FrancophonIA/ELRC3.0 huggingface dataset:
English: The 2-, 4-, and 6-year probability of no occurrence of HCC during nitisinone treatment for patients aged 24 months or younger at the start of treatment and for those older than 24 months at the start of treatment is shown in the following table:
Maltese: Il-probabilità tal-ebda okkorrenza ta' HCC wara sentejn, 4 u 6 snin matul il-kura b'nitisinone għal pazjenti b'età ta' 24 xahar jew inqas fil-bidu tal-kura u għal dawk b'età ta' aktar minn 24 xahar filbidu tal-kura, qed tintwera fit-tabella li ġejja:
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4).
Maltese: Abbażi ta' data minn studju kliniku dwar l-interazzjoni b'80 mg nitisinone fi stat fiss, nitisinone huwa inibitur moderat ta' CYP 2C9 (żieda ta' 2.3 darbiet fl-AUC ta' tolbutamide), għalhekk it-trattament b'nitisinone jista' jwassal għal żieda fil-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali metabolizzati primarjament permezz ta' CYP 2C9 mogħtija fl-istess waqt (ara sezzjoni 4.4).
English: Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash.
Maltese: Effetti sekondarji mhux komuni oħra - żieda fin-numru ta' ċelloli bojod tad-demm (lewkoċitosi), - ħakk (prurite), infjammazzjoni tal-ġilda (dermatite sfoljattiva), raxx.
English: Do not breast-feed while taking this medicine, see section “Do not take Nitisinone MDK”.
Maltese: Treddax waqt li tkun qed tieħu din il-mediċina, ara s- sezzjoni “Tiħux Nitisinone MDK”.
English: The biochemical defect in hereditary tyrosinemia type 1 (HT-1) is a deficiency of fumarylacetoacetate hydrolase, which is the final enzyme of the tyrosine catabolic pathway.
Maltese: Id-difett bijokimiku fit-tirosinemija ereditarja ta' tip 1 (HT-1) hu defiċjenza ta' fumarylacetoacetate hydrolase, li hu l-enzima finali tal-passaġġ kataboliku ta' tyrosine.
English: Data is, however, limited in patients with body weight <20 kg.
Maltese: Madankollu, id-data hi limitata f'pazjenti b'piż tal-ġisem ta' <20 kg.
English: Furosemide AUC∞ was increased 1.7-fold, indicating a weak inhibition of OAT1/OAT3 (see sections 4.4 and 4.5).
Maltese: L-AUC∞ ta' furosemide żdiedet b'1.7 darbiet, u dan jindika inibizzjoni dgħajfa ta' OAT1/OAT3 (ara sezzjonijiet 4.4 u 4.5)
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP1A2, 2C19 or 3A4-mediated metabolism or to induce CYP1A2, 2B6 or 3A4/5.
Maltese: Abbażi ta' studji in vitro, nitisinone mhux mistenni li jinibixxi l-metaboliżmu medjat minn CYP 1A2, 2C19 jew 3A4 jew li jinduċi CYP 1A2, 2B6 jew 3A4/5.
English: Increase in serum alpha-fetoprotein concentration may be a sign of inadequate treatment.
Maltese: Iż-żieda fil-konċentrazzjoni ta' alpha-fetoprotein fis-serum tista' tkun sinjal ta' kura inadegwata.
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone caused a 2.3-fold increase in AUC∞ of the CYP2C9 substrate tolbutamide, which is indicative of a moderate inhibition of CYP2C9.
Maltese: Abbażi ta' data minn studju kliniku dwar l-interazzjoni b'80 mg nitisinone fi stat fiss, nitisinone ikkawża żieda ta' 2.3 darbiet fl-AUC∞ tas-sottostrat ta' CYP 2C9 tolbutamide, li jindika inibizzjoni moderata ta' CYP 2C9.
