FrancophonIA/ELRC3.0 huggingface dataset:
English: In pivotal studies conducted in patients undergoing PCI, events of acute renal failure (0.1%), renal failure (0.1%) and increased serum creatinine (0.2%) were reported to occur after administration of cangrelor in clinical trials (see section 4.8).
Maltese: Fi studji importanti ħafna li saru f'pazjenti li kienet qed issirilhom PCI, avvenimenti ta' insuffiċjenza akuta tal-kliewi (0.1%), insuffiċjenza tal-kliewi (0.1%) u żieda tal-kreatinina fis-serum (0.2%) ġew irrappurtati li jseħħu wara l-għoti ta' cangrelor fil-provi kliniċi (ara sezzjoni 4.8).
English: Possible implications for the in vivo situation have not been investigated, but caution is advised when cangrelor is to be combined with a BCRP substrate.
Maltese: Implikazzjonijiet possibbli għas-sitwazzjoni in vivo ma ġewx investigati, iżda l-kawtela hi rakkomandata meta cangrelor jiġi kkombinat ma' substrat ta' BCRP.
English: Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety.
Maltese: Data mill-popolazzjoni miġbura ta' CHAMPION fuq iktar minn 25,000 pazjent b'PCI tipprovdi sapport kliniku addizzjonali għas-sigurtà.
English: Alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.
Maltese: Alternattivament, doża għolja tal-bidu ta' ticagrelor jew prasugrel, iżda mhux clopidogrel, tista' tingħata sa 30 minuta qabel it-tmiem talinfużjoni, ara sezzjoni 4.5.
English: Anaemia, thrombocytopenia
Maltese: thromboċitopenija
English: Epistaxis, haemoptysis
Maltese: Epistassi, emoptisi,
English: Mean clearance was approximately 43.2 L/kg.
Maltese: Cangrelor għandu volum ta' distribuzzjoni ta' 3.9 L/kg.
English: Reproductive system and breast disorders
Maltese: Disturbi fissistema riproduttiva u fissider
English: Instructions for preparation
Maltese: Istruzzjonijiet għall-preparazzjoni
English: An analysis of non-coronary artery bypass grafting (CABG)-related bleeding is presented in Table 2.
Maltese: coronary artery bypass grafting) qed tiġi ppreżentata f'Tabella 2.
English: Key Secondary Endpoint
Maltese: Punt Aħħari Sekondarju
English: In pivotal studies conducted in patients undergoing PCI, GUSTO (Global Use of Strategies to Open Occluded Arteries), moderate and mild bleeding events were more common in patients treated with cangrelor than in patients treated with clopidogrel, see section 4.8.
Maltese: Fi studji importanti ħafna li twettqu f'pazjenti li kienet qed issirilhom PCI, GUSTO (Global Use of Strategies to Open Occluded Arteries), avvenimenti ta' ħruġ ta' demm moderat u ħafif kienu aktar komuni f'pazjenti kkurati b'cangrelor milli f'pazjenti kkurati bi clopidogrel, ara sezzjoni 4.8.
English: The pharmacokinetic properties of cangrelor have been evaluated and found to be linear in patients and healthy volunteers.
Maltese: II-propjetajiet farmakokinetiċi ta' cangrelor ġew evalwati u nstabu li kienu lineari f'pazjenti u voluntiera b'saħħithom.
English: After reconstitution 1 mL of concentrate contains 10 mg cangrelor and after dilution 1 mL of solution contains 200 micrograms cangrelor.
Maltese: Wara r-rikostituzzjoni, 1 mL ta' konċentrat ikun fih 10 mg ta' cangrelor u wara d-dilwizzjoni, 1 mL ta' soluzzjoni jkun fih 200 mikrogramma ta' cangrelor.
English: Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.
Maltese: Kengrexal, mogħti flimkien ma' acetylsalicylic acid (ASA), hu indikat għat-tnaqqis ta' avvenimenti kardjovaskulari trombotiċi f'pazjenti adulti b'mard tal-arterji koronarji li jkollhom intervent koronarju perkutaneju (PCI - percutaneous coronary intervention) li ma jkunux irċivew inibitur ta' P2Y12 orali qabel il-proċedura PCI u li għalihom, terapija orali b'inibituri ta' b'P2Y12 ma tkunx possibbli jew mixtieqa.
