FrancophonIA/ELRC3.0 huggingface dataset:
English: • In the long-term carcinogenicity study in mice, the highest dose used was 10 mg/kg, which was seen to be genotoxic in the mouse micronucleus study (equivalent to approximately 16-fold the expected human exposure in AUC in patients taking the maximum daily dose of 20 mg cladribine).
Maltese: • Fl-istudju fit-tul dwar il-karċinoġeniċità fil-ġrieden, l-ogħla doża użata kienet ta' 10 mg/kg, li kienet osservata bħala ġenotossika fl-istudju tal-mikronuklei fil-ġrieden (ekwivalenti għal madwar 16-il darba l-esponiment mistenni fil-bniedem fl-AUC f'pazjenti li jieħdu d-doża massima ta' kuljum ta' 20 mg cladribine).
English: The metabolism of cladribine was studied in MS patients following the administration of a single 10-mg tablet and a single 3-mg intravenous dose.
Maltese: Il-metaboliżmu ta' cladribine ġie studjat f'pazjenti b'MS wara l-għoti ta' pillola orali waħda ta' 10 mg u doża waħda ta' 3 mg ġol-vini.
English: Push the tray back into the carton.
Maltese: Imbotta t-trej lura fil-kartuna.
English: How to take your medicine
Maltese: It-tieni ġimgħa ta' trattament
English: There is evidence that cladribine can also cause direct caspase-dependent and -independent apoptosis via the release of cytochrome c and apoptosis-inducing factor into the cytosol of non-dividing cells.
Maltese: Hemm evidenza li cladribine jista' jikkawża wkoll apoptosi diretta dipendenti u indipendenti minn caspase permezz tal-ħruġ taċ-ċitokromju c u fattur li jikkawża l-apoptosi fis-cytosol ta' ċelluli li ma jkunux qed jiddividu.
English: Interruption or delay of MAVENCLAD may be considered until proper resolution of the infection.
Maltese: Interruzzjoni jew ittardjar ta' MAVENCLAD jista' jiġi kkunsidrat sakemm iseħħ fejqan kif suppost tal-infezzjoni.
English: These include: ciclosporin, cyclophosphamide and azathioprine (used to suppress the immune system, for example after organ transplantation); methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis); long-term corticosteroids (used to reduce inflammation, for example in asthma).
Maltese: - ciclosporin, cyclophosphamide u azathioprine, (li jintużaw biex irażżnu s-sistema immuni, pereżempju wara trapjant ta' organu);
English: After oral administration of cladribine across a dose range from 3 to 20 mg, Cmax and AUC increased in a dose-proportional fashion, suggesting that absorption is not affected by rate- or capacity-limited processes up to a 20 mg oral dose.
Maltese: Wara l-għoti mill-ħalq ta' cladribine fuq medda ta' doża minn 3 sa 20 mg, is-Cmax u l-AUC jiżdiedu b'mod proporzjonali mad-doża, u dan jissuġġerixxi li l-assorbiment ma jiġix affettwat minn proċessi li huma limitati mir-rata ta' assorbiment u/jew eliminazzjoni, jew mill-kapaċità tal-passaġġi tal-metabolizmu sa doża orali ta' 20 mg.
English: Table 3 shows how many tablets (1 or 2 tablets) you have to take on each day.
Maltese: Tabella 3 turi kemm pilloli (1 jew 2 pilloli) għandek tieħu f'kull ġurnata.
English: Cladribine has been shown to exert long-lasting effects by preferentially targeting lymphocytes and the autoimmune processes involved in the pathophysiology of MS.
Maltese: Intwera li cladribine jeżerċita effetti li jdumu żmien twil billi jimmira b'mod preferenzjali l-limfoċiti u l-proċessi awtoimmuni involuti fil-patofiżjoloġija ta' MS.
English: Carcinogenicity
Maltese: Karċinoġeneċità
English: Lymphopenia and shingles
Maltese: TA' KIF JINGĦATA
English: Non-clinical safety pharmacological and toxicological assessment of cladribine in animal models relevant for the safety assessment of cladribine did not yield significant findings other than those predicted by the pharmacologic mechanism of cladribine.
Maltese: Valutazzjoni mhux klinika tas-sigurtà farmakoloġika u tossikoloġika ta' cladribine f'mudelli ta' annimali rilevanti għall-valutazzjoni tas-sigurtà ta' cladribine ma wrietx sejbiet sinifikanti minbarra dawk imbassra mill-mekkaniżmu farmakoloġiku ta' cladribine.
