FrancophonIA/ELRC3.0 huggingface dataset:
English: Immunogenicity following a fourth dose (booster dose) at 15 to 18 months of age was evaluated in 44 very preterm, 69 preterm and 127 full term infants.
Maltese: L-immunoġeniċità wara r-raba' doża (doża booster) fl-età ta' 15 sa 18-il xahar kienet evalwata f'44 tarbija li twieldet ħafna qabel iż-żmien, 69 tarbija li twieldet qabel iż-żmien u 127 tarbija li twieldet fi żmienha.
English: 2-dose vial
Maltese: (2 dożi)
English: Post-primary antibody geometric mean concentrations (GMCs) elicited by Synflorix against the seven serotypes in common were lower than those elicited by 7-valent Prevenar.
Maltese: Il-konċentrazzjonijiet ġeometriċi- medji (GMCs) tal-antikorpi wara l-kors primarju kontra s-seba' serotipi komuni li rriżultaw minn Synflorix kienu inqas minn dawk li rriżultaw minn Prevenar 7valenti.
English: The HIV exposure or infection did not appear to alter the effect of Synflorix on pneumococcal carriage up to 24-27 months of age, i.e. up to 15 months following booster vaccination.
Maltese: L-esponiment għall-HIV jew l-infezzjoni talHIV ma dehrux li biddlu l-effett ta' Synflorix fuq il-ġarr pnewmokokkali sa età ta' 24-27 xahar, jiġifieri sa 15-il xahar wara t-tilqima booster.
English: The results of the COMPAS study, which was performed in Latin America, should be interpreted with caution due to possible differences in epidemiology of pneumonia in different geographical locations.
Maltese: Ir-riżultati tal-istudju COMPAS, li sar fl-Amerika Latina, għandhom jiġu interpretati b'attenzjoni minħabba differenzi possibbli fl-epidemijoloġija tal-pnewmonja f'postijiet ġeografiċi differenti.
English: A clinical study evaluated the immunogenicity of Synflorix in 2-dose or 3-dose primed subjects in four European countries.
Maltese: Studju kliniku evalwa l-immunoġeniċità ta' Synflorix f'individwi pprajmjati b'2 dożi jew bi 3 dożi f'erba' pajjiżi Ewropej.
English: N number of subjects per group n/% number/percentage of subjects reporting a first episode of B-CAP anytime from 2 weeks after the administration of the 3rd dose
Maltese: N numru ta' individwi kull grupp n/% numru/perċentwal ta' individwi li jirrapportaw l-ewwel episodju ta' B-CAP fi kwalunkwe żmien minn ġimagħtejn wara l-għoti tat-tielet doża
English: The mean duration follow-up from 2 weeks post-dose 3 in the ATP cohort was 23 months (range from 0 to 34 months) for the interim analysis (IA) and 30 months (range from 0 to 44 months) for the end-of-study analysis.
Maltese: Il-follow-up ta' tul medju minn ġimagħtejn wara d-doża 3 fil-koorti ATP kien ta' 23 xahar (medda minn 0 sa 34 xahar) għall-analiżi interim (IA) u 30 xahar (medda minn 0 sa 44 xahar) għall-analiżi tat-tmiem tal-istudju.
English: The vaccine is a turbid white suspension.
Maltese: Il-vaċċin huwa suspensjoni bajda u mdardra.
English: The majority of these reactions were of mild to moderate severity and were not long lasting.
Maltese: Il-maġġorranza ta' dawn ir-reazzjonjiet kienu ta' severità ħafifa sa moderata u ma damux ħafna.
English: Syringe cap
Maltese: Mhux komuni
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Maltese: Fi trabi li twieldu prematuri ħafna (ta' 28 ġimgħa ta' tqala jew inqas) jistgħu jseħħu perjodi itwal minnormal bejn nifs u ieħor għal 2-3 ijiem wara t-tilqima.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix suspension for injection
Maltese: Synflorix suspensjoni għall-injezzjoni
English: • Synflorix is available in pre-filled syringes for 1 dose with or without needles in packs of 1, 10 or 50.
Maltese: • Synflorix huwa disponibbli f'siringi mimlija għal-lest għal doża 1 b'labar jew mingħajr labar f'pakketti ta' 1, 10 jew 50.
English: Efficacy and effectiveness in clinical trials
Maltese: Effikaċja u l-effettività fil-provi kliniċi
English: Fever > 39 °C rectally (age < 2 years), injection site reactions like injection site induration Uncommon Injection site reactions like injection site haematoma, haemorrhage and nodule Adverse reactions additionally reported after booster vaccination of primary series and/or catch-up vaccination: Nervous system disorders
Maltese: Deni > 39°C fir-rektum (età < sentejn), reazzjonijiet fil-post tal-injezzjoni bħal ebusija fil-post ta' l-injezzjoni
English: Children with a weakened immune system (such as due to human immunodeficiency virus (HIV) infection or immunosuppressive therapy) may not get the full benefit from Synflorix.
Maltese: Tfal b'sistema mmuni mdgħajfa (bħal minħabba infezzjoni tal-virus tal-immunodefiċjenza umana (HIV), terapija immunosoppressiva) jista' ma jeħdux il-benefiċċju komplet minn Synflorix.
English: The vaccine efficacy against B-CAP observed at the interim analysis is presented below (table 2).
Maltese: L-effikaċja tal-vaċċin kontra B -CAP osservata fl-analiżi interim, hija ppreżentata hawn taħt (tabella
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Maltese: Synflorix suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin konjugat (adsorbit) ta' polysaccharide pnewmokokkali
English: Synflorix is not intended for use in adults.
Maltese: Synflorix mhux maħsub għall-użu fl-adulti.
English: Table 1: Number of vaccine serotype IPD cases and vaccine effectiveness (FinIP) or efficacy (COMPAS) in infants below 7 months of age at enrolment receiving at least one vaccine dose (Infant total vaccinated cohort)
Maltese: Tabella 1: Numru ta' każijiet ta' IPD mis-serotipi tal-vaċċin u l-effettività tal-vaċċin (FinIP) jew l-effikaċja (COMPAS)fi trabi ta' taħt is-7 xhur fil-mument tar-reġistrazzjoni li rċevew millanqas doża waħda tal-vaċċin (Grupp totali tat-trabi mlaqqma)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/006 - pack of 1
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/508/006 - pakkett ta' 1
English: Serotype 14 IPD 0
Maltese: ħlief għal serotip 5.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/012 - pack of 10
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/508/012 - pakkett ta' 10
English: This study has shown that the immune responses against the 7 common serotypes were comparable to those elicited by a booster dose of 7-valent Prevenar.
Maltese: Dan l-istudju wera li r-rispons immuni kontra s-7 serotipi komuni kien komparabbli għal dak li rriżulta minn doża booster ta' Prevenar 7-valenti.
English: • The other ingredients are: sodium chloride (see section 2 for further information) and water for injections
Maltese: • Is-sustanzi l-oħra huma: sodium chloride (ara sezzjoni 2 għal aktar informazjoni) u ilma għall injezzjonijiet
English: Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, prenatal exposure to anti-retroviral therapy and/or to HIV, or other causes, may have reduced antibody response to vaccination.
Maltese: Tfal b'rispons immuni indebolit, kemm jekk minħabba l-użu ta' terapija immunosoppressiva, difett ġenetiku, infezzjoni bl-HIV, esponiment ta' qabel it-twelid għal terapija antiretrovirali u/jew għallHIV, jew kawżi oħra, jista' jkollhom tnaqqis fir-rispons tal-antikorpi għat-tilqim.
English: Safety was also assessed in 435 previously unvaccinated children from 2 to 5 years old of which 285 subjects received 2 doses of Synflorix.
Maltese: Is-sigurtà kienet evalwata ukoll f'435 tifel u tifla li ma kinux imlaqqma qabel b'età minn 2 sa 5 snin li minnhom 285 individwu rċievew 2 dożi ta' Synflorix.
English: Unvaccinated infants and children ≥ 7 months of age
Maltese: Trabi u tfal mhux imlaqqma ta' ≥ 7 xhur
English: Following catch-up vaccination in children 12 to 23 months of age, urticaria was reported more frequently (uncommon) compared to the rates observed in infants during primary and booster vaccination.
Maltese: Wara t-tilqim ta' ‘catch-up' fit-tfal minn 12 sa 23 xahar ta' età, l-urtikarja ġiet irrapportata b'mod aktar frekwenti (mhux komuni) meta mqabbla mar-rati osservati fit-trabi waqt it-tilqim primarju u booster.
English: Further information on Azacitidine Celgene can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/azacitidine-celgene.
Maltese: Aktar informazzjoni dwar Azacitidine Celgene tinstab fis-sit elettroniku tal-Aġenzija: www.ema.europa.eu/medicines/human/EPAR/azacitidine-celgene.
English: The most common side effects of Azacitidine Celgene, which may affect more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells), are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Maltese: L-effetti sekondarji l-aktar komuni b'Azacitidine Celgene, li jistgħu jaffettwaw aktar minn 60 % talpazjenti b'sindromi mjelodisplastiċi, CMML jew AML (20 sa 30 % ta' ċelloli anormali) huma reazzjonijiet tad-demm inkluża t-tromboċitopenija (għadd baxx ta' pjastrini), newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellolli bojod tad-demm) u lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), effetti sekondarji li jaffettwaw l-istonku u l-imsaren inklużi nawżja u remettar, u reazzjonjiet fis-sit talinjezzjoni.
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Maltese: • AML li żviluppa minn sindrome mjelodisplastika u l-mudullun jikkonsisti f'bejn 20 u 30 % ta' ċelloli anormali;
English: The active substance in Azacitidine Celgene, azacitidine, belongs to the group ‘antimetabolites' and can be incorporated into the genetic material of cells (RNA and DNA) instead of their natural building-block, cytidine.
Maltese: Is-sustanza attiva f'Azacitidine Celgene, l-ażaċitidina, tappartjeni għall-grupp ta' ‘ antimetaboliti' u tista' tiġi inkorporata fil-materjal ġenetiku taċ-ċelloli (RNA u DNA) minflok l-għamla naturali tagħhom, iċ-ċitidina .
English: Other information about Azacitidine Celgene
Maltese: Informazzjoni oħra dwar Azacitidine Celgene
English: Azacitidine Celgene contains the active substance azacitidine.
Maltese: Azacitidine Celgene fih is-sustanza attiva ażaċitidina.
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML who were unlikely to go on to have a stem cell transplant.
Maltese: L-ewwel studju involva 358 adult b'riskju bejn intermedjarju u għoli għas-sindromi mjelodisplastiċi, CMML jew AML, li ma kinux mistennija li jkollhom trapjant taċċelloli staminali.
English: In the second study, which involved 488 patients with AML who could not have haematopoietic stem cell transplantation and whose bone marrow contained more than 30% abnormal cells, patients receiving Azacitidine Celgene survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Maltese: Fit-tieni studju, li involva 488 pazjent b'AML li ma setgħux ikollhom trapjant ta' ċelloli staminali ematopojetiċi u li l-mudullun tagħhom kien fih aktar minn 30 % ta' ċelloli anormali, il-pazjenti li rċevew Azactidine Celgene għexu medja ta' 10.
English: The recommended dose of Azacitidine Celgene is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Maltese: Id-doża rakkomandata ta' Azacitidine Celgene hija ta' 75 mg għal kull metru kwadru ta' superfiċje talġisem (ikkalkolat skont it-tul u l-piż tal-pazjent).
English: In this study, patients receiving Azacitidine Celgene survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Maltese: F'dan l-istudju, il-pazjenti li kienu qed jingħataw Azacitidine Celgene għexu medja ta' 24.5 xhur, meta mqabbla ma' 15-il xahar f'pazjenti li ngħataw kura konvenzjonali.
English: What are the risks associated with Azacitidine Celgene?
Maltese: X'inhuma r-riskji assoċjati ma' Azacitidine Celgene?
English: Side effects were similar in AML patients with more than 30% abnormal cells.
Maltese: L-effetti sekondarji kienu simili f'pazjenti bl-AML b'iktar minn 30 % taċ-ċelloli anormali.
English: • AML, when the bone marrow has more than 30% abnormal cells.
Maltese: • AML, meta l-mudullun ikun fih iktar minn 30 % ta' ċelloli anormali.
English: As for all medicines, data on the use of Azacitidine Celgene are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Azacitidine Celgene hija ssorveljata kontinwament.
English: How is Azacitidine Celgene used?
Maltese: Kif jintuża Azacitidine Celgene?
English: Azacitidine Celgene is used in patients with an intermediate to high risk of progressing to AML or death;
Maltese: Azacitidine Celgene jintuża f'pazjenti b'riskju bejn intermedjarju u għoli ta' progress għal AML jew għall-mewt;
English: The company that makes Vidaza has agreed that its scientific data can be used for Azacitidine Celgene (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Vidaza qablet li d-data xjentifika tiegħu tista' tintuża għal Azacitidine Celgene (‘kunsens infurmat').
English: How does Azacitidine Celgene work?
Maltese: Kif jaħdem Azacitidine Celgene?
English: The patients' bone marrow contained up to 30% abnormal cells.
Maltese: Il-mudullun tal-pazjenti kien fih sa 30 % ta' ċelloli anormali.
English: Azacitidine Celgene is available as a powder to be made up into a suspension for injection.
Maltese: Azacitidine Celgene jiġi bħala trab biex jiġi magħmul f'sospensjoni għal injezzjoni.
English: Azacitidine Celgene was shown to be more effective than conventional care in extending survival in two main studies.
Maltese: Azacitidine Celgene intwera li huwa aktar effettiv mill-kura konvenzjonali biex tiġi estiża ssopravivenza f'żewġ studji ewlenin.
English: Azacitidine Celgene is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Maltese: Azacitidine Celgene jintuża meta l-mudullun ikun fih bejn 10 u 29% ta' ċelloli anormali u l-mudullun ma jkunx qed jipproduċi ammonti kbar ta' ċelloli bojod tad-demm;
English: The marketing authorisation holder is Torbet Laboratories Limited.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq huwa Torbet Laboratories Limited.
English: The marketing authorisation was renewed on 7 May 2003 and on 7 May 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet mġedda fis-7 ta' Mejju 2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PYLOBACTELL EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) PYLOBACTELL Sommarju ta' l-EPAR għall-pubbliku
English: The active substance in Pylobactell, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C).
Maltese: Is-sustanza attiva f'Pylobactell, 13C-urea, hija l-urea kimika naturali mmarkata bil-karbonju-13 (13C).
English: Pylobactell is a diagnostic test.
Maltese: Pylobactell huwa test dijanjostiku.
English: This means that it contains 13C, a rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
Maltese: Dan ifisser li fiha 13C, forma rara ta' l-atomu tal-karbonju minflok karbonju-12 (12C), l-aktar forma komuni fin-natura.
English: It is available as a kit that includes a white soluble tablet containing 100 mg of the active substance 13C-urea.
Maltese: Huwa disponibbli f'forma ta' kitt li jinkludi pillola bajda li tinħall u li fiha 100 mg tas-sustanza attiva 13C-urea.
English: This 13C-labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Maltese: Dan id-dijossidu tal-karbonju mmarkat 13C jista' jitkejjel minn laboratorji speċjalizzati b'teknika li tissejjaħ "spettrometrija ta' massa".
English: Finally, 30 minutes later (40 minutes after the test meal), the patient collects a further three breath samples.
Maltese: Fl-aħħar, wara 30 minuta (jiġifieri 40 minuta wara l-ikla ta' prova), il-pazjent jiġbor it-tliet kampjuni tan-nifs oħra.
English: Pylobactell was more than 95% sensitive in detecting infection with H. pylori.
Maltese: Pylobactell irriżulta kellu sensittività ogħla minn 95% biex josserva jekk hemmx infezzjoni minn H. pylori.
English: H. pylori produces enzymes called ureases that break down urea into ammonia and carbon dioxide.
Maltese: H. pylori jipproduċi enzimi, li jissejħu ureażi (ureases) li jiddekomponu l-urea f'ammonja u f'dijossidu tal-karbonju.
English: H. pylori is a bacterium that is a factor in diseases such as dyspepsia (heartburn, bloating and nausea), gastritis (inflammation of the stomach) and peptic ulcer disease (ulcers in the stomach or the duodenum).
Maltese: H. pylori huwa batterju li jikkostitwixxi fattur f'mard bħalma huma d-dispepsija (qrusa ta' l-istonku, nefħa u nawżea), il-gastrite (infjammazzjoni fl-istonku) u l-ulċera peptika (ulċeri fl-istonku u fid-duwodenu).
English: Pylobactell is used to diagnose Helicobacter pylori (H. pylori) infection in the stomach and duodenum (the part of the gut just below the stomach).
Maltese: Pylobactell jintuża għad-dijanjożi ta' l-infezzjoni Helicobacter pylori (H. pylori) fl-istonku u fidduwodenu (l-ewwel parti tal-musrana żgħira li tiġi dritt taħt l-istonku).
English: The data to support the use of Pylobactell comes from two main studies of the use of antibiotics to treat H. pylori infection, where it was used as a test. A total of 366 patients underwent both a Pylobactell test and a standard biopsy test (where a sample from the stomach is analysed to see if it is infected).
Maltese: Total ta' 366 pazjent ġie sottopost għal test b'Pylobactell u għal bijopsija standard (test li fih jittieħed kampjun mill-istonku biex jiġi analizzat jekk hemmx infezzjoni).
English: What is Pylobactell?
Maltese: X'inhu Pylobactell?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pylobactell on 7 May 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq fl-Unjoni Ewropea kollha għal Pylobactell fis-7 ta' Mejju 1998.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Pylobactell's benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Pylobactell huma ogħla mir-riskji tiegħu fid-dijanjożi in vivo ta' l-infezzjoni gastroduwodenali minn H. pylori.
English: Why has Pylobactell been approved?
Maltese: Għaliex ġie approvat Pylobactell?
English: Other information about Pylobactell:
Maltese: Aktar tagħrif dwar Pylobactell:
English: How has Pylobactell been studied?
Maltese: Kif ġie studjat Pylobactell?
English: After a further five minutes, the patient takes the Pylobactell tablet dissolved in water.
Maltese: Wara ħames minuti oħra, il-pazjenti jieħu l-pillola ta' Pylobactell maħlula fl-ilma.
English: Pylobactell should not be used in patients who have, or may have gastric (stomach) infection, which might interfere with the breath test.
Maltese: Pylobactell ma għandux jintuża f'pazjenti b'infezzjoni gastrika (flistonku) aċċertata jew suspettata, li jista' jinterferixxi mat-test tan-nifs.
English: First, the patient takes a ‘test meal' (such as 200 ml of pure undiluted orange juice).
Maltese: Il-pazjent għandu l-ewwel jiekol 'ikla ta' prova' (pereżempju 200 ml meraq tal-larinġ pur mhux imħallat bl-ilma).
English: These samples are then sent for analysis at a specialised laboratory.
Maltese: Dawn il-kampjuni mbagħad jintbagħtu għal analiżi f'laboratorju speċjalizzat.
English: Pylobactell is a breath test: breath samples are collected in the tubes provided in the kit.
Maltese: Pylobactell huwa test tan-nifs: il-kampjuni tan-nifs jinġabru f'tubi li jinsabu fil-kitt.
English: If there is an increased level of labelled carbon dioxide in the breath sample after 30 minutes (a positive test), the patient may have H. pylori in the stomach or duodenum.
Maltese: Jekk wara 30 minuta lkampjun tan-nifs fih livell għoli ta' dijossidu tal-karbonju mmarkat (test pożittiv), dan ifisser li lpazjent aktarx għandu infezzjoni minn H. pylori fl-istonku jew fid-duwodenu.
English: How does Pylobactell work?
Maltese: Għal xiex jintuża Pylobactell?
English: If the patient has , the 13C-urea contained in the Pylobactell tablet is broken down and the carbon dioxide in the breath also contains 13C.
Maltese: pylori fl-istonku jew fid-duwodenu, 13C-urea li tinsab fil-pillola ta' Pylobactell tiġi dekomposta u ddijossidu tal-karbonju fin-nifs ukoll fih 13C.
English: What is the risk associated with Pylobactell?
Maltese: X'inhu r-riskju assoċjat ma' Pylobactell?
English: What benefit has Pylobactell shown during the studies?
Maltese: Liema benefiċċju wera Pylobactell waqt l-istudji mwettqa?
English: There are no known side effects of the test.
Maltese: Mhu magħruf l-ebda effett sekondarju fit-test.
English: The full EPAR for Kogenate Bayer 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: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Maltese: L-octocog alfa tiġi prodotta permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': hi magħmula minn ċelloli li ġiet introdotta fihom ġene (DNA) li tagħmilhom kapaċi jipproduċuha.
English: Other information about Kogenate Bayer
Maltese: Aktar informazzjoni dwar Kogenate Bayer
English: It contains the active substance octocog alfa (human coagulation factor VIII).
Maltese: Fih is-sustanza attiva octocog alfa (fattur tal-koagulazzjoni VIII tal-bniedem).
English: Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).
Maltese: Reazzjonijiet ta' ipersensittività assoċjati mal-ġilda (ħakk, ħorriqija u raxx) jistgħu jseħħu b'mod komuni (f'bejn pazjent 1 u 10 pazjenti f'100) iżda reazzjoni allerġika severa hija rari (bejn pazjent 1 u 10 pazjenti f'10,000).
English: This is a summary of the European public assessment report (EPAR) for Kogenate Bayer.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kogenate Bayer.
English: Kogenate Bayer is similar to another medicine that was previously authorised in the EU called Kogenate, but it is prepared differently so that there are no human-derived proteins in the medicine.
Maltese: Kogenate Bayer huwa simili għal mediċina oħra li kienet diġà awtorizzata fl-UE bl-isem Kogenate, iżda huwa ppreparat b'mod differenti sabiex ma jkun hemm l-ebda proteina derivata mill-bniedem filmediċina.
English: Kogenate Bayer as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery.
Maltese: Kogenate Bayer bħala infużjoni kontinwa ġie studjat ukoll fi 15-il pazjent b'emofilja A sottoposti għal kirurġija maġġuri.
English: In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Kogenate Bayer into a vein.
Maltese: Fil-pazjenti li rċevew kura qabel, b'mod ġenerali, 95% tal-fsada rrispondew għal injezzjoni waħda jew tnejn ta' Kogenate Bayer ġo vina.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles and internal organs.
Maltese: Pazjenti bl-emofilja A jkollhom nuqqas tal-fattur VIII, u dan jikkaġuna problemi ta' koagulazzjoni tad-demm, bħal fsada fil-ġogi, fil-muskoli jew fl-organi interni.
English: The active substance in Kogenate Bayer, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Maltese: Is-sustanza attiva f'Kogenate Bayer, l-octocog alfa (fattur ta' koagulazzjoni VIII tal-bniedem), hija sustanza li tgħin lid-demm jagħqad.
English: Why is Kogenate Bayer approved?
Maltese: Għaliex ġie approvat Kogenate Bayer?