FrancophonIA/ELRC3.0 huggingface dataset:
English: All reports of hypoglycaemia in patients with generalised LD and in the subgroup of partial LD patients, have been mild in nature with no pattern of onset or clinical sequelae.
Croatian: Svi prijavljeni slučajevi hipoglikemije u bolesnika s generaliziranim LD-om i podskupini bolesnika s parcijalnim LD-om bili su blage naravi bez uzorka s obzirom na početak ili kliničke posljedice.
English: • Do not insert the needle into a muscle.
Croatian: • Nemojte uvoditi iglu u mišić.
English: Blood glucose abnormal, Blood triglycerides increased, Drug specific antibody present, Glycosylated haemoglobin increased, Weight increased
Croatian: povećanje triglicerida u krvi, prisutnost protutijela specifičnih za lijek, povišeni glikozilirani hemoglobin,
English: Amount of mixed Myalepta solution to inject in ‘Unit' measurements on your 0.3 mL syringe
Croatian: Količina pripremljene otopine lijeka Myalepta koju treba ubrizgati izražena u mjerama za "jedinice" na štrcaljki od 0,3 ml
English: • muscle pain (‘myalgia')
Croatian: • bol u mišićima (mialgija)
English: Weight (kg) x 0.06 mg/kg = Individual patient daily starting dose in mg Weight (kg) x 0.012 mL/kg = Individual patient daily starting volume to inject in mL
Croatian: Težina (kg) x 0,06 mg/kg = početna individualizirana dnevna doza u mg Težina (kg) x 0,012 ml/kg = početni individualizirani dnevni volumen koji treba injicirati u ml
English: The Myalepta powder is dissolved by mixing it with water for injections to make the solution for injecting.
Croatian: Prašak lijeka Myalepta otapa se miješanjem s vodom za injekcije kako bi se dobila otopina za ubrizgavanje.
English: Myalepta is used to treat the complications of not having enough leptin in patients with lipodystrophy.
Croatian: Myalepta se koristi za liječenje komplikacija uzrokovanih manjkom leptina u bolesnika s lipodistrofijom.
English: • Place the vial on a flat, hard surface.
Croatian: • Postavite bočicu na ravnu, čvrstu površinu.
English: Table 7 Adverse reactions reported with Myalepta in > 1 patient during clinical studies in generalised LD and the subgroup of partial LD patients and post-marketing experience System Organ Class
Croatian: Nuspojave prijavljene za lijek Myalepta u > 1 bolesnika tijekom kliničkih ispitivanja u bolesnika s generaliziranim LD-om i podskupini bolesnika s parcijalnim LD-om i iskustva nakon stavljanja lijeka u promet
English: Pruritus, Rash, Urticaria
Croatian: Pruritus, osip, urtikarija
English: Among the 4 patients in the partial LD subgroup between 12 and 18 years of age, mean change to Month 12/LOCF for HbA1c was -0.7% and for TGs was -55.1%.
Croatian: U 4 bolesnika u podskupini s parcijalnim LD-om u dobi između 12 i 18 godina, srednja vrijednost promjene HbA1c do 12. mjeseca/LOCF bila je -0,7%, a za TG je iznosila -55,1%.
English: - The benefits and risks of Myalepta should be carefully considered in patients with acquired LD and/or those with significant haematologic abnormalities (including leukopenia, neutropenia, bone marrow abnormalities, lymphoma and/or lymphadenopathy).
Croatian: - Koristi i rizike od liječenja lijekom Myalepta potrebno je pažljivo razmotriti u bolesnika sa stečenim LD-om i/ili u bolesnika sa značajnim hematološkim abnormalnostima (uključujući leukopeniju, neutropeniju, abnormalnosti koštane srži, limfom i/ili limfadenopatiju).
English: • The active substance is metreleptin.
Croatian: • Djelatna tvar je metreleptin.
English: Do not give this medicine to children below the age of 2 years with generalised lipodystrophy, or below the age of 12 years with partial lipodystrophy.
Croatian: Nemojte davati ovaj lijek djeci s generaliziranom lipodistrofijom mlađoj od 2 godine ili djeci s djelomičnom lipodistrofijom mlađoj od 12 godina, zato što nije poznato kako ovaj lijek djeluje na djecu mlađu od te dobi.
