FrancophonIA/ELRC3.0 huggingface dataset:
English: Imiglucerase is a modified form of the human enzyme acid β-glucosidase produced by recombinant DNA technology.
Croatian: Imigluceraza je modificirani oblik ljudskog enzima kisele β-glukozidaze koja se proizvodi tehnologijom rekombinantne DNK.
English: Cerezyme reduces resting energy expenditure rate.
Croatian: Cerezyme smanjuje potrošnju energije u mirovanju.
English: At initial infusions, Cerezyme should be administered at a rate not exceeding 0.5 unit per kg body weight per minute.
Croatian: Tijekom početnih infuzija Cerezyme se mora primjenjivati brzinom od najviše 0,5 jedinica po kilogramu tjelesne težine u minuti.
English: What you need to know before you are given Cerezyme Do not use Cerezyme
Croatian: Što morate znati prije nego primite Cerezyme Nemojte primjenjivati Cerezyme
English: Administration of doses as low as 15 U/kg of body weight once every 2 weeks has been shown to improve haematological parameters and organomegaly, but not bone parameters.
Croatian: Primjena malih doza od 15 U/kg tjelesne težine jedanput svaka 2 tjedna dovela je do poboljšanja hematoloških vrijednosti i organomegalije, no ne i koštanih parametara.
English: This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage, and an increased need for transfusion.
Croatian: To uključuje povećani rizik od manifestacija na kostima, egzacerbacije citopenije, krvarenja te povećanu potrebu za transfuzijom.
English: Both pregnancy and lactation are known to stress maternal calcium homeostasis and to accelerate bone turnover.
Croatian: Poznato je da razdoblja trudnoće i laktacije predstavljaju opterećenje za homeostazu kalcija i ubrzavaju koštanu pregradnju u majke.
English: Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.
Croatian: Preporučuje se oprez kod primjene lijeka Cerezyme za vrijeme trudnoće i dojenja.
English: Tachycardia*, cyanosis*
Croatian: Tahikardija*, cijanoza*
English: In an ICGG Gaucher Registry analysis of a large cohort of patients (n=528) with Gaucher disease type 1, a time- and dose-dependent effect for Cerezyme was observed for haematological and visceral parameters (platelet count, haemoglobin concentration, spleen and liver volume) within the dose range of 15, 30 and 60 U/kg body weight once every 2 weeks.
Croatian: International Collaborative Gaucher Group (ICGG) Gaucher Registry) provedenoj na velikoj kohorti bolesnika (n=528) s Gaucherovom bolešću tipa 1 zabilježeni su o vremenu i dozi ovisni učinci lijeka Cerezyme na hematološke i visceralne parametre (broj trombocita, koncentracija hemoglobina, volumen slezene i jetre) u rasponu doza od 15, 30 i 60 U/kg tjelesne težine jedanput svaka 2 tjedna.
English: In individuals with Gaucher disease, glucosylceramide degradation is insufficient, leading to accumulation of large quantities of this substrate within the lysosomes of macrophages (termed ‘Gaucher cells'), leading to widespread secondary pathology.
Croatian: U osoba s Gaucherovom bolešću razgradnja glukozilceramida je nedostatna te dolazi do nakupljanja velike količine tog supstrata u lizosomima makrofaga (nazvanih "Gaucherove stanice"), što dovodi do rasprostranjene sekundarne patologije.
English: This should lead to improvement in the safe and effective use of Cerezyme.
Croatian: Time bi se trebala povećati sigurnost i učinkovitost primjene lijeka Cerezyme.
English: People with Gaucher disease have low levels of an enzyme called acid β-glucosidase.
Croatian: Osobe s Gaucherovom bolešću imaju niske razine enzima koji se zove kisela β-glukozidaza.
English: Imiglucerase (recombinant macrophage targeted acid ß-glucosidase) replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus correcting initial pathophysiology and preventing secondary pathology.
Croatian: Imigluceraza (rekombinantna kisela β-glukozidaza koja ciljano djeluje na makrofage) nadomješta nedostatnu enzimsku aktivnost tako što hidrolizira glukozilceramid i tako korigira početnu patofiziologiju i sprječava sekundarnu patologiju.
English: Routine evaluation to detect the presence of pulmonary hypertension after diagnosis of Gaucher disease and over time is recommended.
Croatian: Preporučuje se rutinska obrada radi utvrđivanja plućne hipertenzije po dijagnosticiranju Gaucherove bolesti i povremeno tijekom bolesti.