English: Excipient with known effect Each vial contains 52.2 mg sorbitol.
Maltese: Kull kunjett fih 52.2 mg ta' sorbitol.
English: Thrombotic events at 48 hours in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Maltese: Tabella 3: Avvenimenti trombotiċi wara 48 siegħa f'CHAMPION PHOENIX (popolazzjoni mITT)
English: The GUSTO bleeding scale was measured in the CHAMPION (PHOENIX, PLATFORM, and PCI) clinical trials.
Maltese: L-iskala ta' ħruġ ta' demm GUSTO tkejlet fil-provi kliniċi CHAMPION (PHOENIX, PLATFORM, u PCI).
English: Upper gastrointestinal haemorrhage, mouth haemorrhage, gingival bleeding, oesophageal haemorrhage, duodenal ulcer haemorrhage, haematemesis, lower gastrointestinal haemorrhage, rectal haemorrhage, haemorrhoidal haemorrhage, haematochezia.
Maltese: Emorraġija gastrointestinali fin-naħa ta' fuq, emorraġija mill-ħalq, ħruġ ta' demm ġinġivali, emorraġija esofagali, emorraġija minn ulċera duwodenali, ematemesi, emorraġija gastrointestinali fil-parti t'isfel, emorraġija fir-rektum, emorraġija fil-murliti, ematokeżija.
English: Thrombotic events at 30 days in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Maltese: Tabella 4: Avvenimenti trombotiċi wara 30 jum f'CHAMPION PHOENIX (popolazzjoni mITT)
English: Rare side effects: may affect up to 1 in 1,000 people
Maltese: Effetti sekondarji rari: jistgħu jaffettwaw sa persuna 1 minn kull 1,000
English: Anaphylactic reaction (anaphylactic shock), hypersensitivity
Maltese: Reazzjoni anafilattika (xokk anafilattiku), sensittività eċċessiva
English: GP IIb/IIIa inhibitors were permitted for bailout use only and were used in 2.9% of patients.
Maltese: Inibituri ta' GPIIb/IIIa kienu permessi għal użu bailout biss u ntużaw fi 2.9% tal-pazjenti.
English: In pivotal studies conducted in patients undergoing PCI, there were more cardiac tamponades at 30 days with cangrelor (0.12%) than with clopidogrel (0.02%), (see section 4.8).
Maltese: Fi studji importanti ħafna li saru f'pazjenti li kienet qed issirilhom PCI, kien hemm iktar għafis tal-qalb wara 30 jum b'cangrelor (0.12%) milli bi clopidogrel (0.02%), (ara sezzjoni 4.8).
English: Initial excretion was rapid, such that approximately 50% of the administered radioactivity was recovered in the first 24 hours, and 75% was recovered by 48 hours.
Maltese: It-tneħħija inizjali kienet mgħaġġla, b'tali mod li madwar 50% tar-radjuattività mogħtija ġiet irkuprata fl-ewwel 24 siegħa, u 75% ġiet irkuprata wara 48 siegħa.
English: • severe allergic reactions,
Maltese: • reazzjonijiet allerġiċi severi,
English: Reconstitute each 50 mg/vial by adding 5 mL of sterile water for injection.
Maltese: 50 mg/kunjett billi żżid 5 mL ta' ilma sterili għall-injezzjoni.
English: Kengrexal is not recommended for children and adolescents under 18 years.
Maltese: Kengrexal mhuwiex rakkomandat għall tfal u adolexxenti taħt il-18-il sena.
English: After reconstitution 1 mL contains 10 mg cangrelor.
Maltese: Wara r-rikostituzzjoni, 1 mL ikun fih 10 mg ta' cangrelor.
English: This medicinal product contains 52.2 mg sorbitol in each vial.
Maltese: Dan il-prodott mediċinali fih 52.2 mg sorbitol f'kull kunjett.
English: Ecchymosis (petechiae, purpura)
Maltese: Ekkimożi (tikek żgħar vjola fuq il-ġilda, purpura)
English: The other ingredients are mannitol, sorbitol and sodium hydroxide for pH-adjustment.
