FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of acetylsalicylic acid given before Rapilysin should be at least 250 mg-350 mg and should be followed by 75-150 mg/day, at least until discharge from hospital.
Maltese: Dożaġġ ta' Acetylsalicylic acid Id-doża ta' acetylsalicylic acid mogħti qabel Rapilysin għandha tkun ta' mill-inqas 250 mg-350 mg segwita minn ta' mill-inqas 75-150 mg/kuljum sa meta l-pazjent joħroġ mill-isptar.
English: For information on product incompatibilities see section 4.2.
Maltese: Għal informazzjoni dwar l-inkompatibilitajiet tal-prodott ara sezzjoni 4.2.
English: In dogs repeated dosing of the human peptide reteplase led to immunologic-allergic reactions.
Maltese: Fil-klieb dożaġġ ripetut ta' ‘peptide reteplase' umana wassal għal reazzjonijiet immunoloġiċi-allerġiċi.
English: Arrhythmias (e.g. AV block, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, electromechanical dissociation (EMD)), cardiac arrest, cardiogenic shock and reinfarction
Maltese: Arritmiji (e.ż. blokk tal-AV, fibrillazzjoni atrijali/aġitazzjoni, takikardija ventrikulari/fibrillazzjoni,
English: Take the 10 ml syringe out of the package.
Maltese: Oħroġ is-siringa ta' 10 ml mill-pakkett.
English: • systolic blood pressure higher than 160 mmHg
Maltese: • pressjoni tad-demm sistolika ogħla iktar minn 160 mmHg
English: Rapilysin is administered as a 10 U bolus dose followed by a second 10 U bolus dose 30 minutes later (double bolus).
Maltese: Rapilysin huwa amministrat bħala injezzjoni ta' l-10 U segwita mit-tieni injezzjoni ta' l-10 U 30 minuta wara (injezzjoni doppja).
English: 2 pre-filled glass syringes (borosilicate, type I) for single use, with a bromobutyl plunger stopper and a bromobutyl rubber tip cap, containing 10 ml of solvent.
Maltese: 2 siringi tal-ħġieġ (borosilicate, tip 1) mimlija bil-lest għall-użu ta' darba, b'tap planġer tal bromobutyl u għatu tat-tarf tal-gomma bromobutyl, li fihom 10 ml ta' solvent.
English: The initial dose of acetylsalicylic acid prior to thrombolysis should be at least 250 mg (250 - 350 mg) followed by 75 - 150 mg/day at least until discharge.
Maltese: Id-doża tal-bidu ta' acetylsalicylic acid qabel it-trombolożi għandha tkun mill-inqas ta' 250 mg (250350 mg) segwita minn mill-inqas 75 - 150 mg/kuljum sa meta l-pazjent joħroġ mill-isptar.
English: The frequency of adverse reactions reported is listed in the following table.
Maltese: Il-frekwenza ta' reazzjonijiet avversi rrappurtati hija elenkata fit-tabella li ġejja.
English: INSTRUCTIONS ON USE 16.
Maltese: 60 sa 80 %.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Aġenzija Ewropea dwar ilmediċini: http://www.ema.europa.eu/.
English: Teva Pharmaceuticals Ireland Tel: +353 51 321740
Maltese: Tel: +353 51 321740
English: Overall stroke rates were 1.64 % in the reteplase and 1.79 % in the alteplase group.
Maltese: Ir-rati totali ta' puplesija kienu ta' 1.64 % fil-grupp ta' reteplase u ta' 1.79 % fil-grupp ta' alteplase.
English: - cerebrovascular disease
Maltese: - mard ċerebrovaskulari
English: Heparin should be given for at least 24 hours, preferably for 48-72 hours, in order to keep aPTT values 1.5 to 2 times normal.
Maltese: Heparin għandha tkun mogħtija għal mill-inqas 24 siegħa, preferibbilment għal 48-72
English: Reteplase (10+10 U) dose-dependently reduces plasma fibrinogen levels by about 60 to 80 %.
Maltese: Reteplase (10+10 U) dipendentement mid-doża, inaqqas il-livelli tal-fibrinogen fil-plażma b'madwar
English: - Keep this leaflet.
Maltese: reteplase ma kienet osservata.
English: Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.