English: Dizziness, headache, paraesthesia*
Croatian: Omaglica, glavobolja, parestezija*
English: Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Croatian: Cerezyme se smije primjenjivati samo pod nadzorom liječnika s iskustvom u liječenju Gaucherove bolesti.
English: Gaucher disease is associated with increased glucose production and increased resting energy expenditure rate, which may contribute to fatigue and cachexia.
Croatian: Gaucherova bolest povezana je s povećanom proizvodnjom glukoze te povećanom potrošnjom energije u stanju mirovanja, što može pridonijeti pojavi umora i kaheksije.
English: Pack sizes: 1, 5 or 25 vials per carton.
Croatian: Veličine pakiranja: 1, 5 ili 25 bočica u kutiji.
English: The objectives of the “ICGG Gaucher Registry” are to enhance the understanding of Gaucher disease and to evaluate the effectiveness of enzyme replacement therapy, ultimately leading to improvement in the safe and efficacious use of Cerezyme.
Croatian: Cilj “ICGG registra bolesnika s Gaucherovom bolešću” je pridonijeti razumijevanju Gaucherove bolesti i ocijeniti učinkovitost enzimske nadomjesne terapije, što će naposlijetku dovesti do sigurnije i djelotvornije primjene lijeka Cerezymee.
English: Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health.
Croatian: Ženama koje nikad nisu bile liječene ovim lijekom treba preporučiti da s liječenjem započnu prije začeća kako bi postigle optimalno zdravstveno stanje.
English: Infusion of Cerezyme by the patient or caregiver at home requires training by a health care professional in a clinical setting.
Croatian: Za primjenu infuzije lijeka Cerezyme kod kuće bolesnik ili njegovatelj moraju prethodno proći obuku koju u kliničkom okruženju provodi zdravstveni djelatnik.
English: Mix the infusion solution gently.
Croatian: Otopinu za infuziju lagano promiješajte.
English: But, if you suffer with any shortness of breath you should tell your doctor.
Croatian: Međutim, ako patite od nedostatka zraka, o tome morate obavijestiti svoga liječnika.
English: These skeletal manifestations include bone marrow infiltration, osteonecrosis, bone pain and bone crises, osteopenia and osteoporosis, pathological fractures, and growth impairment.
Croatian: Koštane manifestacije uključuju infiltraciju koštane srži, osteonekrozu, bol u kostima i koštane krize, osteopeniju i osteoporozu, patološke prijelome i zastoj rasta.
English: Cerezyme contains the active substance imiglucerase and is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of plateletsa type of blood cell), spleen or liver enlargement or bone disease.
Croatian: Cerezyme sadrži djelatnu tvar imiglucerazu i primjenjuje se u liječenju bolesnika s potvrđenom dijagnozom Gaucherove bolesti tipa 1 ili tipa 3 koji pokazuju znakove bolesti kao što su: anemija (mali broj crvenih krvnih stanica), sklonost krvarenju (zbog malog broja trombocita - vrste krvnih stanica), povećanje slezene ili jetre te koštane bolesti.
English: The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works.
Croatian: Ciljevi toga registra su unaprijediti razumijevanje Gaucherove bolesti i ocijeniti učinkovitost enzimske nadomjesne terapije kao što je lijek Cerezyme.
English: Cerezyme is supplied in type I borosilicate (clear) glass 20 ml vials.
Croatian: Cerezyme je dostupan u bočicama od 20 ml od borosilikatnog (prozirnog) stakla tipa I.
English: In patients dosages up to 240 U/kg body weight once every two weeks have been used.
Croatian: U bolesnika su primijenjene doze do 240 U/kg tjelesne težine jedanput svaka dva tjedna.
English: Each vial of Cerezyme is for single use only.
Croatian: Jedna bočica lijeka Cerezyme namijenjena je isključivo za jednokratnu uporabu.
English: Adverse reactions are listed by system organ class and frequency (common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)) in the table below.
Croatian: <1/10), manje često (≥1/1000 i <1/100) i rijetko (≥1/10 000 i <1/1000)).
English: This may contribute to skeletal disease burden in Gaucher disease.
Croatian: To može pridonijeti opterećenju koštane bolesti u sklopu Gaucherove bolesti.