Maltese: Is-sustanzi mhux attivi l-oħra huma mannitol, sorbitol u sodium hydroxide għall-aġġustament tal-pH.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: • increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney function,
Maltese: • żieda fil-livelli ta' kreatinina fid-demm (identifikata permezz ta' testijiet tad-demm), li jindikaw tnaqqis fil-funzjoni tal-kliewi,
English: A reversible effect on fertility was observed in male rats treated with Kengrexal (see section 5.3).
Maltese: Effett riversibbli fuq il-fertilità ġie osservat f'firien irġiel ikkurati b'Kengrexal (ara sezzjoni 5.3).
English: For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u id-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Effects on fertility, ability to produce a pregnancy with female partner(s), sperm morphology and sperm motility were observed in the male rat fertility study when cangrelor was administered at human equivalent doses equal to 1.8 fold the recommended PCI dose.
Maltese: Ġew osservati effetti fuq il-fertilità, il-ħila tal-produzzjoni ta' tqala ma' sieħba nisa, il-morfoloġija tal isperma u l-moviment tal-isperma, fi studju dwar il-fertilità f'firien irġiel, meta cangrelor ingħata f'dożi umani ekwivalenti, ugwali għal 1.8 darba tad-doża PCI rakkomandata.
English: Kengrexal contains cangrelor, a direct P2Y12 platelet receptor antagonist that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo.
Maltese: Kengrexal fih cangrelor, antagonist tar-riċetturi tal-plejtlits dirett ta' P2Y12 li jimblokka l-attivazzjoni u l-aggregazzjoni tal-plejtlits indotta minn adenosine diphosphate (ADP) in vitro u ex vivo. Cangrelor jeħel b'mod selettiv u b'mod riversibbli mar-riċettur ta' P2Y12 biex jimpedixxi senjalazzjoni u attivazzjoni tal-plejtlits addizzjonali.
English: Table 1: Adverse reactions for cangrelor in CHAMPION pooled studies within 48 hours System organ class
Maltese: Tabella 1: Reazzjonijiet avversi għal cangrelor fl-istudji miġbura CHAMPION fi żmien 48 siegħa
English: Kengrexal 50 mg powder for concentrate for solution for injection/infusion cangrelor
Maltese: Kengrexal 50 mg, trab għal konċentrat għal soluzzjoni għall-injezzjoni/infużjoni
English: The metabolism of cangrelor is independent of organ function and does not interfere with other drugs metabolised by hepatic enzymes.
Maltese: Il-metaboliżmu ta' cangrelor hu indipendenti mill-funzjoni tal-organi u ma tinterferixxix ma' mediċini oħrajn li jiġu metabolizzati minn enzimi tal-fwied.
English: Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with heart disease.
Maltese: Jekk tuża Kengrexal aktar milli suppost Din il-mediċina se tingħatalek minn professjonist fil-qasam mediku.
English: How to store Kengrexal
Maltese: X'fih Kengrexal
English: Kengrexal is for injection, followed by infusion (drip), into a vein.
Maltese: Kengrexal hu għal injezzjoni, segwit minn infużjoni (dripp), ġo vina.
English: Patients should be transitioned to oral P2Y12 therapy for chronic treatment.
Maltese: Il-pazjenti għandhom jinqalbu għal terapija b'P2Y12 orali għal kura kronika.
English: Following the administration of a 30 microgram/kg bolus followed by a 4 microgram/kg/min infusion, platelet inhibition is observed within two minutes.
Maltese: Wara l-għoti ta' bolus ta' 30 mikrogramma/kg segwit minn infużjoni ta' 4 mikrogrammi/kg/min (id doża ta' PCI), l-inibizzjoni tal-plejtlits tiġi osservata fi żmien żewġ minuti.
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC25.
Maltese: Inibituri tal-aggregazzjoni plejtlits minbarra eparina, Kodiċi ATC:
English: No interaction on cangrelor was observed.
Maltese: Ma ġiet osservata l-ebda interazzjoni fuq cangrelor.
English: Neoplasms benign, malignant and unspecified (includes cysts and polyps)
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: There is no antidote to Kengrexal, however, the pharmacokinetic half-life of Kengrexal is three to six minutes.
