FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you have Prader-Willi syndrome (a chromosomal disorder).
Croatian: • Ako imate Prader-Willijev sindrom (kromosomski poremećaj).
English: Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins.
Croatian: Somatropin je jak metabolički hormon važan za metabolizam lipida, ugljikohidrata i proteina.
English: EXP After first opening, use within 28 days.
Croatian: Nakon prvog otvaranja, upotrijebiti u roku od 28 dana.
English: If the solution is cloudy or contains particulate matter, it should not be used.
Croatian: Ako je otopina zamućena ili sadrži čestice, ne smije se koristiti.
English: Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
Croatian: Uvođenje terapije somatropinom može rezultirati inhibicijom 11βHSD-1 i smanjenim koncentracijama kortizola u serumu.
English: Oedema peripheral*
Croatian: periferni edem*
English: Other medicines and Omnitrope
Croatian: Drugi lijekovi i Omnitrope
English: Growth hormone will help you grow taller if you are still growing, and will also improve your body composition.
Croatian: Hormon rasta može pospješiti rast ako još rastete, a ujedno poboljšava i oblikovanje sastava tijela.
English: Somatropin stimulates the turnover of skeletal bone.
Croatian: Somatropin stimulira pregradnju kostiju skeleta.
English: Somatropin may reduce insulin sensitivity.
Croatian: Somatropin može smanjiti osjetljivost na inzulin.
English: Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated with somatropin (regarding patients undergoing substitution therapy, see section 4.4).
Croatian: Bolesnici s akutnim kritičnim bolestima i komplikacijama nakon operacije na otvorenom srcu, abdominalne operacije, višestruke traume, akutnim respiratornim zatajenjem ili sličnim bolestima ne smiju se liječiti somatropinom (vezano uz bolesnike koji koriste nadomjesnu terapiju vidjeti dio 4.4).
English: If on repeated measurements IGF-I levels exceed +2 SD compared to references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to consider dose adjustment.
Croatian: Ako na ponovljenim mjerenjima razina IGF-I prelazi vrijednost od +2 SD u usporedbi s referentnim vrijednostima za dob i pubertetski status, radi korekcije doze u obzir se može uzeti omjer vrijednosti IGF-I / IGFBP-3.
English: Somatropin increases insulin but fasting blood glucose is commonly unchanged.
Croatian: Somatropin povećava razinu inzulina, no glukoza u krvi izmjerena natašte najčešće ostaje nepromijenjena.
English: For monitoring, the attainment of a normal peak bone mass defined as a T score > -1 (i.e. standardized to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic objectives during the transition period.
Croatian: U svrhu praćenja, postizanje normalne vršne koštane mase definirane kao T-skor > -1 (tj. standardiziran prema prosječnoj vršnoj koštanoj masi u odraslih mjerenoj dvoenergetskom apsorpciometrijom X-zraka, uzimajući u obzir spol i etničku pripadnost) jedan je od terapijskih ciljeva u prijelaznom razdoblju.
English: As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued treatment in this situation should be weighed against the potential risks involved.
Croatian: Budući da nema dostupnih informacija o sigurnosti nadomjesne terapije hormonom rasta u akutnih kritično bolesnih bolesnika, potrebno je odvagnuti koristi od nastavka liječenja u takvoj situaciji u odnosu na moguće rizike koje to uključuje.
English: - Childhood onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Croatian: - Nastup u djetinjstvu: Bolesnici s deficitom hormona rasta tijekom djetinjstva zbog kongenitalnih, genetskih, stečenih ili idiopatskih uzroka.
English: With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of chromosome aberrations have been negative.
Croatian: Uz somatropine, in vitro i in vivo ispitivanja genotoksičnosti u smislu mutacije gena i indukcije aberacija kromosoma bila su negativna.
English: It is therefore not recommended to initiate treatment near onset of puberty.
Croatian: Stoga se ne preporučuje započinjanje liječenja nedugo prije početka puberteta.
English: If necessary, glucocorticoid replacement should be initiated.
Croatian: Ako je potrebno, treba započeti nadomjesnu terapiju glukokortikoidima.