English: By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Maltese: Billi jinibixxi l-kataboliżmu normali ta' tyrosine f'pazjenti b'HT-1, nitisinone jevita l-akkumulazzjoni tal-intermedji tossiċi maleylacetoacetate u fumarylacetoacetate.
English: Nitisinone MDK 2 mg: Each capsule contains 2 mg nitisinone.
Maltese: Nitisinone MDK 2 mg: Kull kapsula fiha 2 mg ta' nitisinone.
English: Nitisinone is not expected to inhibit P-gp, BCRP or OCT2-mediated transport.
Maltese: Nitisinone mhux mistenni li jinibixxi trasport medjat minn P-gp, BCRP jew OCT2.
English: Nitisinone treatment leads to normalised porphyrin metabolism with normal erythrocyte porphobilinogen synthase activity and urine 5-aminolevulinate, decreased urinary excretion of succinylacetone, increased plasma tyrosine concentration and increased urinary excretion of phenolic acids.
Maltese: Il-kura b'nitisinone twassal għal metaboliżmu normalizzat ta' porphyrin bl-attività ta' erythrocyte synthase ta' porphobilinogen normali u 5 aminolevulinate fl-awrina, tnaqqis fit-tneħħija fl-awrina ta'
English: Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8).
Maltese: Kura aġġuntiva għall-kura b'nitisinone, dieta li hi nieqsa minn phenylalanine u tyrosine hi meħtieġa u għandha tiġi segwita b'monitoraġġ tal-amino acids tal-plażma (ara sezzjonijiet 4.4 u 4.8).
English: Each capsule contains 10 mg nitisinone.
Maltese: Kull kapsula fiha 10 mg ta' nitisinone.
English: Restriction of tyrosine and phenylalanine in the diet should limit the toxicity associated with this type of tyrosinemia by lowering tyrosine levels (see section 4.4).
Maltese: Ir-restrizzjoni ta' tyrosine u phenylalanine fid-dieta għandha tillimita t-tossiċità marbuta ma' dan it-tip ta' tirosinemija billi jitnaqqsu l-livelli ta' tyrosine (ara sezzjoni 4.4).
English: In patients with HT1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
Maltese: F'pazjenti b' HT1, dawn l-intermedji jinbidlu għal metaboliti tossiċi succinylacetone u succinylacetoacetate.
English: NTBC study (N=250) Age at start of treatment
Maltese: Studju NTBC (N=250) Numru ta' pazjenti fil-/wara
English: Nitisinone MDK 5 mg: Each capsule contains 5 mg nitisinone.
Maltese: Nitisinone MDK 5 mg: Kull kapsula fiha 5 mg ta' nitisinone.
English: Nitisinone plasma concentration reached in clinical setting is not expected to inhibit OATP1B1, OATP1B3 mediated transport.
Maltese: Il-konċentrazzjoni ta' nitisinone fil-plażma milħuqa f'ambjent kliniku mhix mistennija li tinibixxi t-trasport medjat minn OATP1B1, OATP1B3.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: 5 PROPRJETAJIET FARMAKODINAĠIĊI
English: Exfoliative dermatitis, erythematous rash, pruritus
Maltese: Dermatite bil-qxur, raxx eritematuż, ħakk
English: This special diet is based on low tyrosine and phenylalanine (another amino acid) content.
Maltese: Din id-dieta speċjali hija bbażata fuq kontenut baxx ta' tyrosine u ta' phenylalanine (amino aċidu ieħor).
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarized in the table below.
Maltese: Probabbiltajiet tas-sopravivenza wara sentejn, 4 u 6 snin ta' kura b'nitisinone huma miġbura fil-qosor fit-tabella hawn taħt.
English: Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Maltese: Kura ta' pazjenti adulti u pedjatriċi (f'kull medda ta' età) b'dijanjożi kkonfermata ta' tirosinemija ereditarja ta' tip 1 (HT-1) flimkien ma' restrizzjoni tad-dieta ta' tyrosine u phenylalanine.