English: Renal clearance exceeded the glomerular filtration rate, indicating active renal tubular secretion of cladribine.
Maltese: Madankollu, l-effetti netti f'termini ta' tibdil potenzjali fl-esponiment għal cladribine huma diffiċli biex jiġu mbassra.
English: See package leaflet for guidance.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: th percentile for disability progression was reached between 16 and 23 weeks, while for the cladribine groups it was not reached during the entire study.
Maltese: Għall-plaċebo l-10 perċentil għallprogressjoni tad-diżabilità intlaħaq bejn ġimgħa 16 u 23, filwaqt li għall-gruppi ta' cladribine ma ntlaħaqx matul l-istudju kollu.
English: The dephosphorylation and deactivation of Cd-AMP is catalysed by cytoplasmic 5'-NTase.
Maltese: Id-dephosphorylation u d-diżattivazzjoni ta' Cd-AMP huma kkatalizzati minn 5'-NTase taċ-ċitoplażma.
English: Although cladribine may have a potential for genotoxicity, long-term data in mice and monkeys did not provide any evidence of a relevant increased carcinogenicity risk in humans.
Maltese: Għalkemm cladribine jista' jkollu potenzjal ta' ġenotossiċità, data minn perjodu ta' żmien twil filġrieden u x-xadini ma tat l-ebda evidenza ta' żieda rilevanti fir-riskju ta' karċinoġeniċità fil-bnedmin.
English: How to store MAVENCLAD
Maltese: X'fih MAVENCLAD
English: PHARMACOLOGICAL PROPERTIES
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: In vitro studies indicate that cladribine efflux is only minimally P-gp related.
Maltese: Studji in vitro jindikaw li l-effluss ta' cladribine huwa relatat ma' P-gp b'mod minimu biss.
English: The full EPAR for Nemdatine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 04-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 04-2013.
English: Nemdatine is available as 5 mg, 10 mg, 15 mg and 20 mg tablets and can only be obtained with a prescription.
Maltese: Nemdatine jiġi f'pilloli ta' 5 mg, 10 mg, 15 mg u 20 mg u jista jinkiseb biss b'riċetta ta' tabib.
English: It contains the active substance memantine.
Maltese: Dan fih is-sustanza attiva memantina.
English: This is a summary of the European public assessment report (EPAR) for Nemdatine.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nemdatine.
English: The active substance in Nemdatine, memantine, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Nemdatine, il-memantina, hija mediċina kontra d-dimenza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nemdatine on 22 April 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nemdatine fit-22 ta' April 2013.
English: This means that Nemdatine is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Maltese: Dan ifisser li Nemdatine huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Ebixa.
English: Nemdatine memantine
Maltese: Kif jintuża Nemdatine?
English: Nemdatine is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Maltese: Nemdatine huwa mediċina li tintuża għat-trattament ta' pazjenti bil-marda ta' Alzheimer moderata sa gravi, tip ta' dimenzja (disturb fil-moħħ) li b'mod gradwali taffettwa l-memorja, il-kapaċità intellettwali u l-imġiba.
English: What are the benefits and risks of Nemdatine?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Nemdatine?
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku memantina
English: Why is Nemdatine approved?
Maltese: Għalxiex ġie approvat Nemdatine?
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Maltese: Billi timblokka r-riċetturi NMDA, il-memantina ttejjeb it-trażmissjoni ta' sinjali fil-moħħ u tnaqqas is-sintomi tal-marda ta' Alzheimer.
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Maltese: In-newrotrażmettituri huma sustanzi kimiċi fis-sistema nervuża li jippermettu liċ-ċelluli tan-nervituri jikkomunikaw ma' xulxin.
English: To prevent side effects, the dose of Nemdatine is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Biex jiġu evitati effetti sekondarji, id-doża ta' Nemdatine tiżdied b'mod gradwali matul l-ewwel tliet ġimgħat tat-trattament: fl-ewwel ġimgħa d-doża tkun 5 mg; fit-tieni ġimgħa titla' għal 10 mg; u fit-tielet ġimgħa ssir 15 mg.
English: Because Nemdatine is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Maltese: Billi Nemdatine huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Ebixa.
English: Because Nemdatine is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Nemdatine huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Maltese: Jista' jeħtieġ li titnaqqas id-doża f'pazjenti li jkollhom problemi moderati jew gravi fil-kliewi.
English: Memantine works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches.
Maltese: NMDA li normalment jeħel magħhom in-newrotrażmettitur glutamat.
