FrancophonIA/ELRC3.0 huggingface dataset:
English: nausea, vomiting and diarrhoea (all of which may be severe) constipation abdominal pain2
Slovenian: navzea, bruhanje in driska (vsi so lahko hudi), zaprtje bolečine v trebuhu2
English: febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leucopenia
Slovenian: febrilna nevtropenija nevtropenija (glejte Bolezni prebavil, spodaj) trombocitopenija anemija levkopenija pancitopenija huda krvavitev (v povezavi s trombocitopenijo)
English: (95 % CI) Hazard ratio (95 % CI) N = total number of patients treated.
Slovenian: Razmerje ogroženosti (95-odstotni IZ) n = celotno število zdravljenih bolnikov IZ = interval zaupanja
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Slovenian: Bistri koncentrat je bledo rumene barve in vsebuje 1 mg topotekana na mililiter.
English: Potactasol is for intravenous infusion after reconstitution and dilution.
Slovenian: Zdravilo Potactasol je za intravensko infundiranje po rekonstituciji in redčenju.
English: 30 minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Slovenian: Zdravljenje se je ponavljalo vsake 3 tedne in je trajalo do 1 leta,
English: Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10 % compared with the control group of patients.
Slovenian: (aktivne in neaktivne oblike) se je pri teh bolnikih v primerjavi s kontrolno skupino zmanjšal le za približno 10 %.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Slovenian: Pri tem je treba upoštevati običajne postopke za ustrezno ravnanje z zdravili proti raku in njihovo odstranjevanje, in sicer: - Osebje mora biti ustrezno izurjeno za rekonstitucijo in redčenje zdravila.
English: Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Slovenian: Nevtropenija: Med prvim ciklusom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev < 0,5 x 109/l), ki je pri 20 % bolnikov trajala najmanj sedem dni, pri 77% pa ves čas (v39 % ciklusov zdravljenja).
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide (see section 2).
Slovenian: − Druge sestavine so: manitol (E421), vinska kislina (E334), klorovodikova kislina (E507) in natrijev hidroksid (glejte poglavje 2).
English: The volume of reconstituted concentrate corresponding to the calculated individual dose should be further diluted with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose, to give a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Slovenian: Količino pripravljenega koncentrata, ki ustreza izračunanemu individualnemu odmerku, je treba dodatno razredčiti bodisi z raztopino natrijevega klorida (9 mg/ml(0,9 %) ali 5-odstotno (m/v) glukozo, do končne koncentracije od 25 do 50 mikrogramov na ml raztopine za infundiranje, na primer:
English: Potactasol 4 mg powder for concentrate for solution for infusion Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Slovenian: Potactosol 4 mg prašek za koncentrat za raztopino za infundiranje Steklene viale (8 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 4 mg topotekana.
English: - Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6) - Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.
Slovenian: - huda depresija kostnega mozga že pred začetkom prvega ciklusa, kar je razvidno iz izhodiščnega števila nevtrofilcev < 1,5 x 109/l in/ali števila trombocitov < 100 x 109/l
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 1 mg vials must be reconstituted with 1.1 ml water for injections.
Slovenian: Potactosol 1 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Potactasol 1 mg viale morate rekonstituirati z 1,1 ml vode za injekcije.
English: How to use Potactasol
Slovenian: Kako se uporablja zdravilo Potactasol
English: Cisplatin 50 mg/m2 on day 1, + Topotecan 0,75 mg/m2 on days 1-3, every 21 days
Slovenian: topotekan 0,75 mg/m2 na 1.-3. dan vsakih 21 dni
English: − Pregnant staff should be excluded from working with this medicinal product.
Slovenian: • Nosečnice ne smejo rokovati z zdravilom.
English: A doctor or nurse will give you the reconstituted and diluted Potactasol solution as an infusion (drip), usually into your arm, over about 30 minutes.
Slovenian: Potactasol v infuziji (kapalni), po navadi v roko; infuzija bo trajala približno 30 minut.
English: interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
Slovenian: intersticijska bolezen pljuč (nekateri primeri s smrtnim izidom)
English: Potactasol is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps.
Slovenian: Zdravilo Potactasol je na voljo v vialah iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % CI: 2.6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23).
Slovenian: Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoradioterapiji s cisplatinom je bila mediana preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95-odstotni IZ: 2,6, 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95-odstotni IZ: 2,9, 9,6), razmerje ogroženosti 1,15 (0,59, 2,23).
