FrancophonIA/ELRC3.0 huggingface dataset:
English: Monitoring beyond 6 months is not recommended for patients whose total serum calcium is within the normal limits at 6 months.
Croatian: Nakon šest mjeseci praćenje nije potrebno za one bolesnike koji su u tijekom tog razdoblja imali normalne vrijednosti ukupnog kalcija u serumu.
English: • Inject yourself with Preotact shortly after you have taken your pre-filled pen out of the refrigerator.
Croatian: • Primijenite Preotact neposredno nakon što ste napunjenu brizgalicu izvadili iz hladnjaka.
English: It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3 and 4.4).
Croatian: Tijekom kliničkog programa kontrolirana je praćenjem laboratorijskih vrijednosti i korištenjem prethodno detaljiziranog algoritma postupanja (vidjeti dijelove 4.3 i 4.4).
English: Hypercalciuria
Croatian: Hiperkalciuria
English: Preotact has been studied in patients with pre-existing hypercalciuria.
Croatian: Preotact je ispitan u bolesnika s postojećom hiperkalciurijom.
English: There is no relevant use of Preotact in paediatric patients for the treatment of osteoporosis at high risk of fractures
Croatian: Nema relevantne primjene Preotacta u pedijatrijskoj populaciji za liječenje osteoporoze s visokim rizikom prijeloma.
English: The table below gives an overview of the ADRs where the incidence is at least 0.5% higher in the parathyroid hormone group compared to placebo.
Croatian: Tablica u nastavku daje pregled nuspojava čija je incidencija najmanje 0,5% veća u skupini na paratireoidnom hormonu u odnosu na placebo.
English: Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively.
Croatian: u cijeloj bedrenoj kosti bilo je 0,3%, 1,9% odnosno 3,0% u tri grupe istim redoslijedom.
English: Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka prije uporabe, vidjeti dio 6.6.
English: There are no data available from the use of parathyroid hormone in women of childbearing potential, during pregnancy and breast feeding.
Croatian: Nema dostupnih podataka o primjeni paratireoidnog hormona u žena reproduktivne dobi, tijekom trudnoće i dojenja.
English: The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2,642 postmenopausal osteoporotic women of whom 1,341 received parathyroid hormone.
Croatian: Sljedeći podaci o nuspojavama zasnivaju se na dva placebom kontrolirana ispitivanja u kojima su sudjelovale 2642 žene s osteoporozom u postmenopauzi, od kojih je 1341 primala paratireoidni hormon.
English: • nausea.
Croatian: • umor.
English: Significant increases in hip BMD (total, femoral neck, trochanter) were observed at study endpoint; 1.0, 1.8 and 1.0%, respectively, for Preotact versus -1.1,0.7 and -0.6% for placebo (p<0.001).
Croatian: Na kraju ispitivanja opaženo je značajno povećanje BMD u kuku (ukupno, u vratu femura i trohanteru) 1,0; 1,8; i 1% za Preotact u odnosu na1,1; -0,7; i -0,6% za placebo (p<0,001).
English: Blood alkaline phosphatase increased Anorexia
Croatian: Povećanje serumske alkalne fosfataze Anoreksija
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje česte (mogu zahvatiti do jednog od ukupno 100 ljudi):
English: Preotact is available in a pack with 2 pre-filled pens.
Croatian: Preotact je dostupan u pakovanju sa dvije napunjene brizgalice.
English: Preotact is available in packs of 2 pre-filled pens.
Croatian: Preotact je dostupan u pakovanju od 2 brizgalice.
English: Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide (for pH adjustment)
Croatian: natrijev hidroksid (za prilagodbu pH)
English: The content of the cartridge is reconstituted in the pen.
Croatian: Sadržaj komore se rekonstituira unutar brizgalice.
English: • Screw the pre-filled pen together until the clear front part and the pen body meet.
Croatian: • Zavijanjem sklopite napunjenu brizgalicu dok se prozirni prednji dio i tijelo brizgalice ne dodirnu.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim i umjerenim oštećenjem bubrega (klirens kreatinina 30-80 ml/min).
English: • Do not store the pre-filled pen with the needle on.
Croatian: • Ne čuvajte napunjenu brizgalicu s postavljenom iglom.
English: 2 pre-filled pens per pack.
Croatian: 2 napunjene brizgalice u pakovanju
English: Treatment of suspected overdose should include temporary discontinuation of Preotact, monitoring of serum calcium, and implementation of appropriate, supportive measures, such as hydration.