Maltese: M'hemm l-ebda antidot għal Kengrexal, madankollu, il-half-life farmakokinetika ta' Kengrexal hi minn tlieta sa sitt minuti.
English: Intracranial haemorrhage
Maltese: Emorraġija intrakranjali
English: Of the recovered material, 58% was found in urine and the remaining 35% was found in faeces, presumably following biliary excretion.
Maltese: Mill-materjal irkuprat, 58% instab fi awrina, u l-35% li kien fadal instab fl-ippurgar, preżumibilment wara tneħħija biljari.
English: Allergic reaction is a rare side effect of treatment with Kengrexal (may affect up to 1 in 1,000 people) but may be potentially serious.
Maltese: Reazzjoni allerġika hi effett sekondarju rari tal-kura b'Kengrexal (jista' jaffettwa sa persuna 1 minn kull 1,000) iżda jista' jkun potenzjalment serju.
English: Chiesi Farmaceutici S.p.A. Τηλ: + 39 0521 2791
Maltese: Τηλ: + 39 0521 2791
English: Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal.
Maltese: Trab f'kunjetti tal-ħġieġ (Tip 1) ta' 10 mL, magħluqin b'tapp tal-lastku butyl miksi Flurotec u ssiġillati b'siġill ippjegat tal-aluminju.
English: CABG: Coronary Artery Bypass Graft Surgery; GUSTO: Global Use of Strategies to Open Coronary Arteries; w/o: without a In the CHAMPION pooled analysis, GUSTO Mild was defined as other bleed not requiring blood transfusion or causing haemodynamic compromise.
Maltese: Pazjenti bi kwalunkwe trasfużjoni CABG: Coronary Artery Bypass Graft Surgery; GUSTO: Global Use of Strategies to Open Coronary
English: No pharmacokinetic or pharmacodynamic interaction with cangrelor was observed in an interaction study with aspirin, heparin, or nitroglycerin.
Maltese: Ma ġiet osservata l-ebda interazzjoni farmakokinetika jew farmakodinamika b'cangrelor fi studju dwar l-interazzjonijiet bl-aspirina, eparina, jew nitroglycerin.
English: The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion.
Maltese: Id-doża rakkomandata ta' Kengrexal għal pazjenti li kienet qed issirilhom PCI hija ta' 30 mikrogramma/kg bolus ġol-vini segwit immedjatament minn infużjoni ġol-vini ta' 4 mikrogramma/kg/min.
English: For transition, a loading dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel) should be administered immediately following discontinuation of cangrelor infusion.
Maltese: Għal transizzjoni, doża għolja tal-bidu ta' terapija orali P2Y12 (clopidogrel, ticagrelor jew prasugrel) għandha tingħata immedjatament wara t-twaqqif tal-infużjoni b'cangrelor.
English: Uncommon side effects: may affect up to 1 in 100 people
Maltese: Effetti sekondarji mhux komuni: jistgħu jaffettwaw sa persuna 1 minn kull 100
English: Kengrexal 50 mg powder for concentrate cangrelor
Maltese: U MNEJN GĦANDU JINGĦATA Kengrexal 50 mg, trab għal konċentrat cangrelor
English: EXP
Maltese: IDR
English: The half-life of Kengrexal is three to six minutes, independent of dose.
Maltese: Eliminazzjoni Il-half-life ta' Kengrexal hu minn tlieta sa sitt minuti, u hi indipendenti mid-doża.
English: Table 2: Non-CABG-related bleeding GUSTO bleeding, n (%) CHAMPION pooled
Maltese: Tabella 2: Ħruġ ta' demm mhux relatat ma' CABG Ħruġ ta' demm GUSTO, n (%)
English: Powder for concentrate for solution for injection/infusion.
Maltese: Trab għal konċentrat għal soluzzjoni għall-injezzjoni/infużjoni.
English: Kengrexal is a white to off-white freeze-dried powder.
Maltese: Kengrexal hu biss għall-użu fl-adulti.
English: In patients with severe renal impairment (creatinine clearance 15-30 mL/min) a higher rate of worsening in renal function (3.2%) was reported in the cangrelor group compared to clopidogrel (1.4%).
