FrancophonIA/ELRC3.0 huggingface dataset:
English: - Guidance in the educational materials on: The size of syringes and needles to prescribe Prescribing the dose in both mg and ml and, where a 0.3 mL U100 insulin syringe is used, informing patients on the dose in "units" on the syringe to inject The prescribing of ampoule/vial sizes volumes of water for injection in appropriate volumes to reduce the risk of re-use Pharmacists will be guided in the educational materials on the ancillary items that need to be dispensed to patients including appropriate sized reconstitution and administration syringes and needles, appropriate sized vials/ampoules of water for injection, alcohol swabs and a sharps bin plus how to access Aegerion reconstitution and administration kits containing all of the above items except the water for injection and sharps bin.
Croatian: veličini štrcaljki i igli koju treba propisati propisivanju doze i u mg i u ml te, kad se koristi inzulinska štrcaljka od 0,3 ml U100, informiranju bolesnika o dozi koju treba ubrizgati izraženoj u „jedinicama“ na štrcaljki propisivanju ampula/bočica s vodom za injekcije u odgovarajućim volumenima kako bi se smanjio rizik od ponovne uporabe
English: Acute pancreatitis associated with discontinuation of metreleptin In clinical studies, 6 patients (4 with generalised LD and 2 with partial LD), experienced treatment-emergent pancreatitis.
Croatian: U kliničkim ispitivanjima u 6 je bolesnika (4 s generaliziranim LD-om i 2 s parcijalnim LD-om) zabilježen pankreatitis nastao tijekom liječenja.
English: Males and females ≤ 40 kg
Croatian: Muškarci i žene ≤ 40 kg
English: Cases of T-cell lymphoma have been reported in clinical studies in patients taking Myalepta.
Croatian: U kliničkim ispitivanjima prijavljeni su slučajevi limfoma T-stanica u bolesnika koji su uzimali lijek Myalepta.
English: Metabolism and nutrition disorders Hypoglycaemia Decreased appetite Diabetes mellitus, Hyperphagia, Insulin resistance
Croatian: Diabetes mellitus, hiperfagija, inzulinska rezistencija
English: 20) Check for air pockets and air bubbles.
Croatian: 20) Provjerite da nema zračnih džepova i zračnih mjehurića.
English: Step B: Filling the 1 mL syringe with 0.6 mL of water for injections
Croatian: Korak B: Punjenje štrcaljke od 1 ml s 0,6 ml vode za injekcije
English: Myalepta 3 mg powder for solution for injection EU/1/18/1276/003
Croatian: Myalepta 3 mg prašak za otopinu za injekciju EU/1/18/1276/003
English: 21 gauge 40 mm needle
Croatian: 21 G igla 40 mm
English: • swelling in your hands and feet
Croatian: • bol u zglobovima • oticanje šaka i stopala
English: • Do not remove the needle guard.
Croatian: • Nemojte skidati štitnik igle.
English: 0.300 mL 0.30 mL *Note: Initial and dose increments should be rounded down to the nearest 0.01 mL
Croatian: *Napomena: Početnu dozu i povećanja doze treba zaokružiti nadolje na najbližih 0,01 ml.
English: On a clean, well-lit work surface, place the following items:
Croatian: Na čistu, dobro osvijetljenu radnu površinu stavite sljedeće predmete: • staklenu bočicu s praškom Myalepta
English: Step B: Filling the 3 mL syringe with 2.2 mL of water for injections
Croatian: Korak B: Punjenje štrcaljke od 3 ml s 2,2 ml vode za injekcije
English: • Each 0.5 U is shown as a small line between two 1 U lines.
Croatian: • Svakih 0,5 U prikazuje se kao mala crtica između dviju crtica koje označavaju 1 U.
English: 5) Withdraw 0.6 mL of water for injection into the 1 mL syringe.
Croatian: 5) Izvucite 0,6 ml vode za injekcije u štrcaljku od 1 ml.
English: - Patients and/or caregivers should prepare and administer the first dose under the supervision of a qualified HCP.
Croatian: - Prvu dozu lijeka bolesnici i/ili njegovatelji moraju pripremiti i primijeniti pod nadzorom kvalificiranog zdravstvenog radnika.
English: • Each vial contains 11.3 milligrams of metreleptin.
