FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Docetaxel Accord 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: Docetaxel Accord docetaxel
Maltese: Docetaxel Accord doketaksel
English: Docetaxel Accord is a ‘generic medicine'.
Maltese: Docetaxel Accord huwa ‘medeċina ġenerika'.
English: Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines);
Maltese: Docetaxel Accord jintuża mal-prednisonu jew mal-prednisolonu (mediċini anti-infjammatorji);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Accord on 22 May 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Docetaxel Accord fit-22 ta' Mejju 2012.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Accord.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Docetaxel Accord.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil.
Maltese: Docetaxel Accord jintuża maċ-ċisplatinu u mal-5-fluorouraċile.
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, intwera li Docetaxel Accord huwa komparabbli ma' Taxotere.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Maltese: Docetaxel Accord jintuża maċ-ċisplatinu u mal-5-fluorouraċile (mediċini oħrajn ta' kontra l-kanċer);
English: Docetaxel Accord is a medicine that contains the active substance docetaxel.
Maltese: Docetaxel Accord huwa mediċina li fiha s-sustanza attiva doketaksel.
English: Docetaxel Accord is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Maltese: Docetaxel Accord jintuża biss meta l-għadd ta' newtrofili (il-livell ta' tip ta' ċellola bajda fid-demm) ikun normali (mill-inqas 1,500 ċellola/mm3).
English: Other information about Docetaxel Accord
Maltese: Informazzjoni oħra dwar Docetaxel Accord
English: The active substance in Docetaxel Accord, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva f'Docetaxel Accord, id-doketaksel, tappartieni lill-grupp ta' mediċini ta' kontra lkanċer magħrufa bħala tassani.
English: This means that Docetaxel Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Maltese: Dan ifisser li Docetaxel Accord huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) bl-isem Taxotere.
English: What is Docetaxel Accord?
Maltese: X'inhu Docetaxel Accord?
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: Jista' jintuża wkoll ma' mediċini oħrajn kontra l-kanċer (id-doksorubiċina, iċ-ċiklofosfamide, ittrastużumab jew il-kapeċitabina) fuq pazjenti li ma jkunu għadhom ingħataw l-ebda kura għallkanċer tagħhom jew wara li kuri oħrajn ma jkunux ħadmu, skont it-tip u l-istadju ta' kanċer tassider li jkun qed jiġi ttrattat;
English: Because Docetaxel Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Docetaxel Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Taxotere, il-benefiċċju huwa akbar mir-riskju identifikat.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Maltese: • adenokarċinoma gastriku (tip ta' kanċer tal-istonku) fuq pazjenti li ma jkunu għadhom ingħataw lebda kura għall-kanċer tagħhom.
English: Why has Docetaxel Accord been approved?
Maltese: Għaliex ġie approvat Docetaxel Accord?
English: No additional studies were needed as Docetaxel Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Maltese: L-ebda studju addizzjonali ma kien meħtieġ minħabba li Docetaxel Accord huwa mediċina ġenerika li tingħata b'infużjoni u fiha l-istess sustanza attiva bħall-mediċina ta' referenza, Taxotere.
English: It is available as a concentrate to be made up into a solution for infusion (drip into a vein).
Maltese: Jiġi f'konċentrat li jitħallat f'soluzzjoni għall-infużjoni (dripp fil-vina).
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Accord infusion.
Maltese: Lill-pazjent għandha tingħatalu wkoll mediċina anti-infjammatorja, bħad-deksametasonu, fil-jum ta' qabel l-infużjoni b'Docetaxel Accord.
English: Docetaxel Accord should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Maltese: Jista' jintuża wkoll maċ-ċisplatinu (mediċina oħra kontra l-kanċer) fuq pazjenti li ma jkunu għadhom ingħataw l-ebda kura għall-kanċer tagħhom;
English: Dose (U/kg)
Maltese: Doża (U/kg)
English: ATC code: B02BD14
Maltese: B02BD14
English: Baxalta US, Inc 27 Maple Street Milford
Maltese: US, Inc Baxter Milford 27 Maple Street Milford
English: Tmax (h)
Maltese: t½ (h) Tmax (h)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11 ta' Novembru, 2015
English: It is a glycoprotein.
Maltese: Huwa glikoproteina.
English: 10000 133.3 N/A 4.2 0.75 178 1583 1686 Amax = maximum observed % activity; AUC0-t = area under the concentration-time curve from time 0 to the last measurable concentration; AUC0-∞ = area under the concentration-time curve from time 0 extrapolated to infinity; t½ = terminal half-life; Tmax = time of maximum observed % activity, N/A = not available.