English: - Pull back on the plunger slowly and withdraw just a bit more than the dose prescribed by your doctor into the syringe.
Croatian: - Polagano povucite klip i u štrcaljku uvucite malo više sadržaja od doze koju Vam je propisao liječnik.
English: Fatty tissue of the skin can shrink at the site of injection.
Croatian: Masno tkivo ispod kože može se smanjiti na mjestu injekcije.
English: All other patients will require IGF-I assay and one growth hormone stimulation test.
Croatian: Kod svih drugih bolesnika potrebno je odrediti IGF-I i provesti jedan test stimulacije hormona rasta.
English: Insulin sensitivity
Croatian: Osjetljivost na inzulin
English: During this period, conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism and nutritional status) should have been established and should be maintained during treatment.
Croatian: Za to vrijeme potrebno je primjenjivati konzervativno liječenje insuficijencije bubrega (koje obuhvaća kontrolu acidoze, hiperparatiroidizma i prehrane) te se mora nastaviti i tijekom liječenja.
English: Persons above 60 years should start with a dose of 0.1-0.2 mg per day which should be slowly increased according to individual requirements.
Croatian: Osobe starije od 60 godina trebaju započeti dozom od 0,1-0,2 mg na dan, koju treba polako povećavati sukladno potrebama pojedine osobe.
English: A small percentage of patients may develop antibodies to Omnitrope.
Croatian: Mali postotak bolesnika može razviti protutijela na Omnitrope.
English: Other possible side effects related to your treatment with growth hormone may include the following: You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone.
Croatian: Druge moguće nuspojave povezane s liječenjem hormonom rasta mogu obuhvaćati sljedeće: (u Vas ili Vašeg djeteta) može doći do povišene razine šećera u krvi ili snižene razine hormona štitne žlijezde.
English: This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated.
Croatian: To znači da postoji opasnost od premalog doziranja žena, posebice žena koje primaju oralnu nadomjesnu terapiju estrogenom, te prevelikog doziranja muškaraca.
English: Muscle strength and physical exercise capacity are improved after long-term treatment with somatropin.
Croatian: Snaga mišića i sposobnost za fizičku vježbu poboljšavaju se nakon dugotrajnog liječenja somatropinom.
English: At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.
Croatian: Trenutno nema dovoljno dokaza da bi se mogli dati konkretni savjeti o nastavku liječenja hormonom rasta u bolesnika nakon izlječenja intrakranijalne hipertenzije.
English: The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy subjects and growth hormone deficient patients.
Croatian: Bioraspoloživost supkutano primijenjenog somatropina iznosi približno 80 % i u zdravih ispitanika i u bolesnika s deficitom hormona rasta.
English: * produced in Escherichia coli by recombinant DNA technology.
Croatian: * proizveden tehnologijom rekombinantne DNK u bakteriji Escherichia coli.
English: Both are rapidly increased after treatment with somatropin.
Croatian: Oba volumena se naglo povećavaju nakon liječenja somatropinom.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološke djelane tvari
English: However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Croatian: Međutim, utvrđena je stabilnost u primjeni do 24 sata pri 2 °C - 8 °C u originalnom pakovanju.
English: Talk to your doctor before using Omnitrope.
Croatian: Obratite se svom liječniku prije nego primijenite Omnitrope.
English: A dose correction can be needed after six months of treatment (see section 4.4).
Croatian: Nakon šest mjeseci liječenja može biti potrebna korekcija doze (vidjeti dio 4.4).
English: This presentation is intended for multiple use.
Croatian: Ovaj proizvod je namijenjen za višekratnu upotrebu.
English: Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth.
Croatian: Bolesnicima s nedostatkom ACTH-a treba pažljivo prilagoditi nadomjesnu terapiju glukokortikoidima kako bi se izbjegao inhibitorni učinak na rast.
English: The mean terminal half-life of somatropin after intravenous administration in growth hormone deficient adults is about 0.4 hours.
Croatian: Srednji terminalni poluvijek somatropina nakon intravenske primjene u odraslih osoba s deficitom hormona rasta iznosi oko 0,4 sata.