Maltese: Ikkonnettja ssiringa ma' li ‘spike' għar-rikostituzzjoni u ittrasferixxi l-10 ml tas-solvent fil-kunjett ta' Rapilysin 10 U.
English: Caution should be employed when used with other medicinal products affecting haemostasis such as heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants and antiplatelet agents other than acetylsalicylic acid, such as dipyridamole, ticlopidine, clopidogrel or glycoprotein IIb/IIIa receptor antagonists.
Maltese: Attenzjoni għandha tingħata meta t-terapija trombolitika tkun użata ma' prodotti mediċinali oħra li jaffettwaw l-emostasi bħall-eparina, eparini li għandhom piż molekulari baxx, eparinojdi, mediċina kontra t-tagħqid tad-demm u aġenti ta' kontra l-plejtlets meħuda mill-ħalq, minbarra acetylsalicylic acid , bħal dipyridamole, ticlopidine, clopidogrel jew glycoprotein IIb/IIIa antagonisti tar-riċettur.
English: Transfusions of cryoprecipitate, fibrinogen, fresh frozen plasma and platelets should be considered with clinical and laboratory reassessment after each administration.
Maltese: Trasfużjonijiet ta' cryoprecipitate, fibrinoġen, plażma friska ffriżata u plejtlets għandhom jiġu kkunsidrati ma' rivalutazzjoni klinika u tal-laboratorju wara kull għoti.
English: • bleeding in the gastrointestinal, urinary or genital tract within the past 10 days
Maltese: • ħruġ tad-demm gastrointestinali, urinarju jew fl-apparat ġenitali fl-aħħar 10 t'ijiem
English: Rapilysin is presented as a powder and a solvent for injection (0.56 g powder in a vial and 10 ml solvent in a pre-filled syringe with a reconstitution spike and a needle-pack of 2)
Maltese: Rapilysin huwa fornut bħala trab u solvent għall-injezzjoni (0.56 g trab f'kunjett u 10 ml ta' solvent f'siringa mimlija għal lest bi spike għar-rikostituzzjoni u pakkett tal-labar li fih 2)
English: Solvent: 10 ml Water for injection (prefilled syringe)
Maltese: 10 ml ilma għall-injezzjoni (siringa mimlija għal lest)
English: Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30 °C after dissolving with water for injection.
Maltese: Stabbilità kimika u fiżika waqt l-użu ntweriet għal 8 sigħat f'temperatura ta' bejn 2° u 30 °C wara li jinħall fl-ilma għall-injezzjoni.
English: Reteplase activity is cleared from the plasma at a rate of 283±101 ml/min, resulting in a dominant half-life (t1/2α) of 14.6±6.7 min and a terminal half-life (t1/2ß) of 1.6 hours±39 min. Only minor amounts of reteplase were immunologically detected in the urine.
Maltese: L-attività ta'reteplase hija mneħħija mill-plażma bir-rata ta' 283±101 ml/min, li tirriżulta f'half life (t1/2α) dominanti ta' 14.
English: 2 colourless glass vials (type I) with a rubber (butyl) closure and an aluminium flip-off cap, containing 0.56 mg of powder.
Maltese: 2 kunjetti tal-ħġieġ bla kulur (tip 1) b'għeluq tal-lasktu (butyl) u għatu tal-aluminju flip-off, li jkun fih 0.56 mg ta' trab.
English: Dosage of Rapilysin
Maltese: Tużax Rapilysin
English: Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 12 hours after the onset of acute myocardial infarction AMI symptoms.
Maltese: Rapilysin huwa indikat għat-trattament trombolitiku ta' infart mijokardjali suspettat ma' elevazzjoni ta' l-ST persistenti jew ostruzzjoni reċenti tal-Bundle Branch (Bundle Branch Block) tax-xellug fi żmien 12-il siegħa wara l-bidu tas-sintomi ta' infart mijokardjali akut AMI.
English: 1 vial contains 10 U* reteplase ** in 0.56 g powder 1 prefilled syringe contains 10 ml water for injections.
Maltese: U KWANTITATTIVA Kunjett wieħed fih 10 U* reteplase ** f'0.56 g trab Siringa waħda mimlija għal-lest fiha 10 ml ilma għall-injezzjonijiet.
English: Experiments in rats indicate that the liver and the kidneys are the main organs of active uptake and lysosomal degradation.
