FrancophonIA/ELRC3.0 huggingface dataset:
English: Hamburg 22335 Germany prolonged-release minitablet
Maltese: Hamburg 22335 Il-Ġermanja pillola ċkejkna li terħi lmediċina bil-mod
English: Convulex 300 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Maltese: Convulex 300 mg gastroresistant capsules, soft kapsula gastroreżistenti, ratba
English: 8502 Lannach Austria
Maltese: 8502 Lannach L-Awstrija
English: Convulex 150 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Maltese: Convulex 150 mg gastroresistant capsules, soft kapsula gastroreżistenti, ratba
English: D-22335 Hamburg, Germany
Maltese: D-22335 Hamburg, Il-Ġermanja
English: DEPAKINE CHRONO 500 mg tablet
Maltese: DEPAKINE CHRONO 500 mg pillola
English: ACIDO VALPROICO E SODIO VALPROATO EG 300 mg
Maltese: SODIO VALPROATO EG 300 mg
English: 250mg/5ml syrup
Maltese: 250mg/5ml mistura
English: Convulex 500 mg gastroresistant capsules, soft gastro-resistant capsule, soft
Maltese: Convulex 500 mg gastroresistant capsules, soft kapsula gastroreżistenti, ratba
English: DEPAKINE ENTERIC 500mg tablet
Maltese: DEPAKINE ENTERIC 500mg pillola
English: Propymal Enteric 150 mg 150 mg gastro-resistant capsule, soft
Maltese: Propymal Enteric 150 mg 150 mg kapsula gastroreżistenti, ratba
English: 145.14mg/333.3 mg prolonged-release granules
Maltese: 145.14mg/333.3 mg grani li jerħu l-mediċina bil-mod
English: Orfiril CR 300 mg modified-release capsule
Maltese: Orfiril CR 300 mg kapsula li terħi lmediċina b'mod modifikat
English: Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Maltese: Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm
English: Convulex 300 mg - Kapseln 300 mg gastro-resistant capsule, soft
Maltese: Convulex 300 mg - Kapseln 300 mg kapsula gastroreżistenti, ratba
English: DEPAKINE CHRONO 500mg tablet
Maltese: DEPAKINE CHRONO 500mg pillola
English: VALPROATE RETARD EG 500 MG
Maltese: VALPROATE RETARD EG 500
English: D-39116 Magdeburg Germany espa-valept 300mg esparma GmbH Seepark 7
Maltese: D-39116 Magdeburg Il-Ġermanja espa-valept 300mg esparma GmbH Seepark 7
English: CONVULEX 150 MG 150mg gastro-resistant capsule, soft
Maltese: CONVULEX 150 MG 150mg kapsula gastroreżistenti, ratba
English: Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079
Maltese: Il-Polonja ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079
English: CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany
Maltese: 42 a D-13407 Berlin Il-Ġermanja
English: Valproat-neuraxpharm 150 150 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Maltese: Valproat-neuraxpharm 150 150 mg neuraxpharm Arzneimittel GmbH u.
English: gastro-resistant capsule Oral Use
Maltese: kapsula gastro-reżistenti Użu orali
English: 40 mg/ml syrup
Maltese: 40 mg/ml mistura
English: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Maltese: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm
English: Depakine Chronosphere 50200 mg/DosisRetardgranulat prolonged-release granules
Maltese: Depakine Chronosphere 50200 mg/DosisRetardgranulat grani li jerħu l-mediċina bil-mod
English: Orfiril CR 150 mg modified-release capsule
Maltese: Orfiril CR 150 mg kapsula li terħi lmediċina b'mod modifikat
English: Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
Maltese: Il-Polonja ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
English: 200 mg/ml oral drops, solution
Maltese: 200 mg/ml qtar orali, soluzzjoni
English: Valproat-CT 600 mg Filmtabletten neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Maltese: Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Il-Ġermanja
English: Propymal Enteric 300 mg 300 mg gastro-resistant capsule, soft
Maltese: Propymal Enteric 300 mg 300 mg kapsula gastroreżistenti, ratba
English: Ergenyl Chronosphere 1000 mg Retardgranulat prolonged-release granules
Maltese: Ergenyl Chronosphere 1000 mg Retardgranulat grani li jerħu l-mediċina bil-mod
English: ul.