English: $ Transient injection site reactions in children have been reported.
Croatian: $ Zabilježene su prolazne reakcije na mjestu injekcije u djece.
English: - Insert the needle into the skin in the way your doctor has taught you.
Croatian: - Uvedite iglu u kožu kako Vam je pokazao liječnik.
English: What you need to know before you use Omnitrope
Croatian: Što morate znati prije nego počnete primjenjivati Omnitrope
English: In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
Croatian: U slučaju kronične renalne insuficijencije, bubrežna funkcija prije uvođenja terapije mora biti manja od 50 posto normalne.
English: If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment.
Croatian: Ako se potvrdi ozbiljan nedostatak hormona rasta, liječnik će Vam predložiti nastavak liječenja Omnitropeom.
English: If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be increased to maintain the serum IGF-1 levels within the normal age-appropriate range.
Croatian: Ako žena koja uzima somatropinom započne peroralnu estrogensku terapiju, možda će biti potrebno povećati dozu lijeka somatropinom kako bi se razine IGF-1 u serumu održale unutar normalnog raspona za dob.
English: Symptoms: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Croatian: Simptomi: Akutno predoziranje može isprva uzrokovati hipoglikemiju, a zatim hiperglikemiju.
English: Follow the Instructions for Use of the pen injector.
Croatian: Slijedite upute za upotrebu brizgalice.
English: • During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.
Croatian: • Tijekom liječenja, liječnik će provjeriti postoje li znakovi skolioze, a to je vrsta deformacije kralježnice.
English: Higher doses can be used.
Croatian: Mogu se koristiti i veće doze.
English: If you inject much more than you should, contact your doctor or pharmacist as soon as possible.
Croatian: Ako injicirate više no što ste trebali, što prije zatražite savjet liječnika ili ljekarnika.
English: Myalgia*
Croatian: mialgija*
English: If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Croatian: Ako se ponovno započne liječenje hormonom rasta, nužno je pomno praćenje radi otkrivanja simptoma intrakranijalne hipertenzije.
English: Other possible side effects related to your treatment with growth hormone may include the following:
Croatian: Druge moguće nuspojave povezane s liječenjem hormonom rasta mogu obuhvaćati sljedeće:
English: What Omnitrope contains
Croatian: Što Omnitrope sadrži
English: Omnitrope is a clear and colourless solution for injection.
Croatian: Omnitrope je bistra i bezbojna otopina za injekciju.
English: • Treatment should be continued until you have stopped growing.
Croatian: • Liječenje treba nastaviti do završetka rasta.
English: In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
Croatian: U bolesnika s PWS-om liječenje uvijek mora biti popraćeno prehranom s ograničenim unosom kalorija.
English: Growth hormone can help you grow taller if you have not been able to catch up or maintain normal growth by 4 years of age or later.
Croatian: Hormon rasta može pospješiti rast ako do četvrte godine života ili kasnije niste uspjeli dostići vršnjake ili održati normalan rast.
English: All products:
Croatian: Svi lijekovi:
English: The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
Croatian: Doza se treba postupno povećavati prema individualnim potrebama bolesnika, što se određuje koncentracijom IGF-I.
English: It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and thus do not require dose escalation.
Croatian: Spoznalo se da postoje bolesnici s deficijencijom hormona rasta u kojih razine IGF-I ne postaju normalne usprkos dobrom kliničkom odgovoru pa njima ne treba povisivati dozu.
English: You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone.
Croatian: (u Vas ili Vašeg djeteta) može doći do povišene razine šećera u krvi ili snižene razine hormona štitne žlijezde.
English: As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
Croatian: Budući da se starenjem smanjuje fiziološko stvaranje hormona rasta, potrebna doza se može smanjiti.
English: Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
Croatian: Dok su periferne vrijednosti hormona štitnjače ostale u referentnom rasponu zdravih ispitanika, u bolesnika sa subkliničkim hipotiroidizmom teoretski se može razviti hipotiroidizam.
English: - Growth disturbance associated with Turner syndrome.
Croatian: - Poremećaj rasta povezan s Turnerovim sindromom.
