FrancophonIA/ELRC3.0 huggingface dataset:
English: In adult patients adverse reactions related to fluid retention, such as peripheral oedema, musculoskeletal stiffness, arthralgia, myalgia and paraesthesia are common.
Croatian: U odraslih bolesnika česte su nuspojave vezane uz zadržavanje tekućine, kao što su periferni edem, mišićno-koštana ukočenost, artralgija, mialgija i parestezija.
English: There have been reports of fatalities associated with the use of growth hormone in paediatric patients with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified respiratory infection.
Croatian: Zabilježeni su smrtni slučajevi povezani s primjenom hormona rasta u pedijatrijskih bolesnika s PWSom u kojih je bio prisutan jedan ili više od sljedećih faktora rizika: teška pretilost (bolesnici s omjerom tjelesne težine/visine koji prelazi 200 %), prijašnja oslabljena respiratorna funkcija ili apneja u snu ili neodređena respiratorna infekcija.
English: In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay attention to signs of relapse of the malignancy.
Croatian: Kod nedostatka hormona rasta nastalog zbog liječenja maligne bolesti, preporučuje se praćenje znakova relapsa maligne bolesti.
English: Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD).
Croatian: Dojenčad, djeca i adolescenti - Poremećaj rasta zbog nedovoljnog lučenja hormona rasta (deficit hormona rasta).
English: • Water retention (which shows as puffy fingers or swollen ankles)
Croatian: • zadržavanje vode (očituje se oticanjem prstiju ili gležnjeva)
English: Patients limping during treatment with somatropin should be examined clinically.
Croatian: Bolesnike koji tijekom liječenja somatropinom šepaju potrebno je klinički pregledati.
English: Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease may be considered by your doctor if discomfort or pain in the hip or knee is experienced whilst being treated with Omnitrope.
Croatian: Vaš liječnik može posumnjati na iskliznuće epifize glave femura i Legg-Calvé-Perthesovu bolest ako osjetite nelagodu ili bol u kuku ili koljenu dok se liječite Omnitropeom.
English: The following is a general description of the reconstitution and administration process.
Croatian: U nastavku je naveden opći opis postupka pripreme i primjene.
English: Use with oral oestrogen therapy
Croatian: Primjena s peroralnom estrogenskom terapijom
English: In the post-marketing experience rare cases of sudden death have been reported in patients affected by Prader-Willi syndrome treated with somatropin, although no causal relationship has been demonstrated.
Croatian: Nakon stavljanja lijeka u promet, prijavljeni su rijetki slučajevi iznenadne smrti u bolesnika s PraderWillijevim sindromom liječenih somatropinom, iako nije dokazana nikakva uzročno-posljedična povezanost.
English: - Gently swirl the reconstituted vial until the content is completely dissolved.
Croatian: - Polagano rotirajte bočicu s rekonstituiranim lijekom dok se sadržaj potpuno ne otopi.
English: If during treatment with somatropin patients show signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted, and a new ENT assessment performed.
Croatian: Ako bolesnici tijekom liječenja somatropinom pokazuju znakove opstrukcije gornjih dišnih puteva (uključujući pojavu ili pojačanje hrkanja), mora se prekinuti liječenje i obaviti novi otorinolaringološki pregled.
English: - Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
Croatian: - Poremećaj rasta (skor standardne devijacije (SSD) trenutne visine < -2,5 i SSD prilagođen visini roditelja < -1) u niske djece/adolescenata koji su rođeni mali za gestacijsku dob, s porođajnom težinom i/ili dužinom manjom od -2 standardne devijacije (SD), koja nisu uspjela nadoknaditi zaostajanje u rastu (SSD brzine rasta u visinu < 0 u protekloj godini) do dobi od 4 godine ili kasnije.
English: In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.
Croatian: U osoba koje su preboljele karcinom u djetinjstvu zabilježen je povećani rizik od druge novotvorine u bolesnika liječenih somatotropinom nakon prve novotvorine.
