FrancophonIA/ELRC3.0 huggingface dataset:
English: Jinarc is contraindicated in patients with elevated liver enzymes and/or signs or symptoms of liver injury prior to initiation of treatment that meet the requirements for permanent discontinuation of tolvaptan (see sections 4.3 and 4.4).
Maltese: Jinarc huwa kontraindikat f'pazjenti b'enzimi tal-fwied elevati u/jew b'sinjali jew sintomi ta' ħsara fil-fwied qabel tinbeda l-kura li jissodisfaw ir-rekwiżiti għall-waqfien permanenti ta' tolvaptan (ara sezzjonijiet 4.3 u 4.4).
English: A non-interventional post-authorisation safety study (PASS) to investigate the risks of:
Maltese: Studju mhux intervenzjonali dwar is-sigurta wara l-awtorizzazzjoni (PASS) biex jinvestiga r-riskji ta':
English: Each Jinarc 15 mg tablet contains 15 mg tolvaptan.
Maltese: Kull pillola Jinarc 15 mg fiha 15 mg tolvaptan.
English: Each tablet contains 15 mg tolvaptan.
Maltese: Kull pillola fiha 15 mg tolvaptan.
English: Each 15 mg tablet contains 15 mg tolvaptan.
Maltese: Kull pillola ta' 15 mg fiha 15 mg tolvaptan.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħruf: ma tistax tittieħed stima tal-frekwenza mid-dejta disponibbli
English: Each Jinarc 45 mg tablet contains 45 mg tolvaptan.
Maltese: Kull pillola Jinarc 45 mg fiha 45 mg tolvaptan.
English: Fluid and electrolyte status must be monitored in all patients.
Maltese: L-istat tal-fluwidi u tal-elettroliti għandu jiġi mmonitorjat fil-pazjenti kollha.
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets
Maltese: 28 pillola f'2 folji tal-PVC/fojl tal-aluminju f'kartuna għall-kartiera b'7 × 15 mg u 7 × 45 mg pilloli 56 pillola f'4 folji tal-PVC/fojl tal-aluminju f'kartuna għall-kartiera b'7 × 15 mg u 7 × 45 mg pilloli
English: Uric acid concentrations are to be evaluated prior to initiation of Jinarc therapy, and as indicated during treatment based on symptoms.
Maltese: Konċentrazzjonijiet ta' aċidu uriku għandhom jiġu evalwati qabel ma tinbeda t-terapija b'Jinarc, u kif indikat waqt il-kura abbażi tas-sintomi.
English: • if you had an allergic reaction in the past to benzazepine, tolvaptan or other benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6).
Maltese: benzazepine (eż. benazepril, conivaptan, fenoldopam mesylate jew mirtazapine) jew għal xi sustanza oħra ta' din il-mediċina fil-passat (imniżżla f'sezzjoni 6).
English: EU/1/15/1000/008 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablets (28 × 30 mg + 28 × 60 mg)
Maltese: EU/1/15/1000/008 14-il pillola (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 pillola (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 pillola (28 × 30 mg + 28 × 60 mg)
English: Jinarc is used to treat ADPKD in adults with chronic kidney disease (CKD) stages 1 to 4 with evidence of rapidly progressing disease.
Maltese: Jinarc jintuża biex jikkura ADPKD f'adulti b'marda kronika tal-kliewi (CKD - chronic kidney disease) ta' stadji 1 sa 4 b'evidenza ta' progressjoni mgħaġġla tal-marda.
English: The result of the key secondary composite endpoint is primarily attributed to effects on worsening kidney function and medically significant kidney pain.
Maltese: Ir-riżultat tal-punt finali sekondarju kompost kruċjali (key secondary composite endpoint) huwa primarjament attribwit għall-effetti fuq funzjoni tal-kliewi li qed taggrava u fuq uġigħ fil-kliewi li huwa medikament sinifikanti.
English: Each 45 mg tablet contains 45 mg of tolvaptan.