Maltese: F'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' 15-30 mL/min), rata ogħla ta' aggravament fil-funzjoni tal-kliewi (3.2%) ġiet irrappurtata fil-grupp ta' cangrelor grupp meta mqabbla ma'
English: Primary Endpoint
Maltese: Punt Aħħari Primarju
English: Metabolism of cangrelor is not dependent on CYPs and CYP isoenzymes are not inhibited by therapeutic concentrations of cangrelor or its major metabolites.
Maltese: Il-metaboliżmu ta' cangrelor mhuwiex dipendenti fuq CYPs u l-isoenzimi ta' CYP mhumiex inibiti mill-konċentrazzjonijiet terapewtiċi ta' cangrelor jew il-metaboliti maġġuri tiegħu.
English: Mannitol
Maltese: Treddigħ
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Maltese: Pazjenti b'HFI ma jistgħux ikissru l-fructose, li jista jikkawża effetti sekondarji serji.
English: In the pooled safety population from the CHAMPION trials, the incidence of fatal bleeding within 30 days of dosing was low and similar in patients who received cangrelor compared to clopidogrel (8 [0.1%] vs. 9 [0.1%]).
Maltese: Fil-popolazzjoni miġbura tas-sigurtà mill-provi CHAMPION, l-inċidenza ta' ħruġ ta' demm fatali fi żmien 30 jum mid-dożaġġ kienet baxxa u simili f'pazjenti li rċivew cangrelor meta mqabbla ma' clopidogrel (8 [0.1%] vs. 9 [0.
English: Vascular disorders
Maltese: psewdoanewriżmu vaskulari
English: • Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, difficulty breathing).
Maltese: • Reazzjoni allerġika (raxx, ħakk, tagħfis/nefħa tal-gerżuma, nefħa tal-ilsien jew tax-xufftejn, diffikultà biex tieħu n-nifs 'il ġewwa jew 'il barra).
English: Chiesi Hungary Kft. Tel.: +36-1-429 1060
Maltese: Chiesi Poland Sp. z .o.o. Tel.: + 48 22 620 1421
English: • 30 micrograms per kilogram body weight by injection, followed immediately by
Maltese: • 30 mikrogramma għal kull kilogramm ta' piż tal-ġisem permezz ta' injezzjoni, segwita immedjatament minn
English: Before administration, 5 mL reconstituted solution has to be withdrawn from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose (5%) solution for injection.
Maltese: Qabel kull għoti, 5 mL ta' soluzzjoni rikostitwita għandhom jinġibdu minn kull kunjett u għandhom jiġu dilwiti b'mod addizzjonali b'250 mL ta' sodium chloride 9 mg/mL
English: These included cases of anaphylactic reactions/shock and angioedema (see section 4.8).
Maltese: Dawn kienu jinkludu każijiet ta' reazzjonijiet anafilattiċi/xokk u anġjoedema, (ara sezzjoni 4.8).
English: Cangrelor is deactivated rapidly in the plasma by dephosphorylation to form its primary metabolite, a nucleoside.
Maltese: Cangrelor jiġi ddiżattivat malajr fil-plażma permezz ta' defosforilazzjoni biex jifforma l-metabolit primarju tiegħu, li hu nucleoside.
English: Haematoma infection
Maltese: Instabilità emodinamika,
English: Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Maltese: Tel: + 39 0521 2791
English: Mild w/o ecchymosis, oozing and haematoma <5 cm 98 (1.8) Patients with any transfusion
Maltese: Ħafif b Ħafif w/o ekkimożi, tnixxija u ematoma ta' <5 ċm
English: Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara ‘JIS'.
English: Ear and labyrinth disorders
Maltese: Disturbi filwidnejn u fissistema labirintika
English: Anatomical changes correlated with increased plasma creatinine and urea, and increased albumin and blood cells in urine.
Maltese: Tibdil anatomiku kien jikkorrela ma' żieda tal-kreatinina u urea fil-plażma, u żieda tal-albumina u ċelluli tad-demm fl awrina.
English: Periorbital haematoma, subcutaneous haematoma
Maltese: Ematurija, demm fl-awrina, emorraġija uretrali.
