FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Maltese: Madankollu, l-istudju fejn Enurace 50 tqabbel ma' Propaline (ACE129802) huwa konvinċenti għalkemm ma saritx analiżi ta' non-inferjorità.
English: These results were convincing when compared to the 20 % placebo treated animals that became continent in study ACE129801.
Maltese: Dawn ir-riżultati kienu konvinċenti meta mqabbla ma' l-20% ta' l-annimali ttrattati bil-plaċebo li saru kontinenti fl-istudju ACE129801.
English: Enurace 50 is a tablet formulation containing ephedrine as active ingredient and is indicated for treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovariohysterectomised dogs.
Maltese: Enurace 50 hija formulazzjoni ta' pillola li fiha l-efedrina bħala sustanza attiva u hija indikata għattrattament ta' inkontinenza ta' l-awrina kkawżata minn inkompetenza fil-mekkaniżmu ta' l-isfinteru ta' l-uretra fi klieb li tneħħewlhom l-ovarji.
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the Committee for Medicinal Products for Veterinary Use.
Maltese: Il-kwistjoni ġiet riferuta lillGrupp ta' Koordinazzjoni għal Proċeduri ta' Rikonoxximent Reċiproku u Deċentralizzati CMD(v) u wara, lill-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju.
English: In June 2006 a Mutual Recognition Procedure started with The Netherlands as Reference Member State and six Concerned Member States.
Maltese: F'Ġunju 2006 nbdiet Proċedura ta' Rikonoxximent Reċiproku ma' l-Olanda bħala l-Istat Membru ta' Referenza u sitt Stati Membri Konċernati.
English: In response to the questions related to toxicity, the applicant argued that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin could be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
Maltese: Bi tweġiba għall-mistoqsijiet relatati mat-tossiċità, l-applikant argumenta li minħabba l-effett farmakoloġiku ta' l-efedrina u l-varjazzjoni individwali fid-densità tar-riċevitur, ma seta' jiġi stabbilit l-ebda marġinu ta' sigurtà u ż-żieda fid-dożi tkun assoċjata ma' żieda fl-intensità u fil-frekwenza ta' effetti ħżiena magħrufin sewwa.
English: The CVMP, therefore, concluded that the benefit/risk for this product was favourable.
Maltese: Għalhekk, is-CVMP ikkonkluda li l-benefiċċju/riskju għal dan il-prodott kien favorevoli.
English: France considered the benefit/risk analysis unfavourable for the animal when the adverse effects were weighed against the potential benefits of effective treatment of incontinence.
Maltese: Franza kkunsidrat l-analiżi tal-benefiċċju/riskju bħala waħda mhux favorevoli għall-annimal meta leffetti ħżiena ġew evalwati kontra l-benefiċċji potenzjali tat-trattament effettiv għall-inkontinenza.
English: France and Italy could not agree to the granting of a marketing authorisation as they considered there were potentially serious risks for animal health.
Maltese: Franza u l-Italja ma setgħux jaqblu ma' l-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq billi huma ħassew li kien hemm riskji potenzjali serji għas-saħħa ta' l-annimal.
English: The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit/risk ratio for the treated animal.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għatTqegħid fis-Suq ġie mitlub jipprovdi d-dejta kollha ta' appoġġ biex jiġġustifika l-proporzjon pożittiv tal-benefiċċju/riskju għall-annimal ittrattat.
English: With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “the dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Maltese: Fir-rigward tal-mard kardjovaskulari relatat, l-SPC għandu jiġi modifikat taħt is-sezzjoni 4.5 biex jinkludi s-sentenza “il-funzjonalità kardjovaskulari tal-kelb għandha tiġi evalwata sewwa qabel ma jinbeda t-trattament b'Enurace 50 u għandha tiġi mmonitorjata kull tant żmien matul it-trattament”.
English: Italy could have accepted the application but with revised wording in the SPC.
