FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder demonstrates bioequivalence in the fed state, in compliance with the guidance on the investigation of bioequivalence in place at the time of lifting the suspension.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq juri l-bijoekwivalenza fl-istat mitmugħ, f'konformità mal-gwida dwar l-istħarriġ tal-bijoekwivalenza li tkun fis-seħħ fiż-żmien tat-tneħħija tassospensjoni.
English: Conditions for the lifting of the marketing authorisations suspension
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq
English: Placebo n = 106
Maltese: Plaċebo n = 106
English: Palifermin (60 micrograms/kg/day) n = 106
Maltese: Palifermin (60 mikrogramma/kg/kuljum) n = 106
English: Date of latest renewal: 23 September 2010
Maltese: Data tal-aħħar tiġdid: 23 ta' Settembru 2010
English: p-value*
Maltese: Valur-p*
English: MARKETING AUTHORISATION HOLDER Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm
Maltese: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm
English: Diluted Hydrochloric acid
Maltese: Hydrochloric acid dilwit
English: - The active substance is palifermin.
Maltese: - Is-sustanza attiva hi palifermin.
English: 5550 Airport Boulevard Boulder, Colorado 80301 United States of America
Maltese: Airport Boulevard Boulder, Colorado 80301 L-Istati Uniti
English: Generally, dissolution of Kepivance takes less than 5 minutes.
Maltese: Ġeneralment, id-dissoluzzjoni ta' Kepivance tieħu inqas minn 5 minuti.
English: L-histidine, mannitol, sucrose, polysorbate 20 and diluted hydrochloric acid
Maltese: L-histidine, mannitol, sucrose, polysorbate 20 u hydrochloric acid dilwit
English: Anaphylactic reaction/Hypersensitivity
Maltese: Reazzjoni anafilattiċi/Sensittività eċċessiva
English: Palifermin is a 140 amino acid protein with a molecular weight of 16.3 kilodaltons.
Maltese: Palifermin huwa proteina b'140 amino aċidi b'piż molekolari ta' 16.3 kilodaltons.
English: ** WHO Oral Mucositis Scale: Grade 1 = soreness/erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible
Maltese: Grad 1 = uġigħ/eritema; Grad 2 = eritema, ulċeri, ħila li tiekol ikel solidu; Grad 3 = ulċeri, teħtieġ dieta ta' likwidi biss; Grad 4 = mhux possibli li tiekol
English: Efficacy and safety of palifermin were established in a randomised, double-blind, placebo-controlled study in which patients received high-dose cytotoxic therapy consisting of fractionated total-body irradiation (12 Gy total dose; Day -8 to -5), high-dose etoposide (60 mg/kg; Day -4), and high-dose cyclophosphamide (100 mg/kg; Day -2) followed by PBPC support for the treatment of haematological malignancies ((Non-Hodgkin's Lymphoma (NHL), Hodgkin's disease, Acute Myeloid Leukaemia (AML), Acute Lymphocytic Leukaemia (ALL), Chronic Myeloid Leukaemia (CML), Chronic Lymphocytic Leukaemia (CLL), or multiple myeloma).
Maltese: L-effikaċja u s-sigurtà ta' palifermin kienu stabbiliti fi studju randomised, double-blind u kkontrollat bil-plaċebo fejn il-pazjenti rċivew terapija ċitotossika ta' doża għolja li kienet tikkonsisti f'irradjazzjoni frazzjonata tal-ġisem kollu (doża totali ta' 12 Gy; Jum -8 sa -5), doża għolja ta' etoposide (60 mg/kg; Jum -4), u doża għolja ta' cyclophosphamide (100 mg/kg; Jum -2) segwita minn appoġġ b'PBPC għall-kura ta' tumuri malinni ematoloġiċi (Limfoma Mhux ta' Hodgkin (NHL), marda ta' Hodgkin, Lewkimja Mijelojda Akuta (AML), Lewkimja Limfoċitika Akuta (ALL), Lewkimja Mijelojda Kronika (CML), Lewkimja Limfoċitika Kronika (CLL), jew mijeloma multipla).
English: Median (25th, 75th percentile) days of Median (25th, 75th percentile) days of
Maltese: Medjan (25th, 75th percentile)
English: The incidence of severe (grades 3 and 4) oral mucositis in the 3 groups was 36.8%, 38.3% and 23.9% for the placebo, pre/post CT and pre-CT groups respectively, with no statistical significance being demonstrated.
