FrancophonIA/ELRC3.0 huggingface dataset:
English: Three clinical trials were performed with Aldurazyme to assess its efficacy and safety.
Croatian: Provedena su tri klinička ispitivanja kako bi se ocijenila djelotvornost i sigurnost lijeka Aldurazyme.
English: There is not enough experience of the use of Aldurazyme in pregnant women.
Croatian: Nema dovoljno iskustava s primjenom lijeka Aldurazyme kod trudnica.
English: Additionally, a few patients who had a prior history of severe MPS I- related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and facial oedema (see section 4.4).
Croatian: Nadalje, kod nekoliko bolesnika koji su u povijesti bolesti imali težak poremećaj gornjih dišnih putova i pluća povezan s MPS I javile su se teške reakcije, uključujući bronhospazam, respiratorni arest i edem lica (vidjeti dio 4.4).
English: AUC∞ (h•U/ml) 0.930 ± 0.214 CL (ml/min/kg) 1.96 ± 0.495 Vz (l/kg)
Croatian: CL (ml/min/kg) 1,96 ± 0,495 Vz (l/kg)
English: In clinical studies IARs were usually manageable by slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol or ibuprofen), thus enabling the patient to continue treatment.
Croatian: U kliničkim su se ispitivanjima reakcije povezane s infuzijom obično mogle zbrinuti smanjenjem brzine infuzije i (prethodnom) primjenom antihistaminika i/ili antipiretika (paracetamola ili ibuprofena), čime je bolesniku omogućen nastavak liječenja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: A single patient with pre-existing airway compromise developed a severe reaction three hours from the start of the infusion (at week 62 of treatment) consisting of urticaria and airway obstruction, requiring tracheostomy.
Croatian: Samo se kod jednog bolesnika s već postojećim poremećajem dišnih puteva javila teška reakcija tri sata nakon početka primjene infuzije (u 62. tjednu liječenja), a sastojala se od urtikarije i opstrukcije dišnih puteva koja je zahtijevala traheotomiju.
English: It is recommended that the diluted Aldurazyme solution be administered to patients using an infusion set equipped with an 0.2 µm in-line filter.
Croatian: Preporučuje se razrijeđenu otopinu lijeka Aldurazyme primijeniti kroz infuzijski sustav s ugrađenim filtrom od 0,2 µm.
English: The safety and efficacy of Aldurazyme in patients with renal or hepatic insufficiency have not been evaluated and no dosage regimen can be recommended in these patients.
Croatian: Sigurnost i djelotvornost lijeka Aldurazyme kod bolesnika sa zatajivanjem bubrega ili jetre nisu ocijenjene pa se ne može preporučiti režim doziranja za te bolesnike.
English: If you are treated with Aldurazyme, you may develop infusion-associated reactions.
Croatian: Ako se liječite lijekom Aldurazyme, mogu se javiti reakcije povezane s infuzijom.
English: No information is available on the effects of Aldurazyme on fertility.
Croatian: Nema podataka o učincima lijeka Aldurazyme na plodnost.
English: The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase 3 study (treated for up to 4 years) and 35% of the patients in the under 5 study (up to 1 year of treatment).
Croatian: Većina nuspojava povezanih s primjenom lijeka u kliničkim ispitivanja svrstana je u skupinu reakcija povezanih s infuzijom, koje su se javile kod 53% bolesnika u kliničkom ispitivanju faze III (liječenje u trajanju do 4 godine) te kod 35% bolesnika u ispitivanju u kojemu su sudjelovali bolesnici u dobi do
English: By the end of the Phase 3 study (or at time of early study withdrawal), 13/45 patients had no detectable antibodies by radioimmunoprecipitation (RIP) assay, including 3 patients that had never seroconverted.
Croatian: Do završetka ispitivanja faze III (ili u vrijeme ranijeg izlaska iz ispitivanja) u 13/45 bolesnika, među koje se ubrajaju i 3 bolesnika u kojih serokonverzija nikada nije nastupila, testom radioimunoprecipitacije (RIP) nije otkrivena prisutnost protutijela.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: If these reactions occur, immediate discontinuation of Aldurazyme is recommended and appropriate medical treatment should be initiated.
Croatian: U slučaju takvih reakcija preporučuje se odmah prekinuti infuziju lijeka Aldurazyme i uvesti odgovarajuće liječenje.
