FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Orgalutran if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section6); if you are hypersensitive to gonadotrophin releasing hormone (GnRH) ora GnRH analogue; if you have a moderate or severe kidney or liver disease; if you are pregnant or breast-feeding.
Maltese: Tiħux Orgalutran - jekk inti allerġiku għal ganirelix jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6); - jekk inti tbati minn sensittività eċċessiva għall-ormon li jeħles il-gonadotrophin (GnRH) jew sustanza li tixbah il-GnRH; - jekk inti tbati minn indeboliment moderat jew serju fil-ħidma tal-kliewi jew tal-fwied; - jekk inti tqila jew qed tredda'.
English: Initiation of Orgalutran treatment on day 5 can prevent these premature LH rises without compromising the clinical outcome.
Maltese: Il-bidu tal-kura b'Orgalutran f jum 5 jista' jipprevjeni dawn iż-żidiet prematuri ta' LH mingħajr ma jikkomprometti r-riżultat kliniku.
English: The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 L/h.
Maltese: Il-half life tal-eliminazzjoni (t½) hija madwar 13-il siegħa u t-tneħħija hija madwar 2.4
English: The adverse reactions with Orgalutran using corifollitropin alfa for ovarian stimulation are expected to be similar.
Maltese: Ir-reazzjonijiet avversi b'Orgalutran blużu ta' corifollitropin alfa għall-istimulazzjoni tal-ovarji huma mistennija li jkunu simili.
English: In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 5 days.
Maltese: F' pazjenti li qed jingħataw stimulazzjoni kkontrollata ovarjana il-perijodu medjan tat-trattament b' Orgalutran kien ta' 5 t'ijiem.
English: Orgalutran (0.25 mg) should be injected just under the skin once daily, starting on day 5 or day 6 of stimulation.
Maltese: Orgalutran (0.25 mg) għandu jiġi injettat sewwasew taħt il-ġilda, darba kuljum, jibda fil-5 jew fis-6 jum ta' stimulazzjoni.
English: How to use Orgalutran
Maltese: Mediċini oħra u Orgalutran
English: Each pre-filled syringe is affixed with a needle closed by a needle cover of dry natural rubber/latex which comes into contact with the needle.
Maltese: Kull siringa mimlija lesta, għanda labra li hija magħluqa b'għatu tal-labra magħmul minn gomma naturali mnixxfa/latex li jiġi f'kuntatt mal-labra.
English: Mannitol;
Maltese: Treddigħ
English: In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12 % in Orgalutran treated patients and 25 % in patients treated subcutaneously with a GnRH agonist.
Maltese: Fi studji kliniċi, siegħa wara l-injezzjoni, l-inċidenza ta' mill-inqas reazzjoni lokali waħda moderata jew severa fil-ġilda f'kull ċiklu ta' trattament, kif ġie rrappurtat mill-pazjenti, kienet ta' 12 %
English: Orgalutran is used for
Maltese: Orgalutran jintuża għal
English: Allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips tongue, and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis) have been reported.
Maltese: Ġew irrappurtati reazzjonijiet allerġiċi, kemm mifruxa kif ukoll lokali, inklużi ħorriqija (urtikarja), nefħa fil-wiċċ, fix-xofftejn, fl-ilsien u/jew fil-gerżuma li jistgħu jikkawżaw diffikultà bit-teħid tan-nifs u/jew biex tibla' (anġjoedima u/jew anafilassi).
English: No data on acute toxicity of Orgalutran in humans are available.
Maltese: M' hemmx informazzjoni dwar tossiċità akuta ta' Orgalutran fil-bniedem.
English: In acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg, respectively.
Maltese: Dawn l-effetti kienu osservati biss meta ngħatat injezzjoni ġol-vini ta' ganirelix, b'doża ta' aktar minn 1 u 3 mg/kg rispettivament.
English: If this happens, do not inject Orgalutran, but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two.
Maltese: Jekk jiġri dan, tinjettax Orgalutran, imma neħħi s-siringa, kopri s-sit tat-tilqima b'msiħ li fih hemm id-diżinfettant u applika l-pressjoni; Iddemm għandu jieqaf joħroġ wara minuta jew tnejn.
