FrancophonIA/ELRC3.0 huggingface dataset:
English: In two completed clinical trials, there were 87 paediatric subjects (aged 1 to 17 years) enrolled and exposed to teduglutide for a duration of up to 6 months.
Maltese: F'żewġ provi kliniċi li tlestew, kien hemm 87 individwu pedjatriku (li kellhom minn sena sa 17-il sena) li ġew irreġistrati u esposti għal teduglutide għal massimu ta' 6 xhur.
English: Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after one year of treatment, every 5 years thereafter while on continuous treatment with Revestive, and if they have new or unexplained gastrointestinal bleeding.
Maltese: Hu rakkomandat li ssir kolonskopija/sigmojdoskopija fit-tfal u adolexxenti kollha wara sena ta' kura, u kull 5 snin wara matul kura kontinwa b'Revestive u jekk ikollhom fsad gastrointestinali ġdida jew mhux spjegata.
English: Revestive comes in pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Maltese: Revestive jiġi f'daqsijiet tal-pakkett ta' 1 kunjett bit-trab b'1 siringa mimlija għal-lest jew 28 kunjett bittrab bi 28 siringa mimlija għal-lest.
English: A risk to the breast-fed newborn/infant cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid li jkunu qed jiġu mredda' mhux eskluż.
English: In a phase 1 study, the effect of renal impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 10 mg teduglutide was investigated.
Maltese: Individwu wieħed infatam mis-appoġġ parenterali waqt li kien fuq teduglutide.
English: Revestive comes in pack sizes of 28 vials of powder with 28 pre-filled syringes.
Maltese: Revestive jiġi f'daqsijiet tal-pakkett ta' 28 kunjett bit-trab bi 28 siringa mimlija għal-lest.
English: Colorectal polyp Colonic stenosis Flatulence Intestinal obstruction Pancreatic duct stenosis Pancreatitis Small intestinal stenosis
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: How to store Revestive
Maltese: X'fih Revestive
English: Respiratory tract infection*
Maltese: Infezzjoni fil-passaġġ respiratorju*
English: Paediatric population See also general precautions for adults under this section.
Maltese: Popolazzjoni pedjatrika Ara wkoll il-prekawzjonijiet ġenerali għall-adulti taħt din is-sezzjoni.
English: Cough
Maltese: Solvent
English: Increases in enteral nutrition volume and enteral calories Based on prescribed data, the mean percentage change from baseline at Week 12 in enteral volume, in the ITT population, was 25.82% (±41.59) compared to 53.65% (±57.01) in the standard of care cohort.
Maltese: 82% (±41.59) meta mqabbla ma' 53.65% (±57.01) fil-koorti ta' standard ta' kura.
English: Subcutaneous use vial (glass)
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: EMA/681300/2015 EMEA/H/C/002359
Maltese: EMA/H/C/002359
English: The full EPAR for Zoledronic acid medac 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: It is available as a 4mg/100ml solution for infusion (drip into a vein) and as a 4mg/5ml concentrate for solution for infusion.
Maltese: Tiġi bħala soluzzjoni għal infużjoni ta' 4mg/100ml (dripp fil-vina) u bħala konċentrat għal soluzzjoni għal infużjoni ta' 4mg/5ml.
English: Zoledronic acid medac is a ‘generic medicine'.
Maltese: Zoledronic acid medac huwa ‘mediċina ġenerika'.
English: The usual dose of Zoledronic acid medac is one infusion of 4 mg over at least 15 minutes.
Maltese: Id-doża normali ta' Zoledronic acid medac hija ta' infużjoni waħda ta' 4 mg tul mill-inqas 15-il minuta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid medac on 03 August 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoledronic acid medac fit-03 ta' Awwissu 2012.
English: The active substance in Zoledronic acid medac, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic acid medac, l-aċidu żoledroniku, hija bisfosfonat.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid medac.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zoledronic acid medac.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan jinkludi ksur (ksur fl-għadam), kompressjoni fix-xewka tad-dahar (meta x-xewka tad-dahar tkun kompressa mill-għadam), disturbi fl-għadam li jeħtieġu rradjuterapija (kura bir-radjazzjoni) jew intervent kirurġiku, u iperkalċemija (livelli għoljin ta' kalċju fiddemm).