English: MPS I disease
Croatian: Bolest MPS I
English: With initial administration of Aldurazyme or upon re-administration following interruption of treatment, it is recommended that patients be administered pre-treatment medicines (antihistamines and/or antipyretics) approximately 60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Croatian: Kod prve primjene lijeka Aldurazyme ili kod ponovne primjene nakon prekida liječenja preporučuje se približno 60 minuta prije početka infuzije bolesnicima dati premedikaciju (antihistaminike i/ili antipiretike), kako bi se mogućnost reakcija povezanih s infuzijom svela na najmanju moguću mjeru.
English: The recommended dosage regimen of Aldurazyme is 100 U/kg body weight administered once every week.
Croatian: Preporučeni režim doziranja lijeka Aldurazyme je 100 U/kg tjelesne težine jedanput na tjedan.
English: If clinically indicated, administration of pre-treatment medications with subsequent infusions of Aldurazyme should be considered.
Croatian: Ako je klinički indicirano, treba razmotriti primjenu premedikacije prije sljedećih infuzija lijeka
English: • bluish color of the skin (due to lower levels of oxygen in the blood)
Croatian: Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) • plavičasta boja kože (zbog snižene razine kisika u krvi)
English: If you experience any reaction like this, you should contact your doctor immediately.
Croatian: Ako dobijete takvu reakciju, morate se odmah javiti svom liječniku.
English: MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
Croatian: Nositelj odobrenja Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
English: Patients received either 100 U/kg of Aldurazyme or placebo every week for a total of 26 weeks.
Croatian: Bolesnici su svaki tjedan tijekom ukupno 26 tjedana primali 100 U/kg lijeka Aldurazyme ili placebo.
English: The 200 U/kg IV every 2 weeks regimen may be an acceptable alternative for patients with difficulty receiving weekly infusions; however, there is no evidence that the long term clinical efficacy of these two dose regimens is equivalent.
Croatian: Režim od 200 U/kg intravenski svaka 2 tjedna može biti prihvatljiva alternativa za bolesnike koji imaju poteškoća s primanjem infuzije svaki tjedan.
English: Prior to use visually inspect the solution for particulate matter.
Croatian: Prije uporabe vizualno pregledajte sadrži li otopina čestice.
English: Infusion 1 Mean ± SD
Croatian: Infuzija 1
English: In this 26-week open label study, 33 MPS I patients received 1 of 4 dose regimens of Aldurazyme: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks; or 300 U/kg IV every 2 weeks.
Croatian: U tom su otvorenom ispitivanju u trajanju od 26 tjedana, 33 bolesnika s MPS I primala jedan od četiri ispitivana režima doziranja lijeka Aldurazyme: 100 U/kg intravenski svaki tjedan (preporučena doza), 200 U/kg i.v. svaki tjedan, 200 U/kg i.v. svaka 2 tjedna ili 300 U/kg i.v. svaka 2 tjedna.
English: These reactions may be particularly severe if you have a pre-existing MPS I-related upper airway obstruction.
Croatian: Navedene reakcije mogu biti posebno teške ako već imate začepljenje gornjih dišnih puteva kao posljedicu mukopolisaharidoze I.
English: The recommended dosage regimen of Aldurazyme is 100 U/kg body weight given once every week as an intravenous infusion.
Croatian: Preporučeni režim doziranja lijeka Aldurazyme je 100 U/kg tjelesne težine jedanput tjedno infuzijom u venu.
English: Tel +44 (0)845 372 7101
Croatian: Sanofi Tel +44 (0)845 372 7101
English: ADRs to Aldurazyme reported during the Phase 3 study and its extension in a total of 45 patients age 5 years and older and treated up to 4 years are listed below using the following categories of frequency: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: It is not known whether Aldurazyme appears in breast milk.
Croatian: Nije poznato izlučuje li se Aldurazyme u majčino mlijeko.
English: Aldurazyme contains sodium
Croatian: Aldurazyme sadrži natrij
English: Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Croatian: Aldurazyme se mora primijeniti u odgovarajućem kliničkom okruženju s dostupnom opremom za oživljavanje za slučaj hitne medicinske intervencije.
English: Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Odredite ukupan volumen infuzije na temelju bolesnikove tjelesne težine; 100 ml (ako je tjelesna težina 20 kg ili manje) ili 250 ml (ako je tjelesna težina veća od 20 kg) 0,9% otopine natrijeva klorida za infuziju (9 mg/ml).
