FrancophonIA/ELRC3.0 huggingface dataset:
English: In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Maltese: I-IV li kienu qed jingħataw kimoterapija majelosopressiva li tikkonsisti f' doxorubicin u docetaxel, l-użu ta' pegfilgrastim, bħala doża waħda kull ċiklu, naqqset id-dewmien tan-newtropenja u l-inċidenza ta' newtropenja bid-deni b'mod simili għal dak osservat bl-għoti ta' kuljum ta' filgrastim (medja ta' 11-il għoti kuljum).
English: (ng/ml)
Maltese: 4. GĦAMLA
English: Excipients known to have a recognised action: sorbitol (E420), sodium acetate.
Maltese: Sustanzi mhux attivi li għandhom azzjoni magħrufa: sorbitol E-420, sodium acetate.
English: Do not shake the pre-filled syringe.
Maltese: Rimi ta' siringi użati
English: Neupopeg may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Maltese: Neupopeg jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 30°C) għal perijodu wieħed ta'massimu ta' 72 siegħa.
English: Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea, hypotension, injection site reactions, erythaema and flushing, occurring on initial or subsequent treatment have been reported with Neupopeg.
Maltese: Reazzjonijiet ta' allerġija, inklużi anafilassi, raxx tal-ġilda, urtikarja, anġjoedema, qtugħ ta' nifs, pressjoni baxxa, reazzjonijiet fil-post ta' l-injezzjoni, eritema u fwawar, li seħħew ma' l-ewwel trattament jew ma' trattament ta' wara, ġew rrappurtati b'Neupopeg.
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
Maltese: Fi studju double-blind, kontrollat bil-plaċebo, fuq pazjenti bil-kankru tas-sider ġie evalwat l-effett ta' pegfilgrastim fuq l-inċidenza tan-newtropenja bid-deni wara l-għoti ta' ċiklu ta' kimoterapija assoċjat ma' newtropenja bid-deni b' rata ta' 10-20% (doċetaxel 100mg/m2 kull 3 ġimgħat għal 4 ċikli).
English: Do not use Neupopeg
Maltese: X'fih Neupopeg
English: EXP.:
Maltese: Il-Manifattur:
English: In one study (n=157), which used a 6mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63).
Maltese: Fi studju wieħed (n=157), fejn intużat doża fissa ta' 6 mg ta' pegfilgrastim id-dewmien medju tan-newtropenja grad 4 għall-grupp b'pegfilgrastim kien ta' 1.8 jiem meta mqabbel ma' 1.6 jiem tal-grupp b'filgrastim (differenza ta' 0.23 jiem, 95% CI -0.15, 0.63). Matul l-istudju kollu, ir-rata ta' newtropenja bid-deni kienet ta' 13% tal-pazjenti kkurati b'pegfilgrastim mqabbla ma' 20% tal-pazjenti kkurati b'filgrastim (differenza ta' 7%, 95% CI ta'19%, 5%).
English: How do I prepare my Neupopeg injection?
Maltese: Kif nipprepara l-injezzjoni ta' Neupopeg?
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 ta' tkabbir, ġie rrappurtat li din liskema ta'dożaġġ tirriżulta f'newtropenja ta' grad 4 li ddum medja ta' 5 sa 7 ijiem, u inċidenza ta' 3040% ta' newtropenja bid-deni.
English: Other commonly reported undesirable effects include pain, injection site pain; chest pain (non-cardiac); headache; arthralgia; myalgia; back, limb, musculo-skeletal and neck pain.
Maltese: Effetti mhux mixtieqa oħra rrappurtati b'mod komuni jinkludu uġigħ, uġigħ fis-sitfil-post ta' l-injezzjoni; uġigħ fis-sider (mhx kardijaku); uġigħ ta' ras; artralġja; mijalġja; uġigħ fid-dahar, riġlejn u dirgħajn, muskoloskeletali u fl-għonq.
English: Amgen Inc.
Maltese: Inc.
English: Very rare (< 1/10,000) events of cutaneous vasculitis have been reported in patients treated with Neupopeg.
Maltese: Każijiet rari ħafna (< 1/10,000) ta' infjammazzjoni vaskulari fil-ġilda ġew osservati f' pazjenti li ngħataw Neulasta.
English: Important information about some of the ingredients of Neupopeg Neupopeg contains sorbitol (a type of sugar).
Maltese: Neupopeg fih sorbitol (tip ta' zokkor).
