FrancophonIA/ELRC3.0 huggingface dataset:
English: Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.
Croatian: Liječenje somatropinom treba nastaviti kod djece i adolescenata sve do zatvaranja njihovih epifiza.
English: Set the required dose by turning the black dose knob.
Croatian: Podesite željenu dozu okretanjem crnog dugmeta za doziranje.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane od ozbiljnijih prema manje ozbiljnim.
English: These could be symptoms of a temporary increase in pressure within the brain (intracranial hypertension).
Croatian: To mogu biti simptomi privremenog porasta pritiska u mozgu (intrakranijalna hipertenzija).
English: Growth Hormone (GH) is a chemical messenger made by a small gland in your brain called the pituitary.
Croatian: Hormon rasta je kemijski glasnik kojeg proizvodi mala žlijezda u Vašem mozgu zvana hipofiza.
English: Treatment with NutropinAq is a long-term therapy.
Croatian: Liječenje lijekom NutropinAq je dugoročno.
English: For further information ask your doctor.
Croatian: Obratite se liječniku za više informacija.
English: 2 ml of solution in a cartridge (Type I glass) closed with a stopper (butyl rubber) and a seal (rubber).
Croatian: 2 ml otopine u ulošku (staklo tipa I) zatvorenom čepom (butilna guma) i zaštitnim zatvaračem (guma).
English: Thus, the greatest improvement in adult height was observed in patients who received early GH treatment and oestrogen after age 14 years.
Croatian: Stoga je najveće poboljšanje kod postizanje očekivane visine za odraslu dob uočeno kod bolesnika koji su primali rano liječenje hormonom rasta i estrogen nakon 14. godine.
English: This is reflected by nitrogen retention as demonstrated by a decline in urinary nitrogen excretion and blood urea nitrogen during growth hormone therapy.
Croatian: To se odražava retencijom dušika kako je prikazano padom izlučivanja dušika urinom i smanjenjem razine ureje u krvi tijekom liječenja hormonom rasta.
English: When travelling, place your pen case in a cooler.
Croatian: Kada putujete držite svoju kutiju s brizgalicom u rashlađivaču.
English: Enlarged tonsils leading to snoring, difficulty breathing or swallowing, brief interruption of breathing during sleep (sleep apnea), or fluid in the ear, as well as infections of the ear.
Croatian: Uvećane tonzile uzrokuju hrkanje, otežano disanje ili gutanje, kratki prekid disanja tijekom sna (apneja u snu) ili tekućinu u uhu kao i infekcije uha.
English: A: Your NutropinAq Pen should be stored in the case, inside a refrigerator when a cartridge is inserted.
Croatian: O: NutropinAq brizgalicu treba čuvati u kutiji, unutar hladnjaka kad je umetnut uložak.
English: Talk to you doctor or pharmacist before using NutropinAq.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite NutropinAq.
English: One cartridge contains 10 mg (30 IU) of somatropin * Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
Croatian: Jedan uložak sadrži 10 mg (30 IU) somatropina * Somatropin je ljudski hormon rasta proizveden tehnologijom rekombinantne DNK u stanicama Escherichiae coli.
English: • If during growing, a limp or hip or knee pain develops, ask the doctor for advice.
Croatian: • Ako se tijekom rasta razvije šepanje ili bol u kuku ili koljenu, obratite se liječniku za savjet.
English: • Do not store the NutropinAq Pen with needle attached.
Croatian: • Nemojte čuvati brizgalicu NutropinAq s pričvršćenom iglom.
English: What NutropinAq contains
Croatian: Što NutropinAq sadrži
English: The binding capacity of growth hormone antibodies was lower than 2 mg/l in NutropinAq subjects tested, which has not been associated with adversely affected growth rate.
Croatian: Kapacitet vezivanja protutijela na hormon rasta bio je niži od 2 mg/l kod ispitanika koji su primali NutropinAq što nije bilo povezano s negativnim utjecajima na hormon rasta.
English: The solution for multidose use is clear and colourless.