Maltese: KG
English: 100 mg/ml syrup
Maltese: 100 mg/ml mistura
English: D-22335, Hamburg Germany
Maltese: D-22335, Hamburg Il-Ġermanja
English: Natriumvalproaat ratiopharm chrono 300 mg 300 mg modified-release tablet Oral Use
Maltese: Natriumvalproaat ratiopharm chrono 300 mg 300 mg pillola li terħi lmediċina b'mod modifikat
English: 223 35 Hamburg Germany
Maltese: 223 35 Hamburg Il-Ġermanja
English: Convulex 200 mgKapseln gastro-resistant capsule, soft
Maltese: Convulex 200 mgKapseln kapsula gastroreżistenti, ratba
English: Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln prolonged-release granules
Maltese: Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln grani li jerħu l-mediċina bil-mod
English: Dunajska c. 119
Maltese: Sanofi-Aventis d.o.o. Dunajska c. 119
English: 200 mg/5 ml syrup
Maltese: 200 mg/5 ml mistura
English: VALPROATE DE SODIUM RATIOPHARM L.P.
Maltese: VALPROATE DE SODIUM RATIOPHARM
English: AWD.pharma GmbH & Co. KG Wasastr.
Maltese: AWD.pharma GmbH & Co.
English: 300 mg/ml oral drops, solution
Maltese: 300 mg/ml qtar orali, soluzzjoni
English: Valproinsäure-ratiopharm chrono 500 Retardtabletten 500 mg ratiopharm GmbH D-89070 Ulm Germany
Maltese: Retardtabletten 500 mg ratiopharm GmbH D-89070 Ulm
English: Ergenyl Chronosphere 750 mg Retardgranulat prolonged-release granules
Maltese: Ergenyl Chronosphere 750 mg Retardgranulat grani li jerħu l-mediċina bil-mod
English: Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany
Maltese: Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: 300 mg/ml oral drops
Maltese: 300 mg/ml qtar orali
English: A-1160, Vienna Austria
Maltese: A-1160, Vienna L-Awstrija
English: Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Maltese: Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u.
English: Czech Republic ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Maltese: Ir-Repubblika Ċeka ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm
English: D-22335 Hamburg Germany
Maltese: D-22335 Hamburg Il-Ġermanja
English: Ergenyl Chronosphere 250 mg Retardgranulat prolonged-release granules
Maltese: Ergenyl Chronosphere 250 mg Retardgranulat grani li jerħu l-mediċina bil-mod
English: Depakine Chronosphere 250 mg - Retardgranulat in Beuteln prolonged-release granules
Maltese: Depakine Chronosphere 250 mg - Retardgranulat in Beuteln grani li jerħu l-mediċina bil-mod
English: 200mg/5ml oral solution
Maltese: 200mg/5ml soluzzjoni orali
English: Ergenyl Chronosphere 100 mg Retardgranulat prolonged-release granules
Maltese: Ergenyl Chronosphere 100 mg Retardgranulat grani li jerħu l-mediċina bil-mod
English: 200mg/5ml syrup
Maltese: 200mg/5ml mistura
English: 40mg/ml oral solution
Maltese: 40mg/ml soluzzjoni orali
English: Depakine Chronosphere 750 mg - Retardgranulat in Beuteln prolonged-release granules
Maltese: Depakine Chronosphere 750 mg - Retardgranulat in Beuteln grani li jerħu l-mediċina bil-mod
English: 100 mg/ml oral solution
Maltese: 100 mg/ml soluzzjoni orali
English: 200 mg/ml oral drops
Maltese: 200 mg/ml qtar orali
English: Depakine Chronosphere 100 mg - Retardgranulat in Beuteln prolonged-release granules
Maltese: Depakine Chronosphere 100 mg - Retardgranulat in Beuteln grani li jerħu l-mediċina bil-mod
English: Ergenyl Chronosphere 500 mg Retardgranulat prolonged-release granules
