FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Maltese: Fi studji kliniċi, pazjenti ħadu pioglitazone f'doża aktar mill-għola doża rakkomandata ta' 45 mg kuljum.
English: If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
Maltese: Jekk il-livelli ta' ALT jibqgħu > 3 X l-ogħla limitu tan-normal, it-terapija għandha titwaqqaf.
English: What Pioglitazone Krka looks like and contents of the pack White to almost white round tablets with bevelled edges (diameter 8.0 mm).
Maltese: Kif jidher Pioglitazone Krka u l-kontenut tal-pakkett Pilloli tondi bojod għal kważi bojod bi truf imċanfrin (dijametru ta' 8.0 mm).
English: What Pioglitazone Krka contains - The active substance is pioglitazone.
Maltese: X'fih Pioglitazone Krka - Is-sustanza attiva hija pioglitazone.
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin labyrinth disorders vertigo uncommon
Maltese: Pioglitazone u l-metaboliti attivi kollha huma marbuta b'mod estensiv mal-proteini fil-plażma
English: OTHER
Maltese: Lot
English: as dual oral therapy in combination with - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
Maltese: bħala monoterapija - f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) li mhumiex ikkontrollati sew minn dieta u eżerċizzju li għalihom metformin mhux adattat minħabbla kontraindikazzjonijiet jew intolleranza bħala terapija doppja mill-ħalq f'taħlita ma' - mediċina tat-tip sulphonylurea, f'pazjenti adulti li wrew intolleranza għal metformin jew li għalihom metformin huwa kontraindikat, b'kontroll gliċemiku insuffiċjenti minkejja monoterpija b'mediċina tat-tip sulphonylurea fl-ogħla doża ttollerata
English: In addition, increased fatty deposition and infiltration were observed.
Maltese: Ma kienetx osservata żieda fil-mortalità minn insuffiċjenza talqalb.
English: Adult:
Maltese: Adulti:
English: asthma (bronchospasm)
Maltese: ażżma (bronkospażmu)
English: MedDRA Standard System organ class
Maltese: Standard tasSistemi talOrgani MedDRA
English: Disseminated intravascular coagulation Coagulopathy
Maltese: Koagulazzjoni intravaskulara mifruxa Koagulopatija
English: Mutagenic Potential
Maltese: Potenzjal Mutaġeniku
English: • Determination of Heparin Levels
Maltese: • Determinazzjoni tal-Livelli ta' Heparin
English: Metabolism, elimination and excretion
Maltese: Metaboliżmu, eliminazzjoni u tneħħija
English: An association between aprotinin use and increased mortality has been reported in some nonrandomized observational studies (eg, Mangano 2007, Schneeweiss 2008, Olenchock 2008, Shaw 2008) while other non-randomized studies have not reported such an association (eg, Karkouti 2006, Mangano 2006, Coleman 2007, Pagano 2008, Ngaage 2008, Karkouti, 2009).
Maltese: Assoċjazzjoni bejn l-użu ta' aprotinin u żjieda fil-mortalità kienet irrappurtata f'xi studji ta' osservazzjoni mhux randomised (eż., Mangano 2007, Schneeweiss 2008, Olenchock 2008, Shaw 2008) filwaqt li studji mhux randomised oħra ma rrappurtawx assoċjazzjoni bħal din (eż., Karkouti 2006, Mangano 2006, Coleman 2007, Pagano 2008, Ngaage 2008, Karkouti, 2009).
English: All CABG Primary CABG Repeat CABG
Maltese: CABG ripetuta
English: Aprotinin gave a negative mutagenic response in the Salmonella/microsome and B. subtilis DNA damage system.
Maltese: Aprotinin ta' rispons mutaġeniku negattiv fis-sistema tal-ħsara tad-DNA ta' Salmonella/mikrosomi u B. subtilis.
English: Mortality For the risk of mortality associated with the use of aprotinin see section 4.4.