English: • Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome)
Croatian: • ukočenost u rukama i nogama, bolovi u mišićima • bol ili osjećaj žarenja u šakama ili podlakticama (poznato kao sindrom karpalnog tunela)
English: To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are available.
Croatian: Zasad nema dostupnih podataka o konačnoj visini bolesnika s kroničnom insuficijencijom bubrega koji su liječeni Omnitropeom.
English: This will keep the Omnitrope solution sterile and prevent leaking.
Croatian: Na taj ćete način održati sterilnost otopine lijeka Omnitrope i spriječiti curenje.
English: When growth hormone deficiency continues into adolescence, Omnitrope should be continued until completion of physical development.
Croatian: Ako se nedostatak hormona rasta nastavi i tijekom adolescencije, liječenje Omnitropeom potrebno je nastaviti do završetka fizičkog razvoja.
English: Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for statement on oral oestrogen replacement therapy.
Croatian: Pogledajte i podatke o dijabetesu melitusu i poremećaju štitnjače u dijelu 4.4 te podatke o oralnoj nadomjesnoj terapiji estrogenom u dijelu 4.2.
English: Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth disorders.
Croatian: Postavljanje dijagnoze te započinjanje i praćenje terapije somatropinom trebaju provoditi liječnici odgovarajućih kvalifikacija s iskustvom u dijagnosticiranju i liječenju bolesnika s poremećajima u rastu.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for somatropin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing somatropin is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za somatropin, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) somatropin nepromijenjen, uz predložene izmjene informacija o lijeku.
English: It should be reconstituted with a transfer set as recommended in the information provided with the transfer set.
Croatian: Mora se pripremiti pomoću kompleta za prijenos prema preporukama iz uputa priloženih kompletu za prijenos.
English: - With one hand, pitch a fold of loose skin.
Croatian: - Jednom rukom, primite nabor kože između prstiju.
English: The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.
Croatian: Dozu treba postupno povećavati ili snižavati sukladno potrebama pojedinog bolesnika određenima prema koncentraciji IGF-I.
English: In patients with increased risk for diabetes mellitus (e.g. familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed.
Croatian: U bolesnika s povećanim rizikom od dijabetesa melitusa (npr. zbog dijabetesa u obitelji, pretilosti, jake otpornosti na inzulin, akantoze nigrikans) potrebno je napraviti test oralne podnošljivosti glukoze (OGTT).
English: Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see section 4.4).
Croatian: Hormon rasta smanjuje pretvorbu kortizona u kortizol i može otkriti prethodno neotkriven centralni hipoadrenalizam ili dovesti do neučinkovitosti niskih doza nadomjesne terapije glukokortikoidima (vidjeti dio 4.4).
English: EXP After reconstitution, use within 24 hours.
Croatian: Nakon pripreme, upotrijebiti u roku od 24 sata.
English: Administer the appropriate dose by subcutaneous injection using a sterile pen needle.
Croatian: Primijenite odgovarajuću dozu supkutanom injekcijom pomoću sterilne igle za brizgalicu.
English: In another study with somatropin, no increase in chromosomal abnormalities was found in the lymphocytes of patients who had received long-term somatropin therapy.
Croatian: U drugom ispitivanju somatropina nije opaženo povećanje kromosomskih abnormalnosti u limfocitima bolesnika koji su dugotrajno liječeni somatropinom.
English: In short children/adolescents born SGA, other medical reasons or treatments that could explain growth disturbance should be ruled out before starting treatment.
Croatian: U niske djece/adolescenata rođenih malih za gestacijsku dob potrebno je prije početka liječenja isključiti druge medicinske razloge ili terapije kojima bi se mogli objasniti poremećaji rasta.
English: Remove the pen needle and dispose of it in accordance with local requirements.
Croatian: Odstranite iglu za brizgalicu i odložite je u otpad prema lokalnim propisima.
English: Clinical trials in children with Turner syndrome Table 2
Croatian: Klinička ispitivanja u djece s Turnerovim sindromom Tablica 2
English: ≥ 1/100 to
Croatian: ≥ 1/100 i
English: - Leave the cartridge in the pen, put the cap on the pen, and store it in the refrigerator.