Maltese: LItalja setgħet taċċetta l-applikazzjoni iżda b'formolazzjoni riveduta ta' l-SPC.
English: Date of latest renewal: 19 November 2014
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru 2014
English: Microcrystalline cellulose Low substituted hydroxypropylcellulose Maize starch
Maltese: Microcrystalline cellulose Hydroxypropylcellulose b'sostituzzjoni baxxa Maize starch
English: Thrombocytopenia, leucopenia, eosinophilia
Maltese: Tromboċitotopenija , lewkopenija, eosinofilja
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: Twaqqfu avvenimenti kardjovaskulari ġodda (punt primarju ta' tmien), 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-il xhar, rispettivament.
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex France
Maltese: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex Franza
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Red iron oxide (E172)
Maltese: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518)
English: Hypoglycaemia*, gout* (see section 4.4)
Maltese: Ipogliċemija*, gotta* (ara sezzjoni 4.4)
English: (See section 4.4.)
Maltese: (ara sezzjoni 4.4).
English: (See section 4.5.)
Maltese: (ara sezzjoni 4.5).
English: The use of clopidogrel in CURE was associated with a decrease in the need for thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).
Maltese: L-użu ta' clopidogrel fi CURE kien assoċjat mat-tnaqqis fil-bżonn ta' kura trombolitika (TRR = 43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (TRR = 18.2%; CI: 6.5%, 28.
English: Doses of 100-500 mg/day:
Maltese: Dożi ta' 100- 500 mg/kuljum:
English: DuoPlavin contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: DuoPlavin fih clopidogrel u acetylsalicylic acid (ASA) u jifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' kontra l-plejtlets.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis.
Maltese: Emorraġija gastrointestinali u minn wara lperitonew b'eżitu fatali, pankreatite.
English: At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Maltese: F'konċentrazzjonijiet baxxi (<100 mikrogrammi/ml), kważi 90 % ta' salicylic acid huwa marbut ma' l-albumina.
English: It also contains: lactose and hydrogenated castor oil.
Maltese: Fih ukoll: lactose u castor oil idroġenat.
English: The active substances are clopidogrel and acetylsalicylic acid (ASA).
Maltese: Is-sustanzi attivi huma clopidogrel u acetylsalicylic acid (ASA).
English: Sun.
Maltese: Tel.
English: • Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) and syndrome of asthma, rhinitis, and nasal polyps.
Maltese: • Sensittività eċċessiva għall-mediċini antiinfjammatorji li mhumiex sterojdi (NSAIDs) u sindromu ta' ażma, rinite u qarnit fl-imnieħer.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus, fixed eruption*
Maltese: Dermatite bulloża (nekroliżi tossika talepidermis, is-Sindrome ta' Stevens Johnson, eritema multiforme, exanthematous pustulosis akuta u ġeneralizzata (AGEP)), anġjoedima, sindromu ta' sensittività eċċessiva kkawżat millmediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), raxx eritematożu jew bilqoxra, urtikarja, ekżema u lichen planus, eruzzjonijiet fil-ġilda li dejjem iseħħu fl-istess post (fixed eruption)*
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome)
Maltese: Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tagħhom hija definita skont dawn il-konvenzjonijiet: komuni (≥1/100 sa <1/10) ; mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the deescalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥2 ((5%) in the de-escalation group versus 6% in the control group
Maltese: It-tnaqqis fil-qawwa ggwidat ma rriżultax f'żieda fir-riskju kkombinat ta' avvenimenti iskemiċi (2.5% fil-grupp ta' tnaqqis fil-qawwa vs 3.2% fil-grupp ta' kontroll; p mhux inferjuri =0.0115), u l-anqas fil-punt finali sekondarju prinċipali fsada BARC ≥2 ((5%) fil-grupp ta' tnaqqis fil-qawwa kontra 6% fil-grupp ta' kontroll (p=0.23)).