Maltese: Mortalità Għar-riskju ta' mortalità assoċjat mal-użu ta' aprotinin ara sezzjoni 4.4.
English: Standard emergency treatment may be required, i.e. adrenaline/epinephrine, volume substitution and corticosteroids.
Maltese: Għandu mnejn tkun meħtieġa kura ta' emerġenza standard, i.e. adrenaline/epinephrine, sostituzzjoni tal-volum u kortikosterojdi.
English: Very rare: < 1/10,000
Maltese: Rari ħafna : <1/10,000
English: A H1-antagonist and a H2-antagonist may be administered 15 minutes prior to the test dose of aprotinin.
Maltese: Antagonist ta' H1 u antagonist ta' H2 jista' jingħata 15-il minuta qabel id-doża ta' prova ta' aprotinin.
English: Coronary occlusion/ thrombosis Myocardial infarction Pericardial effusion
Maltese: Iskemija mijokardijaka Okklużjoni koronarja/trombożi Infart mijokardijaku Effużjoni perikardijaka
English: • Activated Clotting Time (ACT)
Maltese: • Ħin ta' Tagħqid Attivat (ACT)
English: A publication by Fergusson et al 2008 analyzed data from a randomized controlled trial, Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), and reported a higher mortality rate in aprotinin-treated patients compared to those treated with tranexamic acid or aminocaproic acid.
Maltese: Pubblikazzjoni minn Fergusson et al 2008 analizzat dejta minn prova randomised ikkontrollata, Konservazzjoni tad-Demm Permezz ta' Antifibrinolitiċi fi Prova Randomised (BART), u rrappurtat rata ta' mortalità ogħla f'pazjenti kkurati b'aprotinin meta mqabbel ma' dawk ikkurati b'tranexamic acid jew b'aminocaproic acid.
English: If there are no signs of allergy, you will be given 100-200 ml <Aprotinin-containing medicinal product> over 20 to 30 minutes, followed by 25 - 50 ml per hour (max. 5 - 10 ml/min) until the end of the operation.
Maltese: Jekk m'hemm l-ebda sinjali ta' allerġija, se tingħata 100-200 ml <prodott mediċinali li fih Aprotinin> fuq medda ta' 20 sa 30 minuta, segwit minn 25-50 ml kull siegħa (massimu 510 ml/min) sat-tmiem tal-operazzjoni.
English: Data from a global pool of placebo-controlled studies in patients undergoing coronary artery bypass graft (CABG) surgery showed that the incidence of serum creatinine elevations >0.5 mg/dL above pretreatment levels was statistically higher at 9.0 % (185/2047) in the full-dose aprotinin group compared with 6.6 % (129/1957) in the placebo group, with an odds ratio of 1.41 (1.12 - 1.79).
Maltese: Dejta mill-ġabra globali ta' studji kkontrollati bil-plaċebo f'pazjenti li kienu qed jagħmlu kirurġija ta' bypass bi graft tal-arterja koronarja (CABG) uriet li l-inċidenza ta' żjidiet tal-krejatinina fis-serum ta' >0.5 mg/dL 'l fuq mil-livelli ta' qabel il-kura kienet statistikament ogħla f'9.0 % (185/2047) filgrupp ta' doża sħiħa ta' aprotinin meta mqabbla ma' 6.6 % (129/1957) fil-grupp tal-plaċebo, b'odds ratio ta' 1.41 (1.12 - 1.79).
English: Adverse drug reactions (ADRs) based on all placebo-controlled clinical studies with aprotinin sorted by CIOMS III categories of frequency (aprotinin n=3817 and placebo n=2682; status: April 2005) are listed in the table below:
Maltese: Reazzjonijiet avversi għall-mediċina (ADRs) ibbażati fuq l-istudji kliniċi kollha kkontrollati bilplaċebo b'aprotinin imqassma skont il-kategoriji ta' frekwenza CIOMS III (aprotinin n=3817 u plaċebo n=2682; status:
English: Important: aprotinin is not a heparin-sparing agent.
