FrancophonIA/ELRC3.0 huggingface dataset:
English: Small bubbles may remain and will not affect the dose.
Slovenian: Drobni mehurčki lahko ostanejo in ne bodo vplivali na odmerek.
English: EXP: {date}
Slovenian: EXP: {številka}
English: If you are using the passive shield (or no shield) proceed to step 13.
Slovenian: Če uporabljate pasivni ščitnik (ali ščitnika ne uporabljate), nadaljujte s korakom 13.
English: Doses used in these US based studies are consistent with the US approved dose regimen.
Slovenian: Odmerki, uporabljeni v teh študijah, izvedenih v ZDA, so v skladu z odobrenim režimom odmerjanja v ZDA.
English: Your doctor or nurse will show you how to do this.
Slovenian: Zdravnik ali medicinska sestra vam bosta pokazala, kako to storiti.
English: Continue with your usual dosage the next day and tell your doctor at your next appointment.
Slovenian: Nadaljujte z uporabo običajnega odmerka naslednji dan in pri naslednjem pregledu o tem obvestite svojega zdravnika.
English: The average change in height SDS after 5 years of treatment was close to 2 standard deviations (SDs).
Slovenian: Povprečna sprememba vrednosti SDS telesne višine po 5 letih zdravljenja je blizu 2 standardnih odklonov (SD).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Scoliosis may progress in any child during rapid growth.
Slovenian: Skolioza lahko napreduje pri vsakem otroku s hitro rastjo.
English: The needle is only sterile on the first use.
Slovenian: Igla je sterilna samo ob prvi uporabi.
English: If you cannot dial the full dose, either start a new cartridge (as described in Part I), or inject the partial dose.
Slovenian: Če ne morete nastaviti polnega odmerka, lahko bodisi načnete nov vložek (kot je opisano v I. delu) bodisi injicirate delni odmerek.
English: If you accidentally turn it too far, go back one click (0.1 mg).
Slovenian: Če ga pomotoma preveč zasučete, pojdite en klik (0,1 mg) nazaj.
English: DO NOT INJECT THE MEDICINE UNTIL YOUR DOCTOR OR NURSE HAS THOROUGHLY TRAINED YOU IN THE PROPER TECHNIQUES.
Slovenian: NE INJICIRAJTE ZDRAVILA, DOKLER VAS ZDRAVNIK ALI MEDICINSKA SESTRA TEMELJITO NE NAUČITA PRAVILNEGA POSTOPKA.
English: • You may remove the pen and cartridge from the refrigerator up to 45 minutes prior to use.
Slovenian: • Injekcijski peresnik in vložek lahko vzamete iz hladilnika do 45 minut pred uporabo.
English: In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse.
Slovenian: Pri bolnikih s predhodno maligno boleznijo je treba posebno pozornost nameniti znakom in simptomom relapsa.
English: If necessary, remove the empty cartridge and discard it properly.
Slovenian: Če je potrebno, odstranite prazni vložek in ga pravilno zavrzite.
English: • Avoid excessive temperatures.
Slovenian: • Izogibajte se izjemnim temperaturam.
English: Q: Why do I keep my medication in the refrigerator?
Slovenian: V: Zakaj moram zdravilo hraniti v hladilniku?
English: In general, the lowest efficacious dose should be administered.
Slovenian: Praviloma je treba uporabljati najmanjši učinkoviti odmerek.
English: Reporting of suspected adverse reactions after authorization of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: Warning and Precautions
Slovenian: Opozorila in previdnostni ukrepi
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.
Slovenian: • Če ste v preteklosti imeli tumor (raka), posebej tumor, ki je vplival na možgane, vam mora zdravnik posvetiti posebno pozornost in vas redno pregledovati glede morebitne ponovitve tumorja.
English: < PC: {number} SN: {number} NN: {number}
Slovenian: PC: {številka} SN: {številka}
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.
Slovenian: Bolnice, mlajše od 11 let, so bili randomizirane tudi na zdravljenje z estrogenom, bodisi v pozni (pri starosti 15 let) ali zgodnji (pri starosti 12 let) adolescenci.
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 uporabite to zdravilo.
English: Each study had a two year treatment period which included a placebo arm, followed by an open label uncontrolled extension in which all patients received somatropin.