Maltese: Linċidenza ta' infjammazzjoni gravi (livelli 3 u 4) tal-mukoża orali fit-3 gruppi kienet ta' 36.8%, 38.3% u 23.9% għall-gruppi tal-plaċebo, ta' qabel/wara il-KT u ta' qabel il-KT rispettivament, u ma' ġiet dimostrata l'ebda sinjifikanza statistika.
English: Common (affects 1 to 10 users in 100) side effects are:
Maltese: Effetti komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100) sekondarji huma:
English: Each pack contains 6 vials.
Maltese: Kull pakkett fih 6 kunjetti.
English: These NOAEL doses were associated with systemic exposures (based on AUC) up to 9.7 and 2.1 times, respectively, anticipated clinical exposure.
Maltese: espożizzjonijiet sistemiċi (ibbażati fuq l-AUC) sa 9.7 u 2.1 darbiet, rispettivament, l-espożizzjoni klinika mistennija.
English: Very common: Common:
Maltese: Komuni ħafna:
English: Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) did not influence palifermin pharmacokinetics.
Maltese: Indeboliment renali ħafif sa moderat (tneħħija ta' krejatinina ta' 30-80 ml/min) ma influwenzax ilfarmakokinetika ta' palifermin.
English: Not known (frequency cannot be estimated from available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tkun stmata mid-data disponibbli)
English: Compared with the placebo group, the pre/post-chemotherapy group had a higher incidence of herpes virus infection (9% vs 0%), oral fungal infection (7% vs 2%) and sepsis/septic shock (12% vs 2%).
Maltese: Meta mqabbel mal-grupp tal-plaċebo, il-grupp ta' qabel/wara l-kimoterapija kellu inċidenza ogħla ta' infezzjoni talvirus tal-erpete (9% vs 0%), infezzjoni fungali orali (7% vs 2%) u xokk sepsis/settiku (12% vs 2%).
English: For information on dose limiting toxicities see section 4.8.
Maltese: Għal tagħrif dwar tossiċitajiet li jillimitaw id-doża ara sezzjoni 4.8.
English: This includes any possible side effects
Maltese: Rappurtar tal-effetti sekondarji
English: The conditioning regimen consisted of total body irradiation (TBI), etoposide and cyclophosphamide.
Maltese: Ir-reġimen ta' kundizzjonament kien jikkonsisti mill-irradjazzjoni tal-ġisem kollu (TBI - total body irradiation), etoposide u cyclophosphamide.
English: Post- myeloablative radiochemotherapy:
Maltese: Radjokemoterapija post- mijeloablattiva:
English: - The other ingredients are mannitol, sucrose, L-histidine, polysorbate 20 and diluted
Maltese: - Is-sustanzi l-oħra huma mannitol, sucrose, L-histidine, polysorbate 20 u hydrochloric acid
English: A total of 27 paediatric patients with leukaemia were randomized to 40, 60 or 80 micrograms/kg/day of palifermin for 3 days pre- and post- hematopoietic stem cell transplantation (HSCT).
Maltese: Total ta' 27 pazjent pedjatriku b'lewkimja ġew randomizzati għal 40, 60 jew 80 mikrogramma/kg/jum ta' palifermin għal 3 ijiem qabel u wara trapjant taċ-ċelloli staminali ematopoietiċi (HSCT - hematopoietic stem cell transplantation).
English: Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli.
Maltese: Kepivance fih is-sustanza attiva palifermin li hija proteina magħmula minn bioteknoloġija f'batterja msejħa Escherichia coli.
English: Inter-subject variability is high with a CV% of about 50% for CL and 60% for Vss.
Maltese: Il-varjabilità bejn il-persuni kienet għolja b'CV% ta' madwar 50% għal CL u 60% għal Vss.
English: The palifermin clinical program in the setting of myelotoxic therapy requiring haematopoietic stem cell (HSC) support included 650 patients with haematologic malignancies enrolled in 3 randomised, placebo-controlled clinical studies and a pharmacokinetic study.
Maltese: Il-programm kliniku ta' palifermin fl-ambjent ta' terapija mijelotossika li teħtieġ appoġġ ta' ċelluli staminali ematopojetiċi (HSC) kien jinkludi 650 pazjent b'tumuri malinni ematoloġiċi li ddaħħlu fi 3 studji kliniċi, randomised, ikkontrollati bil-plaċebo u fi studju farmakokinetiku.
English: Kepivance should not be administered subcutaneously due to poor local tolerability.