Maltese: Importanti: aprotinin mhux sustanza li tipprevjeni t-tnaqqis ta' heparin.
English: A loading dose of 1 - 2 million KIU is administered as a slow intravenous injection or infusion over 20 - 30 minutes after induction of anaesthesia and prior to sternotomy.
Maltese: Doża għolja tal-bidu ta' 1 - 2 miljun KIU tingħata bħala injezzjoni bil-mod jew infużjoni fill-vini fuq medda ta' 20 - 30 minuta wara l-induzzjoni ta' anestesija u qabel sternotomija.
English: Rare: ≥ 1/10,000 to < 1/1,000
Maltese: Rari: ≥ 1/10,000 sa < 1/1,000
English: 6.1 List of excipients [To be completed nationally]
Maltese: 6.1 Lista ta' eċċipjenti [Biex timtela mill-pajjiż partikolari]
English: In the pooled analysis of all placebo-controlled clinical studies, the incidence of investigator-reported myocardial infarction (MI) in aprotinin treated patients was 5.8 % compared to 4.8 % in placebo treated patients, with difference of 0.98 % between the groups (aprotinin n=3817 and placebo n=2682; status: April 2005).
Maltese: Fl-analiżi kollettiva tal-istudji kliniċi kollha kkontrollati bil-plaċebo, l-inċidenza ta' infart mijokardijaku (MI) irrappurtat mill-investigatur f'pazjenti kkurati b'aprotinin kienet ta' 5.8 % meta mqabbel ma' 4.8 % f'pazjenti kkurati bil-plaċebo, b'differenza ta' 0.98 % bejn il-gruppi (aprotinin n=3817 u plaċebo n=2682; status:
English: Pulmonary embolism
Maltese: Emboliżmu filpulmun
English: An ACT is not a standardized coagulation test, and different formulations of the assay are affected differently by the presence of aprotinin.
Maltese: ACT mhux test standardizzat ta' koagulazzjoni, u formulazzjonijiet differenti tal-analiżi huma affettwati b'mod differenti mill-preżenza ta' aprotinin.
English: Full-Dose Aprotinin
Maltese: Aprotinin>.
English: Aminoglycosides are a risk factor for renal dysfunction.
Maltese: Aminoglycosides huma fattur ta' riskju għal disfunzjoni renali.
English: Elderly Reported clinical experience has not identified differences in responses in elderly patients.
Maltese: Anzjani Esperjenza klinika rrappurtata ma identifikatx differenzi fir-rispons f'pazjenti anzjani.
English: After receiving injections of 131I-aprotinin healthy volunteers excreted within 48 hours 25 - 40 % of the labelled substance as metabolites in the urine.
Maltese: Wara li rċevew injezzjonijiet ta' 131I-aprotinin, voluntiera f'saħħithom neħħew 2540 % tas-sustanza ttikkettjata fi żmien 48 siegħa bħala metaboliti fl-awrina.
English: The incidence of serum creatinine elevations >2.0 mg/dL above baseline was similar (1.1 % vs 0.8 %) in both the full-dose aprotinin and placebo group, with an odds ratio of 1.16 (0.73 - 1.85) (see section 4.4).
Maltese: L-inċidenza ta' żjidiet fil-krejatinina tas-serum ta' >2.0 mg/dL 'l fuq mil-linja bażi kienet simili (1.1 % kontra 0.8 %) kemm fil-grupp ta' doża sħiħa ta' aprotinin kif ukoll fil-grupp tal-plaċebo, b'odds ratio ta' 1.16 (0.73 - 1.85) (ara sezzjoni
English: No pharmacokinetic studies are available in patients with terminal renal insufficiency.
Maltese: Studji farmakokinetiċi f'pazjenti b'insuffiċjenza terminali tal-kliewi mhux disponibbli.
