FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that after preparation, the suspension is injected with a short needle into the fatty skin tissue.
Croatian: To znači da se nakon pripreme suspenzija ubrizgava kratkom iglom u potkožno masno tkivo.
English: During normal pregnancy, levels of pituitary growth hormone fall markedly after 20 weeks of gestation, being replaced almost entirely by placental growth hormone by 30 weeks.
Croatian: Tijekom normalne trudnoće, razina pituitarnog hormona rasta znatno opada nakon 20. tjedna gestacije, kada ga gotovo potpuno zamjenjuje placentalni hormon rasta do 30. tjedna.
English: - if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6); - if you have cancer; Tell your doctor if you have an active tumour (cancer).
Croatian: - ako ste alergični na somatropin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6); - ako imate rak;
English: Remove the protective caps from the top of both vials as seen in figure 3a.
Croatian: Uklonite zaštitne poklopce s vrha obje bočice kako je prikazano na slici 3a.
English: Growth hormone regulates the growth and development of cells.
Croatian: Hormon rasta regulira rast i razvoj stanica.
English: It is not known if this medicine passes into breast milk.
Croatian: Nije poznato prelazi li ovaj lijek u majčino mlijeko.
English: No accumulation of hGH following multiple dosing of this medicinal product has been observed.
Croatian: Nije opaženo nakupljanje hGH nakon višestrukih doza ovog lijeka.
English: If necessary, your doctor will gradually increase this dose according to your individual response to the treatment and your blood levels of a growth factor called IGF-I.
Croatian: Po potrebi, liječnik će Vam postupno povisivati tu dozu sukladno Vašem odgovoru na liječenje i razinama čimbenika rasta koji se zove IGF-I u krvi.
English: Non-clinical data revealed no specific hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity.
Croatian: Neklinički podaci nisu ukazali na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza i genotoksičnosti.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and agonists, ATC code: H01AC01
Croatian: Farmakoterapijska skupina: pituitarni i hipotalamički hormoni i analozi, somatropin i agonisti, ATK oznaka: H01AC01
English: Animal studies with this medicinal product are not sufficient to fully assess the reproductive toxicity potential.
Croatian: Ispitivanja na životinjama ovog lijeka nisu dostatna da bi se potpuno mogao procijeniti toksični potencijal na reproduktivni sustav.
English: previous dose Dose change at a time
Croatian: Promjena doze u to vrijeme
English: Do not use any remaining solvent for a second preparation!
Croatian: Nemojte uporabiti preostalo otapalo za drugu pripremu!
English: Somatropin Biopartners is administered subcutaneously once a week.
Croatian: Somatropin Biopartners primjenjuje se supkutano jedanput tjedno.
English: The injection site should be cleaned with an alcohol swab and the suspension injected over a period of 5 seconds.
Croatian: Mjesto injekcije se treba očistiti vaticom natopljenom alkoholom i suspenziju ubrizgati u vremenu od 5 sekundi.
English: To avoid this, always change the injection site between injections.
Croatian: Da biste to izbjegli, uvijek mijenjajte mjesto primjene injekcije.
English: Insert the full length of the needle into the skin fold at a right angle (90 degrees) as shown in figure 12.
Croatian: Uvedite iglu cijelom duljinom u nabor kože pod pravim kutem (90 stupnjeva) kako je prikazano na slici 12.
English: Slowly withdraw the suspension.
Croatian: Polako izvucite suspenziju.
English: After removal of the protective caps from the top of both vials the rubber stoppers should be cleaned with an alcohol swab.
Croatian: Nakon uklanjanja zaštitnih poklopaca s vrha obje bočice, potrebno je očistiti gumene čepove vaticom natopljenom alkoholom.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Side effects can occur with the following frequencies:
Croatian: Nuspojave mogu nastati sljedećom učestalošću:
English: In women taking oral oestrogens, a higher dose of somatropin may be required to achieve the treatment goal, see section 4.2.
Croatian: U žena koje uzimaju peroralne estrogene mogu biti potrebne više doze somatropina da bi se postigao terapijski cilj, vidjeti dio 4.2.
English: Inadequate treatment of hypothyroidism may prevent optimal response to somatropin.
Croatian: Neodgovarajuće liječenje hipotireoidizma može spriječiti optimalni odgovor na somatropin.
English: Hold the fold between the thumb and the forefinger during the entire injection.
Croatian: Držite nabor kože između palca i kažiprsta tijekom cijelog davanja injekcije.
English: Store in a refrigerator (2 - 8°C).
Croatian: Čuvati u hladnjaku (2 -8°C).
