FrancophonIA/ELRC3.0 huggingface dataset:
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Croatian: Po život opasna preosjetljivost (anafilaktička reakcija) na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti dio 4.4).
English: Very common side effects include symptoms of infusion reactions such as headache, nausea, fever, chills and stomach ache.
Croatian: Vrlo česte nuspojave uključuju simptome infuzijskih reakcija kao što su glavobolja, mučnina, vrućica, zimica i bol u želucu.
English: No correlations were found between higher antibody titres or neutralizing antibody positivity and reductions in efficacy measurements or occurrence of anaphylaxis or other hypersensitivity reactions.
Croatian: Nije pronađena povezanost između višeg titra antitijela ili pozitivnih neutralizirajućih protutijela i smanjenja mjera djelotvornosti ili pojave anafilaksije ili drugih reakcija preosjetljivosti.
English: This medicine replaces the natural enzyme N-acetylgalactosamine-6-sulfatase which is lacking in MPS IVA patients.
Croatian: Ovaj lijek zamjenjuje prirodne enzime N-acetilgalaktozamin-6-sulfataza koji nedostaju kod bolesnika koji boluju od MPS IV A.
English: Table 2: Adverse reactions in patients treated with Vimizim
Croatian: Tablica 2: Nuspojave kod bolesnika liječenih Vimizimom
English: The other ingredients are: sodium acetate trihydrate, sodium dihydrogen phosphate monohydrate, arginine hydrochloride, sorbitol, polysorbate 20, and water for injections (see section 2 under ‘Vimizim contains sodium and sorbitol (E420)').
Croatian: Drugi sastojci su: natrijev acetat trihidrat, natrijev dihidrogenfosfat hidrat, argininklorid, sorbitol, polisorbat 20 i voda za injekcije (vidjeti dio 2 pod nazivom „Vimizim sadrži natrij i sorbitol (E 420)”).
English: Diarrhoea, vomiting, oropharyngeal pain, upper abdominal pain, abdominal pain, nausea
Croatian: Proljev, povraćanje, orofaringealna bol, bol u gornjem dijelu trbuha, bol u trbuhu, mučnina
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (Sterile concentrate).
Croatian: OBLIK Koncentrat za otopinu za infuziju (sterilni koncentrat).
English: The sulfatase activity deficiency results in the accumulation of the GAG substrates, KS and chondroitin 6 sulphate (C6S), in the lysosomal compartment of cells throughout the body.
Croatian: Nedostatak aktivnosti sulfataze rezultira nakupljanjem GAG supstrata, KS-a i kondroitin 6 sulfata (C6S) u lizosomima stanica cijelog tijela.
English: Patients received elosulfase alfa 2 mg/kg every week (n=58) or 2 mg/kg every other week (n=59), or placebo (n=59) for a total of 24 weeks.
Croatian: Ispitanici su primali ili elosulfazu alfa 2 mg/kg svaki tjedan (n=58) ili 2 mg/kg svaki drugi tjedan (n=59) ili placebo (n=59) u ukupnom trajanju od 24 tjedna.
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2C - 8C followed by up to 24 hours at 23C - 27C.
Croatian: Kemijska i fizička stabilnost lijeka u primjeni dokazana je u trajanju do 24 sata na temperaturi od 2°C - 8°C, nakon čega slijedi do 24 sata na temperaturi od 23°C - 27°C.
English: MedDRA System organ class
Croatian: MedDRA klasifikacije organskih sustava
English: The recommended dose is 2 mg per kg.
Croatian: Preporučena doza je 2 mg po kilogramu tjelesne težine.
English: The diluted solution is to be mixed gently prior to infusion.
Croatian: Razrijeđenu otopinu potrebno je lagano miješati prije infuzije.
English: Infusion rate may be increased as tolerated by patient.
Croatian: Brzina infuzije može se povećavati u skladu s tolerancijom bolesnika.
English: Pack sizes: 1 vial
Croatian: Veličina pakiranja: 1 bočica.
English: Renal elimination of elosulfase alfa is considered a minor pathway for clearance.
Croatian: Eliminacija elosulfaze alfa putem bubrega se smatra manje značajnim putem klirensa.
English: The calculated total number of vials is rounded up to the next whole vial.