English: The ICGG Gaucher Registry
Croatian: ICGG registar bolesnika s Gaucherovom bolešću
English: The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
Croatian: Zatvarač se sastoji od silikoniziranog butilnog čepa s "flip-off" kapicom s evidencijom otvaranja.
English: Initial doses of 60 U/kg of body weight once every 2 weeks have shown improvement in haematological and visceral parameters within 6 months of therapy and continued use has either stopped progression of or improved bone disease.
Croatian: Uz početnu dozu od 60 U/kg tjelesne težine primijenjenu jedanput svaka 2 tjedna došlo je do poboljšanja hematoloških i visceralnih pokazatelja unutar 6 mjeseci terapije, a nastavak primjene je ili zaustavio napredovanje ili doveo do poboljšanja koštane bolesti.
English: What you need to know before you are given Cerezyme.
Croatian: Što morate znati prije nego počnete primite Cerezyme
English: The recommended dose is 60 units/kg body weight given once every 2 weeks.
Croatian: Preporučena doza je 60 jedinica/kg tjelesne težine, a primjenjuje se jedanput svaka 2 tjedna.
English: Unopened vials: Store in a refrigerator (2°C - 8°C)
Croatian: Neotvorene bočice: Čuvati u hladnjaku (2°C - 8°C)
English: Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ICGG Gaucher Registry” (see section 5.1).
Croatian: Liječnike i zdravstvene djelatnike potiče se upisati bolesnike s Gaucherovom bolešću, uključujući i one s kroničnim neuropatskim manifestacijama bolesti, u “ICGG registar bolesnika s Gaucherovom bolešću” (vidjeti dio 5.1).
English: Treatment with Cerezyme at a dose of 60 U/kg body weight once every 2 weeks, showed improvement in bone pain as early as 3 months, decrease in bone crises within 12 months, and improvement in bone mineral density after 24 months of treatment (Sims et al, 2008).
Croatian: Liječenje lijekom Cerezyme u dozi od 60 U/kg tjelesne težine jedanput svaka 2 tjedna dovelo je do smanjenja bolova u kostima već nakon 3 mjeseca, smanjenja koštanih kriza unutar 12 mjeseci i poboljšanja mineralne gustoće kosti nakon 24 mjeseca liječenja (Sims i sur., 2008.).
English: Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „Rok valjanosti“.
English: In pregnant Gaucher patients and those intending to become pregnant, a risk-benefit treatment assessment is required for each pregnancy.
Croatian: U bolesnica s Gaucherovom bolešću koje su trudne ili planiraju zatrudnjeti potrebno je procijeniti odnos rizika i koristi liječenja u svakoj trudnoći.
English: EU/1/97/053/001 Cerezyme 200 Units 1 vial of powder for concentrate for solution for infusion EU/1/97/053/002 Cerezyme 200 Units 25 vials of powder for concentrate for solution for infusion EU/1/97/053/003 Cerezyme 400 Units 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 Cerezyme 400 Units 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 Cerezyme 400 Units 25 vials of powder for concentrate for solution for infusion
Croatian: EU/1/97/053/001 Cerezyme 200 jedinica 1 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/002 Cerezyme 200 jedinica 25 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/003 Cerezyme 400 jedinica 1 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/004 Cerezyme 400 jedinica 5 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/005 Cerezyme 400 jedinica 25 bočica s praškom za koncentrat za otopinu za infuziju
English: It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Croatian: Preporučuje se bolesnike, u kojih se sumnja na smanjeni odgovor na liječenje, periodički provjeravati stvaraju li IgG protutijela na imiglucerazu.
English: Onset of such symptoms has occurred during or shortly after infusions.
Croatian: Nastupili su tijekom infuzije ili neposredno nakon nje.
English: EU/1/97/053/001 1 vial of powder for concentrate for solution for infusion EU/1/97/053/002 25 vials of powder for concentrate for solution for infusion
Croatian: EU/1/97/053/001 1 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/002 25 bočica s praškom za koncentrat za otopinu za infuziju
English: Pack sizes: 1 or 25 vials per carton.
Croatian: Veličine pakiranja: 1 ili 25 bočica u kutiji.
English: Patients with Gaucher disease may also have a low grade inflammatory profile.
Croatian: Bolesnici s Gaucherovom bolešću također mogu imati upalu niskog stupnja.
English: Gaucher disease is a rare recessively inherited metabolic disorder that results from a deficiency of the lysosomal enzyme acid β-glucosidase.