Croatian: • Jedna bočica sadrži 11,3 miligrama metreleptina.
English: They will provide a ‘sharps disposal container' for you to put your used vials, syringes and needles in.
Croatian: Oni će Vam dati i "spremnik za oštre predmete" u koji trebate odlagati iskorištene bočice,
English: • Each 0.1 mL is shown as a smaller line between the big lines.
Croatian: • Svakih 0,1 ml prikazuje se kao manja crtica između velikih crtica.
English: T-cell lymphoma
Croatian: Limfom T-stanica
English: Glass ampoule of water for injection
Croatian: Staklena ampula vode za injekcije
English: Name and address of the manufacturer of the biological active substance Sandoz GmbH - BP Kundl
Croatian: Sandoz GmbH - BP Kundl Biochemiestrasse 10 6250 Kundl
English: Large dose reductions of 50% or more of baseline insulin requirements may be needed in the first 2 weeks of treatment.
Croatian: U prva 2 tjedna liječenja mogu biti potrebna velika smanjenja doze od 50% ili više od početnih potreba za inzulinom.
English: Among 24 patients with generalised LD who had a baseline TG level 5.65 mmol/l or greater and data available at Month 12, the mean (SD) baseline TG level was 31.7 mmol/l (33.68) and the mean percent reduction in triglycerides at Month 12 was 72%.
Croatian: Između 24 bolesnika s generaliziranim 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 31,7 mmol/l (33,68), a srednja vrijednost postotnog smanjenja triglicerida u 12. mjesecu bila je 72%.
English: 25 kg patient is initiated at 0.06 mg/kg of Myalepta.
Croatian: Bolesnik težine 25 kg započinje s dozom od 0,06 mg/kg lijeka Myalepta.
English: Myalepta 11.3 mg powder for solution for injection EU/1/18/1276/001
Croatian: Myalepta 11,3 mg prašak za otopinu za injekciju EU/1/18/1276/001
English: o If your dose is more than 5 mg, you will use a 2.5 mL syringe.
Croatian: o Ako primjenjujete dozu veću od 5 mg, upotrebljavat ćete štrcaljku od 2,5 ml.
English: This medicine is for use in children aged 2 years and above, adolescents and adults with generalised lipodystrophy; it is also for use in children aged 12 years and above, adolescents and adults with partial lipodystrophy.
Croatian: Ovaj lijek namijenjen je za primjenu u djece u dobi od 2 godine i starije, adolescenata i odraslih s generaliziranom lipodistrofijom.
English: For doses of: > 1.5 mg - 5 mg / 0.3 - 1.0 mL volume daily
Croatian: Za doze od: > 1,5 mg - 5 mg / 0,3 - 1,0 ml volumena dnevno
English: Do not over-tighten the needle.
Croatian: Nemojte previše zategnuti iglu.
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: LD patients with a blocking activity against metreleptin and concurrent infections responded to standard of care treatment (see section 4.4).
Croatian: Bolesnici s LD-om s blokirajućom aktivnosti protiv metreleptina i istodobnim infekcijama odgovorili su na liječenje standardnom skrbi
English: Among 45 patients with generalised LD who had a baseline HbA1c of 7% or greater and data available at Month 12, the mean (SD) baseline HbA1c was 9.6% (1.63) and the mean reduction in HbA1c at Month 12 was 2.8%.
Croatian: Među 45 bolesnika s generaliziranim LD-om koji su imali početni HbA1c od 7% ili viši i za koje su bili dostupni podaci u 12. mjesecu, srednja vrijednost (SD) početne razine HbA1c bila je 9,6% (1,63), a srednja vrijednost smanjenja HbA1c u 12. mjesecu bila je 2,8%.
English: ‘Unit' measurement volume in 0.3 mL
Croatian: Volumen u „jedinicama“ koji treba injicirati u štrcaljki od 0,3 ml
English: − A starting dose is 2.5 mg (0.5 mL of solution).
Croatian: − početna je doza 2,5 mg (0,5 ml otopine).
English: Table 4 Required administration syringe per Myalepta dose Syringe
Croatian: Tablica 4. Štrcaljka potrebna za primjenu za dozu lijeka Myalepta Štrcaljka
English: - Rotation of injection sites is recommended in patients co administering insulin (or other SC 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: Step C: Dissolving Myalepta
Croatian: Korak C: Otapanje lijeka Myalepta
English: Myalepta 5.8 mg powder for solution for injection Using a 3 mL syringe with a 21-gauge or smaller diameter needle, withdraw 1.1 mL of water for injection.
