FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim and 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of -16.8 %,-1.1 %).
Maltese: Irrata totali ta' newtropenija bid-deni kienet ta' 9% tal-pazjenti ttrattati b'pegfilgrastim u 18% talpazjenti ttrattati b'filgrastim (differenza ta' 9%, CI ta' 95% ta' -16.
English: - sickle cell crises in patients with sickle cell anaemia.
Maltese: - jekk inti għandek anemija taċ-ċellula sickle.
English: - Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Maltese: - Sindrome ta' Stevens-Johnson, li tista' tidher bħala rqajja' ċirkulari ħomor li jixbhu l-bersalli, ħafna drabi b'infafet ċentrali fuq it-torso, tqaxxir tal-ġilda, ulċeri fil-ħalq, il-griżmejn, limnieħer, il-ġenitali u l-għajnejn u li tista' tibda b'deni u sintomi li jixbhu l-influwenza.
English: Thrombocytopenia1 Leukocytosis1
Maltese: Uġigħ fis-sit talinjezzjoni1;
English: Patients with renal impairment
Maltese: Sindrome ta' Distress
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Maltese: Fi-provi kliniċi, pegfilgrastim ingħata b'mod sikur 14-il jum qabel il-kimoterapija.
English: There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Maltese: M'hemmx informazzjoni suffiċjenti dwar l-eliminazzjoni ta' pegfilgrastim/metaboliti fil-ħalib tas-sider tal-bniedem, u riskju għat-trabi ta' twelid/trabi ma jistax jiġi eskluż.
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile neutropenia.
Maltese: Fin-nuqqas ta' appoġġ ta' fattur tat-tkabbir, ġie rrappurtat li dan il-kors ta' dożaġġ iwassal għal newtropenija ta' grad 4 li ddum medja ta' 5 sa 7 ijiem, u inċidenza ta' 30 - 40% ta' newtropenija bid-deni.
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 4.8 and 5.2).
Maltese: Barra dan kienet osservata inċidenza ogħla ta' newtropenija bid-deni fi tfal iżgħar b'età ta' 0-5 snin (75%) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (70% u 33%, rispettivament) u ma' adulti (ara sezzjonijiet 4.8 u 5.2).
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Maltese: Intwera li pegfilgrastim u filgrastim għandhom modi ta' azzjoni identiċi, u jikkawżaw żieda sinifikanti fl-għadd ta' newtrofili fid-demm periferali fi żmien 24 siegħa, b'żidiet minuri fil-monoċiti u/jew fil-limfoċiti.
English: The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Maltese: L-avvenimenti avversi kienu simili għal dawk f'individwi li jirċievu dożi aktar baxxi ta' pegfilgrastim.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m² every 3 weeks for 4 cycles).
Maltese: Fi studju double-blind, ikkontrollat bil-plaċebo, f'pazjenti b'kanċer tas-sider ġie evalwat l-effett ta' pegfilgrastim fuq l-inċidenza tan-newtropenija bid-deni wara l-għoti ta' kors ta' kimoterapija assoċjat ma' rata ta' newtropenija bid-deni ta' 10-20% (docetaxel 100 mg/m² kull 3 ġimgħat għal 4 ċikli).
English: Capillary leak syndrome
Maltese: Sindrome ta' tnixxija tal-kapillari
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Maltese: Żidiet ħfief sa moderati li jerġgħu lura għan-normal, u mingħajr effetti kliniċi assoċjati, fil-uric acid u f'alkaline phosphatase kienu osservati b'mod mhux komuni; żidiet ħfief sa moderati li jerġgħu lura għan-normal, u mingħajr effetti kliniċi assoċjati, f'lactate dehydrogenase, kienu osservati b'mod mhux komuni f'pazjenti li ngħataw pegfilgrastim wara kimoterapija ċitotossika.
English: Common side effects (may affect up to 1 in 10 people) - pain at the site of injection.
Maltese: Effetti Komuni (jistgħu jaffetwaw sa wieħed minn kull 10 persuna) - uġigħ fil-post tal-injezzjoni.
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Maltese: Is-sigurtà u l-effikaċja ta' pegfilgrastim ma ġewx investigati f'pazjenti b'sindrome majelodisplastika, lewkimja majeloġenika kronika, u f'pazjenti b'Lewkimja Majelojde Akuta (AML) sekondarja; għalhekk, dan m'għandux jintuża f'pazjenti bħal dawn.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Għalhekk, id-daqs tal-milsa għandu jiġi mmonitorjat b'attenzjoni (per eżempju b'eżaminazzjoni klinika, b'eżami ultrasoniku).