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: Ir-rata totali ta' newtropenja bid-deni kienet ta' 9% tal-pazjenti kkurati b'pegfilgrastim u 18% tal-pazjenti kkurati b'filgrastim (differenza ta' 9%, 95% CI ta' -16.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Għalhekk, id-daqs tal-milza għandu jiġi monitorjat b'attenzjoni (per eżempju b' eżaminazzjoni klinika, b' eżami ultrasoniku).
English: Rare (≥ 1/10,000 to < 1/1,000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
Maltese: Effeti mhux mixtieqa rari (≥ 1/10,000 u < 1/1,000) tal-pulmun, b' mod partikulari pulmonite interstizjali, ġew rrappurtati wara l-għoti tal-fattur li jistimola l-kolonji ta' granuloċiti.
English: Neupopeg is a solution for injection in a pre-filled pen (6 mg/0.6 ml).
Maltese: Neupopeg huwa soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (6 mg/ 0.6ml).
English: Check the expiry date on the pre-filled syringe label (EXP).
Maltese: Iċċekkja d-data ta' skadenza fuq it-tikketta tas-siringa mimlija għal-lest (JIS/EXP).
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ħafna ta' intoleranza għal fructose m' għandhomx jieħdu din il-mediċina.
English: Choose a site at least 5 cm away from the belly button (navel) (see picture 4).
Maltese: Agħzel post mill-anqas 5cm 'il bogħod miż-żokkra (ara stampa 4).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull siringa mimlija għal-lest fiha 6mg ta' pegfilgrastim f' 0.6ml (10mg/ml) soluzzjoni għallinjezzjoni).
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: *Magħmul f' ċellui ta' Escherichia coli b' teknoloġija rikombinanti-DNA u wara b' konjugazzjoni ma' polyethylene glycol (PEG). **Il-konċentrazzjoni hija ta' 20 mg/ml jekk tiġi nkluża l-porzjoni PEG.
English: NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection.
Maltese: Neupopeg 6 mg soluzzjoni għall-injezzjoni.
English: Check the expiry date on the pre-filled pen label (EXP:).
Maltese: DATA TA' META JISKADI EXP:
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Maltese: Huwa parti minn grupp ta' proteini msejħa ċitokini, u jixbaħ ħafna lill-proteina naturali (fattur li jistimola l-kolonji ta' granuloċiti) li hija prodotta millġisem tiegħek.
English: The most suitable places to inject yourself are:
Maltese: DATA TA' META JISKADI JIS.:
English: Neupopeg is essentially sodium-free.
Maltese: Neupopeg huwa essenzjalment mingħajr sodium.
English: • Remove the grey needle shield (see picture 2).
Maltese: • Neħħi l-għatu griż tal-labra (ara Stampa 2).
English: Marketing Authorisation Holder: Dompé Biotec S.p.A.
Maltese: FIS-SUQ Dompé Biotec S.p.A.
English: Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
Maltese: Is-sustanzi l-oħra huma sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall-injezzjoni.
English: • if you have sickle cell anaemia;
Maltese: • inti tqila;
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Maltese: Dan il-prodott mediċinali m' għandux jitħallat ma' prodotti mediċinali oħra, partikularment ma' soluzzjonijiet ta' sodium chloride.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/003
Maltese: FIS-SUQ EU/1/02/228/003
English: Some of the reported cases have resulted in respiratory failure or Adult Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4)
Maltese: Ftit mill-każijiet rrappurtati rriżultaw f' inkapaċità respiratorja jew sindromu tat-tbatija respiratorja fladulti (ARDS), li jistgħu jkunu fatali (ara sezzjoni 4.4)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/001-002
Maltese: FIS-SUQ EU/1/02/228/001
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I : Sommarju tal- Karatteristiċi talProdott, sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection Pegfilgrastim
Maltese: TAL-PRODOTT MEDIĊINALI Neupopeg 6 mg Soluzzjoni għall-injezzjoni Pegfilgrastim2.
English: How do you, or the person injecting you, use Neupopeg pre-filled pen (SureClick)?
Maltese: Kif inti, jew il-persuna li se tinjettak, tuża il-pinna mimlija għal-lest b'Neupopeg (SureClick)?
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest fih lastiku naturali niexef (mnissel mill-latex) (ara sezzjoni 4.4).
English: In animal models concomitant administration of Neupopeg and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Maltese: Fi studji fuq annimali, l-għoti ta' Neupopeg u 5-fluorouracil (5- FU) jew anti-metaboliti oħra wriet żjieda fil-majelosoppressjoni.