Maltese: Kepivance m'għandux jingħata taħt il-ġilda minħabba tollerabilità lokali batuta.
English: After reconstitution: 24 hours at 2 °C - 8 °C, protected from light.
Maltese: Wara r-rikostituzzjoni: 24 siegħa f'temperatura ta' 2 °C - 8 °C, protett mid-dawl.
English: Face oedema, oedema mouth
Maltese: • nefħa jew ħmura tal-vaġina
English: The frequency listed below is defined using the following convention: very common (> 1/10), common (≥ 1/100 to < 1/10), not known (frequency cannot be estimated from available data).
Maltese: Il-frekwenza elenkata hawn taħt hija definita premezz tal-konvenzjoni li ġejja: komuni ħafna (> 1/10), komuni (≥ 1/100 sa < 1/10), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: For the primary endpoint, which was incidence of cataract development or progression at 12 months (defined as an increase of ≥ 0.3 in the LOCS III score), a greater proportion of subjects experienced cataract development in the palifermin group compared with the placebo group (28.6 % in the placebo group vs 48.1% in the palifermin group).
Maltese: Għall-punt aħħari primarju, li kienet l-inċidenza tal-iżvilupp jew progressjoni ta' katarretti wara 12-il xahar (definiti bħala żieda ta' ≥ 0.3 fil-punteġġ ta' LOCS III), proporzjon akbar ta' persuni kellhom żvilupp ta' katarretti fil-grupp ta' palifermin meta mqabbel mal-grupp tal-plaċebo (28.6 % fil-grupp tal-plaċebo vs 48.1% fil-grupp ta' palifermin).
English: The incidence of ulcerative oral mucositis was 57.9% in the placebo arm, 68.7% in the pre/post CT group and 51.4% in the pre-CT group.
Maltese: L-inċidenza ta' infjammazzjoni tal-mukoża orali ulċerattiva hija ta' 57.9% fit-trattament bil plaċebo, 68.7% fil-grupp ta' qabel/wara il-KT u 51.4% fil-grupp ta' qabel il-KT. L-ebda wieħed miż żewġ reġimi ta' dożaġġ ma wrew riżultati li kienu statistikament sinjifikanti mqabbla mal-plaċebo.
English: No accumulation of palifermin occurred after 3 consecutive daily doses of 20 and 40 micrograms/kg (healthy volunteers) or 60 micrograms/kg (adult patients) or 40 to 80
Maltese: Ma dehret l-ebda akkumulazzjoni ta' palifermin wara 3 dożi konsekuttivi ta' kuljum ta' 20 u 40 mikrogramma/kg (voluntiera b'saħħithom) jew 60 mikrogramma/kg (pazjenti adulti) jew 40 sa 80 mikrogramma/kg (pazjenti pedjatriċi).
English: KGF receptors are known to be expressed on the lens of the eye. Cataractogenic effects of palifermin cannot be excluded (see section 5.1).
Maltese: Effetti katarattoġeniċi ta' palifermin ma jistgħux jiġu esklużi (ara sezzjoni 5.1).
English: In this study (n = 281), patients with multiple myeloma received conditioning with melphalan (200 mg/m2) prior to autologous haematopoietic stem cell transplantation.
Maltese: F'dan l-istudju (n = 281), pazjenti li jbagħtu minn mijeloma multipla rċevew trattament bil-melfalan (200 mg/m2) qabel it-trapjant taċ-ċelluli staminali ematopojetiċi awtologi.
English: Long term safety
Maltese: Sigurtà fit-tul
English: Once reconstituted, Kepivance contains 5 mg/ml of palifermin.
Maltese: Kepivance rikostitwit fiha 5 mg/ml ta' palifermin
English: Median (25th, 75th percentile) Cumulative Dose (morphine mg equivalents) Patient Incidence of Total Parenteral Nutrition (TPN)
Maltese: Doża Kumulattiva (ekwivalenti għal morphine mg) Inċidenza ta' Pazjenti b'Nutrizzjoni
English: The most commonly reported adverse drug reactions (reported in > 1/10 patients) are reactions consistent with the pharmacologic action of Kepivance on skin and oral epithelium, e.g. oedema, including peripheral oedema, and hypertrophia of oral structures.
