FrancophonIA/ELRC3.0 huggingface dataset:
English: • and tell your doctor if Omnitrope has been prescribed to stimulate growth but you have already stopped growing (closed epiphyses).
Croatian: • obavijestite svog liječnika ako je Omnitrope propisan za stimulaciju rasta, a Vi ste već prestali rasti (zatvorene epifize).
English: Based on this information, these types of patients should not be treated with somatropin.
Croatian: Na temelju tih informacija, ovakvi se bolesnici ne smiju liječiti somatropinom.
English: If you use more Omnitrope than you should
Croatian: Ako primijenite više Omnitropea nego što ste trebali
English: Scoliosis may progress in any child during rapid growth.
Croatian: Skolioza može progredirati u svakog djeteta tijekom naglog rasta.
English: • medicines to control epilepsy (anticonvulsants),
Croatian: • lijekove za kontrolu epilepsije (antikonvulzive),
English: Turner syndrome is a genetic disorder in girls that can affect growth - your doctor will have told you if you have this.
Croatian: Turnerov sindrom je genetski poremećaj u djevojčica koji može utjecati na rast - ako bolujete od njega, o tome će Vas obavijestiti liječnik.
English: The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you.
Croatian: Doza ovisi o Vašoj visini, stanju zbog kojeg se liječite i o tome koliko dobro hormon rasta djeluje na Vas.
English: - Use the solution immediately.
Croatian: - Otopinu odmah iskoristite.
English: Treatment should be discontinued after the first year if you are not responding or if you have reached your final height and stopped growing.
Croatian: Liječenje se mora prekinuti nakon prve godine ako ne reagirate na lijek ili ako ste postigli konačnu visinu i prestali rasti.
English: Keep a note of any missed injections and tell your doctor at your next check-up.
Croatian: Zabilježite sve propuštene injekcije i o tome obavijestite liječnika prilikom sljedećeg pregleda.
English: Your blood sugar level could fall too low and later rise too high.
Croatian: Razina šećera u krvi mogla bi Vam se previše smanjiti, a nakon toga previše porasti.
English: What Omnitrope is and what it is used for
Croatian: Što je Omnitrope i za što se koristi
English: Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
Croatian: Ženama može biti potrebna veća doza nego muškarcima, s time da muškarci pokazuju povećanje osjetljivosti na IGF-I tijekom vremena.
English: Not Known (cannot be estimated from available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis.
Croatian: Priprema se mora provesti u skladu s pravilima dobre prakse, osobito u pogledu asepse.
English: Their diagnosis should be considered in a child with a discomfort or pain in the hip or knee.
Croatian: Te dijagnoze treba uzeti u obzir u djeteta s nelagodom ili bolom u kuku ili koljenu.
English: Long-term overdose could result in signs and symptoms consistent with the known effects of human growth hormone excess.
Croatian: Dugoročno predoziranje može rezultirati znakovima i simptomima koji su u skladu s poznatim učincima viška ljudskog hormona rasta.
English: Treatment should not be used in children who have almost stopped growing after puberty.
Croatian: Liječenje se ne smije primijeniti u djece koja su gotovo prestala rasti nakon puberteta.
English: The maximum recommended daily dose should not be exceeded (see section 4.2).
Croatian: Maksimalna preporučena dnevna doza se ne smije prekoračiti (vidjeti dio 4.2).
English: Do not attempt to inject unless you are sure you understand the procedure and requirements for the injection.
Croatian: Ne pokušavajte injicirati lijek ako ne razumijete postupak i preduvjete za injekciju.
English: In particular, inform your doctor if you are taking or have recently taken any of the following medicines.
Croatian: Posebice, obavijestite svog liječnika ako uzimate ili ste nedavno uzeli bilo koji od dolje navedenih lijekova.
English: It is also natural to have a higher level of growth hormone at night.
Croatian: Također je prirodno da su razine hormona rasta više noću.
English: However, no link has been made between these cases and treatment with Omnitrope.
Croatian: Međutim, nije ustanovljena povezanost između tih slučajeva i liječenja Omnitropeom.
English: Your excessive fat will decrease and your reduced muscle mass will improve.
Croatian: Prekomjerno masno tkivo će se smanjiti, a smanjena mišićna masa će se povećati.