English: In addition, the company that markets Zoledronic acid medac will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Maltese: Barra minn hekk il-kumpanija li tawtorizza Zoledronic acid medac għat-tqegħid fis-suq ser tipprovdi kard biex tinforma lill-pazjenti bir-riskji tal-osteonekrożi fix-xedaq (ħsara lill-għadam tax-xedaq, li tista' twassal għal uġigħ, selħiet fil-ħalq jew laxkament fis-snien) u biex ittihom struzzjonijiet biex jikkuntattjaw lit-tabib tagħhom jekk ikollhom is-sintomi.
English: Zoledronic acid medac zoledronic acid
Maltese: Tagħrif ieħor dwar Zoledronic acid medac
English: This means that Zoledronic acid medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Maltese: Dan ifisser li Zoledronic acid medac huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Zometa.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid medac has been shown to have comparable quality and to be bioequivalent to Zometa.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Zoledronic acid medac intwera li għandu kwalità li tixbah lil dik ta' Zometa u li huwa bijoekwivalenti.
English: What is Zoledronic acid medac?
Maltese: X'inhu Zoledronic acid medac?
English: Because Zoledronic acid medac 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 Zoledronic acid medac huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċji u r-riskji tagħha huma meqjusa li huma analogi għal dawk tal-mediċini ta' referenza.
English: It is not recommended for patients with severe kidney problems.
Maltese: Mhuwiex rakkomandat għal pazjenti bi problemi serji fil-kliewi.
English: A risk management plan has been developed to ensure that Zoledronic acid medac is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zoledronic acid medac jintuża bl-aktar mod sigur possibbli.
English: Zoledronic acid medac is a medicine that contains the active substance zoledronic acid.
Maltese: Zoledronic acid medac huwa mediċina li fiha s-sustanza attiva aċidu żoledroniku.
English: The company provided data from the published literature on zoledronic acid.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar l-aċidu żoledroniku.
English: How has Zoledronic acid medac been studied?
Maltese: Kif ġie studjat Zoledronic acid medac ?
English: Why has Zoledronic acid medac been approved?
Maltese: Għaliex ġie approvat Zoledronic acid medac?
English: What are the benefits and risks of Zoledronic acid medac?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Zoledronic acid medac?
English: Further information on Sprycel can be found on the Agency's website ema.europa.eu/medicines/human/EPAR/Sprycel.
Maltese: Aktar informazzjoni dwar Sprycel tinstab fis-sit elettroniku talAġenzijaema.europa.eu/medicines/human/EPAR/Sprycel.
English: Other information about Sprycel
Maltese: Informazzjoni oħra dwar Sprycel
English: The most common side effects with Sprycel (seen in more than 1 patient in 10) are infection, suppression of the bone marrow (decreasing numbers of blood cells), headache, haemorrhage (bleeding), pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing), diarrhoea, vomiting, nausea (feeling sick), abdominal pain (belly ache), skin rash, musculoskeletal pain, tiredness, swelling in the legs and arms and in the face, fever.
Maltese: L-effetti sekondarji l-aktar komuni bi Sprycel (li dehru f'aktar minn pazjent 1 minn kull 10) huma infezzjoni, suppressjoni tal-mudullun (tnaqqis fin-numri ta' ċelloli ta' demm), uġigħ ta' ras, emorraġija (fsada), effużjoni plewrali (fluwidu madwar il-pulmun), dispnea (diffikultà fit-teħid tan-nifs), dijarrea, rimettar, nawżja (dardir), uġigħ addominali (uġigħ fiż-żaqq), raxx tal-ġilda, uġigħ muskuloskeletali, għeja, nefħa fir-riġlejn u fid-dirgħajn u fil-wiċċ, deni.
English: Sprycel is available as tablets (20, 50, 70, 80, 100 and 140 mg) and a powder to make up a suspension (10 mg/ml) to be taken by mouth.