Slovenian: Vsaka študija je imela še dveletno obdobje zdravljenja, ki je vključevalo skupino s placebom, sledil pa je odprt nenadzorovan podaljšek, v katerem so vsi bolniki prejemali somatropin.
English: Press the white reset button.
Slovenian: Pritisnite beli nastavitveni gumb.
English: The solution for multidose use is clear and colourless.
Slovenian: Raztopina za večkratno uporabo je bistra in brezbarvna.
English: Pack sizes of 1, 3 and 6 cartridges.
Slovenian: Velikost pakiranja: 1, 3 ali 6 vložkov.
English: Somatropin should not be used for growth promotion in patients with closed epiphyses.
Slovenian: Somatropina se ne sme uporabljati za spodbujanje rasti pri bolnikih z zaprtimi epifizami.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
Slovenian: Ker so bila poročila o teh neželenih učinkih pridobljena spontano iz populacije neznane velikosti, njihove pogostnosti ni mogoče zanesljivo oceniti.
English: • in children if the bones have already stopped growing.
Slovenian: • pri otrocih, če je rast kosti že končana.
English: Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
Slovenian: Ženske lahko potrebujejo večje odmerke kot moški, pri čemer se občutljivost za IGF-I pri moških s časom povečuje.
English: Now you are ready to administer the dose.
Slovenian: Zdaj ste pripravljeni za injiciranje odmerka.
English: A: This ensures that the plunger push rod completely resets itself back to the starting position.
Slovenian: O: To zagotovi, da se potisni nosilec bata popolnoma vrne na začetni položaj.
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 the therapeutic indication of use.
Slovenian: Diagnozo in zdravljenje s somatropinom morajo začeti ter nadzorovati zdravniki, ki so ustrezno usposobljeni in izkušeni za diagnosticiranje in vodenje bolnikov z navedenimi terapevtskimi indikacijami.
English: Do not throw the larger cap away as it will be used later for proper needle removal and disposal.
Slovenian: Večjega pokrovčka ne vrzite proč, ker ga boste potrebovali za pravilno odstranitev in zavrženje igle.
English: Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Lumbar spine BMD had statistically significant increases in both treated groups, and the increase was dose dependent.
Slovenian: BMD ledvene hrbtenice se je statistično pomembno povečala v obeh skupinah zdravljenja, povečanje pa je bilo odvisno od odmerka.
English: Under the proposed indications, the use of somatropin is not expected to result in an unacceptable risk to the environment.
Slovenian: Uporaba somatropina v skladu s predlaganimi indikacijami ne predstavlja nesprejemljivega tveganja za okolje.
English: The clicks are only audible confirmation that the black dose knob has been moved.
Slovenian: Kliki so le slišna potrditev, da se je črni odmerni gumb premaknil.
English: Overall, 171 patients were exposed to somatropin for an average of 3.5 or 2.8 years.
Slovenian: Somatropinu je bilo tako izpostavljenih 171 bolnikov, in sicer v povprečju za 3,5 oziroma 2,8 let.
English: If the medicine does not appear within a few seconds, you may need to push the reset button again.
Slovenian: Če se zdravilo ne pojavi v nekaj sekundah, boste morali še enkrat pritisniti nastavitveni gumb.
English: Body composition
Slovenian: Telesna sestava
English: Your doctor may need to adjust the dose of NutropinAq or of the other medicines: - Oestrogen taken orally or other sex hormones
Slovenian: Zdravnik bo morda moral prilagoditi odmerek zdravila NutropinAq ali drugih zdravil: - Estrogen, ki se ga jemlje peroralno, ali drugi spolni hormoni.
English: This leaflet was last revised in <{Month/YYYY}>
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec/LLLL}
English: Batteries typically last 24 months and have a 4-week life from the time the „bt‟ first starts blinking.
Slovenian: Baterije praviloma trajajo 24 mesecev; od trenutka, ko začne prvič utripati oznaka ‘bt', pa trajajo še 4 tedne.
English: If you stop using NutropinAq too early or for too long, the results will not be as expected.
Slovenian: Če zdravilo NutropinAq prenehate uporabljati prezgodaj ali ga predolgo ne uporabljate, ne bodo doseženi pričakovani rezultati zdravljenja.
English: Follow the instructions in this section if you are using the pen for the first time or are replacing an empty cartridge.
Slovenian: Navodila v tej točki upoštevajte, če injekcijski peresnik uporabljate prvič ali če menjate prazen vložek.