Croatian: - Uložak ostavite u brizgalici, zatvorite brizgalicu zatvaračem i čuvajte je u hladnjaku.
English: In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population.
Croatian: U bolesnika s endokrinim poremećajima, uključujući deficit hormona rasta, češća je pojava epifiziolize u području kuka nego u općoj populaciji.
English: In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean.
Croatian: U oba slučaja, cilj liječenja je postići koncentraciju faktora rasta sličnog inzulinu (IGF-I) unutar 2 SSD
English: - Omnitrope is given as an injection under the skin.
Croatian: - Omnitrope se daje kao injekcija pod kožu.
English: • During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
Croatian: • Ako se tijekom liječenja pojavi infekcija pluća, obavijestite o tome svog liječnika kako bi mogao liječiti infekciju.
English: The absolute bioavailability of somatropin seems to be similar in males and females following subcutaneous administration.
Croatian: Čini se da je apsolutna bioraspoloživost somatropina nakon supkutane primjene slična u muškaraca i žena.
English: The glass cartridge is irreversibly integrated in a transparent container and assembled to a plastic mechanism with a threaded rod at one extremity.
Croatian: Stakleni uložak je trajno ugrađen u prozirni spremnik i sastavljen s plastičnim mehanizmom sa štapićem s navojima na jednom kraju.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po ml, tj. zanemarive količine natrija.
English: † Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
Croatian: † Zabilježeno u djece s deficitom hormona rasta liječene somatropinom, međutim čini se da je incidencija slična onoj u djece bez deficita hormona rasta.
English: • Your doctor will check your blood sugar and insulin levels before the start of treatment and every year during treatment.
Croatian: • Liječnik će Vam prije započinjanja liječenja i svake godine tijekom liječenja provjeravati razine šećera i inzulina u krvi.
English: Adults - Replacement therapy in adults with pronounced growth hormone deficiency.
Croatian: Odrasli - Nadomjesna terapija za odrasle s izraženim deficitom hormona rasta.
English: Take the vial with the powder, push the needle through the rubber closure and inject the solvent slowly into the vial aiming the stream of liquid against the glass wall in order to avoid foam.
Croatian: Uzmite bočicu s praškom, uvedite iglu kroz gumeni čep i polako injicirajte otapalo u bočicu tako da se mlaz tekućine slijeva niz staklenu stjenku, kako bi se spriječilo stvaranje pjene.
English: - Before you make an injection, clean your skin well with an alcohol swab.
Croatian: - Prije injiciranja, dobro očistite kožu tupferom namočenim alkoholom.
English: Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates.
Croatian: Liječenje se mora obustaviti ako je brzina rasta u visinu < 2 cm/godinu i, ako je potrebna potvrda, kada je koštana dob > 14 godina (djevojčice) ili > 16 godina
English: Long-term administration of somatropin to growth hormone deficient patients with osteopenia results in an increase in bone mineral content and density at weight-bearing sites.
Croatian: Dugotrajna primjena somatropina u bolesnika s deficitom hormona rasta praćenog osteopenijom rezultira povećanjem sadržaja minerala i gustoće kostiju na mjestima opterećenja.
English: In 56 patients who were continuously treated and have reached (near) final height, the mean change from height at start of treatment was +1.90 SDS (0.033 mg/kg body weight per day) and +2.19 SDS (0.067 mg/kg body weight per day).
Croatian: U 56 neprekidno liječenih bolesnika koji su dostigli (gotovo) konačnu visinu, srednja promjena u visini od početka liječenja iznosila je +1,90 SSD (0,033 mg/kg tjelesne težine na dan) i +2,19 SSD (0,067 mg/kg tjelesne težine na dan).
English: • If you have diabetes, you should closely monitor your blood sugar level during treatment with somatropin and discuss the results with your doctor to determine whether you need to change the dose of your medicines to treat diabetes.
Croatian: • Ako imate dijabetes, tijekom liječenja somatropinom morate pomno pratiti razinu šećera u krvi i o rezultatima obavijestiti liječnika radi odluke o eventualnoj potrebi za promjenom doze lijekova za liječenje dijabetesa.