Maltese: Kull pillola ta' 45 mg fiha 45 mg tolvaptan.
English: United Kingdom Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 (0)203 747 5300
Maltese: Tel: +44 (0)203 747 5300
English: 30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
Maltese: Pillola ta' 30 mg: blu, tonda, b'“OTSUKA” u “30” imnaqqxa fuq naħa waħda.
English: Medicinal products with high sodium content such as effervescent analgesic preparations and certain sodium containing treatments for dyspepsia may also increase serum sodium concentration.
Maltese: Prodotti mediċinali b'kontenut għoli ta' sodium bħal preparazzjonijiet analġeżiċi effervexxenti u ċertu kura għal dispepsja li fiha s-sodium ukoll jistgħu jżidu l-konċentrazzjoni tas-sodium fis-serum.
English: Each tablet contains 30 mg tolvaptan.
Maltese: Kull pillola fiha 30 mg tolvaptan.
English: EU/1/15/1000/011 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablets (28 × 30 mg + 28 × 90 mg)
Maltese: EU/1/15/1000/011 14-il pillola (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 pillola (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 pillola (28 × 30 mg + 28 × 90 mg)
English: EU/1/15/1000/020 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablets (28 × 30 mg + 28 × 90 mg)
Maltese: EU/1/15/1000/020 14-il pillola (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 pillola (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 pillola (28 × 30 mg + 28 × 90 mg)
English: Co-administration of tolvaptan with grapefruit juice, a moderate to strong CYP3A inhibitor, produced a doubling of peak tolvaptan concentrations (Cmax).
Maltese: L-għoti ta' tolvaptan flimkien ma' meraq tal-grejpfrut, inibitur moderat sa qawwi ta' CYP3A, ipproduċa irduppjar tal-konċentrazzjonijiet massimi ta' tolvaptan (Cmax).
English: Tolvaptan treatment must be initiated and monitored under the supervision of physicians with expertise in managing ADPKD and a full understanding of the risks of tolvaptan therapy including hepatic toxicity and monitoring requirements (see section 4.4).
Maltese: Kura b'tolvaptan għandha tinbeda' u tiġi mmonitorjata taħt is-superviżjoni ta' tobba b'esperjenza fl-immaniġġjar ta' ADPKD u b'għarfien komplut tar-riskji ta' terapija b'tolvaptan inkluż tossiċità epatika u ħtiġijiet ta' monitoraġġ (ara sezzjoni 4.4).
English: EU/1/15/1000/017 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablets (28 × 30 mg + 28 × 60 mg)
Maltese: EU/1/15/1000/017 14-il pillola (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 pillola (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 pillola (28 × 30 mg + 28 × 60 mg)
English: Excipient(s) with known effect
Maltese: Eċċipjent(i) b'effett magħruf
English: Co-administration with vasopressin analogues
Maltese: Għoti flimkien ma' analogi ta' vasopressin
English: Each Jinarc 30 mg tablet contains 30 mg tolvaptan.
Maltese: Kull pillola Jinarc 30 mg fiha 30 mg tolvaptan.
English: 7 × 30 mg tablets and 7 × 60 mg tablets in card packaging 14 × 30 mg tablets and 14 × 60 mg tablets in card packaging 28 × 30 mg tablets and 28 × 60 mg tablets in card packaging
Maltese: 7 × 30 mg pilloli u 7 × 60 mg pilloli fl-ippakkjar tal-kartuna 14 × 30 mg pilloli u 14 × 60 mg pilloli fl-ippakkjar tal-kartuna 28 × 30 mg pilloli u 28 × 60 mg pilloli fl-ippakkjar tal-kartuna
English: 35 % reduction in the LS means of change in eGFR of -2.34 mL/min/1.73 m in tolvaptan group relative to a -3.61 mL/min/1.73 m in placebo group observed over the course of one year.