English: - Your doctor may check the level of sugar in your urine or blood since it may be affected by this
Croatian: - Liječnik Vam može provjeriti razinu šećera u mokraći i krvi budući da ovaj lijek može na to utjecati.
English: If you are breast-feeding only use this medicine if your doctor indicates it is clearly necessary.
Croatian: Ako dojite, smijete primjenjivati ovaj lijek samo ako Vam liječnik kaže da je to jasno potrebno.
English: Safety and efficacy in adults with GHD was assessed in a phase III, double-blind, randomized, placebo-controlled, parallel-group, multicentre study.
Croatian: Sigurnost i djelotvornost u odraslih s NHR bila je procijenjena u dvostruko slijepom, randomiziranom, placebom kontroliranom, multicentričnom ispitivanju faze III na usporednim skupinama.
English: With the exception of injection site related reactions and the formation of antibodies to rhGH which were reported more frequently in children than in adults the safety profile of Somatropin Biopartners is similar for children and adults.
Croatian: Uz iznimku reakcija povezanih s mjestom injekcije i stvaranje protutijela na rhGH koja su bila zabilježena češće u djece nego u odraslih, sigurnosni profil Somatropina Biopartners sličan je kod djece i odraslih.
English: Repeated adjustments in dose may be required, dependent on patients' IGF-I response.
Croatian: Možda će biti potrebno ponovno prilagoditi dozu, ovisno o odgovoru IGF-I u bolesnika.
English: For children and adolescents aged 2 to 18 years somatropin
Croatian: Za djecu i adolescente u dobi od 2 do 18 godina somatropin
English: Injection site related reactions, mostly swelling at the injection site, were reported in approximately 43% of the paediatric patients.
Croatian: Reakcije povezane s mjestom injekcije, većinom otok na mjestu injekcije, zabilježene su u približno 43% pedijatrijskih bolesnika.
English: Conversion from patient body weight to dose, number of vials, total injection volume and number of injections in paediatric patients
Croatian: Pretvorba tjelesne težine bolesnika u dozu, broj bočica, ukupni volumen injekcije i broj injekcija u pedijatrijskih bolesnika
English: Some patients may develop antibodies to this medicinal product.
Croatian: Neki bolesnici mogu razviti protutijela na ovaj lijek.
English: Patient bodyweight (kg)
Croatian: Tjelesna težina bolesnika (kg)
English: Slowly release the skin during the injection.
Croatian: Polako pustite nabor kože tijekom injekcije.
English: There is no antidote for somatropin overdose.
Croatian: Nema antidota za predoziranje somatropinom.
English: Similar results were achieved for all other parameters assessed including height SDS (standard deviation score), bone maturation, IGF-I and IGF BP-3.
Croatian: Slični su rezultati bili postignuti za sve druge procijenjene parametre uključujući SDS (skor standardne devijacije) visine, sazrijevanje kostiju, IGF-I i IGF BP-3.
English: This is because the doctor will stop the treatment should a tumour occur.
Croatian: Razlog je taj što će liječnik zaustaviti liječenje u slučaju nastanka tumora.
English: Detailed information on how to administer this medicinal product is provided in section 3 of the patient leaflet.
Croatian: Detaljne informacije o tome kako primijeniti ovaj lijek nalaze se u dijelu 3 Upute o lijeku.
English: Once a normal peak bone mass is attained patients should be switched to Somatropin Biopartners for adults, if clinically indicated, and the dosing recommendation for adults should be followed.
Croatian: Nakon što se jednom postigne normalna vršna koštana masa, bolesnici se moraju prebaciti na Somatropin Biopartners za odrasle, ako je to klinički indicirano, i moraju slijediti preporuke za doziranje kod odraslih.
English: Safely dispose of all used injection needles and syringes after a single use.
Croatian: Bacite na siguran način sve uporabljene igle i štrcaljke za injekciju nakon jednokratne primjene.
English: The metabolic fate of hGH involves classical protein catabolism in both the liver and kidney.
Croatian: Metabolički ishod za hGH uključuje klasični katabolizam proteina u jetri i bubrezima.
English: After the injection, wait a few seconds, then quickly withdraw the needle with the plunger still pushed down.
Croatian: Nakon injekcije, pričekajte nekoliko sekundi, a zatim brzo izvucite iglu dok je klip još uvijek potisnut.
English: The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be increased resulting in lower plasma levels of these compounds.
Croatian: Klirens spojeva koje metabolizira citokrom P450 3A4 (npr. spolni steroidi, kortikosteroidi, antikonvulzivi i ciklosporin) može biti povećan, dovodeći do nižih razina ovih spojeva u plazmi.