Maltese: Esperimenti fil-firien ma indikawx li l-fwied u l-kliewi huma l-organi prinċipali ta' l-użu attiv u degradazzjoni lisosomali.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq rikostizzjoni tal-prodott mediċinali qabel ma' jingħata, ara sezzjoni 6.6.
English: Heparin, vitamin K antagonists and medicinal product that alter platelet function (such as acetylsalicylic acid, dipyridamole and abciximab) may increase the risk of bleeding if administered prior to, during or after reteplase therapy.
Maltese: Heparin, antagonisti tal-vitamina K u prodotti mediċinali li jibdlu l-funzjoni tal-plejtlits (bħal acetylsalicylic acid, dipyridamole u abciximab) jisgħu jżidu r-riskju ta' ħruġ tad-demm jekk ikunu mogħtija qabel, waqt jew wara t-terapija b'reteplase.
English: Retrospective analyses of clinical studies did not reveal any clinically relevant interactions with medicinal product used concomitantly with reteplase in patients with acute myocardial infarction.
Maltese: Analiżi retrospettiva ta' studji kliniċi ma żvelatx xi azzjonijiet reċiproċi klinikament rilevanti ma' prodotti mediċinali użati konkomitament ma' reteplase f'pazjenti b'infart mijokardjali akut.
English: Because thrombolytic therapy increases the risk of bleeding, reteplase is contra-indicated in the following situations: - known haemorrhagic diathesis - patients with current concomitant therapy with oral anticoagulants (e.g. warfarin sodium) - intracranial neoplasm, arteriovenous malformation or aneurysm - neoplasm with increased bleeding risk - history of cerebrovascular accident - recent (< 10 days) prolonged and vigorous external heart massage - severe uncontrolled hypertension - active peptic ulceration - portal hypertension (oesophageal varices) - severe liver or renal dysfunction - acute pancreatitis, pericarditis, bacterial endocarditis
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi eċċipjenti elenkati fis-sezzjoni 6.1. Minħabba li t-terapija trombolitika żżid ir-riskju ta' ħruġ tad-demm, reteplase huwa kontra-indikat fissitwazzjonijiet li ġejjin: - pazjenti li hu magħruf li għandhom dijatesi emorragika - pazjenti b'terapija konkomitanti kurrenti b'mediċina kontra t-tagħqid tad-demm meħuda mill ħalq (eż. warfarin sodium ) - neoplażma fil-kranju, formazzjoni difettuża arterjovenuża jew anewriżma - neoplażma b'riskju miżjud ta' ħruġ tad-demm
English: Mitral regurgitation, pulmonary embolism, other systemic embolism/cerebral embolism and ventricular septal defect
Maltese: (EMD)), arrest kardijaku, xokk kardjoġeniku u infart ripetut Rigurġitazzjoni mitrali, emboliżmu pulmonari, emboliżmu sistemiku ieħor/emboliżmu ċerebrali u difett tas septal ventrikulari
English: A large comparative mortality trial (INJECT) in approx. 6000 patients showed that reteplase reduced the incidence of heart failure (secondary efficacy criterion) in a significant manner and was at least equally effective in terms of reducing mortality (primary efficacy criterion) when compared to streptokinase.
Maltese: Prova kbira komparattiva tal-mortalità (INJECT) f'madwar 6 000 pazjent uriet li reteplase naqqas l inċidenza ta' attakki tal-qalb (kriterju sekondarju ta' l-effikaċja) b'mod sinifikanti, u kien mill-inqas effettiv indaqs, fit-termini tan-nuqqas tal-mortalità (kriterju primarju ta' l-effikaċja), meta mqabbel ma' streptokinase.
English: At present, insufficient data in patients with a diastolic blood pressure > 100 mmHg prior to thrombolytic therapy are available for reteplase.
Maltese: Bħalissa, hemm informazzjoni insuffiċjenti disponibbli għal reteplase dwar pazjenti bi pressjoni tad demm dijastolika ta' >100 mmHg qabel it-terapija trombolitika.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: • septic inflammation of a vein with blood clotting (septic thrombophlebitis) or blocked blood vessels at an infected site
Maltese: • infjammazzjoni settika ta' xi vina flimkien ma' embolu (tromboflebite settika) jew vini u arterji imblukkati f'xi parti infettata
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent published on the European medicines web-portal.
