FrancophonIA/ELRC3.0 huggingface dataset:
English: Prolonged overdose may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone.
Croatian: Dugotrajno predoziranje može dovesti do pojačanog rasta ušiju, nosa, usana, jezika i jagodičnih kostiju.
English: Not known: Insulin resistance*
Croatian: Nepoznato: inzulinska rezistencija*
English: The recommended weekly dose in children (i.e. 0.5 mg/kg/week) should not be exceeded as there is limited experience with higher doses in this patient group.
Croatian: Ne smiju se prekoračiti preporučene tjedne doze u djece (tj. 0,5 mg/kg/tjedan) jer je iskustvo s višim dozama u ove skupine bolesnika ograničeno.
English: Where childhood-onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
Croatian: Kada se NHR koji je nastao u djetinjstvu nastavlja i u adolescenciji, liječenje se mora nastaviti da bi se postigao potpuni tjelesni razvoj (npr. sastav tijela, koštana masa).
English: Hold the syringe firmly by the finger grip.
Croatian: Prstima čvrsto uhvatite štrcaljku.
English: The somatropin in this medicinal product is a polypeptide hormone of recombinant DNA origin.
Croatian: Somatropin u ovom lijeku je polipeptidni hormon porijeklom iz rekombinantne DNK.
English: Large doses of somatropin may impair glucose tolerance.
Croatian: Velike doze somatropina mogu narušiti toleranciju glukoze.
English: This medicine is used to treat adults with a lack (deficiency) of growth hormone who - already had growth hormone deficiency when they were children or - do not have enough growth hormone during adulthood.
Croatian: Ovaj lijek primjenjuje se za liječenje odraslih s nedostatkom (deficijencijom) hormona rasta koji - već imaju nedostatak hormona rasta od djetinjstva ili - nemaju dovoljno hormona rasta u odrasloj dobi.
English: Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein (HDL)-cholesterols, and decreases total plasma cholesterol.
Croatian: Somatropin potiče metabolizam lipida; povećava masne kiseline u plazmi i kolesterol u lipoproteinima visoke gustoće (HDL) te snižava ukupni kolesterol u plazmi.
English: Common: Hypertension,increased blood pressure
Croatian: Često: hipertenzija, povišen krvni tlak
English: Treatment with growth hormone may facilitate the development of adrenal insufficiency and potentially fatal adrenal crises in patients with organic GHD or idiopathic panhypopituitarism.
Croatian: Liječenje hormonom rasta može pospješiti razvoj insuficijencije nadbubrežne žlijezde i potencijalno smrtonosne adrenalne krize u bolesnika s organskim NHR ili idiopatskim panhipopituitarizmom.
English: In general, Cmax and AUC increased approximately proportionally with dose over a dose range of 0.2 to 0.7 mg/kg in prepubertal children with GHD.
Croatian: Općenito su se Cmax i tmax povećavali približno proporcionalno dozi u rasponu doza od 0,2 do 0,7 mg/kg u predpubertetske djece s NHR.
English: The recommended dose is 0.5 mg of somatropin per kilogram of body weight injected once a week.
Croatian: Preporučena doza je 0,5 mg somatropina po kilogramu tjelesne težine ubrizgana jedanput tjedno.
English: If the flow stops or bubbles appear, gently tap the syringe with your fingers.
Croatian: Ako se prestane puniti ili se pojave mjehurići, nježno kucnite prstima po štrcaljki.
English: In paediatric patients there is no evidence that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in patients with a history of pituitary pathology.
Croatian: U pedijatrijskih bolesnika nema dokaza da nadomjestak hormona rata utječe na stopu povratka ili ponovnog rasta intrakranijalnih novotvorina, ali standarna klinička praksa zahtijeva redovite preglede hipofize metodama oslikavanja u bolesnika koji u anamnezi imaju patologiju hipofize.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavulijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: After 6 months of weekly treatment with Somatropin Biopartners, there was a statistically significant reduction of 1.6 kg in fat mass in the Somatropin Biopartners group compared to the placebo group.
Croatian: Nakon 6 mjeseci liječenja Somatropinom Biopartners svakog tjedna postojalo je statistički značajno smanjenje mase masnog tkiva za 1,6 kg u skupini koja je primala Somatropin Biopartners u usporedbi sa skupinom koja je primala placebo.
English: Thyroxine replacement therapy may therefore need to be initiated or adjusted.
Croatian: Stoga će možda biti potrebno započeti ili prilagoditi nadomjesnu terapiju tiroksinom.
English: Any remaining solvent should not be used for a second preparation.
Croatian: Preostalo otapalo ne smije se upotrijebiti za drugu pripremu.