Maltese: Id-differenza fit-trattament fil-bidla eGFR osservata f'din il-prova kienet ta' 1.27 mL/min/1.73 m2, li tirrapreżenta tnaqqis ta' 35 % fil-medji LS ta' bidla f'eGFR ta'2.34 mL/min/1.73 m2 fil-grupp ta' tolvaptan relattiv għal -3.61 mL/min/1.73 m2 fil-grupp tal-plaċebo osservat fuq il-perijodu ta' sena.
English: Jinarc is contraindicated during breast-feeding (see section 4.3).
Maltese: Jinarc hu kontraindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: Fourteen metabolites have been identified in plasma, urine and faeces; all but one were also metabolised by CYP3A.
Maltese: Kienu identifikati erbatax-il metabolit fil-plażma, fl-awrina u fl-ippurgar; kollha ħlief wieħed kienu metabolizzati wkoll minn CYP3A.
English: 7 × 30 mg tablets and 7 × 90 mg tablets in card packaging 14 × 30 mg tablets and 14 × 90 mg tablets in card packaging 28 × 30 mg tablets and 28 × 90 mg tablets in card packaging
Maltese: 7 × 30 mg pilloli u 7 × 90 mg pilloli fl-ippakkjar tal-kartuna 14 × 30 mg pilloli u 14 × 90 mg pilloli fl-ippakkjar tal-kartuna 28 × 30 mg pilloli u 28 × 90 mg pilloli fl-ippakkjar tal-kartuna
English: The risk of hepatic damage in patients with severely reduced renal function (i.e. eGFR < 20) may be increased; these patients should be carefully monitored for hepatic toxicity.
Maltese: Ir-riskju ta' ħsara epatika f'pazjenti b'funzjoni tal-kliewi mnaqqsa b'mod sever (jiġifieri eGFR < 20) jista' jiżdied; dawn il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni għal tossiċità epatika.
English: Generalised rash
Maltese: Raxx, Ħakk
English: During the first 18 months of treatment, Jinarc can only be supplied to patients whose physician has determined that liver function supports continued therapy.
Maltese: Matul l-ewwel 18-il xahar ta' kura, Jinarc jista' jiġi pprovdut biss lill-pazjenti li t-tabib tagħhom ikun iddetermina li l-funzjoni tal-fwied tappoġġja kontinwazzjoni tat-terapija.
English: Measurements of urine osmolality are recommended to monitor the adequacy of vasopressin inhibition.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Pregnancy
Maltese: Internazzjonali
English: Abdominal pain, Abdominal distension, Constipation, Dyspepsia,
Maltese: Uġigħ ta' żaqq, Nefħa addominali, Stitikezza, Dispepsja, Marda ta' rifluss gastroesofagali
English: Abnormal hepatic function
Maltese: GĦAMLA KWALITATTIVA
English: Each 30 mg tablet contains 30 mg tolvaptan.
Maltese: Kull pillola ta' 30 mg fiha 30 mg tolvaptan.
English: The key secondary endpoint was a comparison of the efficacy of tolvaptan treatment vs. placebo in reducing the decline of annualized eGFR slope across all measured time points in the trial.
Maltese: Il-punt finali sekondarju ewlieni kien paragun tal-effikaċja tattrattament ta' tolvaptan vs. plaċebo fit-tnaqqis tad-deklin tal-inklinazzjoni ta' eGFR annwalizzata filpunti kollha mkejla tal-ħin tal-prova.
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets
Maltese: 28 pillola f'2 folji tal-PVC/fojl tal-aluminju f'kartuna għall-kartiera b'7 × 30 mg u 7 × 60 mg pilloli 56 pillola f'4 folji tal-PVC/fojl tal-aluminju f'kartuna għall-kartiera b'7 × 30 mg u 7 × 60 mg pilloli
English: • dry mouth
Maltese: • uġigħ ta' żaqq
English: Consult your doctor if symptoms of nausea, vomiting, fever, tiredness, loss of appetite, pain in the abdomen, dark urine, jaundice (yellowing of skin or eyes), itching of your skin or joint and muscle pain with fever occur.
