FrancophonIA/ELRC3.0 huggingface dataset:
English: • Each 0.5 mL is shown as a number next to a big line.
Croatian: • Svakih 0,5 ml prikazuje se kao brojka uz veliku crticu.
English: • Do not attach the needle to the syringe.
Croatian: • Nemojte postavljati iglu na štrcaljku.
English: Vascular disorders
Croatian: Očitavanje štrcaljke
English: o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur.
Croatian: o Primjena istodobno s inzulinom i drugim antidijabetičkim lijekovima može izazvati hipoglikemiju.
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a white plastic flip-off cap.
Croatian: To je bijeli prašak u staklenoj bočici s gumenim čepom i aluminijskim prstenom s bijelim plastičnim flip-off zatvaračem.
English: Do not use the solution if discoloured or cloudy, or if particulate matter remains.
Croatian: Nemojte upotrijebiti otopinu ako je promijenila boju ili je zamućena ili su u njoj zaostale čvrste čestice.
English: 0.156 mL 0.15 mL
Croatian: 0,156 ml
English: For males > 40 kg once daily dose
Croatian: Za muškarce težine > 40 kg jedna dnevna doza
English: Table 8 Primary outcome results in an open-label, single-arm study (NIH 991265/20010769) in evaluable patients with generalised LD treated with metreleptin at 12 months Parameter n
Croatian: Rezultati primarnih ishoda u otvorenom ispitivanju s jednim krakom (NIH 991265/20010769) nakon 12 mjeseci za bolesnike s generaliziranim LD-om liječene metreleptinom koje je bilo moguće procijeniti
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a red plastic flip-off cap.
Croatian: To je bijeli prašak u staklenoj bočici s gumenim čepom i aluminijskim prstenom s crvenim plastičnim flip-off zatvaračem.
English: Three cases of T-cell lymphoma have been reported while using metreleptin in clinical studies.
Croatian: Tijekom primjene metreleptina u kliničkim ispitivanjima prijavljena su tri slučaja limfoma T-stanica.
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a blue plastic flip-off cap.
Croatian: To je bijeli prašak u staklenoj bočici s gumenim čepom i aluminijskim prstenom s plavim plastičnim flip-off zatvaračem.
English: • who have generalised lipodystrophy (the whole of your body does not have enough fatty tissue) It is used, when other treatments have been ineffective, in adults, and adolescents 12 years or over:
Croatian: Lijek Myalepta primjenjuje se kad drugi načini liječenja nisu učinkoviti u odraslih osoba i adolescenata u dobi od 12 godina ili više:
English: syringe to inject
Croatian: Prašak za otopinu za injekciju
English: In 43 patients with hepatic data available, the mean changes at Month 12 in alanine aminotransferase, versus baseline (112.5 U/L) was -53.1 U/L, and aspartate aminotransferase versus baseline (75.3 U/L) was -23.8 U/L.
Croatian: bila je -53,1 U/l, a aspartat aminotransferaze u odnosu na početnu vrijednost (75,3 U/l) -23,8 U/l.
English: o Non-compliance with or abrupt withdrawal of Myalepta may result in worsening of hypertriglyceridaemia and associated pancreatitis: - Risk factors include patients with a history of pancreatitis or severe hypertriglyceridaemia.
Croatian: Nepridržavanje uputa za uzimanje lijeka ili nagli prekid uzimanja lijeka Myalepta mogu za posljedicu imati pogoršanje hipertrigliceridemije i povezanog pankreatitisa:
English: Symptoms of low blood sugar levels include:
Croatian: Znakovi visokog i niskog šećera u krvi Simptomi niskih razina šećera u krvi uključuju:
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap.
Croatian: I (3 ml) s čepom od klorobutilne gume i aluminijskim prstenom/crvenim plastičnim flip-off zatvaračem.
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/blue plastic flip-off cap.
Croatian: I (3 ml) s čepom od klorobutilne gume i aluminijskim prstenom/plavim plastičnim flip-off zatvaračem.