English: Aprotinin is a broad spectrum protease inhibitor which has antifibrinolytic properties.
Maltese: Aprotinin huwa inibitur ta' protease bi spettru wiesa li għandu kwalitajiet antifibrinolitiċi.
English: Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Uncommon: ≥ 1/1,000 to < 1/100
Maltese: Mhux komuni: ≥ 1/1,000 sa < 1/100
English: Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitors, ATC code: B02AB01
Maltese: Sustanzi kontra l-emorraġiji, inibituri ta' proteinase, Kodiċi ATC:
English: Myocardial ischaemia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: After intravenous injection, rapid distribution of aprotinin occurs into the total extracellular space, leading to an initial decrease in plasma aprotinin concentration with a half-life of 0.3 - 0.7 h. At later time points, (i.e. beyond 5 hours post-dose) there is a terminal elimination phase with a half-life of about 5 - 10 hours.
Maltese: Wara injezzjoni ġol-vini, isseħħ distribuzzjoni rapida ta' aprotinin fl-ispazju ekstraċellulari totali, li twassal għal tnaqqis inizjali fil-konċentrazzjoni ta' aprotinin fil-plażma b'half-life ta' 0.3 - 0.7 h.
English: An appropriate aprotinin-specific IgG antibody test may be considered before administration of aprotinin (see section 4.3).
Maltese: IgG speċifiċi għal aprotinin (ara sezzjoni 4.3).
English: • ADRs derived from post-marketing reports are printed in bold italic
Maltese: • ADRs derivati minn rapporti ta' wara t-tqegħid fis-suq huma stampati b'tipi grassi u filkorsiv
English: The initial bolus infusion is followed by the administration of a continuous infusion of 250,000 - 500,000 KIU per hour until the end of the operation.
Maltese: L-infużjoni bolus tal-bidu hija segwita b'għoti ta' infużjoni kontinwa ta' 250,000 - 500,000
English: While protocols vary, a minimal celite ACT of 750 seconds or kaolin ACT of 480 seconds, independent of the effects of haemodilution and hypothermia, is recommended in the presence of aprotinin.
Maltese: Filwaqt li protokolli jvarjaw, fil-preżenza ta' aprotinin huwa rrakkomandat ACT minimu ta' celite ta' 750 sekonda jew ACT ta' kaolin ta' 480 sekonda, indipendenti mill-effetti ta' emodilwazzjoni u ipotermja.
English: 4.5 Interaction with other medicinal products and other forms of interaction Aprotinin has a dose-dependent inhibitory effect on the action of thrombolytic agents, e.g. streptokinase, urokinase, alteplase (r-tPA).
Maltese: Aprotinin għandu effett inibitorju dipendenti mid-doża fuq l-azzjoni ta' sustanzi antitrombolitiċi, eż. streptokinase, urokinase, alteplase (r-tPA).
English: Injection and infusion site reactions Infusion site (thrombo-) phlebitis
Maltese: Reazzjonijiet fissit tal-injezzjoni u l-infużjoni (Trombo-) flebite fis-sit tal-infużjoni
English: In rabbits, daily intravenous doses of 100,000 KIU/kg produced no evidence of maternal toxicity, embryotoxicity, fetotoxicity, or teratogenicity.
Maltese: KIU/kg ma pproduċew l-ebda evidenza ta' tossiċità fl-omm, fl-embriju, filfetu, jew teratoġeniċità.
English: Mortality Information on mortality from randomized clinical trials is provided in section 5.1.
Maltese: Mortalità Informazzjoni dwar il-mortalità minn provi kliniċi randomised hija pprovduta f'sezzjoni 5
English: Allergic reaction Anaphylactic / anaphylactoid reaction
Maltese: Reazzjoni allerġika Reazzjoni anafilattika/ anafilattojda
English: if a positive aprotinin-specific IgG antibody test is available, showing an increased risk of an allergic reaction to <Aprotinin-containing medicinal product>.