Maltese: Ergenyl Chronosphere 500 mg Retardgranulat grani li jerħu l-mediċina bil-mod
English: 29.03 mg/66.66 mg prolonged-release granules
Maltese: 29.03 mg/66.66 mg grani li jerħu l-mediċina bil-mod
English: ORFIRIL LONG 150 mg 150 mg prolonged-release capsule
Maltese: ORFIRIL LONG 150 mg 150 mg kapsula li terħi lmediċina bil-mod
English: Valproinsäure-ratiopharm chrono 300 Retardtabletten 300 mg ratiopharm GmbH D-89070 Ulm Germany
Maltese: Retardtabletten 300 mg ratiopharm GmbH D-89070 Ulm
English: Convulex gastro-resistant capsule, soft
Maltese: Convulex kapsula gastroreżistenti, ratba
English: 60 mg/ml oral solution
Maltese: 60 mg/ml soluzzjoni orali
English: Depakine Chronosphere 500 mg - Retardgranulat in Beuteln prolonged-release granules
Maltese: Depakine Chronosphere 500 mg - Retardgranulat in Beuteln grani li jerħu l-mediċina bil-mod
English: 300 mg (199,8 mg/ 87 mg) modified-release tablet Oral Use
Maltese: 300 mg (199,8 mg/ 87 mg)
English: Sanofi-Aventis d.o.o.
Maltese: Sanofi-Aventis
English: Depakine Chronosphere 300 mg modified-release tablet Oral Use
Maltese: Depakine Chronosphere 300 mg pillola li terħi lmediċina b'mod modifikat
English: 0.33g/g prolonged-release granules
Maltese: 0.33g/g grani li jerħu l-mediċina bil-mod
English: ORFIRIL LONG 1000 MG 1000mg prolonged-release granules
Maltese: ORFIRIL LONG 1000 mg 1000 mg grani li jerħu l-mediċina bil-mod
English: prolonged-release minitablet
Maltese: Hoeilaart Il-Belġju
English: CONVULEX 300 MG 300mg gastro-resistant capsule, soft
Maltese: CONVULEX 300 MG 300mg kapsula gastroreżistenti, ratba
English: Ergenyl Chronosphere 50 mg Retardgranulat prolonged-release granules
Maltese: Ergenyl Chronosphere 50 mg Retardgranulat grani li jerħu l-mediċina bil-mod
English: ORFIRIL LONG 300 MG 300mg prolonged-release capsule, hard
Maltese: ORFIRIL LONG 300 MG 300mg kapsula li terħi lmediċina bil-mod, iebsa Użu orali
English: Diplexil coated tablet
Maltese: Diplexil pillola miksija
English: 200 mg/ml oral solution
Maltese: 200 mg/ml soluzzjoni orali
English: RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany
Maltese: Graf Arco Strasse 3 89079 Ulm
English: Convulex 150 mgKapseln gastro-resistant capsule, soft
Maltese: Convulex 150 mgKapseln kapsula gastroreżistenti, ratba
English: 50 mg/ml syrup
Maltese: 50 mg/ml mistura
English: SODIUM VALPROATE TABLETS BP 200MG 200mg coated tablet
Maltese: TABLETS BP 200MG 200mg pillola miksija
English: ORFIRIL LONG 150 MG 150mg prolonged-release capsule, hard
Maltese: ORFIRIL LONG 150 MG 150mg kapsula li terħi lmediċina bil-mod, iebsa Użu orali
English: 60mg/ml oral solution
Maltese: 60mg/ml soluzzjoni orali
English: 50mg/ml syrup
Maltese: 50mg/ml mistura
English: MAPHILEP 200MG MR TABLETS
Maltese: MAPHILEP 200MG
English: 200mg/ml oral solution
Maltese: 200mg/ml soluzzjoni orali
English: Depakine Chronosphere 50 mg - Retardgranulat in Beuteln prolonged-release granules
Maltese: Depakine Chronosphere 50 mg - Retardgranulat in Beuteln grani li jerħu l-mediċina bil-mod
English: CONVULEX 500 mg gastro-resistant capsule, soft
Maltese: CONVULEX 500 mg kapsula gastroreżistenti, ratba
English: Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany
Maltese: Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u.