Maltese: Ikkonsulta t-tabib tiegħek jekk iseħħu sintomi ta' dardir, rimettar, deni, għeja, telf ta' aptit, uġigħ fl-addome, awrina skura, suffejra (sfurija tal-ġilda jew tal-għajnejn), ħakk tal-ġilda jew uġigħ fil-ġogi u fil-muskoli flimkien ma' deni.
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets
Maltese: 28 pillola f'2 folji tal-PVC/fojl tal-aluminju f'kartuna għall-kartiera b'7 × 30 mg u 7 × 90 mg pilloli 56 pillola f'4 folji tal-PVC/fojl tal-aluminju f'kartuna għall-kartiera b'7 × 30 mg u 7 × 90 mg pilloli
English: Prior to launch of Jinarc in each Member State the Marketing Authorisation Holder must agree the content and format of the educational programme, including communication media and distribution modalities with each National Competent Authority.
Maltese: Qabel ma Jinarc jitqiegħed fis-suq f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiftiehem dwar il-kontenut u d-disinn tal-programm edukattiv, inkluż komunikazzjoni permezz tal-midja u l-modalitajiet ta' distribuzzjoni ma' kull Awtorità Kompetenti Nazzjonali.
English: • liver function abnormal
Maltese: • funzjoni anormali tal-fwied
English: How to store Jinarc
Maltese: X'fih Jinarc
English: In patients treated with tolvaptan the reduction in eGFR was significantly less than in patients treated with placebo (p < 0.0001).
Maltese: F'pazjenti trattati b'tolvaptan it-tnaqqis f'eGFR kien b'mod sinjifikanti inqas milli f'pazjenti trattati bi plaċebo (p < 0.0001).
English: Patients receiving digoxin or other narrow therapeutic P-gp substrates (e.g., dabigatran) must therefore be managed cautiously and evaluated for excessive effects when treated with tolvaptan.
Maltese: Pazjenti li jirċievu digoxin jew sottostrati oħra ta' P-gp b'indiċi terapewtiku (therapeutic index) dejjaq (eż. dabigatran) għalhekk għandhom jiġu mmaniġġjati b'attenzjoni u evalwati għal effetti eċċessivi meta kkurati b'tolvaptan.
English: Concomitant use of medicinal products that are potent CYP3A inducers (e.g., rifampicin) will decrease tolvaptan exposure and efficacy.
Maltese: L-użu fl-istess waqt ta' prodotti mediċinali li huma indutturi qawwija ta' CYP3A (eż. rifampicin) inaqqas l-espożizzjoni u l-effikaċja ta' tolvaptan.
English: Each 90 mg tablet contains 90 mg of tolvaptan.
Maltese: Kull pillola ta' 90 mg fiha 90 mg tolvaptan.
English: Each Jinarc 90 mg tablet contains 90 mg tolvaptan.
Maltese: Kull pillola Jinarc 90 mg fiha 90 mg tolvaptan.
English: The safety and efficacy of Jinarc in CKD stage 5 have not been adequately explored and therefore tolvaptan treatment should be discontinued if renal insufficiency progresses to CKD stage 5.
Maltese: Is-sigurtà u l-effikaċja ta' Jinarc f'CKD stadju 5 ma kinux esplorati b'mod xieraq u għalhekk kura b'tolvaptan għandha titwaqqaf jekk linsuffiċjenza tal-kliewi timxi għal CKD stadju 5.
English: Idiosyncratic hepatic toxicity
Maltese: Tossiċità idjosinkratika tal-fwied
English: • experience swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Maltese: • ikollok nefħa fil-wiċċ, xufftejn jew ilsien, ħakk, raxx ġeneralizzat, jew tħarħir sever jew qtugħ ta' nifs (sintomi ta' reazzjoni allerġika).