English: Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into the upper range of normal, not exceeding the 2 SDS.
Croatian: Bolesnicima s normalnim koncentracijama IGF-I na početku liječenja treba davati hormon rasta sve dok razina IGF-I ne dostigne gornji dio raspona normalnih vrijednosti, ne prelazeći 2 SSD.
English: Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Croatian: Bolesnike sa šećernom bolešću, intolerancijom glukoze ili dodatnim čimbenicima rizika za šećernu bolest potrebno je pažljivo pratiti tijekom terapije somatropinom.
English: - Check for air bubbles in the syringe.
Croatian: - Provjerite ima li u štrcaljki mjehurića zraka.
English: Water and mineral metabolism
Croatian: Metabolizam vode i minerala
English: It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Croatian: Može uzrokovati toksične reakcije i anafilaktoidne reakcije u dojenčadi i djece mlađe od 3 godine.
English: The observed difference is likely due to slow absorption from the injection site following subcutaneous administration.
Croatian: Opažena razlika vjerojatno nastaje zbog spore apsorpcije s mjesta injiciranja nakon supkutane primjene.
English: • oestrogen taken orally or other sex hormones,
Croatian: • estrogen koji uzimate kroz usta ili drugi spolni hormoni
English: Growth hormone deficiency is associated with decreased plasma and extracellular volumes.
Croatian: Deficit hormona rasta je povezan sa smanjenjem volumena plazme i izvanstaničnog volumena.
English: Somatropin also increases cardiac output, but the mechanism has yet to be clarified.
Croatian: Somatropin povećava i minutni volumen, no mehanizam još nije razjašnjen.
English: • Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of treatment)
Croatian: • zadržavanje vode (očituje se oticanjem prstiju ili gležnjeva, kratkotrajno na početku liječenja).
English: There are no or limited amount of data from the use of somatropin in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni somatropina u trudnica ograničeni.
English: After reconstitution, one ml contains 15 mg benzyl alcohol.
Croatian: Nakon pripreme, jedan ml sadrži 15 mg benzilnog alkohola.
English: The powder is white and the solvent is a clear, colourless solution.
Croatian: Prašak je bijeli, a otapalo je bistra, bezbojna otopina.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i vanjskom pakiranju iza Rok valjanosti/EXP.
English: Omnitrope has given rise to the formation of antibodies in approximately 1% of patients.
Croatian: Omnitrope dovodi do stvaranja protutijela u približno 1 % bolesnika.
English: • If you experience worsening abdominal pain you should inform your doctor.
Croatian: • Ako osjetite pogoršanje boli u trbuhu, obavijestite o tome svog liječnika.
English: The clinical significance of this finding is unclear.
Croatian: Klinička važnost tog nalaza nije jasna.
English: Solvent: water for injections benzyl alcohol
Croatian: Otapalo: voda za injekcije benzilni alkohol
English: Do not share your needles.
Croatian: Nemojte igle dijeliti s drugima.
English: Chronic renal insufficiency
Croatian: Kronična renalna insuficijencija
English: Somatropin treatment should be stopped at kidney transplantation.
Croatian: Liječenje somatropinom mora se prekinuti u slučaju transplantacije bubrega.
English: This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects.
Croatian: Ovu dozu treba postupno povećavati ili snižavati sukladno rezultatima krvne pretrage, kao i kliničkom odgovoru i nuspojavama.
English: Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and lipoproteins.
Croatian: Somatropin inducira jetrene receptore LDL kolesterola i utječe na profil lipida i lipoproteina u serumu.
English: Do not massage the injection site.
Croatian: Nemojte trljati mjesto injiciranja.
English: After reconstitution, from a microbiological point of view, an immediate use is recommended.
Croatian: Nakon pripreme, s mikrobiološkog stajališta, preporučuje se odmah primijeniti lijek.
English: In adults as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.
Croatian: U odraslih i u djece, somatropin održava normalan sastav tijela povećavanjem zadržavanja dušika i stimulacijom rasta skeletnih mišića te mobilizacijom tjelesne masti.
English: Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients.