Maltese: 10000 133.3 N/A 4.2 0.75 178 1583 1686 Amax = attività % massima osservata; AUC0-t = erja taħt il-kurva tal-konċentrazzjoni-ħin minn ħin 0 sal-aħħar konċentrazzjoni mkejla; AUC0-∞ = erja taħt il-kuva tal-konċentrazzjoni-ħin minn ħin 0 estrapolata sal-infinità; t½ = half-life terminali;
English: Tabulated list of adverse reactions:
Maltese: Lista tabulata tar-reazzjonijiet avversi:
English: 500 U
Maltese: OBIZUR 500
English: A total of 24/28 (86%) had successful control (resolution) of the initial bleeding episode.
Maltese: Total ta' 24/28 (86%) kellhom kontroll (riżoluzzjoni) li rnexxa tal-episodju ta' fsada inizjali.
English: The osmolality of the formulation buffer ranges between 59 and 65 10% mOsm/kg H2O.
Maltese: L-osmolalità tal-firxiet ta' protezzjoni tal-formulazzjonijiet tvarja bejn 59 u 65 10% mOsm/kg H2O.
English: Do not over tighten (Figure D).
Maltese: Tissikkax iżżejjed (Figura D).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: 17 IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: • Alcohol swabs
Maltese: • Swabs tal-alkoħol
English: OBIZUR (antihaemophilic Factor VIII (recombinant), porcine sequence) is a purified protein that has 1448 amino acids with an approximate molecular mass of 175kDa.
Maltese: OBIZUR (Fattur VIII antiemofiliku (rikombinanti), sekwenza tal-porċini) huwa proteina ppurifikata li għandha 1448 aċidu amminiku b'massa molekulari ta' madwar 175 kDa.
English: Subject Dose (U)
Maltese: Individwu Doża (U)
English: • Same number of 1 mL solvent syringes and sterile vial adapters
Maltese: • L-istess numru ta' siringi ta' solvent ta' 1 mL u adapters tal-kunjetti sterili
English: Remove the plastic package (Figure E).
Maltese: Neħħi l-pakkett tal-plastik (Figura E).
English: Manufacturer Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Maltese: Manifattur Baxter AG Industriestrasse 67 A-1221 Vienna L-Awstrija
English: Frequencies have been evaluated according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi ġew evalwati skont il-konvezjoni li ġejja: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Frequency and Duration of Subsequent Dosing
Maltese: Frekwenza u Durata tad-Dożaġġ Sussegwenti
English: - The solvent is 1 ml sterilised water for injections.
Maltese: - Is-solvent huwa 1 ml ilma sterilizzat għall-injezzjonijiet.
English: A positive response was observed in 95% (19/20) of subjects evaluated at 8 hours and 100% (18/18) at 16 hours.
Maltese: Ġie osservat rispons pożittiv f'95% (19/20) tal-individwi evalwati wara 8 sigħat u 100% (18/18) wara 16-il siegħa.
English: The median number of daily infusions per subject was 1.76 (range: 0.2 to 5.6).
Maltese: In-numru medjan ta' infużjonijiet ta' kuljum għal kull individwu kien 1.76 (medda: 0.2 sa 5.6).
English: • fluid transfer device with an integral plastic spike
Maltese: • apparat għat-trasferiment tal-fluwidu b'ponta tal-plastik integrali
English: Baseline hFVIII activity t½ (h)
Maltese: Attività hFVIII fil-linja bażi (%)
English: Preferred MedDRA term Frequency
Maltese: Terminu MedDRA preferut
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hija skont is-sistema tal-klassifika tal-organi MedDRA (SOC u Livell ta' Terminu Preferut).
English: OTHER Baxalta Logo
Maltese: OĦRAJN Baxalta Logo
English: - The other ingredients in the powder are polysorbate 80, sodium chloride (see also section 2),
Maltese: - Is-sustanzi l-oħra fit-trab huma polysorbate 80, sodium chloride (ara wkoll is-sezzjoni 2),
English: Positive test for inhibitory antibodies against porcine Factor VIII (see section 4.4)
Maltese: Test pożittiv għal antikopri inibitorji kontra l-Fattur VIII tal-porċini (ara sezzjoni 4.4)
English: The maximum blood FVIII activity must not exceed 200%.