Croatian: Kod sumnje na predoziranje potrebno je privremeno prekinuti primjenu Preotacta, nadzirati razinu kalcija u serumu i primijeniti neophodne dodatne mjere, kao što je nadoknadu volumena.
English: • smell disturbance, taste disturbance.
Croatian: • poremećaji osjeta mirisa i okusa.
English: • Screw the needle off.
Croatian: • Odvijte iglu.
English: Point the needle straight up and press the blue injection button until it is fully depressed.
Croatian: Držite iglu uspravno i pritisnite do kraja plavo dugme za injektiranje.
English: • increased level of calcium in the blood,
Croatian: • povećanje razine kalcija u krvi,
English: Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments.
Croatian: Paratireoidni hormon se uspješno eliminira iz krvi preko receptorima posredovnog procesa u jetri i kidanjem u manje proteinske dijelove.
English: The combination was effective regardless of age, baseline rate of bone turnover, or baseline BMD.
Croatian: Kombinacija se pokazala djelotvorna bez obzira na dob, stopu pregradnje kostiju ili početnu vrijednost mineralne gustoće kostiju.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ukoliko imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili ljekarniku.
English: This will release most of the air in the pre-filled pen and is called ‘priming'.
Croatian: Time ćete osloboditi većinu zraka iz napunjene brizgalice.
English: • increased level of calcium in the urine,
Croatian: • povećanje razine kalcija u urinu,
English: Keep the product protected from light.
Croatian: Čuvati zaštićeno od svjetlosti.
English: • Never store your pre-filled pen with the needle attached.
Croatian: • Nikad ne čuvajte napunjenu brizgalicu s nataknutom iglom.
English: • sodium hydroxide.
Croatian: • natrijev hidroksid.
English: Patients initiated on Preotact therapy should be monitored at months 1, 3 and 6 for elevated levels of serum and/or urinary calcium.
Croatian: Preotactom potrebno je nadzirati u prvom, trećem i šestom mjesecu liječenja, zbog povećanja kalcija u serumu i/ili mokraći.
English: In the Preotact clinical program, accidental overdose has been reported.
Croatian: U kliničkom ispitivanju Preotacta zabilježeno je nenamjerno predoziranje.
English: The dose counter
Croatian: Brojač doza
English: - If you have any further questions, ask your doctor or your pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku
English: Press the yellow release button to release the blue injection button.
Croatian: Pritisnite žuto dugme kako bi se oslobodilo plavo dugme za injektiranje.
English: Common (may affect up to 1 in 10 people):
Croatian: Česte (mogu se javiti kod do 1 od 10 korisnika):
English: Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP.
Croatian: Preotact se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na napunjenoj brizgalici kao EXP i pakovanju kao Rok valjanosti.
English: • if you suffer from severe kidney problems;
Croatian: • ako patite od ozbiljnih bubrežnih problema;
English: Caution should be exercised in patients receiving cardiac glucosides due to the risk of digitalis toxicity if hypercalcemia develops (see section 4.5).
Croatian: Bolesnika koji uzimaju srčane glikozide Potreban je oprez u bolesnika koji uzimaju srčane glikozide zbog rizika od toksičnosti digitalisa ako se razvije hiperkalciemija (vidi dio 4.5)
English: • You can store the unmixed pre-filled pen at temperatures between 2-25°C.
Croatian: • Napunjenu brizgalicu u kojoj lijek nije izmiješan možete čuvati na temperaturi između 2 i 25oC.
English: During the 28-day period the reconstituted solution can be stored for up to 7 days at temperatures below 25°C.
Croatian: Tijekom tog 28-dnevnog razdoblja, rekonstituirana otopina se do 7 dana može čuvati na temperaturi do 25oC.
English: • Take the daily injection • Store the pre-filled pen
Croatian: • Primijenite jednu injekciju na dan • Spremite napunjenu brizgalicu
English: • Press the yellow release button to release the blue injection button.
Croatian: • Pritisnite žuto dugme kako biste oslobodili plavo dugme za injektiranje.
English: The needle pre-filled pen is full number of index outer needle cover needle inner needle cover
Croatian: igla vanjski poklopac igle unutrašnji poklopac igle
English: • if you suffer from high calcium levels in your blood or other disturbances in the calcium
Croatian: • ako imate visoku razinu kalcija u krvi ili patite od drugih poremećaja metabolizma kalcija i fosfora;
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled pen
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE Napunjena brizgalica
English: Do not shake the pre-filled pen
Croatian: Ne tresite napunjenu brizgalicu.