Croatian: Omnitrope je izazvao stvaranje protutijela u približno 1 % bolesnika.
English: Data from an interaction study performed in growth hormone deficient adults suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Croatian: Podaci dobiveni ispitivanjem interakcija provedenim na odraslim osobama s deficitom hormona rasta pokazuju da se primjenom somatropina može povećati klirens spojeva za koje je poznato da ih metaboliziraju izoenzimi citokroma P450.
English: In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended.
Croatian: U slučaju jake ili učestale glavobolje, problema s vidom, mučnine i/ili povraćanja preporučuje se fundoskopija radi otkrivanja papiloedema.
English: Injection site reaction$
Croatian: reakcija na mjestu injekcije$
English: This dosage should be gradually increased according to blood test results as well as clinical response and side effects.
Croatian: Ta se doza mora postupno povećavati prema rezultatima krvnih pretraga, kao i kliničkom odgovoru i nuspojavama.
English: In addition, patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses, following initiation of somatropin treatment (see section 4.5).
Croatian: Pored toga, bolesnicima koji se liječe nadomjesnom terapijom glukokortikoidima zbog prethodno dijagnosticiranog hipoadrenalizma može biti potrebno povisiti dozu održavanja ili dozu u stresnim situacijama nakon što započnu liječenje somatropinom (vidjeti dio 4.5).
English: Omnitrope is a biosimilar medicinal product.
Croatian: Omnitrope je biosličan lijek.
English: There have been rare cases of sudden death in patients with Prader-Willi syndrome.
Croatian: U rijetkim je slučajevima zabilježena iznenadna smrt u bolesnika s Prader-Willijevim sindromom.
English: • If you are receiving somatropin for growth hormone deficiency following a previous tumour (cancer), you should be examined regularly for recurrence of the tumour or any other cancer.
Croatian: • Ako primate somatropin zbog deficita hormona rasta nakon liječenja tumora (karcinoma), morate obavljati redovite preglede radi mogućnosti ponovne pojave tumora ili nekog drugog karcinoma.
English: Children born small or too light at birth
Croatian: Djeca rođena mala ili prelagana
English: • treat persons with pronounced growth hormone deficiency.
Croatian: • liječenje osoba s izraženim nedostatkom hormona rasta.
English: Solution for injection in a cartridge for SurePal 5, SurePal 10, SurePal 15.
Croatian: Otopina za injekciju u ulošku za SurePal 5, SurePal 10, SurePal 15.
English: The binding capacity of these antibodies is low and there is no effect on growth rate.
Croatian: Ova protutijela imaju nisku sposobnost vezanja pa nemaju učinka na brzinu rasta.
English: Important information about some of the ingredients of Omnitrope
Croatian: Važne informacije o nekim sastojcima Omnitropea
English: If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
Croatian: Ako se papiloedem potvrdi, potrebno je razmotriti dijagnozu benigne intrakranijalne hipertenzije te po potrebi prekinuti liječenje hormonom rasta.
English: - Select the site of injection.
Croatian: - Odaberite mjesto injiciranja.
English: In women on oral oestrogen replacement, a higher dose of growth hormone may be required to achieve the treatment goal (see section 4.4).
Croatian: U žena na nadomjesnoj peroralnoj estrogenskoj terapiji možda će biti potrebna viša doza hormona rasta kako bi se postigao cilj liječenja (vidjeti dio 4.4).
English: In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required.
Croatian: U bolesnika liječenih somatropinom može se otkriti prethodno nedijagnosticirani centralni (sekundarni) hipoadrenalizam, tako da može biti potrebna nadomjesna terapija glukokortikoidima.
English: • If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.
Croatian: • Ako ste na nadomjesnoj terapiji glukokortikoidima, redovito se savjetujte s liječnikom jer će Vam možda biti potrebno prilagoditi dozu glukokortikoida.
English: Injecting Omnitrope - Select the site of injection.
Croatian: Injiciranje Omnitropea - Odaberite mjesto injiciranja.
English: The daily dosage should not exceed 2.7 mg.
Croatian: Dnevna doza ne smije prekoračiti 2,7 mg.