Maltese: Sprycel jiġi bħala pilloli (20, 50, 70, 80, 100 u 140 mg) u trab biex issir sospensjoni (10 mg/ml) li għandha tittieħed mill-ħalq.
English: • CML in ‘chronic', ‘accelerated' and ‘blast' phases.
Maltese: • CML f'fażijiet “kronika”, “aċċellerata” u “blast”.
English: Sprycel contains the active substance dasatinib.
Maltese: Sprycel fih is-sustanza attiva dasatinib.
English: Sprycel received a marketing authorisation valid throughout the European Union on 20 November
Maltese: Sprycel irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fl20 ta'Novembru 2006.
English: Two studies were in patients with chronic CML (198 and 36 patients), one was in accelerated CML (120 patients), one was in myeloid blast CML (80 patients), and one was in Ph+ ALL and lymphoid blast CML (81 patients).
Maltese: Saru żewġ studji f'pazjenti b'CML kronika (198 u 36 pazjent), wieħed kien f'CML aċċellerata (120 pazjent), wieħed kien f'CML mijelojde blast (80 pazjent), u wieħed kien f'Ph+ ALL u CML limfojde blast (81 pazjent).
English: The active substance in Sprycel, dasatinib, belongs to a group of medicines that block enzymes known as protein kinases.
Maltese: Is-sustanza attiva f'Sprycel, id-dasatinib, tappartjeni lil grupp ta' mediċini li jimblokkaw l-enzimi magħrufa bħala proteini kinażi.
English: This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably.
Maltese: Din l-enzima hija prodotta miċ-ċelloli tal-lewkimja, u ġġiegħlhom jimmultiplikaw mingħajr kontroll.
English: Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
Maltese: Sprycel jintuża meta kuri oħrajn inkluż imatinib (mediċina oħra kontra l-kanċer) ma jaħdmux jew jikkawżaw effetti sekondarji inkwetanti;
English: • chronic myeloid leukaemia (CML) in the ‘chronic' phase in newly diagnosed patients who are ‘Philadelphia chromosome positive' (Ph+).
Maltese: • lewkimja mijelojde kronika (CML) fil-fażi “kronika” f'pazjenti li jkunu għadhom kif ġew iddijanjostikati li huma “pożittivi għall-kromożoma Philadelphia” (Ph+).
English: Sprycel was more effective than imatinib: within one year, 77% of patients receiving Sprycel no longer had the Philadelphia chromosome in their blood cells, compared with 66% of patients receiving imatinib.
Maltese: Sprycel kien iktar effettiv minn imatinib: fi żmien sena, 77 % tal-pazjenti li kienu qed jirċievu Sprycel ma kienx għad kellhom il-kromożoma Philadelphia fiċ-ċelloli tad-demm tagħhom, meta mqabbla ma' 66 % talpazjenti li kienu qed jirċievu imatinib.
English: Sprycel is a cancer medicine.
Maltese: Sprycel huwa mediċina kontra l-kanċer.
English: As for all medicines, data on the use of Sprycel are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Sprycel hija ssorveljata kontinwament.
English: • Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast' CML.
Maltese: • lewkimja limfoblastika akuta Ph+ (ALL), fejn il-limfoċiti (tip ieħor ta' ċellola bajda tad-demm) jimmultiplikaw malajr wisq, jew f'CML “limfojde blast”.
English: What are the risks associated with Sprycel?
Maltese: X'inhuma r-riskji assoċjati ma' Sprycel?
English: Dasatinib acts mainly by blocking the Bcr-Abl protein kinase.
Maltese: Id-dasatinib taġixxi prinċipalment billi timblokka l-proteina kinażi Bcr-Abl.
English: • newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).
Maltese: • Ph+ ALL li tkun għadha kif ġiet iddijanjostika flimkien ma' kimoterapija (mediċini kontra l-kanċer).
English: In addition, the number of white blood cells containing the Philadelphia chromosome was reduced in around 33 to 66% of treated patients in the five main studies.
Maltese: Barra minn hekk, in-numru taċ-ċelloli bojod tad-demm li fihom il-kromożoma Philadelphia tnaqqas f'madwar 33 sa 66 % tal-pazjenti kkurati fil-ħames studji ewlenin.