English: Diabetes mellitus can lead to increased urination, thirst and hunger.
Slovenian: Sladkorna bolezen lahko povzroči pogostejše uriniranje, žejo in lakoto.
English: Metabolic alterations in these patients include normalisation of IGF-I serum levels.
Slovenian: Presnovne spremembe pri teh bolnikih vključujejo normalizacijo koncentracije IGF-I v serumu.
English: The incidence of these AEs was also high in the placebo groups.
Slovenian: Pojavnost teh neželenih učinkov je bila visoka tudi v skupini, ki je prejemala placebo.
English: Benefits if using this medicine
Slovenian: Koristi uporabe tega zdravila
English: Absorption The absolute bioavailability of recombinant human growth hormone after subcutaneous administration is about 80%.
Slovenian: Absolutna biološka uporabnost rekombinantnega humanega rastnega hormona po subkutani uporabi je okrog 80 %.
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).
Slovenian: Stopnja rasti se je v obeh študijah po prvem letu zmanjšala, vendar pa je bila do 48. meseca zdravljenja še vedno večja od stopnje pred zdravljenjem (7,1 cm/leto).
English: These side effects appear usually in adults early in treatment and are short-lived.
Slovenian: Ti neželeni učinki se običajno pojavijo pri odraslih kmalu po uvedbi zdravljenja in so kratkotrajni.
English: NutropininAq is a registered trademark of Genentech, Inc.
Slovenian: NutropinAq je registrirana blagovna znamka podjetja Genentech, Inc.
English: Tell your doctor immediately if you notice any change or increase in growth of birthmarks and/or moles (melanocytic naevus).
Slovenian: Nemudoma obvestite svojega zdravnika, če opazite kakršne koli spremembe ali povečano rast materinih in/ali drugih znamenj (melanocitni nevus).
English: Symptoms usually occur within the first eight weeks of the initiation of NutropinAq therapy.
Slovenian: Simptomi se ponavadi pojavijo v prvih osmih tednih po začetku zdravljenja z zdravilom NutropinAq.
English: Gather all of these components prior to use.
Slovenian: Pred uporabo pripravite vse te dele.
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.
Slovenian: Vrednosti IGF-I so se od izhodiščnih vrednosti 43 ng/ml povečale na 252 ng/ml v 36. mesecu, kar je približno normalna pričakovana vrednost pri otrocih te starosti.
English: When these antibodies were found in patients, it did not prevent them from growing.
Slovenian: Pri bolnikih, pri katerih so jih odkrili, protitelesa niso preprečila rasti.
English: This continued to increase in those patients treated for 36 and 48 months.
Slovenian: Povečevanje vrednosti se je nadaljevalo tudi pri tistih bolnikih, ki so se zdravili 36 in 48 mesecev.
English: Height gains were maintained in the patients treated for 36 or 48 months.
Slovenian: Pridobivanje telesne višine se je ohranilo pri bolnikih, ki so se zdravili 36 ali 48 mesecev.
English: Endogenous growth hormone production may also increase in some individuals with end-stage renal disease.
Slovenian: Endogeno nastajanje rastnega hormona se lahko pri nekaterih posameznikih s končnim stadijem ledvične bolezni tudi zveča.
English: It is unknown whether somatropin/metabolites are excreted in human milk.
Slovenian: Ni znano, če se somatropin/presnovki izločajo v materino mleko.
English: To guard against the spread of infection, follow these safety measures:
Slovenian: Za zaščito pred okužbo upoštevajte naslednje varnostne ukrepe:
English: In case of a tumour or re-growth of previous tumours (confirmed by your doctor), treatment with NutropinAq must be stopped immediately.
Slovenian: V primeru tumorja ali ponovne rasti prejšnjega tumorja (ki ga je potrdil zdravnik), je treba zdravljenje z zdravilom NutropinAq takoj prekiniti.
English: You should also check the pen to see that the black dose knob is moving up and down properly and that the LCD counter is working.
Slovenian: Preveriti morate tudi, če se črni odmerni gumb še pravilno premika navzgor in navzdol in ali LCD-števec deluje.
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.
Slovenian: Te spremembe so bile zelo pomembne pri 12-mesečni časovni točki v obeh študijah in v 24-mesečni časovni točki v študiji pri bolnikih z začetkom pomanjkanja v otroštvu.