Croatian: Izračunat broj bočica zaokružuje se na sljedeću punu bočicu.
English: Vimizim contains sodium and sorbitol (E 420)
Croatian: Vimizim sadrži natrij i sorbitol (E420)
English: Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
Croatian: Vimizim je indiciran za liječenje mukopolisaharidoze tip IV A (Morquiov A sindrom, MPS IV A) kod bolesnika svih dobi.
English: Preparation of the Vimizim infusion
Croatian: Priprema infuzije Vimizima
English: Vimizim must be diluted prior to administration.
Croatian: Vimizim se mora razrijediti prije primjene.
English: The active substance is elosulfase alfa.
Croatian: Djelatna tvar je elosulfaza alfa.
English: For instructions for dilution of the medicinal product prior to administration, see section 6.6.
Croatian: Za upute o razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Spinal/Cervical cord compression
Croatian: Kompresija kralježničke/cervikalne moždine
English: Other very common adverse reactions were diarrhoea, mouth and throat pain, dizziness and trouble breathing.
Croatian: Ostale vrlo česte nuspojave bile su proljev, bol u ustima i grlu, omaglica i poteškoće s disanjem.
English: Patients who could walk more than 30 meters (m) but less than 325 m in a 6 Minute Walk Test (MWT) at baseline were enrolled in the study.
Croatian: Ispitanici koji su, na početku ispitivanja, mogli hodati više od 30 metara, ali manje od 325 metara u 6-minutnom testu hodanja (engl.
English: This medicinal product contains 8 mg sodium per vial, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult, and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Croatian: Jedna bočica ovog lijeka sadrži 8 mg natrija, što odgovara 0,4% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu, a primjenjuje se u 0,9% otopini natrijevog klorida (9 mg/ml) za infuziju (vidjeti dio 6.6).
English: Vimizim vs. placebo
Croatian: Vimizim nasuprot placebu
English: No accumulation of elosulfase alfa in plasma was evident following weekly dosing
Croatian: Nije primijećena akumulacija elosulfaze alfa u plazmi nakon tjednog doziranja.
English: Management of IRs should be based on the severity of the reaction and include slowing or temporary interruption of the infusion and/or administration of additional antihistamines, antipyretics, and/or corticosteroids.
Croatian: Liječenje reakcija povezanih s infuzijom mora se temeljiti na težini reakcije i uključiti usporavanje ili privremeni prekid infuzije i/ili davanje dodatnih antihistaminika, antipiretika i/ili kortikosteroida.
English: The recommended dose regimen for adults and children is 2 mg/kg body weight given once every week through a drip into a vein (intravenous infusion).
Croatian: Preporučen režim doze za odrasle i djecu je 2 mg/kg tjelesne težine primijenjen jednom tjedno infuzijom u venu (intravenskom infuzijom).
English: The majority of the patients presented with short stature, impaired endurance, and musculoskeletal symptoms.
Croatian: Većina ispitanika bila je nižeg rasta, smanjene izdržljivosti i s poremećajima mišićno-koštanog sustava.
English: The number of vials to be diluted is based on the individual patient's weight.
Croatian: Broj bočica koji je potrebno razrijediti ovisi o individualnoj težini bolesnika.
English: The recommended dose of elosulfase alfa is 2 mg/kg of body weight administered once a week.
Croatian: Preporučena doza elosulfaze alfa je 2 mg/kg tjelesne težine davana jednom tjedno.
English: The assessment of adverse reactions is based on the exposure of 176 patients with MPS IVA, ages 5 to 57 years old to 2 mg/kg elosulfase alfa once a week (n=58), 2 mg/kg elosulfase alfa once every other week (n=59), or placebo (n=59) in a randomised, double-blind, placebo-controlled study.
Croatian: Procjena nuspojava temelji se na izlaganju 176 ispitanika s MPS IV A, u dobi od 5 do 57 godina, dozi od 2 mg/kg elosulfaze alfa jednom tjedno (n=58), dozi od 2 mg/kg elosulfaze alfa jednom svaki drugi tjedan (n=59) ili placebu (n=59) u randomiziranoj, dvostruko slijepoj, placebom kontroliranom ispitivanju.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg elosulfase alfa*.