English: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘DuoPlavin contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘DuoPlavin contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172) - Polishing agent: carnauba wax
Maltese: - Il-qalba tal-pillola: mannitol (E421), macrogol 6000, microcrystalline cellulose, hydroxypropylcellulose b'sostituzzjoni baxxa, maize starch, castor oil idroġenat ( ara sezzjoni 2 ‘DuoPlavin fih castor oil idroġenat'), stearic acid u silica anidrat kollojdali - Fil-kisi tal-pillola: lactose monohydrate (ara sezzjoni 2 ‘DuoPlavin fih il-lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide isfar (E172) - Sustanza li tagħti l-lostru: carnauba wax
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel plus ASA group and 363 (5.8%) in the ASA 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 flimkien ma'ASA u 363 (5.8%) fil-grupp ikkurat b'ASA].
English: Hydrogenated castor oil Stearic acid
Maltese: Castor oil idroġenat
English: This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged DAPT group (p<0.01).
Maltese: Din id-differenza statistikament sinifikanti kienet ikkawżata l-iżjed minħabba li kien hemm inqas avvenimenti ta' fsada ,mingħajr ma ġiet irrapportata ebda differenza fil-punti finali iskemiċi (p=0.36), waqt li BARC ≥2 episodji ta' fsada seħħ b'mod anqas frekwenti fil-grupp ta' DAPT ta' tnaqqis fil-qawwa (4.0%) kontra 14.9% fil-grupp DAPT ta' mingħajr bidla (p<0.01).
English: The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%.
Maltese: Ir-riskju assolut ta' difett fil-formazzjoni kardjovaskulari żdied minn inqas minn 1 % sa madwar 1.5 %.
English: Adults and elderly
Maltese: Adulti u anzjani
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) plus ASA (75-325 mg once daily) or ASA alone (N=6,303), (75-325 mg once daily) and other standard therapies.
Maltese: Ilpazjenti kienu randomised għal clopidogrel (doża tal-bidu ta' 300 mg u wara 75 mg/jum, N = 6,259) flimkien ma' ASA (75-325 mg darba kuljum) jew ASA waħdu (N = 6,303), (75-325 mg darba kuljum) u terapiji oħra normali.
English: Eye bleeding (conjunctival, ocular, retinal)
Maltese: Dmija fl-għajnejn (konġuntivali, okulari, retinali )
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30, 30x1, 50x1, 90x1 and 100x1 tablets
Maltese: FOLJA/ 30, 30x1, 50x1, 90x1 u 100x1 pilloli
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastro-duodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASArelated GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Maltese: Disturbi gastro-intestinali tannaħa ta' fuq tal-imsaren (esofaġite, ulċerazzjoni esofaġeali, perforazzjoni,gastrite erosiva, dwodenite erosiva, ulċera/perforazzjoni gastro-dwodenali*, disturbi gastro-intestinali tan-naħa t'isfel talimsaren (ulċeri talintestin iż-żgħir [ġeġunu u ilju] u l-kbir [kolon u rettu] kolite u perforazzjoni intestinali)*; sintomi gastriċi u tan-naħa ta' fuq ta' l-imsaren* bħal gastralġja (ara sezzjoni 4.4); dawn irreazzjonijiet gastrointestinali relatati ma' ASA jistgħu jew jistgħu ma jkunux assoċjati ma' emorraġija u jistgħu jseħħu b'kwalunkwe doża ta' acetylsalicylic acid u kemm f'pazjenti b'sintomi ta' twissija jew mingħajr u kemm f'pazjenti li m'għandhomx passat mediku ta' avvenimenti gastro-intestinali serji*.
English: Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a hypersensitivity reaction due to acetylsalicylic acid* or clopidogrel**
Maltese: Sindrome ta' Kounis (anġina allerġika vasospastika / infart mijokardijaku allerġiku) f'kuntest ta' reazzjoni ta' sensittività eċċessiva għal acetylsalicylic acid* jew clopidogrel**
English: DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA).