English: 1 single use pre-filled syringe with automatic needle guard (0.6 mL).
Maltese: 1 siringa mimlija għal-lest għall-użu ta' darba b'għatu ta' protezzjoni tal-labra awtomatiku (0.6 mL).
English: • Keep used syringes out of the sight and reach of children.
Maltese: • Fulphila jingħata bħala injezzjoni fit-tessut kemm kemm taħt il-ġilda.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulphila 6 mg injection pegfilgrastim
Maltese: U MNEJN GĦANDU JINGĦATA Fulphila 6 mg injezzjoni pegfilgrastim
English: Pregnancy and breast--feeding
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim* f'0.6 mL ta' soluzzjoni għall-injezzjoni.
English: The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Maltese: Is-sigurtà u l-effikaċja ta' pegfilgrastim ma ġewx evalwati f'pazjenti li kienu qed jirċievu kimoterapija assoċjata ma' majelosoppressjoni ittardjata eż., nitrosoureas.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: * Magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija tat-tfassil tad-DNA segwita minn konjugazzjoni ma' polyethylene glycol (PEG). ** Il-konċentrazzjoni hija ta' 20 mg/mL jekk jiġi inkluż il-porzjoni PEG.
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim,
Maltese: II, randomised u double-blind f'pazjenti li kienu qed jirċievu kimoterapija għal lewkimja majelojde akuta de novo, pegfilgrastim (doża waħda ta' 6 mg) kien imqabbel ma' filgrastim, mogħtija waqt kimoterapija ta' induzzjoni.
English: This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Maltese: Din il-mediċina fiha 30 mg ta' sorbitol f'kull siringa mimlija għal-lest li hu ekwivalenti għal 50 mg/mL.
English: Each pack contains 1 pre-filled syringe.
Maltese: Kull pakkett fih 1 siringa mimlija għal-lest.
English: - serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
Maltese: - reazzjonijiet allerġiċi serji, inkluż anafilassi (debbulizza, pressjoni titbaxxa, tbatija biex tieħu n-nifs, nefħa fil-wiċċ).
English: Fulphila is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Maltese: Fulphila jintuża biex inaqqas id-dewmien ta' newtropenija (għadd baxx ta' ċelluli bojod fid-demm) u l-okkorrenza ta' newtropenija bid-deni (għadd baxx ta' ċelluli bojod fid-demm u deni) li jistgħu jkunu kkawżati minn kimoterapija ċitotossika (mediċini li jeqirdu ċ-ċelluli li jikbru malajr).
English: Rare side effects (may affect up to 1 in 1,000 people) - inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Maltese: Effetti sekondarji rari (jistgħu jaffetwaw sa wieħed minn kull 1,000 persuna) - infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għallġisem), ara sezzjoni 2. - fsada mill-pulmun (emorraġija pulmonari).
English: Long term outcome was not studied (see section 4.4).
Maltese: Ir-riżultat fit-tul ma ġiex studjat (ara sezzjoni 4.4).
English: Mylan EPD bvba/sprl
Maltese: ImportantI: aqbad is-siringa kif muri fl-istampa
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pegfilgrastim, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal pegfilgrastim, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Fulphila is injected subcutaneously.
Maltese: Fulphila jiġi injettat taħt il-ġilda.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Maltese: Mhux rakkomandata bidla fid-doża f'pazjenti b'indeboliment tal-kliewi, inkluż dawk b'mard tal-kliewi fl-aħħar stadju.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Fulphila: - if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch.
Maltese: Twissijiet u prekawzjonijiet Kellem lit-tabib, lill-ispiżjar jew lill-infermier tiegħek qabel tuża Fulphila: - jekk inti jkollok reazzjoni allerġika inkluż indeboliment, tbaxxija tal-pressjoni tad-demm, diffikultà biex tieħu n-nifs, nefħa fil-wiċċ (anafilassi), ħmura u fwawar, raxx tal-ġilda u partijiet tal-ġilda bil-ħakk. - jekk inti jkollok sogħla, deni u diffikultà biex tieħu nifs.
English: You can use:
Maltese: Important:
English: - chest pain.
Maltese: Aħżen fi friġġ.