English: OTHER
Maltese: Amgen
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a single use pre-filled syringe (0.6 ml).
Maltese: FARMAĊEWTIKA U KONTENUT Soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest (0.6 ml).
English: Rare (≥ 1/10,000 to < 1/1,000) cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Maltese: Ġew rrappurtati każijiet rari (≥ 1/10,000 sa < 1/1,000) tas-sindromu Sweet, għalkemm f'ċertu każijiet it-tumur malinn ematoloġiku li hemm minn taħt jista' jkollu sehem f'dan.
English: B. Maintaining firm skin pinch, (1) press and (2) release the green button on top.
Maltese: Żomm il-ġilda maqrusa sod, (1) agħfas u (2) itlaq il-buttuna ħadra li hemm in-naħa ta' fuq.
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, administered during induction chemotherapy.
Maltese: II, randomised, double-blind f' pazjenti li reġgħet qabdithom lewkimja majelojde akuta u li qed jirċievu il-kimoterapija għaliha, ġie mqabbel pegfilgrastim (doża waħda ta' 6 mg) ma' filgrastim waqt il-kimoterapija tal-bidu.
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Maltese: Wara doża waħda ta' pegfilgrastim taħt il-ġilda, l-ogħla konċentrazzjoni fis-serum ta' pegfilgrastim tintlaħaq minn 16 sa 120 siegħa wara d-dożaġġ u l-konċentrazzjonijiet fis-serum ta' pegfilgrastim jinżammu tul il-perjodu ta' newtropenja wara l-kimoterapija majelosoppressiva.
English: 2 release 1 press
Maltese: 2 itlaq 1 għafas
English: The safety and efficacy of Neupopeg administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' l-għoti ta' Neupopeg ma' ċitoġenetiċi t(15;17) f' pazjenti taħt il-55 sena li reġgħet qabdithom lewkimja majelojde akuta mill-ġdid, għad ma ġewx stabiliti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/002
Maltese: FIS-SUQ EU/1/02/228/002
English: The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
Maltese: 3. LISTA TA' SUSTANZI MHUX ATTIVI Sustanzi mhux attivi: sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall-injezzjoni.
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 mekkaniżmu ta' azzjoni identiku, u jikkawżaw żjieda sinifikanti fl-għadd ta' newtrofili fid-demm periferali fi żmien 24 siegħa, b' żjidiet minuri fil-monoċiti u/jew fil-limfoċiti.
English: Pack size of one, for single use only.
Maltese: Pakkett ta' waħda, għall-użu ta' darba.
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 low subcutaneous doses.
Maltese: Ma kien hemm l-ebda effett mhux mixtieq osservat fil-frieħ ta' firien tqal li ngħataw pegfilgrastim taħt il-ġilda, iżda fil-fniek pegfilgrastim ikkawża tossiċita` fl-embriju/fetu (telfien ta'l-embriju) f'dożi baxxi taħt il-ġilda.
English: If there are particles in it, you must not use it. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Maltese: Għal injezzjoni aktar komda, ħalli is-siringa mimlija għal-lest toqgħod għal 30 minuta sabiex tilħaq temperatura ambjentali, jew żomm is-siringa mimlija għal-lest delikatament f'idejk għal ftit minuti.
English: The safety and efficacy of Neupopeg 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' Neupopeg għad ma ġewx investigati f' pazjenti b' sindromu majelodisplastiku, lewkimja mjeloġenika kronika, u f' pazjenti b' Lewkimja Majelojde Akuta sekondarja; għalhekk, Neupopeg m' għandux jintuża f' pazjenti bħal dawn.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
Maltese: Kull pinna mimlija għal-lest fiha 6 mg ta' pegfilgrastim f' soluzzjoni ta' 0.6 ml.
English: EXPIRY DATE
Maltese: 1għafas
English: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Maltese: Tnaqqis fid-dewmien tan-newtropenja u ta' l-inċidenza ta' newtropenja bid-deni f'pazjenti kkurati b'kimoterapija ċitotossika għal tumur malinn (bl-eċċezzjoni ta' lewkimja majelojde kronika u sindromi majelodisplastiċi).
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (see section 5.1).
Maltese: Tagħrif kliniku limitat jissuġerixxi li l-effett fuq il-ħin biex tirkupra minn newtropenja severa f' pazjenti li reġgħet qabdithom lewkimja majelojde mill-ġdid, hija komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5.1).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a single use pre-filled pen (0.6 ml).