English: Table 5 Conversion table for the 0.3 mL U100 insulin syringe Weight of child Dose of Myalepta
Croatian: Tablica 5. Tablica konverzije za inzulinsku štrcaljku 0,3 ml 100 j.
English: 0.168 mL 0.16 mL
Croatian: 0,168 ml
English: 0.204 mL 0.20 mL
Croatian: 0,204 ml
English: 18) With the needle in the vial, turn the vial and syringe upside down.
Croatian: 18) Dok je igla još u bočici, okrenite bočicu i štrcaljku naopako.
English: Individual patient once daily dose in mg = 5 mg Amount to inject once daily dose = 1 mL
Croatian: Individualizirana doza za bolesnicu jedanput dnevno u mg = 5 mg
English: • stomach pain, feeling sick (nausea) and being sick (vomiting)
Croatian: • bol u trbuhu, mučnina ili povraćanje • nesvjesticu ili osjećaj omaglice
English: • thigh
Croatian: • drhtavica.
English: 0.144 mL 0.14 mL
Croatian: 0,144 ml
English: • The patient information leaflet
Croatian: • Sažetak opisa svojstava lijeka
English: See steps 6-8 below on removal of air pockets and air bubbles from the syringe.
Croatian: Za uklanjanje zračnih džepova i zračnih mjehurića pogledajte korake 6-8 u nastavku.
English: In clinical trials (Studies NIH 991265/20010769 and FHA101), the rate of ADAs for generalised LD and the partial LD patients studied and with data available were 88% (65 out of 74 patients).
Croatian: (ADA) za ispitivane bolesnike s generaliziranim LD-om i bolesnike s parcijalnim LD-om i s dostupnim podacima bila je 88% (65 od 74 bolesnika).
English: 0.252 mL 0.25 mL
Croatian: 0,252 ml
English: How to stop using Myalepta
Croatian: Kako prekinuti primjenu lijeka Myalepta
English: Starting daily dose (injection volume)
Croatian: Ponderirana prosječna dnevna doza (tj.
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih ozbiljnih nuspojava jer će
English: Do not use this medicine if the solution is not clear, is coloured or has bits or lumps in it. Do not throw away any medicines via wastewater or household waste.
Croatian: Nemojte upotrijebiti ovaj lijek ako otopina nije bistra, ako je promijenila boju ili ako u sebi ima grudice.
English: Myalepta 11.3 mg powder for solution for injection.
Croatian: Myalepta 11,3 mg prašak za otopinu za injekciju.
English: Among 15 patients in the partial LD subgroup who had a baseline TG level 5.65 mmol/L or greater and data available at Month 12, the mean (SD) baseline triglyceride level was 27.6 mmol/L (32.88) and the mean percent reduction in TGs at Month 12 was 53.7%.
Croatian: HbA1c (%) Srednja vrijednost (SD) P Trigliceridi natašte (mmol/l) Srednja vrijednost (SD) P SD = standardna devijacija Među 15 bolesnika u podskupini s parcijalnim LD-om koji su imali početnu razinu TG-a od 5,65 mmol/l ili višu i za koje su bili dostupni podaci u 12. mjesecu, srednja vrijednost (SD) početne razine TG-a bila je 27,6 mmol/l (32,88), a srednja vrijednost postotnog smanjenja TG-a u 12. mjesecu bila je 53,7%.
English: 0.132 mL 0.13 mL
Croatian: 0,132 ml
English: • Do not remove the needle from the vial.
Croatian: • Nemojte vaditi iglu iz bočice.
English: 0.288 mL 0.28 mL
Croatian: 0,288 ml
English: Myalepta 3 mg powder for solution for injection.
Croatian: Myalepta 3 mg prašak za otopinu za injekciju.
English: How to store Myalepta
Croatian: Kako čuvati lijek Myalepta
English: Myalepta 5.8 mg powder for solution for injection.
Croatian: Myalepta 5,8 mg prašak za otopinu za injekciju.