English: TGs for the generalised LD group were noted in all age groups with larger mean changes observed in the older age group (-42.9%) compared to the younger age groups (-10.5% and -14.1%).
Croatian: Srednje vrijednosti smanjenja TG-a u odnosu na početnu vrijednost do 12. mjeseca/LOCF za skupinu s generaliziranim LD-om opažene su u svim dobnim skupinama, s tim da su veće srednje vrijednosti promjene zabilježene u starijoj dobnoj skupini (-42,9%) u usporedbi s mlađim dobnim skupinama (-10,5% i -14,1%).
English: The adverse reactions reported in generalised LD and this subgroup of partial LD patients are listed in Table 7.
Croatian: Nuspojave prijavljene u bolesnika s generaliziranim LD-om i u ovoj podskupini bolesnika s parcijalnim LD-om navedene su u Tablici 7.
English: In case of hypoglycaemic events of a non-severe nature, food intake management may be considered as an alternative to dose-adjustment of anti-diabetics according to the treating physician's opinion.
Croatian: U slučajevima hipoglikemije blaže naravi prehrana se može razmotriti kao alternativa prilagodbi doze antidijabetičkih lijekova, ovisno o mišljenju nadležnog liječnika.
English: • You will be given the 2.5 mL syringe to use if your daily dose is more than 5 mg up to 10 mg, which as a volume is greater than 1.0 mL of Myalepta solution.
Croatian: • Dobit ćete štrcaljku od 2,5 ml ako vaša dnevna doza iznosi više od 5 mg sve do 10 mg, a to je volumen koji je veći od 1,0 ml otopine lijeka Myalepta.
English: The weighted average daily dose (i.e., the average dose taking into account duration of treatment at different doses) for all 31 patients with baseline body weight greater than 40 kg was 7.0 mg during the first year of treatment, and 8.4 mg over the entire study period.
Croatian: Prosječna doza uzimajući u obzir trajanje liječenja pri različitim dozama) za svih 31 bolesnika s početnom tjelesnom težinom iznad 40 kg bila je 7,0 mg tijekom prve godine liječenja i
English: Overall, 30 (97%) patients were female, 26 (84%) were Caucasian, 2 (7%) Hispanic, and 0 Black.
Croatian: Sveukupno je bilo 30 (97%) ženskih bolesnika, 26 (84%) pripadnika bjelačke populacije, 2 (7%)
English: − A starting dose is 0.06 mg (0.012 mL of solution) for each kilogram of body weight.
Croatian: − početna je doza 0,06 mg (0,012 ml otopine) po kilogramu tjelesne težine.
English: Based on clinical response (e.g. inadequate metabolic control) or other consideration (e.g. tolerability issues, excessive weight loss especially in paediatric patients), the dose may be decreased, or increased to the maximum dose listed in Table 1.
Croatian: (npr. Problemi nepodnošljivosti, pretjerani gubitak težine, posebno u pedijatrijskih bolesnika) doza se može smanjiti ili povećati do najviše doze navedene u Tablici
English: Deep vein thrombosis
Croatian: Tromboza dubokih vena
English: Plastic ampoule of water for injection
Croatian: Plastična ampula vode za injekcije
English: • If your dose is 1.50 mg (0.30 mL of solution) or less, you will need to use a 0.3 mL syringe.
Croatian: • Ako je Vaša doza 1,50 mg (0,30 ml otopine) ili manje, trebat ćete upotrebljavati štrcaljku od 0,3 ml.
English: Attach the needle to the syringe.
Croatian: Postavite iglu na štrcaljku.
English: Push the plunger all the way down.
Croatian: Potisnite klip do kraja.
English: 30 gauge 13 mm needle
Croatian: 30 G igla 13 mm
English: • Do not touch the exposed needle on your syringe as it is sterile, and you may damage the needle or injure yourself.
Croatian: • Nemojte doticati izloženu iglu na štrcaljki jer je sterilna, a možete i oštetiti iglu ili se ozlijediti.
English: This is the same as 0.005 mL.
Croatian: To odgovara količini od 0,005 ml.
English: Non-compliance with, or abrupt discontinuation of, Myalepta may result in worsening hypertriglyceridaemia and associated pancreatitis, particularly in patients with risk factors for pancreatitis (e.g. history of pancreatitis, severe hypertriglyceridaemia) (see section 4.8).