Croatian: Myalepta 5,8 mg prašak za otopinu za injekciju Pomoću štrcaljke od 3 ml s iglom promjera 21 G ili manjeg izvucite 1,1 ml vode za injekcije.
English: 5) Withdraw 2.2 mL of water for injection into the 3 mL syringe.
Croatian: 5) Izvucite 2,2 ml vode za injekcije u štrcaljku od 3 ml.
English: You should not use Myalepta if you are pregnant or might become pregnant.
Croatian: Ne smijete primjenjivati lijek Myalepta ako ste trudni ili ako možete zatrudnjeti, zato što nije poznato kako će metreleptin utjecati na vaše nerođeno dijete.
English: “Instructions for Use” (section 7) for more information on reading and using the different syringes.
Croatian: Za više informacija o očitavanju i uporabi različitih štrcaljki pogledajte "Upute za uporabu" (dio 7.).
English: Table 9 Primary outcome results in study (NIH 991265/ 20010769) of evaluable patients in the partial LD subgroup treated with metreleptin at 12 months
Croatian: Tablica 9. Rezultati primarnih ishoda u ispitivanju (NIH 991265/20010769) nakon 12 mjeseci u podskupini bolesnika s parcijalnim LD-om liječenih metreleptinom koje je bilo moguće procijeniti
English: Step B: Filling the 3 mL syringe with 1.1 mL of water for injections
Croatian: Korak B: Punjenje štrcaljke od 3 ml s 1,1 ml vode za injekcije
English: Excipients: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment)
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: glicin, saharoza, polisorbat 20, glutamatna kiselina, natrijev hidroksid (za prilagodbu pH)
English: When discontinuing Myalepta in patients with risk factors for pancreatitis (e.g. history of pancreatitis, severe hypertriglyceridaemia), tapering of the dose over a two-week period is recommended in conjunction with a low-fat diet. During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed.
Croatian: Ako se metreleptin mora ukinuti iz bilo kojeg razloga, preporučuje se postupno smanjenje doze tijekom dvotjednog razdoblja uz dijetu s niskim udjelom masti, vidjeti dio 4.2. Tijekom postupnog smanjenja pratite razine triglicerida i po potrebi razmotrite uvođenje ili prilagodbu doze lijekova za snižavanje razine lipida.
English: o The 0.3 mL syringe will show the injection amount in ‘Unit' instead of ‘mL'.
Croatian: o Na štrcaljki od 0,3 ml količina injekcije iskazana je u jedinici (U), a ne u ml.
English: For females > 40 kg once daily dose
Croatian: Za žene težine > 40 kg jedna dnevna doza
English: 21 gauge 40 mm needle Myalepta 5.8 mg powder for solution for injection 3.0 mL
Croatian: 21 G igla 40 mm Myalepta 5,8 mg prašak za otopinu za injekciju 3,0 ml
English: Table 2 Dose calculation Weight and gender Starting dose calculation
Croatian: Tablica 2. Izračun doze
English: The individual patient dose = 1.5 mg
Croatian: Individualna doza za bolesnika = 0,9 mg.
English: Additionally, adverse reactions from post-marketing sources are also presented.
Croatian: Također su prikazane i nuspojave prijavljene nakon stavljanja lijeka u promet.
English: • blood-thinning medicines (such as warfarin or phenprocoumon)
Croatian: • teofilin koji se primjenjuje za probleme s plućima kao što je astma • lijekove za razrjeđivanje krvi (npr. varfarin ili fenprokumon)
English: Myalepta 11.3 mg powder for solution for injection Using a 3 mL syringe with a 21-gauge or smaller diameter needle, withdraw 2.2 mL of water for injection.
Croatian: Myalepta 11,3 mg prašak za otopinu za injekciju Pomoću štrcaljke od 3 ml s iglom promjera 21 G ili manjeg izvucite 2,2 ml vode za injekcije.
English: Remaining reconstituted product should be discarded after use.
Croatian: Preostali rekonstituirani lijek mora se zbrinuti u otpad nakon uporabe.