Maltese: L-iktar reazzjonijiet avversi tal-mediċina li kienu rrappurtati b'mod komuni (irrappurtati f > 1/10 pazjenti) huma reazzjonijiet konsistenti mal-azzjoni farmakoloġika ta' Kepivance fuq il-ġilda u l-epitelju orali, eż. edema, li tinkludi edema periferali, u ipertrofija tal-istrutturi orali.
English: Systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female fertility parameters were seen at doses ≥ 300 micrograms/kg/day (5-fold higher than the recommended human dose).
Maltese: Tossiċità sistemika (sinjali kliniċi u/jew tibdil fil-piż tal-ġisem) u effetti avversi fuq il-parametri tal-fertilità fl-irġiel u nisa kienu osservati f'dożi ta' ≥ 300 mikrogramma/kg/kuljum (5 darbiet ogħla mid-doża rakkomandata fil-bniedem).
English: Safety and efficacy has not been evaluated in patients with hepatic impairment (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ma ġewx evalwati f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: Kepivance should be reconstituted with 1.2 ml water for injections.
Maltese: Kepivance għandu jiġi rikostitwit b'1.2 ml ilma għall-injezzjonijiet.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara r-rikostruzzjoni tal-prodott medicinali, ara sezzjoni 6.3.
English: Oral mucosal hypertrophy / Hypertrophy of tongue papillae,Oral mucosal discolouration / Tongue discolouration, Tongue disorder (e.g. redness, bumps), Tongue oedema
Maltese: Ipertrofija mukuża orali/Ipertrofija tal papilli tal-ilsien, Tibdil fil-kulur tal mukuża orali/tibdil fil-kulur tal-ilsien
English: Lip swelling, eyelid oedema
Maltese: IL-KONTENUT SKONT IL-PIŻ, VOLUM JEW PARTI
English: In patients with end-stage renal disease (requiring dialysis) palifermin clearance was decreased by 10% (n = 6).
Maltese: F'pazjenti b'marda renali fl-aħħar stadju (li teħtieġ id-dijalisi), it-tneħħija ta' palifermin kienet mnaqqsa b'10% (n = 6).
English: No adverse developmental effects were observed in rats and rabbits at doses of up to 300 and 60 micrograms/kg/day, respectively.
Maltese: Ma kienu osservati l-ebda effetti avversi fuq l-iżvilupp fil-firien u fniek f'dożi sa 300 u 60 mikrogramma/kg/kuljum, rispettivament.
English: Approximately dose-linear pharmacokinetics were observed in healthy volunteers after single dose administration up to 250 micrograms/kg.
Maltese: Kienet osservata ftit jew wisq farmakokinetika lineari mad-doża f'voluntiera b'saħħithom wara għoti ta' doża waħda sa 250 mikrogramma/kg.
English: For information on preparation and administration of Kepivance, please see information for healthcare professionals at the end of this leaflet.
Maltese: Għal informazzjoni dwar il-preparazzjoni u l-għoti ta' Kepivance, jekk jogħġbok ara informazzjoni għal professjonisti fil-qasam tal-kura tas-saħħa fl-aħħar ta' dan il-fuljett.
English: A single dose of 250 micrograms/kg has been administered intravenously to 8 healthy volunteers without severe or serious adverse effects.
Maltese: Doża waħda ta' 250 mikrogramma/kg ingħatat ġol-vini lil 8 voluntiera b'saħħithom mingħajr effetti avversi severi jew serji.
English: In a single dose study the clearance of palifermin was approximately 30% lower in 8 healthy subjects aged 66-73 years after a dose of 90 micrograms/kg than in younger subjects (≤ 65 years) after a dose of 180 micrograms/kg.
Maltese: Fi studju ta' doża waħda, l-eliminazzjoni ta' palifermin kien bejn wieħed u ieħor 30% iktar baxx fi 8 suġġetti b'saħħithom li kellhom bejn 66 u 73 sena wara doża ta' 90 mikrogramma/kg milli f'individwi iżgħar fl-età (≤ 65 sena) wara doża ta' 180 mikrogramma/kg.
English: SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR
Maltese: MANIFATTURTAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: In addition, there was a higher incidence of infections in patients administered palifermin pre- and post-chemotherapy (49.5%) compared with patients who received placebo (24.6%).
Maltese: Barra minn hekk, kien hemm inċidenza ogħla ta' infezzjonijiet f'pazjenti li ngħataw palifermin qabel u wara l-kimoterapija (49.5%) meta mqabbel ma' pazjenti li rċevew plaċebo (24.6%).