Croatian: Akutni pankreatitis povezan s obustavljanjem lijeka Myalepta Nepridržavanje uputa ili nagli prekid primjene lijeka Myalepta mogu izazvati pogoršanje hipertrigliceridemije i povezanog pankreatitisa, naročito u bolesnika s rizičnim čimbenicima za pankreatitis, npr. Povijest pankreatitisa, teška hipertrigliceridemija (vidjeti dio 4.8).
English: Among 18 patients in the partial LD subgroup who had a baseline HbA1c level 8% or greater and data available at Month 12, the mean (SD) baseline HbA1c level was 9.9% (1.59) and the mean reduction in HbA1c at Month 12 was 1.3%.
Croatian: Među 18 bolesnika u podskupini s parcijalnim LD-om koji su imali početnu razinu HbA1c 8% ili višu i za koje su bili dostupni podaci u 12. mjesecu, srednja vrijednost (SD) početne razine HbA1c bila je 9,9% (1,59), a srednja vrijednost smanjenja HbA1c u 12. mjesecu bila je 1,3%.
English: Step F: Injecting Myalepta
Croatian: Korak F: Ubrizgavanje lijeka Myalepta
English: What Myalepta is used for
Croatian: Za što se koristi Myalepta
English: • You must check for air pockets or air bubbles in your 1 mL syringe.
Croatian: • Morate provjeriti ima li zračnih džepova ili zračnih mjehurića u štrcaljki od 1 ml.
English: Females > 40 kg
Croatian: Žene > 40 kg
English: Patients and/or carers should prepare and administer the first dose of the medicinal product under the supervision of a qualified healthcare professional.
Croatian: Prvu dozu lijeka bolesnici i/ili njegovatelji trebaju pripremiti i primijeniti pod nadzorom kvalificiranog zdravstvenog radnika.
English: • a glass vial (with rubber stopper)
Croatian: • staklenoj bočici (s gumenim čepom).
English: • Hold the ampoule so that the top is facing up.
Croatian: • Držite ampulu tako da vrh bude okrenut prema gore.
English: • You must check for air pockets or air bubbles in your 3 mL syringe.
Croatian: • Morate provjeriti ima li zračnih džepova ili zračnih mjehurića u štrcaljki od 3 ml.
English: o Hypersensitivity has been reported with Myalepta use including anaphylaxis, urticaria and generalised rash.
Croatian: o Uz primjenu lijeka Myalepta prijavljene su pojave preosjetljivosti, uključujući anafilaksiju, urtikariju i generalizirani osip.
English: After reconstitution, the solution must be administered immediately and cannot be stored for later use.
Croatian: Nakon rekonstitucije otopina se mora odmah upotrijebiti i ne može se pohraniti za buduću uporabu.
English: • The 1 mL syringe and needle will be provided separately.
Croatian: • Štrcaljka od 1 ml i igla isporučuju se zasebno.
English: Unused reconstituted solution should be discarded after use.
Croatian: Neiskorištenu rekonstituiranu otopinu potrebno je zbrinuti nakon uporabe.
English: Once insulin requirements have stabilised, dose adjustments of other anti-diabetics may also be needed in some patients.
Croatian: Nakon što se potrebe za inzulinom stabiliziraju, u nekih bolesnika mogu biti potrebne prilagodbe doze drugih antidijabetičkih lijekova.
English: Step D: Filling the syringe with Myalepta for injection
Croatian: Korak D: Punjenje štrcaljke lijekom Myalepta za injekciju
English: • Healthcare professionals training material
Croatian: • Materijal za obuku zdravstvenih radnika
English: 31 gauge 8 mm needle
Croatian: 31 G igla 8 mm
English: Remove the needle cover.
Croatian: Skinite poklopac igle.
English: Using the 1 mL syringe
Croatian: Uporaba štrcaljke od 1 ml
English: • The 0.3 mL syringe shows the injection amount in ‘U' instead of ‘mL'.
Croatian: • Na štrcaljki od 0,3 ml količina injekcije iskazana je u "U" a ne u "ml".
English: Consider dose increase before stopping treatment.
Croatian: Prije ukidanja lijeka razmotrite povećanje doze.
English: Closely monitor blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogues and combination treatment.
Croatian: Pozorno pratite glukozu u krvi u bolesnika koji istodobno uzimaju inzulinsku terapiju, naročito onih koji uzimaju visoke doze ili sekretagoge inzulina ili kombiniranu terapiju.
