FrancophonIA/ELRC3.0 huggingface dataset:
English: Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (which is the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.
Maltese: L-ebda effett klinikament rilevanti mhuwa kkunsidrat probabbli għall-użu okkażjonali ta' ibuprofen (ara sezzjoni 4.5). Filwaqt li m'hemm ebda dejta disponibbli għal dexibuprofen, huwa raġonevoli li wieħed jassumi li tista' teżisti interazzjoni simili bejn dexibuprofen (= S(+)-ibuprofen) (l-enantiomer farmakoloġikament attiv ta' ibuprofen) u acetylsalicylic acid f'doża baxxa.
English: Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.
Maltese: Għalkemm hemm inċertezzi dwar l-estrapolazzjoni ta' din id-dejta għas-sitwazzjoni klinika, il-possibbiltà li l-użu regolari, fit-tul ta' ibuprofen jista' jnaqqas l-effetti ta' protezzjoni tal-qalb ta' acetylsalicylic acid f'doża baxxa ma jistgħux jiġu esklużi.
English: Buvidal (buprenorphine)
Maltese: Buvidal (buprenorfina)
English: Further information on Buvidal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Buvidal.
Maltese: ema.europa.eu/medicines/human/EPAR/Buvidal.
English: During the 25 weeks of treatment, 35% of patients given Buvidal had a negative urine test, compared with 28% of patients taking the comparator tablets.
Maltese: Matul il-25 ġimgħa ta' kura, 35 % tal-pazjenti li kienu qed jieħdu Buvidal kellhom test negattiv tal-urina, meta mqabbla ma' 28 % tal-pazjenti li kienu qed jieħdu l-pilloli komparaturi.
English: Other information about Buvidal
Maltese: Informazzjoni oħra dwar Buvidal
English: The reference medicine for Buvidal is Subutex.
Maltese: Il-mediċina ta' referenza għal Buvidal hija Subutex.
English: Buvidal contains the active substance buprenorphine and is a ‘hybrid medicine'.
Maltese: Buvidal fih is-sustanza attiva buprenorfina u huwa "mediċina ibrida".
English: A study involving 428 patients with opioid dependence showed that Buvidal was effective at reducing patients' intake of opioid drugs.
Maltese: Studju li involva 428 pazjent bid-dipendenza tal-oppjojdi wera li Buvidal kien effettiv fit-tnaqqis tatteħid tad-drogi oppjojdi tal-pazjenti.
English: Buvidal is a medicine used to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Maltese: Buvidal huwa mediċina li tintuża għall-kura tad-dipendenza fuq id-drogi oppjojdi (narkotiċi) bħalleroina u l-morfina.
English: What are the risks associated with Buvidal?
Maltese: X'inhuma r-riskji assoċjati ma' Buvidal?
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Buvidal is given in a different way.
Maltese: Dan ifisser li huwa simili għal "mediċina ta' referenza" li fiha l-istess sustanza attiva, iżda Buvidal jingħata b'mod differenti.
English: The most common side effects with buprenorphine (which may affect more than 1 in 10 people) are headache, nausea (feeling sick), hyperhidrosis (excessive sweating), insomnia (difficulty sleeping), drug withdrawal syndrome and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Buvidal (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 jinkludu wġigħ ta' ras, nawżja (tħossok ma tiflaħx), iperidrożi (għaraq eċċessiv), insomnja (diffikultà flirqad), sindromu ta' astinenza mill-mediċina u wġigħ.
English: For patients dependent on long-acting opioids (e.g. methadone), the dose of methadone is reduced to below 30 mg per day before starting Buvidal.
Maltese: Għall-pazjenti dipendenti fuq oppjojdi li jaġixxu fit-tul (eż. l-metadon), id-doża tal-metadon titnaqqas għal taħt 30 mg kuljum qabel jibdew Buvidal.
English: Buvidal is used in adults and adolescents aged over 16 years who are also receiving medical, social and psychological support.