English: 15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
Maltese: Pillola ta' 45 mg: blu, kwadra, b'“OTSUKA” u “45” imnaqqxa fuq naħa waħda.
English: Otsuka Pharma Scandinavia AB Tlf: +46854 528 660
Maltese: Tlf: +46854 528 660
English: The results of the primary endpoint, the rate of change in TKV for subjects randomised to tolvaptan (normalised as percentage) to the rate of change for subjects on placebo, were highly statistically significant.
Maltese: Ir-riżultati tal-punt finali primarju (primary endpoint), ir-rata ta' bidla f'TKV għall-individwi randomised għal tolvaptan (normalizzati bħala persentaġġ) imqabbla mar-rata ta' bidla għall-individwi fuq il-plaċebo, kienu statistikament sinifikanti ħafna.
English: Concurrent monitoring for symptoms that may indicate liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, dark urine or jaundice) is recommended.
Maltese: Huwa rakkomandat li jsir monitoraġġ fl-istess waqt għal sintomi li jistgħu jindikaw ħsara fil-fwied (bħal għeja, anoreksja, dardir, skumdità fil-parti ta' fuq tal-lemin tal-addome, rimettar, deni, raxx, ħakk, awrina skura jew suffejra).
English: Two fertility studies in rats showed effects on the parental generation (decreased food consumption and body weight gain, salivation), but tolvaptan did not affect reproductive performance in males and there were no effects on the foetuses.
Maltese: Żewġ studji dwar il-fertilità fil-firien urew effetti fuq il-ġenerazzjoni tal-ġenituri (tnaqqis fil-konsum tal-ikel u fiż-żieda fil-piż tal-ġisem, salivazzjoni), iżda tolvaptan ma kellux effett fuq l-eżekuzzjoni riproduttiva fl-irġiel u ma kienx hemm effetti fuq il-feti.
English: Longer term data are not currently available to show whether long-term therapy with Jinarc continues to slow the rate of renal function decline and affect clinical outcomes of ADPKD, including delay in the onset of end-stage renal disease.
Maltese: Attwalment mhemmx dejta disponibbli għal perijodu ta' żmien itwal li turi jekk terapija fit-tul b'Jinarc tkomplix tnaqqas ir-rata ta' tnaqqis tal-funzjoni renali u jekk taffettwax l-effetti kliniċi ta' ADPKD, li jinkludu dewmien għall-bidu tal-marda tal-kliewi tal-aħħar stadju.
English: Dose reduction of tolvaptan is recommended for patients while taking moderate or strong CYP3A inhibitors (see section 4.2).
Maltese: Tnaqqis fid-doża ta' tolvaptan hu rakkomandat għal pazjenti waqt li jkunu qed jieħdu inibituri moderati jew qawwija ta' CYP3A (ara sezzjoni 4.2).
English: In patients with suspected tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended.
Maltese: F'pazjenti b'suspett ta' doża eċċessiva ta' tolvaptan, hija rakkomandata valutazzjoni tas-sinjali vitali, tal-konċentrazzjonijiet tal-elettroliti, tal-ECG u tal-istat tal-fluwidi.
English: • the risk of hepatotoxicity associated with the use of Jinarc
Maltese: • reazzjonijiet allerġiċi (ara hawn fuq)
English: Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Għamla Farmaċewtika
English: EMEA Number
Maltese: Mnejn jingħata
English: The full EPAR for Clopidogrel TAD can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 07-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2017.
English: Clopidogrel TAD is a ‘generic medicine'.
Maltese: Clopidogrel TAD huwa "mediċina ġenerika".
English: Clopidogrel TAD
Maltese: Clopidogrel TAD jista
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel TAD.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Clopidogrel TAD.
English: Other information about Clopidogrel TAD
Maltese: Informazzjoni oħra dwar Clopidogrel TAD
English: • peripheral arterial disease (problems with blood flow in the arteries);
Maltese: • ikollhom mard fl-arterji periferali (problemi fil-fluss tad-demm fl-arterji);
English: • recently had a myocardial infarction (heart attack).