Croatian: Otopina za višedoznu primjenu je bistra i bezbojna.
English: Cell growth: Treatment with somatropin results in an increase in both the number and size of skeletal muscle cells.
Croatian: 2. Rast stanica: Liječenje somatropinom rezultira u porastu i broja i veličine stanica poprečnoprugastih mišića.
English: Q: Why do I have to rewind the black dose knob on my NutropinAq Pen every time I replace the cartridge?
Croatian: P: Zašto moram vratiti unatrag crno dugme za doziranje na svojoj NutropinAq brizgalici svaki put kada mijenjam uložak?
English: If the solution is cloudy or hazy or contains any solid matter, the cartridge should not be used.
Croatian: Ako je otopina zamućena ili mutna ili sadrži krute čestice, uložak se ne smije koristiti.
English: However, growth hormone treatment has not been shown to increase the incidence or severity of scoliosis.
Croatian: Međutim, nije utvrđeno da liječenje hormonom rasta povećava incidenciju ili ozbiljnost skolioze.
English: A: The NutropinAq Pen is designed to last 24 months from the time you first use your pen.
Croatian: O: NutropinAq brizgalica dizajnirana je kako bi trajala barem 24 mjeseca od prve uporabe.
English: Serum concentration of inorganic phosphorus are increased in patients with growth hormone deficiency after NutropinAq therapy due to metabolic activity associated with bone growth and increased tubular reabsorption in the kidney.
Croatian: Serumske koncentracije anorganskog fosfora povećavaju se kod bolesnika s nedostatkom hormona rasta nakon liječenja lijekom NutropinAq zbog metaboličke aktivnosti povezane s rastom kostiju i povećanom tubularnom reapsorpcijom u bubrezima.
English: Rare: Gynaecomastia
Croatian: Rijetko: ginekomastija
English: Return the cartridge to your pharmacist or prescribing doctor.
Croatian: Vratite uložak ljekarniku ili liječniku koji Vam je propisao lijek.
English: Of the 3 patients with a central nervous system tumour, 2 patients experienced a recurrent medulloblastoma and 1 patient experienced a histiocytoma.
Croatian: Od tri bolesnika s tumorom središnjeg živčanog sustava, dva su bolesnika imala recidiv meduloblastoma, a jedan je bolesnik imao histiocitom.
English: Since somatropin therapy following renal transplantation has not been adequately tested, NutropinAq treatment should be terminated after that surgery.
Croatian: S obzirom da liječenje somatropinom nakon transplantacije bubrega nije ispitano na odgovarajući način, nakon takvog kirurškog zahvata potrebno je prekinuti liječenje NutropinAq.
English: If you have diabetes and associated severe/worsening eye disease you should not be treated with NutropinAq.
Croatian: Ako imate dijabetes i popratno pogoršanje bolesti/tešku bolest očiju ne smijete se liječiti lijekom NutropinAq.
English: Patients received an s.c. dose of 0.125 mg/kg three times a week or 0.054 mg/kg/day, both regimens giving a cumulative weekly dose of approximately 0.375 mg/kg.
Croatian: Bolesnici su primili supkutanu dozu od 0,125 mg/kg tri puta tjedno ili 0,054 mg/kg/dan, a oba režima dala su kumulativnu tjednu dozu od približno 0,375 mg/kg.
English: Growth hormone deficiency should be confirmed appropriately prior to treatment.
Croatian: Nedostatak hormona rasta treba potvrditi na odgovarajući način prije početka samog liječenja.
English: You should consult your doctor regularly as you may need adjustment of your glucocorticoid dose.
Croatian: Morate redovito posjećivati svog liječnika jer će Vam možda biti potrebno prilagoditi dozu glukokortikoida.
English: You have to inject NutropinAq every day under the skin (subcutaneous injection).
Croatian: NutropinAq svaki dan pod kožu (supkutana injekcija).
English: To guard against the spread of infection, follow these safety measures:
Croatian: Pridržavajte se ovih sigurnosnih mjera kako biste se zaštitili od širenja infekcije:
English: Patients with inadequate growth hormone secretion sometimes experience fasting hypoglycaemia that is improved by treatment with somatropin.