English: • who are receiving or who has previously received radiation therapy to the skeleton
Croatian: • koji primaju ili koji su prethodno primali terapiju zračenjem koštanog sustava • sa zloćudnim bolestima koštanog sustava ili metastazama kostiju
English: Pre-filled pen(after reconstitution): Store in a refrigerator (2-8°C).
Croatian: Napunjena brizgalica (nakon pripreme za primjenu): Čuvati u hladnjaku (2-8oC).
English: Hypercalcemia
Croatian: Hiperkalciemija
English: Pull the cap straight off from the front end of the pre-filled pen.
Croatian: Povlačenjem uklonite poklopac s prednjeg dijela napunjene brizgalice.
English: Patients in the Preotact treatment group had a 61% relative risk reduction of a new vertebral fracture at month 18 compared to the patients in the placebo group.
Croatian: U bolesnica liječenih Preotactom relativni rizik novih prijeloma kralježaka u 18 mjesecu terapije bio je smanjen za 61% u odnosu na skupinu koja je primala placebo.
English: Marketing Authorisation Holder NPS Pharma Holdings Limited Grand Canal House 1 Grand Canal Street Upper Dublin 4
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet NPS Pharma Holdings Limited Grand Canal House
English: A total of 238 postmenopausal women, were randomly assigned to one of the following treatment groups; Preotact (100 micrograms parathyroid hormone), alendronate (10 mg), or the combination of both, and followed for 12 months.
Croatian: Preotact (100 mikrograma paratireoidnog hormona), alendronat (10 mg), ili kombinacija oba lijeka, te praćeno tijekom 12 mjeseci.
English: For all subjects who received parathyroid hormone 100 micrograms blood uric acid increase was reported for 8 subjects (0.6%) and hyperuricemia was reported for 5 subjects (0.4%).
Croatian: Od svih ispitanica koje su primale 100 mikrograma paratireoidnog hormona, povećanje urične kiseline zabilježeno je kod 8 ispitanica (0,6%),
English: Preotact is used to treat osteoporosis in women past menopause with high risk of fractures.
Croatian: Preotact se koristi za liječenje osteoporoze kod žena u postmenopauzi koje imaju visoki rizik prijeloma kosti.
English: The pivotal study was an 18-month double-blind, placebo-controlled, phase III study (TOP) of the effect of Preotact on fracture incidence in women with postmenopausal osteoporosis.
Croatian: Pivotalno ispitivanje bilo je 18-mjesečno dvostruko slijepo, placebom kontrolirano ispitivanje faze III (TOP) o utjecaju
English: • Add a needle
Croatian: • Dodajte iglu
English: Hold on to the clear front end of the pre-filled pen and screw the needle all the way onto the clear front end of the pre-filled pen.
Croatian: Držeći napunjenu brizgalicu za prozirni prednji dio, zakretanjem navijte iglu sve do prozirnog prednjeg dijela napunjene brizgalice.
English: Reconstituted solution: Store in a refrigerator (2-8°C).
Croatian: Rekonstituirana otopina: Čuvati u hladnjaku (2-8oC).
English: Crimp cap (containing a rubber seal): Aluminium .The rubber seal is made of bromobutyl rubber.
Croatian: Navojni zatvarač (sadrži gumeni čep): Aluminij.
English: After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone.
Croatian: Nakon rekonstitucije, svaka doza od 71,4 mikrolitara sadrži 100 mikrograma paratireoidnog hormona.
English: • Calcium and vitamin D supplementation should be withdrawn
Croatian: • Nadomjeske kalcija i vitamina
English: Rats treated with near life-time daily injections had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to an epigenetic mechanism.
Croatian: Štakorima koji su gotovo tijekom cijelog životnog vijeka primali dnevnu injekciju, vjerojatno zbog epigenetskog mehanizma, razvijali su o dozi ovisne koštane formacije i imali povećanu incidenciju koštanih tumora, uključujući osteosarkom.
English: Preotact should therefore not be used in patients with severe hepatic impairment (see section 4.3).
Croatian: Preotact se stoga ne smije koristiti u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: Powder and solvent for solution for injection.
Croatian: Prašak i otapalo za injekcijsku otopinu.
English: Your doctor may advise you to take supplementary calcium and vitamin D. Your doctor will tell you how much you should take each day.
Croatian: Liječnik će Vam reći koliku dozu morate uzimati svaki dan.
English: The container closure system is comprised of a dual-chamber cartridge, a center stopper, a crimp cap (containing a rubber seal) sealing the first chamber containing lyophilised powder and an end stopper sealing the second chamber containing the solvent for mixing.
Croatian: (sadrži gumeni čep) koji brtvi prvu komoru s liofiliziranim praškom i zadnjeg čepa koji brtvi drugu komoru s otapalom za miješanje.