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 1 mg elosulfaze alfa*.
English: Each vial contains 5 mg elosulfase alfa in 5 ml of solution (1 mg/ml).
Croatian: Jedna bočica sadrži 5 mg elosulfaze alfa u 5 ml otopine (1 mg/ml).
English: In clinical studies, spinal/cervical cord compression (SCC) was observed both in patients receiving Vimizim and patients receiving placebo.
Croatian: U kliničkim ispitivanjima, kompresija kralježničke/cervikalne moždine prijavljena je kod bolesnika koji su primili i Vimizim i placebo.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza Rok valjanosti ili EXP.
English: Infusion reactions
Croatian: Reakcije povezane s infuzijom
English: The primary endpoint was the change from baseline in the 6 MWT distance compared to placebo at Week 24.
Croatian: Primarna mjera ishoda bila je promjena od početne vrijednosti u razdaljini u 6-minutnom testu hodanja u usporedbi s placebom u 24. tjednu.
English: The baseline mean (±SD) normalised standing height z-score was - 1.6 (±1.61).
Croatian: Početna srednja (±SD) normalizirana z-vrijednost visine u stojećem položaju iznosila je -1,6 (±1,61).
English: Serious IRs were observed in clinical studies and included anaphylaxis, hypersensitivity and vomiting.
Croatian: Primijećene su ozbiljne reakcije povezane s infuzijom u kliničkim ispitivanjima koje su uključivale anafilaksiju, preosjetljivost i povraćanje.
English: It is not known if Vimizim impacts human fertility.
Croatian: Nije poznato utječe li Vimizim na plodnost kod ljudi.
English: Clear glass vial (Type I) with a butyl rubber stopper and a flip-off crimp seal (aluminium) with a plastic cap.
Croatian: Prozirna staklena bočica (tipa I) s čepom od butil gume i zaštitnim aluminijskim zatvaračem s plastičnom kapicom.
English: Enzyme uptake by cells into lysosomes is mediated by cation independent mannose-6-phosphate receptors leading to restored GALNS activity and clearance of KS and C6S.
Croatian: Unos enzima u lizosome putem stanica posredovan je kation neovisnim manoza-6-fosfat receptorom što dovodi do ponovnog uspostavljanja aktivnosti GALNS-a i klirensa KS-a i C6S.
English: If severe IRs occur, immediately stop the infusion and initiate appropriate treatment.
Croatian: Ako se dogodi teška reakcija povezana s infuzijom, odmah prekinite infuziju i započnite odgovarajuću terapiju.
English: No association was apparent between the total antibody titre and elosulfase clearance.
Croatian: Nije primijećena povezanost između ukupnog titra protutijela i klirensa elosulfaze.
English: No impairment of fertility has been observed in nonclinical studies (see section 5.3) with elosulfase alfa.
Croatian: U nekliničkim ispitivanjima nije primijećen utjecaj elosulfaze alfa na plodnost (vidjeti dio 5.3).
English: The calculated volume of Vimizim from the appropriate number of vials is slowly withdrawn using caution to avoid excessive agitation.
Croatian: Izračunati volumen Vimizima iz odgovarajućeg broja bočica potrebno je izvući polagano s oprezom kako bi se izbjeglo prekomjerno mućkanje lijeka.
English: concentrate for solution for infusion 1 vial
Croatian: koncentrat za otopinu za infuziju 1 bočica
English: This medicine contains 100 mg sorbitol in each 5 ml vial which is equivalent to 40 mg/kg.
Croatian: Ovaj lijek sadrži 100 mg sorbitola u jednoj bočici od 5 ml, što odgovara 40 mg/kg.
English: Treatment with Vimizim may be started at as young as an age possible and is intended for long term use.
Croatian: Liječenje Vimizimom je predviđeno za dugotrajnu upotrebu i njegovo davanje treba započeti u što ranijoj dobi.
English: The diluted solution is to be visually inspected for particulate matter prior to use.
Croatian: Razrijeđenu otopinu potrebno je prije upotrebe vizualno provjeriti radi eventualnog postojanja čestica.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at 23C - 27C during administration.