English: 1, D-pClPhe
Maltese: • Nefħa fil-wiċċ
English: Uncommon: may affect up to 1 in 100 women Headache
Maltese: Mhux komuni: jistgħu jaffettwaw sa mara waħda minn kull 100 Uġigħ ta' ras
English: The chance of having a side effect is described by the following categories:
Maltese: Iċ-ċans li inti jkollok effett skondarju huwa deskritt permezz tal-kategoriji li ġejjin:
English: The incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions.
Maltese: L-inċidenza ta' malformazzjonijiet konġenitali wara t-tekniċi tar-riproduzzjoni assistita għandha mnejn tkun kemm kemm ogħla wara konċepiment spontanju.
English: Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART).
Maltese: Orgalutran għandu jintuża matul l-istimulazzjoni kkontrollata ovarjana fil-każ tat-tekniċi tarriproduzzjoni assistita (ART).
English: Tel: + 386 1 5204201 msd.slovenia@merck.com
Maltese: Tel: + 421 2 58282010 dpoc_czechslovak@merck.com
English: Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG).
Maltese: Il-maturazzjoni finali taċ-ċelluli tal-bajd fil-follikuli tista' tiġi kkaġunata billi tingħata lchorionic gonadotrophin tal-bniedem (hCG).
English: Disposable pre-filled syringes (siliconised type I glass), containing 0.5 mL of sterile, ready for use, aqueous solution closed with a rubber piston that does not contain latex.
Maltese: Siringi li jintużaw u jistgħu jintremew mimlijin lesti, (ħġieġ silikonizzat tip I), li fihom 0.5 mL soluzzjon ta' l-ilma li hi sterili u lesta biex tintuża magħluqa b' pistun tal-gomma li ma fihx latex.
English: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tel/Tél: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: 6, L-hArg(Et2)
Maltese: Il-pH (kejl tal-aċidità)
English: Merck Sharp & Dohme (Sweden) AB Tel: + 46 77570 04 88 medicinskinfo@merck.com
Maltese: Tel: + 46 77570 04 88 medicinskinfo@merck.com
English: Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased.
Maltese: Billi nisa infertili li jkunu qegħdin fuq programm ta' riproduzzjoni assistita, u partikolarment fertilizzazzjoni in vitro (IVF), ta' spiss ikollhom anormalitajiet fit-tubi, l-inċidenza ta' tqalat ektopiċi tista' tiżdid.
English: After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach peak levels (Cmax) of approximately 15 ng/mL within 1 to 2 hours (tmax).
Maltese: Wara l-għoti ta' doża waħda ta' 0.25 mg taħt il-ġilda, il-livelli ta' ganirelix fis-serum jogħlew malajr u jilħqu l-ogħla livelli (Cmax) ta' madwar 15 ng/mL fi żmien siegħa sa sagħtejn (tmax).
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: + 421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201 msd.slovenia@merck.com
English: The metabolites are small peptide fragments formed by enzymatic hydrolysis of ganirelix at restricted sites.
Maltese: Il-metaboliti huma biċċiet żgħar ta' peptidi ffurmati wara l-idrolosi enżimatika fuq il-ganirelix f' siti ristretti.
English: FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see section 5.1).
Maltese: Laġġustamenti tad-doża ta' FSH għandhom jiddependu fuq in-numru u d-daqs tal-follikuli li jkunu qed jiżviluppaw, milli fuq il-livell ta' oestradiol li jiċċirkola (ara sezzjoni 5.1).
English: 5340 BH Oss, The Netherlands.
Maltese: Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, L-Olanda.
English: Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) were similar to those after a single subcutaneous dose.
Maltese: Il-parametri farmakokinetiċi wara ħafna dożi ta' Orgalutran taħt il-ġilda (injezzjoni darba kuljum) kienu simili għal dawk wara doża waħda taħt il-ġilda.
English: Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic adverse reactions.
Maltese: Meta doża waħda ta' Orgalutran ingħatat taħt il-ġilda waqt studji kliniċi, nstab li ma kien hemm l-ebda reazzjonijiet avversi sistemiċi, sakemm d-doża laħqet it-12 mg.
English: • Swelling of face, lips, tongue, and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis)
Maltese: • Nefħa fil-wiċċ, fix-xofftejn, fl-ilsien, u/jew fil-gerżuma li jistgħu jikkawżaw diffikultà biex tieħu n-nifs u/jew biex tibla' (anġjoedima u/jew anafilassi)
English: The major circulating component in plasma is ganirelix.