Maltese: L-attività massima fid-demm ta' FVIII ma għandhiex taqbeż il-200%.
English: In the clinical trial of OBIZUR for acquired haemophilia, 29 adult subjects were evaluable for safety.
Maltese: Fil-prova klinika ta' OBIZUR għal emofilja akkwiżita, 29 individwu adult setgħu jiġu evalwati għas-sigurtà.
English: • pre-filled (type I glass) syringes with a stopper (butyl rubber), a rubber tip cap and a Luer Lock adapter
Maltese: • siringi mimlijin għal-lest (ħġieġ tat-tip I) b'tapp (lastku tal-butyl), għatu b'ponta tal-lastku u adapter Luer Lock
English: Development of inhibitory antibodies
Maltese: Żvilupp ta' antikorpi inibitorji
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: 18 IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC:
English: Major moderate to severe intramuscular, retroperitoneal, gastrointestinal, intracranial bleeding
Maltese: Fsada ġol-muskoli, retroperitonali, gastrointestinali, fil-kranju moderata sa severa kbira
English: Solvent Sterilised water for injections
Maltese: Solvent Ilma sterilizzat għall-injezzjonijiet
English: Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
Maltese: Kull kunjett fih 4.4 mg (198 mM) sodju għal kull ml ta' soluzzjoni rikostitwita.
English: Marketing authorisation holder Baxalta Innovations GmbH Industriestrasse 67
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Baxalta Innovations GmbH Industriestrasse 67
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) are possible and may progress to severe anaphylaxis (including shock) (see section 4.4).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjodema, ħruq u tingiż fis-sit tal-injezzjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, nawsja, irrikwetezza, takikardija, tagħfis tas-sider, tnemnim, rimettar, tħarħir) huma possibbli u jistgħu jaggravaw għal anafilassi severa (inkluż xokk) (ara sezzjoni 4.4).
English: Monitor Factor VIII activity and clinical condition 30 minutes after the first injection and 3 hours after administering OBIZUR.
Maltese: Immonitorja l-attività tal-Fattur VIII u l-kundizzjoni klinika 30 minuta wara l-ewwel injezzjoni u 3 sigħat wara l-għoti ta' OBIZUR.
English: Of those subjects treated with OBIZUR as first-line therapy, defined as no immediate previous use of anti-haemorrhagic agents prior to the first OBIZUR treatment, 16/17 (94%) had eventual treatment success reported.
Maltese: Minn dawk l-individwi kkurati b'OBIZUR bħala t-terapija preferuta, iddefiniti bħala l-ebda użu preċedenti immedjat ta' aġenti kontra l-emorraġiji qabel l-ewwel kura b'OBIZUR, 16/17 (94%) kienu rrapportaw li eventwalment il-kura rnexxiet.
English: One pack of OBIZUR contains 1, 5 or 10 each of the following
Maltese: Pakkett wieħed ta' OBIZUR fih 1, 5 jew 10 minn dawn
English: Baxter AG Industriestrasse 67 A-1221 Vienna AUSTRIA
Maltese: Baxter AG Industriestrasse 67 1221 Vjenna L-AWSTRIJA
English: OBIZUR contains the active substance susoctocog alfa, antihaemophilic Factor VIII, porcine sequence.
Maltese: OBIZUR fih is-sustanza attiva susoctocog alfa,il-Fattur VIII antiemofiliku, sekwenza tal-porċini.
English: You should be aware of the early signs of allergic reactions (see section 4 for signs and symptoms).
Maltese: Għandek tkun konxju tas-sinjali bikrin ta' reazzjonijiet allerġiċi (ara sezzjoni 4 għal sinjali u sintomi).
English: The safety and efficacy of OBIZUR for the treatment of serious bleeding episodes in subjects with acquired haemophilia with autoimmune inhibitory antibodies to human Factor VIII was investigated in a prospective, non-randomised, open-label trial of 28 subjects (18 Caucasian, 6 Black, and 4 Asian).
Maltese: Is-sigurtà u l-effikaċja ta' OBIZUR għall-kura ta' episodji ta' fsada serji f'individwi b'emofilja akkwiżita b'antikopri inibitorji awtoimmuni għall-Fattur VIII tal-bniedem kienu investigati fi prova b'tikketta mikxufa, mhux randomizzata, prospettiv ta' 28 individwu (18-il Kawkasu, 6 Suwed, u 4 Ażjatiċi).
English: Activated Factor VIII acts as a co-factor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X, which ultimately converts prothrombin into thrombin.