Maltese: Buvidal jintuża fl-adulti u fiż-żgħażagħ minn 16-il sena 'l fuq li jkunu qed jingħataw ukoll appoġġ mediku, soċjali u psikoloġiku.
English: The active substance in Buvidal, buprenorphine, is a partial opioid agonist (it acts like an opioid drug but less powerfully).
Maltese: Is-sustanza attiva f'Buvidal, il-buprenorfina, hija agonista parzjali tal-oppjojdi (taġixxi bħal droga taloppjojde iżda b'inqas qawwa).
English: As for all medicines, data on the use of Buvidal are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Buvidal hija ssorveljata kontinwament.
English: Buvidal must not be used in patients with severe respiratory insufficiency (inability to breathe properly) and severe liver problems and in patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Maltese: Buvidal m'għandux jintuża f'pazjenti bi problemi ta' insuffiċjenza respiratorja severa (inabbiltà fit-teħid tan-nifs) u problemi severi fil-fwied u f'pazjenti xurbana jew li qed jesperjenzaw sintomi ta' astinenza tal-alkoħol.
English: Why is Buvidal authorised in the EU?
Maltese: Għaliex Buvidal huwa awtorizzat fl-UE?
English: Side effects reported with Buvidal are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Buvidal huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Patients who have never taken buprenorphine before should be given a 4 mg buprenorphine tablet and be monitored for one hour before being given Buvidal, to make sure they tolerate the medicine.
Maltese: Pazjenti li qatt ma ħadu l-buprenorfina qabel għandhom jingħataw pillola tal-buprenorfina ta' 4mg u jkunu mmonitorjati għal siegħa qabel jingħataw Buvidal, biex jiġi żgurat li jittolleraw il-mediċina.
English: For the full list of side effects and restrictions of Buvidal, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Buvidal, ara l-fuljett ta' tagħrif.
English: Although information on the long-term safety of the new formulation was lacking, the Agency's view was that the benefit of Buvidal outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għalkemm kien hemm nuqqas ta' informazzjoni dwar is-sigurtà fit-tul tal-formolazzjoni l-ġdida, fl-opinjoni tal-Aġenzija l-benefiċċju ta' Buvidal jegħleb ir-riskju identifikat u jista' jiġi awtorizzata għall-użu fl-UE.
English: While Subutex is available as sublingual tablets (tablets to be placed under the tongue), Buvidal is available as a solution for injection under the skin.
Maltese: F'dan l-istudju, Buvidal tqabbel ma' pilloli għal taħt l-ilsien li fihom il-buprenorfina u mediċina oħra, in-nalossina (li tintuża biex tipprevjeni użu ħażin.
English: For patients dependent on short-acting opioids (e.g. morphine or heroin), the first dose is given at least 6 hours after the patient last used an opioid.
Maltese: Għall-pazjenti dipendenti fuq oppjojdi li jaġixxu malajr (eż. l-morfina jew l-eroina), l-ewwel doża tingħata mill-inqas 6 sigħat wara li l-pazjent ikun ħa oppjojde l-aħħar.
English: What measures are being taken to ensure the safe and effective use of Buvidal?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Buvidal?
English: Intravenous use vial (glass)
Maltese: Użu ġol-vina kunjett (ħġieġ)
English: MA (EU) number
Maltese: Numru tal-MA (UE) Isem (ivvintat)
English: (Invented) name
Maltese: Numru ta' l-EU Isem inventat
English: Strada Statale 17, Km 22
Maltese: Statale 17, Km 22
English: Strada Statale 17, Km 22 67019 Scoppito (AQ) Italy
Maltese: Statale 17, Km 22 67019 Scoppito (AQ) - L-Italja
English: It may harm them,
Maltese: operazzjoni li ser issirlek (anki tas-snien) fis-sebat ijiem li ġejjin.