English: The Committee recommended that Nemdatine be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Nemdatine ikun approvat għall-użu fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nemdatine has been shown to have comparable quality and to be bioequivalent to Ebixa.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Nemdatine għandu kwalità komparabbli u li huwa bijoekwivalenti għal Ebixa.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Nemdatine, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Nemdatine, fosthom il-prekawzjonijiet xierqa li jridu jkunu segwiti mill-professjonisti fil-kura tas-saħħa u l-pazjenti.
English: How has Nemdatine been studied?
Maltese: Kif ġie studjat Nemdatine?
English: The Prescriber Guide should highlight the following:
Maltese: Il-Gwida li jippreskrivi għandu jenfasizza li ġej:
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Maltese: Qabel l-distribuzzjoni tal-gwida riċetta f'kull Stat Membru, id-detentur tal-awtorizazzjoni għat-tqegħid fis-suq għandu jaqbel dwar ilkontenut u format tal-materjal edukattiv, flimkien ma' pjan ta' komunikazzjoni, l-awtorità kompetenti nazzjonali.
English: • Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
Maltese: • Kriterji ta' l-għażla tal-pazjent li jinkludi Pioglitazone m'għandux jintuża bħala kura primarja u tenfasizza l-ħtieġa għal reviżjoni regolari tal-benefiċċju tat-trattament.
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Maltese: ANNESS KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI
English: • This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Maltese: • Dan il-pakkett edukattiv huwa mmirat biex issaħħaħ l-għarfien ta' riskji importanti identifikati ta' kanċer tal-bużżieqa u insuffiċjenza tal-qalb u r-rakkomandazzjonijiet ġenerali maħsuba biex jottimizzaw il-marġni benefiċċju-riskju fil-livell tal-pazjent.
English: • The risk of heart failure and relevant risk minimisation advice.
Maltese: • Ir-riskju ta' insuffiċjenza tal-qalb u parir rilevanti għat-tnaqqis tar-riskju.
English: • The risk of bladder cancer and relevant risk minimisation advice.
Maltese: • Ir-riskju ta' riskju tal-kanċer tal-bużżieqa u parir rilevanti għat-tnaqqis tar-riskju.
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer,
Maltese: • Kawtela fl-użu fl-anzjani fid-dawl tar-riskji relatati ma' l-età (b'mod partikolari l-kanċer tal bużżieqa, ksur u insuffiċjenza tal-qalb).
English: • The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Maltese: • Il-pakkett edukattiv tabib għandu jkun fih:
English: Package size l t o r
Maltese: 112-il pillola l t o r
English: Packaging
Maltese: Il-pakkett
English: Haemorrhage intracranial d *
Maltese: Emorraġija intrakranjali d *
English: The active substance is cangrelor.
Maltese: Is-sustanza attiva hi cangrelor.
English: 48155 Münster GERMANY
Maltese: 48155 Münster
English: Cytochrome P450 (CYP)
Maltese: Ċitokrom P450 (CYP)
English: Acetylsalicylic acid, heparin, nitrogycerin
Maltese: Acetylsalicylic acid, eparina, nitrogycerin
English: Death/MI/IDR/ST
Maltese: Mewt/MI/IDR/ST
English: Moderate
Maltese: Moderat
English: Chiesi Bulgaria EOOD Teл.
Maltese: Chiesi Bulgaria EOOD
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: In vitro inhibition of BCRP by the metabolite ARC-69712XX at clinically relevant concentrations has been observed.
Maltese: Ġiet osservata inibizzjoni in vitro ta' BCRP mill-metabolit ARC-69712XX f'konċentrazzjonijiet klinikament rilevanti.
English: Sorbitol is a source of fructose.
Maltese: Sorbitol huwa sors ta' fructose.
English: Rash, pruritus, urticaria f
Maltese: Raxx, ħakk, urtikarja f
English: OR = odds ratio; CI = confidence interval; IDR = ischaemia-driven revascularisation; MI = myocardial infarction; mITT = modified intent-to-treat; ST = stent thrombosis.
Maltese: IDR (ischaemia-driven revascularisation) = vaskularizzazzjoni mill-ġdid xprunata minn iskemija; MI (myocardial infarction) = infart mijokardijaku; mITT (modified intent-to-treat) = modifikat b'intenzjoni li jikkura; ST (stent thrombosis) = trombożi tal-istent.
English: Adverse reactions are classified according to frequency and system organ class.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-frekwenza u s-sistema talklassifika tal-organi.
English: Date of first authorisation: 23 March 2015 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Marzu 2015
English: The median duration of cangrelor infusion was 129 minutes.
Maltese: Ilmedjan tat-tul ta' żmien tal-infużjoni ta' cangrelor kien ta' 129 minuta.