English: Clinical trials in children with Turner syndrome
Croatian: Klinička ispitivanja u djece s Turnerovim sindromom
English: Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin.
Croatian: Leukemija Leukemija je zabilježena u malog broja bolesnika s deficijencijom hormona rasta, od kojih su neki bili liječeni somatropinom.
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear.
Croatian: lagano povucite klip unatrag; nježno kuckajte po štrcaljki, s iglom usmjerenom prema gore, sve dok mjehurići ne nestanu.
English: Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calvé-Perthes is more frequent in case of short stature.
Croatian: Iskliznuće epifize glave femura nastaje češće u slučaju endokrinih poremećaja, a Legg-Calvé-Perthesova bolest češća je u slučaju niskog stasa.
English: Formation of antibodies to the injected growth hormone but these do not seem to stop the growth hormone from working.
Croatian: Stvaranje protutijela na injicirani hormon rasta koja, čini se, ne ometaju djelotvornost hormona rasta.
English: In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/kg body weight per day have been used for treatment until final height is reached.
Croatian: Tijekom kliničkih ispitivanja kod niske djece/adolescenata koji su rođeni mali za gestacijsku dob u liječenju su korištene doze od 0,033 i 0,067 mg/kg tjelesne težine na dan do postizanja konačne visine.
English: Your doctor will show you how to inject Omnitrope.
Croatian: Liječnik će Vam pokazati kako injicirati Omnitrope.
English: Serum concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Croatian: Somatropin povećava serumske koncentracije IGF-I (faktora rasta sličnog inzulinu - I) i IGFBP3 (proteina koji veže faktor rasta sličan inzulinu - 3).
English: - Be sure that the tip of the syringe is in the Omnitrope reconstituted solution.
Croatian: Provjerite je li vrh štrcaljke u rekonstituiranoj otopini Omnitropea.
English: Follow the instructions that come with the transfer set.
Croatian: Pridržavajte se uputa koje ste dobili uz komplet za prijenos.
English: EXP After reconstitution, use within 21 days.
Croatian: Nakon pripreme, upotrijebiti u roku od 21 dana.
English: • Numbness/tingling
Croatian: • utrnulost/trnci
English: • If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar level during therapy with somatropin.
Croatian: • Ako ste izloženi riziku za razvoj dijabetesa, liječnik će tijekom terapije somatropinom morati pratiti razinu šećera u krvi.
English: In addition to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores.
Croatian: Pored pojačavanja lipolize, somatropin smanjuje i unos triglicerida u zalihe tjelesne masti.
English: Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
Croatian: Kad deficijencija hormona rasta nastala u djetinjstvu traje do adolescencije, potrebno je nastaviti s liječenjem kako bi se postigao potpuni tjelesni razvoj (npr. sastav tijela, koštana masa).
English: In patients above 60 years, therapy should start with a dose of 0.1 - 0.2 mg per day and should be slowly increased according to individual patient requirements.
Croatian: U bolesnika starijih od 60 godina terapiju treba započeti dozom od 0,1 - 0,2 mg na dan i polako je povisivati sukladno potrebama pojedinog bolesnika.
English: Pack sizes of 1, 5 or 10.
Croatian: Veličine pakovanja: 1, 5 ili 10.
English: Elderly patients may be more sensitive to the action of Omnitrope, and therefore may be more prone to develop adverse reactions.
Croatian: Stariji bolesnici mogu biti osjetljiviji na djeovanje lijeka Omnitrope pa stoga mogu biti skloniji razvoju nuspojava.
English: Tables 1-6 show the adverse reactions ranked under headings of System Organ Class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data) for each of the indicated conditions.
Croatian: Tablice 1-6 prikazuju nuspojave razvrstane prema Klasifikaciji organskih sustava i učestalosti sukladno sljedećoj konvenciji: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i
English: Visceral adipose tissue is particularly responsive to somatropin.
Croatian: Visceralno masno tkivo osobito je osjetljivo na somatropin.
English: Omnitrope is intended for subcutaneous use.