English: Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172)
Maltese: Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171)
English: 67019 Scoppito (AQ) - Italy or
Maltese: 67019 Scoppito (AQ) - L-Italja jew
English: Possible side effects
Maltese: Effetti sekondarju possibbli
English: (listed in section 6).
Maltese: (ara sezzjoni 4.5).
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: 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: 6, boulevard de l'Europe, F-21800 Quétigny, France or
Maltese: 6, boulevard de l'Europe, F-21800 Quétigny, Franza jew
English: While you are taking Plavix:
Maltese: Tiħux Plavix:
English: Plavix contains lactose.
Maltese: Plavix fih lactose.
English: Delpharm Dijon 6, Boulevard de l'Europe F-21800 Quétigny France
Maltese: Delpharm Dijon 6, Boulevard de l'Europe F-21800
English: SANOFI-AVENTIS Zrt.
Maltese: Magyarország SANOFI-AVENTIS Zrt.
English: TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
Maltese: TROPICAL-ACS ( L-Ittestjar tas-Sensibilità għall-Inibizzjoni tal-Plejtlits fuq Trattament Kroniku kontra l-Plejtlits għal Sindromi Koronarji Akuti- Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc cedex France
Maltese: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc cedex Franza
English: Manufacturer:
Maltese: Manifatturi:
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Maltese: Irreazzjonijiet avversi klinikament rilevanti li ġew osservati fl-istudji CAPRIE, CURE, CLARITY, COMMIT u ACTIVE-A huma diskussi hawn taħt.
English: PVC/PVDC/Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 film-coated tablets.
Maltese: Folji tal-PVC/PVDC/Aluminju jew folji kollha kemm huma tal-aluminju f'kaxxi tal-kartun li fihom 7, 14, 28, 30, 84, 90 u 100 pillola miksija b'rita.
English: Thrombocytopenia, leucopenia, eosinophilia
Maltese: lewkopenja, eosinofilja
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Maltese: Ilmetabolit attiv isir primarjament minn CYP2C19 b'kontribuzzjonijiet minn bosta enzimi CYP oħra li jinkludu CYP1A2, CYP2B6 u CYP3A4.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Maltese: Purpura tromboċitopenika trombotika (TTP) (ara sezzjoni 4.4), anemija aplastika, panċitopenja, agranuloċitosi, tromboċitopenja severa, emofilja A akwiżita, granuloċitopenja, anemija
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Maltese: 75 mg/jum kien jikkompara ma' ASA 325 mg/jum f'CAPRIE irrispettivament mill-età, sess u razza.
English: Week 2 (for boxes of 14, 28 and 84 tablets) Week 3 (for boxes of 28 and 84 tablets) Week 4 (for boxes of 28 and 84 tablets)
Maltese: Ġimgħa 2 (għall-kaxxa ta' 14, 28 u 84 pilloli) Ġimgħa 3 (għall-kaxxa ta' 28 u 84 pilloli) Ġimgħa 4 (għall-kaxxa ta' 28 u 84 pilloli)
English: Plavix contains lactose
Maltese: Plavix fih lactose
English: If Plavix is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Maltese: Jekk Plavix huwa fornut ġo folji tal-PVC/PVDC/Aluminju, aħżen f'temperatura taħt 30°C.
English: The recommended dose for ASA was 75 to 100 mg/day.
Maltese: Id-doża rrakkomandata ta'ASA kienet ta' 75 sa 100 mg/day.
English: The patient population included 19.7% women and 29.2% patients ≥ 65 years.
Maltese: Il-grupp ta' pazjenti studjati kien jinkludi 19.7% nisa u 29.2% pazjenti ≥65 sena.
English: The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).
Maltese: 43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (RRR = 18.2%; CI: 6.5%, 28.
English: 1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France
Maltese: 1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, Franza
English: Thu
Maltese: Tl
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Maltese: 31.1%), 89.5% heparin, 78.7% imblokkaturi tar-riċetturi beta, 54.7% l-inibituri ACE u 63% statins.