Maltese: Il-komponent ewlieni li jiċċirkola fil-plażma huwa l-ganirelix.
English: Controlled ovarian hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses.
Maltese: L-istimulazzjoni eċċessiva kkontrollata ta' l-ovarji permezz tal-FSH jew corifollitropin alfa, tista' tibda fit-2 jew 3 jum tal-mestrwu.
English: Orgalutran is available in packs of 1 or 5 pre-filled syringes.
Maltese: Orgalutran jista' jinkiseb f pakketti ta' 1 jew 5 siringi mimlijin lesti.
English: OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
Maltese: L-OHSS għandha tiġi ttrattata skond is-sintomi tal-pazjent, eż. b'serħan, infużjoni ġol-vina ta' soluzzjonijiet jew colloids ta' l-elettroliti u eparina.
English: • For emergency surgery/urgent procedures
Maltese: • Għal kirurġija ta' emerġenza/proċeduri urġenti
English: Thromboembolic Events
Maltese: Episodji Tromboemboliċi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru 2015
English: 4 factor), activated PCCs (aPCCs) and recombinant factor VIIa.
Maltese: fattur 3 u fattur 4), PCCs attivati (aPCCs) u fattur VIIa rikombinanti.
English: D-88397 Biberach an der Riss Germany
Maltese: D-88397 Biberach an der Riss Il-Ġermanja
English: RE-VERSE AD included data for 503 patients: 301 patients with serious bleeding (Group A) and 202 patients requiring an urgent procedure/surgery (Group B).
Maltese: RE-VERSE AD inkludiet dejta għal 503 pazjenti: 301 pazjent bi fsada serja (Grupp A) u 202 pazjenti li kellhom bżonn proċedura/kirurġija urġenti (Grupp B).
English: Immunogenicity
Maltese: Immunoġeniċita
English: Idarucizumab was rapidly eliminated with a total clearance of 47.0 mL/min (gCV 18.4 %), an initial half-life of 47 minutes (gCV 11.4 %) and a terminal half-life of 10.3 h (gCV 18.9 %).
Maltese: mL/min (gCV 18.4%), half-life inizjali ta' 47 minuta (gCV 11.4%) u half-life terminali ta' 10.3 h (gCV 18.9%).
English: Pack size of 2 vials.
Maltese: Daqs tal-pakkett ta' 2 kunjetti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1056/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1056/001
English: Hereditary fructose intolerance
Maltese: Intolleranza ereditarja għall-fruttożju
English: It will not reverse the effects of other anticoagulants (see section 5.1).
Maltese: Ma jaqlibx lura l-effetti ta' antikoagulanti oħrajn (ara sezzjoni 5.1).
English: • other anticoagulants (e.g. thrombin inhibitors other than dabigatran, Factor Xa inhibitors including low-molecular weight heparin, vitamin K-antagonists, heparin).
Maltese: • antikoagulanti oħrajn (eż. inibituri tat-thrombin għajr dabigatran, inibituri tal-Fattur Xa inkluż eparina ta' piż molekulari baxx, antagonisiti tal-vitamina K, eparina).
English: Based on pharmacokinetic data from 347 patients with different degrees of renal function (median creatinine clearance 21 - 99 mL/min) it is estimated that mean idarucizumab exposure (AUC0-24h) increases by 38% in patients with mild (CrCl 50-<80 mL/min), by 90% in moderate (30-<50 mL/min) and by 146% in severe (0-<30 mL/min) renal impairment.
Maltese: Abbażi tad-dejta farmakokinetika minn 347 pazjent bi gradi differenti tal-funzjoni renali (eliminazzjoni medjana tal-kreatinina 21 - 99 mL/min) huwa stmat li l-esponiment medju għal idarucizumab (AUC0 - 24 h) jiżdied bi 38% f'pazjenti b'indeboliment tal-kliewi ħafif (CrCl 50-<80 mL/min), b'90% f'pazjenti b'indeboliment tal-kliewi moderat (30-<50 mL/min) u b'146% f'pazjenti b'indeboliment tal-kliewi sever (0-<30 mL/min).