English: When properly mixed, the Myalepta solution should be clear and free of lumps of dry powder, bubbles or foam.
Croatian: Kad je pravilno izmiješana, otopina lijeka Myalepta treba biti bistra i bez grudica suhog praška,
English: • bruising, reddening, itching or hives where the injection is given
Croatian: • modrice, crvenilo, svrbež ili koprivnjača na mjestu primjene injekcije
English: • Each vial contains 3 milligrams of metreleptin.
Croatian: • Jedna bočica sadrži 3 miligrama metreleptina.
English: 21 gauge 40 mm needle Myalepta 11.3 mg powder for solution for injection 3.0 mL
Croatian: 21 G igla 40 mm Myalepta 11,3 mg prašak za otopinu za injekciju 3,0 ml
English: 5) Withdraw 1.1 mL of water for injection into the 3 mL syringe.
Croatian: 5) Izvucite 1,1 ml vode za injekcije u štrcaljku od 3 ml.
English: • Each 0.1 mL is shown as a number with a big line.
Croatian: • Svakih 0,1 ml prikazuje se kao brojka s velikom crticom.
English: In order to ensure patients and carers understand the correct dose to be injected, the prescriber should prescribe the appropriate dose both in milligrams and the volume in millilitres.
Croatian: liječnik mora propisati odgovarajuću dozu izraženu i u miligramima i volumno u mililitrima.
English: Amount of mixed Myalepta solution
Croatian: Količina pripremljene otopine lijeka Myalepta
English: With the syringe still in the ampoule, turn the ampoule and syringe upside down.
Croatian: Dok je štrcaljka još u ampuli, okrenite ampulu i štrcaljku naopako.
English: Large dose reductions of 50% or more of baseline insulin requirements may be needed in the initial phases of treatment.
Croatian: U početnoj fazi liječenja mogu biti potrebna velika smanjenja doze, od 50% ili više od početnih potreba za inzulinom.
English: • Patients/carers educational material
Croatian: • Edukacijski materijal za zdravstvene radnike • Edukacijski materijal za bolesnike/njegovatelje
English: There is a risk of hypoglycaemia in patients treated with Myalepta who are on anti-diabetic therapy.
Croatian: U bolesnika liječenih lijekom Myalepta koji uzimaju antidijabetičke lijekove postoji rizik od hipoglikemije.
English: Metreleptin has not been studied in patients with impaired renal or hepatic function.
Croatian: Oštećenje funkcije bubrega i jetre Metreleptin nije ispitivan u bolesnika s oštećenjima bubrežne ili jetrene funkcije.
English: The AUC exposure of pregnant mice was approximately 2 to 3 times greater than observed in non-pregnant mice after 10 mg/kg subcutaneous administration of metreleptin.
Croatian: 3 puta veća od one zabilježene u neskotnih ženki nakon supkutane primjene 10 mg/kg metreleptina.
English: In order to address the potential safety concerns and/or lack of efficacy related to immunogenicity of Myalepta, the applicant should submit an integrated analysis of immunogenicity measured according to validated assays.
Croatian: Kako bi se razmotrila potencijalna sigurnosna pitanja i/ili nedjelotvornost u vezi s imunogeničnosti lijeka Myalepta,
English: No formal pharmacokinetic studies were conducted in patients with hepatic impairment.
Croatian: Nisu provedena formalna farmakokinetička ispitivanja u bolesnika s oštećenjem funkcije bubrega.
English: The benefits and risks of treatment should be carefully considered in patients with acquired generalised LD and/or in patients with significant haematological abnormalities (including leukopenia, neutropenia, bone marrow abnormalities, lymphoma, and/or lymphadenopathy).
Croatian: Koristi od liječenja i rizike potrebno je pažljivo razmotriti u bolesnika sa stečenim generaliziranim LD-om i/ili u bolesnika sa značajnim hematološkim abnormalnostima (uključujući leukopeniju,
English: o If your dose is more than 1.5 mg up to 5 mg, you will use a 1 mL syringe.
Croatian: o Ako primjenjujete dozu veću od 1,5 mg a do 5 mg, upotrebljavat ćete štrcaljku od 1 ml.