English: Plavix contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Plavix fih clopidogrel u jifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' kontra lplejtlets.
English: The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9% (114 events) in the guided de-escalation group versus 11% (137 events) in the control group (p=0.14).
Maltese: Linċidenza kumulattiva tal-avvenimenti kollha ta' fsada (klassi 1 sa 5 ta' BARC) kienet ta' 9% (114-il avveniment) fil-grupp iggwidat ta' tnaqqis fil-qawwa kontra 11% (137 avveniment) fil-grupp ta' kontroll (p=0.14).
English: The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Maltese: L-istudju ACTIVE-A (N=7,554), kien wieħed ikkontrollat bil-plaċebo, magħmul f'postijiet varji,double-blind u randomized u li qabbel clopidogrel 75 mg/day + ASA (N=3,772) ma' plaċebo +
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: (emartrożi), artrite, artralġja, majalġja
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Sanofi Belgium
English: DAPT group (p<0.01).
Maltese: 3%) fil-grupp ta' DAPT mingħajr tibdil (p<0.01).
English: Sanofi A/S Tlf: +45 45 16 70 00
Maltese: Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
English: Plavix contains hydrogenated castor oil
Maltese: Plavix fih il-castor oil idroġenat
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) fil metabolizzaturi intermedji.
English: The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Maltese: Il-grupp studjat inkluda 27.8% nisa, 58.4% pazjenti ≥60 sena (26% ≥70 sena) u 54.5% tal-pazjenti li rċevew is sustanzi fibrinolitiċi.
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Maltese: L-assorbiment huwa mill inqas ta' 50%, skond l-eskrezzjoni fl-urina ta' metaboliti ta' clopidogrel.
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Maltese: In-numru ta' pazjenti li għaddew mill-punt primarju ta' tmiem [mewt kardjovaskulari (CV), infart mijokardijaku (MI) jew puplesija] kien 582 (9.3%) fil-grupp ikkurat bi clopidogrel u 719 (11.4%) filgrupp ikkurat bil-plaċebo, li jissarraf fi tnaqqis fir-riskju relattiv ta' 20% (95% CI ta' 10%-28%; p=0.00009) għall-grupp ikkurat bi clopidogrel (tnaqqis fir-riskju relattiv ta' 17% f'pazjenti li kienu kkurati b'mod konservattiv, 29% meta kellhom anġoplastija koronarja transluminali perkutanja
English: Plavix 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Plavix 300 mg
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose, Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Maltese: macrogol 6000 u hydroxypropylcellulose b'sostituzzjoni baxxa Rita tal-pillola: lactose monohydrate (iz-zokkor li jinsab fil-ħalib), hypromellose (E464), triacetin (E1518), iron oxide aħmar (E172) u titanium dioxide (E171), Sustanza li tagħti l-lostru: carnauba wax .
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 fiċ ċirkulazzjoni), u waħda bl-intervent ta' ċitokromi P450 multipli. Clopidogrel jiġi mmetabolizzat l ewwel f'metabolit intermedjarju 2-oxo-clopidogrel.
English: Plavix 300 mg film-coated tablets Pink, oblong, engraved with «300» on one side and «1332» on the other side.
Maltese: Plavix 300 mg pilloli miksijin b'rita Roża, oblunga, b'«300» imnaqqax fuq naħa waħda u «1332» imnaqqax fuq in-naħa l-oħra.
English: Other medicines and Plavix
Maltese: Mediċini oħra u Plavix
English: Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Maltese: +32 (0)2 710 54 00 (Belgique/Belgien)
English: Date of first authorisation: 15 July 1998 Date of latest renewal: 15 July 2008
Maltese: Data tal-aħħar tiġdid: 15 ta' Lulju 2008
English: How to take Plavix
Maltese: X'fih Plavix
English: Week 1
Maltese: Ħ Ġimgħa 1
English: There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Maltese: Ma kien hemm ebda differenza statistikament sinifikanti bejn iż-żewġ gruppi fir-rata ta' fsada li twassal għall-mewt (1.1% fil-grupp clopidogrel + ASA u 0.7% fil-grupp plaċebo +ASA ) u fir-rata ta' puplesija emorraġika (0.8% u 0.6%, rispettivament).