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
Slovenian: Na podlagi znanstvenih zaključkov za somatropin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) somatropin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
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.
Slovenian: Ko so te spremembe povezane z zvečanjem celotne količine telesne vode in kostne mase, je skupni učinek zdravljenja s somatropinom sprememba telesne sestave; učinek se med nadaljevanjem zdravljenja ohrani.
English: Some patients may develop antibodies (a type of protein produced by the body) to somatropin.
Slovenian: Pri nekaterih bolnikih se lahko razvijejo protitelesa (vrsta beljakovine, ki jo proizvaja telo) proti somatropinu.
English: Avoid areas of extreme temperature.
Slovenian: Izogibajte se predelom s skrajnimi temperaturami.
English: Do not shake vigorously as it could denature the protein.
Slovenian: Ne stresajte močno, da ne boste denaturirali beljakovine.
English: • If your pen requires cleaning, do not place under water.
Slovenian: • Če je injekcijski peresnik potreben čiščenja, ga ne dajajte v vodo.
English: For further information ask your doctor.
Slovenian: Za dodatne informacije se posvetujte z zdravnikom.
English: This results in a measurable increase in body length until these growth plates fuse at the end of puberty.
Slovenian: Posledica je merljivo zvečanje telesne višine, dokler se ploščice na koncu pubertete ne zaprejo.
English: In older or overweight patients, lower doses may be necessary.
Slovenian: Pri starejših bolnikih in bolnikih s prekomerno telesno maso utegnejo biti potrebni manjši odmerki.
English: If you experience any of these symptoms, you should inform your doctor.
Slovenian: Če opazite katerega od teh simptomov, morate o tem obvestiti svojega zdravnika.
English: For instructions for use and handling of the medicinal product, see section 6.6.
Slovenian: Za navodila za pripravo in ravnanje z zdravilom glejte poglavje 6.6.
English: Q: What should I do if there is not enough solution left in the cartridge for my next dose?
Slovenian: V: Kaj naj naredim, če v vložku ni več dovolj zdravila za odmerek, ki ga potrebujem?
English: IGF-I levels, which were low at study entry, were restored to within the normal range with somatropin therapy.
Slovenian: Vrednosti IGF-I, ki so bile nizke ob vstopu v študijo, so se po zdravljenju s somatropinom vrnile v normalne vrednosti.
English: Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani za 28 dni pri temperaturi 2 °C - 8 °C.
English: This means that there is a risk that women, especially those on oral oestrogen therapy, are undertreated while men are over-treated.
Slovenian: To pomeni, da pri ženskah, še posebej tistih, ki se zdravijo s peroralnimi estrogeni, obstaja tveganje za nezadostno zdravljenje, pri moških pa za prekomerno zdravljenje.
English: Long-term overdose could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.
Slovenian: Dolgoročno preveliko odmerjanje bi lahko povzročilo simptome in znake gigantizma in/ali akromegalije, kot so znani pri presežku rastnega hormona.
English: Q: Is it possible to turn the black dose knob back if I click too many times?
Slovenian: V: Lahko črni odmerni gumb zasučem nazaj, če ga zavrtim za preveč klikov?
English: Always store the pen and cartridges in a clean, safe place in the refrigerator at a temperature between 2-8°C and out of children's reach and sight.
Slovenian: Injekcijski peresnik in vložke vedno shranjujte na čistem, varnem mestu v hladilniku, pri temperaturi 2 °C - 8 °C in nedosegljive otrokom.
English: Cell growth: Treatment with somatropin results in an increase in both the number and size of skeletal muscle cells.
Slovenian: Rast celic: Zdravljenje s somatropinom zveča število in velikost skeletnih mišičnih celic.
English: Shown below are the items necessary for giving an injection.
Slovenian: Spodaj so narisani deli, potrebni za injiciranje.
English: Therefore, the benefit-risk assessment for continuing treatment should be performed carefully.
Slovenian: Zato je treba oceno koristi in tveganja nadaljnjega zdravljenja skrbno pretehtati.
English: Psychiatric disorders Uncommon: Personality disorder
Slovenian: Psihiatrične motnje Občasni: osebnostna motnja
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.
Slovenian: Skupno 58 % in 65 % bolnikov, ki so se zdravili s somatropinom, in so v izhodišču imeli telesno višino, manjšo od normalne, je v 24. mesecu doseglo telesno višino v mejah normale.