English: Glass vial of water for injection
Croatian: Staklena bočica vode za injekcije
English: - Tapering the dose over a two-week period is recommended in conjunction with a low fat diet. - Patients should be monitored during tapering.
Croatian: - Preporučuje se postepeno smanjenje doze tijekom dvotjednog razdoblja uz dijetu s niskim udjelom masti.
English: The weighted average daily dose (i.e., the average dose taking into account duration of treatment at different doses) for the 48 patients with baseline body weight greater than 40 kg was 2.6 mg for males and 5.2 mg for females during the first year of treatment, and 3.7 mg for males and 6.5 mg for females over the entire study period.
Croatian: 48 bolesnika s početnom tjelesnom težinom iznad 40 kg bila je 2,6 mg za muškarce i 5,2 mg za žene tijekom prve godine liječenja, i 3,7 mg za muškarce i 6,5 mg za žene tijekom cijelog razdoblja ispitivanja.
English: • All of the water for injection should be injected into the vial.
Croatian: • U bočicu treba ubrizgati cijelu količinu vode za injekcije.
English: • Remove the needle cover.
Croatian: • Skinite poklopac igle.
English: o If your dose is 1.5 mg or less, you will use a 0.3 mL syringe.
Croatian: o Ako primjenjujete dozu od 1,5 mg ili manje, upotrebljavat ćete štrcaljku od 0,3 ml.
English: After reconstitution with 1.1 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Croatian: Nakon rekonstitucije s 1,1 ml vode za injekcije (vidjeti dio 6.6), jedan ml sadrži 5 mg metreleptina.
English: Myalepta 3 mg powder for solution for injection 1.0 mL
Croatian: Myalepta 3 mg prašak za otopinu za injekciju 1,0 ml
English: Attach the needle to the 1 mL syringe.
Croatian: Postavite iglu na štrcaljku od 1 ml.
English: After reconstitution with 2.2 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Croatian: Nakon rekonstitucije s 2,2 ml vode za injekcije (vidjeti dio 6.6), jedan ml sadrži 5 mg metreleptina.
English: - Monitoring of blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogues and combination treatment is warranted.
Croatian: Opravdano je pozorno pratiti glukozu u krvi u bolesnika koji istodobno uzimaju inzulinsku terapiju, naročito u onih koji uzimaju visoke doze, ili sekretagoge inzulina i kombiniranu terapiju.
English: • Pull up until the top rim of the plunger lines up with the black 0.6 mL line.
Croatian: • Povlačite dok se gornji rub klipa ne poravna s crnom crticom koja označava 0,6 ml.
English: • sudden severe pain in your stomach (abdomen)
Croatian: • oštru bol u trbuhu (abdomenu) • vrlo brze otkucaje srca.
English: Needle gauge and length Myalepta dose range to be administered
Croatian: Raspon doze lijeka Myalepta koji treba primijeniti
English: In the generalised LD group, the number of patients according to age group was as follows: 5 patients < 6 years (including a single patient < 2 years), 12 patients ≥ 6 to < 12 years and 28 patients aged ≥ 12 to < 18 years; in the partial LD subgroup, there were no patients < 12 years of age and 4 patients ≥ 12 to < 18 years.
Croatian: 28 bolesnika u dobi od ≥ 12 do < 18 godina; u podskupini s parcijalnim LD-om nije bilo bolesnika u dobi
English: 9) With 1.1 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Croatian: 9) Kad se u štrcaljki nalazi 1,1 ml vode za injekcije, izvadite štrcaljku iz bočice ili ampule.
English: Both males and females > 40 kg
Croatian: Muškarci i žene > 40 kg
English: 9) With 0.6 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Croatian: 9) Kad se u štrcaljki nalazi 0,6 ml vode za injekcije, izvadite štrcaljku iz bočice ili ampule.
English: • Do not over-tighten the needle.
Croatian: • Nemojte previše zategnuti iglu.
English: • Pull up until the top rim of the plunger lines up with the black 1.1 mL line.
Croatian: • Povlačite dok se gornji rub klipa ne poravna s crnom crticom koja označava 1,1 ml.
English: • Pull the plunger down to the 1.1 mL line to draw air into the syringe.
Croatian: • Povucite klip igle prema dolje do crtice koja označava 1,1 ml da biste uvukli zrak u štrcaljku.