Croatian: Ako se ne upotrijebi odmah, vrijeme čuvanja i uvjeti čuvanja u primjeni odgovornost su korisnika i obično ne bi smjeli biti dulji od 24 sata na temperaturi od 2°C do 8°C, nakon čega slijedi do 24 sata na temperaturi od 23°C - 27°C za vrijeme primjene.
English: A total of 173 patients subsequently enrolled in an extension study in which patients received 2 mg/kg of elosulfase alfa every week or 2 mg/kg every other week, and then all were switched to 2 mg/kg every week upon availability of the Week 24 results.
Croatian: U produžetak ispitivanja naknadno je uključeno ukupno 173 ispitanika, a ispitanici su primali ili dozu elosulfaze alfa od 2 mg/kg svaki tjedan ili 2 mg/kg svaki drugi tjedan, a nakon dobivenih rezultata nakon 24. tjedna svi su prebačeni na dozu od 2 mg/kg svaki tjedan.
English: Impact of antibodies on elosulfase alfa pharmacokinetics was assessed.
Croatian: Procijenjen je utjecaj protutijela na farmakokinetiku elosulfaze alfa.
English: • Patient dose (mg) divided by 1 (mg/ml concentrate of Vimizim) = Total number of ml of
Croatian: • Bolesnikova doza (mg) podijeljena s 1 (mg/ml koncentrata Vimizima) = ukupan broj ml
English: Vimizim 1 mg/ml concentrate for solution for infusion elosulfase alfa
Croatian: Vimizim 1 mg/ml koncentrat za otopinu za infuziju elosulfaza alfa
English: Do not use Vimizim if the solution is discoloured or it contains visible particles.
Croatian: Vimizim se ne smije upotrijebiti ako je otopina promijenila boju ili primijetite vidljive čestice.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 ml VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA od 5 ml
English: * Infusion rate may be increased as tolerated by patient.
Croatian: * Brzina infuzije može se povećavati u skladu s bolesnikovim podnošenjem.
English: The modelled treatment effect for the percent change in urine KS, compared to placebo, was -40.7 % (CI95, -49.0, -32.4; p<0.0001) for the 2 mg/kg per week regimen.
Croatian: Modelirani učinak liječenja za postotak promjene KS-a u mokraći u usporedbi s placebom bio je -40,7 % (CI95, -49,0; -32,4; p<0,0001) za režim doze od 2 mg/kg/tjedno.
English: The Vimizim solution should be clear to slightly opalescent and colourless to pale yellow.
Croatian: Otopina Vimizima mora biti prozirna do blago opalescentna i bezbojna do blijedožute boje.
English: The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
Croatian: Bistar do blago opalescentan i bezbojan do blijedožut koncentrat ne smije imati vidljivih čestica.
English: Elosulfase alfa is intended to provide the exogenous enzyme N-acetylgalactosamine-6-sulfatase that will be taken up into the lysosomes and increase the catabolism of the GAGs KS and C6S.
Croatian: Elosulfaza alfa je zamišljena kao egzogeni nadomjestak enzima Nacetilgalaktozamin-6-sulfataze koji će biti transportiran u lizosome i povećati katabolizam GAG-ova, KS-a i C6S.
English: The modelled treatment effect in the distance walked in 6 minutes, compared to placebo, was 22.5 m (CI95, 4.0, 40.9; p=0.0174) for the 2 mg/kg per week regimen.
Croatian: Modelirani učinak liječenja na udaljenost prehodanu za 6 minuta u usporedbi s placebom bio je 22,5 m (CI95, 4,0; 40,9; p=0,0174) za režim doziranja od 2 mg/kg/tjedno.
English: N 58 6-Minute walk test (meters) Mean SD
Croatian: N 6-minutni test hodanja (u metrima) Srednja vrijednost  standardna devijacija
English: Sodium restricted diet
Croatian: Prehrana s ograničenjem unosa natrija
English: Each ml of concentrate contains 1 mg elosulfase alfa.
Croatian: Jedan ml koncentrata sadrži 1 mg elosulfaze alfa.
English: Vimizim is slowly added to the infusion bag using care to avoid agitation.
Croatian: Vimizim se polagano dodaje u infuzijsku vrećicu kako bi se izbjeglo prekomjerno mućkanje lijeka.