English: Each 50 mL vial contains 2 g sorbitol and 25 mg sodium (see section 4.4).
Maltese: Kull kunjett ta' 50 mL fih 2 g sorbitol u 25 mg sodju (ara sezzjoni 4.4).
English: Pre-existing antibodies with cross-reactivity to idarucizumab were detected in approximately 12 % (33/283) of the phase I subjects and 3.8% (19/501) of the patients.
Maltese: Antikorpi pre-eżistenti b'reattività inkroċjata għal idarucizumab ġew rilevati f'madwar 12% (33/283) tas-suġġetti ta' Fażi I u fi 3.8% (19/501) tal-pazjenti.
English: Compared to 272 patients without hepatic impairment, the median AUC of idarucizumab was changed by -6%, 37% and 10% in patients with AST/ALT elevations of 1 to <2x ULN (N=34), 2 to <3x ULN (N=3) and >3x ULN (N=21), respectively.
Maltese: Meta mqabbla ma' 272 pazjent mingħajr indeboliment tal-fwied, l-AUC medjana ta' idarucizumab ġiet mibdula b'-6%, 37% u 10% f'pazjenti b'żidiet f'AST/ALT ta' 1 sa <2x ULN (N=34), 2 sa <3x ULN (N=3) u >3x ULN (N=21), rispettivament.
English: • volume expanders.
Maltese: • aġenti tal-espansjoni tal-volum.
English: Dabigatran exerts pronounced effects on parameters of the endogenous thrombin potential (ETP).
Maltese: Dabigatran jeżerċita effetti li jinħassu fuq il-parameteri tal-potenzjal ta' thrombin endoġenu (ETP).
English: The recommended dose of Praxbind contains 4 g sorbitol as an excipient.
Maltese: Id-doża rakkomandata ta' Praxbind hija 4 g sorbitol bħala eċċipjent.
English: Urinary protein testing
Maltese: Prova tal-proteini fl-awrina
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB37
Maltese: Kategorija farmakoterapewtika: prodotti terapewtiċi l-oħra kollha, antidoti, Kodiċi ATC:
English: In Phase I studies Praxbind has been investigated in subjects with a creatinine clearance ranging from 44 to 213 mL/min.
Maltese: Fi studji ta' Fażi I, Praxbind ġie investigat f'suġġetti b'eliminazzjoni tal-kreatinina li tvarja minn 44 sa 213 mL/min.
English: In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death.
Maltese: F'pazjenti b'intolleranza ereditarja għall-fruttożju, l-għoti parenterali ta' sorbitol ġie assoċjat ma' rapporti ta' ipogliċemija, ipofosfatemija, aċidożi metabolika, żieda fl-aċidu uriku, indeboliment akut tal-fwied bi tkissir tal-funzjoni ta' eskrezzjoni u sintetika, u mewt.
English: Treatment-emergent possibly persistent anti-idarucizumab antibodies with low titers were observed in 4 % (10/224) of the phase I subjects and 1.6% (8/501) of the patients suggesting a low immunogenic potential of idarucizumab.
Maltese: Antikorpi anti-idarucizumab possibbilment persistenti li jfeġġu wara l-kura b'titers baxxi ġew osservati f'4% (10/224) tas-suġġetti ta' Fażi I u f'1.6% (8/501) tal-pazjenti, u dan jissuġġerixxi potenzjal immunoġeniku baxx ta' idarucizumab.
English: The transient proteinuria usually peaked about 4 h after idarucizumab administration and normalised within 12-24 hours.
Maltese: Il-proteinurja temporanja normalment laħqet il-massimu wara 4 sigħat wara l-għoti ta' idarucizumab u nnormalizzat ruħha fi żmien 12-24 siegħa.
English: • The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL)
Maltese: • Id-doża rakkomandata ta' Praxbind hija 5 g (2 x 2.5 g/50 mL).
English: Boehringer Ingelheim RCV GmbH & Co KG Viena-Sucursala Bucuresti Tel: +40 21 302 2800
Maltese: KG Viena-Sucursala Bucuresti Tel: +40 21 302 2800
English: Following the intravenous infusion of a 5 g dose, the geometric mean volume of distribution at steady state (Vss) was 8.9 L (geometric coefficient of variation (gCV) 24.8 %).