Croatian: Bolesnici s neodgovarajućim lučenjem hormona rasta ponekad osjete hipoglikemiju natašte koja se poboljšava uz liječenje somatropinom.
English: The pharmacokinetic properties of NutropinAq have only been investigated in healthy adult males.
Croatian: Farmakokinetička svojstva lijeka NutropinAq ispitana su samo na zdravim odraslim muškim dobrovoljcima.
English: NutropinAq reduces insulin sensitivity; glucose tolerance impairment was reported in both the pivotal and supportive clinical trials and the post-marketing surveillance survey.
Croatian: NutropinAq smanjuje osjetljivost na inzulin; oštećenje tolerancije na glukozu prijavljeno je i u glavnom i u suportivnim kliničkim ispitivanjima te u izvješćima nakon stavljanja lijeka u promet
English: In adults NutropinAq is used for:
Croatian: Kod odraslih se NutropinAq koristi:
English: Decrease in the number of red blood cells in the blood (anaemia), decrease in blood sugar level (hypoglycaemia) and increase in phosphate levels (hyperphosphatemia).
Croatian: Pad broja crvenih krvnih stanica (anemija), pad razine šećera u krvi (hipoglikemija) i porast razine fosfata u krvi (hiperfosfatemija).
English: • If your body does not make enough growth hormone as an adult.
Croatian: • ako Vaše tijelo, u odrasloj dobi, ne stvara dovoljno hormona rasta.
English: In children it tells the body to grow, help the bones to develop normally and, in later adult life, GH helps to maintain a normal body shape and metabolism.
Croatian: Kod djece ovaj hormon diktira rast, potpomaže normalan razvoj kostiju i kasnije u odraslom životu potpomaže održati normalan oblik tijela i metabolizam.
English: The NutropinAq Pen allows for administration of a minimum dose of 0.1 mg to a maximum dose of 4.0 mg, in 0.1 mg increments.
Croatian: NutropinAq omogućava primjenu minimalne doze od 0,1 mg do maksimalne doze od 4,0 mg u koracima od 0,1 mg.
English: If you inject too much NutropinAq, your blood sugar level may decrease and become too low and then rise too high (hyperglycaemia).
Croatian: Ako ubrizgate previše lijeka NutropinAq, razine šećera u Vašoj krvi mogu pasti i postati preniske, a potom previsoke (hiperglikemija).
English: * Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
Croatian: * Somatropin je ljudski hormon rasta proizveden tehnologijom rekombinantne DNK u stanicama Escherichiae coli.
English: Vomiting, stomach pain, wind (flatulence) and feeling of sickness (nausea).
Croatian: Povraćanje, bol u trbuhu, vjetrovi (flatulencija) i osjećaj gađenja (mučnina).
English: Torre Realia, Plaza de Europa, 41-43 08908 L'Hospitalet de Llobregat, Barcelona Tel: + 34 - 936 - 858 100
Croatian: Torre Realia, Plaza de Europa, 41-43 08908 L'Hospitalet de Llobregat Barcelona
English: Blanchardstown Industrial Park Blanchardstown Dublin 15, Ireland Tel: +353 (0) 1 809 8256
Croatian: Ipsen Pharmaceuticals Limited Blanchardstown Industrial Park Blanchardstown Dublin 15, Ireland Tel: +353 (0) 1 809 8256
English: In children with chronic renal insufficiency:
Croatian: Kod djece s kroničnom bubrežnom insuficijencijom:
English: Q: What should I do if I drop my NutropinAq Pen?
Croatian: P: Što moram učiniti ako ispustim svoju NutropinAq brizgalicu?
English: However, no cause and effect relationship with growth hormone treatment has been proven.
Croatian: Međutim, nije dokazan uzročno-posljedični odnos s liječenjem hormonom rasta.
English: Twist off the needle and discard it properly.
Croatian: Odvrnite iglu i pravilno je zbrinite.