English: EU/1/03/253/003 25 Vials
Croatian: EU/1/03/253/001-003
English: For instruction on dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: If these reactions occur, the Aldurazyme infusion should be stopped immediately and appropriate treatment will be started by your doctor.
Croatian: Dođe li do tih reakcija, liječnik mora odmah prekinuti infuziju lijeka Aldurazyme i započeti odgovarajuće liječenje.
English: The most frequent adverse drug reactions (ADRs) were: headache, nausea, abdominal pain, rash, arthralgia, backpain, pain at extremity, flushing, pyrexia, infusion site reactions, blood pressure increased, oxygen saturation decreased,
Croatian: Najčešće nuspojave bile su: glavobolja, mučnina, bol u abdomenu, osip, artralgija, bol u leđima, bol u ekstremitetima, crvenilo praćeno osjećajem užarenosti, pireksija, alergijske reakcije na mjestu infuzije, povišen krvni tlak, smanjena zasićenost kisikom, tahikardija i zimica.
English: The initial infusion rate of 2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h.
Croatian: Početna brzina infuzije od 2 U/kg/h može se, ako bolesnik podnosi, postupno povećavati svakih petnaest minuta, do najviše 43 U/kg/h.
English: Each vial of 5 ml contains 500 U of laronidase.
Croatian: Jedna bočica od 5 ml sadrži 500 U laronidaze.
English: In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol/ibuprofen and/or corticosteroids) and a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the previous reaction occurred.
Croatian: U slučaju ponovne umjerene reakcije povezane s infuzijom ili ponovnog uvođenja lijeka nakon jedne teške reakcije, treba razmotriti premedikaciju (antihistaminicima i paracetamolom/ibuprofenom i/ili kortikosteroidima) te smanjenje brzine infuzije na 1/2 - 1/4 brzine pri kojoj se reakcija prethodno pojavila.
English: Pack size: 1, 10 and 25 vials per carton.
Croatian: Veličina pakiranja: 1, 10 i 25 bočica u kutiji.
English: Careful consideration should be given to the patient's clinical status prior to administration of Aldurazyme.
Croatian: Prije primjene lijeka Aldurazyme treba pažljivo razmotriti klinički status bolesnika.
English: Patients with an acute underlying illness at the time of Aldurazyme infusion appear to be at greater risk for IARs.
Croatian: Bolesnici koji u vrijeme infuzije lijeka Aldurazyme boluju od neke akutne podležeće bolesti izloženi su većem riziku od reakcija povezanih s infuzijom.
English: People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body.
Croatian: Bolesnici s bolešću MPS I imaju male količine enzima koji se zove α-L-iduronidaza i koji razgrađuje specifične tvari u organizmu (glukozaminoglikane) ili tog enzima uopće nemaju.
English: The proportion of patients with mild left ventricular hypertrophy decreased from 53% (10/19) to 17% (3/18), and mean left ventricular mass normalized for body surface area decreased by 0.9 Z-Score (n=17).
Croatian: na 17% (3/18), a srednja vrijednost mase lijeve klijetke, normalizirana prema tjelesnoj površini, smanjila se za 0,9 Z-vrijednosti (n=17).
English: Post-marketing experience of infusion-associated reactions revealed reporting of cyanosis, hypoxia, tachypnoea, pyrexia, vomiting, chills and erythema, in which some of these reactions were severe.
Croatian: Nakon stavljanja lijeka u promet, u sklopu reakcija povezanih s infuzijom prijavljene su cijanoza, hipoksija, tahipneja, pireksija, povraćanje, zimica i eritem.
English: In case of a mild or moderate IAR, treatment with antihistamines and paracetamol/ibuprofen should be considered and/or a reduction in the infusion rate to half the infusion rate at which the reaction occurred.
Croatian: Ako se pojavi blaga ili umjerena reakcija povezana s infuzijom, treba razmotriti primjenu antihistaminika i paracetamola/ibuprofena i/ili smanjenje brzine infuzije na polovicu brzine pri kojoj se reakcija pojavila.
English: A phase 4 study was conducted to evaluate the pharmacodynamic effects on urinary GAGs, liver volume, and 6MWT, of different Aldurazyme dose regimens.