Maltese: IgG speċifiċi għal aprotinin, li juri żjieda fir-riskju ta' reazzjoni allerġika għal <prodott mediċinali li fih Aprotinin>.
English: The aprotinin molecule is metabolised to shorter peptides or amino acids by lysosomal activity in the kidney.
Maltese: Il-molekola ta' aprotinin hija metabolizzata għal peptidi jew aċidi aminiċi iqsar permezz ta' attività lisosomali fil-kliewi.
English: Laboratory monitoring of anticoagulation during cardiopulmonary bypass Aprotinin is not a heparin-sparing agent and it is important that adequate anticoagulation with heparin be maintained during aprotinin-therapy.
Maltese: Monitoraġġ tal-laboratorju ta' antikoagulazzjoni matul bypass kardjopulmonari Aprotinin mhuwiex sustanza li tipprevjeni t-tnaqqis ta' heparin u huwa importanti li tinżamm antikoagulazzjoni adegwata b'heparin waqt terapija b'aprotinin.
English: The test is further influenced by variable dilution effects and the temperature experienced during cardiopulmonary bypass.
Maltese: It-test huwa nfluwenzat ukoll minn effetti ta' dilwizzjoni varjabbli u mit-temperatura esperjenzata matul il-bypass kardjopulmonari.
English: If activated clotting time (ACT) is used to maintain adequate anticoagulation, a minimal celite-ACT of 750 seconds or kaolin-ACT of 480 seconds, independent of the effects of haemodilution and hypothermia, is recommended in the presence of aprotinin.
Maltese: Jekk jintuża l-ħin ta' tagħqid attivat (ACT) biex tiżamm antikoagulazzjoni adegwata, huwa rrakkomandat minimu ta' celite-ATT ta' 750 sekonda jew kaolin-ACT ta' 480 sekondi, indipendenti mill-effetti ta' emodilwazzjoni u ipotermja, fil-preżenza ta' aprotinin.
English: Rare: may affect up to 1 in 1,000 patients blood clot in blood vessels (arteries) severe allergic reaction (anaphylactic / anaphylactoid reaction)
Maltese: Rari: jistgħu jaffettwaw sa pazjent wieħed minn kull 1,000 - embolu tad-demm fil-kanali tad-demm (arterji) - reazzjoni allerġika severa (reazzjoni anafilattika / anafilaktojda)
English: An analysis of all pooled placebocontrolled studies in patients undergoing coronary artery bypass graft (CABG) has found elevations of serum creatinine values >0.5 mg/dL above baseline in patients with aprotinin therapy (see section 5.1).
Maltese: Analiżi tal-istudji kkontrollati bil-plaċebo miġbura kollha f'pazjenti li qed jagħmlu bybass bi graft tal-arterja koronarja (CABG) sabu elevazzjonijiet tal-valuri tal-krejatinina fis-serum ta' >0.5 mg/dL 'l fuq mil-linja bażi f'pazjenti b'terapija ta' aprotinin (ara sezzjoni 5.1).
English: These metabolites lacked enzyme-inhibitory activity.
Maltese: Dawn il-metaboliti ma kellhomx l-attività inibitorja tal-enzimi.
English: Consult the manufacturer of the ACT test regarding the interpretation of the assay in the presence of aprotinin.
Maltese: Ikkonsulta mal-manifattur tat-test ta' ACT dwar l-interpretazzjoni tal-analiżi fil-preżenza ta' aprotinin.
English: By forming reversible stoichiometric enzyme-inhibitor complexes, aprotinin acts as an inhibitor of human trypsin, plasmin, plasma kallikrein and tissue kallikrein, thus inhibiting fibrinolysis.
