FrancophonIA/ELRC3.0 huggingface dataset:
English: A dose correction can be needed after six months of treatment (see section 4.4).
Slovenian: Prilagodi se ga lahko po šestih mesecih zdravljenja (glejte poglavje 4.4).
English: Somatropin also increases cardiac output, but the mechanism has yet to be clarified.
Slovenian: Somatropin prav tako zveča minutni srčni volumen, vendar njegov mehanizem še ni pojasnjen.
English: To verify growth disturbance, growth should be followed for a year preceding institution of therapy.
Slovenian: Da bi potrdili motnje rasti, je treba rast spremljati eno leto pred začetkom zdravljenja.
English: Experience with prolonged treatment in adults and in patients with PWS is limited.
Slovenian: Izkušenj s podaljšanim zdravljenjem odraslih in bolnikov s PWS je malo.
English: Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
Slovenian: Ženske utegnejo potrebovati večje odmerke od moških, kajti pri moških se občutljivost na IGF-I sčasoma zveča.
English: In children
Slovenian: Pri otrocih
English: However, there is no evidence of an increased risk of leukaemia without predisposition factors, such as radiation to the brain or head.
Slovenian: Vendar ni dokazov za povečano tveganje za levkemijo brez predispozicijskih dejavnikov, kot je obsevanje možganov ali glave.
English: The following is a general description of the reconstitution and administration process.
Slovenian: V nadaljevanju sledi splošni opis postopka rekonstitucije in uporabe.
English: Experience in patients with Silver-Russell syndrome is limited.
Slovenian: Izkušenj pri bolnikih s SilverRussellovim sindromom je malo.
English: In addition, the following actions have been demonstrated.
Slovenian: Ugotovili pa so še naslednje delovanje:
English: In children Omnitrope is used to treat the following growth disturbances:
Slovenian: Zdravilo Omnitrope se pri otrocih uporablja za zdravljenje naslednjih motenj v rasti:
English: In children such adverse reactions are uncommon.
Slovenian: Take neželene reakcije so pri otrocih občasne.
English: You should only be given this medicine by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.
Slovenian: Zdravilo vam sme dati samo zdravnik z izkušnjami v zdravljenju z rastnim hormonom, ki je vašo diagnozo potrdil.
English: It has the same structure as natural human growth hormone which is needed for bones and muscles to grow.
Slovenian: Po zgradbi je enak naravnemu človeškemu rastnemu hormonu, ki je potreben za rast kosti in mišic.
English: It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and thus do not require dose escalation.
Slovenian: Upoštevati je treba, da obstajajo bolniki s PRH, pri katerih se ravni IGF-I ne normalizirajo, kljub dobremu kliničnemu odzivu, zato odmerka ni treba povečati.
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.
Slovenian: Vaš zdravnik vam bo svetoval, kakšen je vaš individualni odmerek zdravila Omnitrope v miligramih (mg) na podlagi vaše telesne mase v kilogramih (kg) ali vaše telesne površine, ki jo bo izračunal iz vaše višine in telesne mase v kvadratnih metrih (m2), ter vam izdelal režim zdravljenja.
English: • Type 2 diabetes • A decrease in the levels of the hormone Cortisol in your blood
Slovenian: • sladkorna bolezen tipa 2 • znižanje ravni hormona kortizola v krvi
English: Tables 1-6 show the adverse reactions ranked under headings of System Organ Class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data) for each of the indicated conditions.
Slovenian: V preglednicah 1-6 so prikazani neželeni učinki, razvrščeni po organskih sistemih, z navedbo pogostnosti po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov) za vsako indicirano stanje.
English: Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates.
Slovenian: Zdravljenje je treba prekiniti, če je hitrost rasti < 2 cm/leto oz. če je kostna starost > 14 let (deklice) ali > 16 let (dečki), kar je v skladu z zapiranjem epifiznih rastnih ploščic.
English: It is therefore not recommended to initiate treatment near onset of puberty.
Slovenian: Zato se ne priporoča začetek zdravljenja tik pred začetkom pubertete.
English: Symptoms: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Slovenian: Simptomi: Akutno preveliko odmerjanje lahko najprej povzroči hipoglikemijo, pozneje pa hiperglikemijo.
English: Inject your growth hormone at about the same time every day.
Slovenian: Rastni hormon si vsak dan injicirajte ob istem času.
English: Leukaemia†
Slovenian: levkemija†
English: Literature data from untreated SGA children/adolescents without early spontaneous catch-up suggest a late growth of 0.5 SDS.
Slovenian: Podatki iz literature o nezdravljenih otrocih/mladostnikih, ki se rodijo MGS, brez zgodnjega spontanega približevanja, kažejo pozno rast 0,5 SSD.
English: A small percentage of patients may develop antibodies to Omnitrope.
Slovenian: Pri majhnem odstotku bolnikov se lahko razvijejo protitelesa za zdravilo Omnitrope.
English: The binding capacity of these antibodies has been low and no clinical changes have been associated with their formation, see section 4.4.
Slovenian: Sposobnost vezave teh protiteles je majhna in kliničnih sprememb, povezanih z njihovim nastajanjem, ni, glejte poglavje 4.4.
English: All other patients will require IGF-I assay and one growth hormone stimulation test.
Slovenian: Pri vseh drugih bolnikih je treba opraviti test IGF-I in en stimulacijski test rastnega hormona.
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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Other possible side effects related to your treatment with growth hormone may include the following: You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone.
Slovenian: Drugi možni neželeni učinki, povezani z zdravljenjem z rastnim hormonom, lahko vključujejo naslednje: pri vas (ali vašem otroku) se lahko pojavijo visoke ravni sladkorja v krvi ali znižane ravni ščitničnega hormona.
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.
Slovenian: Podatkov o farmakokinetičnih lastnostih somatropina pri starejših ljudeh in otrocih, pri različnih rasah ter pri bolnikih z ledvično, jetrno ali srčno insuficienco bodisi ni bodisi so nepopolni.
English: Remove the pen needle and dispose of it in accordance with local requirements.
Slovenian: Iglo peresnika odstranite in zavrzite v skladu z lokalnimi predpisi.
English: - Childhood onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Slovenian: - Začetek v otroštvu: pri bolnikih, ki so imeli pomanjkanje rastnega hormona v otroštvu zaradi prirojenega, genetskega, pridobljenega ali idiopatskega vzroka.
English: Clinical trials in PWS
Slovenian: Klinična preskušanja pri PWS
English: - Pull back on the plunger slowly and withdraw just a bit more than the dose prescribed by your doctor into the syringe.
Slovenian: - Počasi potiskajte bat nazaj in načrpajte v brizgo le nekoliko večjo količino, kot je odmerek, ki vam ga je predpisal zdravnik.
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).
Slovenian: Najprimernejša mesta za injiciranje so tkiva s plastjo maščobe med kožo in mišicami, npr. stegno ali trebuh (razen popka ali pasu).
English: If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment.
Slovenian: Če se potrdi hudo pomanjkanje rastnega hormona, bo vaš zdravnik predlagal nadaljevanje zdravljenja z zdravilom Omnitrope.
English: For instructions for use and handling see section 6.6.
Slovenian: Za navodila za pripravo in ravnanje z zdravilom glejte poglavje 6.6.
English: For monitoring, the attainment of a normal peak bone mass defined as a T score > -1 (i.e. standardized to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic objectives during the transition period.
Slovenian: Za nadziranje je doseg normalne najvišje kostne mase, opredeljene kot seštevek T > -1 (tj. standardizirano na povprečno odraslo najvišjo kostno maso, izmerjeno z dvoenergetsko rentgensko absorpciometrijo z upoštevanjem spola in etnične pripadnosti), eden od ciljev zdravljenja v prehodnem obdobju.
English: Omnitrope is a recombinant human growth hormone (also called somatropin).
Slovenian: Zdravilo Omnitrope je rekombinantni humani rastni hormon (imenovan tudi somatropin).
English: Oedema peripheral*
Slovenian: periferni edem*
English: In adults as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.
Slovenian: Pri odraslih in tudi pri otrocih vzdržuje normalno zgradbo organizma tako, da povečuje retenco dušika in spodbuja rast skeletnih mišic, ter z mobilizacijo telesne maščobe.
English: • If you have Prader-Willi syndrome (a chromosomal disorder).
Slovenian: • če imate Prader-Willijev sindrom (kromosomska motnja).
English: Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Slovenian: Po prvem letu zdravljenja je treba zdravilo prenehati uporabljati, če je SSD hitrosti rasti manj kot +1.
English: Your doctor may need to adjust the dose of Omnitrope or of the other medicines:
Slovenian: Zdravnik bo morda moral prilagoditi odmerek zdravila Omnitrope ali drugih zdravil:
English: • Your doctor will check your blood sugar and insulin levels before the start of treatment and every year during treatment.
Slovenian: • Vaš zdravnik bo preverjal ravni sladkorja v krvi in insulina, preden se začnete zdraviti in nato vsako leto med zdravljenjem.
English: Reduced serum cortisol levels
Slovenian: Zmanjšanje ravni kortizola v serumu
English: If you inject much more than you should, contact your doctor or pharmacist as soon as possible.
Slovenian: Če ste si injicirali večji odmerek, kot bi smeli, se čim prej posvetujte s svojim zdravnikom ali farmacevtom.
English: Dose recommendations in paediatric patients
Slovenian: Priporočeno odmerjanje pri pediatričnih bolnikih
English: • Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome)
Slovenian: • bolečina ali pekoč občutek v rokah ali podlahteh (znana kot sindrom karpalnega kanala)
English: If you use more Omnitrope than you should
Slovenian: Če ste uporabili večji odmerek zdravila Omnitrope, kot bi smeli
English: Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth disorders.
Slovenian: Diagnozo in zdravljenje s somatropinom mora začeti in nadzirati zdravnik, ki je ustrezno usposobljen in ima izkušnje pri diagnosticiranju in obravnavanju bolnikov z motnjami rasti.
English: Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into the upper range of normal, not exceeding the 2 SDS.
Slovenian: Bolniki z normalnimi koncentracijami IGF-I na začetku zdravljenja prejemajo rastni hormon do zgornje meje normalne vrednosti IGF-I, ki ne presega 2 SDS.
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.
Slovenian: Rastni hormone poviša ekstratiroidno pretvorbo T4 v T3, kar lahko povzroči zmanjšanje serumske vrednosti T4 in zvečanje koncentracije T3.
English: Because of the presence of benzyl alcohol the medicinal product must not be given to premature babies or neonates.
Slovenian: Zaradi vsebnosti benzilalkohola se zdravila ne sme dajati nedonošenčkom ali novorojencem.
English: Keep a note of any missed injections and tell your doctor at your next check-up.
Slovenian: Zabeležite si morebitne izpuščene injekcije in to ob naslednjem pregledu predložite svojemu zdravniku.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na ml, kar v bistvu pomeni »brez natrija«.
English: • thyroid hormones,
Slovenian: • ščitnične hormone,
English: Children born small or too light at birth
Slovenian: Otroci, ki se rodijo premajhni ali prelahki
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.
Slovenian: Očistek učinkovin, ki se presnavljajo s pomočjo citokroma P 450 3A4 (na primer spolni steroidi, kortikosteroidi, antikonvulzivi in ciklosporin), se lahko posebej zveča, zaradi česar se zmanjša njihova plazemska koncentracija.
English: At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.
Slovenian: Trenutno ni dovolj dokazov za pripravo priporočil glede nadaljevanja zdravljenja z rastnim hormonom pri bolnikih z odpravljeno intrakranialno hipertenzijo.
English: The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you.
Slovenian: Odmerek je odvisen od vaše velikosti, bolezni, zaradi katere se zdravite, in od učinka, ki ga ima rastni hormon na vas.
English: Nevertheless, corticosteroid replacement therapy should be optimised before initiation of therapy.
Slovenian: Kljub temu pa je treba pred uvedbo zdravljenja optimirati nadomestno zdravljenje s kortikosteroidom.
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.
Slovenian: Ali se somatropin izloča v mleko, ni znano, toda verjetnost absorpcije nespremenjene beljakovine iz dojenčkovih prebavil je izjemno majhna.
English: Mortality was higher in patients treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%.
Slovenian: Umrljivost je bila večja pri bolnikih, ki so se zdravili s 5,3 mg ali 8 mg somatropina na dan, kot pri bolnikih, ki so dobivali placebo (42 % proti 19 %).
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.
Slovenian: Drugi neželeni učinki zdravila se lahko obravnavajo kot učinki zdravil razreda somatropina, kot so na primer možna hiperglikemija zaradi zmanjšane občutljivosti na insulin, zmanjšane ravni prostega tiroksina in benigna intrakranialna hipertenzija.
English: The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in a different place each time.
Slovenian: Koža okoli mesta injiciranja lahko postane neravna ali bulasta, toda če si zdravilo injicirate vsakič na drugo mesto, se to ne bi smelo zgoditi.
English: • During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.
Slovenian: • Med zdravljenjem vas bo zdravnik pregledal, da ugotovi morebitne znake skolioze, vrste deformacije hrbtenice.
English: Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01.
Slovenian: Farmakoterapevtska skupina: hormoni sprednjega režnja hipofize in sorodne učinkovine, oznaka ATC: H01AC01.
English: - Growth disturbance associated with Turner syndrome.
Slovenian: - Motnje pri rasti, povezane s Turnerjevim sindromom.
English: Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
Slovenian: Kjer se PRH, ki se je začelo v otroštvu, nadaljuje v adolescenco, je treba zdravljenje nadaljevati, da se doseže celovit somatski razvoj (npr. sestava telesa, kostna masa).
English: During this period, conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism and nutritional status) should have been established and should be maintained during treatment.
Slovenian: V tem času je treba začeti konzervativno zdravljenje ledvične insuficience (ki vključuje nadzor acidoze, hiperparatiroidizma in prehranjenosti) in ga nadaljevati med zdravljenjem.
English: Scoliosis is common in patients with PWS.
Slovenian: Skolioza je pri bolnikih s PWS pogosta.
English: - If the solution is cloudy (and the cloudiness does not disappear within ten minutes) or contains particles, it should not be used.
Slovenian: - Če je raztopina motna (in motnost ne izgine v 10 minutah) ali vsebuje delce, je ne smete uporabiti.
English: Consequently monitoring of thyroid function should therefore be conducted in all patients.
Slovenian: Posledično je treba pri vseh bolnikih nadzirati delovanje ščitnice.
English: In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
Slovenian: Pri bolnikih s PWS mora biti zdravljenje vedno v kombinaciji s prehrano z manjšim vnosom kalorij.
English: Both are rapidly increased after treatment with somatropin.
Slovenian: Obe vrednosti se po zdravljenju s somatropinom hitro zvečata.
English: Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
Slovenian: Uvedba zdravljenja s somatropinom lahko povzroči zaviranje 11βHSD-1 in zmanjšanje koncentracij kortizola v serumu.
English: In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean.
Slovenian: V obeh primerih je cilj zdravljenja doseči koncentracijo insulinu podobnega rastnega dejavnika (IGFI) znotraj 2 SDS s starostno korekcijo srednje vrednosti.
English: some of whom have been treated with somatropin.
Slovenian: pri čemer so bili nekateri zdravljeni s somatropinom.
English: • oestrogen taken orally or other sex hormones,
Slovenian: • estrogen, ki se ga jemlje peroralno, ali drugi spolni hormoni,
English: - Insert the needle into the skin in the way your doctor has taught you.
Slovenian: - Iglo zapičite v kožo tako, kot vam je pokazal zdravnik.
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.
Slovenian: Učinke somatropina na izboljšanje stanja so preučevali v dveh s placebom kontroliranih preskušanjih, v kateri je bilo vključenih 522 kritično bolnih odraslih bolnikov z zapleti po kirurškem posegu na odprtem srcu, abdominalnem kirurškem posegu, večkratnih nezgodnih poškodbah ali akutni pljučni odpovedi.
English: In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.
Slovenian: Pri otrocih, ki so preživeli raka, so poročali o povečanem tveganju za sekundarne novotvorbe pri bolnikih, zdravljenih s somatropinom po svoji prvi novotvorbi.
English: - Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
Slovenian: - Motnje rasti (vrednost standardnega odklona (SDS, Standard Deviation Score) trenutne višine < -2,5 in SDS višine, korigirane glede na starše < -1) pri majhnih otrocih/mladostnikih, ki so se rodili majhni za svojo gestacijsko starost (MGS) s porodno maso in/ali dolžino manj kot -2 standardni deviaciji (SD), in ki niso dosegli ustrezne rasti (SDS hitrosti rasti (HR) < 0 v zadnjem letu) pri starosti 4 leta ali več.
English: There have been reports of fatalities associated with the use of growth hormone in paediatric patients with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified respiratory infection.
Slovenian: Obstajajo poročila o smrtnih primerih, povezanih z uporabo rastnega hormona pri otrocih s PWS, ki so imeli enega ali več od naslednjih dejavnikov tveganja: čezmerna debelost (bolniki, ki razmerje telesna masa/višina presegajo za 200 %), motnje dihanja v anamnezi ali apneja v spanju ali neugotovljena okužba dihal.
English: If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be increased to maintain the serum IGF-1 levels within the normal age-appropriate range.
Slovenian: Če se ženska, ki jemlje somatropin, začne zdraviti s peroralnimi estrogeni, bo odmerek somatropina morda treba povečati, da se vrednosti serumskega IGF-1 ohranijo v normalnem starostno primernem razponu.
English: This dosage should be gradually increased according to blood test results as well as clinical response and side effects.
Slovenian: Ta odmerek se lahko postopoma povečuje glede na rezultate krvnih preiskav, klinični odziv in neželene učinke.
English: Patients limping during treatment with somatropin should be examined clinically.
Slovenian: Bolnike, ki med zdravljenjem s somatropinom šepajo, je treba klinično pregledati.
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.
Slovenian: - Bodite pozorni na to, da si zdravilo injicirate najmanj 1 cm stran od mesta zadnjega injiciranja in da zamenjate mesto injiciranja, kot so vas naučili.
English: Do not use if the solution is cloudy or contains particles.
Slovenian: Raztopine ne uporabljajte, če je motna ali vsebuje delce.
English: Somatropin must not be used when there is any evidence of activity of a tumour.
Slovenian: Somatropina se ne sme uporabljati, če obstajajo znaki dejavnega tumorja.
English: What Omnitrope is and what it is used for
Slovenian: Kaj je zdravilo Omnitrope in za kaj ga uporabljamo
English: Do not pass it on to others.
Slovenian: Svojega peresnika ne dajajte drugim.
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.
Slovenian: Pri vseh bolnikih, pri katerih se je pojavila druga ali podobna akutna kritična bolezen, je treba pretehtati morebitno korist zdravljenja s somatropinom v primerjavi z morebitnim tveganjem.
English: Do your injection in the place you have been shown by your doctor.
Slovenian: Injicirajte si ga na mesto, ki vam ga pokaže zdravnik.
English: Water and mineral metabolism
Slovenian: Presnavljanje vode in mineralov
English: Follow the Instructions for Use of the pen injector.
Slovenian: Upoštevajte navodila za uporabo peresnika za injiciranje.