English: 9) With 2.2 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Croatian: 9) Kad se u štrcaljki nalazi 2,2 ml vode za injekcije, izvadite štrcaljku iz bočice ili ampule.
English: • Hold the ampoule so that the tip is facing up.
Croatian: • Držite ampulu tako da vršak bude okrenut prema gore.
English: Individual patient once daily dose in mg = 2.5 mg Amount to inject once daily dose = 0.5 mL
Croatian: Individualizirana doza za bolesnika jedanput dnevno u mg = 2,5 mg
English: There is a risk of hypoglycaemia in patients treated with Myalepta who are on anti-diabetic medicinal products, in particular insulin or insulin secretagogues (e.g. sulphonylureas).
Croatian: Hipoglikemija s istodobnom primjenom inzulina i drugih antidijabetičkih lijekova U bolesnika koji se liječe lijekom Myalepta, a uzimaju antidijabetičke lijekove, naročito inzulin ili sekretagoge inzulina (npr. Sulfonilureje), postoji rizik od hipoglikemije.
English: • Pull the plunger down to the 0.6 mL line to draw air into the syringe.
Croatian: • Povucite klip igle prema dolje do crtice koja označava 0,6 ml da biste uvukli zrak u štrcaljku.
English: • Pull up until the top rim of the plunger lines up with the black 2.2 mL line.
Croatian: • Povlačite dok se gornji rub klipa ne poravna s crnom crticom koja označava 2,2 ml.
English: − A starting dose is 5 mg (1 mL of solution).
Croatian: − početna je doza 5 mg (1 ml otopine).
English: After dissolving the vial contents in 0.6 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Croatian: Nakon otapanja sadržaja bočice u 0,6 mililitra vode za injekcije, jedan mililitar sadrži 5 miligrama metreleptina.
English: With the needle still in the vial, turn the vial and syringe upside down.
Croatian: Dok je igla još u bočici, okrenite bočicu i štrcaljku naopako.
English: • diarrhoea
Croatian: • dijabetes
English: o Neutralising antibodies may develop on Myalepta therapy.
Croatian: o Tijekom liječenja lijekom Myalepta mogu nastati neutralizirajuća protutijela.
English: • Pull the plunger down to the 2.2 mL line to draw air into the syringe.
Croatian: • Povucite klip igle prema dolje do crtice koja označava 2,2 ml da biste uvukli zrak u štrcaljku.
English: Signs of high fat
Croatian: Znakovi povišene masnoće
English: 12) Insert the needle of the 1 mL syringe containing the 0.6 mL of water for injection all the way into the Myalepta vial containing the powder.
Croatian: 12) Umetnite iglu štrcaljke od 1 ml koja sadrži 0,6 ml vode za injekcije skroz u bočicu koja sadrži prašak lijeka Myalepta.
English: - Large dose reductions of 50% or more of baseline insulin requirements may be needed in the first 2 weeks of Myalepta treatment.
Croatian: U prva 2 tjedna liječenja lijekom Myalepta mogu biti potrebna velika smanjenja doze od 50 % ili više od početnih potreba za inzulinom.
English: 12) Insert the needle of the 3 mL syringe containing the 1.1 mL of water for injection all the way into the Myalepta vial containing the powder.
Croatian: 12) Umetnite iglu štrcaljke od 3 ml koja sadrži 1,1 ml vode za injekcije skroz u bočicu koja sadrži prašak lijeka Myalepta.
English: 12) Insert the needle of the 3 mL syringe containing the 2.2 mL of water for injection all the way into the Myalepta vial containing the powder.
Croatian: 12) Umetnite iglu štrcaljke od 3 ml koja sadrži 2,2 ml vode za injekcije skroz u bočicu koja sadrži prašak lijeka Myalepta.
English: After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Croatian: Nakon rekonstitucije s 0,6 ml vode za injekcije (vidjeti dio 6.6), jedan ml sadrži 5 mg metreleptina.
English: • One 1 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
Croatian: • jedna štrcaljka od 1 ml s iglom od 40 mm promjera 21 G za otapanje praška
English: Attach the needle to the 3 mL syringe.
Croatian: Postavite iglu na štrcaljku od 3 ml.
English: • One 3 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
Croatian: • jedna štrcaljka od 3 ml s iglom od 40 mm promjera 21 G za otapanje praška