Maltese: DuoPlavin huwa indikat għall-prevenzjoni sekondarja ta' avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qegħdin jieħdu kemm clopidogrel u kemm acetylsalicylic acid (ASA).
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), bone marrow failure*, aplastic anaemia, pancytopenia, bicytopenia*, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia, haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency* (see section 4.4)
Maltese: Tromboċitopenika Trombotika (TTP) (ara sezzjoni 4.4), insuffiċjenza talmudullun*, anemija aplastika, panċitopenija, biċitopenija*, agranuloċitosi tromboċitotopenija severa, emofilja A akwiżita, granuloċitopenija, anemija, anemija emolitika f'pazjenti b'insuffiċjenza ta' glucose-6-phosphate dehydrogenase* (G6PD)
English: Each film-coated tablet contains 8 mg of lactose and 3.3 mg of hydrogenated castor oil.
Maltese: Kull pillola miksija b'rita fiha 8 mg ta' lactose u 3.3 mg ta' castor oil idroġenat.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30x1, 50x1, 90x1 and 100x1 tablets
Maltese: FOLJA/30x1, 50x1, 90x1 u 100x1 pilloli
English: • the foetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
Maltese: - tossiċità kardjopulmonarja ( għeluq prematur tad-ductus arteriosus u ipertensjoni pulmonarja); - disfunzjoni renali li tista' twassal għall-insuffiċjenza renali b'oligo-idroamnjożi;
English: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic (PK) interactions.
Maltese: Saru numru ta' studji kliniċi oħra bi clopidogrel u prodotti mediċinali oħra li ngħataw flimkien biex tiġi investigata l-possibilita` ta' interazzjonijiet farmakodinamiċi u farmakokinetiċi.
English: DuoPlavin 75 mg/75 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28, 30 and 84 film-coated tablets.
Maltese: DuoPlavin 75 mg/75 mg pilloli miksijin b'rita Folji tal-aluminjum f'kaxxi tal-kartun li fihom 14, 28, 30 u 84 pillola miksija b'rita.
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Maltese: Ulċera ta' l-istonku u ulċera tadduodenum, gastrite, rimettar, tqalligħ, stitikezza, gass flistonku
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 14, 28 and 84 tablets
Maltese: FOLJA/ 14, 28 u 84 pillola
English: Uricosurics (benzbromarone, probenecid, sulfinpyrazone) Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Maltese: Urikosuriċi (benzbromarone, probenecid, sulfinpyrazone) Hemm bżonn ta' kawtela għax ASA jista' jinibixxi l-effetti tas-sustanzi urikosuriċi permezz ta' leliminazzjoni kompetitiva ta' aċidu uriku.
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 is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/
English: There is an increased risk of bleeding due to the potential additive effect.
Maltese: Hemm żieda fir-riskju ta' fsada minħabba lpotenzjal ta' effett addizzjonali.
English: The following symptoms are associated with moderate intoxication: dizziness, headache, tinnitus, confusion and gastrointestinal symptoms (nausea, vomiting and gastric pain).
Maltese: Is-sintomi li ġejjien huma assoċjati ma' intossikazzjoni moderata: sturdament, uġigħ ta' ras, żanżin filwidnejn (tinnitus), konfużjoni, u sintomi gastro-intestinali (dardir, rimettar u uġigħ gastriku).
English: Other medicines and DuoPlavin
Maltese: Mediċini oħra u DuoPlavin
English: Colloidal anhydrous silica
Maltese: Silica anidrat kollojdali
English: Repeated doses of clopidogrel 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: Each film-coated tablet contains 7 mg of lactose and 3.3 mg of hydrogenated castor oil.
Maltese: Kull pillola miksija b'rita fiha 7 mg ta' lactose u 3.3 mg ta' castor oil idroġenat.
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
English: Patients were randomized to receive either prasugrel 5 or 10 mg/d (Days 0-14) (n=1306), or prasugrel 5 or 10 mg/d (Days 0-7) then de-escalated to clopidogrel 75 mg/d (Days 8-14) (n=1304), in combination with ASA (<100 mg/day).