Croatian: Ispitivanje faze IV provedeno je kako bi se ispitali farmakodinamički učinci različitih režima doziranja lijeka Aldurazyme na glikozaminoglikane u mokraći, volumen jetre i 6MWT.
English: Package leaflet: Information for the user Aldurazyme 100 U/ml concentrate for solution for infusion Laronidase
Croatian: Uputa o lijeku: Informacije za korisnika Aldurazyme 100 U/ml koncentrat za otopinu za infuziju laronidaza
English: 25 vials of concentrate for solution for infusion.
Croatian: 25 bočica koncentrata za otopinu za infuziju.
English: MedDRA Preferred term
Croatian: preporučeni izraz
English: Infusion 12 Mean ± SD
Croatian: Infuzija 12
English: Purified laronidase is a glycoprotein with a molecular weight of approximately 83 kDa. Laronidase is comprised of 628 amino acids after cleavage of the N-terminus.
Croatian: Pročišćena laronidaza je glikoprotein, molekularne mase od približno 83 kDa.
English: This medicinal product contains 1.29 mmol sodium per vial.
Croatian: Jedna bočica ovog lijeka sadrži 1,29 mmol natrija.
English: - The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.
Croatian: - Drugi sastojci su natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, polisorbat 80, voda za injekcije.
English: Of the 26 patients with abnormal liver volumes at pre-treatment baseline, 22 (85%) achieved a normal liver size by the end of the study.
Croatian: 2 U obje je skupine nadmašena najmanja klinički značajna razlika (-0,24) Od 26 bolesnika s povećanom jetrom prije početka liječenja, jetra je postigla normalnu veličinu kod 22 bolesnika (85%) do završetka ispitivanja.
English: Before dilution, visually inspect each vial for particulate matter and discoloration.
Croatian: Prije razrjeđivanja vizualno pregledajte svaku bočicu i provjerite sadrži li čestice i je li sadržaj promijenio boju.
English: Sodium chloride,
Croatian: Chinese Hamster Ovary,
English: There are inadequate data on the use of Aldurazyme in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka Aldurazyme kod trudnica.
English: mean 5.6median 3.0 0.009 0.9 - 8.6
Croatian: srednja vrijednost medijan 3,0 0,009
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ
English: Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Pomiješane volumene lijeka Aldurazyme dodajte u 0,9% otopinu natrijeva klorida za infuziju (9 mg/ml).
English: Angioneurotic edema, swelling face, urticaria, pruritus, cold sweat, alopecia, hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva osip angioneurotski edem, oticanje lica, urtikarija, pruritus, hladan znoj, alopecija, hiperhidroza eritrem, edem lica, laringealni edem, periferni edem
English: Puh/Tel: + 358 201 200 300
Croatian: Sanofi Oy Puh/Tel: + 358 201 200 300
English: A Phase 2 open-label, 1-year study was conducted that mainly assessed the safety and pharmacokinetics of Aldurazyme in 20 patients less than 5 years of age at the time of enrolment (16 patients with the severe phenotype and 4 with the intermediate phenotype).
Croatian: Provedeno je jednogodišnje otvoreno ispitivanje faze II u kojemu su se uglavnom ocjenjivale sigurnost i farmakokinetika lijeka Aldurazyme kod 20 bolesnika koji su u trenutku uključenja bili mlađi od
English: Infusion 26 Mean± SD
Croatian: Infuzija 26
English: Mix the solution for infusion gently.
Croatian: Lagano promiješajte otopinu za infuziju.
English: Nausea, abdominal pain Vomiting, diarrhoea
Croatian: Poremećaji probavnog sustava mučnina, bol u abdomenu povraćanje, proljev
English: The patients were scheduled to receive Aldurazyme 100 U/kg weekly infusions for a total duration of 52 weeks.
Croatian: Bolesnici su svaki tjedan tijekom ukupno 52 tjedana primali infuziju lijeka Aldurazyme u dozi od 100 U/kg.
English: Some of the IARs were severe.
Croatian: Neke od tih reakcija bile su teške.