English: In a study involving 106 children and adolescents with newly diagnosed Ph+ ALL, patients were treated with Sprycel and chemotherapy.
Maltese: Fi studju li involva 106 itfal u adoloxxenti b'ALL Ph+ li kienu għadhom kif ġew iddijanjostikati, ilpazjenti ġew ikkurati bi Sprycel u b'kimoterapija.
English: In patients with CML in other phases (accelerated, myeloid blast and lymphoid blast) and in ALL, around 25 to 33% of the patients had complete response.
Maltese: F'pazjenti b'CML f'fażijiet oħra (aċċellerata, mijelojde blast u limfojde blast) u f'ALL, madwar 25 sa 33 % tal-pazjenti wrew rispons komplet.
English: Two further studies compared the effects of Sprycel taken once or twice a day, one in 670 patients with chronic phase CML and the other in 611 patients with advanced phase CML or Ph+ ALL.
Maltese: Żewġ studji oħra qabblu l-effetti ta' Sprycel meħud darba jew darbtejn kuljum, wieħed f'670 pazjenti b'CML fil-fażi kronika u l-ieħor f'611-il pazjent b'CML fil-fażi avvanzata jew b'Ph+ ALL.
English: How is Sprycel used?
Maltese: Kif jaħdem Sprycel?
English: In comparison, using results of previous studies, the figure was 49% in patients who had received chemotherapy alone and 59% in patients who had received imatinib and chemotherapy.
Maltese: B'paragun, bl-użu ta' riżultati ta' studji preċedenti, iċ-ċifra kienet 49 % f'pazjenti li kienu rċevew kimoterapija waħidha u 59 % f'pazjenti li kienu rċevew imatinib u kimoterapija.
English: Once- and twice-daily Sprycel had similar effectiveness, but the once-daily dose caused fewer side effects.
Maltese: Sprycel meħud darba u darbtejn kuljum kellu effikaċja simili, iżda d-doża ta' darba kuljum ikkawżat inqas effetti sekondarji.
English: Another main study looked at the effectiveness of Sprycel in 113 children with Ph+ chronic phase CML, including 29 patients who could not use imatinib or it had not worked, as well as 84 newly diagnosed children who had not been previously treated.
Maltese: Studju ewlieni ieħor ħares lejn l-effikaċja ta' Sprycel f'113-il tifel u tifla b'CML fil-fażi kronika Ph+, inkluż 29 pazjent li ma setgħux jużaw imatinib jew li fuqhom ma kienx ħadem, kif ukoll 84 tifel u tifla li kienu għadhom kemm ġew iddijanjostikati u li ma kinux ġew ikkurati preċedentement.
English: A further study involving 519 patients compared Sprycel with imatinib in treating newly diagnosed Ph+ patients with chronic phase CML who had not received any previous treatment.
Maltese: Studju ieħor li involva 519-il pazjent qabbel Sprycel ma' imatinib fil-kura ta' pazjenti Ph+ li kienu għadhom kif ġew iddijanjostikati b'CML fil-fażi kronika li ma kinux irċivew xi kura preċedenti.
English: For the full list of side effects and restrictions with Sprycel, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet bi Sprycel, ara l-fuljett ta' tagħrif.
English: By blocking Bcr-Abl kinase, as well as other kinases, Sprycel helps to reduce the number of leukaemia cells.
Maltese: Billi jimblokka Bcr-Abl kinażi, kif ukoll kinażijiet oħra, Sprycel jgħin biex inaqqas in-numru ta' ċelloli tal-lewkimja.
English: Side effects reported with Sprycel are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Sprycel huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: A response was seen in around 90% of patients who could not use imatinib or it had not worked, and in 94% of newly diagnosed patients.
Maltese: Deher rispons f'madwar 90 % tal-pazjenti li ma setgħux jużaw imatinib jew li fuqhom ma kienx ħadem, u f'94 % talpazjenti li kienu għadhom kif ġew iddijanjostikati.
English: The five main studies of Sprycel in adults involved 515 patients, all of whom had received treatment with imatinib, which had not worked or had stopped working.