Maltese: B'mod arbitrarju l-pazjenti ntgħażlu biex jirċievu jew prasugrel 5 jew 10 mg/ġ (Ġranet 0-14) (n=1306), jew prasugrel 5 jew 10 mg/ġ (Ġranet 0-7) fejn imbagħad ilqawwa tnaqqset għal clopidogrel 75 mg/ġ (Ġranet 8-14) (n=1304), flimkien ma' ASA (<100 mg/ġurnata).
English: How to take DuoPlavin
Maltese: X'fih DuoPlavin
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 50x1 film-coated tablet 84 film-coated tablets 90x1film-coated tablet 100x1 film-coated tablet 30 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 x 1 pillola miksija b'rita 50 x 1 pillola miksija b'rita 84 pillola miksija b'rita 90 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita 30 pillola miksija b'rita
English: Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Maltese: Wara doża orali ta' clopidogrel 14C-tikkettat fil-bniedem, bejn wieħed u ieħor 50% kien mneħħi fl urina u bejn wieħed u ieħor 46% ħareġ fl-ippurgar fl-intervall ta' 120 siegħa wara d-dożaġġ.
English: DuoPlavin 75 mg/100 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28 and 84 film-coated tablets.
Maltese: DuoPlavin 75 mg/100 mg pilloli miksijin b'rita Folji tal-aluminjum f'kaxxi tal-kartun li fihom 14, 28 u 84 pillola miksija b'rita.
English: Interactions with the following medicinal products with higher (anti-inflammatory) doses of ASA have also been reported: angiotensin converting enzyme (ACE) inhibitors, phenytoin, beta blockers, diuretics, and oral hypoglycemic agents.
Maltese: B'dożi ogħla (anti-infjammatori) ta' ASA ġew ukoll irrapportati interazzjonijiet mal-prodotti mediċinali li ġejjien:inibituri ta' l-enzima li tikkonverti anġjotensin (ACE), phenytoin, beta-blokkanti, dijuretiċi u sustanzi ipogliċemiċi li jittieħdu mill-ħalq.
English: DuoPlavin 75 mg/75 mg film-coated tablets EU/1/10/619/001 - Cartons of 14 film-coated tablets in aluminium blister packs EU/1/10/619/002 - Cartons of 28 film-coated tablets in aluminium blister packs EU/1/10/619/003 - Cartons of 30x1 film-coated tablet in aluminium blister packs EU/1/10/619/004 - Cartons of 50x1 film-coated tablet in aluminium blister packs EU/1/10/619/005 - Cartons of 84 film-coated tablets in aluminium blister packs EU/1/10/619/006 - Cartons of 90x1film-coated tablet in aluminium blister packs EU/1/10/619/007 - Cartons of 100x1film-coated tablet in aluminium blister packs EU/1/10/619/015 - Cartons of 30 film-coated tablet in aluminium blister packs
Maltese: DuoPlavin 75 mg/75 mg pilloli miksijin b'rita EU/1/10/619/001 - Kaxex ta' 14-il pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/002 - Kaxex ta' 28 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/003 - Kaxex ta' 30 x 1 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/004 - Kaxex ta' 50 x 1 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/005 - Kaxex ta' 84 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/006 - Kaxex ta' 90 x 1 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/007 - Kaxex ta' 100 x 1 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/015 - Kaxex ta' 30 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum
English: Other side effects include:
Maltese: Appel depuis l'étranger:
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 50x1 film-coated tablet 84 film-coated tablets 90x1film-coated tablet 100x1 film-coated tablet
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 x 1 pillola miksija b'rita 50 x 1 pillola miksija b'rita 84 pillola miksija b'rita 90 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC30.
Maltese: Eparina, Kodiċi ATC: B01AC30
English: Vascular disorders Haematoma
Maltese: Disturbi vaskulari Ematoma