English: Fulphila contains sorbitol and sodium acetate This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Maltese: Dan il-prodott mediċinali fih 30 mg ta' sorbitol f'kull siringa mimilja għal-lest li hu ekwivalenti għal 50 mg/mL.
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Maltese: Sensittività eċċessiva, inkluż reazzjonijiet anafilattiċi, li seħħew mal-ewwel trattament jew ma' trattament sussegwenti ġew irrappurtati f'pazjenti ttrattati b'pegfilgrastim.
English: There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Maltese: Ma kien hemm l-ebda effett avvers osservat fil-frieħ ta' firien tqal li ngħataw pegfilgrastim taħt ilġilda, iżda fil-fniek pegfilgrastim intwera li jikkawża tossiċità fl-embriju/fetu (telfien tal-embriju) b'dożi kumulattivi bejn wieħed u ieħor 4 darbiet id-doża rakkomandat għall-bniedem, li ma dehrux meta fniek tqal ġew esposti għad-doża rakkomandata fil-bniedem.
English: 1 tablet bottle (glass) + syringe (plastic)
Maltese: Daqs talpakkett flixkun (ħġieġ) + siringa (plastik)
English: MA (EU) Number (Invented) name
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 25 January 2010
Maltese: 25 ta' Jannar 2010
English: 1 Article 33 (4) of Directive 2001/82/EC.
Maltese: 1 L-Artikolu 33 (4) tad-Direttiva 2001/82/KE.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Spain, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovakia and Slovenia.
Maltese: L-applikazzjoni ġiet ippreżentata fil-qafas tal-Artikolu 32 tadDirettiva 2001/82/KE, kif emendata, fejn l-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri kkonċernati kienu l-Belġju, il-Bulgarija, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, Spanja, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latva, il-Litwanja, l-Olanda, il-Polonja, ilPortugall, ir-Rumanija, is-Slovakkja u s-Slovenja.
English: The Mutual Recognition Procedure UK/V/0335/001/MR started on 29 January 2009.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku UK/V/0335/001/MR bdiet fid-29 ta' Jannar 2009.
English: The Rapporteur and Co-Rapporteur appointed were Dr. F. Descamps (Belgium) and Dr. A.-M. Brady (the United Kingdom) respectively.
Maltese: Ir-Rapporteur u l-Korapporteur maħturin kienu Dr. F. Descamps (Belġju) u Dr. A.-M. Brady (Renju Unit) rispettivament.
English: Opinion following an Article 33 (4)
Maltese: Opinjoni wara referenza skont l-Artikolu 33 (4)
English: The Marketing Authorisation Holder (Fort Dodge Animal Health Ltd) submitted an application for Mutual Recognition Procedure of Poulvac Bursa Plus (lyophilisate for suspension in drinking water, 102.2-103.4 EID50/dose), indicated for chickens from 10 days of age for oral administration via the drinking water.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (Fort Dodge Animal Health Ltd) issottometta applikazzjoni għal Proċedura ta' Rikonoxximent Reċiproku għal Poulvac Bursa Plus (lijofilizzat għal sospensjoni fl-ilma tax-xorb, 102.2-103.4 EID50/doża), indikat għal flieles minn età ta' 10 jiem li jingħata b'mod orali permezz tal-ilma tax-xorb.
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Il-Kumitat għall-prodotti mediċinali għal użu veterinarju (CVMP)
English: Opinion following an Article 33 (4)F F referral for Poulvac Bursa Plus and associated names
Maltese: Opinjoni wara referenza skont l-Artikolu 33 (4)F F għal Poulvac Bursa Plus u l-ismijiet assoċjati
English: Poulvac Bursa Plus is a live vaccine against Infectious Bursal Disease Virus (IBDV), also known as Gumboro disease.
Maltese: Poulvac Bursa Plus huwa vaċċin ħaj kontra l-Virus tal-Marda Infettiva tal-Bursa (IBDV), magħrufa wkoll bħala l-marda ta' Gumboro.
English: referral for Poulvac
Maltese: għal
English: During its 13-15 October 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by a majority of 25 out of 27 votes an opinion concluding that objections raised by Belgium should not prevent the granting of a Marketing Authorisation.