English: A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/L.
Maltese: Dieta iktar ristretta ta' tyrosine u phenylalanine għandha tiġi implimentata fil-każ li l-livell ta' tyrosine fil-plażma jkun iktar minn 500 micromol/L.
English: Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Maltese: Treddax waqt li tkun qed tieħu din il-mediċina, ara s- sezzjoni “Tqala u treddigħ”.
English: Nitisinone MDK capsules are 15.7 mm long, white, opaque, hard gelatin capsules, imprinted with “Nitisinone” and the strength “2 mg”, “5 mg” or “10 mg”, in black.
Maltese: 7mm, bojod, opaki, kapsuli iebsin u magħmula minn ġelatina, bil-kliem “Nitisinone” u l-qawwa “2 mg”, “5 mg” jew “10 mg”, stampata bl-iswed fuqhom.
English: Nitisinone treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolized through CYP2C9, such as warfarin and phenytoin, should be carefully monitored.
Maltese: Pazjenti ttrattati b'nitisinone li huma ttrattati fl-istess waqt bi prodotti mediċinali b'tieqa terapewtika dejqa metabolizzati permezz ta' CYP 2C9, bħal warfarin u phenytoin, għandhom jiġu mmonitorjati b'attenzjoni.
English: Nitisinone MDK may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin)
Maltese: - Mediċini għall-epilessija (bħal phenytoin) - Mediċini kontra t-tagħqid tad-demm (bħal warfarin)
English: Common eye related side effects (may affect more than 1 in 10 people) caused by higher tyrosine levels are inflammation in the eye (conjunctivitis), opacity and inflammation in the cornea (keratitis), sensitivity to light (photophobia) and eye pain.
Maltese: Effetti sekondarji komuni relatati mal-għajnejn (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) kkawżati minn livelli ta' tyrosine ogħla huma infjammazzjoni fl-għajn (konġuntivite), opaċità u infjammazzjoni fil-kornea (keratite), sensittività għad-dawl (fotofobija) u uġigħ fl-għajnejn.
English: From clinical study and post marketing data there are no indications that the safety profile is different in different subsets of the paediatric population or different from the safety profile in adult patients.
Maltese: Minn studju kliniku u data ta' wara t-tqegħid fis-suq m'hemm ebda indikazzjoni li l-profil tas-sigurtà huwa different f'subsettijiet differenti ta' popolazzjoni pedjatrika jew differenti mill-profil tas-sigurtà f'pazjenti adulti.
English: Each capsule contains 5 mg nitisinone.
Maltese: Kull kapsula fiha 5 mg ta' nitisinone.
English: Nitisinone MDK 10 mg: Each capsule contains 10 mg nitisinone.
Maltese: Nitisinone MDK 10 mg: Kull kapsula fiha 10 mg ta' nitisinone.
English: Nitisinone caused an approximate 30% decrease in chlorzoxazone AUC∞, indicative of a weak induction of CYP2E1.
Maltese: Nitisinone ikkawża tnaqqis ta' madwar 30% fl-AUC∞ ta' chlorzoxazone, li jindika induzzjoni dgħajfa ta' CYP 2E1.
English: In 10 healthy male volunteers, after administration of a single dose of nitisinone capsules (1 mg/kg body weight) the terminal half-life (median) of nitisinone in plasma was 54 hours (ranging from 39 to 86 hours).
Maltese: F'10 voluntiera rġiel b'saħħithom, wara l-għoti ta' doża waħda ta' kapsuli ta' nitisinone (1 mg /kg ta' piż tal-ġisem) il-half-life terminali (medjan) ta' nitisinone fil-plażma kien ta' 54 siegħa
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: How to store Nitisinone MDK
Maltese: Tiħux Nitisinone MDK:
English: Eye-related adverse reactions, such as conjunctivitis, corneal opacity, keratitis, photophobia, and eye pain, related to elevated tyrosine levels are therefore common.