English: Myalepta 5.8 mg powder for injection metreleptin
Croatian: Myalepta 5,8 mg prašak za otopinu za injekciju metreleptin
English: • fainting or feeling dizzy
Croatian: • mučnina ili povraćanje
English: 0.276 mL 0.27 mL
Croatian: 0,276 ml
English: • a feeling of general discomfort, uneasiness or pain (‘malaise')
Croatian: • opći osjećaj neugode, nelagode ili boli (loše osjećanje) • povećanje masnoća u krvi (trigliceridi)
English: Each vial contains 3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Croatian: Nakon rekonstitucije jedan ml sadrži 5 mg metreleptina (5 mg/ml)
English: 0.180 mL 0.18 mL
Croatian: 0,180 ml
English: 0.192 mL 0.19 mL
Croatian: 0,192 ml
English: 0.108 mL 0.10 mL
Croatian: 0,108 ml
English: Myalepta 11.3 mg powder for injection metreleptin
Croatian: Myalepta 11,3 mg prašak za otopinu za injekciju metreleptin
English: Myalepta 3 mg powder for injection metreleptin
Croatian: Myalepta 3 mg prašak za otopinu za injekciju metreleptin
English: • shaking.
Croatian: • proljev.
English: 0.264 mL 0.26 mL
Croatian: 0,264 ml
English: 1.1 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Croatian: Nakon otapanja sadržaja bočice u 1,1 mililitar vode za injekcije, jedan mililitar sadrži 5 miligrama metreleptina.
English: There have been reports of generalised hypersensitivity (e.g. anaphylaxis, urticaria or generalised rash) in patients using Myalepta.
Croatian: U bolesnika koji su uzimali lijek Myalepta prijavljeni su slučajevi generalizirane preosjetljivosti (npr. Anafilaksa, urtikarija ili generalizirani osip).
English: 2.2 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Croatian: Nakon otapanja sadržaja bočice u 2,2 mililitra vode za injekcije, jedan mililitar sadrži 5 miligrama metreleptina.
English: • You will be given the 1 mL syringe to use if your daily dose is more than 1.5 mg up to 5 mg,
Croatian: • Dobit ćete štrcaljku od 1 ml ako vaša dnevna doza iznosi više od 1,5 mg sve do 5 mg, a to je volumen koji je veći od 0,3 ml, sve do 1,0 ml otopine lijeka Myalepta.
English: Table 1 Metreleptin recommended dose Baseline weight
Croatian: Preporučena doza metreleptina
English: 25 kg patient is initiated at 0.012 mL/kg = 0.3 mL of Myalepta solution to inject
Croatian: Individualizirana doza za bolesnika = 1,5 mg Bolesnik težine 25 kg započinje s dozom od 0,012 ml/kg = 0,3 ml Myalepta otopine za injekciju.
English: Your doctor, nurse or pharmacist should provide you separately with the appropriate syringes and needles, wipes and water for injections to enable you to prepare and inject Myalepta.
Croatian: jastučiće od vate i vodu za injekciju kako biste mogli pripremiti i primijeniti lijek Myalepta injekcijom.
English: 0.240 mL 0.24 mL
Croatian: 0,240 ml
English: Peak serum leptin (endogenous leptin and metreleptin) concentration (Cmax) occurred approximately 4.0 hours after subcutaneous administration of single doses ranging from 0.1 to 0.3 mg/kg in healthy adult subjects.
Croatian: 4,0 sati nakon supkutane primjene pojedinačnih doza u rasponu od 0,1 do 0,3 mg/kg u zdravih odraslih ispitanika.
English: o The risk of medication error: - Responsibility of the prescribing physician to provide appropriate training to the patient/carer who will administer the treatment and that the first dose should be administered in the presence of a doctor or nurse - The requirement to perform regular follow-ups with the patient/carer to ensure continued correct and compliant Myalepta reconstitution and treatment - Guidance on the appropriate syringe size ancillary administration set to prescribe according to the dosage of Myalepta and how to read the syringe volumes - How to access a video on line which shows step by step how to reconstitute, measure the correct dose and administer it subcutaneously o The association between LD and lymphoma and that the patient will be monitored during treatment.