English: It is therefore crucial to assess baseline and stress doses of glucocorticoids which may need to be adjusted when growth hormone therapy is initiated.
Croatian: Stoga je od ključne važnosti procijeniti početne vrijednosti i stresnu dozu glukokortikoida koju će možda biti potrebno prilagoditi kad započne terapija hormonom rasta.
English: For children heavier than 40 kg, two vials (a 10 mg and a 20 mg vial or two vials of 20 mg) can be used according to the body weight as indicated in the table below.
Croatian: Za djecu tjelesne težine veće od 40 kg, mogu se primijeniti dvije bočice (jedna bočica od 10 mg i jedna od 20 mg ili dvije bočice od 20 mg) sukladno tjelesnoj težini kako je navedeno u tablici niže.
English: Clean the rubber stopper of both vials with an alcohol swab (figure 3b).
Croatian: Očistite gumeni čep na obje bočice vaticom natopljenom alkoholom (slika 3b).
English: Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations.
Croatian: Hormon rasta povećava ekstratiroidno konverzija T4 u T3, što može dovesti do smanjenja koncentracije T4 u serumu i povećanja koncentracije T3 u serumu.
English: It is recommended to monitor thyroid function following an overdose.
Croatian: Preporučuje se pratiti funkciju štitne žlijezde nakon predoziranja.
English: It is unknown whether somatropin or its metabolites are excreted in human breast milk; however, absorption of intact protein from the gastrointestinal tract of the infant is unlikely.
Croatian: Nije poznato izlučuju li se somatropin ili njegovi metaboliti u majčino mlijeko; međutim, nije vjerojatna apsorpcija cijelog proteina iz gastrointestinalnog trakta dojenčeta.
English: Storage conditions of the unopened product
Croatian: Uvjeti čuvanja neotvorenog lijeka
English: Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective.
Croatian: Hormon rasta smanjuje pretvaranje kortizona u kortizol i može otkriti prethodno neotkriveni centralni hipoadrenalizam ili dovesti do neučinkovitosti nadomjesne terapije niskim dozama glukokortikoidima.
English: Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin.
Croatian: Nastanak u odrasloj dobi: Bolesnici s NHR u odrasloj dobi definirani su kao bolesnici s poznatom hipotalamičko-pituitarnom patologijom i najmanje jednim dodatnim nedostatkom hormona hipofize osim prolaktina.
English: IGF-I SDS lower than -1
Croatian: IGF-I SDS niži od -1
English: The recommended starting dose is 2 mg of somatropin injected once a week.
Croatian: Preporučena početna doza je 2 mg somatropina ubrizgana jedanput tjedno.
English: The results showed weekly administered Somatropin Biopartners to be non inferior to daily administered recombinant hGH with respect to the primary endpoint of height velocity after 12 months.
Croatian: Rezultati su pokazali da tjedno primjenjivan Somatropin Biopartners nije bio inferioran svakodnevno primjenjivanom rekombinantnom hGH s obzirom na primarni ishod brzine povećanja visine nakon 12 mjeseci.
English: -0.5 mg (all patients) IGF-I = insulin-like growth factor-I, SDS = standard deviation score.
Croatian: -0,5 mg (svi bolesnici) IGF-I = inzulinu sličan čimbenik rasta-1, SDS = skor standardne devijacije.
English: It is recommended that a maximum injection volume of 1 mL per injection site, corresponding to a dose of 20 mg of somatropin, should not be exceeded.
Croatian: Ne preporučuje se prekoračiti najveći volumen injekcije 1 ml po mjestu injekcije, što odgovara dozi od 20 mg somatropina.
English: Not all pack sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve velične pakiranja.
English: This pivotal phase III study comprised 151 adult patients with GHD of adult- or childhood-onset and lasted 6 months.
Croatian: Ovo glavno ispitivanje faze III uključilo je 151 odraslog bolesnika s NHR nastalim u odrasloj dobi ili djetinjstvu i trajalo je 6 mjeseci.
English: Progression of scoliosis can occur in patients who experience rapid growth.
Croatian: Pogoršanje skolioze može nastati u bolesnika u kojih dolazi do ubrzanog rasta.
English: Warm the solvent vial to room temperature by gently rolling it between your hands.
Croatian: Zagrijte bočicu s otapalom na sobnu temperaturu tako što ćete je nježno trljati između dlanova.
English: In a randomized, parallel-group, multicentre Phase III study, 178 children between 3 and 12 years of age with organic and/or idiopathic GHD were randomised to receive either weekly administered Somatropin Biopartners (0.5 mg/kg/week) or daily administered recombinant hGH (0.03 mg/kg/day) for 12 months.