English: Q: Can I store my NutropinAq Pen in the freezer?
Croatian: P: Mogu li čuvati svoju NutropinAq brizgalicu u zamrzivaču?
English: Two pivotal, multicentre, placebo-controlled, double-blind studies have been conducted in patients diagnosed with adult growth hormone deficiency (AGHD), one in adult-onset AGHD (n=166) and the other in childhood-onset AGHD (n=64).
Croatian: Dva glavna multicentrična, placebom kontrolirana, dvostruko slijepa ispitivanja provedena su kod bolesnika kojima je dijagnosticiran nedostatak hormona rasta kod odraslih, jedno kod osoba kod kojih se nedostatak pojavio u odrasloj dobi (n=166) i drugo kod osoba kod kojih se nedostatak hormona pojavio u djetinjstvu (n=64).
English: Protein metabolism
Croatian: Metabolizam proteina
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 morate se redovito kontrolirati kod svog liječnika jer će Vam možda biti potrebno prilagoditi dozu glukokortikoida.
English: If you have an underactive thyroid gland leading to low levels of thyroid hormone (hypothyroidism) it should be treated before you start NutropinAq treatment.
Croatian: Ako imate slab rad štitnjače što uzrokuje niske razine tiroidnih hormona (hipotireoza) trebate se liječiti prije nego počnete primati NutropinAq.
English: Children treated with somatropin have an increased risk of developing pancreatitis compared to adults treated with somatropin.
Croatian: Djeca liječena somatropinom imaju povećani rizik od razvoja pankreatitisa u usporedbi s odraslim bolesnicima.
English: Limited published data suggest that the plasma clearance and average steady-state plasma concentration of somatropin may not be different between young and elderly patients.
Croatian: Ograničeni objavljeni podaci ukazuju da je moguće da nema razlike u plazmatskom klirensu i prosječnim ravnotežnim koncentracijama somatropina između mlađih i starijih bolesnika.
English: Reduced ability to absorb sugar (glucose) from your blood leading to high blood sugar levels (hyperglycemia).
Croatian: Smanjena sposobnost apsorpcije šećera (glukoze) iz krvi uzrokuje visoke razine šećera u krvi (hiperglikemija).
English: - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion.
Croatian: - Dugoročno liječenje djece sa zastojem rasta zbog neodgovarajućeg lučenja endogenog hormona rasta.
English: Somatropin therapy should be continued in children and adolescents until their epiphysis are closed, or up to the time of renal transplantation.
Croatian: Liječenje somatropinom treba nastaviti kod djece i adolescenata sve dok se njihove epifize ne zatvore ili do trenutka transplantacije bubrega.
English: Rare: Tonsillar hypertrophy Uncommon: Adenoidal hypertrophy
Croatian: Rijetko: hipertrofija tonzila Manje često: hipertrofija adenoida
English: Childhood-onset: Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started.
Croatian: Početak bolesti u dječjoj dobi: Bolesnike koji su kao djeca imali nedostatak hormona rasta treba ponovno ispitati kako bi se potvrdio nedostatak hormona rasta u odrasloj dobi prije početka nadomjesne terapije s lijekom NutropinAq.
English: Intracranial hypertension was reported in the post-marketing surveillance survey.
Croatian: Intrakranijalna hipertenzija prijavljena je u izvješćima nakon stavljanja lijeka u promet.
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 terapiji estrogenom možda će biti potrebna viša doza hormona rasta kako bi se postigao cilj liječenja (vidjeti dio 4.4).
English: Serum calcium is not significantly altered by somatropin.
Croatian: Somatropin ne mijenja znatno serumski kalcij.
English: However, no somatropin accumulation has been reported in children with chronic renal failure or end-stage renal disease dosed with current regimens.
Croatian: No, nije zabilježena akumulacija somatropina kod djece s kroničnim zatajenjem bubrega ili završnim stadijem bubrežne bolesti koji su na aktualnom režimu doziranja.
English: Girls with Turner syndrome commonly reported abnormally heavy bleeding at menstruation.