English: Inject the medicine as instructed by your doctor who will also tell you what dose to use and how to inject this dose with the vials you have been prescribed.
Croatian: Ubrizgajte ovaj lijek prema uputama liječnika koji će Vam također reći koju dozu da primijenite i kako da ubrizgate tu dozu pomoću bočica koje su Vam propisane.
English: You should not use Somatropin Biopartners if you are pregnant or are trying to become pregnant.
Croatian: Ne smijete primjenjivati Somatropin Biopartners ako ste trudni ili pokušavate zatrudnjeti.
English: In the pivotal paediatric study, antibody responses to somatropin at two or more consecutive visits were observed in 33% of the patients.
Croatian: U glavnom pedijatrijskom ispitivanju, odgovor protutijela na somatropin prilikom dva ili više uzastopnih posjeta bio je opažen u 33% bolesnika.
English: Doses in excess of human therapeutic doses have shown adverse effects on reproductive function in male and female rats and male dogs, possibly through disruption of hormonal regulation.
Croatian: Pokazalo se da doze više od terapijskih doza za ljude imaju štetne učinke na reproduktivnu funkciju mužjaka i ženki štakora i mužjaka pasa, moguće putem prekida hormonske regulacije.
English: Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete ili ste nedavno primjenjivali ili planirate primijeniti bilo koje druge lijekove.
English: After the powder is evenly mixed with the solvent provided, this medicine is injected under the skin.
Croatian: Nakon što se prašak jednoliko promiješa s priloženim otapalom, ovaj lijek se ubrizgava pod kožu.
English: The most frequently reported adverse reactions in children were injection site related reactions, most of them being mild to moderate in intensity.
Croatian: Najčešće zabilježene nuspojave u djece bile su reakcije povezane s mjestom primjene, većinom blagog do umjerenog intenziteta.
English: Common: Epistaxis
Croatian: Često: epistaksa
English: There are no specific studies which address local tolerance in animals after subcutaneous injection, but data available from the repeated-dose toxicity studies revealed swelling and inflammatory infiltrate at the injection sites.
Croatian: Nema posebnih ispitivanja koja su se bavila lokalnom podnošljivošću u životinja nakon supkutane injekcije, ali podaci dostupni iz ispitivanja toksičnosti ponovljenih doza otkrili su otok i upalni infiltrat na mjestu injekcije.
English: Young adult patients with closed epiphyses who have previously been treated as children for GHD should be re-evaluated for GHD using the criteria for adult patients (see section 4.1) before replacement therapy is commenced at the doses recommended for adults.
Croatian: Mladi odrasli bolesnici sa zatvorenim epifizama koji su prethodno bili liječeni kao djeca zbog NHR moraju se ponovno procijeniti na NHR prema kriterijima za odrasle bolesnike (vidjeti dio 4.1) prije početka nadomjesne terapije dozama koje se preporučuju za odrasle.
English: For women taking oral oestrogens the starting dose is usually 3 mg injected once a week.
Croatian: Za žene koje uzimaju oralne estrogene, početna doza je obično 3 mg ubrizgana jedanput tjedno.
English: This medicinal product is not indicated for the treatment of patients with growth failure due to Prader-Willi syndrome unless they also have a diagnosis of GHD.
Croatian: Ovaj lijek nije indiciran za liječenje bolesnika sa zastojem u rastu zbog Prader-Willijevog sindroma, osim ako imaju i dijagnozu NHR.
English: Remove the needle guard.
Croatian: Uklonite štitnik za iglu.
English: If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Croatian: Ako se ponovno započne s liječenjem hormonom rasta, potrebno je pažljivo pratiti simptome intrakranijalne hipertenzije.
English: Leukaemia has been reported in a small number of GHD patients, some of whom have been treated with somatropin.
Croatian: Leukemija je bila zabilježena u malog broja bolesnika s NHR, od kojih su neki bili liječeni somatropinom.
English: Female (not on oral oestrogen)
Croatian: žene (ne na peroralnom estrogenu)
English: • Somatropin must not be used for growth promotion in children with closed epiphyses.
Croatian: • Somatropin se ne smije primjenjivati za poticanje rasta u djece sa zatvorenim epifizama.
English: When it stimulates the growth of cells in the long bones of the legs and spine, it causes an increase in height.
Croatian: Kad potiče rast stanica u dugim kostima nogu i kralježnice, uzrokuje povećanje tjelesne visine.
English: However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Croatian: Međutim, nema dokaza da je incidencija leukemije povišena u primatelja hormona rasta bez predisponirajućih čimbenika.
English: In view of this, it is unlikely that continued replacement therapy with somatropin would be necessary in growth hormone deficient women in the third trimester of pregnancy.
Croatian: S obzirom na to, kontinuirana nadomjesna terapija somatropinom najvjerojatnije ne bi bila potrebna u žena s nedostatkom hormona rasta u trećem tromjesečju trudnoće.
English: Do not inject this medicine yourself unless you have received training and you understand the procedure.
Croatian: Nemojte ubrizgavati ovaj lijek sami sebi ako Vam nisu pokazali kako i ako ne razumijete postupak.
English: If you use more Somatropin Biopartners than you should, you should consult your doctor.
Croatian: Ako primijenite više Somatropina Biopartners nego što ste trebali, morate se obratiti svom liječniku.
English: Development of new tumours or reappearance of previously existing tumours has been reported during treatment with growth hormones.
Croatian: Razvoj novih tumora ili ponovna pojava prethodno postojećih tumora zabilježena je tijekom liječenja hormonima rasta.
English: Somatropin has not been shown to increase the incidence or severity of scoliosis.
Croatian: Nije se pokazalo da somatropin povećava incidenciju ili težinu skolioze.
English: The safety profile of Somatropin Biopartners is generally consistent with the well known safety profile of daily growth hormone treatments.
Croatian: Sigurnosni profil Somatropina Biopartners općenito je sukladan dobro poznatom sigurnosnom profilu svakodnevnog liječenja hormonom rasta.
English: If the symptoms leading to the dose reduction disappear, at the judgment of the physician, the dose may be maintained at the decreased level or increased according to the dose adjustment scheme described above.
Croatian: Ako simptomi koji su doveli do sniženja doze nestanu, prema procjeni liječnika doza se može održavati na toj sniženoj razini ili povisiti sukladno shemi za prilagodbu prikazanoj gore.
English: After reconstitution: From a microbiological point of view, the product must be used immediately.
Croatian: Nakon rekonstitucije: s mikrobiološkog stajališta, lijek se mora odmah primijeniti.
English: Testing for antibodies to somatropin may be considered in patients with otherwise unexplained lack of growth response.
Croatian: Testiranje na protutijela na somatropin može se razmotriti u bolesnika s inače neobjašnjivim izostankom odgovora u pogledu rasta.
English: Inject the suspension over a period of 5 seconds by gently pushing the plunger until the syringe is empty.
Croatian: Ubrizgavajte suspenziju tijekom razdoblja od 5 sekundi nježnim potiskivanjem klipa sve dok se štrcaljka ne isprazni.
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 potvrdi edem papile, potrebno je uzeti u obzir dijagnozu benigne intrakranijalne hipertenzije i, po potrebi, prekinuti liječenje hormonom rasta.
English: The dosage of somatropin should be decreased in cases of persistent oedema or severe paraesthesia, in order to avoid the development of carpal tunnel syndrome.
Croatian: Dozu somatropina potrebno je sniziti u slučajevima perzistentnih edema ili teške parestezije, kako bi se izbjegao razvoj sindroma karpalnog kanala.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Initially, patients should have their IGF-I levels assessed at 3- to 4-weekly intervals until IGF-I SDS is in the target range of -0.5 to +1.5.
Croatian: U početku je kod bolesnika potrebno procijeniti razine IGF-I u vremenskim razmacima od 3 do 4 tjedna sve dok IGF-I SDS ne bude u ciljnom rasponu od -0,5 do +1,5.
English: Very common: Formation of antibodies against growth hormone (33%), see section “Descriptions of selected adverse reactions”, under “Immunogenicity”.
Croatian: Vrlo često: stvaranje protutijela na hormon rasta (33%), vidjeti dio „Opis odabranih nuspojava“ pod „Imunogeničnost“.
English: If a drop of blood appears, maintain the pressure for a
Croatian: Ako se pojavi kapljica krvi, zadržite pritisak nekoliko trenutaka.
English: Withdraw the syringe and discard it.
Croatian: Izvucite štrcaljku i bacite je.
English: The generation of such antibodies with low binding activity is unlikely to be clinically relevant.
Croatian: Stvaranje takvih protutijela s niskom aktivnošću vezanja najvjerojatnije nije klinički važna.
English: A similar improvement was observed for the secondary efficacy endpoints namely increase in lean body mass, serum IGF-I and IGF-I SDS.
Croatian: Slično poboljšanje bilo je opaženo za sekundarne ishode djelotvornosti, naime, povećanje bezmasne tjelesne mase, serumskog IGF-I i IGF-I SDS.
English: Somatropin Biopartners contains human growth hormone, also called somatropin.
Croatian: Somatropin Biopartners sadrži ljudski hormon rasta, koji se još zove somatropin.
English: Not all pack sizes may be available in your country.
Croatian: Na tržištu u Vašoj zemlji ne moraju se nalaziti sve veličine pakiranja.
English: Patients with prior malignancies should be examined routinely for progression or recurrence.
Croatian: Bolesnici koji su prethodno imali zloćudnu bolest moraju se redovito pregledavati zbog progresije ili povratka bolesti.
English: The subcutaneous injection should always be administered at the same time of the day to increase compliance and the site of injection must be varied to prevent lipoatrophy.
Croatian: Supkutanu injekciju mora se uvijek primjenjivati u isto doba dana kako bi se povećala suradljivost, a mjesto primjene injekcije mora se mijenjati da se spriječi lipoatrofija.
English: If not used immediately, the suspension must be reconstituted again by swirling immediately before injection.
Croatian: Ako se ne primijeni odmah, suspenzija se mora ponovno rekonstituirati mućkanjem kružnim pokretima neposredno prije injekcije.
English: The weekly dose of 0.5 mg of somatropin per kilogram of body weight should not be exceeded due to limited experience with higher doses in children.
Croatian: Tjedna doza od 0,5 mg somatropina po kilogramu tjelesne težine ne smije se prekoračiti zbog ograničenog iskustva s višim dozama u djece.
English: What Somatropin Biopartners is and what it is used for What you need to know before you use Somatropin Biopartners
Croatian: Što je Somatropin Biopartners i za što se koristi Što morate znati prije nego počnete primjenjivati Somatropin Biopartners
English: The treatment goal should be IGF-I concentrations within -0.5 and +1.5 SDS of the age corrected mean.
Croatian: Cilj liječenja moraju biti koncentracije IGF-I unutar -0,5 i +1,5 SDS za srednju vrijednost korigiranu za dob.
English: Insulin sensitivity
Croatian: Inzulinska osjetljivost
English: Few patients discontinued treatment due to injections site reactions, see section 4.8.
Croatian: Malo je bolesnika prekinulo liječenje zbog reakcija na mjestu primjene, vidjeti dio 4.8.
English: In the children receiving Somatropin Biopartners a higher incidence of (non-serious) injection site reactions and a higher rate of formation of (non-neutralising) antibodies against somatropin as compared to children with daily administered recombinant growth hormone were observed (see also sections 4.4 and 4.8).
Croatian: U djece koja su primala Somatropin Biopartners opažena je viša incidencija reakcija na mjestu injekcije (koje nisu bile ozbiljne) i viša stopa stvaranja protutijela (koja nisu bila neutralizirajuća) na somatropin u usporedbi s djecom kojima se svakodnevno primjenjivao rekombinantni hormon rasta (vidjeti također dijelove 4.4 i 4.8).
English: Vials and solvent required for preparation of one dose*
Croatian: Bočice i otapalo potrebno za pripremu jedne doze*
English: The recommended and maximum dose is 0.5 mg/kg / week and should not be exceeded.
Croatian: Preporučena i maksimalna doza je 0,5 mg/kg tjedno i ne smije se prekoračiti.
English: For dosage instruction, see table below.
Croatian: Upute za doziranje pogledati u tablici niže.
English: Non-clinical pharmacokinetic and pharmacodynamic studies in dogs and juvenile monkeys showed that Somatropin Biopartners released recombinant hGH in a prolonged manner and increased serum IGF-I for an extended period up to 5-6 days.
Croatian: Neklinička farmakokinetička i farmakodinamička ispitivanja u pasa i mladih majmuna pokazala su da je Somatropin Biopartners oslobađao rekombinantni hGH na produljen način i povisio IGF-I u serumu za dulje razdoblje u trajanju do 5-6 dana.
English: There is an increased risk that paediatric patients with prior malignancies may develop second neoplasm when treated with growth hormone, especially if treatment of the primary malignancy involved radiotherapy.
Croatian: Postoji povećani rizik da pedijatrijski bolesnici s prethodnim zloćudnim bolestima mogu razviti sekundarnu novotvorinu kad se liječe hormonom rasta, osobito ako je liječenje primarne zloćudne bolesti uključivalo radioterapiju.
English: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Croatian: Akutno predoziranje može dovesti u početku do hipoglikemije, a poslije toga do hiperglikemije.
English: - oestrogen taken orally or other sex hormones - medicines to treat epilepsy - cyclosporine: a medicine to suppress the immune system
Croatian: - estrogen koji se uzima kroz usta ili drugi spolni hormoni - lijekovi za liječenje epilepsije - ciklosporin: lijek za potiskivanje djelovanja imunološkog sustava