Maltese: Billi jifforma kumplessi riversibbli li jinibixxu l-enzimi stojkometriċi , aprotinin jaġixxi bħala inibitur ta' tripsin, plasmin, kallikrein tal-plażma u kallikrein tat-tessut, umani u b'hekk jinibixxi l-fibrinolisi.
English: Very rare: may affect up to 1 in 10,000 patients swelling on or around the location of the injected skin (injection and infusion site reactions, infusion site (thrombo-) phlebitis) blood clot in the lungs (pulmonary embolism) severe blood clotting disorder that results in tissue damage and bleeding (disseminated intravascular coagulation) inability of the blood to clot or coagulate normally (coagulopathy) severe allergic shock (anaphylactic shock), which is potentially life threatening
Maltese: (trombo-) flebite fis-sit tal-infużjoni) - embolu tad-demm fil-pulmun (emboliżmu fil-pulmun) - disturb sever fit-tagħqid tad-demm li jirriżulta fi ħsara fit-tessut u fsada (koagulazzjoni disseminata intravaskulari) - id-demm ma jagħqadx b'mod normali (koagulopatija) - xokk allerġiku sever (xokk anafilattiku), b'potenzjal ta' periklu għall-ħajja
English: Frequencies are defined as:
Maltese: Frekwenzi huma ddefiniti bħala:
English: NAME OF THE MEDICINAL PRODUCT <Aprotinin-containing medicinal product> [See Annex I - To be completed nationally]
Maltese: <Prodotti mediċinali li fihom aprotinin> [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Fertility There are no adequate and well-controlled studies addressing fertility in men or women.
Maltese: Fertilità M'hemmx studji adegwati u kkontrollati tajjeb li jindirizzaw il-fertilità fl-irġiel jew fin-nisa.
English: • Fixed Heparin Dosing
Maltese: • Dożaġġ Fiss ta' Heparin
English: <Aprotinin-containing medicinal product> belongs to a group of medicines called anti-fibrinolytics, i.e. medicines to prevent blood loss.
Maltese: <prodott mediċinali li fih Aprotinin> jagħmel parti minn grupp ta' mediċini msejħa anti-fibrinolitiċi, i.e. mediċini biex jipprevjenu telf ta' demm.
English: How to store <Aprotinin-containing medicinal product> Contents of the pack and other information
Maltese: Kif taħżen <prodott mediċinali li fih Aprotinin> Kontenut tal-pakkett u informazzjoni oħra
English: The most serious adverse reaction was myocardial infarction.
Maltese: L-aktar reazzjoni avversa serja kienet infart mijokardijaku.
English: Additional note on use with extracorporeal circulation In patients undergoing cardiopulmonary bypass with aprotinin therapy, one of the following methods is recommended to maintain adequate anticoagulation:
Maltese: F'pazjenti li għaddejjin minn bypass kardjopulmonari b'terapija ta' aprotinin, huwa rrakkomandat wieħed minn tliet metodi biex tinżamm antikoagulazzjoni adegwata:
English: In general, the total amount of aprotinin administered per treatment course should not exceed 7 million KIU.
Maltese: B'mod ġenerali, l-ammont totali ta' aprotinin mogħti għal kull kors ta' kura m'għandux jaqbeż 7 miljun KIU.
English: Oliguria, acute renal failure, renal tubular necrosis
Maltese: Insuffiċjenza akuta tal-kliewi, nekrosi tat-tubi talkliewi
English: Paediatric population The safety and efficacy in children below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' aprotinin fi tfal b'età inqas minn 18-il sena ma ġewx determinati s'issa .
English: Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Maltese: Aprotinin huwa indikat għall-użu profilattiku biex inaqqas telf ta' demm u trasfużjoni tad-demm f'pazjenti adulti li għandhom riskju kbir ta' telf ta' demm maġġuri u li għaddejjin minn bypass kardjopulmonari iżolat waqt kirurġija bi graft (i.e. kirurġija ta' bypass bi graft tal-arterja koronarja li ma sseħħx flimkien ma' kirurġija kardjovaskulari oħra).