Croatian: U edukacijskim materijalima potrebno je ljekarnike uputiti u pomoćni pribor koji treba dati bolesnicima, uključujući štrcaljke i igle za rekonstituciju i primjenu odgovarajuće veličine, bočice/ampule vode za injekcije odgovarajuće veličine, jastučiće od vate natopljene alkoholom i spremnike za oštre predmete te kako nabaviti komplete za rekonstituciju i primjenu Aegerion koji sadrže sav gore navedeni pribor, osim vode za injekcije i spremnika za oštre predmete.
English: Males and females ≤ 40 kg 0.06 mg/kg (0.012 mL/kg)
Croatian: 0,06 mg/kg (0,012 ml/kg)
English: 0.216 mL 0.21 mL
Croatian: 0,216 ml
English: Package leaflet: Information for the patient Myalepta 5.8 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Myalepta 5,8 mg prašak za otopinu za injekciju metreleptin
English: This will include for example instructions for handling possible ADRs o Allergic reactions can occur with Myalepta use.
Croatian: o Prilikom primjene lijeka Myalepta može doći do alergijskih reakcija.
English: • Remove the needle guard.
Croatian: • Skinite štitnik igle.
English: Package leaflet: Information for the patient Myalepta 11.3 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Myalepta 11,3 mg prašak za otopinu za injekciju metreleptin
English: o Loss of efficacy, potentially due to neutralising antibodies, may occur in patients on Myalepta therapy.
Croatian: U bolesnika koji se liječe lijekom Myalepta može doći do smanjenja djelotvornosti, potencijalno uzrokovanog neutralizirajućim protutijelima.
English: Myalepta 3 mg powder for solution for injection Using a 1 mL syringe with a 21-gauge or smaller diameter needle, withdraw 0.6 mL of water for injection.
Croatian: Pomoću štrcaljke od 1 ml s iglom promjera 21 G ili manjeg izvucite 0,6 ml vode za injekcije.
English: Package leaflet: Information for the patient Myalepta 3 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Myalepta 3 mg prašak za otopinu za injekciju metreleptin
English: Read the “Instructions for Use” (see section 7) for how to make the solution before injecting.
Croatian: O tome kako pripremiti otopinu prije ubrizgavanja pročitajte u "Uputama za uporabu"
English: 17) Insert the needle through the centre of the rubber bung, all the way into the vial containing the dissolved Myalepta solution.
Croatian: 17) Kroz središte gumenog čepa do kraja umetnite iglu u bočicu s pripremljenom otopinom lijeka
English: Abdominal pain, Nausea
Croatian: Bol u abdomenu,
English: Myalepta 3 mg powder for solution for injection
Croatian: Myalepta 3 mg prašak za otopinu za injekciju
English: Myalepta 11.3 mg powder for solution for injection Type I glass vial (5 mL) with a bromobutyl rubber stopper and an aluminium seal/white plastic flip-off cap.
Croatian: I (5 ml) s čepom od bromobutilne gume i aluminijskim prstenom/bijelim plastičnim flip-off zatvaračem.
English: Myalepta 5.8 mg powder for solution for injection
Croatian: Myalepta 5,8 mg prašak za otopinu za injekciju
English: You might feel dizzy or tired when using this medicine.
Croatian: Dok primjenjujete ovaj lijek možete osjećati omaglicu ili umor.
English: • Insert the 3 mL syringe needle into the vial, through the rubber seal.
Croatian: • Umetnite iglu štrcaljke od 3 ml u bočicu kroz gumeni čep. • Igla treba biti okrenuta prema dolje.
English: 0.120 mL 0.12 mL
Croatian: 0,120 ml
English: • Insert the 1 mL syringe needle into the vial, through the rubber seal.
Croatian: • Umetnite iglu štrcaljke od 1 ml u bočicu kroz gumeni čep. • Igla treba biti okrenuta prema dolje.