Maltese: Wara l-infużjoni ġol-vini ta' doża ta' 5 g, il-volum medju ġeometriku ta' distribuzzjoni fi stat fiss (Vss) kien ta' 8.9 L (il-koeffiċjent ġeometriku tal-varjazzjoni kien (gCV) 24.8%).
English: Representative values for pharmacokinetic and pharmacodynamics parameters were established on the basis of healthy subjects aged 45-64 years receiving 5 g idarucizumab (see sections 5.1 and 5.2).
Maltese: Valuri rappreżentattivi għall-parametri farmakokinetiċi u farmakodinamiċi ġew stabbiliti fuq il-bażi ta' suġġetti b'saħħithom ta' bejn 45-64 sena li kienu qed jirċievu 5 g idarucizumab (ara sezzjonijiet 5.1 u 5.2).
English: Mild symptoms of potential hypersensitivity (pyrexia, bronchospasm, hyperventilation, rash or pruritus) were reported.
Maltese: Ġew irrapportati sintomi ħfief ta' sensittivita eċċessiva potenzjali (deni, bronkospażmu, iperventilazzjoni, raxx jew prurite).
English: 6.1 List of excipients sodium acetate trihydrate acetic acid sorbitol polysorbate 20 water for injection
Maltese: 6.1 Lista ta' eċċipjenti triidrat tal-aċetat tas-sodju aċidu tal-aċetat sorbitol polisorbat 20 ilma għall-injezzjoni
English: Safety pharmacology studies have demonstrated no effects on the respiratory, central nervous or cardiovascular system.
Maltese: Studji ta' sigurtà farmakoloġika ma wrew ebda effett fuq is-sistema respiratorja, nervuża ċentrali jew kardjovaskulari.
English: In single cases the transient proteinuria persisted for more than 24 hours.
Maltese: F'każijiet singoli, il-proteinurja temporanja ppersistiet għal aktar minn 24 siegħa.
English: The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL).
Maltese: Id-doża rakkomandata ta' Praxbind hija 5 g (2 x 2.5 g/50 mL).
English: NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion Idarucizumab
Maltese: Praxbind 2.5 g/50 mL soluzzjoni għal injezzjoni/infużjoni Idarucizumab
English: Praxbind is for single-use only and does not contain preservatives (see section 6.3).
Maltese: Praxbind huwa għal użu ta' darba biss u ma fihx preservattivi (ara sezzjoni 6.3).
English: Older people/Sex/Race
Maltese: Anzjani/Sess/Razza
English: Serum samples from 283 subjects in phase I trials (224 volunteers treated with idarucizumab) and 501 patients were tested for antibodies to idarucizumab before and after treatment.
Maltese: Kampjuni ta' serum minn 283 suġġett fi provi ta' Fażi I (224 voluntier ikkurati b'idarucizumab) u 501 pazjent ġew ittestjati għal antikorpi għal idarucizumab qabel u wara l-kura.
English: One prospective, open-label, non-randomized, uncontrolled study (RE-VERSE AD) was conducted to investigate the treatment of adult patients who presented with dabigatran-related life-threatening or uncontrolled bleeding (Group A) or who required emergency surgery or urgent procedures (Group B).
Maltese: Twettaq studju wieħed, kontinwu prospettiv, bit-tikketta mikxufa, mhux randomizzat u mhux ikkontrollat (RE-VERSE AD) sabiex jinvestiga l-kura ta' pazjenti adulti li ġew bi fsada ta' theddida għall-ħajja jew mhux ikkontrollata relatata ma' dabigatran (Grupp A) jew li kellhom bżonn ta' kirurġija ta' emerġenza jew proċeduri urġenti (Grupp B).
English: Handling instructions:
Maltese: Eċċipjenti:
English: Praxbind causes transient proteinuria as a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously (see section 5.2).
Maltese: Praxbind jikkawża proteinurja temporanja bħala reazzjoni fiżjoloġika għal fluss eċċessiv ta' proteina fil-kliewi wara applikazzjoni bolus/għal żmien qasir ta' 5 g idarucizumab mogħti ġol-vini (ara sezzjoni 5.2).
English: The idarucizumab formulation did not produce haemolysis of human whole blood in vitro.
Maltese: Il-formulazzjoni ta' idarucizumab ma pproduċietx emoliżi tad-demm sħiħ uman in vitro.