English: However, there is no evidence of an increased risk of leukaemia without predisposition factors, such as radiation to the brain or head.
Croatian: Međutim, nema dokaza povećanog rizika od leukemije bez predisponirajućih čimbenika, kao što je zračenje mozga ili glave.
English: Experience in patients with Silver-Russell syndrome is limited.
Croatian: Iskustva s bolesnicima sa Silver-Russellovim sindromom su ograničena.
English: Insert the needle into the pinched skin at an angle of 45° to 90°.
Croatian: Uvedite iglu u nabor kože koja Vam je između prstiju pod kutom od 45° do 90°.
English: Testing for antibodies to somatropin should be carried out in any patient with otherwise unexplained lack of response.
Croatian: Testiranje na protutijela na somatropin treba provesti u svakog bolesnika s inače neobjašnjivim izostankom odgovora.
English: Patients with PWS and one or more of these risk factors may be at greater risk.
Croatian: Rizik u bolesnika s PWS-om i jednim ili više od navedenih faktora rizika može biti veći.
English: You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.
Croatian: znojenje, pospanost i općenito se "ne osjećati dobro", a mogli biste se i onesvijestiti.
English: • If you have Turner syndrome.
Croatian: • Ako imate Turnerov sindrom.
English: Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Croatian: Liječenje se mora obustaviti nakon prve godine liječenja ako je SSD brzine rasta manji od + 1.
English: What Omnitrope looks like and contents of the pack
Croatian: Kako Omnitrope izgleda i sadržaj pakiranja
English: Check with your doctor, nurse or pharmacist if you are not sure.
Croatian: Provjerite sa svojim liječnikom, medicinskom sestrom ili ljekarnikom ako niste sigurni.
English: Marketing Authorisation Holder Sandoz GmbH
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Sandoz GmbH
English: Wash your hands before you continue with the next steps.
Croatian: Prije prelaska na sljedeće korake operite ruke.
English: With your other hand, hold the syringe as you would a pencil.
Croatian: Drugom rukom uzmite štrcaljku kao olovku.
English: If blood comes into the syringe, the needle has entered a blood vessel.
Croatian: Ako u štrcaljku uđe krv, igla je ušla u krvnu žilu.
English: Pull back the plunger very slightly with one hand.
Croatian: Jednom rukom vrlo lagano povucite nazad klip.
English: It may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Croatian: Može uzrokovati toksične reakcije i alergijske reakcije u dojenčadi i djece mlađe od 3 godine.
English: In children such adverse reactions are uncommon.
Croatian: Takve nuspojave su manje česte u djece.
English: Because of the presence of benzyl alcohol the medicinal product must not be given to premature babies or neonates.
Croatian: Zbog prisutnosti benzilnog alkohola, ne smije se dati nedonoščadi ili novorođenčadi.
English: This can be tested by your doctor and if necessary your doctor will prescribe the adequate treatment.
Croatian: Vaš liječnik to može utvrditi pretragama i, po potrebi, propisati odgovarajuće liječenje.
English: Follow the instructions given to you by your doctor.
Croatian: Pridržavajte se uputa koje ste dobili od liječnika.
English: Omnitrope (MAH: Sandoz), Zomacton and associated names (MAH: Ferring), Norditropin and associated names (MAH: Novo Nordisk), Genotropin and associated names (MAH: Pfizer)
Croatian: Omnitrope (nositelj odobrenja: Sandoz), Zomacton i pridružena imena(nositelj odobrenja: Ferring), Norditropin i pridružena imena (nositelj odobrenja: Novo Nordisk), Genotropin i pridružena imena (nositelj odobrenja: Pfizer)
English: The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Croatian: Primjerenost veličine doze hormona rasta stoga se mora kontrolirati svakih 6 mjeseci.
English: Somatropin must not be used for growth promotion in children with closed epiphyses.
Croatian: Somatropin se ne smije koristiti za poticanje rasta u djece sa zatvorenim epifizama.
English: Therefore, in order to achieve an equivalent clinical and biochemical response compared to men dose adjustments may need to be considered by the prescriber in female patients.
Croatian: Stoga, kako bi se postigao jednak klinički i biokemijski odgovor u usporedbi s onim u muškaraca, u bolesnica možda treba razmotriti prilagodbu doze pri propisivanju lijeka.
English: Instructions for Use provided with SurePal).
Croatian: vidjeti upute za upotrebu priložene uz SurePal).
English: To verify growth disturbance, growth should be followed for a year preceding institution of therapy.
Croatian: Da bi se potvrdio poremećaj rasta, rast se mora pratiti jednu godinu prije uvođenja terapije.
English: The binding capacity of these antibodies has been low and no clinical changes have been associated with their formation, see section 4.4.
Croatian: Sposobnost vezanja tih protutijela bila je niska, a s njihovim stvaranjem nisu bile povezane nikakve kliničke promjene, vidjeti dio 4.4.
English: It has the same structure as natural human growth hormone which is needed for bones and muscles to grow.
Croatian: Strukturom je jednak prirodnom ljudskom hormonu rasta, koji je potreban za rast kostiju i mišića.
English: Always use this medicine exactly as your doctor or pharmacist or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako su Vam rekli Vaš liječnik, ljekarnik ili medicinska sestra.
English: Your doctor may need to adjust the dose of Omnitrope or of the other medicines:
Croatian: Liječnik će možda trebati prilagoditi Vašu dozu lijeka Omnitrope ili drugih lijekova:
English: • Experience in patients above 80 years is limited.
Croatian: • Iskustvo u bolesnika starijih od 80 godina je ograničeno.
English: Omnitrope is a recombinant human growth hormone (also called somatropin).
Croatian: Omnitrope je rekombinantni ljudski hormon rasta (koji se naziva i somatropin).
English: Most people do their injections into their thigh or their bottom.
Croatian: Većina ljudi daje si injekciju u natkoljenicu ili stražnjicu.
English: - 2 cleansing swabs (not supplied in the pack).
Croatian: - 2 tupfera za čišćenje (nije isporučeno u pakovanju).
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: - Prader-Willi syndrome (PWS), for improvement of growth and body composition.
Croatian: - Prader-Willijev sindrom (PWS) za poboljšanje rasta i oblikovanja tijela.
English: But it is unknown if these 2 pathologies are more frequent or not while treated with somatropin.
Croatian: Međutim, nije poznato jesu li ova 2 patološka stanja češća ili ne za vrijeme liječenja somatotropinom.
English: It is not known if somatropin is excreted into breast milk, but absorption of intact protein from the gastrointestinal tract of the infant is extremely unlikely.
Croatian: Nije poznato izlučuje li se somatropin u majčino mlijeko, no vjerojatnost apsorpcije intaktnog proteina iz gastrointestinalnog trakta djeteta je izuzetno mala.
English: Although rare, pancreatitis should be considered in somatropin-treated children who develop abdominal pain.
Croatian: Iako je rijedak, pankreatitis treba uzeti u obzir u djece liječene somatropinom koja razviju abdominalnu bol.
English: Somatropin is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti somatropin tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: You should only be given this medicine by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.
Croatian: Lijek Vam smije dati samo liječnik koji ima iskustva s liječenjem hormonom rasta i koji je potvrdio
English: • After reconstitution, from a microbiological point of view, the product should be used immediately.
Croatian: • Nakon pripreme, s mikrobiološkog stajališta, lijek se mora odmah upotrijebiti.
English: If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Even higher doses have been used.
Croatian: Korištene su i veće doze.
English: If you are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you use growth hormone.
Croatian: Ako planirate ili ste imali veliku operaciju, ili ćete boraviti u bolnici zbog bilo kojeg razloga, obavijestite o tome svog liječnika i podsjetite ostale liječnike da primjenjujete hormon rasta.
English: - Make sure you inject at least 1 cm from your last injection site and that you change the places where you inject, as you have been taught.
Croatian: - Pazite da injicirate na mjestu koje je najmanje 1 cm udaljeno od mjesta na kojem ste zadnji put primili injekciju i da prema uputama mijenjate mjesto injiciranja.
English: Do not use if the solution is cloudy or contains particles.
Croatian: Nemojte koristiti otopinu ako je mutna ili sadrži čestice.
English: It is best to use your growth hormone regularly.
Croatian: Najbolje je hormon rasta primjenjivati redovito.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for somatropin, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za somatropin, znanstveni zaključci CHMP-a su sljedeći:
English: Dispose of the syringes safely in a closed container.
Croatian: Štrcaljke odložite u otpad na siguran način u zatvorenom spremniku.
English: These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency.
Croatian: Ti se bolesnici moraju podvrgnuti odgovarajućem dinamičkom ispitivanju radi dijagnosticiranja ili isključivanja nedostatka hormona rasta.
English: The clinical relevance of these findings may be limited.
Croatian: Klinička važnost tih saznanja može biti ograničena.
English: Do your injection in the place you have been shown by your doctor.
Croatian: Dajte si injekciju na mjesto koje Vam je pokazao Vaš liječnik.
English: • Your doctor will give you diet restrictions to follow to control your weight.
Croatian: • Liječnik će Vam dati upute za ograničenje prehrane kojih se morate pridržavati radi kontrole
English: - Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).
Croatian: - Mijenjajte mjesta injiciranja kako biste smanjili rizik od lokalne lipoatrofije (lokaliziranog smanjenja potkožnog masnog tkiva).
English: Your doctor may need to adjust the dose of these medicines or the dose of somatropin.
Croatian: Vaš liječnik će možda morati promijeniti dozu tih lijekova ili dozu somatropina.
English: In children Omnitrope is used to treat the following growth disturbances:
Croatian: Omnitrope se u djece koristi za liječenje sljedećih poremećaja rasta:
English: Inject your growth hormone at about the same time every day.
Croatian: Injiciranje Omnitropea Ubrizgajte hormon rasta svakog dana u približno isto vrijeme.
English: The best sites for injection are tissues with a layer of fat between skin and muscle, such as the thigh or belly (except the navel or waistline).
Croatian: Najbolja mjesta za injiciranje su tkiva u kojima se između kože i mišića nalazi sloj masti, kao što su bedro ili trbuh (osim pupka i područja struka).
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 pojačava ekstratiroidno pretvaranje T4 u T3, što može dovesti do smanjenja koncentracije T4 i povećanja koncentracije T3 u serumu.
English: Your doctor will advise you about your individualised dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body surface area calculated from your height and weight in square metres (m2), as well as your treatment schedule.
Croatian: Liječnik će Vas obavijestiti o dozi Omnitropea u miligramima (mg) koja je određena posebno za Vas prema Vašoj tjelesnoj težini u kilogramima (kg) ili prema površini tijela u kvadratnim metrima (m2) izračunatoj na temelju visine i težine, kao i o rasporedu liječenja.
English: Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
Croatian: Liječenje se ne smije primjenjivati kod pedijatrijskih bolesnika s brzinom rasta manjom od 1 cm na godinu i onih koji su blizu zatvaranja epifiza.
English: In children • Stiffness in the arms and legs
Croatian: • ukočenost u rukama i nogama
English: Do not change the dosage and treatment schedule without consulting your doctor.
Croatian: Nemojte bez savjetovanja s liječnikom mijenjati dozu ni raspored liječenja.
English: Somatropin must not be used when there is any evidence of activity of a tumour.
Croatian: Somatropin se ne smije primijeniti ako je dokazana aktivnost tumora.
English: Mortality was higher in patients treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%.
Croatian: Smrtnost je bila veća u bolesnika liječenih s 5,3 ili 8 mg somatropina dnevno u usporedbi s bolesnicima koji su primali placebo, 42 % naspram 19 %.
English: Experience in patients above 80 years is limited.
Croatian: Iskustvo u bolesnika starijih od 80 godina je ograničeno.
English: Remove the syringe and needle.
Croatian: Izvadite štrcaljku i iglu.
English: After injecting - After injection, press the injection site with a small bandage or sterile gauze for several seconds.
Croatian: - Nakon injiciranja, pritisnite mjesto injiciranja malim zavojem ili sterilnom gazom nekoliko sekundi.
English: Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01.
Croatian: Farmakoterapijska skupina: hormoni prednjeg režnja hipofize i njihovi analozi, ATK oznaka: H01AC01.
English: In adults
Croatian: U odraslih
English: Gently swirl the vial a few times until the content is completely dissolved.
Croatian: Lagano rotirajte bočicu nekoliko puta dok se sadržaj potpuno ne otopi.
English: • If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor for specific advice relating to puberty and treatment with this medicine.
Croatian: • Ako ste se rodili premali ili prelagani, a sada ste u dobi između 9 i 12 godina, od liječnika zatražite konkretne savjete vezane uz pubertet i liječenje ovim lijekom.
English: Consequently monitoring of thyroid function should therefore be conducted in all patients.
Croatian: Zbog toga je potrebno pratiti funkciju štitne žlijezde u svih bolesnika.
English: It will also stop air going back into the pen and the needle clogging up.
Croatian: Spriječit će se i ulazak zraka u brizgalicu i začepljenje igle.
English: • synthetic adrenal hormones (corticosteroids).
Croatian: • sintetičke hormone nadbubrežne žlijezde (kortikosteroide).
English: • if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of Omnitrope.
Croatian: • ako ste alergični (preosjetljivi) na somatropin ili neki drugi sastojak ovog lijeka.
English: Dose recommendations in paediatric patients
Croatian: Preporučene doze u pedijatrijskih bolesnika
English: The effects of somatropin on recovery were studied in two placebo controlled trials involving 522 critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.
Croatian: Učinci somatropina na oporavak bili su ispitani u dva placebom kontrolirana ispitivanja koja su uključila 522 kritično bolesna odrasla bolesnika s komplikacijama nakon operacije na otvorenom srcu, abdominalne operacije, višestruke traume ili akutnog respiratornog zatajenja.
English: - If the solution is cloudy (and the cloudiness does not disappear within ten minutes) or contains particles, it should not be used.
Croatian: Ako je otopina mutna (i zamućenost ne nestane u roku od deset minuta) ili sadrži čestice, ne smije se koristiti.
English: The clearance of compounds metabolised by cytochrome P 450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in lower plasma levels of these compounds.
Croatian: P 450 3A4 (npr. spolni steroidi, kortikosteroidi, antikonvulzivi i ciklosporin) može se osobito povećati što rezultira niskom razinom tih spojeva u plazmi.
English: - Carefully inspect the solution before injecting it and use only if clear and colourless.
Croatian: - Pomno provjerite otopinu prije injiciranja i primijenite je samo ako je bistra i bezbojna.
English: In all patients developing other or similar acute critical illness, the possible benefit of treatment with somatropin must be weighed against the potential risk involved.
Croatian: U svih bolesnika u kojih se razvija druga ili slična akutna kritična bolest, moguća korist od liječenja somatropinom mora se odvagnuti u odnosu na moguće rizike koje to uključuje.
English: Other adverse drug reactions may be considered somatropin class effects, such as possible hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign intra-cranial hypertension.
Croatian: Druge nuspojave mogu se smatrati učincima klase somatotropina, kao što su moguća hiperglikemija prouzročena smanjenom osjetljivošću na insulin, snižena razina slobodnog tiroksina i benigna intrakranijalna hipertenzija.
English: This means that it is injected through a short injection needle into the fatty tissue just under your skin.
Croatian: To znači da se kratkom injekcijskom iglom ubrizgava u masno tkivo neposredno ispod kože.
English: • If you were small or too light at birth.
Croatian: • Ako ste rođeni mali ili prelagani.
English: 10 A-6250 Kundl Austria
Croatian: A-6250 Kundl Austrija
English: 0.33 mm x 12.7 mm) for withdrawing the solvent from the vial (not supplied in the pack).
Croatian: 0,33 mm x 12,7 mm) za izvlačenje otapala iz bočice (nije isporučeno u pakovanju).
English: In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate.
Croatian: U djece s nedovoljno endogenog hormona rasta, somatropin stimulira linearni rast i povećava brzinu rasta.
English: Literature data from untreated SGA children/adolescents without early spontaneous catch-up suggest a late growth of 0.5 SDS.
Croatian: Podaci iz literature od neliječene djece/adolescenata koji su rođeni mali za gestacijsku dob bez ranog spontanog ubrzanog rasta, sugeriraju kasniji rast od 0,5 SSD.
English: Experience with prolonged treatment in adults and in patients with PWS is limited.
Croatian: Iskustva s produljenim liječenjem odraslih i bolesnika s PWS-om su ograničena.
English: Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or incomplete.
Croatian: Informacije o farmakokinetici somatropina u gerijatrijskim i pedijatrijskim populacijama, različitim rasama te u bolesnika s insuficijencijom bubrega, jetre ili srca nedostaju ili nisu potpune.
English: Leukaemia†
Croatian: leukemija†