English: The modelled treatment effect in stairs climbed per minute, compared to placebo, was 1.1 stairs/minute (CI95, -2.1, 4.4; p=0.4935) for the 2 mg/kg per week regimen.
Croatian: Modelirani učinak liječenja na broj prijeđenih stepenica u minuti u usporedbi s placebom bio je 1,1 stepenica/minuti (CI95, -2,1; 4,4; p=0,4935) za režim doziranja od 2 mg/kg/tjedno.
English: NAME OF THE MEDICINAL PRODUCT Vimizim 1 mg/ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA Vimizim 1 mg/ml koncentrat za otopinu za infuziju
English: In an open-label study, 15 paediatric patients with MPS IVA under the age of 5 years (9 months to <5 years) received 2 mg/kg of Vimizim once a week for 52 weeks.
Croatian: A mlađih od 5 godina (9 mjeseci do < 5 godina) primalo je 2 mg/kg Vimizima jednom tjedno tijekom 52 tjedna.
English: This medicinal product contains 100 mg sorbitol in each vial which is equivalent to 40 mg/kg.
Croatian: Jedna bočica ovog lijeka sadrži 100 mg sorbitola, što odgovara 40 mg/kg.
English: Therefore, appropriate medical support must be readily available when elosulfase alfa is administered.
Croatian: Prema tome, pri primjeni elosulfaze alfa mora biti spremna odgovarajuća liječnička podrška.
English: Home administration under the supervision of an appropriately trained healthcare professional may be considered for patients who are tolerating their infusions well.
Croatian: Kod bolesnika koji dobro podnose infuzije može se razmotriti primjena kod kuće pod nadzorom zdravstvenog radnika s odgovarajućom obukom.
English: The volume of Vimizim is to be slowly added to the sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Croatian: Volumen Vimizima polako se dodaje u 0,9% otopinu natrijevog klorida (9 mg/ml) za infuziju.
English: How to store Vimizim
Croatian: Kako primjenjivati Vimizim
English: When diluted in 250 ml, the initial infusion rate should be 6 ml/hr.
Croatian: Kad se razrijedi u 250 ml, početna brzina infuzije treba biti 6 ml/sat.
English: • the calculation of the infusion rate
Croatian: • izračun brzine infuzije
English: Pack sizes: 1 vial of 5 ml
Croatian: Veličina pakiranja: 1 bočica od 5 ml.
English: What Vimizim looks like and contents of the pack Vimizim is supplied as a concentrate for solution for infusion (sterile concentrate).
Croatian: Vimizim se isporučuje kao koncentrat za otopinu za infuziju (sterilni koncentrat).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vimizim 1 mg/ml sterile concentrate elosulfase alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vimizim 1 mg/ml sterilni koncentrat elosulfaza alfa i.v. primjena nakon razrjeđivanja
English: All patients developed antibodies to elosulfase alfa in clinical studies.
Croatian: U kliničkim ispitivanjima svi ispitanici razvili su antitijela na elosulfazu alfa.
English: Each vial of 5 ml contains 5 mg elosulfase alfa.
Croatian: Jedna bočica od 5 ml sadrži 5 mg elosulfaze alfa.
English: A detailed history with regard to HFI symptoms has to be taken for each patient prior to being given this medicinal product.
Croatian: Prije primjene ovog lijeka potrebno je od svakog bolesnika uzeti detaljnu anamnezu s obzirom na simptome nasljednog nepodnošenja fruktoze.
English: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork Ireland
Croatian: BioMarin International Limited Shanbally, Ringaskiddy, Co.
English: When diluted in 100 ml, the initial infusion rate should be 3 ml/hr.
Croatian: Kada se razrijedi u 100 ml, početna brzina infuzije treba biti 3 ml/sat.
English: Vimizim has to be diluted with sodium chloride 9 mg/ml (0.9 %) solution for infusion using aseptic technique.
Croatian: Vimizim se mora razrijediti s 0,9% otopinom natrijevog klorida (9 mg/ml) za infuziju primjenom aseptičke tehnike.
English: Infusion reactions (IRs) were the most commonly observed adverse reactions in clinical studies.
Croatian: Reakcije povezane s infuzijom bile su najčešće prijavljene nuspojave u kliničkim ispitivanjima i mogu uključivati alergijske reakcije.