Maltese: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma stabbiliti fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwa sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Mild impairment of renal function did not significantly affect the pharmacokinetic properties of reteplase.
Maltese: Ma sarux studji dwar l-effett ta' prodotti mediċinali oħra mal-effett farmaċewtiku tal-prodott mediċinali.
English: Fat embolism, which may lead to corresponding consequences in the complications organs concerned4
Maltese: Korriment, avvelenament u komplikazzjonijiet proċedurali
English: Heparin and Rapilysin are incompatible when combined in solution.
Maltese: Heparin u Rapilysin ma jistgħux jitħalltu fl-istess soluzzjoni.
English: • if you have severe uncontrolled high blood pressure (hypertension).
Maltese: • jekk inti għandek pressjoni tad-demm għolja serja mhux ikkontrollata (ipertensjoni).
English: It is given within 12 hours after the onset of symptoms.
Maltese: Huwa mogħti fi żmien 12-il siegħa wara l-bidu tas-sintomi.
English: Reteplase is a recombinant plasminogen activator that catalyzes the cleavage of endogenous plasminogen to generate plasmin.
Maltese: Reteplase huwa attivatur rikombinanti tal-plażminoġen li jikkatalizza l-qtugħ (dak li jkisser ilmolekula) endoġeniku tal-plażminoġen biex jipproduċi l-plażmin.
English: Gastrointestinal haemorrhage (haematemesis, melena), gingival or genitourinary bleeding
Maltese: emorraġija ċerebrali, epistassi, emoptisi, emorraġija fl-għajnejn u ekkimosi
English: * Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
Maltese: * Il-potenza ta' reteplase hija rapreżentata f'unitajiet (U) billi tintuża referenza standard li hija speċifika għal reteplase u li mhix komparabbli ma' unitajiet użati għall-aġenti trombolitiċi oħra.
English: Very rare side effects (may affect up to 1 in 10,000 people)
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000 persuni)
English: Powder and solvent for injection (contains 2x [0.56 g of powder in a vial and 10 ml solvent in a prefilled syringe with reconstitution spike and needle])
Maltese: U KONTENUT Trab u solvent għall-injezzjoni (fiħ 2x [0.56 g ta' trab f'kunjett u 10 ml ta' solvent f'siringa mimlija għal lest bi spike għar-rikostituzzjoni u labra])
English: Rapilysin 10 U powder and solvent for solution for injection Water for injections for Rapilysin 10 U solution for intravenous use
Maltese: Rapilysin 10 U trab u solvent għas-soluzzjoni għall-injezzjoni Ilma għall-injezzjonijiet għal soluzzjoni Rapilysin 10 U għal użu ġol-vini
English: Rapilysin 10 U powder and solvent for solution for injection.
Maltese: Trab u solvent ta' Rapilysin 10 U għal soluzzjoni għall-injezzjoni.
English: Heparin should be administered for at least 24 hours, preferably for 48 - 72 hours, aiming to keep aPTT values 1.5 to 2 times normal.
Maltese: Eparina għandha tingħata għal mill-inqas 24 siegħa, preferibilment għal 48 - 72 siegħa, bl-iskop li jżomm valuri ta' l-aPTT minn 1.5 sa 2 ta' dawk normali.
English: Cardiac disorders3
Maltese: Disturbi fil-qalb3
English: Cerebral haemorrhage2
Maltese: Emorraġija ċerebrali2
English: Plasmin in turn degrades fibrin, which is the main component of the matrix of thrombi, thereby exerting its thrombolytic action.
Maltese: Il-plażmin wara, jiddegrada l-fibrin, li huwa l-komponent prinċipali tal-matriċi tat-trombi (thrombi), u permezz ta' dan, jeżerċita l-azzjoni trombolitika tiegħu.
English: Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Iceland.
Maltese: Reykjavikurvegi 76-78 220
English: In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with 0.9 % sodium chloride or 5 % glucose solution prior to and following the Rapilysin injection.
Maltese: 0.9% soluzzjoni ta' sodium chloride jew 5% soluzzjoni ta' dextrose , qabel u wara l-injezzjoni ta' Rapilysin.