Croatian: Gaucherova bolest je rijedak recesivno nasljedan metabolički poremećaj koji nastaje uslijed nedostatka lizosomalnog enzima kisele β-glukozidaze.
English: Hypersensitivity
Croatian: Reakcije preosjetljivosti
English: Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Croatian: Na temelju režima doziranja u pojedinog bolesnika odredite broj bočica koje treba rekonstituirati te ih izvadite iz hladnjaka.
English: After reconstitution, promptly dilute vials and do not store for subsequent use.
Croatian: Nakon rekonstitucije odmah razrijedite sadržaj bočica i nemojte ih spremati za kasniju uporabu.
English: The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Croatian: Prašak za koncentrat za otopinu za infuziju mora se rekonstituirati s vodom za injekcije, razrijediti 0,9%-tnom otopinom natrijevog klorida za intravensku primjenu, a zatim primijeniti intravenskom infuzijom.
English: In a study investigating 2 cohorts of patients treated with a median dose of 80 U/kg body weight every 4 weeks and a median dose of 30 U/kg body weight every 4 weeks, among the patients with bone marrow burden score ≥ 6, more patients in the higher dose cohort (33%; n=22) achieved a decrease in the score of 2 points after 24 months of Cerezyme treatment compared with patients in the lower dose cohort (10%; n=13) (de Fost et al, 2006).
Croatian: U ispitivanju u kojem su sudjelovale 2 kohorte bolesnika liječenih medijanom doze od 80 U/kg tjelesne težine svaka 4 tjedna te medijanom doze od 30 U/kg tjelesne težine svaka 4 tjedna, među bolesnicima s opterećenjem koštane srži ≥ 6, smanjenje zbroja za 2 boda nakon 24 mjeseca liječenja lijekom Cerezyme postigao je veći broj bolesnika u kohorti koja je primala višu dozu (33%; n=22)
English: ** Imiglucerase is a modified form of human acid β-glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages.
Croatian: ** Imigluceraza je modificirani oblik ljudske kisele β-glukozidaze koja se proizvodi tehnologijom rekombinantne DNK na staničnoj kulturi sisavaca, odnosno jajnika kineskog hrčka (engl.
English: Vomiting, nausea, abdominal cramping, diarrhoea
Croatian: Povraćanje, mučnina, grčevi u abdomenu, proljev
English: Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ICGG Gaucher Registry”.
Croatian: Liječnike i zdravstvene djelatnike potiče se upisati bolesnike s Gaucherovom bolešću, uključujući i one s kroničnim neuropatskim manifestacijama bolesti, u “ICGG registar bolesnika s Gaucherovom bolešću”.
English: Similarly, in an ICGG Gaucher Registry analysis of bone mineral density using dual-energy X-ray absorptiometry (DXA) in 342 patients, after 8 years of treatment normal bone mineral density was achieved with a Cerezyme dose of 60 U/kg body weight once every 2 weeks, but not with lower doses of 15 and 30 U/kg body weight once every 2 weeks (Wenstrup et al, 2007).
Croatian: X-ray absorptiometry, DXA) u 342 bolesnika, nakon 8 godina liječenja je normalna mineralna gustoća kosti postignuta uz dozu lijeka Cerezyme od 60 U/kg tjelesne težine jedanput svaka 2 tjedna, no ne i s nižim dozama od 15 i 30 U/kg tjelesne težine jedanput svaka 2 tjedna (Wenstrup i sur., 2007.).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 25 VIALS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE (1 BOČICA, 25 BOČICA)
English: Cerezyme is a white to off-white powder.
Croatian: Cerezyme je bijeli ili bjelkasti prašak.
English: Infusion rate increases should occur under supervision of a health care professional.
Croatian: Povećanje brzine infuzije mora nadgledati zdravstveni djelatnik.
English: How Cerezyme is given
Croatian: Kako se Cerezyme primjenjuje
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PRILOG II. A. PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: These have included itching, flushing, hives/localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin, fall in blood pressure and backache.
Croatian: Među njima su bili svrbež, navale crvenila, koprivnjača/lokalizirano oticanje kože ili sluznice usta ili grla, nelagoda u prsnom košu, ubrzani otkucaji srca, plavičasta koža, nedostatak zraka, trnci, osjećaj bockanja, žarenja ili utrnulost kože, pad krvnog tlaka i bol u leđima.