Maltese: Waqt il-laqgħa tiegħu tat-13-15 ta' Ottubru 2009, is-CVMP, fid-dawl tad-dejta ġenerali sottomessa u tad-diskussjoni xjentifika fi ħdan il-Kumitat, adotta b'maġġoranza ta' 25 minn 27 vot, l-opinjoni li tikkonkludi li l-oġġezzjonijiet imqajma mill-Belġju ma għandhomx iwaqqfu l-għoti tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: Given its residual pathogenicity, the vaccine strain, V877, is classified as “intermediate plus” and also known as a “hot” strain.
Maltese: Minħabba l-patoġeniċità residwa tagħha, ir-razza tal-vaċċin, V877, hija kklassifikata bħal “intermedja plus” u magħrufa wkoll bħala razza “taħraq”.
English: Bursa Plus and associated names
Maltese: Poulvac Bursa Plus u l-ismijiet assoċjati
English: On 13 July 2009 the United Kingdom, referred the matter to the Agency under Article 33 (4) of Directive 2001/82/EC due to concerns raised by Belgium regarding an unfavourable benefit and risk balance of the vaccine.
Maltese: Fit-13 ta' Lulju 2009, ir-Renju Unit irrefera l-kwistjoni lill-Aġenzija skont l-Artikolu 33 (4) tad-Direttiva 2001/82/KE minħabba tħassib imqajjem mill-Belġju dwar bilanċ ta' benefiċċju u riskju mhux favorevoli tal-vaċċin.
English: On the basis of the grounds for referral, the points considered by the CVMP were whether the studies carried out by the Marketing Authorisation Holder were sufficient to address the risks associated with immunosuppression in a comprehensive way and whether the benefit/risk balance was favourable for the vaccine Poulvac Bursa Plus.
Maltese: Fuq il-bażi tar-raġunijiet tar-referenza, il-punti kkunsidrati mis-CVMP kienu jekk l-istudji li saru midDetentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq kinux biżżejjed biex jindirizzaw ir-riskji assoċjati mal-immunosuppressjoni b'mod komprensiv u jekk il-bilanċ ta' benefiċċju/riskju kienx favorevoli għallvaċċin Poulvac Bursa Plus.
English: Written explanations were provided by the Marketing Authorisation Holder on 17 August 2009.
Maltese: Fis-17 ta' Awwissu 2009, ingħataw spjegazzjonijiet bil-miktub mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: Uncommon (PTPs)*
Maltese: Mhux komuni (PTPs)*
English: (See section 4 “Possible side effects”).
Maltese: (Ara sezzjoni 4 “Effetti sekondarji possibbli”).
English: PK parameters
Maltese: Parametri PK
English: The osmolality is ≥ 380 mOsmol/kg.
Maltese: L-ożmolalità hija ≥ 380 mOsmol/kg.
English: Repeat injections every 12 to 24 hours.
Maltese: Irrepeti l-injezzjonijiet kull 12 sa 24 siegħa.
English: Perioperative management (surgical prophylaxis)
Maltese: Ġestjoni perioperattiva (profilassi kirurġika)
English: The mean (SD) age was 3.3 (1.55) and 8.1 (1.92) years respectively.
Maltese: Il-medja tal-età (SD) kienet ta' 3.3 (1.55) u 8.1 (1.92) snin rispettivament.
English: Baxalta Innovations GmbH A-1221 Vienna Austria
Maltese: Baxalta Innovations GmbH A-1221 Vienna L-Awstrija
English: Date of first authorisation: 08 January 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08 ta' Jannar 2018
English: Table 3: Pharmacokinetic parameters using the chromogenic assay (Arithmetic mean ± SD)
Maltese: Tabella 3: Parametri farmakokinetiċi bl-użu tal-assaġġ kromoġeniku (Medja aritmetika ± SD)
English: EU/1/17/1247/003 EU/1/17/1247/004 EU/1/17/1247/007 EU/1/17/1247/008 EU/1/17/1247/011 EU/1/17/1247/012 EU/1/17/1247/013 EU/1/17/1247/014
Maltese: EU/1/17/1247/007 EU/1/17/1247/008 EU/1/17/1247/011 EU/1/17/1247/012 EU/1/17/1247/013 EU/1/17/1247/014
English: Immune tolerance induction (ITI) No clinical data for use of ADYNOVI in ITI are available.
Maltese: Induzzjoni ta' Tolleranza Immuni (ITI) M'hemm l-ebda data klinika disponibbli għall-użu ta' ADYNOVI f'ITI.
English: ADYNOVI contains sodium, see section 2.