English: • Bleeding at the injection site, e.g. blood blister (haematoma)
Maltese: • Fsada fil-post ta' l-injezzjoni, e.ż. nuffata bid-demm (ematoma)
English: Additional studies in human plasma samples in vitro suggest that complexation with C1-inactivator, α2-antiplasmin and α2-antitrypsin contributes to the inactivation of reteplase in plasma.
Maltese: Studji addizzjonali ta' kampjuni ta' plażma tal-bnedmin in vitro jissuġġerixxu li l-azzjoni reċiproka ma' inattivatur-C1, antiplażmin-α2- u antitrypsin-α2 tikkontribwixxi għall-inattivazzjoni ta' reteplase fil-plażma.
English: • if you have had external heart massage within the past 10 days.
Maltese: • jekk inti kellek massaġġ tal-qalb estern fl-aħħar 10 t'ijiem.
English: Adverse reactions seen with reteplase
Maltese: Reazzjonijiet avversi li dehru b'reteplase
English: It is strongly recommended that antiarrhythmic therapy for bradycardia and/or ventricular tachyarrhythmias (e.g. ventricular tachycardia or fibrillation) be available when reteplase is administered.
Maltese: Huwa rrakkommandat bil-qawwa li t-terapija antiarritmijaka għallbradikardija u/jew takiarritmiji ventrikulari (eż. takikardija jew fibrillazzjoni ventrikulari) tkun disponibbli meta reteplase jkun mogħti .
English: Wacker Biotech GmbH Heinrich-Damerow-Str. 4 06120 Halle
Maltese: Bl-ispike għar-rikostituzzjoni u s-siringa għadhom imwaħħlin mal-kunjett, dawwar il-kunjett bil-mod biex tħoll it-trab tar-Rapilysin 10 U.
English: Reproductive toxicity studies were performed in rats (fertility and embryo-foetotoxicity study including a littering phase) and in rabbits (embryo-foetotoxicity study, dose-range finding only).
Maltese: Studji dwar tossiċità riproduttiva kienu magħmula f'firien (studju dwar fertilità u embrijofetotossiċità li kien jinkludi fażi ta' tferrigħ) u fil-fniek (studju dwar embrijo-fetotossiċità, sejba talvarjazzjoni fid-doża biss).
English: Contents of the pack and other information What Rapilysin contains
Maltese: Kontenut tal-pakket u informazzjoni oħra X'fih Rapilysin
English: In two clinical trials aiming primarily at coronary artery patency (RAPID I and II) reteplase was associated with higher early patency rates (primary efficacy criterion), as well as with a lower incidence of heart failure (secondary efficacy criterion) than alteplase (3 hour and "accelerated" dosage regimens).
Maltese: F'żewġ provi kliniċi bl-iskop ewlieni tal-ftuħ ta' arterja koronarja imblukkata (RAPID I u II) reteplase kien assoċjat ma' rati għola ta' ftuħ tal-bidu (kriterju primarju ta' l-effikaċja), kif ukoll ma' inċidenza aktar baxxa ta' attakki tal-qalb (kriterju sekondarju ta' l-effikaċja) minn alteplase (kors ta' 3 sigħat u dożaġġ "aċċelerat").
English: This leaflet was last revised in <{MM/YYYY}>
Maltese: Disturbi ġenerali u kondizzjonijiet ta'
English: Available evidence on reteplase does not indicate an antibody-mediated origin of these hypersensitivity reactions.
Maltese: Evidenza disponibbli fuq reteplase ma tindikax li dawn ir-reazzjonijiet ta' sensittività eċċessiva huma oriġinati mill-antikorpi.
English: The injection must not be given mistakenly outside the vein.
Maltese: Inkompatibilitajiet oħra jistgħu jeżistu wkoll.
English: Each bolus is administered as a slow intravenous injection within 2 minutes.
Maltese: Kull injezzjoni tingħata bħala injezzjoni bil-mod ġol-vini fuq perjodu ta' 2 minuti.
English: This plasminogenolysis occurs preferentially in the presence of fibrin.
Maltese: Din il-plażminoġenolożi sseħħ preferenzjalment fil-preżenza tal-fibrin.