English: • sodium chloride,
Croatian: • natrijev klorid,
English: • reddening of the skin (erythema) at injection site,
Croatian: • crvenilo kože (eritem) na mjestu uboda,
English: Preotact is supplied in a pre-filled pen containing a cartridge.
Croatian: Preotact dolazi u obliku napunjene brizgalice koja sadrži uložak.
English: • irritation of the skin at the injection site,
Croatian: • iritacija kože na mjestu uboda, • gubitak teka,
English: Preotact should therefore not be used in patients with severe renal impairment (see section 4.3).
Croatian: Preotact se stoga ne smije koristiti u bolesnika s teškim oštećenjem bubrega (vidjeti dio 4.3).
English: • decreased muscle strength, muscle cramps, dizziness,
Croatian: • gubitak mišićne snage, mišićni grčevi, omaglica,
English: Caution should be exercised in
Croatian: Potreban je oprez kod
English: Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
Croatian: u cijelom kuku povećao se za 9%, 6%, odnosno, 2%, u te 3 grupe.
English: Serum calcium concentrations reach a maximum between 6 and 8 hours post dose and normally return to baseline by 20 to 24 hours after each administration of parathyroid hormone.
Croatian: Koncenracija serumskog kalcija dostiže maksimum između 6 i 8 sati nakon primjene i u pravilu se vraća na početnu vrijednost
English: The volume of distribution at steady-state following intravenous administration is approximately 5.4 l. Interindividual variability in the volume of distribution of parathyroid hormone is about 40%.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže nakon intravenske primjene paratireoidnog hormona je otprilike 5,4 l.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection.
Croatian: OBLIK Prašak i otapalo za otopinu za injekciju.
English: Only mix one pen at the time.
Croatian: Izmiješajte lijek samo u jednoj brizgalici.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka napunjena brizgalica sadrži 1,61 mg paratireoidnog hormona što odgovara 14 doza.
English: Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time.
Croatian: Nakon pripreme uloška za primjenu, smije se čuvati na temperaturi do 25oC do 7 dana tijekom razdoblja uporabe od 28 dana.
English: Although gout, arthralgia and nephrolithiasis were reported as ADRs, the relationship to elevations in uric acid due to Preotact administration has not been fully established.
Croatian: Premda su giht, artralgija i nefrolitijaza prijavljeni kao nuspojave,
English: No studies have been conducted in patients with severe hepatic impairment.
Croatian: Ispitivanja na bolesnicima s teškim oštećenjem jetre nisu provedena.
English: Dysgeusia
Croatian: Disgeuzija Parozmija
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Croatian: dopunjeni RMP mora se podnijeti istovremeno uz sljedeće Periodičko izvješće o neškodljivosti lijeka
English: Posology The recommended dose is 100 micrograms of parathyroid hormone administered once-daily
Croatian: Doziranje Preporučena doza je 100 mikrograma paratireoidnog hormona primijenjenog jednom dnevno.
English: After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone produced in Escherichia coli by recombinant DNA technology For a full list of excipients, see section 6.1.
Croatian: Nakon rekonstitucije, svaka doza od 71,4 mikrolitara sadrži 100 mikrograma paratireoidnog hormona proizvedenog u Escherichia coli rekombinantnom DNA tehnologijom.
English: Elevated serum calcium was observed during Preotact treatment.
Croatian: Tijekom liječenja Preotactom zabilježeno je povećanje kalcija u serumu.
English: Preotact is injected using a pre-filled pen.
Croatian: Preotact se uštrcava korištenjem napunjene brizgalice.
English: • citric acid monohydrate,
Croatian: • citratnu kiselinu hidrat,
English: • with severe hepatic impairment
Croatian: • s teškim oštećenjem bubrega • s teškim oštećenjem jetre
English: The first chamber contains 1.61 mg parathyroid hormone as powder and the second chamber contains 1.13 ml of solvent.
Croatian: Prva komora sadrži 1,61 mg paratireoidnog hormona u obliku praška, a druga 1,13 ml otapala.
English: Each cartridge inside the prefilled pen contains 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses).
Croatian: Svaki uložak unutar napunjene brizgalice sadrži 1,61 mg paratireoidnog hormona i 1,13 ml otapala (14 doza).
English: There is no data available in patients with severe hepatic impairment.
Croatian: Za bolesnike s teškim oštećenjem jetre nema dostupnih podataka.