English: Kengrexal contains sodium and sorbitol
Maltese: Kengrexal fih sodium u sorbitol
English: • rash, pruritus, urticaria,
Maltese: • raxx, ħakk, urtikarja,
English: Bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors
Maltese: Bivalirudin, eparina ta' piż molekulari baxx, fondaparinux, u inibituri ta' GP IIb/IIIa
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku.
English: Breast cancer resistance protein (BCRP)
Maltese: Proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein)
English: Cangrelor has a volume of distribution of 3.9 L. Cangrelor is 97-98% plasma-protein bound.
Maltese: Cangrelor jeħel f'ammont ta' 97-98% malproteini tal-plażma.
English: Haematoma >5 cm
Maltese: Ematoma >5 ċm
English: • 4 micrograms per kilogram body weight per minute by infusion (drip), for at least 2 hours.
Maltese: • 4 mikrogrammi għal kull kilogramm ta' piż tal-ġisem kull minuta (dripp), għal mill-inqas sagħtejn.
English: Mild a
Maltese: Ħafif a
English: Mild w/o ecchymosis, oozing and haematoma <5 cm 707 (5.6) Patients with any transfusion
Maltese: Ħafif w/o ekkimożi, tnixxija u ematoma ta' <5 ċm 707 (5.6) Pazjenti bi kwalunkwe trasfużjoni
English: Impairment of fertility
Maltese: Indeboliment tal-fertilità
English: Paediatric population Cangrelor has not been evaluated in a paediatric population (see sections 4.2 and 5.1).
Maltese: Cangrelor ma ġiex evalwat fil-popolazzjoni pedjatrika (ara sezzjonijiet 4.2 u 5.1).
English: Menorrhagia, penile haemorrhage
Maltese: Menorraġija, emorraġija mill pene
English: Kengrexal is available in packs of 10 vials.
Maltese: Kengrexal hu disponibbli f'pakketti ta' 10 kunjetti.
English: ** Transfusion was uncommon 101/12,565 (0.8%).
Maltese: * Jinkludi avvenimenti b'riżultat fatali. ** It-trasfużjoni kienet mhux komuni 101/12,565 (0.8%).
English: Nervous system disorders
Maltese: Disturbi fis sistema nervuża
English: Significant reductions in death/MI/IDR/ST and ST observed in the cangrelor group at 48 hours were maintained at 30 days (Table 4).
Maltese: Tnaqqis sinifikanti f'mewt/MI/IDR/ST u ST osservat fil-grupp ta' cangrelor wara 48 siegħa nżamm wara 30 jum (Tabella 4).
English: In CHAMPION PHOENIX, cangrelor significantly reduced (relative risk reduction 22%; absolute risk reduction 1.2%) the primary composite endpoint of all-cause mortality, MI, IDR, and ST compared to clopidogrel at 48 hours (Table 3).
Maltese: F'CHAMPION PHOENIX, cangrelor naqqas b'mod sinifikanti (tnaqqis tar-riskju relattiv 22%; tnaqqis tar-riskju assolut 1.2%) il-punt aħħari tal-kompost primarju tal-mortalità mill-kawżi kollha, MI, IDR, u ST meta mqabbla ma' clopidogrel wara 48 siegħa (Tabella 3).
English: Chiesi Pharma AB Tlf: +46 8 753 35 20
Maltese: Tlf: +46 8 753 35 20
English: Fructose intolerance
Maltese: Intolleranza għal fructose
English: Cangrelor is contraindicated in patients with any history of stroke/TIA, (see sections 4.3 and 4.8).
Maltese: Cangrelor hu kontraindikat f'pazjenti bi kwalunkwe storja medika ta' puplesija/TIA, (ara sezzjonijiet 4.3 u 4.8).
English: Other medicines and Kengrexal
Maltese: Mediċini oħra u Kengrexal
English: The pharmacokinetic/pharmacodynamic (PK/PD) effect of cangrelor is maintained consistently for the duration of the infusion.
Maltese: L-effett farmakokinetiku/farmakodinamiku (PK/PD) ta' cangrelor jinżamm b'mod konsistenti għat-tul taż żmien tal-infużjoni.
English: • Any history of stroke or transient ischaemic attack (TIA).
Maltese: • Kwalunkwe storja medika ta' puplesija jew attakk iskemiku transitorju (TIA - transient ischaemic attack).
English: Patients with coronary atherosclerosis were included who required PCI for stable angina (58%), non-ST-segment elevation acute coronary syndrome (NSTE-ACS) (26%), or ST-elevation myocardial infraction (STEMI) (16%).