Maltese: • reċentement kellhom infart mijokardijaku (attakk tal-qalb).
English: Clopidogrel TAD contains the active substance clopidogrel.
Maltese: Clopidogrel TAD fih is-sustanza attiva klopidogrel.
English: The active substance in Clopidogrel TAD, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva fi Clopidogrel TAD, il-klopidogrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel TAD is used together with aspirin, the dose of which should not be higher than 100 mg.
Maltese: Fil-każi ta' sindromu koronarju akut u ta' fibrillazzjoni atrijali, Clopidogrel TAD jintuża flimkien ma' aspirina, fejn id-doża m'għandhiex taqbeż il-100 mg.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel TAD on 23 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Clopidogrel TAD valida fl-Unjoni Ewropea kollha fit-23 ta' Settembru 2009.
English: Clopidogrel TAD is available as tablets containing 75 mg clopidogrel.
Maltese: Clopidogrel TAD jiġi bħala pilloli li fihom 75 mg klopidogrel.
English: Because Clopidogrel TAD is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Peress li Clopidogrel TAD huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Maltese: • ikollhom fibrillazzjoni atrijali (kontrazzjonijiet irregolari u mgħaġġla tal-kavitajiet ta
English: The standard dose is one 75-mg tablet once a day.
Maltese: Id-doża standard hija pillola waħda ta' 75mg kuljum.
English: Clopidogrel TAD is a medicine used to prevent problems caused by blood clots in adults who have:
Maltese: Clopidogrel TAD huwa mediċina li tintuża biex tipprevjeni problemi kkawżati minn emboli tad-demm f'adulti li:
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Maltese: Imbagħad ilkura titkompla b'doża standard ta' 75-mg darba kuljum tul tal-inqas erba' ġimgħat (fil-każi ta' infart mijokardiku b'elevazzjoni tas-segment ST) jew sa 12-il xahar (fil-każi ta' anġina instabbli jew infart mijokardiku ‘mingħajr il-mewġa Q').
English: Clopidogrel TAD can be started between a few days and 35 days after the attack;
Maltese: Clopidogrel TAD jista' jinbeda fl-ewwel ftit jiem u 35 jum wara l-attakk;
English: This means that Clopidogrel TAD is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Clopidogrel TAD huwa simili għall-"mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Because Clopidogrel TAD is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Clopidogrel TAD huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċini ta' referenza.
English: Why is Clopidogrel TAD approved?
Maltese: Għaliex ġiet approvat Clopidogrel TAD?
English: What are the benefits and risks of Clopidogrel TAD?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Clopidogrel TAD?
English: How has Clopidogrel TAD been studied?
Maltese: Kif ġie studjat Clopidogrel TAD?
English: clopidogrel
Maltese: Jin
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Maltese: Is-sindromu koronarju akut huwa grupp ta' problemi fil-qalb li jinkludu l-attakki tal-qalb u l-anġina instabbli (tip sever ta' uġigħ fis-sider).
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar ilmediċini ġeneriċi, ara d-dokument mistoqsijiet-u-tweġibiet hawnhekk.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Maltese: • ikollhom kundizzjoni li tissejjaħ ‘sindromu koronarju akut', meta għandu jittieħed ma' aspirina (mediċina oħra li tipprevjeni l-emboli tad-demm).
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Maltese: -pazjenti li jkollhom tal-inqas fattur ta' riskju wieħed li jiżviluppawlhom problemi vaskulari bħal attakk tal-qalb jew puplesija, li ma jkunux jistgħu jieħdu antagonisti tal-vitamina-K (mediċini oħra li jipprevjenu l-emboli tad-demm) u li jkunu f'riskju baxx li jkollhom fsada.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini huma bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
Maltese: Fis-sindromu koronarju akut, ġeneralment il-kura tibda b'doża ta' tagħbija ta' erba' pilloli.