English: 6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 1 mL syringe.
Croatian: 6) Bez obzira jeste li izvukli vodu za injekcije iz bočice ili ampule, morate provjeriti da u štrcaljki od 1 ml nema zračnih džepova ili zračnih mjehurića.
English: The syringe will now be facing up.
Croatian: Sad će štrcaljka biti okrenuta prema gore.
English: • being clumsy and dropping things
Croatian: • nespretnost i ispuštanje predmeta iz ruku
English: This is the same as 0.05 mL.
Croatian: To odgovara količini od 0,05 ml.
English: 6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 3 mL syringe.
Croatian: 6) Bez obzira jeste li izvukli vodu za injekcije iz bočice ili ampule, morate provjeriti da u štrcaljki od 3 ml nema zračnih džepova ili zračnih mjehurića.
English: Dose of Myalepta
Croatian: Doza lijeka Myalepta
English: If you forget to use Myalepta
Croatian: Ako ste zaboravili primijeniti lijek Myalepta
English: How Myalepta works
Croatian: Kako djeluje Myalepta
English: 4) Take the 1 mL syringe out of the plastic wrapper.
Croatian: 4) Izvadite štrcaljku od 1 ml iz plastičnog omotača.
English: Place the vial on a hard, flat surface.
Croatian: Postavite bočicu na čvrstu, ravnu površinu.
English: If you stop using Myalepta
Croatian: Ako prestanete uzimati lijek Myalepta
English: - In case of hypoglycaemic events of a non-severe nature, food intake management may be considered as an alternative to dose adjustment of anti-diabetics.
Croatian: U slučajevima hipoglikemije blaže naravi režim prehrane može se razmotriti kao alternativa prilagodbi doze antidijabetičkih lijekova.
English: Fat tissue increased, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling, Malaise, Peripheral swelling
Croatian: Povećanje masnog tkiva, hemoragija na mjestu injiciranja, bol na mjestu injiciranja, pruritus na mjestu injiciranja, oticanje na mjestu injiciranja,
English: 4) Take the 3 mL syringe out of the plastic wrapper.
Croatian: 4) Izvadite štrcaljku od 3 ml iz plastičnog omotača.
English: An association between the development of neutralising antidrug antibodies and serious and severe infections cannot be excluded, and, continuation of Myalepta should be at the discretion of the prescriber.
Croatian: Ne može se isključiti povezanost nastanka neutralizirajućih protutijela na lijek s ozbiljnim i teškim infekcijama te je odluka o nastavku liječenja lijekom Myalepta u nadležnosti propisivača.
English: Table 3 Required syringe for Myalepta reconstitution with water for injection Syringe
Croatian: Tablica 3. Štrcaljka potrebna za rekonstituciju lijeka Myalepta vodom za injekcije Štrcaljka
English: After reconstitution, each mL contains 5 mg of metreleptin.
Croatian: Nakon rekonstitucije jedan ml sadrži 5 mg metreleptina.
English: Using the 2.5 mL syringe
Croatian: Uporaba štrcaljke od 2,5 ml
English: Fatigue, Injection site bruising, Injection site erythema, Injection site reaction
Croatian: Umor, modrice na mjestu injiciranja, eritem na mjestu injiciranja, reakcija na mjestu injiciranja
English: Once insulin requirements have stabilised, dose adjustments of other anti-diabetics may also be needed in some patients to minimise the risk of hypoglycaemia.
Croatian: Nakon stabiliziranja potreba za inzulinom, u nekih bolesnika mogu biti potrebne prilagodbe doza drugih antidijabetičkih lijekova kako bi se minimizirao rizik od hipoglikemije.
English: An association between the development of Neutralising Antibodies (NAbs) and serious and severe infections cannot be excluded and the continuation of Myalepta should be at the discretion of the prescriber.
Croatian: Ne može se isključiti povezanost nastanka neutralizirajućih protutijela (NAB) s ozbiljnim i teškim infekcijama te je odluka o nastavku liječenja lijekom Myalepta u nadležnosti propisivača.
English: With the needle still in the ampoule, pull the plunger up carefully.
Croatian: Dok je igla još u ampuli, pažljivo povucite klip prema gore.