Maltese: Il-ħames studji ewlenin ta' Sprycel fl-adulti involvew 515-il pazjent li kollha kemm huma kienu rċevew kura b'imatinib, li ma kinitx ħadmet jew waqfet taħdem.
English: Why is Sprycel authorised in the EU?
Maltese: Għaliex Sprycel ġie awtorizzat fl-UE?
English: • newly diagnosed Ph+ CML in the ‘chronic' phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
Maltese: • Ph+ CML li tkun għadha kif ġiet iddijanjostikata fil-fażi “kronika”, jew Ph+ CML meta kuri oħrajn li jinkludu lil imatinib ma jkunux jistgħu jingħataw jew ma jkunux ħadmu;
English: 20014 Nerviano (Milan) Italy
Maltese: Nerviano (Milan) Italja
English: 2 needles 19 G1
Maltese: 2 labar 19 G 1
English: - age over 75 years
Maltese: • età ta' aktar minn 75 sena
English: Teva Pharmaceuticals Polska Sp. Z o.o.
Maltese: Teva Pharmaceuticals Polska Sp. Z o.o. Tel.
English: delirium, agitation, confusion, depression, psychosis)
Maltese: delirju, aġitazzjoni, konfużjoni, depressjoni, psikosi)
English: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois France
Maltese: 52, Rue Marcel et Jacques Gaucher 94120
English: In the alteplase group 33.0 % were fatal and 39.8 % were disabling.
Maltese: Filgrupp ta' alteplase 33.0 % kienu fatali u 39.8 % kkawżaw diżabilità.
English: Teva Norway AS Tlf: +47 66 77 55 90
Maltese: Norway AS Tlf: +47 66 77 55 90
English: Dosage of Acetylsalicylic Acid
Maltese: Dożaġġ ta' Acetylsalicylic Acid
English: Teva Sweden AB Tel: +46 42 12 11 00
Maltese: Actavis ABTeva Sweden AB Tel: +46 42 12 11 00
English: Date of first authorisation: 29 August 1996 Date of last renewal: 29 August 2006
Maltese: Data ta' l-aħħar tiġdid: 29 ta' Awissu 2006
English: Dosage of Heparin
Maltese: Dożaġġ ta' Heparin
English: Actavis Italy S.p.A. Nerviano Plant Via Pasteur 10
Maltese: Nerviano Plant Via Pasteur 10
English: ** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
Maltese: ** Attivatur rikombinanti ta' plasminogen prodott f'Echerichia coli permezz ta' teknoloġija ta' DNA
English: Immune system disorders
Maltese: Disturbi fis-sistema talimmunità
English: • hypersensitivity (e.g. allergic reactions)
Maltese: • Sensittività eċċessiva (e.ż. reazzjonijiet allerġiċi)
English: Reteplase 10 U (recombinant plasminogen activator, thrombolytic agent)
Maltese: Reteplase 10 U (attivatur rikombinanti ta' plażminoġen, aġent trombolitiku)
English: Hypersensitivity reactions (e.g. allergic reactions)1
Maltese: Reazzjonijiet ta' sensittività eċċessiva (e.ż. reazzjonijiet allerġiċi)1
English: Rapilysin contains the active substance reteplase(a recombinant plasminogen activator).
Maltese: Rapilysin fiha is-sustanza attiva reteplase (attivatur rikombinanti ta' plażminoġen).
English: Other medicines and Rapilysin:
Maltese: Mediċini oħra u Rapilysin:
English: • Events related to the nervous system (e.g. epileptic seizure, convulsion, speech disorder,
Maltese: • Episodji relatati mas-sistema nervuża (e.ż. attack epilettiku, konvulżjoni, disturbi fil-kelma,
English: - The active substance is reteplase 10U/10 ml after reconstitution.
Maltese: - Is-sustanza attiva hija reteplase 10U/10ml wara r-rikostituzzjoni.
English: In the reteplase group, 49.4 % of these strokes were fatal and 27.1 % were disabling.
Maltese: Fil-grupp ta' reteplase, 49.4 % ta' dawn il-puplesiji kienu fatali u 27.1 % ikkawżaw diżabilità.