English: Convulex 500 mgKapseln gastro-resistant capsule, soft
Maltese: Convulex 500 mgKapseln kapsula gastroreżistenti, ratba
English: DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada modified-release granules
Maltese: DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada grani li jerħu l-mediċina b'mod modifikat
English: 22335 Hamburg Germany
Maltese: 22335 Hamburg Il-Ġermanja
English: CONVULEX 150 mg gastro-resistant capsule, soft
Maltese: CONVULEX 150 mg kapsula gastroreżistenti, ratba
English: UAB ,,Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2
Maltese: UAB ,,Sanofi Aventis“
English: 333 mg + 145 mg prolonged-release tablet Oral Use
Maltese: 333 mg + 145 mg pillola li terħi lmediċina bil-mod
English: 87 mg /199.8 mg prolonged - release tablet
Maltese: 87 mg /199.8 mg pillola li terħi lmediċina bil-mod
English: gastro-resistant capsule, hard
Maltese: kapsula gastroreżistenti, iebsa
English: Luxembourg
Maltese: Wien
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Maltese: Lista ta'l-ismijiet, għamla farmaċewtika (għamliet farmaċewtiċi), qawwa (qawwiet) tal-prodott(i) mediċinali, mnejn jingħata, l-applikant(i) fl-istati membri
English: Applicant company name, address
Maltese: L-Applikant
English: Half-life (minutes)
Maltese: Half-life (minuti)
English: Relative Risk [95% CI]
Maltese: Riskju Relattiv [95% CI]
English: Overall population (ITT)
Maltese: Popolazzjoni totali (ITT)
English: (see section 4.3 of SmPC).
Maltese: (ara sezzjoni 4.3 ta' SmPC)
English: pvalue*
Maltese: p-value*
English: - The active substance is bivalirudin.
Maltese: - Is-sustanza attiva hija bivalirudin.
English: Clearance (ml/min/kg)
Maltese: Tneħħija (ml/min/kg)
English: Thrombotic (9/110, 8.2%) and major bleeding events (2/110, 1.8%) were observed in the study.
Maltese: Kienu osservati avvenimenti trombotiċi (9/110, 8.2%) u ta' fsada maġġuri (2/110, 1.8%) fl-istudju.
English: Other frequently reported adverse events were decreased pedal pulse, catheter site haemorrhage, abnormal pulse, and nausea (8.2%, 7.3%, 6.4% and 5.5%, respectively).
Maltese: Avvenimenti avversi oħra rrappurtati ta' spiss kienu tnaqqis fil-polz pedali, emorraġija fis-sit talkateter, rata anormali tal-polz, u dardir (8.2%, 7.3%, 6.4% u 5.5%, rispettivament).
English: • subacute bacterial endocarditis
Maltese: • endokardite batterika subakuta
English: A total of 92.9% of patients treated underwent primary PCI as their primary management strategy.
Maltese: Total ta' 92.9% talpazjenti trattati kienu sottoposti għal PCI primarju bħala l-istrateġija primarja ta' immaneġġjar.