English: Cerezyme contains sodium
Croatian: Cerezyme sadrži natrij
English: Genzyme Europe B.V. Paasheuvelweg 25
Croatian: Genzyme Europe B.V.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika koji su na dijeti s kontroliranim unosom natrija.
English: EU/1/97/053/003 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 25 vial of powder for concentrate for solution for infusion
Croatian: EU/1/97/053/003 1 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/004 5 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/005 25 bočica s praškom za koncentrat za otopinu za infuziju
English: Flushing*, hypotension*
Croatian: Navale crvenila*, hipotenzija*
English: The most frequent disease manifestations are hepatosplenomegaly, thrombocytopenia, anaemia, and skeletal pathology, The skeletal abnormalities are frequently the most debilitating and disabling features of Gaucher disease.
Croatian: Najčešće manifestacije bolesti su hepatosplenomegalija, trombocitopenija, anemija i koštana patologija.
English: Cerezyme, 400 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1, 5 or 25).
Croatian: Cerezyme 400 jedinica dolazi u obliku praška za koncentrat za otopinu za infuziju (u bočici, pakiranja od 1, 5 ili 25 bočica).
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: Cerezyme is supplied as a white to off-white powder.
Croatian: Cerezyme je bijeli do bjelkasti prašak.
English: Imiglucerase
Croatian: Razrjeđivanje
English: Cerezyme 200 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1 or 25).
Croatian: Cerezyme 200 jedinica dolazi u obliku praška za koncentrat za otopinu za infuziju (u bočici, pakiranja od 1 ili 25 bočica).
English: Any unused solution should be discarded.
Croatian: Neupotrijebljena otopina se mora zbrinuti.
English: It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles.
Croatian: Da bi se uklonile čestice proteina preporučuje se razrijeđenu otopinu primjenjivati kroz “in-line” filter male sposobnosti vezanja proteina s porama veličine 0,2 µm.
English: The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
Croatian: Gaucherovom bolešću nije utvrđena i zato se za te manifestacije ne može preporučiti poseban režim doziranja (vidjeti dio 5.1).
English: Cerezyme decreases chitotriosidase, a biomarker for glucosylceramide accumulation in macrophages and response to treatment.
Croatian: biokemijski pokazatelj kumulacije glukozilceramida u makrofagima i odgovora na liječenje.
English: Maintenance therapy every 4 weeks (Q4) at the same cumulative dose as the bi-weekly (Q2) dose has been studied in adult patients with stable residual Gaucher disease type 1.
Croatian: U odraslih bolesnika sa stabilnom rezidualnom Gaucherovom bolešću tipa 1 ispitana je terapija održavanja svaka 4 tjedna (Q4) istom kumulativnom dozom kao i kod primjene lijeka svaka 2 tjedna (Q2).
English: The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2°C - 8°C) and in the dark.
Croatian: Samo razrijeđena otopina može se čuvati do 24 sata, i to na hladnom (2°C - 8°C) i tamnom mjestu.
English: • Guide for Healthcare Professionals Treating Patients with Gaucher Disease.
Croatian: • Priručnika za bolesnike s Gaucherovom bolešću koji primaju infuziju kod kuće • Vodiča za zdravstvene radnike koji liječe bolesnike s Gaucherovom bolešću
English: After reconstitution it is a clear, colourless liquid, free from foreign matter.
Croatian: Nakon rekonstitucije, otopina je bistra, bezbojna tekućina i ne sadrži vidljive čestice.
English: Excipients: For the full list of excipients, see section 6.1.
Croatian: Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
English: The reconstituted solution contains 40 units imiglucerase per ml.
Croatian: Rekonstituirana otopina sadrži 40 jedinica imigluceraze po ml.
English: Use Aseptic Technique
Croatian: Primijenite aseptički postupak Rekonstitucija
English: Do not use this medicine after the expiry date printed on the labelling after the letters “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake "Rok valjanosti".
English: A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
Croatian: U liječenju nekih ili svih neneuroloških manifestacija bolesti učinkovitim su se pokazali brojni režimi doziranja.
English: After reconstitution, the solution contains 0.62 mmol sodium (200 U/5 mL).
Croatian: Nakon rekonstitucije, otopina sadrži 0,62 mmol natrija (200 U/5 ml).
English: Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.
Croatian: Bolesnici se moraju savjetovati da u slučaju pojave spomenutih simptoma prekinu infuziju i jave se svom liječniku.