English: Potactasol is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
Slovenian: - če imate vnetje pljuč z znaki, kot so kašelj, zvišana telesna temperatura in težave z dihanjem; glejte tudi poglavje 4, "Možni neželeni učinki".
English: Potactasol 4 mg powder for concentrate for solution for infusion Potactasol 4 mg vials must be reconstituted with 4 ml water for injections.
Slovenian: Potactosol 4 mg prašek za koncentrat za raztopino za infundiranje Vsebino viale z zdravilom Potactasol 4 mg je treba rekonstituirati s 4 ml vode za injekcije.
English: Potactasol 1 mg powder for concentrate for solution for infusion Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Slovenian: Potactosol 1 mg prašek za koncentrat za raztopino za infundiranje Steklene viale (5 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 1 mg topotekana.
English: − Personnel handling this medicinal product during reconstitution and dilution should wear protective clothing including mask, goggles and gloves.
Slovenian: - Osebje, ki pripravlja zdravilo, mora med rekonstitucijo in redčenjem nositi zaščitna oblačila,
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Median (95 % CI) Hazard ratio (95 % CI)
Slovenian: Mediana vrednost (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ)
English: A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate.
Slovenian: Študija je bila opravljena pri bolnikih, pri katerih je po zdravljenju prve linije prišlo do ponovitve (mediana časa do napredovanja od zdravljenja prve linije: 84 dni za peroralni topotekan in NPO, 90 dni za samo NPO) in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
English: 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Slovenian: 2 O nevtropeničnem kolitisu, vključno z nevtropeničnim kolitisom s smrtnim izidom, so poročali kot o zapletu s topotekanom povzročene nevtropenije (glejte poglavje 4.4).
English: Potactasol contains sodium
Slovenian: Zdravilo Potactasol vsebuje natrij
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od1.000 bolnikov)
English: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C in normal light conditions, and for 24 hours at 2°C to 8°C when protected from light.
Slovenian: Kemična in fizikalna stabilnost koncentrata sta dokazani za 24 ur pri temperaturi 25 ± 2 °C v normalnih svetlobnih pogojih in za 24 ur pri temperaturi od 2 do 8 °C, če je zaščiten pred svetlobo.
English: gastrointestinal perforation Hepatobiliary disorders Common:
Slovenian: Pogostnost neznana gastrointestinalna perforacija
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Slovenian: 2,0 mg/m2/dan pri uporabi G-CSF in 1,4 mg/m2/dan brez uporabe G-CSF (glejte poglavje 5.2).
English: - Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections.
Slovenian: zvišana telesna temperatura resno poslabšanje splošnega stanja lokalni simptomi, npr. vnetje žrela ali pekoč občutek pri uriniranju hude bolečine v trebuhu, zvišana telesna temperatura in driska (ki je v redkih primerih krvava) so lahko znaki vnetja črevesa (nevtropeničnega kolitisa)
English: ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
Slovenian: cisplatin 50 mg/m2 na 1. dan vsakih 21 dni cisplatin 50 mg/m2 na 1. dan +
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Slovenian: Ustrezno količino tako pripravljene raztopine je treba še dodatno razredčiti bodisi z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml)ali s 5-odstotno (m/v) raztopino glukoze, da nastane končni pripravek s koncentracijo med 25 in 50 mikrogramov/ml.
English: Potactasol 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Slovenian: Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 1 mg topotekana (v obliki klorida).
English: Potactasol 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Slovenian: Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 4 mg topotekana (v obliki klorida).
English: Each vial contains 1 mg topotecan (as hydrochloride).
Slovenian: Ena viala vsebuje 1 mg topotekana (kot klorida).
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 %
Slovenian: Ob hudi nevtropeniji so med prvim ciklusom zdravljenja pri 16 % bolnikov opazili zvišano telesno temperaturo ali okužbo, 23 % bolnikov pa je imelo takšne neželene učinke ves čas (v 6 % ciklusov zdravljenja).
English: Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Slovenian: Kemična in fizikalna stabilnost raztopine po redčenju koncentrata z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za infundiranje je dokazana za 4 ure pri temperaturi 25 ± 2 °C v normalnih svetlobnih razmerah.
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Slovenian: bruhanje (32 %), driska (18 %), zaprtje (9 %) in vnetje ustne sluznice (14 %).
English: Powder for concentrate for solution for infusion.