Maltese: FARMAĊEWTIKA U KONTENUT Soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (0.6 ml).
English: PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (SureClick).
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick).
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: Il-fattur li jistimola l-kolonji ta' granuloċiti jista' jippromwovi it-tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jidhru fi ftit ċelluli mhux majelojdi in vitro.
English: Allergic-type reactions to Neupopeg, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.
Maltese: Reazzjonijiet ta' allerġija għal Neupopeg, inklużi ħmura u fwawar, raxx tal-ġilda, partijiet tal-ġilda ibbuzzati li jqabbdu l-ħakk u anafilassi ( indeboliment, tbaxxija tal-pressjoni tad-demm, tbatija biex tieħu n-nifs, nefħa fil-wiċċ), ġew irrappurtati f'każijiet rari (hemm ċans li jseħħu f' anqas minn pazjent 1 f' kull 1000 pazjent)..
English: What Neupopeg looks like and contents of the pack Neupopeg is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Maltese: Neupopeg huwa soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest (6 mg/ 0.6ml).
English: OTHER Octapharma-Logo
Maltese: Octapharma-Logo
English: Date of latest renewal: 26 april 2019
Maltese: Data tal-aħħar tiġdid: 26 ta' April 2019
English: See section 2, “Nuwiq contains sodium”.
Maltese: Ara sezzjoni 2, "Nuwiq fih sodium".
English: EU/1/14/936/001 EU/1/14/936/002 EU/1/14/936/003 EU/1/14/936/004 EU/1/14/936/005 EU/1/14/936/006 EU/1/14/936/007
Maltese: EU/1/14/936/001 EU/1/14/936/002 EU/1/14/936/003 EU/1/14/936/004
English: Octapharma Nordic AB (Sweden)
Maltese: Octapharma Nordic AB (Sweden) Teл.:
English: Nuwiq contains sodium
Maltese: Nuwiq fih sodium
English: IVR = Incremental in vivo recovery, CL = Clearance, SD = Standard deviation
Maltese: IVR = (Incremental in vivo recovery) Irkupru inkrementali in vivo, CL = (Clearance) Tneħħija, SD = Devjazzjoni standard
English: AUC = Area under the curve (FVIII:C), T1/2 = Terminal half-life,
Maltese: Erja taħt il-kurva (FVIII:C), T1/2 = Half-life terminali,
English: Deutschland Octapharma GmbH Tel: +49 2173 9170
Maltese: Octapharma GmbH Tel: +49 2173 9170
English: Frequency of adverse drug reactions (ADRs) in clinical trials
Maltese: Frekwenza ta' reazzjonijiet avversi għal mediċina (ADRs) fi provi kliniċi
English: The immunogenicity of Nuwiq was evaluated in clinical trials in 190 previously treated patients with severe haemophilia A (129 adult and 61 paediatric patients).
Maltese: L-immunoġeniċità ta' Nuwiq kienet evalwata fi provi kliniċi f'190 pazjent b'emofilja A severa li kienu trattati qabel (129 adult u 61 pazjent pedjatriku).
English: Name and address of the manufacturer(s) of the biological active substance(s) Octapharma AB
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i) Octapharma AB
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Maltese: Dejta disponibbli hi deskritta fissezzjoni 4.8. 5.1 u 5
English: Inject the solution into the vein at a slow speed, not faster than 4 mL per minute.
Maltese: Injetta s-soluzzjoni ġol-vina b'veloċità baxxa, mhux aktar minn 4 mL kull minuta.
English: Nuwiq is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells.
Maltese: Nuwiq hu prodott bit-teknoloġija rikombinanti tad-DNA f'ċelluli embrijoniċi tal-kliewi 293F (human embryonic cells, HEK) umani modifikati ġenetikament.
English: The median consumption of Nuwiq for prophylaxis per month was 521.9 IU/kg.
Maltese: Il-konsum medjan ta' Nuwiq għal profilassi kull xahar kien ta' 521.9 IU/kg.
English: During clinical studies with Nuwiq in previously treated paediatric (2 to 11 years, n = 58), adolescent (12 to 17 years, n = 3) and adult patients (n = 129) with severe haemophilia A, a total of 12 adverse drug reactions (ADRs) (8 in adults, 4 in children) were reported in 8 patients (4 adults, 4 children).