English: For doses of: > 5 mg - 10 mg / > 1.0 mL volume daily
Croatian: Za doze od: > 5 mg - 10 mg / > 1,0 ml volumena dnevno
English: Metreleptin mimics the physiological effects of leptin by binding to and activating the human leptin receptor, which belongs to the Class I cytokine family of receptors that signals through the JAK/STAT transduction pathway.
Croatian: Metreleptin oponaša fiziološke učinke leptina tako što se vezuje na, i aktivira, receptor humanog leptina, koji pripada u skupinu
English: Remove the vial from the refrigerator and allow the vial to warm for 10 minutes to reach room temperature (20 °C-25 °C) prior to reconstitution.
Croatian: Izvadite bočicu iz hladnjaka i ostavite da se 10 minuta zagrijava do sobne temperature
English: • weight gain
Croatian: • porast na težini
English: Lymphoma
Croatian: Limfom
English: • This syringe shows the injection amount in mL, so you should inject the amount your doctor, nurse, or pharmacist has told you to. You do not need to convert the amount from mL to Units.
Croatian: • Na ovoj štrcaljki količina injekcije označena je u ml, tako da trebate ubrizgati količinu koju su vam rekli liječnik, medicinska sestra ili ljekarnik.
English: For the 32 patients with generalised LD who were receiving oral anti-diabetic medicinal products at baseline, 7 (22%) were able to discontinue their use.
Croatian: Od 32 bolesnika s generaliziranim LD-om koji su na početku peroralno uzimali antidijabetičke lijekove, njih 7 (22%)
English: • Each 5 U is shown as a number with a big line.
Croatian: • Svakih 5 U prikazuje se kao brojka s velikom crticom.
English: • Without the needle attached, insert the 1 mL syringe tip into the top of the plastic ampoule as far as possible.
Croatian: • Vrh štrcaljke od 1 ml bez igle umetnite u vrh plastične ampule što je dublje moguće.
English: • If there is less than 1.1 mL of water for injection in the syringe, draw more water for injection into the syringe and repeat the steps 6 and 7 until you have 1.1 mL in the syringe.
Croatian: • Ako u štrcaljki ima manje od 1,1 ml vode za injekcije, u štrcaljku povucite još vode za injekciju i ponavljajte korake 6 i 7 dok u štrcaljki ne bude 1,1 ml vode.
English: Insert the 3 mL syringe into the glass ampoule.
Croatian: Umetnite štrcaljku od 3 ml u staklenu ampulu.
English: Table 6 Dose adjustment calculation Adjust dose as follows (if necessary)
Croatian: Tablica 6. Izračun prilagodbe doze
English: o The requirement to perform regular follow-ups with the patient/carer to ensure continued correct and compliant Myalepta reconstitution and treatment.
Croatian: o Obavezu redovitih provjera bolesnika/njegovatelja kako bi se osiguralo da se rekonstituiranje i liječenje lijekom Myalepta trajno provodi ispravno i u skladu s uputama.
English: Insert the 1 mL syringe into the glass ampoule.
Croatian: Umetnite štrcaljku od 1 ml u staklenu ampulu.
English: Before opening the water for injection ampoule, prepare the 1 mL syringe by attaching the needle to it. Do not over-tighten the needle.
Croatian: Prije otvaranja ampule s vodom za injekcije pripremite štrcaljku od 1 ml tako da na nju pričvrstite iglu.
English: o T-cell lymphoma - Acquired LDs are associated with autoimmune disorders.
Croatian: - Stečene lipodistrofije (LD) povezuju se s autoimunim poremećajima.
English: Remaining solution should be discarded after use.
Croatian: Preostalu otopinu potrebno je zbrinuti u otpad nakon uporabe.
English: • If there is less than 2.2 mL of water for injection in the syringe, draw more water for injection into the syringe and repeat the steps 6 and 7 until you have 2.2 mL in the syringe.
Croatian: • Ako u štrcaljki ima manje od 2,2 ml vode za injekcije, u štrcaljku povucite još vode za injekciju i ponavljajte korake 6 i 7 dok u štrcaljki ne bude 2,2 ml vode.
English: o For example, if you have been prescribed a 5 mg dose of Myalepta, 5 mg divided by 5 gives you 1 mL which is the amount you need to inject of the solution, using a 1 mL syringe.
Croatian: Na primjer, ako Vam je propisana doza od 5 mg lijeka Myalepta, 5 mg podijeljeno s 5 daje
English: • Without the needle attached, insert the 3 mL syringe tip into the top of the plastic ampoule as far as possible.