Maltese: Il-Fattur VIII attivat jaġixxi bħala ko-fattur għall-Fattur IX attivat, u jaċċellera l-konverżjoni tal-Fattur X għal Fattur X attivat, li finalment jikkonverti l-protrombina f'trombina.
English: • Health care professional brochure including a detailed calculation of number of vials for a patient weighing for example 70 kg
Maltese: • Fuljett għall-professjonisti tal-kura tas-saħħa inkluż kalkolu dettaljat tan-numru ta' kunjetti għal pazjent li jiżen pereżempju 70 kg
English: What OBIZUR contains - The active substance is susoctocog alfa (antihaemophilic Factor VIII, porcine sequence produced by recombinant DNA technology).
Maltese: X'fih OBIZUR - Is-sustanza attiva hijasusoctocog alfa (Fattur VIII antiemofiliku, sekwenza tal-porċini prodotta b'teknoloġija tad-DNA rikombinanti).
English: Table 1: Individual pharmacokinetic data for factor VIII activity after administration of the final dose of OBIZUR to 5 subjects with acquired haemophilia.
Maltese: Tabella 1: Dejta farmakokinetika tal-individwi għall-attività tal-fattur VIII wara l-għoti tad-doża finali ta' OBIZUR lil 5 individwi b'emofilja akkwiżita.
English: Initial dose (U/kg)  Product strength (U/vial) × Body weight (kg) = Number of vials e.g. for a 70 kg subject the number of vials for an initial dose will be calculated as follows: 200 U/kg  500 U/vial × 70 kg = 28 vials
Maltese: Doża tal-bidu (U/kg)  Qawwa tal-prodott (U/kunjett) × Piż tal-ġisem (kg) = Numru ta' kunjetti eż. għal individwu ta' 70 kg, in-numru ta' kunjetti għal doża inizjali ser jiġi kkalkolat kif ġej: 200
English: Although factor VIII activity determined by the chromogenic assay is generally lower than the Factor VIII activity determined by the one-stage clotting assay, post-infusion Factor VIII activities in patients with acquired haemophilia in clinical study OBI-1-301 tended to be higher when determined with the chromogenic assay than with the one-stage clotting assay (see section 4.4).
Maltese: Għalkemm l-attività tal-fattur VIII determinata mill-assaġġ kromoġeniku hija ġeneralment iktar baxxa mill-attività ta' Fattur VIII determinata mill-assaġġ ta' għaqid tad-demm ta' stadju wieħed, attivitajiet ta' Fattur VIII ta' wara l-infużjoni f'pazjenti b'emofilja akkwiżita fi studju kliniku OBI-1-301 kellhom it-tendenza li jkunu ogħla meta ddeterminati bl-assaġġ kromoġeniku milli bl-assaġġ ta' għaqid tad-demm ta' stadju wieħed (ara sezzjoni 4.4).
English: - Swelling of lips and tongue - Burning and stinging at the injection site - Chills, flushing - Hives, generalised itching - Headache, low blood pressure - Lethargy, sickness, restlessness - Rapid beating of the heart, tightness of the chest - Tingling, vomiting - Wheezing
Maltese: - Nefħa fix-xufftejn u l-ilsien - Ħruq u tingiż fis-sit tal-injezzjoni - Tertir, fwawar - Urtikarja, ħakk ġeneralizzat - Uġigħ ta' ras, pressjoni għolja tad-demm - Letarġija, mard, nuqqas ta' kwiet - Taħbit mgħaġġel tal-qalb, tagħfis tas-sider - Tnemnim, rimettar - Tħarħir
English: The Factor VIII/von Willebrand factor complex consists of two molecules (Factor VIII and von Willebrand factor) with different physiological functions.
Maltese: Il-kumpless tal-Fattur VIII/fattur von Willebrand jikkonsisti minn żewġ molekuli (il-Fattur VIII u l-fattur von Willebrand) b'funzjonijiet fiżjoloġiċi differenti.
English: In the initial 24 hour period, the median total dose of 493 U/kg were utilized in the clinical study with a median of 3 infusions.
Maltese: Fil-perjodu inizjali ta' 24 siegħa, intużat id-doża totali medjana ta' 493 U/kg fl-istudju kliniku b'medjan ta' 3 infużjonijiet.
English: Dosing
Maltese: Pożoloġija
English: Monitor Factor VIII activity immediately prior to and 30 minutes after subsequent doses and refer to the table below for recommended target Factor VIII trough levels.