English: Assessment of potential for allergic reactions
Maltese: Stima tal-potenzjal ta' reazzjonijiet allerġiċi
English: <Aprotinin-containing medicinal product>
Maltese: <Prodott mediċinali li fih aprotinin>
English: Uncommon: may affect up to 1 in 100 patients chest pain (myocardial ischaemia, coronary occlusion / thrombosis), heart attack (myocardial infarction) leakage of heart fluid into the surrounding body cavity (pericardial effusion) blood clot (thrombosis) kidney disease (acute renal failure, renal tubular necrosis) passing less urine than is normal
Maltese: Biex tiġi evitata nkompatibilità fiżika ta' aprotinin u heparin meta jiżdied mas-soluzzjoni tal-bidu talpompa, kull sustanza għandha tiżdied matul iċ-ċirkolazzjoni mill-ġdid tas-soluzzjoni tal-bidu talpompa biex tiġi żgurata dilwizzjoni adegwata qabel jitħallat mal-komponent l-ieħor.
English: In-hospital Mortality in a pool of Randomized Clinical Trials (Population: All Global CABG Patients Valid for Safety)
Maltese: Inċidenza ta' Mortalità f'ġabra ta' Provi Kliniċi Randomised (Popolazzjoni:
English: You should specifically tell your doctor if you take: - medicines used to dissolve blood clots, such as streptokinase, urokinase, alteplase (r-tPA) - aminoglycosides (antibiotics, medicines used to treat infections)
Maltese: Għandek speċifikament tgħid lit-tabib tiegħek jekk tieħu: - mediċini użati biex iħollu emboli tad-demm, bħal streptokinase, urokinase, alteplase (r-tPA) - aminoglycosides (antibijotiċi, mediċini użati biex jikkuraw infezzjonijiet)
English: Re-exposure to aprotinin
Maltese: Esponiment mill-ġdid għal aprotinin
English: The safety of aprotinin has been evaluated in more than forty five phase II and phase III studies including more than 3800 patients exposed to aprotinin.
Maltese: III li nkludew aktar minn 3800 pazjent esposti għal aprotinin.
English: Administration of aprotinin, especially to patients who have received aprotinin (including aprotinin containing fibrin sealants) in the past requires a careful risk/benefit assessment because an allergic reaction may occur (see sections 4.3 and 4.8).
Maltese: Għoti ta' aprotinin, speċjalment lill-pazjenti li fl-imgħoddi rċevew aprotinin (inklużi siġillanti ta' fibrin li fihom aprotinin) jeħtieġ stima b'attenzjoni tar-riskji u l-benefiċċji peress li tista' sseħħ reazzjoni allerġika (ara sezzjonijiet 4.3 u 4.8).
English: Aprotinin should be infused using a central venous catheter.
Maltese: Aprotinin għandu jingħata bħala infużjoni permezz ta' kateter ċentrali fil-vini.
English: In general, you will not be given more than 700 ml of <Aprotinin-containing medicinal product> at any one time.
Maltese: B'mod ġenerali, mhux se tingħata aktar minn 700 ml ta' <prodott mediċinali li fih Aprotinin> fi kwalunkwe ħin.
English: A retrospective review showed that the incidence of an allergic/anaphylactic reaction following reexposure is increased when the re-exposure occurs within 6 months of the initial administration (5.0 % for re-exposure within 6 months and 0.9 % for re-exposures greater than 6 months).
Maltese: Analiżi retrospettiva wriet li l-inċidenza ta' reazzjoni allerġika/anafilattika wara esponiment mill-ġdid tiżdied meta l-esponiment mill-ġdid isseħħ fi żmien 6 xhur mill-għoti inizjali (5.0 % għall-esponiment mill-ġdid fi żmien 6 xhur u 0.9 % għall-esponimenti mill-ġdid wara aktar minn 6 xhur).