Croatian: U randomiziranom, multicentričnom ispitivanju faze III na usporednim skupinama, 178 djece u dobi između 3 i 12 godina s organskim i/ili idiopatskim NHR bilo je randomizirano u skupinu koja je primala tjedno primjenjivan Somatropin Biopartners (0,5 mg/kg/tjedan) ili svakodnevno primjenjivan rekombinantni hGH (0,03 mg/kg/dan) tijekom 12 mjeseci.
English: The maximum injection volume per injection site should not exceed 1 mL.
Croatian: Najveći volumen injekcije po mjestu injekcije ne smije biti veći od 1 ml.
English: This medicine is used to treat failure to grow normally (growth deficiency) in children and adolescents aged 2 to 18 years with insufficient secretion of growth hormone.
Croatian: Ovaj lijek primjenjuje se za liječenje izostanka normalnog rasta (zastoja u rastu) djece i adolescenata u dobi od 2 do 18 godina s nedostatnim izlučivanjem hormona rasta.
English: With regard to antibodies against host cell proteins, low anti-S. cerevisiae protein antibody titres similar to levels in the normal untreated population were found in some patients treated with this medicinal product.
Croatian: S obzirom na protutijela protiv staničnih proteina domaćina, u nekih bolesnika liječenih ovim lijekom pronađeni su niski titri protutijela na protein S. cerevisiae u sličnim razinama kao kod normalne neliječene populacije.
English: Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like growth factor-I (IGF-I) concentrations (< -2 standard deviation score (SDS)), who may be considered for one test.
Croatian: Nastanak u djetinjstvu: U bolesnika u kojih je izolirani NHR nastao u djetinjstvu (nema dokaza hipotalamičko-pituitarne bolesti niti zračenja glave) moraju se napraviti dva dinamička testa nakon završetka rasta, osim kod onih s niskim koncentracijama inzulinu sličnog čimbenika rasta-1 (IGF-I) (skor < -2 standardne devijacije (SDS)), kod kojih se može razmotriti jedan test.
English: For monitoring, the attainment of a normal peak bone mass defined as a T score > - 1 (i.e. standardised to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account gender and ethnicity) is one of the therapeutic objectives during the transition period.
Croatian: Kod praćenja, postizanje normalne vršne koštane mase definirane kao T rezultat >-1 (tj., standardiziran prema prosječnoj vršnoj koštanoj masi u odraslih mjerenoj dvostrukom apsorpciometrijom X-zraka uzimajući u obzir spol i etnicitet) jedan je od terapijskih ciljeva tijekom prijelaznog razdoblja.
English: Blood and the lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava
English: What Somatropin Biopartners is and what it is used for
Croatian: Što je Somatropin Biopartners i za što se koristi
English: The appropriate volume should be withdrawn in a sterile syringe via a sterile 26-gauge needle: The vial should be turned upside down, with the syringe in, and the tip of the needle should be placed in the suspension which is then slowly withdrawn.
Croatian: U sterilnu štrcaljku potrebno je izvući odgovarajući volumen kroz sterilnu iglu od 26 Gaugea: bočica s uvedenom štrcaljkom treba biti okrenuta naopako, a vršak igle postavljen u suspenziju koja se potom polako izvlači.
English: In cases of severe or recurrent headache, visual problems, nausea, and/or vomiting, a fundoscopy for papilloedema is recommended.
Croatian: U slučajevima teške ili ponavljajuće glavobolje, tegoba s vidom, mučnine i/ili povraćanja, preporučuje se fundoskopija zbog sumnje na edem papile.
English: From reproductive toxicity studies performed with other somatropin products there is no evidence of an increased risk of adverse reactions to the embryo or foetus.
Croatian: Iz ispitivanja reproduktivne toksičnosti provedenih s drugim somatropinskim lijekovima, nema dokaza povećanog rizika od nuspojava za embrij ili fetus.
English: The biological effects of somatropin are equivalent to those of hGH of pituitary origin.
Croatian: Biološki učinci somatropina jednaki su učincima hGH porijekla iz hipofize.
English: The apparent terminal half-life was about 16.8 h in adults, presumably reflecting slow absorption from the site of injection.
Croatian: Prividni poluvijek iznosio je oko 16,8 sati u odraslih, vjerojatno odražavajući sporu apsorpciju s mjesta injekcije.
English: The powder is white to almost white, the solvent is a clear liquid.
Croatian: Prašak je bijeli do gotovo bijeli, a otapalo je bistra tekućina.