Maltese: Għalhekk, huma komuni reazzjonijiet avversi relatati mal-għajnejn, bħal konġuntivite, opaċità tal-kornea, keratite, fotofobija, u uġigħ fl-għajnejn, relatati ma' livelli ta' tyrosine elevati.
English: Each capsule contains 2 mg nitisinone.
Maltese: Kull kapsula fiha 2 mg ta' nitisinone.
English: Start age > 24 months
Maltese: Età fil-bidu > 24 xahar
English: Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
Maltese: Nitisinone ma weriex potenzjal karċinoġeniku fi studju li dam 26 ġimgħa dwar riskju ta' kanċer fi ġrieden transġeniċi (TgrasH2).
English: 24 months.
Maltese: 24-il xahar.
English: Imprint ˗ Black iron oxide (E172) ˗ Shellac
Maltese: Ossidu tal-ħadid iswed (E 172), glejż tax-xellak
English: Restriction of tyrosine and phenylalanine in the diet should limit toxicity associated with this type of tyrosinemia.
Maltese: Ir-restrizzjoni ta' tyrosine u phenylalanine fid-dieta għandha tillimita t-tossiċità marbuta ma' dan it-tip ta' tirosinemija.
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range).
Maltese: Din il-mediċina tintuża għall-kura ta' marda rari msejħa tirosinemija ereditarja tip 1 fl- adulti, adolexxenti u fit-tfal (f'kull medda ta' età).
English: Eye problems could be a sign of inadequate dietary control (see section 4).
Maltese: Problemi ta' għajnejn, ara sezzjoni 4, jistgħu jkunu sinjal ta' kontroll inadegwat tad-dieta.
English: Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules nitisinone
Maltese: Nitisinone MDK 2 mg kapsuli iebsin Nitisinone MDK 5 mg kapsuli iebsin Nitisinone MDK 10 mg kapsuli iebsin nitisinone
English: Therefore, mothers receiving nitisinone must not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
Maltese: Għalhekk, ommijiet li jkunu qed jieħdu nitisinone m'għandhomx ireddgħu, għax ir-riskju lit-tarbija li tkun qed terda' ma jistax jiġi eskluż (ara sezzjonijiet 4.3 u 5.3).
English: Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules
Maltese: Nitisinone MDK 2 mg kapsuli iebsin Nitisinone MDK 5 mg kapsuli iebsin Nitisinone MDK 10 mg kapsuli iebsin
English: The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Maltese: Id-doża tal-bidu ta' kuljum rakkomandata fil-popolazzjoni pedjatrika u adulta hi ta' 1 mg/kg ta' piż tal-ġisem li jingħataw mill-ħalq.
English: Inflammation of the eyelid (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).
Maltese: Infjammazzjoni tal-kappell tal-għajn (blefarite) huwa effett sekondarju mhux komuni (jista' jaffettwa sa persuna 1 minn kull 100).
English: Elevated tyrosine levels have been associated with toxicity to eyes, skin, and the nervous system.
Maltese: Livelli għoljin ta' tyrosine kienu assoċjati ma' tossiċità tal-għajnejn, tal-ġilda, u tas-sistema nervuża.
English: Population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Maltese: 207 pazjenti li kellhom l-HT-1.
English: Dose adjustment
Maltese: Tqala u treddigħ
English: Nitisinone is metabolised in vitro by CYP 3A4 and dose-adjustment may therefore be needed when nitisinone is co-administered with inhibitors or inducers of this enzyme.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Nitisinone jiġi metabolizzat in vitro minn CYP 3A4 u jista' jkun hemm bżonn ta' aġġustament taddoża meta nitisinone jingħata flimkien ma' inibituri jew inducers ta' din l-enzima.
English: Tabulated list of adverse reactions The adverse reactions listed below by MedDRA system organ class and absolute frequency, are based on data from a clinical trial and post-marketing use.
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt skont is-sistema tal-klassifika tal-organi MedDRA u skont il-frekwenza assoluta, huma bbażati fuq data minn prova klinika u wara l-użu għat-tqegħid fis-suq.
English: Thrombocytopenia, leucopenia, granulocytopenia
Maltese: Il-pazjenti kollha Età fil-bidu
English: HDPE plastic bottle with LDPE plastic cap containing 60 capsules.
Maltese: Il-kapsuli huma ppakkjati fi fliexken tal-plastik.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Skin and subcutaneous tissue disorders
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Succinylacetone inhibits the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate.
Maltese: Succinylacetone jinibixxi s-sintesi tal-passaġġ ta' porphyrin li jwassal għall-akkumulazzjoni ta' 5-aminolevulinate.
English: - Your eyes will be checked by an ophthalmologist before and regularly during nitisinone treatment.
Maltese: - Għajnejk se jiġu ċċekkjati minn oftalmoloġista qabel u b'mod regolari matul it-trattament b'nitisinone.
English: White, opaque capsules of 15.7 mm imprinted with black ink “10 mg” on the cap and “Nitisinone” on the body.
Maltese: Kapsuli bojod, opaki (15.7 mm), stampati b'linka sewda “10 mg” fuq it-tapp u “Nitisinone” fuq ilparti ta' barra.
English: Nitisinone treatment may therefore result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9.
Maltese: Għalhekk trattament b'nitisinone jista' jwassal għal żieda fil-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali mogħtija fl-istess waqt metabolizzati primarjament permezz ta' CYP 2C9.
English: If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day.
Maltese: Jekk succinylacetone fl awrina jkun jista' jiġi osservat wara xahar mill-bidu tal-kura b'nitisinone, id-doża ta' nitisinone għandha tiżdied għal 1.5 mg/kg ta' piż tal-ġisem / kuljum.
English: Mothers receiving nitisinone must not breast-feed (see sections 4.6 and 5.3).
Maltese: Ommijiet li jkunu qed jużaw nitisinone m'għandhomx ireddgħu (ara sezzjonijiet 4.6 u 5.3). 4.4
English: White, opaque capsules of 15.7 mm imprinted with black ink “5 mg” on the cap and “Nitisinone” on the body.
Maltese: Kapsuli bojod, opaki (15.7 mm), stampati b'linka sewda “5 mg” fuq it-tapp u “Nitisinone” fuq il-parti ta' barra.
English: White, opaque capsules of 15.7 mm imprinted with black ink “2 mg” on the cap and “Nitisinone” on the body.
Maltese: Kapsuli bojod, opaki (15.7 mm), stampati b'linka sewda “2 mg” fuq it-tapp u “Nitisinone” fuq il-parti ta' barra.
English: In an international survey of patients with HT-1 on treatment with dietary restriction alone, it was found that HCC had been diagnosed in 18% of all patients aged 2 years and above.
Maltese: HCC kienet ġiet iddijanjostikata fi 18% tal-pazjenti kollha li kellhom sentejn u aktar.
English: There was no evidence of in vivo genotoxicity (mouse micronucleus assay and mouse liver unscheduled DNA synthesis assay).
Maltese: Ma kien hemm l-ebda evidenza ta' ġenotossiċità in vivo (fl-assaġġ tal-mikronukleu tal-ġrieden u fl-assaġġ tas-sinteżi mhux skedata tad-DNA tal-fwied tal-ġrieden).
English: Dose-adjustment of these co-administered medicinal products may be needed (see section 4.5).
Maltese: Jista' jkun hemm bżonn ta' aġġustament fiddoża ta' dawn il-prodotti mediċinali mogħtija fl-istess waqt (ara sezzjoni 4.5).
English: Nitisinone MDK with food and drink
Maltese: Nitisinone MDK ma' ikel u xorb
English: Nitisinone does not inhibit CYP2D6 since metoprolol AUC∞ was not affected by the administration of nitisinone.
Maltese: Nitisinone ma jinibixxix CYP 2D6 peress li l-AUC∞ ta'
English: However, nitisinone has been co-administered with food during the generation of efficacy and safety data.
Maltese: Madankollu, nitisinone ingħata flimkien mal-ikel matul produzzjoni ta' data fuq leffikaċja u s-sigurtà.
English: AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Maltese: AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm
English: Important side effects
Maltese: Effetti sekondarji importanti
English: 08409 Vilnius Lithuania
Maltese: LT-08409 Vilnius Il-Litwanja
English: Each mL of solution contains 50 mg of sorbitol.
Maltese: Kull mL ta' soluzzjoni fiha 50 mg sorbitol.
English: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Maltese: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) huwa magħmul minn Escherichia coli K802 b'teknoloġija rikombinanti-DNA.
English: During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Biograstim.
Maltese: Fi studji kliniċi, 541 pazjent b'kanċer u 188 volontiera f'saħħithom ġew esposti għal Biograstim.
English: Biograstim contains the active substance filgrastim.
Maltese: Biograstim fih is-sostanza attiva filgrastim.
English: Date of latest renewal: 25 July 2013.
Maltese: Data tal-aħħar tiġdid: 25 ta' Lulju 2013.
English: Biograstim contains sorbitol.
Maltese: Biograstim fih sorbitol.
English: 9/L).
Maltese: NUMRU(I)
English: Acute grade II-IV GvHD
Maltese: GvHD akuta ta' grad II - IV
English: Haematuria, proteinuria
Maltese: Ematurja, protejnurja
English: Biograstim should not be diluted with sodium chloride solution.
Maltese: Biograstim m'għandux jiġi dilwit ma' soluzzjoni ta' sodium chloride.
English: 0.8 mL
Maltese: INDIVIDWALI 0.8 mL
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Maltese: Is-sigurta' u l-effikaċja ta' filgrastim għadhom ma ġewx determinati s'issa f'pazjenti b'Lewkimja Majelojde Akuta de novo li għandhom inqas minn 55 sena u ċitoġenetiċi normali [t(8;21), t(15;17), u inv(16)].
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Biograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Maltese: Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta'glucose 50 mg/mL (5%), Biograstim huwa kompatibbli mal-ħġieġ u varji tipi ta' plastik, fosthom il-PVC, polyolefin (co-polymer ta' polypropylene u polyethylene) u polypropylene.
English: Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Maltese: Biograstim huwa indikat għall-mobilizzazzjoni taċ-ċelluli proġenitriċi tad-demm periferali(PBPC).
English: ● Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation
Maltese: Riskju relattiv (95% CI) ta' GvHD u TRM wara l-kura b'G-CSF wara trapjant tal-mudullun Pubblikazzjoni Perjodu tal istudju
English: Meta-analysis a
Maltese: Meta-analiżi
English: Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli.
Maltese: Filgrastim huwa proteina magħmul permezz ta' proċess bioteknoloġiku ġol-batterju Escherichia coli.
English: Reduce to 0.5 MIU (5 µg)/kg/day
Maltese: MIU (5 µg)/kg/jum
English: Excipients: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
Maltese: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, ilma għall-injezzjoni.
English: Component of a multipack, cannot be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatment.
English: 0.5 mL
Maltese: INDIVIDWALI 0.5 mL
English: In normal stem cell donors
Maltese: F'donaturi normali ta' ċelluli staminali
English: After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Maltese: Wara d-dilwit: Stabilità kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita kienet demostrata għal 24 siegħa f'temperatura ta' 2°C - 8°C.
English: EU/1/08/450/001 EU/1/08/450/002 EU/1/08/450/003 EU/1/08/450/004 EU/1/08/450/009
Maltese: EU/1/08/450/001 EU/1/08/450/002 EU/1/08/450/003 EU/1/08/450/004