Slovenian: koncentrat za raztopino za infundiranje.
English: − Personnel should be trained to reconstitute and dilute the the medicinal product.
Slovenian: Zdravilo mora pripraviti in razredčiti usposobljeno osebje.
English: Each vial contains 4 mg topotecan (as hydrochloride).
Slovenian: Ena viala vsebuje 4 mg topotekana (kot klorida).
English: Hepatic impairment
Slovenian: splošno slabo počutje
English: Ovarian and small cell lung carcinoma
Slovenian: Karcinom jajčnika in drobnocelični pljučni karcinom Začetni odmerek
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion
Slovenian: Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje
English: pruritus
Slovenian: srbenje
English: Yellow lyophilisate.
Slovenian: Okvara ledvic
English: Before infusion, Potactasol powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows: - Potactasol 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Potactasol 4 mg with 4 ml water for injections Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
Slovenian: - Potactasol 1 mg z 1,1 ml vode za injekcije (ker vsebuje 10 % prepolnjenja) - Potactasol 4 mg s 4 ml vode za injekcije
English: Mannitol (E421) Tartaric acid (E334) Sodium hydroxide Hydrochloric acid (E507)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421) vinska kislina (E334) natrijev hidroksid klorovodikova kislina (E507)
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Slovenian: Hude oblike (3. ali 4. stopnje) motenj so ugotavljali z naslednjimi pogostnostmi: navzea (4 %), bruhanje (3 %), driska (2 %) in vnetje ustne sluznice (1 %).
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Slovenian: Pred naslednjo uporabo topotekana mora biti število nevtrofilcev ≥ 1,5 x 109/l, število trombocitov ≥ 100 x 109/l in vrednost hemoglobina ≥ 9 g/dl (po prejemu transfuzije,če je ta potrebna).
English: Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Slovenian: Pogostnost neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) hude bolečine v trebuhu, občutek slabosti, bruhanje krvi, črno ali krvavo blato (to so lahko simptomi gastrointestinalne perforacije ali predrtja stene prebavil),
English: In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum based chemotherapy (n = 112 and 114, respectively), the response rate (95 % CI) was 20.5 % (13 %, 28 %) versus 14 % (8 %, 20 %) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Slovenian: Stopnja odzivnosti na zdravljenje (95-odstotni interval zaupanja) je znašala 20,5 % (13 %, 28 %) oziroma 14 % (8 %, 20 %), mediana časa do napredovanja pa 19 tednov za topotekan in 15 tednov za paklitaksel (razmerje ogroženosti 0,7 [0,6, 1,0]).
English: The following information is intended for healthcare professionals only:
Slovenian: Informacije namenjene samo zdravstvenemu osebju: Potactasol
English: Effective contraception methods should be used to avoid becoming pregnant or fathering a child while on treatment with Potactasol.
Slovenian: Uporabljati morate učinkovito kontracepcijo zaščito, da v času zdravljenja z zdravilom
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Slovenian: Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
English: Potactasol is not recommended in case of severe kidney impairment; - if you have liver problems.
Slovenian: Zdravila Potactasol ni priporočljivo uporabljati pri bolnikih s hudo okvaro ledvic.
English: One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Slovenian: pri katerih je prišlo do ponovitve ≥ 90 dni po koncu ene predhodne sheme kemoterapije, so izvedli eno študijo faze II (Študija 065) in eno študijo faze III (Študija 396) (glejte preglednico 1).
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n = 9) and Cmax (23 %, n = 11) was noted on day 5.
Slovenian: 13 bolnicam z rakom jajčnika so 5. dan opazili rahlo povečanje vrednosti AUC (za 12%, n = 9) in Cmax
English: Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Slovenian: Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
English: Topotecan monotherapy is indicated for the treatment of: - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Slovenian: - bolnikih s ponovitvijo drobnoceličnega pljučnega raka, pri katerih ponovno prve linije ni primerno (glejte poglavje 5.1).
English: Relapsed ovarian cancer
Slovenian: Ponovitev drobnoceličnega pljučnega raka
English: Potactasol 1 mg powder for concentrate for solution for infusion topotecan
Slovenian: Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje topotekan
English: anaphylactic reaction angioedema urticaria
Slovenian: zvišana telesna temperatura astenija utrujenost
English: In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Slovenian: Pri bolnikih s ponovitvijo dovzetnega drobnoceličnega pljučnega raka je bil celoten odstotek odziva na topotekan 24,3 %, na kombinacijo CAV pa 18,3 %.