English: B - A Risk diff. (95% CI)
Maltese: B - A Diff. fir-risk (95% CI)
English: Pulmonary haemorrhage Dyspnoea a
Maltese: Emorraġija pulmonari Dispneja a
English: Rash, Urticaria
Maltese: Raxx, Urtikarja
English: • Haematoma (bruising)
Maltese: • Ematoma (tbenġil)
English: *clopidogrel pre-angiography or pre-PCI
Maltese: *klopidogrel pre-anġjografija jew pre-PCI
English: Angiox contains sodium
Maltese: Angiox fih sodium
English: OUTER CARTON (pack of 10 vials)
Maltese: KARTUNA TA' BARRA (pakkett ta' 10 kunjetti)
English: Uncommon (≥1/1,000 to <1/100)
Maltese: Mhux Komuni (≥1/1,000 sa <1/100)
English: Following angiographic assessment, patients were triaged to either medical management (33%), PCI (56%) or CABG (11%).
Maltese: Wara valutazzjoni anġjografika, il-pazjenti ġew soġġetti jew għal amministrazzjoni medika (33%), PCI (56%) jew għal CABG (11%).
English: Elimination follows a first order process with a terminal half-life of 25  12 minutes in patients with normal renal function.
Maltese: L-eliminazzjoni ssegwi proċess ta' l-ewwel ordni b'half-life terminali ta' 25  12-il minuta f'pazjenti b'funzjoni tal-kliewi normali.
English: HORIZONS 30-day study results (intent-to-treat population)
Maltese: HORIZONS riżultati ta' studju ta' 30 jum (populazzjoni intenzjonata li tiġi trattata)
English: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028-Barcelona Tel.: +34 93 600 37 00
Maltese: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028-Barcelona
English: In REPLACE-2, bleeding data were collected separately from adverse events.
Maltese: F'REPLACE-2, id-dejta dwar fsada nġabret separatament mill-episodji avversi.
English: (For full information on posology see section 4.2 of SmPC)
Maltese: (Għal informazzjoni sħiħa dwar il-pożoloġija ara sezzjoni 4.2 ta' SmPC).
English: Per-protocol bivalirudin (N=2,994)
Maltese: Skont il- protokol bivalirudin (N=2,994)
English: Thrombocytopenia Anaemia
Maltese: Tromboċitopenija Anemija
English: Normal renal function (≥ 90ml/min) Mild renal impairment (60-89 ml/min) Moderate renal impairment (30-59 ml/min) Severe renal impairment (10-29 ml/min) Dialysis dependent patients (off-dialysis)
Maltese: Funzjoni tal-kliewi normali (≥ 90ml/min) Indeboliment ħafif tal-kliewi (60-89 ml/min) Indeboliment moderat tal-kliewi (30-59 ml/min) Indeboliment sever tal-kliewi (10-29 ml/min) Pazjenti dipendenti fuq dijalisi (barra d-dijalisi)
English: Angiox is available in packs of 10 vials.
Maltese: Angiox huwa disponibbli f'pakketti ta' 10 kunjetti.
English: The following data are based on a clinical study of bivalirudin in 13,819 patients with ACS; 4,612 were randomised to bivalirudin alone, 4,604 were randomised to bivalirudin plus GP IIb/IIIa inhibitor and 4,603 were randomised to either unfractionated heparin or enoxaparin plus GP IIb/IIIa inhibitor.
Maltese: Din id-dejta li ġejja hija bbażata fuq studju kliniku ta' bivalirudin fi 13,819-il pazjent b'ACS; 4,612 ġew randomised għal bivalirudin biss u 4,604 ġew randomised għal bivalirudin u inibitur GP IIb/IIIa, u 4,603 ġew randomised għal jew eparina mhux frazzjonata jew enoxaparin flimkien ma' inibitur GP IIb/IIIa.
English: Coronary stent thrombosis including reports with fatal outcome c
Maltese: Trombożi wara stent koronarja inklużi rapporti b'eżitu finali c,
English: Angiox 250 mg powder for concentrate bivalirudin
Maltese: Angiox 250 mg trab għal konċentrat bivalirudin
English: Bival alone (N=2,911) %
Maltese: Bival waħdu (N=2,911) %
English: The medicinal products incompatible with bivalirudin at higher concentrations are: dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam and promethazine HCl.