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see section 5.1).
Maltese: Il-parametri ta' koagulazzjoni relevanti huma l-Ħin tat-Thromboplastin Parzjali Attivat (aPTTactivated Partial Thromboplastin Time), il-Ħin ta' Thrombin dilwit (dTT - diluted Thrombin Time), jew il-Ħin ta' Koagulazzjoni tal-Ecarin (ECT - Ecarin Clotting Time) (ara sezzjoni 5.1).
English: It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity, approximately 300-fold more potent than the binding affinity of dabigatran for thrombin.
Maltese: Huwa framment ta' antikorp monoklonali umanizzat (Fab) li jeħel ma' dabigatran b'affinita għolja ħafna, madwar 300 darba aktar qawwi mill-affinita ta' twaħħil ta' dabigatran għal thrombin.
English: The line must be flushed with sodium chloride 9 mg/ml (0.9 %) solution for injection prior to and at the end of infusion.
Maltese: Il-linja għandha tiġi flaxxjata bi kloror tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni qabel u wara li tintemm l-infużjoni.
English: Thrombin generation parameters
Maltese: Parametri ta' ġenerazzjoni ta' thrombin
English: After intravenous administration of 5 g idarucizumab, 32.1 % (gCV 60.0 %) of the dose was recovered in urine within a collection period of 6 hours and less than 1 % in the following 18 hours.
Maltese: Wara għoti ġol-vini ta' 5 g idarucizumab, 32.1% (gCV 60.0%) tad-doża ġiet rkuprata fl-awrina fi żmien perjodu ta' kollezzjoni ta' 6 sigħat u inqas minn 1% fit-18-il siegħa sussegwenti.
English: Praxbind (2x2.5 g/50 mL) is administered intravenously, as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
Maltese: Praxbind (2 x 2.5 g/50 mL) jingħata ġol-vini, bħala żewġ infużjonijiet konsekuttivi għal 5 sa 10 minuti kull waħda jew bħala injezzjoni bolus.
English: Three randomised, double-blind, placebo-controlled Phase I studies in 283 subjects (224 treated with idarucizumab) were conducted to assess the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of idarucizumab, given alone or after administration of dabigatran etexilate.
Maltese: Saru tliet studji ta' Fażi I randomizzati, double-blind, ikkontrollati bi plaċebo f'283 suġġett (224 ikkurati b'idarucizumab) biex jiġu vvalutati s-sigurtà, l-effikaċja u t-tollerabilita, il-farmakokinetika u l-farmakodinamika ta' idarucizumab, mogħti waħdu jew wara l-għoti ta' etessilat tad-dabigatran.
English: Thus idarucizumab will not reverse the effects of other anticoagulants.
Maltese: Ma jaqblibx lura l-effetti ta' antikoagulanti oħrajn.
English: Most patients in both Groups A and B, achieved complete reversal of the anticoagulant effect of dabigatran (dTT: 98.7%; ECT: 82.2%; aPTT: 92.5% of evaluable patients, respectively) in the first 4 hours after administration of 5 g idarucizumab.
Maltese: Ħafna mill-pazjenti kemm fil-Grupp A kif ukoll fil-Grupp B, laħqu qlib lura komplet tal-effett antikoagulanti ta' dabigatran (dTT: 98.7%; ECT: 82.2%; aPTT:
English: Dabigatran prolongs the clotting time of coagulation markers such as diluted Thrombin Time (dTT), Thrombin Time (TT), activated Partial Thromboplastin Time (aPTT) and Ecarin Clotting Time (ECT), which provide an approximate indication of the anticoagulation intensity.
Maltese: Dabigatran itawwal il-ħin ta' koagulazzjoni tal-markaturi tal-koagulazzjoni bħall-Ħin ta' Thrombin dilwit (dTT), Ħin ta' Thrombin (TT), Ħin tat-Thromboplastin Parzjali Attivat (aPTT) u Ħin ta' Koagulazzjoni Ecarin (ECT), li jipprovdu indikazzjoni approssimattiva tal-intensita tal-antikoagulazzjoni.
English: These tests were used to assess the anticoagulant effect of dabigatran.
Maltese: Dawn it-testijiet intużaw biex jivvalutaw l-effetti antikoagulanti ta' dabigatran.