English: Other medicines and Kepivance
Maltese: Mediċini oħra u Kepivance
English: 6.25 mg of powder in a vial (Type I glass) with a rubber stopper, an aluminium seal and a plastic flip
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 6.25 mg trab f'kunjett (ħġieġ tat-Tip I) b'tapp tal-lasktu, siġill tal-aluminju u għatu flip-off tal-plastik.
English: Dose-dependent epithelial cell proliferation was observed 48 hours post-dosing in healthy subjects given single intravenous doses of 120 to 250 micrograms/kg.
Maltese: Proliferazzjoni taċċelluli tal-epitilju dipendenti mid-doża kienet osservata 48 siegħa wara d-dożaġġ f'persuni b'saħħithom li ngħataw dożi waħidom ta' 120 sa 250 mikrogramma/kg minn ġol-vini.
English: Cataractogenic effects of palifermin cannot be excluded following results of ophthalmologic examinations in a subset of patients (n = 66; 14 in the placebo group, 52 in the palifermin group) who were followed for 12 months after the acute phase of the above post-approval study.
Maltese: Effetti katarattoġeniċi ta' palifermin ma jistgħux jiġu esklużi wara r-riżultati ta' eżamijiet oftalmoloġiċi f'sottosett ta' pazjenti (n = 66; 14 fil-grupp tal-plaċebo, 52 fil-grupp ta' palifermin) li ġew segwiti 12-il xahar wara l-fażi akuta tal-istudju ta' wara l-approvazzjoni imsemmi hawn fuq.
English: • darkening of an area of skin (hyperpigmentation);
Maltese: • uġigħ fil-ġogi (artralġja);
English: In a small multiple-dose study in paediatric patients (1 to 16 years old) receiving 40, 60 or 80 micrograms/kg/day for 3 days pre- and post- HSCT, there was no effect of age on the pharmacokinetics of palifermin although a large variability was observed in the estimated parameters.
Maltese: Fi studju żgħir b'aktar minn doża waħda f'pazjenti pedjatriċi (1 sa 16-il sena) li rċievew 40, 60 jew 80 mikrogramma/kg/jum għal 3 ijiem qabel u wara HSCT, ma kien hemm ebda effett tal-età fuq il farmakokinetiċi ta' palifermin għalkemm ġiet osservata varjabilità kbira fil-parametri stimati.
English: • eyelid swelling;
Maltese: • raxx fil-ġilda;
English: There was an imbalance in age distribution with more elderly (> 65 years) patients in the palifermin group.
Maltese: Kien hemm żbilanċ fid-distribuzzjoni tal-età b'aktar persuni anzjani (> 65 sena) fil-grupp ta' palifermin.
English: Not known: Very common:
Maltese: Mhux magħruf:
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03A F08.
Maltese: Sustanzi detossifikanti għall-kura antineoplastika, Kodiċi ATC:
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min), clearance was decreased by 22% (n = 5).
Maltese: < 30 ml/min), it-tneħħija kienet mnaqqsa b'22% (n = 5).
English: Dose limiting toxicities were observed in 36% (5 of 14) patients receiving 6 doses of 80 micrograms/kg/day administered intravenously over 2 weeks (3 doses preceding and three doses following myeloablative therapy).
Maltese: Tossiċitajiet li jillimitaw id-doża kienu osservati f'36% (5 minn 14) tal-pazjenti li rċivew 6 dożi ta' 80 mikrogramma/kg/kuljum mogħtija ġol-vini fuq medda ta' ġimagħtejn (3 dożi qabel u 3 dożi wara terapija mijeloablattiva).
English: After single intravenous doses of 20 to 250 micrograms/kg (healthy volunteers) and 60 micrograms/kg (cancer patients), palifermin exhibited rapid extravascular distribution In patients with haematological malignancies mean Vss was 5 l/kg and mean clearance about 1300 ml/hour/kg with an average terminal half-life of approximately 4.5 hours.
Maltese: Wara dożi singulari ġol-vini ta' 20 sa 250 mikrogramma/kg (voluntiera b'saħħithom) u 60 mikrogramma/kg (pazjenti bil-kanċer), palifermin wera distribuzzjoni ekstravaskulari mgħaġla.
English: The contents should be swirled gently during dissolution.
Maltese: Il-kontenuti għandhom jiddawru bil-mod waqt id-dissoluzzjoni.
English: Adverse reactions from clinical trials and spontaneous reporting
Maltese: Reazzjonijiet avversi minn provi kliniċi u rappurtaġġ spontanju.