English: Not known:
Slovenian: Pogostnost neznana:
English: How to store Potactasol
Slovenian: Dajanje zdravila Potactasol
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: Previdnostni ukrepi pred ravnanjem z zdravilom in njegovo uporabo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
Slovenian: ekstravazacija3 Pogostnost neznana vnetje sluznice
English: Blood and lymphatic system disorders Very common:
Slovenian: Bolezni krvi in limfatičnega sistema
English: The mean metabolite:parent AUC ratio was < 10 % for both total topotecan and topotecan lactone.
Slovenian: Tako za celotni topotekan kot za topotekan lakton je srednje razmerje med vrednostima AUC presnovka in matične učinkovine manjše od 10 %.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN UPORABE
English: Potactasol INSTRUCTIONS ON USE
Slovenian: B. NAVODILO ZA UPORABO
English: mucosal inflammation
Slovenian: vnetje ustne sluznice
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan, as Potactasol 1 mg contains a 10 % overage of fill.
Slovenian: Ker vsebuje zdravilo Potactasol 10% prebitek, ima nastala bledo rumena raztopina koncentracijo 1 mg topotekana na ml.
English: - Fever.
Slovenian: - Zvišana telesna temperatura.
English: How Potactasol is prepared
Slovenian: Priprava zdravila Potactasol
English: At the end of this period the product can be put back in the refrigerator.
Slovenian: Na koncu tega obdobja lahko zdravilo vrnete nazaj v hladilnik.
English: Singapore 637377
Slovenian: Singapur 637377
English: 5 Wald confidence interval.
Slovenian: 5 Waldov interval zaupanja.
English: The majority (90.9%) of patients were female.
Slovenian: Večina (90,9 %) bolnikov je bila ženskega spola.
English: Your doctor will calculate this.
Slovenian: To bo izračunal vaš zdravnik.
English: Safety Data from Other Clinical Studies
Slovenian: Podatki o varnosti iz drugih kliničnih študij
English: p-value (using repeated measures analysis)
Slovenian: Vrednost p (z uporabo analize ponovljenih meritev)
English: However, due to the lack of wellcontrolled studies, uncertainties remain.
Slovenian: Vendar zaradi pomanjkanja dobro kontroliranih študij negotovosti ostajajo.
English: For adults:
Slovenian: Za odrasle:
English: Approximately half were White (49.0%).
Slovenian: Približno pol jih je bilo belcev (49,0 %).
English: No substantial differences were seen in safety and efficacy related to age.
Slovenian: Znatnih razlik v varnosti in učinkovitosti, povezanih s starostjo, ni bilo.
English: However, chemical and physical stability has been demonstrated for 24 hours at 2°C - 8°C.
Slovenian: Vendar pa je bila dokazana kemična in fizikalna stabilnost za čas 24 ur pri temperaturi med 2 °C in 8 °C.
English: As with all proteins there is a potential for immunogenicity.
Slovenian: Kot pri vseh beljakovinah obstaja možnost za pojav imunogenosti.
English: Fatigue and health-related quality of life were relevant secondary endpoints.
Slovenian: Utrujenost in z zdravjem povezana kakovost življenja sta bili relevantni sekundarni končni stanji.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 ºC).
English: Patients with other diseases
Slovenian: Bolniki z drugimi boleznimi
English: The safety profiles in the different paediatric subsets of age appear similar.
Slovenian: Varnostni profili pri različnih pediatričnih starostnih podskupinah so se zdeli podobni.
English: Pontevedra 36400
Slovenian: Pontevedra 36400 Španija
English: This card is named: “Patient Safety Card”.
Slovenian: Ta kartica se imenuje: »opozorilna kartica za bolnika«.
English: 1 Based on the Kaplan-Meier product limit method.
Slovenian: 1 Na podlagi Kaplan-Meierjeve metode ‘product limit'.
English: Patients reported improved health-related quality of life (QoL).
Slovenian: Bolniki so poročali o izboljšanju kakovosti življenja (QoL).
English: Instructions:
Slovenian: Navodila:
English: Following each infusion, you will be monitored for about one hour.
Slovenian: Po vsaki infuziji bodo vaše stanje spremljali približno eno uro.
English: Responses were similar across all ages from 5 months to 17 years of age.
Slovenian: Odziv je bil podoben pri vseh starostih od 5 mesecev do 17 let starosti.