English: The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Croatian: Koncentrat za otopinu za infuziju mora se razrijediti s 0,9% otopinom natrijeva klorida za infuziju (9 mg/ml)
English: Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Croatian: Laronidaza je rekombinantni oblik humane α-L-iduronidaze i dobiva se tehnologijom rekombinantne
English: Cyanosis, hypoxia, tachypnoea, bronchospasm, respiratory arrest
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja respiratorni distres, dispneja, kašalj cijanoza, hipoksija, tahipneja, bronhospazam, respiratorni arest
English: Musculoskeletal pain
Croatian: • bolovi u mišićima
English: To address the heterogeneity in disease manifestation across patients, using a composite endpoint that summed up clinically significant changes across five efficacy variables (percent predicted normal FVC, 6MWT distance, shoulder flexion range of motion, AHI, and visual acuity) the global response was an improvement in 26 patients (58%), no change in 10 patients (22%), and a deterioration in 9 patients (20%).
Croatian: Zbog heterogenih manifestacija bolesti kod različitih bolesnika, odgovor na liječenje mjeren je kompozitnom mjerom ishoda koja je objedinila klinički značajne promjene u pet varijabli djelotvornosti (postotak predviđenog normalnog FVC-a, udaljenost prijeđena u šestominutnom testu, raspon pokretljivosti ramena u fleksiji, indeks apneja/hipopneja i oštrina vida).
English: The clear to slightly opalescent and colourless to pale yellow solution should be free of visible particles.
Croatian: Otopina mora biti bistra do blago opalescentna te bezbojna do blijedožuta i ne smije sadržavati vidljive čestice.
English: Psychiatric disorders
Croatian: Psihijatrijski poremećaji nemir
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: If you are given more Aldurazyme than needed No case of overdose of Aldurazyme has been reported.
Croatian: Ako primite više lijeka Aldurazyme nego što ste trebali
English: 10 vials of concentrate for solution for infusion.
Croatian: 10 bočica koncentrata za otopinu za infuziju.
English: In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks or 300 U/kg IV every 2 weeks.
Croatian: U ispitivanju faze IV su 33 bolesnika oboljela od MPS I primala lijek prema jednom od sljedeća četiri režima doziranja: 100 U/kg intravenski svaki tjedan (preporučena doza), 200 U/kg i.v. svaki tjedan,
English: median 38.5 0.066 -2.0 - 79.0
Croatian: srednja vrijednost medijan 38,5 0,066
English: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Croatian: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ujedinjeno Kraljevstvo Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: Very common oxygen saturation decreased Very common
Croatian: Pretrage povišen krvni tlak vrlo često smanjena zasićenost kisikom vrlo često
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Croatian: Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: Patients who have developed antibodies or symptoms of IARs should be treated with caution when administering Aldurazyme (see sections 4.3 and 4.8).
Croatian: Aldurazyme se mora primjenjivati uz oprez kod bolesnika u kojih su se razvila protutijela ili simptomi reakcije povezane s infuzijom (vidjeti dijelove 4.3 i 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS)
Croatian: KUTIJA (1 BOČICA, 10 BOČICA, 25 BOČICA)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion laronidase
Croatian: Aldurazyme 100 U/ml koncentrat za otopinu za infuziju laronidaza
English: Method of administration Aldurazyme is to be administered as an intravenous infusion.
Croatian: Aldurazyme se primjenjuje intravenskom infuzijom.
English: • paleness
Croatian: • omaglica
English: Patients with absent to low antibody levels showed a robust reduction in urinary GAG level, whereas patients with high antibody titers showed variable reduction in urinary GAG.
Croatian: Kod bolesnika bez protutijela ili s niskom razinom protutijela opaženo je snažno smanjenje glikozaminoglikana (GAG) u mokraći, dok je kod bolesnika s visokim titrom protutijela smanjenje
English: How Aldurazyme is given
Croatian: Kako primjenjivati Aldurazyme
English: Four patients underwent dosage increases to 200 U/kg for the last 26 weeks because of elevated urinary GAG levels at Week 22.
Croatian: GAG-a u mokraći u 22. tjednu četvorici je bolesnika doza u posljednjih 26 tjedana povećana na
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80
Croatian: natrijev klorid natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat polisorbat 80 voda za injekcije
English: What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion.
Croatian: Aldurazyme je dostupan u obliku koncentrata za otopinu za infuziju.
English: One ml of the solution in the vial contains 100 U of laronidase.
Croatian: Jedan mililitar otopine u bočici sadrži 100 U laronidaze.
English: Dosage
Croatian: MedDRA
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: O tome treba voditi računa kod bolesnika koji su na režimu prehrane s ograničenjem unosa natrija.