English: The usual dose of Kepivance is 60 micrograms of Kepivance per kilogram of bodyweight per day.
Maltese: Id-doża tas-soltu ta' Kepivance hija 60 mikrogamma ta' Kepivance kull kilogramma ta' piż tal-ġisem kuljum.
English: Patient Incidence of Febrile Neutropenia 92% 75% * Using Cochran-Mantel-Haenszel (CMH) test stratified for study centre.
Maltese: * Bl-użu tat-test Cochran-Mantel-Haenszel (CMH) stratifikat għaċ-ċentru tal-istudju.
English: The potential risk to the human embryo or foetus is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali għallembriju jew fetu uman.
English: The pharmacokinetics of palifermin were studied in healthy volunteers and patients with haematological malignancies.
Maltese: Il-farmakokinetika ta' palifermin kienet studjata f'voluntiera b'saħħithom u pazjenti b'tumuri malinni ematoloġiċi.
English: However, the administration of palifermin did not affect heparin´s anticoagulant effect in the experimental conditions (single dose, subtherapeutic dose regimen).
Maltese: Madankollu, l-amministrazzjoni ta' palifermin ma affettwatx l-effett antikoagulanti tal-eparina fil-kundizzjonijiet sperimentali (doża waħdanija, reġimen tad-doża subterapewtiku).
English: • increase in lipase and amylase levels (digestive enzymes) in the blood (which do not require treatment and usually return to normal after stopping treatment with Kepivance).
Maltese: • żieda fil-livelli ta lipase u amylase (enżimi diġestivi) fid-demm (li ma jeħtiġux kura u ġeneralment jirritornaw għan-normal wara li titwaqqaf il-kura b'Kepivance)
English: Renal impairment Dose adjustment in patients with renal impairment is not necessary (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: In studies in rats, no adverse effects on reproductivity/fertility parameters were observed at doses of up to 100 micrograms/kg/day.
Maltese: Ma kienu osservati l-ebda effetti avversi fuq il-parametri tarriproduzzjoni u tal-fertilità f'dożi ta' mhux aktar minn 100 mikrogramma/kg/kuljum.
English: The safety and efficacy of Kepivance in children aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Kepivance fit-tfal minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: Vaginal oedema and vulvovaginal erythema
Maltese: Analġesja Opjoda għall-mukosite orali:
English: NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection Palifermin
Maltese: Kepivance 6.25 mg trab għall-injezzjoni Palifermin
English: The efficacy and safety of palifermin have only been established in association with conditioning regimens for autologous haematopoietic stem cell support that comprise total body irradiation and high dose chemotherapy (cyclophosphamide and etoposide) (see section 5.1).
Maltese: L-effikaċja u s-sigurtà ta' palifermin ġew stabbiliti biss flimkien mal-korsijiet tal-ikkundizzjonar għal sostenn ta' ċelluli staminali ematopojetiċi awtologi li jinkludi l-irradjazzjoni totali tal-ġisem u kimoterapija b'doża qawwija (cyclophosphamide u etoposide) (ara sezzjoni 5.1).
English: These no observed adverse effect level (NOAEL) doses were associated with systemic exposures up to 2.5 times greater than anticipated clinical exposure.
Maltese: Dawn il-livelli ta' doża mingħajr l-ebda effetti avversi osservati (NOAEL) kienu assoċjati ma' espożizzjonijiet sistemiċi sa 2.5 darbiet aktar mill-espożizzjoni klinika mistennija.
English: Patient incidence of WHO Grade 4 oral Median (25th, 75th percentile) days of
Maltese: Medjan (25th, 75th percentile) ta' ġranet ta' mukosite orali ta' Grad 2/3/4 skont id-WHO
English: Blood amylase increased and Lipase Increased1
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: In fertility/general reproductive toxicity studies in rats, palifermin treatment was associated with systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female reproductive/fertility parameters at doses greater than or equal to 300 micrograms/kg/day.
Maltese: Fi studji dwar it-tossiċità fuq il-fertilità u l-funżjoni riproduttiva ġenerali fil-firien, kura b'palifermin kienet assoċjata ma' tossiċità sistemika (sinjali kliniċi u/jew tibdil fil-piż tal-ġisem) u effetti avversi fuq il-parametri tar-riproduzzjoni u tal-fertilità maskili u femminnili f'dożi akbar minn jew ugwali għal 300 mikrogramma/kg/kuljum.