English: • back pain,
Croatian: • bol u leđima,
English: Langebjerg 1, 4000 Roskilde
Croatian: Nycomed Danmark ApS Langebjerg 1, 4000 Roskilde Denmark
English: Parosmia
Croatian: PRIMJENU
English: • hydrochloric acid,
Croatian: • kloridnu kiselinu,
English: Effect on bone mineral density (BMD)
Croatian: Slično, volumetrijski trabekularni BMD
English: • increased level of alkaline phosphatase in the blood ,
Croatian: • povećanje razine urične kiseline u krvi, • povećanje razine alkalne fosfataze u krvi,
English: • have a high level of calcium in your urine;
Croatian: • imate visoku razinu kalcija u mokraći;
English: Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen Parathyroid hormone
Croatian: Preotact 100 mikrograma prašak i otapalo za otopinu za injekciju u napunjenim brizgalicama Paratireoidni hormon
English: Preotact is a powder and solvent for solution for injection in a pre-filled pen.
Croatian: Preotact je prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici.
English: THE PRE-FILLED PEN
Croatian: NAPUNJENA BRIZGALICA
English: Ask your doctor or pharmacist for advice before taking any medicine Do not use Preotact if you are pregnant or breast-feeding.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije uzimanja bilo kojeg lijeka.
English: The medicinal product is supplied in a pre-filled pen containing a dual-chamber cartridge.
Croatian: Lijek dolazi u obliku napunjene brizgalice s uloškom sa dvije komore.
English: • constipation, diarrhoea,
Croatian: • zatvor, proljev,
English: Injection site irritation
Croatian: Iritacija na mjestu injekcije
English: Volumetric trabecular BMD at the lumbar spine increased by 38% over baseline at 18 months.
Croatian: Volumetrijski trabekularni BMD u lumbalnoj kralježnici povećao se tijekom
English: Each pre-filled pen contains 1.61 mg of parathyroid hormone as powder and 1.13 ml of solvent.
Croatian: Svaka napunjena brizgalica sadrži 1,61 mg paratireoidnog hormona u obliku praška i 1,13 ml otapala.
English: Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses.
Croatian: Svaka napunjena brizgalica sadrži 1,61 mg paratiroidnog hormona što odgovara ukupno 14 doza.
English: • You can store the mixed pre-filled pen for up to 7 days outside the refrigerator (below 25°C)
Croatian: • Brizgalica se može čuvati najviše 7 dana izvan hladnjaka (na temperaturi do 25oC) tijekom razdoblja upotrebe od 28 dana
English: There is no data available in patients with severe renal impairment.
Croatian: Za bolesnike s teškim oštećenjem bubrega nema dostupnih podataka.
English: One year of therapy, showed the following results: the increases in lumbar spine BMD above baseline were similar in the Preotact and combination-therapy groups (6.3 and 6.1%, respectively), but were somewhat smaller in the alendronate group (4.6%).
Croatian: Jednogodišnje liječenje pokazalo je sljedeće rezultate: povećanje BMD iznad početnih vrijednosti u lumbalnoj kralježnici bilo je slično u grupi na Preotactu i grupi koja je primala kombiniranu terapiju
English: • with metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism
Croatian: • s već postojećom hiperkaciemijom ili drugim poremećajima u metabolizmu kalcija i fosfora • s metaboličkim bolestima kostiju različitim od primarne osteoporoze (uključujući hiperparatireoidizam i Pagetovu bolest kostiju) • s neobjašnjivim porastom koštano-specifične alkalne fosfataze
English: There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function.
Croatian: U ispitivanju provedenom na 6 muškaraca i 6 žena sa blagim poremećajima funkcije jetre i usporedbom s grupom od 12 ispitanika s normalnom funkcijom jetre, primijećeno je malo povećanje od 20% u osnovnim vrijednostima izloženosti (AUC) paratiroidnom hormonu.
English: Management of elevated serum calcium
Croatian: Praćenje povećanja kalcija u serumu
English: Nervous system disorders Common
Croatian: Povećanje urične kiseline u serumu Poremećaji živčanog sustava Često
English: In the pivotal study, Preotact increased BMD in the lumbar spine after 18 months treatment by 6.5% compared with -0.3% for placebo (p<0.001).
Croatian: mjeseci liječenja u usporedbi sa -0,3% za placebo (p<0,001).
English: Injection site erythema
Croatian: Eritem na mjestu injekcije Umor
English: Overdose management
Croatian: Postupanje kod predoziranja
English: Keep the pre-filled pen in the outer carton in order to protect from light.
Croatian: Radi zaštite od svjetlosti, napunjenu brizgalicu čuvati u u kutiji.