Maltese: Il-prodotti mediċinali inkompatibbli ma' bivalirudin f'konċentrazzjonijiet ogħla huma dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam u promethazine HCl.
English: ACT values 5 minutes after bivalirudin bolus average 365 +/- 100 seconds.
Maltese: Il-medja tal-valuri ta' l-ACT 5 minuti wara bolus ta' bivalirudin hija ta' 365 ±100 sekonda.
English: Peritoneal haemorrhage, Retroperitoneal haematoma, Vomiting
Maltese: Emorraġija peritoneali, Ematoma retroperitoneali, Rimettar
English: Ferrer-Galenica A.E. Τηλ: +30 210 5281700
Maltese: Τηλ: +30 210 5281700
English: Date of first authorisation: 20.09.2004 Date of latest renewal: 23.06.2014
Maltese: Data tal-aħħar tiġdid: 23.06.2014
English: Bivalirudin is metabolized by proteases, including thrombin.
Maltese: Bivalirudin huwa metabolizzat minn proteases, fosthom it-thrombin.
English: Tabulated list of adverse reactions
Maltese: Lista tar-reazzjonijiet avversi f' tabella
English: INR increased d
Maltese: INR miżjud d
English: Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, or tirofiban.
Maltese: Saru studji ta' l-interazzjoni b'inibituri tal-platelets, fosthom acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, jew tirofiban.
English: 3, representing a ≥50% decrease in platelets from baseline.
Maltese: 3, li jirrappreżenta tnaqqis ta' ≥50% fil-plejtlits mil-linja bażi.
English: There was no statistically significant difference in the rates of stent thrombosis between treatment arms at 30 days (p=0.3257) and 1 year (p=0.7754).
Maltese: Ma kienx hemm differenza statistikament sinifikanti fir-rati ta' trombożi stent bejn iż-żewġt gruppi ta' trattament f'ġurnata 30 (p=0.3257) u sena (p=0.7754).
English: 30 day Composite MACE
Maltese: Riżultat Kompost ta' 30 jum MACE
English: The HORIZONS Trial (Patients with STEMI undergoing primary PCI)
Maltese: Il-prova HORIZONS (Patients with STEMI li huma sottoposti għal PCI primarju)
English: The majority of these cases were non-fatal.
Maltese: Il-maġġoranza ta' dawn il-każijiet kienu mhux fatali.
English: Additional anti-platelet therapy utilised in the study included acetylsalicylic acid and clopidogrel.
Maltese: Kura addizzjonali kontra-plejtlits wżata fl-istudju inkludiet acetylsalicylic acid u klopidogrel.
English: Gastrointestinal haemorrhage (including haematemesis, melaena, oesophageal haemorrhage, anal haemorrhage), Retroperitoneal haemorrhage, Gingival haemorrhage, Nausea
Maltese: Emorraġija gastrointestinali (inklużi ematemeżi, malaena, emorraġija esofagali,emorraġija anali), Emorraġija retroperitoneali, Emorraġija ġinġivali
English: The following medicinal products should not be administered in the same intravenous line as bivalirudin since they result in haze formation, micro-particulate formation or gross precipitation; alteplase, amiodarone HCl, amphotericin B, chlorpromazine hydrochloride (HCl), diazepam, prochlorperazine edisylate, reteplase, streptokinase and vancomycin HCl.
Maltese: Il-prodotti mediċinali li ġejjin m'għandhomx jingħataw fl-istess linja intravenuża ma' bivalirudin billi jwasslu għal formazzjoni ta' ċpar, formazzjoni ta' partikuli żgħar ħafna jew preċipitazzjoni qawwija; alteplase, amiodarone HCl, amphotericin B, chlorpromazine hydrochloride (HCl), diazepam, prochlorperazine edisylate, reteplase, streptokinase u vancomycin HCl.
