Acino Pharma 75 mg pilloli miksija b'rita Clopidogrel
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Maltese: Wara dożi ripetuti ta' 75 mg ta' clopidogrel kuljum, f'persuni b'mard sever tal-kliewi (tneħħija talkreatinina minn 5 sa 15 ml/min), l-inibizzjoni ta' l-agreggrazzjoni tal-plejtlets indotti minn ADP kien iktar baxx (25%) minn dak osservat f'persuni f'saħħithom, madankollu it-titwil fil-ħin tad-dmija kien simili għal dak osservat f'persuni f'saħħithom li kienu qed jingħataw 75 mg ta' clopidogrel kuljum.Barra minn hekk, it-tolleranza klinika kienet tajba fil-pazjenti kollha.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha 75 mg ta' clopidogrel (bħala besilate).
English: Eye bleeding (conjunctival, ocular, retinal)
Maltese: Fsada fl-għajn (tal-konġuntiva, okulari, tar-retina)
English: The clinically relevant adverse reactions observed in the CAPRIE study are discussed below.
Maltese: Ir-reazzjonijiet avversi klinikament rilevanti li ntwerew fl-istudju CAPRIE huma diskussi hawn taħt.
English: Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Maltese: Dożi repetuti ta' 75 mg kuljum ipproduċew inibizzjoni sostanzjali ta' l-aggregazzjoni tal-plejtlets indotti minn ADP mill-ewwel ġurnata; dan żied progressivament u laħaq livell fiss bejn Jum 3 u Jum 7.
English: • Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Maltese: • Pazjenti li għandhom infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard stabbilit ta' l-arterji periferali.
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel Acino Pharma').
Maltese: Madanakollu, jekk id-demm li ħiereġ jinkwetak, għandek tkellem lit-tabib tiegħek minnufih (ara sezzjoni 2 'Oqgħod attent ħafna b'Clopidogrel Acino Pharma').