English: • a glass ampoule
Croatian: • staklenoj ampuli ili
English: Pregnancy
Croatian: mučnina
English: 0.228 mL 0.22 mL
Croatian: 0,228 ml
English: See section 2 “How to stop using Myalepta” for more information.
Croatian: "Kako prekinuti primjenu lijeka Myalepta".
English: Sodium Hydroxide (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari glicin saharoza polisorbat 20 glutamatna kiselina natrijev hidroksid (za prilagodbu pH)
English: The potential risk for humans is unknown.
Croatian: Moguć rizik za ljude nije poznat.
English: At 182 weeks
Croatian: 182. tjedan
English: Date of latest renewal: 10 June 2008
Croatian: Datum posljednje obnove: 10. lipnja 2008.
English: ATC code: A16AB05.
Croatian: ATK oznaka: A16AB05.
English: Antibody status should be regularly monitored and reported.
Croatian: Treba redovito kontrolirati i prijavljivati status protutijela.
English: Eighteen patients completed the study.
Croatian: Ispitivanje je dovršilo 18 bolesnika.
English: Some of these reactions may be severe.
Croatian: Neke od tih reakcija mogu biti teške.
English: What Aldurazyme is and what is it used for
Croatian: Što je Aldurazyme i za što se koristi
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta.
English: The total volume of the administration should be delivered in approximately 3-4 hours.
Croatian: Ukupni volumen lijeka mora se primijeniti tijekom približno 3-4 sata.
English: • increased body temperature
Croatian: • povišena tjelesna temperatura
English: The number of these reactions decreased the longer that patients were on Aldurazyme.
Croatian: Broj tih reakcija se smanjivao što su bolesnici dulje primali Aldurazyme.
English: Other medicines and Aldurazyme
Croatian: Drugi lijekovi i Aldurazyme
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: This patient tested positive for IgE.
Croatian: Bolesnik je bio pozitivan na IgE.
English: They accumulate in many tissues in the body, which causes the symptoms of MPS I.
Croatian: One se nakupljaju u mnogim tkivima u tijelu, što uzrokuje pojavu simptoma bolesti MPS I.
English: Laronidase may be excreted in milk.
Croatian: Laronidaza se može izlučivati u mlijeko.
English: Shoulder flexion Range Of Motion (degrees)
Croatian: Raspon pokretljivosti ramena u fleksiji (stupnjevi)
English: • cold sweat, heavy sweating
Croatian: • hladan znoj, obilno znojenje
English: Cmax showed an increase over time.
Croatian: Vrijednost Cmax s vremenom se povećavala.
English: If you are allergic (hypersensitive) to laronidase or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični (preosjetljivi) na laronidazu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute.
Croatian: Jedinica aktivnosti (U) definira se kao hidroliza jednog mikromola supstrata (4-MUI) po minuti.
English: Talk to your doctor before using Aldurazyme.
Croatian: Obratite se svom liječniku prije nego primite Aldurazyme.
English: Other side effects include the following:
Croatian: Ostale nuspojave obuhvaćaju sljedeće:
English: Pharmacotherapeutic group: Enzymes.
Croatian: Farmakoterapijska skupina: enzimi.
English: From a microbiological safety point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora odmah upotrijebiti.
English: The type of IARs was similar to those seen in other clinical studies.
Croatian: Vrste reakcija povezanih s infuzijom bile su slične onima koje su primijećene u drugim kliničkim ispitivanjima.
English: You may be given additional medication such as antihistamines and paracetamol to help prevent allergic-type reactions.
Croatian: Možda ćete dobivati dodatne lijekove poput antihistaminika i paracetamola kako bi se spriječile alergijske reakcije.
English: Phase 3, 26 weeks of treatment compared to placebo p value Confidence interval
Croatian: Faza III, 26 tjedana liječenja u usporedbi s placebom p-vrijednost Interval pouzdanosti
English: CHAQ/HAQ Disability Index 2
Croatian: CHAQ/HAQ indeks onesposobljenosti2
English: • cold hands or feet
Croatian: • bljedilo • hladne šake ili stopala
English: Genotoxic and carcinogenic potential are not expected.