Maltese: (2 sa 11-il sena, n=58) u adulti (n=129) trattati qabel b'emofilja A severa, total ta' 12-il reazzjoni avversa għall-mediċina (adverse drug reactions, ADRs) (8 f'adulti, 4 fit-tfal) kienu rapportati fi 8 pazjenti (4 adulti, 4 itfal).
English: No studies were performed on the mutagenic potential of Nuwiq.
Maltese: Ma sarux studji dwar il-potenzjal mutaġeniku ta' Nuwiq.
English: There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Nuwiq.
Maltese: Hemm probabilità rari li tista' tesperjenza reazzjoni anafilattika (reazzjoni allerġika, severa, li tiġi f'daqqa) għal Nuwiq.
English: One mL of reconstituted solution contains 7.35 mg sodium (18.4 mg sodium per vial).
Maltese: Eċċipjent b'effett magħruf mL wieħed ta' soluzzjoni rikostitwita fih 7.35 mg sodium (18.4 mg sodium f'kull kunjett).
English: Chromogenic assay Median (range) AUC (hr*IU/mL) 22.3 (8.4 - 38.1) 21.2 (8.4 - 32.6) 23.3 (17.4 - 35.5) 33.5 (28.9 - 38.1) T1/2 (hr) IVR (%/IU/kg) 2.5 (1.7 - 3.2) CL (mL/hr/kg) 2.7 (1.5 - 6.4) Normal weight: BMI 18.5-25 kg/m2, Pre-adipose: BMI 25-30 kg/m2, Adipose: BMI > 30 kg/m2, SD = Standard deviation
Maltese: AUC (hr*IU/mL) 22,3 (8,4 - 38,1) 21,2 (8,4 - 32,6) 23,3 (17,4 - 35,5) 33,5 (28,9 - 38,1)
English: Each powder vial contains 250, 500, 1000, 2000, 2500, 3000 or 4000 IU of simoctocog alfa.
Maltese: Kull kunjett ta' trab fih 250, 500, 1000, 2000, 2500, 3000 jew 4000 IU ta' simoctocog alfa.
English: Prophylaxis: In a clinical study in 32 adult patients with severe haemophilia A, the median consumption of Nuwiq for prophylaxis was 468.7 IU/kg/month.
Maltese: Fi studju kliniku fi 32 pazjent adult b'emofilja A severa, il-konsum medjan ta' Nuwiq għal profilassi kienet ta' 468.7 IU/kg/xahar.
English: Excipient related considerations (sodium content) This medicinal product contains less than 1 mmol sodium (23 mg) per vial.
Maltese: Konsiderazzjonijiet marbuta mal-eċċipjenti (kontenut ta' sodium) Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) kull kunjett.
English: MedDRA Standard System
Maltese: Sistema tal-Klassifika Standard tal-Organi
English: Nuwiq can be used for all age groups.
Maltese: Nuwiq jista' jintuża għal kwalunkwe età.
English: It is recommended that not more than 4 mL per minute be administered.
Maltese: Huwa rakkomandat li ma jingħatax aktar minn 4 mL kull minuta.
English: However for patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Maltese: Madankollu, pazjenti li jkunu rċivew kura b'Fattur VIII fil-passat (aktar minn 150 jum ta' kura), irriskju huwa mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Octapharma S.A. Tel: +34 91 6487298
Maltese: S.A. Tel: +34 91 6487298
English: Nuwiq contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
Maltese: Nuwiq fih is-sustanza attiva fattur VIII ta' koagulazzjoni rikombinanti umana (simoctocog alfa).
English: A higher median dose of Nuwiq was required to treat bleedings in children (43.9 IU/kg) than in adults (33.0 IU/kg), and a higher median dose was required to treat moderate to major than minor bleedings (78.2 IU/kg vs. 41.7 IU/kg).
Maltese: Doża medjana ogħla ta' Nuwiq kienet meħtieġa sabiex jiġu trattati emorraġiji fi tfal (43.9 IU/kg) milli f'adulti (33.0 IU/kg), u doża medjana ogħla kienet meħtieġa sabiex jiġu trattati emorraġiji moderati sa maġġuri milli dawk minuri (78.2 IU/kg kontra 41.7 IU/kg).
English: AUC (hr*IU/mL)
Maltese: AUC (hr*IU/mL) T1/2 (hr)
English: Octapharma Hellas SA Τηλ: +30 210 8986500
Maltese: Τηλ: +30 210 8986500
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) kull kunjett, jiġifieri essenzjalment ‘ħielsa mis-sodium'.