Maltese: Pazjenti b'aterosklerożi koronarja ġew inklużi, li kienu jeħtieġu PCI għal anġina stabbli (58%), sindrome koronarju akut b'żieda tas-segment mhux ST (NSTE-ACS - non-ST-segment elevation acute coronary syndrome) (26%), infart mijokardijaku b'żieda fl-ST (STEMI - ST-elevation myocardial infraction) (16%).
English: The mean steady state concentration of cangrelor during a constant intravenous infusion of 4 micrograms/kg/min is 488 ng/mL.
Maltese: Il-medja talkonċentrazzjoni fl-istat fiss ta' cangrelor matul infużjoni kostanti ġol-vini ta' 4 mikrogrammi/kg/min hi ta' 488 ng/mL.
English: After dilution 1 mL contains 200 micrograms cangrelor.
Maltese: Wara d-dilwizzjoni, 1 mL ikun fih 200 mikrogramma ta' cangrelor.
English: In patients undergoing PCI, standard procedural adjunctive therapy should be implemented (see section 5.1).
Maltese: F'pazjenti li tkun qed issirilhom PCI, terapija addizzjonali standard proċedurali għandha tiġi implimentata (ara sezzjoni 5.1).
English: Haematocrit decreased, haemoglobin decreased**
Maltese: Investigazzjonijiet Tnaqqis flematokrit, tnaqqis flemoglobina**
English: A higher rate of serious cases of hypersensitivity were recorded with cangrelor (0.05%) than with control (0.007%).
Maltese: Rata ogħla ta' każijiet serji ta' sensittività eċċessiva ġiet irrekordjata b'cangrelor (0.05%) milli bil-kontroll (0.007%).
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(jiet) farmakokinetika(ċi)/farmakodinamika(ċi)
English: Kengrexal is an anti-platelet medicine that contains the active substance cangrelor.
Maltese: Kengrexal hu mediċina kontra l-plejtlits li fih is-sustanza attiva cangrelor.
English: Sodium hydroxide (for pH-adjustment)
Maltese: Sodium hydroxide (għal aġġustament tal-pH)
English: The primary clinical evidence for the efficacy of cangrelor is derived from CHAMPION PHOENIX, a randomised, double-blind study comparing cangrelor (n=5,472) to clopidogrel (n=5,470), both given in combination with aspirin and other standard therapy, including unfractionated heparin (78%), bivalirudin (23%), LMWH (14%) or fondaparinux (2.7%).
Maltese: clopidogrel (n=5,470), li t-tnejn ingħataw flimkien ma' aspirina u terapija oħra standard, li tinkludi eparina mhux frazzjonata (78%), bivalirudin (23%), LMWH (14%) jew fondaparinux (2.7%).
English: Cangrelor has a half-life of three to six minutes.
Maltese: Cangrelor għandu half-life ta' minn tlieta sa sitt minuti.
English: Erythema, rash erythematous, rash pruritic.
Maltese: Eritema, raxx eritematuż, raxx pruritiku.
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
English: In clinical studies, cangrelor has been co-administered with bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors (abciximab, eptifibatide, tirofiban) with no apparent effect upon the pharmacokinetics or pharmacodynamics of cangrelor.
Maltese: fondaparinux, u inibituri ta' GP IIb/IIIa (abciximab, eptifibatide, tirofiban) bla ebda effett apparenti fuq il-farmakokinetika jew il-farmakodinamika ta' cangrelor.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Retroperitoneal haemorrhage,* peritoneal haematoma, gastrointestinal haemorrhage a
Maltese: Emorraġija retroperitonali,* ematoma peritoneali,
English: IDR a p-values based on Chi-squared test.
Maltese: a valuri p ibbażati fuq test Chi-squared.
English: Each vial contains 50 mg cangrelor.
Maltese: Kull kunjett fih 50 mg ta' cangrelor.
English: Table 4:
Maltese: Teл.:
English: Cangrelor exhibits inhibition of activation and aggregation of platelets as shown by aggregometry (light transmission and impedance), point-of care assays, such as the VerifyNow P2Y12test, VASP-P and flow cytometry.
Maltese: Cangrelor juri inibizzjoni ta' attivazzjoni u aggregazzjoni tal-plejtlits kif muri minn aggregometrija (trasmissjoni u impedenza tad-dawl), assaġġi tal-punt ta' kura, bħat-test VerifyNow P2Y12, VASP-P u ċitometrija tal-fluss.
English: Pelvic haemorrhage
Maltese: Emorraġija pelvika