Croatian: Ne očekuje se da bi lijek mogao imati genotoksičan ni karcinogen potencijal.
English: Remove the required vials from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature (below 30˚C).
Croatian: Potrebne bočice izvadite iz hladnjaka otprilike 20 minuta prije pripreme kako bi se ugrijale na sobnu temperaturu (ispod 30°C).
English: Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na izravne niti neizravne štetne učinke na trudnoću, razvoj embrija/fetusa, porod ili postnatalni razvoj (vidjeti dio 5.3).
English: Apnea/Hypopnea Index (AHI)
Croatian: Indeks apneja/hipopneja (AHI)
English: Aldurazyme is an artificial enzyme called laronidase.
Croatian: Aldurazyme je umjetni enzim koji se naziva laronidaza.
English: • influenza like illness
Croatian: • bolest nalik gripi
English: The occurrence of IgE antibodies was not fully explored.
Croatian: protutijela nije u potpunosti istražena.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti pojedinačne doze, toksičnosti ponovljenih doza i reproduktivne toksičnosti.
English: The current medical standards for emergency treatment are to be observed.
Croatian: Moraju se poštivati važeći zdravstveni standardi za hitno liječenje.
English: : +359 (0)2 970 53 00 Česká republika sanofi-aventis, s.r.o.
Croatian: Тел.: +359 (0)2 970 53 00 Česká republika sanofi-aventis, s.r.o.
English: Store at 2°C - 8°C.
Croatian: Čuvati na 2°C - 8°C.
English: This can replace the natural enzyme which is lacking in MPS I disease.
Croatian: On može nadomjestiti prirodni enzim koji nedostaje kod bolesnika s bolešću MPS I.
English: What you need to know before you are given Aldurazyme
Croatian: Što morate znati prije nego počnete primati Aldurazyme
English: 1 The decrease in percent predicted FVC is not clinically significant over this timeframe, and absolute lung volumes continued to increase commensurate with changes in height in growing paediatric patients.
Croatian: 1 Smanjenje postotka predviđenog FVC-a nije klinički značajno u tom vremenskom razdoblju, a apsolutni plućni volumen nastavio se povećavati proporcionalno promjenama visine u pedijatrijskih bolesnika u rastu.
English: The pharmacokinetic profile in patients less than 5 years old was similar to that of older and less severely affected patients.
Croatian: Farmakokinetički profil kod bolesnika mlađih od 5 godina bio je sličan onomu kod starijih bolesnika s manje teškim oblicima bolesti.
English: Aldurazyme should not be mixed with other medicinal products in the same infusion.
Croatian: Aldurazyme se ne smije miješati u istoj infuziji s drugim lijekovima.
English: Patients were enrolled with a Forced Vital Capacity (FVC) less than 80% of the predicted value and had to be able to stand for 6 minutes and to walk 5 meters.
Croatian: Forced Vital Capacity, FVC) iznosio manje od 80% predviđene vrijednosti i koji su mogli stajati 6 minuta te hodati 5 metara.
English: Therefore Aldurazyme should not be used during pregnancy unless clearly necessary.
Croatian: Aldurazyme se stoga ne smije primjenjivati tijekom trudnoće osim ako to nije izričito neophodno.
English: • leakage of the drug into the surrounding tissue at the site of injection, which may cause swelling or redness
Croatian: • istjecanje lijeka u okolno tkivo na mjestu injekcije koje može prouzročiti oticanje ili crvenilo
English: It is given to treat the non-neurological manifestations of the disease.
Croatian: Namijenjen je liječenju manifestacija te bolesti koje nisu neurološke naravi.
English: Instruction for use - dilution and administration
Croatian: Upute za uporabu - razrjeđivanje i primjena
English: Preclinical data did not reveal any significant adverse finding (see section 5.3).
Croatian: Pretklinički podaci nisu ukazali ni na kakve značajne štetne učinke (vidjeti dio 5.3).