English: What Rapilysin looks like and contents of the pack
Maltese: Kif jidher Rapilysin u l-kontenuti tal-pakkett
English: As with other plasminogen activators a rebound phenomenon then occurs during which fibrinogen levels reach a maximum within 9 days and remain elevated for up to 18 days.
Maltese: Bħall-attivaturi oħra talplasminogen, il-fenomenu ta' ‘rebound' imbagħad isseħħ waqt li l-livelli tal-fibrinogen jilħqu massimu fi żmien 9 t'ijiem u jibqgħu għoljin sa 18-il jum.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA
English: Reconstituted product:
Maltese: Prodott rikostitwit:
English: The recommended dose of heparin is 5000 I.U.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C.
English: The most frequent adverse drug reaction associated with reteplase treatment is haemorrhage.
Maltese: L-aktar reazzjoni mhux mixtieqa frekwenti tal-mediċina assoċjata mat-trattament b'reteplase hija l emorraġija.
English: This medicinal product should not be mixed with Heparin and/or acetylsalicylic acid.
Maltese: Dan il-prodott mediċinali m'għandux jitħallat ma' Heparin u/jew acetylsalicylic acid.
English: Haemopericardium, retroperitoneal bleeding, cerebral haemorrhage, epistaxis, haemoptysis, eye haemorrhage and ecchymosis
Maltese: - anormalità serja tal-fwied jew tal-kliewi - pankreatite akuta , perikardite, endokardite tal-batterji akuta
English: • Chest Pain / angina, low blood pressure and heart failure /shortness of breath may reappear
Maltese: Iskemija rikorrenti/anġina, pressjoni baxxa u insuffiċjenza tal-qalb/edema pulmonari
English: White powder and clear colourless liquid (water for injections).
Maltese: Trab abjad u likwidu ċar u bla kulur (ilma għall-injezzjonijiet).
English: Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus).
Maltese: Rapilysin jingħata bħala 10 U doża injettata segwita mit-tieni 10 U doża injettata 30 minuta wara
English: • high likelihood of a blood clot in the heart (e.g. as a result of narrowing of a heart valve or atrial fibrillation)
Maltese: • probabbiltà għolja ta' embolu fil-qalb (eż. li jirriżulta minn tidjiq ta' xi valv tal-qalb jew fibrilazzjoni atrijali)
English: Uncommon Very rare
Maltese: Komuni ħafna
English: Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.
Maltese: Dan jinkludi xi effett sekondarju li mhuwiex elenkat f'dan il-fuljett.
English: Solvent: Water for injections
Maltese: Solvent: ilma għall-injezzjonijiet.
English: Antibody formation to the reteplase molecule has not been seen.
Maltese: Il-formazzjoni ta' l-anti-korpi għall-molekula ta' reteplase ma ġietx osservata.
English: As with other thrombolytic agents, recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema have been reported frequently as sequelae of myocardial infarction and/or thrombolytic administration.
Maltese: Bħal b'aġenti trombolitiċi oħra, iskemija / anġina rikorrenti, ipotensjoni u insuffiċjenza tal-qalb / edema pulmonary kienu rrappurtati b'mod frekwenti bħala konsegwenza ta' infart mijokardijaku u / jew għotja trombolitika.
English: In rabbits, vaginal bleedings and abortions possibly associated to prolonged haemostasis, but no foetal abnormalities were noted.
Maltese: Fil-fniek, ħruġ tad-demm vaġinali u aborti possibbilment assoċjati ma' emostasi fit-tul, kienu osservati, iżda l-ebda anormalitajiet fetali ma kienu osservati.
English: Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cut down sites and needle puncture sites).
Maltese: Għalhekk, it-terapija trombolitika teħtieġ attenzjoni partikulari għall-partijiet kollha fejn il-ħruġ tad-demm hu possibbli (inklużi partijiet fejn kien hemm inserzjoni bil-katerer, partijiet arterjali u tal-vini li kienu mtaqqba, ‘cut down sites' u partijiet li kienu mtaqqba bil-labar).
English: Withdraw 10 ml of Rapilysin 10 U solution back into the syringe.
Maltese: Iġbed 10 ml ta' soluzzjoni ta'Rapilysin 10 U lura ġos-siringa.
English: ANNEX II
Maltese: MANIFATTUR(I)
English: Recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema
Maltese: Suomi/Finland ratiopharm Oy Puh/Tel: