FrancophonIA/ELRC3.0 huggingface dataset:
English: Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Maltese: Adalimumab jeħel ma' proteina speċifika (fattur tan-nekrosi tat-tumur jew TNFα), li tinsab f'livelli aktar għolja f'mard infjammatorju bħal artrite rewmatika, artrite psorjatika u infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis).
English: This may cause severe allergic reactions in patients sensitive to latex.
Maltese: Dan jista' jikkaġuna reazzjonijiet allerġiċi severi f'pazjenti li huma sensittivi għal-latex.
English: • Trudexa should not be used if you have moderate to severe heart failure.
Maltese: • Trudexa m'għandux jintuża jekk int tbati minn insuffiċjenza tal-qalb minn moderata sa severa.
English: PHARMACEUTICAL FORM AND CONTENTS 4 pre-filled syringes, each containing 40 mg adalimumab 4 alcohol pads
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 4 siringi mimlijin għal-lest, li fihom 40 mg adalimumab kull waħda 4 kuxxinetti bl-alkoħol
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml vial contains 40 mg adalimumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed ta' 0.8 mg adalimumab
English: • anxiety, depression, feeling sleepy and difficulty sleeping;
Maltese: • ansjetà, depressjoni, tħossok bi ngħas u diffikultà biex torqod;
English: • As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will check you for signs and symptoms of tuberculosis before starting Trudexa.
Maltese: • Peress illi ġew irrappurtati każi ta' tuberkulosi f'pazjenti kkurati b'Trudexa, qabel tibda Trudexa, it-tabib tiegħek se jeżaminak għal sinjali u sintomi tat-tuberkulosi.
English: Concurrent administration of TNF-antagonists and anakinra
Maltese: Disturbi fl-għajnejn
English: • After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Maltese: • Wara li tinjetta Trudexa, armi s-siringa użata immedjatament f'kontenitur speċjali, kif qallek it tabib, l-infermier jew l-ispiżjar tiegħek.
English: Study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Maltese: Studju V evalwa 799 pazjent adult li jbatu minn artrite rewmatika attiva minn moderata sa severa li għada fil-bidu (il-medja ta' kemm ilha li bdiet il-marda kien ta' 9 xhur) li ma kinux qatt għadhom ħadu methotrexate.
English: There is limited safety experience of surgical procedures in patients treated with Trudexa.
Maltese: L-esperjenza ta' sigurtà ta' proċeduri kirurġiċi f'pazjenti kkurati b'Trudexa hija limitata.
English: Rare pulmonary oedema, pharyngeal oedema, pleural effusion, pleurisy
Maltese: Mhux Komuni pressjoni għolja b'mod anormali, fwawar, ematoma
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial containing 40 mg adalimumab 1 sterile injection syringe with fixed needle 2 alcohol pads
Maltese: U KONTENUT Kunjett wieħed fih 40 mg adalimumab Siringa sterili għall-injezzjoni bil-labra mwaħħla 2 kuxxinetti bl-alkoħol
English: Trudexa, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, Studies VI and VII.
Maltese: It-teħid ta' 40 mg Trudexa ġimgħa iva u ġimgħa le ġie studjat f'pazjenti li jbatu minn artrite psorjatika attiva minn moderata sa severa f'żewġ studji kontrollati bil-plaċebo, Studji VI u VII.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/004
Maltese: FIS-SUQ EU/1/03/257/004
English: Lietuva Abbott Laboratories Baltics
Maltese: Abbott Laboratories (Magyarország)
English: NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe with needleguard Adalimumab
Maltese: Trudexa 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Adalimumab
English: When combining controlled portions of ten trials (I-IX and CHARM) and ongoing open label extension studies with a median duration of approximately 2. years including 4843 patients and over 13000 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 13.6 per 1000 patient years.
Maltese: Meta wieħed jgħaqqad il-provi kontrollati (I-IX u CHARM) b'porzjonijiet ta' ghaxra u l-istudji extension open-label li għadhom sejrin bħalissa ma' durazzjoni medja ta' bejn wieħed u ieħor sentejn (2), li jinkludu 4843 pazjent u aktar minn 13000 sena ta' pazjent ta' terapija, ir-rata ta' tumuri malinni osservati, minbarra limfoma u kanċer tal-ġilda li m'humiex melanoma, hija ta' bejn wieħed u ieħor 13.6 kull 1000 sena ta' pazjent.
English: − Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
Maltese: - It-tabib tiegħek se jagħtik ukoll Kartuna ta' Twissija tal-Pazjent, li fiha informazzjoni importanti dwar is-sigurtà, li inti għandek tkun taf biha qabel tingħata Trudexa u waqt il-kura b'Trudexa.
English: • rash, itching, hair loss;
Maltese: • raxx, ħakk, taqa' x-xagħar;
English: Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Maltese: Trudexa jista' ukoll jintuża għall-kura ta' l-artrite rewmatika attiva u progressiva severa, mingħajr ma tkun ingħatat kura b'methotrexate qabel.
English: Trudexa is intended for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Maltese: Trudexa huwa intenzjonat għall-kura ta' l-artrite rewmatika, artrite psorjatika u infjammazzjoni talvertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis).
English: • skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing;
Maltese: • disturbi fil-ġilda (bħal psorjasi, ekżema jew infezzjonijiet), raxx li jqabbdek il-ħakk, dewmien biex ifiqu l-feriti;
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml pre-filled syringe contains 40 mg adalimumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Siringa waħda ta' 0.8 ml mimlija għal-lest fiha 40 mg adalimumab
English: Carriers of HBV who require treatment with Trudexa should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Maltese: Persuni li jġorru l-HBV u li jkollhom bżonn ilkura b'Trudexa għandhom jiġu monitorjati għal sinjali u sintomi ta' infezzjoni HBV attiva matul itterapija u għal ħafna xhur wara li titwaqqaf it-terapija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/007
Maltese: FIS-SUQ EU/1/03/257/007
English: Trudexa 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needleguard for hospital and caregiver use:
Maltese: Trudexa 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest li tintuża darba biss (ħġieġ tip I) għall-użu mill-pazjent:
English: Uncommon neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, ,
Maltese: Dawn it-terapiji jinkludu methotrexate, leflunomide, hydroxychloroquine,
English: OUTER CARTON
Maltese: TIKKETTA
English: If the needle is not correctly lined up with the centre of the stopper, you will feel constant resistance as it goes through the stopper and no “pop.” The needle may then enter at an angle and bend, break or prevent proper removal of the vial contents.
Maltese: Ilformazzjoni ta' anti-korpi kienet iktar baxxa meta Trudexa ingħata flimkien ma' methotrexate, meta pparagunat ma' l-użu ta' Trudexa waħdu bħala kura.
English: • If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Maltese: • Jekk inti tiżviluppa sintomi li huma tipiċi għall-infezzjonijiet, bħal deni, sogħla persistenti, tnaqqis fil-piż, jew nuqqas ta' kwiet fil-ġisem, irrikorri għall-għajnuna medika immedjatament.
English: In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Maltese: Fi prova klinika esploratorja li evalwat l-użu ta'aġent ieħor għal kontra t-TNF, infliximab, f'pazjenti li jbatu minn mard kroniku li jimblokka l-pulmun (COPD), minn moderat sa sever, ġew irrappurtati aktar tumuri malinni, l-aktar fil-pulmun, jew ir-ras u l-għonq, f'pazjenti kkurati b'infliximab meta pparagunati ma' pazjenti kontrollati.
English: Table 5: Radiographic Mean Changes Over 12 Months in Study III
Maltese: Table 5: Tibdil Medju Radjografiku fuq perjodu ta' 12 -il xahar fi Studju III
English: Skin and subcutaneous tissue disorders cutaneous vasculitis
Maltese: Tumuri malinni u disturbi fit-tkattir taċ-ċelloli fil-limfa.
English: During treatment with Trudexa, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Maltese: Matul il-kura b'Trudexa, terapiji oħra (eż., corticosteroids u/jew aġenti immunomodulatorji) għandhom jiġu aġġustati għall-aħjar effett.
English: Clinical remission
Maltese: KLINIKU
English: Common cough, nasopharyngeal pain congestion
Maltese: Mhux Komuni sinkope, migranja, tregħid, disturbi fl-irqad
English: Uncommon haematuria, renal impairment, bladder and urethral symptoms,
Maltese: Rari ematurja, indeboliment renali, sintomi filbużżieqa ta' l-awrina u fl-uretra proteinuria, uġigħ renali
English: In Study III, where Trudexa treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score and its components, the erosion score and joint space narrowing score.
Maltese: Fi Studju III, fejn pazjenti kkurati bTrudexa kienu ilhom ibatu mill-artrite rewmatika għal medja ta' 11 -il sena, il-ħsara strutturali fil-ġogi kienet stimata radjografikament u ġiet espressa bħala bidla filpunteġġ totali Sharp u l-komponenti tiegħu, il-punteġġ relatat ma' erożjoni u tnaqqis fl-ispazju filġogi.
English: Uncommon skin papilloma
Maltese: Biex tinjetta lilek innifsek
English: Take special care with Trudexa:
Maltese: Waqt il-kura b'Trudexa:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/003
Maltese: FIS-SUQ EU/1/03/257/003
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt il-kura ta' manteniment, il-corticosteroids jistgħu jiġu mnaqqsa ftit ftit sakemm ma jibqgħux jingħataw, u dan skond il-linji gwida tal-prattika klinika.
English: Pihatörmä 1A/Gårdsbrinken 1B FIN-02240 Espoo/Esbo Puh/Tel: + 358 (0) 9 7518 4120
Maltese: Pihatörmä 1A/Gårdsbrinken 1B FIN-02240
English: PHARMACEUTICAL FORM AND CONTENTS 2 pre-filled pens, each containing 40 mg adalimumab 2 alcohol pads
Maltese: U KONTENUT 2 siringi mimlijin għal-lest, li fihom 40 mg adalimumab kull waħda 2 kuxxinetti bl-alkoħol
English: • increased lipid values, appetite disorders;
Maltese: • żieda fil-valuri tal-lipidi, disturbi fl-aptit;
English: Week 26
Maltese: Ġimgħa 26
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Maltese: Kull kunjett b'doża waħda ta' 0.8 ml fih 40 mg adalimumab.
English: The second received 20 mg of Trudexa every week for 52 weeks.
Maltese: Tat-tieni grupp irċevew 20 mg ta' Trudexa kull ġimgħa għal 52 ġimgħa.
English: Study VI with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
Maltese: Studju VI li dam 24 ġimgħa, tratta 313 pazjent adult li kellhom rispons mhux adegwat għall-kura b'mediċina antiinfjammatorja mhux sterojdi, u minn dawn, bejn wieħed u ieħor 50% kienu qegħdin jieħdu methotrexate.
English: The injection is complete when the yellow indicator stops moving.
Maltese: L-injezzjoni tkun kompleta meta s-sinjal l-isfar jieqaf jiċċaqlaq.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/005
Maltese: FIS-SUQ EU/1/03/257/005
English: Thereafter, patients enrolled in an open-label extension phase in which 40 mg of Trudexa was administered every other week up to 60 months.
Maltese: Wara dan, il-pazjenti ħadu sehem fil-fazi ta' estenzjoni ta' l-istudju open-label fejn ingħataw 40 mg Trudexa ġimgħa iva u ġimgħa le sa 60 xahar.
English: In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Trudexa and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Trudexa monotherapy at week 52 and responses were sustained at week 104 (see Table 4).
Maltese: Fi Studju V li sar fuq pazjenti li jbatu minn artrite rewmatika li għada fil-bidu tagħha u li qatt ma ngħataw methotrexate, it-terapija kombinata b'Trudexa u methotrexate wasslet għal risponsi għallACR b'mod aktar mgħaġġel u li kienu sinifikatament akbar f'ġimgħa 52, milli meta ingħata methotrexate bħala kura waħdu u Trudexa bħala kura waħdu, u r-risponsi kienu mantenuti f'ġimgħa 104 (ara Tabella 4).
English: Subcutaneous use
Maltese: TAL-PRODOTT
English: Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients (Studies VI-VII) compared with patients in rheumatoid arthritis clinical studies.
Maltese: Provi kliniċi ta' l-artrite rewmatika: fi provi kliniċi kontrollati ta' l-artrite rewmatika (Studji
English: • If you develop symptoms of heart failure (shortness of breath or swelling of the feet) seek medical attention immediately.
Maltese: • Jekk tiżviluppa sintomi ta' insuffiċjenza tal-qalb (qtugħ ta' nifs jew nefħa fissaqajn), irrikorri għall-għajnuna medika immedjatament.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Maltese: Jekk jitfaċċaw sintomi tat-tuberkulosi (sogħla persistenti, tnaqqis fil-piż, nuqqas ta' kwiet fil-ġisem, deni ħafif), jew titfaċċa xi infezzjoni oħra waqt jew wara t-terapija, għid lit-tabib tiegħek immedjatament.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of Studies I − IX, CLASSIC I, GAIN and CHARM was 5.7% for patients taking Trudexa and 5.3% for control treated patients.
Maltese: I-IX, CLASSIC I, GAIN u CHARM ma baqgħux jieħdu l-kura minħabba effetti avversi kien ta' 5.7% għall-pazjenti li kienu qegħdin jieħdu Trudexa u 5.3% għal pazjenti kkurati b'mod kontrollat.
English: Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Maltese: L-anti-korpi monoklonali huma proteini li jagħrfu lil u jeħlu ma' proteini uniċi oħra.
English: EMA/818330/2015 EMEA/H/C/000613
Maltese: EMEA/H/C/000613
English: Evoltra clofarabine
Maltese: Evoltra klofarabin
English: Other information about Evoltra
Maltese: Informazzjoni oħra dwar Evoltra
English: The full EPAR for Evoltra 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: The summary of opinion of the Committee for Orphan Medicinal Products for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Evoltra jista' jinstab fuq is-sit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white blood cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Evoltra (li dehru f'aktar minn pazjent 1 minn 10) kienu newtropenja febrili (livelli baxxi ta' ċelloli bojod fid-demm bid-deni), ansjetà, uġigħ ta' ras, ħmura (ħmura tal-wiċċ), remettar, dijarea, nawżja (dardir), sindromu ta' eritrodisestesija palmo-plantari (raxx u wġigħ fl-idejn u s-saqajn), prurite (ħakk), piressija (deni), infjammazzjoni mukożali (infjammazzjoni tal-membrani umdi, bħar-rita tal-ħalq) u għeja.
English: This is a summary of the European public assessment report (EPAR) for Evoltra.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Evoltra.
English: In the main study, 20% of the patients went into remission (12 out of 61).
Maltese: Fl-istudju prinċipali, 20% tal-pazjenti marru f'remissjoni (12 minn 61).
English: Clofarabine is an ‘analogue' of adenine, which is part of the fundamental genetic material of cells (DNA and RNA).
Maltese: Il-klofarabin huwa ‘analogu' ta' adenin, li huwa parti mill-materjal ġenetiku fundamentali taċ-ċelloli (DNA u RNA).
English: What is the risk associated with Evoltra?
Maltese: X'inhu r-riskju assoċjat ma' Evoltra?
English: Evoltra is a cancer medicine that contains the active substance clofarabine.
Maltese: Evoltra huwa mediċina kontra l-kanċer li tinkludi s-sustanza attiva klorfarabin.
English: Evoltra has been authorised under ‘exceptional circumstances'.
Maltese: Evoltra ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: It belongs to the group of cancer medicines called ‘antimetabolites'.
Maltese: Din tappartjeni għall-grupp ta' mediċini kontra l-kanċer imsejjaħ 'antimetaboliti'.
English: Evoltra is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell).
Maltese: Evoltra jintuża biex jikkura tfal u adulti sa 21 sena b'lewkimja limfoblastika akuta (ALL), li hija kanċer tal-limfoċiti (tip ta' ċelloli bojod tad-demm).
English: Because the number of patients with ALL is low, the disease is considered ‘rare', and Evoltra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 February 2002.
Maltese: Minħabba li n-numru ta' pazjenti b'ALL huwa wieħed baxx, il-marda hija meqjusa bħala ‘rari', u Evoltra ġie denominat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fil-5 ta' Frar 2002.
English: Evoltra has been examined in one study of 61 patients below 21 years of age with ALL.
Maltese: Evoltra ġie eżaminat fi studju wieħed ta' 61 pazjent taħt l-età ta' 21 sena b'ALL.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Evoltra fid-29 ta' Mejju 2006.
English: A risk management plan has been developed to ensure that Evoltra is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Evoltra jintuża bl-aktar mod sigur possibbli.
English: What information is still awaited for Evoltra?
Maltese: Liema informazzjoni għadha mistennija għal Evoltra?
English: The average age of the treated patients was 12 years.
Maltese: L-età medja tal-pazjenti kkurati kienet ta' 12-il sena.
English: This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
Maltese: Dan ifisser illi l-klofarabin jissostitwixxi l-adenin fil-ġisem, u jinterferixxi mal-enzimi involuti fil-produzzjoni ta' materjal ġenetiku, imsejjaħ 'polimerażi tad-DNA' u 'reduktażi tal-RNA'.
English: The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells).
Maltese: Is-sustanza attiva f'Evoltra, il-klofarabin, hija ċitotossika (mediċina li toqtol ċelloli li qegħdin jinqasmu, bħaċ-ċelloli tal-kanċer).
English: The recommended dose is 52 mg per square metre of body surface area (calculated using the patient's height and weight).
Maltese: Id-doża rakkomandata hija ta' 52 mg għal kull metru kwadru tal-erja tas-superfiċje tal-ġisem (ikkalkulata permezz tat-tul u l-piż tal-pazjent).
English: The company that makes Evoltra will set up a registry to monitor the medicine's side effects.
Maltese: Il-kumpanija li tipproduċi Evoltra se tistabbilixxi reġistru biex timmonitorja l-effetti sekondarji talmediċina.
English: After treatment with Evoltra, 10 patients were able to go on to have a stem cell transplant.
Maltese: Wara kura b'Evoltra, 10 pazjenti seta' jsirilhom trapjant ta' ċelloli staminali.
English: What benefit has Evoltra shown during the studies?
Maltese: Liema benefiċċju wera Evoltra matul l-istudji?
English: Overall, the patients in the study survived for an average of 66 weeks.
Maltese: B'mod ġenerali, il-pazjenti flistudju għexu għal medja ta' 66 ġimgħa.
English: How has Evoltra been studied?
Maltese: Kif ġie studjat Evoltra?
English: How does Evoltra work?
Maltese: Għal xiex jintuża Evoltra?
English: Stem cells are cells that can develop into different types of cell.
Maltese: Iċ-ċelloli staminali huma ċelloli li jistgħu jiżviluppaw f'tipi differenti ta' ċelloli.
English: Sachet (PE/alu/PET)
Maltese: Qartas (PE/alu/PET)
English: 100 mg Powder for Oral Suspension
Maltese: 100 mg Trab għal suspensjoni orali
English: 30 sachets + 2 syringes + 1 mixing cup
Maltese: 30 qratas + 2 siringi + 1 tazza tat-taħlit
English: MA EU Number (Invented) name
Maltese: Numru ta' l-EU Isem (ivvintat)
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 1 vial
Maltese: 5 kunjetti
English: EU/1/16/1098/001 EU/1/16/1098/002 EU/1/16/1098/003 EU/1/16/1098/004 EU/1/16/1098/005
Maltese: EU/1/16/1098/001 EU/1/16/1098/002 EU/1/16/1098/003 EU/1/16/1098/004
English: 1 See section 4.2; NA: Not available
Maltese: 1 Ara sezzjoni 4.2; NA: Mhux disponibbli
English: QR code to be included + http://www.alprolix-instructions.com
Maltese: QR biex tiġi inkluża + http://www.alprolix-instructions.com
English: See sections 5.1 and 5.2.
Maltese: Ara sezzjonijiet 5.1 u 5
English: Factor IX level required (%) (IU/dL)
Maltese: fattur IX (%) (IU/dL)
English: Perioperative management (surgical prophylaxis):
Maltese: Immaniġġjar perioperattiv (profilassi kirurġika):
English: Powder: sucrose, L-histidine, mannitol, polysorbate 20, sodium hydroxide, hydrochloric acid
Maltese: Trab: sucrose, L-histidine, mannitol, polysorbate 20, sodium hydroxide, hydrochloric acid
English: Each vial of ALPROLIX contains nominally 250, 500, 1000, 2000 or 3000 IU eftrenonacog alfa.
Maltese: Kull kunjett ta' ALPROLIX nominalment fih 250, 500, 1000, 2000 jew 3000 IU ta' eftrenonacog alfa.
English: Table 3: Pharmacokinetic parameters of ALPROLIX (50 IU/kg dose)
Maltese: Tabella 3: Parametri farmakokinetiċi ta' ALPROLIX (doża ta' 50
English: Table 5: Comparison of PK Parameters of ALPROLIX (rFIXFc) by Age Category PK Parameters1
Maltese: Paragun tal-Parametri PK ta' ALPROLIX (rFIXFc) skont il-Kategorija ta' Età Parametri PK1
English: Table 2: Adverse reactions reported for ALPROLIX in clinical trials
Maltese: Tabella 2: Reazzjonijiet avversi rrappurtati għal ALPROLIX fil-provi klinici
English: ALPROLIX 250 ALPROLIX 500 ALPROLIX 1000 ALPROLIX 2000 ALPROLIX 3000
Maltese: ALPROLIX 250 ALPROLIX 500
English: MRT (h) Vss (mL/kg) Time to 1% (days)2
Maltese: Vss (mL/kg) Żmien sa 1% (jiem)2
English: • The active substance is eftrenonacog alfa (recombinant coagulation factor IX, Fc fusion protein).
Maltese: • Is-sustanza attiva hi eftrenonacog alfa (fattur tal-koagulazzjoni IX rikombinanti, proteina talfużjoni Fc).
English: Adverse events were monitored for a total of 561 subject years.
Maltese: Avvenimenti avversi ġew immonitorjati għal total ta' 561 sena ta'