English: Pharmacotherapeutic group: antithrombotic agent, ATC Code: B01AD07
Maltese: Kategorija farmakoterapewtika: aġent antitrombotiku, Kodiċi ATC:
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥
Maltese: Il-frekwenzi huma definiti bħala 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) u mhux magħruf (ma tistax tittieħed stima mid dejta disponibbli).
English: Genotoxicity of reteplase was excluded by a complete battery of tests at different genetic end points in vitro and in vivo.
Maltese: Ġenotossiċità ta' reteplase kienet eskluża minn sensiela kompleta ta' eżamijiet f'endpoints ġenetiċi in vitro u in vivo differenti.
English: Following intravenous bolus injection of 10 + 10 U in patients with acute myocardial infarction reteplase antigen is distributed in plasma with a dominant half-life (t1/2α) of 18±5 min and eliminated with a terminal half-life (t1/2ß) of 5.5 hours±12.5 min at a clearance rate of 121±25 ml/min.
Maltese: Wara injezzjoni ġol-vini ta' 10 + 10 U f'pazjenti b'infart mijokardjali akut, l-antiġen ta' reteplase huwa mqassam fil-plażma b'half life (t1/2α) dominanti ta' 18±5 min u eliminat ma' half life (t1/2ß)
English: 2 reconstitution spikes
Maltese: 2 spikes għar-rikostituzzjoni
English: A clinical trial in approximately 15 000 patients comparing reteplase with the accelerated dose regimen of alteplase (GUSTO III) (2:1 randomisation reteplase: alteplase) did not show statistically different results for the primary endpoint of 30-day mortality (reteplase: 7.47 %, alteplase 7.23 %, p = 0.61) or for the combined endpoint of 30-day mortality and non-fatal disabling stroke (reteplase: 7.89 %, alteplase 7.88 %, p = 0.99).
Maltese: (reteplase: 7.47 %, alteplase 7.23 %, p = 0.61) jew għal endpoint mħallta ta' mortalità f'perijodu ta' 30 jum u f'puplesija mhux fatali li tikkawża diżabilità (reteplase: 7.89 %, alteplase 7.88 %, p = 0.99).
English: The reconstituted solution contains 1 U reteplase per ml.
Maltese: Is-soluzzjoni rikostitwita fiha 1 U reteplase kull ml.
English: For further information see section 4.4, section bleeding.
Maltese: Għal aktar informazzjoni ara sezzjoni 4.4, fis-sezzjoni tal-ħruġ tad-demm.
English: Reductions of plasma levels of plasminogen and α2-antiplasmin normalise within 1 to 3 days.
Maltese: Tnaqqis fil-livelli tal-plażma tal-plasminogen u ta' l-α2-antiplasmin jinnormalizzaw fi żmien 1 sa 3
English: 10 U reteplase
Maltese: reteplase10 U
English: 220 Hafnarfjordur Iceland.
Maltese: Hafnarfjordur Islanda
English: - systolic blood pressure at entry > 160 mmHg
Maltese: - pressjoni tad-demm sistolika ta' > 160 mmHg meta jkun deċiż it-trattament
English: The relative contribution of the inhibitors to inactivation of reteplase decreases as follows: C1-inactivator > α2antiplasmin > α2-antitrypsin.
Maltese: inattivatur-C1 > antiplażmin-α2 > antitrypsin-α2.
English: Serious anaphylaxis/anaphylactoid reactions1
Maltese: Anafilassi serja/reazzjonijiet anafilattojdi1
English: For information on product incompatibilities see section 6.2.
Maltese: Għal informazzjoni dwar l-inkompatibilitajiet tal-prodott ara sezzjoni 6.2.
English: Prothrombin activation fragment 1 levels and thrombin-antithrombin III-complexes increase during thrombolysis indicating thrombin production of which the clinical relevance is unknown.
Maltese: Il-framment ta' l attivazzjoni ta' protrombin tal-livelli 1 u t-trombin-antitrombin kumplessi-III iżżid waqt it-trombolożi u tindika l-produzzjoni tat-trombin, liema rilevanza klinika mhijiex magħrufa.