English: Pharmacotherapeutic group: antithrombotic agents, Direct thrombin inhibitors, ATC code: B01AE06.
Maltese: Kategorija farmakoterapewtika: sustanzi anti-trombotiċi, Inibituri ta' trombin diretti, Kodiċi ATC:
English: • Brief information on preparation and administration instructions.
Maltese: • Informazzjoni fil-qasir fuq l-istruzzjonijiet dwar il-preparazzjoni u t-teħid.
English: Immune system disorders
Maltese: Disturbi tassistema immuni
English: In REPLACE-2 thrombocytopenia occurred in 20 bivalirudin-treated patients (0.7%).
Maltese: Fir-REPLACE-2 tromboċitopenja ġrat f' 20 pazjent trattat b' bivalirudin (0.7%).
English: Toxicity in animals upon repeated or continuous exposure (1 day to 4 weeks at exposure levels of up to 10 times the clinical steady state plasma concentration) was limited to exaggerated pharmacological effects.
Maltese: It-tossiċità fl-annimali wara esponiment ripetut jew kontinwu (ġurnata sa 4 ġimgħat f'livelli ta' esponiment sa 10 darbiet il-konċentrazzjoni klinika fissa fil-plażma) kienet limitata għal effetti farmakoloġiċi esaġerati.
English: REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations
Maltese: Riżultati ta' studju REPLACE-2: punti ta' l-aħħar f' jum-30 (popolazzjoni intenzjonata biex tiġi trattata u dawk skont il-protokol)
English: The REPLACE-2 Trial (Patients undergoing PCI)
Maltese: Il-Prova REPLACE-2 (Pazjenti sottoposti għal PCI)
English: Angiox contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Maltese: Angiox fih inqas minn 1mmol sodium (23 mg) f'kull vjala, jiġifieri essenzjalment “mingħajr sodium”.
English: • severe uncontrolled hypertension
Maltese: • pressjoni għolja severa mhux ikkontrollata
English: Angiox is contraindicated in patients with:
Maltese: Angiox huwa kontra-indikat f'pazjenti bi:
English: • In patients with moderate renal impairment (GFR 30-59 ml/ min) the infusion rate should be reduced to 1.4 mg/kg/h.
Maltese: • F'pazjenti b'insuffiċjenza renali moderata (GFR 30-59 ml/min) r-rata ta' infużjoni trid titnaqqas għal 1.4 mg/kg/h.
English: ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for the overall population (ITT)
Maltese: Tabella 3. Prova ta' ACUITY; differenzi fir-riskju wara 30 jum u sena għal punt ta' tmiem iskemiku kompost u l-komponenti tiegħu għall-popolazzjoni totali (ITT)
English: A total of 3,602 patients were randomised to receive either bivalirudin (1,800 patients) or unfractionated heparin plus a GP IIb/IIIa inhibitor (1,802 patients).
Maltese: Total ta' 3,602 pazjenti kienu randomised biex jieħdu jew bivalirudin (1,800 pazjent) jew eparina mhux frazjonizzata flimkien ma' inhibitur ta' GP IIb/IIIa (1,802 pazjenti).
English: Mannitol Sodium hydroxide 2% (for pH adjustment)
Maltese: Mannitol Sodium hydroxide 2% (għal aġġustamnet tal-pH).
English: Epistaxis, Haemoptysis, Pharyngeal haemorrhage
Maltese: Epistaxi, emoptiżi, emorraġija tal-farinġi
English: The steady-state volume of distribution is 0.1 l/kg.
Maltese: Il-volum tad-distribuzzjoni fiss huwa ta' 0.1 l/kg.
English: This may, rarely, result in a stroke or be fatal.
Maltese: Dan jista', rarament, jirriżulta f'puplesija jew ikun fatali.