Croatian: Kod djevojčica s Turnerovim sindromom česta su nenormalno obilna krvarenja prilikom menstruacije.
English: Skeletal growth: growth hormone and its mediator IGF-I stimulate skeletal growth in growth hormone deficient children by an effect on the epiphyseal plates of long bones.
Croatian: Rast kostura: hormon rasta i njegov medijator IGF-I stimuliraju rast kostura kod djece s nedostatkom hormona rasta učinkom na epifizne zone rasta dugih kostiju.
English: They are more likely to develop increased pressure in the brain (intracranial hypertension), with the greatest risk at the beginning of treatment, although children with organic growth hormone deficiency and Turner syndrome also have an increased incidence.
Croatian: Takva su djeca sklonija razviju pritiska u mozgu (intrakranijalna hipertenzija) s najvećim rizikom takvih događaja na početku liječenja, iako djeca s organskim nedostatkom hormona rasta i Turnerovim sindromom također imaju povećanu incidenciju.
English: Fundoscopic examination is recommended at the initiation and periodically during the course of treatment.
Croatian: Pregled fundoskopom preporučuje se na početku liječenja te periodički tijekom liječenja.
English: What NutropinAq is and what it is used for What you need to know before you use NutropinAq How to use NutropinAq
Croatian: Što je NutropinAq i za što se koristi Što morate znati prije nego počnete primjenjivati NutropinAq Kako primjenjivati NutropinAq Moguće nuspojave
English: There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Croatian: Također postoje izvješća o apneji u snu i iznenadnoj smrti nakon početka liječenja hormonom rasta kod pedijatrijskih bolesnika s Prader-Willi sindromom koji su imali jedan ili više sljedećih faktora rizika: tešku pretilost, opstrukcije gornjih dišnih putova ili apneje u snu u anamnezi ili neidentificiranu infekciju dišnih putova.
English: The effects of growth hormone on recovery were studied in two placebo-controlled clinical trials involving 522 adult patients who were critically ill due to complications following open-heart or abdominal surgery, multiple accidental traumas, or who were having acute respiratory failure.
Croatian: Učinci hormona rasta na oporavak proučavani su u dva placebom kontrolirana klinička ispitivanja koja su uključivala 522 odrasla bolesnika koji su bili kritično bolesni zbog komplikacija nakon kirurških zahvata na otvorenom srcu ili abdomenu, višestrukih ozljeda u nesrećama ili koji su imali akutno zatajenje disanja.
English: Pain, bleeding, bruising, rash and itching at the site of injection.
Croatian: Bol, krvarenje, nastanak modrica, osip i svrbež na mjestu injekcije.
English: Contact your doctor or nurse for a replacement if either the pen or cartridge does not work.
Croatian: Obratite se svom liječniku ili medicinskoj sestri za zamjenu ako brizgalica ili uložak ne rade ispravno.
English: IGF-I levels, which were low at study entry, were restored to within the normal range with somatropin therapy.
Croatian: Razine IGF-I, koje su bile niske prilikom ulaska u ispitivanje, terapijom vraćene su unutar normalnog raspona.
English: NutropinAq is designed to withstand a nominal (one hour maximum) period of time outside of the refrigerator on a daily basis.
Croatian: NutropinAq osmišljen je kako bi izdržao svakodnevno uobičajeno razdoblje (najduže jedan sat) izvan hladnjaka.
English: Tell your doctor immediately if you experience visual changes, bad or frequent headaches, associated with feeling sick (nausea) or vomiting.
Croatian: Odmah obavijestite svog liječnika ako imate problema s vidom, teške ili učestale glavobolje povezane s mučninom ili povraćanjem.
English: Somatropin induces retention of sodium, potassium and phosphorus.
Croatian: Somatropin uzrokuje retenciju natrija, kalija i fosfora.
English: Although rare, pancreatitis should be considered in somatropintreated children who develop abdominal pain.