English: • You have been told by your doctor that you have an intolerance to some sugars.
Maltese: • It-tabib tiegħek qallek li għandek intolleranza għal xi tipi ta' zokkor.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Elderly
Maltese: Ewlieni
English: Cardiac tamponade (pericardial haemorrhage)
Maltese: Għafis tal-qalb (emorraġija perikardjali)
English: Onset of P2Y12 inhibition occurs rapidly upon cangrelor administration.
Maltese: kontaminazzjoni mikrobjali, il-prodott għandu jintuża immedjatament.
English: The bolus volume should be administered rapidly (<1 minute), from the diluted bag via manual intravenous push or pump.
Maltese: Il-volum tal-bolus għandu jingħata malajr (<1 minuta), mill-borża dilwita permezz ta' push ġol-vini jew pompa.
English: Aseptic procedures should be used for the preparation of Kengrexal.
Maltese: Proċeduri asettiċi għandhom jintużaw għall-preparazzjoni ta' Kengrexal.
English: Reproductive toxicity
Maltese: GĦAMLA FARMAĊEWTIKA
English: Cardiac tamponade
Maltese: toraċiċi u medjastinali
English: Cerebral haemorrhage, cerebrovascular accident.
Maltese: Emorraġija ċerebrali, inċident ċerebrovaskulari.
English: Investigations
Maltese: LISTA
English: Wound haemorrhage, vascular pseudoaneurysm
Maltese: .2 Pożoloġija u metodu ta' kif għandu jingħata
English: You may receive acetylsalicylic acid (ASA) while you are treated with Kengrexal or another type of anti-platelet medicine (e.g., clopidogrel) before and after you are treated with Kengrexal.
Maltese: Inti tista' tirċievi acetylsalicylic acid (ASA) waqt li tkun qed tiġi kkurat b'Kengrexal jew tip ieħor mediċina kontra l-plejtlits (eż., clopidogrel) qabel u wara li tkun ġejt ikkurat b'Kengrexal.
English: Following the intravenous administration of a 2 micrograms/kg/min infusion of [3H] cangrelor to healthy male volunteers, 93% of total radioactivity was recovered.
Maltese: Wara l-għoti ġol vini ta' infużjoni ta' 2 mikrogrammi/kg/min ta' [3H] ta' cangrelor lil irġiel voluntiera b'saħħithom,
English: Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor.
Maltese: Kull kunjett fih cangrelor tetrasodium li jikkorrispondi għal 50 mg ta' cangrelor.
English: b In CHAMPION PHOENIX, GUSTO Mild was defined as other bleeding requiring intervention but not requiring blood transfusion or causing haemodynamic compromise.
Maltese: b F'CHAMPION PHOENIX, GUSTO ħafif ġie definit bħala ħruġ ta' demm ieħor li kien jeħtieġ intervent iżda li ma kienx jeħtieġ trasfużjoni tad-demm jew li jikkawża kompromess emodinamiku.
English: A pharmacodynamic interaction study has also been conducted with cangrelor and ticagrelor.
Maltese: Twettaq ukoll studju dwar interazzjonijiet farmakodinamiċi b'cangrelor u ticagrelor.
English: Paediatric Population
Maltese: Popolazzjoni pedjatrika
English: There are no or limited amount of data from the use of Kengrexal in pregnant women.
Maltese: M'hemmx data jew hemm data limitata dwar l-użu ta' Kengrexal f'nisa tqal.
English: Administration of 600 mg clopidogrel immediately after the cessation of the cangrelor infusion results in the anticipated full pharmacodynamic effect.
Maltese: L-għoti ta' 600 mg ta' clopidogrel immedjatament wara t-twaqqif tal-infużjoni ta' cangrelor jirriżulta fl-effett farmakodinamiku sħiħ antiċipat.
English: For storage conditions after reconstitution and dilution of the medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Vessel puncture site haematoma b
Maltese: Ematoma talvina/arterja fis-sit tat-titqibab
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Maltese: -Artikolu 30 tad-Direttiva 2001/83/KE
English: What is Vepesid?
Maltese: 'inhu Vepesid?
English: What are the conclusions of the CHMP?
Maltese: -konklużjonijiet tas-CHMP?