Maltese: Immonitorja l-attività tal-Fattur VIII minnufih qabel u 30 minuta wara dożi sussegwenti u rreferi għat-tabella hawn taħt għal-livelli minimu ta' Fattur VII fil-mira rrakkomandati.
English: Use aseptic technique during the reconstitution procedure.
Maltese: Uża teknika asettika matul il-proċedura ta' rikostituzzjoni.
English: High and sustained Factor VIII activity in blood may predispose to thromboembolic events.
Maltese: Attività għolja u sostnuta ta' Fattur VIII fid-demm tista' tippredisponi għal episodji tromboemboliċi.
English: Pharmacokinetic data from 5 subjects with acquired haemophilia whilst in a non-bleeding state are presented in Table 1.
Maltese: Dejta farmakokinetika minn 5 individwi b'emofilja akkwiżita waqt stat mhux ta' fsada hija ppreżentata fit-Tabella 1.
English: Inhibitor titres of up to 29 Bethesda units were recorded at baseline yet subjects responded positively to OBIZUR.
Maltese: Titri tal-inibitur sa 29 unità ta' Bethesda kienu rreġistrati fil-linja bażi, madankollu l-individwi rrispondew b'mod pożittiv għal OBIZUR.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity.However, in repeated dose toxicity studies, the incidence and severity of glomerulopathy observed in monkeys intravenously administered OBIZUR at doses of 75, 225 and 750 U/kg/day tended to increase over time.
Maltese: Madankollu, fi studju dwar tossiċità minn doża ripetuta, l-inċidenza u s-severità ta' glomerulopatija osservata fix-xadini li ngħataw OBIZUR fil-vina f'dożi ta' 75, 225 u 750
English: The mean recovery rate after the initial dose of 200 U/kg was 1.06 ± 0.75 U/ml per U/kg (range 0.10-2.61) measured with the one stage coagulation assay.
Maltese: Ir-rata medja ta' rkupru wara d-doża tal-bidu ta' 200 U/kg kienet 1.06 ± 0.75 U/ml għal kull U/kg (medda ta' 0.10-2.61) imkejla bl-assaġġ ta' koagulazzjoni fi stadju wieħed.
English: Remove the plastic cap from the OBIZUR powder vial (Figure A).
Maltese: Neħħi l-għatu tal-plastik mill-kunjett ta' trab ta' OBIZUR (Figura A).
English: Three subjects included in pharmacokinetic analysis had a detectable anti-porcine factor VIII inhibitor titre at baseline (≥ 0.6 Bethesda Units (BU)/mL).
Maltese: Tliet individwi inklużi fl-analiżi farmakokinetika kellhom titri tal-inibitur tal-fattur VIII kontra l-porċini rilevabbli fil-linja bażi (≥ 0.6
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu <, and on the website of {name of MS Agency (link)}>.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu < u fuq is-sit elettroniku ta' {isem ta' l-Istat Membru/Aġenzija (link)}>.
English: Prior to launch of Obizur in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' OBIZUR f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-programm edukattiv, inkluż il-mezz ta' komunikazzjoni, il-modalitajiet tad-distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Efficacy and safety data in patients with acquired haemophilia are limited (see section 5.1).
Maltese: Id-dejta dwar l-effikaċja u s-sigurtà f'pazjenti b'emofilja akkwiżita huma limitati (ara sezzjoni 5.1).
English: Excipient(s) with known effect Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
Maltese: Eċċipjent(i) b'effett magħruf Kull kunjett fih 4.4 mg (198 mM) sodju għal kull ml ta' soluzzjoni rikostitwita.
English: Snap off the tamper resistant cap of the pre-filled solvent syringe (Figure C).
Maltese: Aqsam l-għatu kontra t-tbagħbis tas-siringa tas-solvent mimlija għal-lest (Figura C).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1035/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1035/001
English: OBIZUR 500 U powder and solvent for solution for injection Susoctocog alfa
Maltese: U trab u solvent għal soluzzjoni għall-injezzjoni Susoctocog alfa
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi awtorizzazzjoni għat-tqegħid fis-suq taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) Nru 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li gejjin:
English: Peel back the cover of the vial adapter package (Figure B).
Maltese: Neħħi l-għatu mill-pakkett tal-adapter tal-kunjett (Figura B).
English: Common side effects (may affect up to 1 in 10 people) - Development of antibodies against the medicine
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) - L-iżvilupp ta' antikorpi kontra l-mediċina