Croatian: • Vrh štrcaljke od 3 ml bez igle umetnite u vrh plastične ampule što je dublje moguće.
English: Limited clinical data exists in children less than 2 years old for generalised LD patients and less than 12 years old in partial LD patients.
Croatian: Podaci za djecu mlađu od 2 godine za bolesnike s generaliziranim LD-om i mlađu od 12 godina za bolesnike s parcijalnim LD-om ograničeni su.
English: For doses of: ≤ 1.5 mg /≤ 0.3 mL volume daily
Croatian: Za doze od: ≤ 1,5 mg / ≤ 0,3 ml volumena dnevno
English: A total of 148 patients with generalised and partial LD received metreleptin during clinical studies.
Croatian: Tijekom kliničkih ispitivanja ukupno je 148 bolesnika s generaliziranim i parcijalnim LD-om primilo metreleptin.
English: Before opening the water for injection ampoule, prepare the 3 mL syringe by attaching the needle to it. Do not over-tighten the needle.
Croatian: Prije otvaranja ampule s vodom za injekcije pripremite štrcaljku od 3 ml tako da na nju pričvrstite iglu.
English: Example: A 15 kg patient is initiated at 0.06 mg/kg of Myalepta.
Croatian: Primjer: bolesnik težine 15 kg započinje s dozom od 0,06 mg/kg lijeka Myalepta.
English: Using the 0.3 mL syringe
Croatian: Uporaba štrcaljke od 0,3 ml
English: Rotation of injection sites is recommended in patients co-administering insulin (or other subcutaneous medicinal products) and Myalepta.
Croatian: Preporučuje se rotiranje mjesta uboda u bolesnika u kojih se istodobno primjenjuju inzulin (ili drugi lijek koji se primjenjuje supkutano) i Myalepta.
English: • Each 1 U is shown as a smaller line between the big lines.
Croatian: • Svaka 1 U prikazuje se kao manja crtica između velikih crtica.
English: • Each 0.01 mL is shown as a smaller line.
Croatian: • Svakih 0,01 ml prikazuje se kao manja crtica.
English: • The 3 mL syringe and needle will be provided separately.
Croatian: • Štrcaljka od 3 ml i igla isporučuju se zasebno.
English: • swelling and reddening of the skin, hives
Croatian: • oticanje i crvenilo kože, koprivnjaču
English: Myalepta 5.8 mg powder for solution for injection EU/1/18/1276/005
Croatian: Myalepta 5,8 mg prašak za otopinu za injekciju EU/1/18/1276/005
English: • If there is less than 0.6 mL of water for injection in the syringe, draw more water for injection into the syringe and repeat the steps 6 and 7 until you have 0.6 mL in the syringe.
Croatian: • Ako u štrcaljki ima manje od 0,6 ml vode za injekcije, u štrcaljku povucite još vode za injekciju i ponavljajte korake 6 i 7 dok u štrcaljki ne bude 0,6 ml vode.
English: • Each vial contains 5.8 milligrams of metreleptin.
Croatian: • Jedna bočica sadrži 5,8 miligrama metreleptina.
English: The median fasting leptin concentration at baseline was 1.0 ng/mL in males (range: 0.3-3.3 ng/mL) and 1.1 ng/mL in females (range: 0.2-5.3 ng/mL) using the LINCO RIA test method.
Croatian: (raspon: 0,3-3,3 ng/ml) i 1,1 ng/ml u ispitanica (raspon: 0,2-5,3 ng/ml) primjenom ispitne metode LINCO RIA.
English: For males and females ≤ 40 kg once daily dose
Croatian: Za muškarce i žene težine ≤ 40 kg jedna dnevna doza
English: In 24 patients with renal data available, the mean change at Month 12 in protein excretion rate versus baseline (1,675.7 mg/24hr) was -906.1 mg/24 hr.
Croatian: U 24 bolesnika za koje postoje podaci o bubrežnoj funkciji, srednja vrijednost promjene stope izlučivanja proteina u 12. mjesecu u odnosu na početnu vrijednost (1675,7 mg/24 h)
English: • Keeping the bottom of the ampoule still, snap the tip off.
Croatian: • Pridržavajući dno ampule na mjestu, odlomite vršak.