Croatian: Iako je rijedak, pankreatitis treba uzeti u obzir kod djece koja se liječe somatropinom, a imaju bolove u abdomenu.
English: The NutropinAq is designed to withstand a nominal (one hour maximum) period of time outside of the refrigerator on a daily basis.
Croatian: NutropinAq osmišljen je kako bi izdržao svakodnevno uobičajeno razdoblje (maksimalno sat vremena) izvan hladnjaka.
English: This side effect is uncommon, it may affect up to 1 in 100 patients.
Croatian: Ova nuspojava je manje česta i može zahvatiti do jednog na 100 bolesnika.
English: Your NutropinAq Pen works without shields.
Croatian: Vaša NutropinAq brizgalica djeluje bez štitnika.
English: Growth hormone deficiency
Croatian: Nedostatak hormona rasta
English: Do not use this medicine after the expiry date which is stated on the label of the cartridge and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici uloška i kutiji iza oznake „Rok valjanosti“.
English: Organ growth: Growth hormone increases the size of internal organs, including kidneys, and increases red blood cell mass.
Croatian: Rast organa: Hormon rasta povećava veličinu unutarnjih organa, uključujući i bubrege kao i porast mase eritrocita.
English: Conversely, if a woman on NutropinAq discontinues oral oestrogen therapy, the dose of NutropinAq may need to be reduced to avoid excess of growth hormone and/or side effects (see section 4.5).
Croatian: Suprotno tomu, ako žena koja uzima NutropinAq prekine peroralnu terapiju estrogenom, dozu lijeka NutropinAq možda će biti potrebno smanjiti kako bi se izbjegao višak hormona rasta i/ili nuspojave (vidjeti dio 4.5).
English: Inspect all new cartridges prior to use.
Croatian: Prije uporabe pregledajte sve nove uloške.
English: In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked requiring glucocorticoid replacement therapy.
Croatian: Kod bolesnika liječenih somatropinom može se otkriti prethodno nedijagnosticirani središnji (sekundarni) hipoadrenalizam tako da može biti potrebna nadomjesna terapija glukokortikoidima.
English: Both the liver and the kidney have been shown to be important protein catabolising organs for growth hormone.
Croatian: Pokazalo se da su i jetra i bubrezi važni za proteinski katabolizam hormona rasta.
English: These changes were highly significant at the 12-month time point in both studies, and at the 24-month time point in the childhood-onset study.
Croatian: Te su promjene bilo izrazito značajne u 12. mjesecu u oba ispitivanja te u 24. mjesecu kod ispitivanja na odraslim bolesnicima kod kojih se nedostatak hormona pojavio u djetinjstvu.
English: The NutropinAq dosage and administration schedule should be individualised for each patient.
Croatian: Raspored doziranja i primjene lijeka NutropinAq treba prilagoditi svakom pojedinom bolesniku.
English: Increased heart rate (tachycardia) and high blood pressure (hypertension).
Croatian: Ubrzan rad srca (tahikardija) i povišeni krvni tlak. (hipertenzija).
English: In genotoxicity studies with other recombinant growth hormone preparations, there was no evidence of gene mutation in bacterial reverse mutation assays, chromosomal damage in human lymphocyte and mouse bone marrow cells, gene conversion in yeast or unscheduled DNA synthesis in human carcinoma cells.
Croatian: Nije provedeno ispitivanje kancerogenosti i genotoksičnosti s lijekom NutropinAq. Kod ispitivanja genotoksičnosti s drugim rekombinantnim pripravcima hormona rasta nije bilo dokaza mutacije gena u ispitivanjima reverzne bakterijske mutacije, oštećenja kromosoma na humanim limfocitima i stanicama koštane srži miševa, konverzije gena kod kvasca ili neplanirane sinteze DNK na humanim stanicama karcinoma.
English: Animal studies with somatropin showed that growth hormone localises to highly perfused organs, particularly the liver and kidney.
Croatian: Ispitivanja somatropina na životinjama pokazala su da se hormon rasta nakuplja u dobro prokrvljenim organima, posebice u jetri i bubrezima.