English: The data on growth rate and height SDS were broadly similar to those observed in the pivotal studies.
Slovenian: Podatki o stopnji rasti in vrednosti SDS telesne višine so v veliki meri podobni podatkom iz ključnih študij.
English: A small percentage of patients may develop antibodies to the protein somatropin.
Slovenian: Pri majhnem odstotku bolnikov se lahko razvijejo protitelesa proti beljakovini somatropinu.
English: • If you have Prader-Willi syndrome, you should not be treated with NutropinAq unless you have growth hormone deficiency.
Slovenian: • Če imate Prader-Willijev sindrom, se ne smete zdraviti z zdravilom NutropinAq, razen če imate pomanjkanje rastnega hormona.
English: There are no or limited data from the use of somatropin in pregnant women.
Slovenian: Podatkov o uporabi somatropina pri nosečnicah ni oziroma so omejeni.
English: Then the doctor can increase the dose depending on your response.
Slovenian: Zdravnik lahko odmerek nato glede na odziv bolnika poveča.
English: You can turn the black dose knob backwards until the correct number appears in the LCD.
Slovenian: O: Da. Črni odmerni gumb lahko zasučete nazaj, dokler se na prikazovalniku LCD ne pojavi pravo število.
English: Tissue Growth
Slovenian: Tkivna rast
English: It should only be used to estimate the dosage remaining in the cartridge.
Slovenian: Namenjena je samo za oceno preostale količine v vložku.
English: System Organ Class Reactions observed in Pivotal and Supportive Clinical Trials (in 642 patients)
Slovenian: Organski sistem Neželeni učinki, opaženi v ključnih in podpornih kliničnih preskušanjih (pri 642 bolnikih)
English: For 51 patients who achieved near-adult height after an average duration of treatment of 6 years in males and 5 years in females, the mean near-adult height SDS was -0.7 in males and -1.2 in females.
Slovenian: Pri 51 bolnikih, ki so po povprečnem trajanju zdravljenja 6 let pri moških in 5 let pri ženskah dosegli skoraj odraslo telesno višino, je srednja vrednost SDS skoraj odrasle telesne višine znašala -0,7 pri moških in -1,2 pri ženskah.
English: In carcinogenicity studies testing biologically recombinant active growth hormone in rats and mice, no increase in the incidence of tumors was shown.
Slovenian: Pri študijah kancerogenosti pri biološkem testiranju aktivnega rekombinantnega rastnega hormona pri podganah in miših niso odkrili večje pojavnosti tumorjev.
English: In case of severe and persistent abdominal pain, consult your doctor.
Slovenian: V primeru pojava hude in trajne bolečine v trebuhu se posvetujte s svojim zdravnikom.
English: • If you accidentally touch the cartridge rubber seal, clean it with an alcohol swab.
Slovenian: • Če se po nesreči dotaknete gumijaste zapore, jo očistite z alkoholnim zložencem.
English: Always store your disposal container out of the reach of children.
Slovenian: Vsebnik za odstranjevanje vedno hranite nedosegljiv otrokom.
English: Supportive data are provided by two other studies, in which patients were given a dose of 0.3 or 0.6 mg/kg/week either as a daily injection or three times per week, or 0.029 mg/kg/day.
Slovenian: Na voljo so podporni podatki iz dveh drugih študij, v katerih so bolniki prejemali odmerek 0,3 ali 0,6 mg/kg/teden, bodisi v obliki vsakodnevne injekcije bodisi v obliki injekcije trikrat na teden, ali odmerek 0,029 mg/kg/dan.
English: The pharmacokinetic properties of NutropinAq have only been investigated in healthy adult males.
Slovenian: Farmakokinetične lastnosti zdravila NutropinAq so bile raziskane samo pri zdravih odraslih moških.
English: Growth hormone deficiency should be confirmed appropriately prior to treatment.
Slovenian: Pomanjkanje rastnega hormona je treba pred zdravljenjem ustrezno potrditi.
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.
Slovenian: Dolgotrajno zdravljenje opic med brejostjo in dojenjem in novorojenih živalih do adolescence, spolne zrelosti in razmnoževanja ni pokazalo znatnih motenj plodnosti, brejosti, poroda, dojenja ali razvoja potomstva.
English: 1 DNA Way South San Francisco CA 94080-4990 USA
Slovenian: South San Francisco CA 94080-4990