English: The apparent terminal half-life was about 7.4 h in children, presumably reflecting slow absorption from the site of injection.
Croatian: Prividni poluvijek iznosio je oko 7,4 sati u djece, vjerojatno odražavajući sporu apsorpciju s mjesta injekcije.
English: Somatropin has no or negligible influence on the ability to drive and use machines.
Croatian: Somatropin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Any suspension remaining after the injection should
Croatian: Sva preostala suspenzija nakon injekcije mora se baciti.
English: Additionally, it promotes cellular protein synthesis and nitrogen retention.
Croatian: Uz to, potiče staničnu sintezu proteina i zadržavanje dušika.
English: Animal studies are insufficient with respect to reproductive toxicity (see section
Croatian: Ispitivanja na životinjama su nedostatna za konačan zaključak u pogledu reproduktivne toksičnosti (vidjeti dio 5.3).
English: Rare, may affect up to 1 in 100 people - abnormal sensation such as prickling, tingling and itchiness - high blood pressure
Croatian: Rijetko, mogu se javiti u do 1 na 100 osoba - nenormalni osjet poput bockanja, trnaca i svrbeža - visoki krvni tlak
English: Somatropin Biopartners has no or negligible effects on the ability to drive and use machines.
Croatian: Somatropin Biopartners ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Croatian: Bolesnici sa šećernom bolešću, intolerancijom glukoze ili dodatnim čimbenicima rizika za šećernu bolest moraju se pažljivo nadzirati tijekom terapije somatropinom.
English: Your doctor will stop your treatment with this medicine if there is evidence of cancerous growth; - if you are a child that has already stopped growing; - if you are ill due to a serious heart or stomach operation; - if you are being treated for more than one injury following a serious accident; - if you experience sudden serious breathing problems.
Croatian: Vaš liječnik će zaustaviti liječenje ovim lijekom ako postoji dokaz rasta tumora; - ako ste dijete koje je već prestalo rasti; - ako ste bolesni zbog ozbiljne operacije na srcu ili želucu; - ako se liječite od više od jedne ozljede nakon ozbiljne nezgode; - ako iznenada razvijete ozbiljne tegobe s disanjem.
English: Patients receiving concomitant glucocorticoid therapy should have their dose carefully adjusted to avoid an inhibitory effect on growth.
Croatian: Bolesnicima koji istovremeno primaju terapiju glukokortikoidima moraju se pažljivo prilagoditi doze kako bi se izbjegao inhibirajući učinak na rast.
English: Somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Croatian: Primjena somatropina može povećati klirens spojeva za koje se zna da ih metaboliziraju izoenzimi citokroma P450.
English: No information in patients with renal or hepatic impairment is available and particular dose recommendations cannot be given.
Croatian: Nema dostupnih informacija o bolesnicima s oštećenjem funkcije bubrega ili jetre te se ne mogu dati preporuke za konkretne doze.
English: After accidental intramuscular injection, hypoglycaemia may occur.
Croatian: Nakon slučajne intramuskularne injekcije može se razviti hipoglikemija.
English: In patients with hypopituitarism receiving thyroxin replacement therapy, hyperpituitarism may develop.
Croatian: U bolesnika s hipopituitarizmom koji primaju nadomjesnu terapiju tiroksinom može se razviti hiperpituitarizam.
English: Common: injection site pain (9.9%), injection site discolouration (8.8%), injection site erythema (7.7%), injection site nodule (4.4%), injection site reaction (1.1%), injection site warmth (1.1%), pyrexia (2.6%), oedema (local and generalised)*
Croatian: Često: bol na mjestu injekcije (9,9%), promjena boje na mjestu injekcije (8,8%), eritem na mjestu injekcije (7,7%), čvorić na mjestu injekcije (4,4%), reakcija na mjestu injekcije (1,1%), toplina na mjestu injekcije (1,1%), pireksija (2,6%), edem (lokalizirani i generalizirani)*
English: Common: Paraesthesia, hypoaesthesia, carpal tunnel syndrome, dizziness, somnolence Rare: Benign intracranial hypertension*
Croatian: Često: parestezija, hipoestezija, sindrom karpalnog kanala, omaglica, pospanost Rijetko: benigna intrakranijalna hipertenzija*
English: Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with GHD.
Croatian: Dijagnozu i terapiju ovim lijekom moraju započeti i nadzirati liječnici s odgovarajućim iskustvom u dijagnozi i liječenju bolesnika s NHR.
English: Few patients discontinued treatment due to injections site reactions.
Croatian: Malo je bolesnika prekinulo liječenje zbog reakcija na mjestu injekcije.