Maltese: ADYNOVI fih is-sodium, ara s-sezzjoni 2.
English: The table presented below is according to the MedDRA system organ classification (System Organ Class and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hija skont is-sistema tal-klassifika tal-organi MedDRA (Sistema talKlassifika tal-Organi u Livell ta' Terminu Preferut).
English: Repeat injections every 8 to 24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Maltese: Irrepeti l-injezzjonijiet kull 8 sa 24 siegħa sakemm ikun hemm fejqan adegwat tal-ferita, u wara kompli tterapija għal mill-inqas 7 ijiem oħra biex tinżamm attività tal-fattur VIII ta' 30% sa 60% (IU/dL).
English: Administer over a period of up to 5 minutes (maximum infusion rate 10 ml per min).
Maltese: Agħti fuq perjodu ta' mhux aktar 5 minuti (rata ta' infuzjoni massima ta' 10 mL kull min).
English: Required international units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Maltese: Unitajiet internazzjonali meħtieġa (IU) = piż tal-ġisem (kg) x żieda fil-fattur VIII mixtieqa (%) x 0.5
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: Rurioctocog alfa pegol is a covalent conjugate of octocog alfa consisting of 2,332 amino acids with polyethylene glycol (PEG) reagent (MW 20 kDa).
Maltese: Rurioctocog alfa pegol huwa konjugat kovalenti ta' octocog alfa li jikkonsisti minn 2,332 ta' aċidi amminiċi b'reaġent polyethylene glycol (PEG) (MW 20 kDa).
English: Of the 70 bleeding episodes observed during the paediatric study, 82.9% were controlled with 1 infusion and 91.4% were controlled with 1 or 2 infusions.
Maltese: Mis-70 episodju ta' fsada osservati waqt l-istudju pedjatriku, 82.9% kienu kkontrollati b'infużjoni 1 u 91.4% kienu kkontrollati b'infużjoni 1 jew 2.
English: ADYNOVI is usually injected into a vein (intravenously) by your doctor or nurse.
Maltese: ADYNOVI ġeneralment jiġi injettat ġo vina (minn ġol-vina) minn tabib jew infermier.
English: or 1000 IU rurioctocog alfa pegol.
Maltese: IU rurioctocog alfa pegol.
English: ADYNOVI Paediatric patients (6-<12 years) N = 17 Dose: 50 ± 10 IU/kg
Maltese: ADYNOVI Pazjenti pedjatriċi (6-<12-il sena) N=17 Doża: 50 ± 10 IU/kg
English: Excipients: mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80
Maltese: Eċċipjenti: mannitol, trehalose di-hydrate, histidine, glutathion, sodium chloride, calcium chloride di-hydrate, tris(hydroxymethyl)aminomethane, polysorbate 80
English: The active substance rurioctocog alfa pegol is a covalent conjugate of the protein octocog alfa* with a 20 kDa polyethylene glycol (PEG).
Maltese: Is-sustanza attiva rurioctocog alfa pegol huwa konjugat kovalenti tal-proteina octocog alfa* b'20 kDa polyethylene glycol (PEG).
English: 6.3 Shelf life
Maltese: Half-life terminali
English: MedDRA Standard System Organ Class
Maltese: Standard MedDRA
English: ADYNOVI Adults (18 years and older) N = 18 Dose: 45 ± 5 IU/kg
Maltese: ADYNOVI Adulti (18-il sena u aktar) N=18 Doża: 45 ± 5
English: Results for Incremental Recovery and Cmax determined by individual PK in parenthesis.
Maltese: Ir-riżultati għall-Irkupru Inkrementali u s-Cmass determinati minn PK individwali filparentesi.
English: Cardiovascular events
Maltese: Episodji kardjovaskulari
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jiġi nnutat li ABR mhijiex komparabbli bejn konċentrati tal-fattur differenti u bejn studji kliniċi differenti.
English: Repeat injections every 8 to 24 hours until threat is resolved.
Maltese: Irrepeti l-injezzjonijiet kull 8 sa 24 siegħa sakemm tieqaf it-theddida.
English: ADYNOVI Adolescents (12-<18 years) N = 8 Dose: 45 ± 5 IU/kg
Maltese: ADYNOVI Adolexxenti (12-<18-il sena) N=8 Doża: 45 ± 5
English: End of 3-month room temperature storage:
Maltese: Tmiem perjodu ta' ħażna ta' 3 xhur f'temperatura ambjentali: