FrancophonIA/ELRC3.0 huggingface dataset:
English: Always store your disposal container out of the reach of children.
Croatian: Uvijek držite svoj spremnik za otpad izvan dohvata djece.
English: Overall, 171 patients were exposed to somatropin for an average of 3.5 or 2.8 years.
Croatian: Sveukupno je 171 bolesnika bilo izloženo somatropinu u prosječnom trajanju od 3,5 ili 2,8 godina.
English: Actions that have been demonstrated for human growth hormone include:
Croatian: Akcije koje su išle u prilog humanom hormonu rasta uključuju:
English: Q: What is the maximum dose the NutropinAq Pen can deliver in one injection?
Croatian: P: Koja je maksimalna doza lijeka koju NutropinAq brizgalica može dostaviti u jednoj injekciji?
English: If you experience any of these symptoms, you should inform your doctor.
Croatian: Ako iskusite neki od ovih simptoma, trebali bi obavijestiti svog liječnika.
English: The improvements in growth were not accompanied by undue advancement of bone age, which would jeopardise future growth potential.
Croatian: Poboljšanja u rastu nisu bila popraćena pretjeranim napredovanjem u rastu kosti koji bi ugrozio potencijal budućeg rasta.
English: Turner syndrome
Croatian: Turnerov sindrom
English: Your doctor or nurse will show you how to do this.
Croatian: Vaš liječnik ili medicinska sestra pokazat će Vam kako se to radi.
English: • Use needles only once.
Croatian: • Upotrijebite iglu samo jednom.
English: It is important to change the place where you have your injection every day to avoid damaging your skin.
Croatian: Važno je svaki dan mijenjati mjesto ubrizgavanja kako bi se izbjeglo oštećenje kože.
English: Batteries typically last 24 months and have a 4-week life from the time the „bt‟ first starts blinking.
Croatian: Baterije obično traju 24 mjeseca i traju 4 tjedna kada simbol „bt“ počne treperiti.
English: Diabetes mellitus can lead to increased urination, thirst and hunger.
Croatian: Dijabetes melitus može uzrokovati pojačano mokrenje, žeđ i glad.
English: As shown by the illustrations below, NutropinAq pen and cartridges are available in two designs (with or without additional yellow colour).
Croatian: Kako je prikazano na donjim slikama, brizgalica lijeka NutropinAq i ulošci dostupni su u dva dizajna (s ili bez dodatne žute boje).
English: Non-clinical data reveal no special hazard for human based on conventional acute and repeated-dose toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti akutne i ponovljenih doza.
English: Metabolic alterations in these patients include normalisation of IGF-I serum levels.
Croatian: Izmjene u metabolizmu kod ovih bolesnika uključuju normalizaciju serumskih razina IGF-I.
English: Patients under 11 years of age were also randomised to receive oestrogen therapy, either in late (aged 15 years) or early (aged 12 years) adolescence.
Croatian: Bolesnici mlađi od 11 godina bili su također randomizirani kako bi primali terapiju estrogenom bilo u kasnoj (u dobi od 15 godina) ili u ranijoj (u dobi od 12 godina) adolescenciji.
English: If you have injected more NutropinAq than you should have, contact your doctor for advice.
Croatian: Ako ste ubrizgali više lijeka NutropinAq nego što ste trebali, obratite se svom liječniku za savjet.
English: Mortality was higher (41.9 % vs. 19.3 %) among growth hormone treated patients (doses 5.38 mg/day) compared to those receiving placebo.
Croatian: Smrtnost je bila viša (41,9 % nasuprot 19,3 %) među bolesnicima liječenim hormonom rasta (doze od 5,3 do 8 mg/dan) u usporedbi s onima koji su primali placebo.
English: Do not throw the larger cap away as it will be used later for proper needle removal and disposal.
Croatian: Nemojte baciti veći pokrov jer će Vam kasnije trebati za pravilno uklanjanje igle i njeno odlaganje.
English: Warning and Precautions
Croatian: Upozorenja i mjere opreza
English: The average change in height SDS after 5 years of treatment was close to 2 standard deviations (SDs).
Croatian: Prosječna promjena u rezultatu standardne devijacije visine nakon pet godina liječenja bila je bliska 2 standardne devijacije (SD).
English: Long-term overdose could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.
Croatian: Dugoročno predoziranje može uzrokovati znakove i simptome gigantizma i/ili akromegalije što je u skladu s poznatim učincima viška hormona rasta.
English: IGF-I levels increased from a baseline of 43 ng/ml to 252 ng/ml at 36 months, which approximate to the normal levels expected in children of this age.
Croatian: Razine IGF-I povećale su se s početne vrijednosti od 43 ng/ml do 252 ng/ml u 36 mjeseci što se približava normalnim razinama očekivanim kod djece te dobi.
English: If necessary, remove the empty cartridge and discard it properly.
Croatian: Ako je potrebno, skinite prazni uložak i zbrinite ga na pravilan način.
English: You can turn the black dose knob backwards until the correct number appears in the LCD.
Croatian: Možete okrenuti crno dugme za doziranje unatrag sve dok se na LCD zaslonu ne pojavi točan broj.
English: Some patients may develop antibodies (a type of protein produced by the body) to somatropin.
Croatian: Neki bolesnici mogu razviti protutijela (vrsta proteina koje proizvodi Vaše tijelo) na somatropin.
English: After this training, you will be able to inject yourself or be injected by a trained care-giver.
Croatian: Nakon ove obuke moći ćete si sami ubrizgavati lijek ili će Vam ga ubrizgavati obučeni njegovatelj.
English: This is not unusual for solutions containing proteins like NutropinAq and does not affect the strength of the product.
Croatian: To nije neobično za otopine koje sadrže proteine poput lijeka NutropinAq i ne utječe na jačinu lijeka.
English: If this appears to be particularly troublesome, you should discuss it with your doctor.
Croatian: Ako su te nuspojave naročito problematične, trebate ih raspraviti s liječnikom.
English: • If you accidentally touch the cartridge rubber seal, clean it with an alcohol swab.
Croatian: • Ako slučajno dodirnete gumeni čep uloška, očistite ga alkoholnom vaticom.
English: The average treatment time was 4.7 years in the somatropin three times a week group and 4.6 years in the somatropin daily group.
Croatian: Prosječno vrijeme liječenje iznosilo je 4,7 godina u skupini koja je primala somatropin tri puta tjedno i 4,6 godina u skupini koja je primala somatropin svaki dan.
English: The dose of NutropinAq to be injected will be decided by your doctor.
Croatian: Dozu lijeka NutropinAq koju treba ubrizgati odredit će Vaš liječnik.
English: Somatropin has no known effect on the ability to drive or to use machines.
Croatian: Somatropin nema poznatih utjecaja na sposobnost upravljanja vozilima i rada na strojevima.
English: We also suggest you consult your doctor or nurse for a demonstration.
Croatian: Također Vam predlažemo da se obratite svom liječniku ili medicinskoj sestri za demonstraciju primjene lijeka.
English: What NutropinAq is and what it is used for
Croatian: Što je NutropinAq i za što se koristi
English: It should only be used to estimate the dosage remaining in the cartridge.
Croatian: Smije se koristiti samo za procjenu preostale doze u ulošku.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, Somatropin and analogues, ATC Code: H01 AC 01
Croatian: Farmakoterapijska skupina: Hormoni hipofize i hipotalamusa i analozi, somatropin i analozi, ATK oznaka: H01 AC 01
English: For each injection you should use a new sterile injection needle.
Croatian: Za svako ubrizgavanje trebate upotrijebiti novu, sterilnu iglu za injekcije.
English: • If you have had a tumour (cancer) in the past, specially a tumour affecting the brain, your doctor should pay special attention and examine you regularly for a possible return of the tumour.
Croatian: • Ako ste prije imali tumor (rak), osobito tumor na mozgu, Vaš liječnik treba obratiti posebnu pozornost i redovito Vas pregledavati zbog mogućeg povrata tumora.
English: Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Protect from intense light.
Croatian: Zaštitite lijek od jake svjetlosti.
English: The growth rate decreased after the first year in both studies, but continued to be greater than pretreatment levels for up to 48 months treatment (7.1 cm/year).
Croatian: Stopa rasta smanjena je nakon prve godine u oba ispitivanja ali je nastavila biti veća od razina prije liječenja do 48. mjeseca liječenja (7,1 cm/godinu).
English: Acute overdose could lead to hyperglycaemia.
Croatian: Akutno predoziranje može uzrokovati hiperglikemiju.
English: • Do not let your NutropinAq Pen and/or cartridge freeze.
Croatian: • Nemojte dozvoliti da se Vaš NutropinAq i/ili uložak smrznu.
English: • When your kidneys are damaged and they lose their ability to function normally with an impact on growth.
Croatian: • kad su Vaši bubrezi oštećeni i gube sposobnost normalnog rada što utječe na rast.
English: Of the 139 patients included, 128 completed the first 12 months of therapy, with an average treatment time of 3.2 and 4.6 years and a total exposure of 542 patient years.
Croatian: Od uključenih 139 bolesnika, njih 128 dovršilo je prvih 12 mjeseci liječenja s prosječnim vremenom liječenja od 3,2 i 4,6 godina i ukupnim izlaganjem od 542 bolesničke godine.
English: Monitoring is advisable when somatropin is administered in combination with medicinal products known to be metabolised by CYP450 liver enzymes, such as corticosteroids, sex steroids, anticonvulsants, and cyclosporin.
Croatian: Preporučuju se kontrole kad se somatropin primjenjuje u kombinaciji s lijekovima za koje se zna da se metaboliziraju jetrenim enzimima CYP450, kao što su kortikosteroidi, spolni hormoni, antikonvulzivi i ciklosporin.
English: If you have intracranial hypertension, your doctor may decide to temporarily reduce or discontinue NutropinAq therapy.
Croatian: Ako imate intrakranijalnu hipertenziju, Vaš liječnik može odlučiti privremeno smanjiti ili prekinuti terapiju lijekom NutropinAq.
English: If you use more NutropinAq than you should
Croatian: Ako primijenite više lijeka NutropinAq nego što ste trebali
English: During pregnancy, maternal somatropin will largely be replaced by placental growth hormone.
Croatian: Tijekom trudnoće majčin somatropin će većinom biti zamijenjen posteljičnim hormonom rasta.
English: The effect of NutropinAq has not been assessed in conventional animal fertility studies (see section 5.3) or clinical studies.
Croatian: Učinak lijeka NutropinAq nije procijenjen u standardnim ispitivanjima plodnosti na životinjama (vidjeti dio 5.3) ili u kliničkim ispitivanjima.
English: In case of severe and persistent abdominal pain, consult your doctor.
Croatian: U slučaju teške i uporne boli u trbuhu obratite se svom liječniku.
English: Needles from other countries may not fit on your NutropinAq Pen.
Croatian: Igle iz drugih država možda neće odgovarati Vašoj brizgalici NutropinAq.
English: In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse.
Croatian: U bolesnika s prethodnom zloćudnom bolesti potrebno je posvetiti posebnu pozornost znakovima i simptomima povratka zloćudne bolesti.
English: A new needle should be used for every injection.
Croatian: Trebate koristiti novu iglu za svaku injekciju.
English: From the 236 patients enrolled into the clinical studies 3 patients had a central nervous system tumour.
Croatian: Od ukupno 236 bolesnika uključenih u klinička ispitivanja 3 bolesnika imalo je tumor središnjeg živčanog sustava.
English: Other medicines and NutropinAq
Croatian: Drugi lijekovi i NutropinAq
English: Somatropin is not recommended during pregnancy and should be discontinued if pregnancy occurs.
Croatian: Somatropin se ne preporučuje tijekom trudnoće te u slučaju iste treba prekinuti njegovu primjenu.
English: For instructions for use and handling of the medicinal product, see section 6.6.
Croatian: Za upute za uporabu i rukovanje lijekom, vidjeti dio 6.6.
English: Do not shake vigorously as it could denature the protein.
Croatian: Nemojte snažno tresti jer može doći do denaturacije proteina.
English: Change the injection sites to avoid discomfort.
Croatian: Mijenjajte mjesta ubrizgavanja kako biste izbjegli nelagodu.
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: If you stop using NutropinAq too early or for too long, the results will not be as expected.
Croatian: NutropinAq prerano ili ga uzimate predugo, rezultati neće biti u skladu s očekivanim.
English: This results in a measurable increase in body length until these growth plates fuse at the end of puberty.
Croatian: To rezultira u mjerljivom porastu duljine tijela sve dok se zone rasta ne spoje pred kraj puberteta.
English: Indication specific side effects seen during clinical trials
Croatian: Nuspojave specifične za indikacije uočene tijekom kliničkih ispitivanja
English: When these antibodies were found in patients, it did not prevent them from growing.
Croatian: Kad se ova protutijela otkriju kod bolesnika, utvrđeno je da ne sprječavaju rast.
English: Curvature of the spine (scoliosis).
Croatian: Zakrivljenost kralježnice (skolioza).
English: • If you have Prader-Willi syndrome, you should not be treated with NutropinAq unless you have growth hormone deficiency.
Croatian: • Ako imate Prader-Willi sindrom, ne smijete se liječiti lijekom NutropinAq osim ako nemate nedostatak hormona rasta.
English: When these alterations are coupled with the increase in total body water and bone mass, the overall effect of somatropin therapy is to modify body composition, an effect that is maintained with continued treatment.
Croatian: Kad se ove izmjene spoje s porastom ukupne količine vode i koštane mase ukupni učinak liječenja somatropinom je izmjena sastava tijela što je učinak koji se održava uz kontinuirano liječenje.
English: A total of 58% and 65% of somatropin-treated patients, who were below normal range at baseline, had reached heights within the normal range by Month 24.
Croatian: Ukupno 58 % i 65 % bolesnika liječenih somatropinom koji su bili ispod normalnog raspona na početku, doseglo je visine unutar normalnog raspona do 24. mjeseca.
English: Height gains were maintained in the patients treated for 36 or 48 months.
Croatian: Dobitak na visini održan je kod bolesnika liječenih od 36 do 48 mjeseci.
English: Ipsen Portugal - Produtos Farmacêuticos, S.A. Alameda Fernão Lopes, nº 16A, 1ºB 1495-190 Algés
Croatian: Ipsen PortugalProdutos Farmacêuticos S.A. Alameda Fernão Lopes, nº 16A, 1ºB 1495-190 Algés
English: Linear growth is facilitated in part by growth hormone-stimulated protein synthesis.
Croatian: Linearni rast olakšan je djelomično sintezom proteina koju stimulira hormon rasta.
English: If your cartridge or pen is damaged, ask your doctor or nurse for a replacement.
Croatian: Ako su Vaš uložak ili brizgalica oštećeni, pitajte svog liječnika ili medicinsku sestru za zamjenu.
English: If this is not done, liquid will come out of the needle when a new cartridge is placed into the pen.
Croatian: Ukoliko to ne učinite, tekućina će istjecati iz igle kad se novi uložak stavi u brizgalicu.
English: Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
Croatian: Ženama mogu biti potrebne više doze nego muškarcima, s time da u muškaraca dolazi do povećanja osjetljivosti na IGF-I tijekom vremena.
English: One ml contains 5 mg of somatropin*
Croatian: Jedan ml sadrži 5 mg somatropina*
English: Occasionally, after refrigeration, you may notice that small colourless particles are present in the NutropinAq solution.
Croatian: Povremeno, nakon čuvanja u hladnjaku možete primijetiti male bezbojne čestice u otopini lijeka NutropinAq.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {BLISTER}
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {BLISTER}
English: Absorption The absolute bioavailability of recombinant human growth hormone after subcutaneous administration is about 80%.
Croatian: Apsolutna bioraspoloživost rekombinantnog humanog hormona rasta nakon supkutane primjene iznosi približno 80%.
English: Shown below are the items necessary for giving an injection.
Croatian: U nastavku je prikazan pribor potreban za davanje injekcije.
English: Your doctor may need to adjust the dose of NutropinAq or of the other medicines: - Oestrogen taken orally or other sex hormones
Croatian: Liječnik će Vam možda trebati prilagoditi dozu lijeka NutropinAq ili drugih lijekova: - Estrogen koji uzimate na usta ili drugi spolni hormoni
English: This leaflet was last revised in <{Month/YYYY}>
Croatian: Ova uputa je zadnji puta revidirana u <{mjesec.GGGG}>
English: This continued to increase in those patients treated for 36 and 48 months.
Croatian: Taj trend je nastavljao rasti kod bolesnika liječenih tijekom 36 i 48 mjeseci.
English: If no drop of medicine appears, push the white reset button again.
Croatian: Ako se ne pojavi kapljica lijeka, ponovno pritisnite bijelo dugme za resetiranje.
English: One pivotal, multicentre, open label, controlled study has been conducted in Turner Syndrome.
Croatian: Jedno glavno, multicentrično, otvoreno, kontrolirano ispitivanje provedeno je kod Turnerova sindroma.
English: Read all the instructions for use carefully (on the reverse) before you start using NutropinAq Pen.
Croatian: Pažljivo pročitajte sve upute (na poleđini brizgalice) prije nego počnete koristiti brizgalicu NutropinAq.
English: What NutropinAq looks like and contents of the pack
Croatian: Kako NutropinAq izgleda i sadržaj pakiranja
English: In case of a tumour or re-growth of previous tumours (confirmed by your doctor), treatment with NutropinAq must be stopped immediately.
Croatian: U slučaju tumora ili ponovnog rasta prethodnih tumora (koje je dijagnosticirao Vaš liječnik) potrebno je odmah prekinuti liječenje lijekom NutropinAq.
English: Long-term treatment of monkeys during pregnancy and lactation and of newborn animals until adolescence, sexual maturity and reproduction did not indicate substantial disturbances of fertility, pregnancy, delivery, nursing or development of progeny.
Croatian: Dugoročno liječenje majmuna tijekom graviditeta i laktacije te novorođene mladunčadi do adolescencije, spolne zrelosti i razmnožavanja nije ukazalo na znatne smetnje u plodnosti, fertilitetu, porodu, dojenju ili razvoju potomstva.
English: After subcutaneous bolus administration, the mean terminal half-life t½ of somatropin is about 2.3 hours.
Croatian: Nakon supkutane bolus primjene, srednja vrijednost terminalnog poluživota t½ somatropina iznosio je 2,3 sata.
English: Under the proposed indications, the use of somatropin is not expected to result in an unacceptable risk to the environment.
Croatian: Ako se koristi u skladu s odobrenim indikacijama, ne očekuje se da će primjena somatropina uzrokovati neprihvatljivi rizik za okoliš.
English: • There may be an increased risk of developing an inflammation of the pancreas (pancreatitis) in children compared to adults treated with growth hormone.
Croatian: • Moguć je povećani rizik od razvoja upale gušterače (pankreatitisa) kod djece u usporedbi s odraslima koji su liječeni hormonom rasta.
English: Press the white reset button.
Croatian: Pritisnite bijelo dugme za resetiranje.
English: • A small number of growth hormones deficient patients treated with growth hormone have had leukaemia (blood cancer).
Croatian: • Mali broj bolesnika s nedostatkom hormona rasta koji su liječeni hormonom rasta dobili su leukemiju (rak krvi).
English: NutropinAq contains somatropin which is a recombinant growth hormone similar to the human's natural growth hormone made by your body.
Croatian: NutropinAq sadrži somatropin koji je rekombinantni hormon rasta sličan prirodnom ljudskom hormonu rasta kojeg stvara Vaše tijelo.
English: The adverse reactions reported in both adults and children receiving Nutropin, NutropinAq, Nutropin Depot or Protropin (somatrem) are listed in the table below, based on experience from clinical trials all approved indications (642 patients) and post-marketing sources which included a surveillance survey (National Cooperative Growth Study [NCGS] in 35,344 patients).
Croatian: Nuspojave prijavljene kod odraslih i djece koji primaju Nutropin, NutropinAq, Nutropin Depot ili Protropin (somatrem) navedene su u tablici u nastavku, a na temelju iskustva iz kliničkih ispitivanja svih odobrenih indikacija (642 bolesnika) i izvješća nakon stavljanja lijeka u promet koja su uključivala ankete praćenja (Američka nacionalna studija o rastu - National Cooperative Growth Study [NCGS] u 35 344 bolesnika).
English: Information about the pharmacokinetics of somatropin in elderly and paediatric populations, in different races or genders and in patients with renal or hepatic impairment is incomplete.
Croatian: Informacije o farmakokinetici somatropina u starijih i u pedijatrijskoj populaciji te u različitih rasa ili spolova kao i kod bolesnika s oštećenjem bubrega ili jetre nisu potpune.
English: Intracranial hypertension
Croatian: Intrakranijalna hipertenzija
English: NutropinAq is a solution for injection (in a cartridge (10 mg/2 ml) - pack size of 1, 3 and 6).
Croatian: NutropinAq je otopina za injekciju (u ulošku (10 mg/2 ml) - veličine pakiranja 1, 3 i 6).
English: • Clean the cartridge rubber seal with an alcohol swab or cotton ball saturated with alcohol.
Croatian: • Očistite gumeni čep uloška alkoholnom ili pamučnom vaticom natopljenom alkoholom.
English: This means that there is a risk that women, especially those on oral oestrogen therapy, are undertreated while men are over-treated.
Croatian: To znači da postoji rizik da su žene, posebice one na peroralnoj terapiji estrogenom, premalo liječene, dok su muškarci pretjerano liječeni.
English: Somatropin should not be used for growth promotion in patients with closed epiphyses.
Croatian: Somatropin se ne smije koristiti za poticanje rasta u bolesnika sa zatvorenim epifizama.
English: A: This ensures that the plunger push rod completely resets itself back to the starting position.
Croatian: O: Tako osiguravate da se potisni klip potpuno vrati na početni položaj.
English: For subsequent injections with the NutropinAq Pen, attach a new needle, push the white reset button and dial your dose.
Croatian: Za daljnje injekcije s NutropinAq brizgalicom, pričvrstite novu iglu, pritisnite bijelo dugme za resetiranje i odaberite svoju dozu.
English: Ask advice from you doctor before you stop using NutropinAq.
Croatian: Pitajte svog liječnika za savjet prije nego prestanete uzimati NutropinAq.
English: On the basis of the scientific conclusions for somatropin the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing somatropin is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za somatropin, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) somatropin nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Then turn the dose knob clockwise until the first click position is reached (approximately 1/4 turn).
Croatian: Potom okrenite dugme za doziranje u smjeru kazaljke na satu sve dok ne dosegnete položaj prvog klika (približno za 1/4 okreta).
English: The dosage scale located beside the window of the cartridge holder should not be used as a dose measurement.
Croatian: Dozirna ljestvica smještena pokraj prozorčića držača uloška ne smije se koristiti za mjerenje doze.
English: System Organ Class Reactions observed in Pivotal and Supportive Clinical Trials (in 642 patients)
Croatian: Reakcije primijećene u glavnom i suportivnim kliničkim ispitivanjima (u 642 bolesnika)