English: Female (on oral oestrogen)
Croatian: žene (na peroralnom estrogenu)
English: Excessive glucocorticoid therapy can inhibit the actions of hGH.
Croatian: Prekomjerna terapija glukokortikoidima može inhibirati djelovanje hGH.
English: There have been reports of sleep apnoea and sudden death after initiating growth hormone therapy in patients with Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Croatian: Zabilježeni su slučajevi apneje u snu i iznenadne smrti nakon početka terapije hormonom rasta u bolesnika s Prader-Willijevim sindromom, koji su imali jedan ili više od sljedećih čimbenika rizika: izrazitu pretilost, anamnezu opstrukcije gornjih dišnih puteva ili apneju u snu ili neidentificiranu respiratornu infekciju.
English: If you use more Somatropin Biopartners than you should
Croatian: Ako primijenite više Somatropina Biopartners nego što ste trebali
English: What Somatropin Biopartners looks like and contents of the pack
Croatian: Kako Somatropin Biopartners izgleda i sadržaj pakiranja
English: The binding activity of these antibodies has been low and no clinical consequences have been associated with their formation.
Croatian: Ova protutijela imaju malu sposobnost vezanja i njihovo stvaranje nije povezano ni s kakvim kliničkim posljedicama.
English: IGF-I SDS greater than +2
Croatian: IGF-I SDS veći od +2
English: Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis.
Croatian: Budući da somatropin povećava brzinu rasta, bolesnike sa skoliozom u anamnezi koji se liječe somatropinom treba nadzirati zbog progresije skolioze.
English: Common: Increased blood phosphorus, increased or decreased IGF Description of selected adverse reactions
Croatian: Često: povišen fosfor u krvi, povišen ili snižen IGF Opis odabranih nuspojava
English: * Each vial contains an overfill of somatropin powder to allow the withdrawal of the required amount of somatropin when reconstituted (see section 6.6).
Croatian: *Jedna bočica sadrži nešto više praška somatropina kako bi se omogućilo izvlačenje potrebne količine somatropina nakon rekonstitucije (vidjeti dio 6.6).
English: Very rare, may affect up to 1 in 1,000 people - sleeplessness - enlargement of the male breast
Croatian: Vrlo rijetko, mogu se javiti u do 1 na 1000 osoba - nesanica - povećanje dojki kod muškaraca
English: Cases of malignant and benign tumour recurrences, de-novo and secondary tumours have been reported in temporal relationship with somatropin therapy.
Croatian: Zabilježeni su slučajevi ponovne pojave zloćudnog ili benignog tumora, novonastalih i sekundarnih tumora vremenski povezanih s terapijom somatropinom.
English: Any child with the onset of a limp during growth hormone therapy should be evaluated.
Croatian: Svako se dijete koje počne šepati tijekom terapije hormonom rasta mora pregledati.
English: Somatropin may induce insulin resistance.
Croatian: Somatropin može izazvati inzulinsku rezistenciju.
English: Hypothyroidism may develop in patients with central subclinical hypothyroidism after initiating therapy with growth hormone.
Croatian: Hipotireoidizam se može razviti u bolesnika s centralnim supkliničkim hipotireoidizmom nakon početka terapije hormonom rasta.
English: The tmax was later and the half-life longer following the administration of Somatropin Biopartners than when immediate release products had been previously administered once daily to the same subjects reflecting the slower and more prolonged release of hGH from the site of injection of Somatropin Biopartners.
Croatian: Nakon primjene Somatropina Biopartners, tmax nastupio je kasnije i poluvijek je bio dulji nego kad su se prethodno primjenjivali lijekovi s neposrednim oslobađanjem jedanput na dan u istih ispitanika, što je bio odraz sporijeg i dugotrajnijeg oslobađanja hGH s mjesta injekcije Somatropina Biopartners.
English: Rare, may affect up to 1 in 1,000 people - symptoms of increased pressure in the skull such as severe and recurrent headache, visual changes, nausea and/or vomiting
Croatian: Rijetko, mogu se javiti u do 1 na 1000 osoba - simptomi povišenog krvnog tlaka u lubanji kao što su jake i ponavljajuće glavobolje, promjene vida, mučnina i/ili povraćanje
English: Because hGH may induce a state of insulin resistance, an adjustment of the insulin dose may be required.
Croatian: Budući da hGH može izazvati inzulinsku rezistenciju, može biti potrebna prilagodba doze inzulina.
English: This medicince is injected once a week.
Croatian: Ovaj se lijek primjenjuje jedanput tjedno putem injekcije.
English: Dose requirements may decline with increasing age.
Croatian: Potrebna doza može biti niža s povećanjem dobi.