English: Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Maltese: (75 mg/kuljum, n=22,961) jew il-plaċebo (n=22,891), flimkien ma' ASA (162 mg/kuljum), għal 28
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Maltese: In-numri ta' pazjenti li kellhom punt ko-primarju ta' tmiem (mewt b'CV, MI, puplesija jew iskemija li mhux qed tirrisondi għall-kura) kien 1 035 (16.5%) fil-grupp ikkurat bi clopidogrel u 1 187 (18.7%) fil-grupp ikkurat bil-plaċebo, tnaqqis ta' 14% fir-riskju relattiv) (95% CI ta' 6%-21%, p= 0.0005) għall-grupp ikkurat bi clopidogrel.
English: 28 film-coated tablets 30 film-coated tablets 50x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 14 film-coated tablets 7 film-coated tablets
Maltese: 28 pillola miksija b'rita 30 pillola miksija b'rita 50x1 pilloli miksijin b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 100 pillola miksija b'rita 14-il pillola miksija b'rita 7 pilloli miksija b'rita
English: Bleeding events defined as all BARC occurred in 30 patients (9.3%) in the de-escalated DAPT group and in 76 patients (23.5%) in the unchanged DAPT group (p<0.01).
Maltese: Avvenimenti ta' fsada definiti bħala kollha BARC seħħew f'30 pazjent (9.3%) fil-grupp ta' DAPT ta' tnaqqis filqawwa u f'76 pazjenti (23.5%) fil-grupp ta' DAPT mingħajr tibdil (p<0.01)
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Il-frekwenza tagħhom hija definita skond dawn il konvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥/1,000 sa <1/100); rari (≥1/10,000 sa
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Maltese: Dan il-benefiċċju ġie l-iktar mit-tnaqqis li kien statistikament sinifikanti ta' l-inċidenza ta' MI [287 (4.6%) fil-grupp ikkurat bi clopidogrel u 363 (5.8%) fil-grupp ikkurat bil-plaċebo].
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30, 50x1, 90 or 100 tablets
Maltese: FOLJI/ 30, 50x1, 90 jew 100 pillola
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Maltese: 600 mg/150 mg, l-espożizzjoni tal-metabolit attiv kienet akbar milli bis-sistema ta' dożaġġ ta' 300 mg/75 mg.
English: There was an excess of intracranial bleeding in the clopidogrel + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Maltese: Kien hemm iżjed fsada ġewwa l-kranju fil-grupp ta' kura clopidogrel + ASA meta mqabbel mal-grupp plaċebo + ASA (1.4% kontra 0.8%, rispettivament).
English: Plavix 75 mg film-coated tablets Plavix 300 mg film-coated tablets
Maltese: Plavix 75 mg pilloli miksijin b'rita Plavix 300 mg pilloli miksijin b'rita
English: If HPR≥46 units, the patients were escalated back to prasugrel 5 or 10 mg/d for 11.5 months; if HPR<46 units, the patients continued on clopidogrel 75 mg/d for 11.5 months.
Maltese: Jekk l-HPR≥46 unità, il-pazjenti reġgħu marru lura fuq ittrattament aktar qawwi ta' prasugrel 5 jew 10 mg/ġ għal 11.5 xhur; jekk l-HPR<46 unità, il-pazjenti komplew fuq clopidogrel 75 mg/ġ għal 11.5 xhur.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Maltese: Fil-metabolizzaturi dgħajfa, l espożizzjoni tal-metabolit attiv tnaqqset b'63-71% meta mqabbla 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.