Croatian: Omnitrope je namijenjen za potkožnu primjenu.
English: - Adult onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin.
Croatian: - Nastup u odrasloj dobi: Bolesnici s teškom deficijencijom hormona rasta povezanom s deficijencijom drugih hormona zbog poznate hipotalamičke ili hipofizne patologije i nedostatkom najmanje jednog hormona hipofize koji nije prolaktin.
English: Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected.
Croatian: Prije započinjanja liječenja hormonom rasta treba provjeriti prisutnost apneje u snu priznatim metodama kao što su polisomnografija ili noćna oksimetrija te se u slučaju sumnje na apneju u snu bolesnik mora nadzirati.
English: If during the evaluation of upper airway obstruction, pathological findings are observed, the child should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the respiratory disorder prior to initiating growth hormone treatment.
Croatian: Ako se tijekom provjere postoji li opstrukcija gornjih dišnih puteva pronađu patološki nalazi, dijete treba uputiti specijalistu otorinolaringologije zbog liječenja i rješavanja respiratornog poremećaja prije započinjanja liječenja hormonom rasta.
English: Push up the plunger slowly back to the correct dose.
Croatian: Polagano potisnite klip do točne doze.
English: Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope.
Croatian: Istodobno liječenje glukokortikoidima inhibira učinke lijeka Omnitrope na poticanje rasta.
English: Aim the stream of liquid against the glass wall in order to avoid foam.
Croatian: Usmjerite mlaz tekućine tako da se slijeva niz staklenu stijenku, kako bi se spriječilo stvaranje pjene.
English: • If you walk with a limp or if you start to limp during your growth hormone treatment, you should inform your doctor.
Croatian: • Ako šepate ili tijekom liječenja hormonom rasta počnete šepati, obavijestite o tome svog liječnika.
English: There have been no clinical studies conducted with somatropin containing products in breast-feeding women.
Croatian: Nisu provedena klinička ispitivanja lijekova koji sadrže somatropin u dojilja.
English: • Type 2 diabetes • A decrease in the levels of the hormone Cortisol in your blood
Croatian: • sniženje razine hormona kortizola u krvi
English: In patients who continue growth hormone therapy after childhood GHD, the recommended dose to restart is 0.2 - 0.5 mg per day.
Croatian: U bolesnika koji nastavljaju s terapijom hormonom rasta nakon djetinjstva u kojem je nastala deficijencija hormona rasta, preporučena doza za ponovni početak liječenja iznosi 0,2 - 0,5 mg na dan.
English: The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
Croatian: Način primjene Injekciju treba dati supkutano i mijenjati mjesto injiciranja radi sprječavanja lipoatrofije.
English: Nevertheless, corticosteroid replacement therapy should be optimised before initiation of therapy.
Croatian: Ipak, prije uvođenja terapije potrebna je optimizacija nadomjesne terapije kortikosteroidima.
English: - After reconstitution, Omnitrope is given as an injection under the skin.
Croatian: - Nakon pripreme, Omnitrope se daje kao injekcija pod kožu.
English: If you continue Omnitrope after treatment during childhood you should start with 0.2-0.5 mg per day.
Croatian: Ako nastavite primijenjivati Omnitrope nakon provedenog liječenja tijekom djetinjstva, trebate započeti s dozom od 0,2-0,5 mg na dan.
English: In patients with hypopituitarism on standard replacement therapy, the potential effect of growth hormone treatment on thyroid function must be closely monitored
Croatian: U bolesnika s hipopituitarizmom koji uzimaju standardnu nadomjesnu terapiju, mogući učinak liječenja hormonom rasta na funkciju štitne žlijezde mora se izrazito pažljivo pratiti.
English: In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Croatian: Prilikom drugih ispitivanja opće toksičnosti, lokalne podnošljivosti i reproduktivne toksičnosti somatropina nisu opaženi klinički relevantni učinci.
English: Indication mg/kg body weight dose per day mg/m² body surface area dose per day
Croatian: Indikacija mg/kg tjelesne težine dnevna doza mg/m² tjelesne površine dnevna doza