English: The diluted solution is administered to patients using an infusion set.
Croatian: Razrijeđena otopina se daje bolesnicima pomoću kompleta za infuziju.
English: For single use only Read the package leaflet before use.
Croatian: Samo za jednokratnu upotrebu Prije uporabe pročitajte uputu o lijeku Intravenska primjena nakon razrjeđivanja
English: An infusion bag containing sodium chloride 9 mg/ml (0.9 %) solution for infusion is obtained suitable for intravenous administration.
Croatian: Uzima se infuzijska vrećica koja sadrži 9 mg/ml (0,9%) otopinu natrijeva klorida za infuziju koja je prikladna za intravensku primjenu.
English: • Summary of Product Characteristics and Patient Information Leaflet
Croatian: • Sažetak opisa svojstava lijeka i uputu o lijeku
English: When diluted with 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 6 ml/hr.
Croatian: Ako je lijek razrijeđen u 250 ml 0,9% otopine natrijevog klorida (9 mg/ml) za infuziju; početna brzina infuzije mora biti 6 ml/sat.
English: * One patient in the Vimizim group dropped out after 1 infusion ‡ Model-based mean of Vimizim versus placebo, adjusted for baseline
Croatian: ‡ Srednja vrijednost bazirana na modelu Vimizim nasuprot placebu, prilagođena za početnu vrijednost
English: At Week 104 mean (±SD) normalised standing height z-score was -3.1 (±
Croatian: Srednja (±SD) normalizirana z-vrijednost visine u stojećem položaju u 104. tjednu iznosila je -3,1 (±1,13).
English: Diluted Vimizim solution is to be administered to patients using an infusion set.
Croatian: Razrijeđena otopina Vimizima daje se bolesnicima putem kompleta za infuziju.
English: An infusion set equipped with an in-line 0.2 μm filter can be used.
Croatian: Može se upotrijebiti komplet za infuziju opremljen s ugrađenim filtrom od 0,2 μm.
English: The secondary endpoints were the change from baseline in the 3 Minute Stair Climb Test (MSCT) and urine KS levels at Week 24.
Croatian: Sekundarne mjere ishoda bile su promjene od početne vrijednosti u 3-minutnom testu penjanja stepenicama (engl.
English: Sodium acetate trihydrate Sodium dihydrogen phosphate monohydrate Arginine hydrochloride Sorbitol (E 420)
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat trihidrat natrijev dihidrogenfosfat hidrat argininklorid sorbitol (E420) polisorbat 20 voda za injekcije
English: A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from a 100 ml or 250 ml infusion bag equal to the total volume of Vimizim to be added.
Croatian: Iz vrećice za infuziju od 100 ml ili 250 ml potrebno je izvući i odbaciti onoliki volumen 0,9% otopine natrijevog klorida (9 mg/ml) za infuziju koji odgovara ukupnom volumenu koncentrata Vimizima koji se dodaje.
English: Warnings and precautions - If you are treated with Vimizim, you may develop infusion reactions.
Croatian: - Ako se liječite Vimizimom, možete razviti reakciju na infuziju.
English: An infusion set equipped with an in-line 0.2 µm filter can be used.
Croatian: Može se upotrijebiti komplet za infuziju opremljen ugrađenim filtrom od 0,2 µm.
English: How Vimizim works
Croatian: Kako djeluje Vimizim
English: The recommended dose regimen is 2 mg/kg body weight administered once every week through a drip into a vein (by intravenous infusion).
Croatian: Preporučen režim doziranja je 2 mg/kg tjelesne težine primijenjen jednom tjedno intravenskom infuzijom.
English: Patients weighing less than 25 kg should receive a total volume of 100 ml.
Croatian: Bolesnici s težinom manjom od 25 kg moraju primiti ukupni volumen 100 ml infuzije.
English: Before dilution, each vial is to be inspected for particulate matter and discolouration.
Croatian: Prije razrjeđivanja, potrebno je provjeriti svaku bočicu radi eventualnog postojanja čestica i promjene boje.
English: It is not known whether Vimizim is excreted in breast milk.
Croatian: Nije poznato izlučuje li se Vimizim u majčino mlijeko.