FrancophonIA/ELRC3.0 huggingface dataset:
English: As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued treatment in this situation should be weighed against the potential risks involved.
Slovenian: Ker ni na voljo podatkov o varnosti nadomestnega zdravljenja z rastnim hormonom pri akutno kritično bolnih bolnikih, je treba pretehtati koristi nadaljnjega zdravljenja v primerjavi z morebitnim tveganjem.
English: In patients with increased risk for diabetes mellitus (e.g. familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed.
Slovenian: Pri bolnikih z zvečano nevarnostjo pojava diabetesa mellitusa (npr. anamneza sladkorne bolezni v družini, debelost, velika odpornost proti insulinu, acanthosis nigricans) je treba opraviti peroralni glukozno tolerančni test (OGTT).
English: • For single use only.
Slovenian: • Samo za enkratno uporabo.
English: - Pull the needle straight out of the skin.
Slovenian: - Nato iglo izvlecite iz kože.
English: Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth.
Slovenian: Pri bolnikih s pomanjkanjem ACTH je treba nadomestno zdravljenje z glukokortikoidi skrbno prilagoditi, da bi preprečili kakršen koli zaviralni učinek na rast.
English: Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
Slovenian: Zdravila se ne sme dajati pediatričnim bolnikom, ki na leto zrastejo manj kot 1 cm in pri katerih so se epifize že skoraj zaprle.
English: The observed difference is likely due to slow absorption from the injection site following subcutaneous administration.
Slovenian: Razlika je verjetno posledica počasne absorpcije z mesta injiciranja po subkutani uporabi zdravila.
English: Omnitrope has given rise to the formation of antibodies in approximately 1% of patients.
Slovenian: Zdravilo Omnitrope povzroči nastajanje protiteles pri približno 1 % bolnikov.
English: The absolute bioavailability of somatropin seems to be similar in males and females following subcutaneous administration.
Slovenian: Absolutna biološka uporabnost somatropina je videti po njegovi subkutani uporabi pri ženskah in moških podobna.
English: Do not massage the injection site.
Slovenian: Mesta injiciranja ne masirajte.
English: In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
Slovenian: Pri kronični ledvični insuficienci mora biti pred uvedbo zdravljenja delovanje ledvic manjše od 50 odstotkov normalnega delovanja.
English: As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
Slovenian: Ker se normalno fiziološko nastajanje rastnega hormona z leti zmanjšuje, se po potrebi zmanjša tudi njegov odmerek.
English: - Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).
Slovenian: - Menjavajte mesta injiciranja, da boste tako čim bolj zmanjšali nevarnost lokalne lipoatrofije (lokalnega zmanjšanja maščobnega tkiva pod kožo).
English: • If you are receiving somatropin for growth hormone deficiency following a previous tumour (cancer), you should be examined regularly for recurrence of the tumour or any other cancer.
Slovenian: • Če prejemate somatropin zaradi pomanjkanja rastnega hormona po predhodnem tumorju (raku), vas morajo redno pregledovati, da bi ugotovili morebitne znake ponovitve bolezni ali druge vrste raka.
English: Gently swirl the vial a few times until the content is completely dissolved.
Slovenian: Vialo nekajkrat narahlo zavrtite, dokler se vsebina povsem ne raztopi.
English: Higher doses can be used.
Slovenian: Uporabiti je možno višje odmerke.
English: In adult patients adverse reactions related to fluid retention, such as peripheral oedema, musculoskeletal stiffness, arthralgia, myalgia and paraesthesia are common.
Slovenian: Neželene reakcije pri odraslih, ki so povezane z zastajanjem tekočin, kot so periferni edem, mišično-skeletna okorelost, artralgija, mialgija in parestezija, se pojavijo pogosto.
English: Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope.
Slovenian: Sočasno zdravljenje z glukokortikoidi zavre učinke spodbujanja rasti zdravila Omnitrope.
English: • Leukaemia (This has been reported in a small number of growth hormone deficiency patients,
Slovenian: • levkemija (O njej so poročali pri majhnem številu bolnikov s pomanjkanjem rastnega hormona,
English: There have been rare cases of sudden death in patients with Prader-Willi syndrome.
Slovenian: Obstajajo redki primeri nenadne smrti pri bolnikih s Prader-Willijevim sindromom.
English: This gives your skin and the area under your skin time to recover from one injection before it gets another one in the same place.
Slovenian: S tem koži in predelu pod kožo omogočite, da po injiciranju okreva, preden si zdravilo naslednjič injicirate na isto mesto.
English: • Your doctor should examine your kidney function and your growth rate before starting somatropin.
Slovenian: • Vaš zdravnik mora preveriti delovanje vaših ledvic in stopnjo rasti pred začetkom zdravljenja s somatropinom.
English: In SGA children/adolescents it is recommended to measure the IGF-I level before start of treatment and twice a year thereafter.
Slovenian: Pri otrocih/mladostnikih, ki so MGS, se priporoča merjenje ravni IGF-I pred začetkom zdravljenja in nato dvakrat na leto.
English: Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD).
Slovenian: Dojenčki, otroci in mladostniki - Motnje rasti zaradi nezadostnega izločanja rastnega hormona (pomanjkanje rastnega hormona, PRH).
English: • If you have diabetes, you should closely monitor your blood sugar level during treatment with somatropin and discuss the results with your doctor to determine whether you need to change the dose of your medicines to treat diabetes.
Slovenian: • Če imate sladkorno bolezen, morate med zdravljenjem s somatropinom skrbno nadzirati ravni sladkorja v krvi in se o rezultatih pogovoriti z zdravnikom, ki bo določil, ali morate spremeniti odmerek zdravila za zdravljenje sladkorne bolezni.
English: EXP After reconstitution, use within 24 hours.
Slovenian: EXP Po rekonstituciji porabite v 24 urah.
English: With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of chromosome aberrations have been negative.
Slovenian: V genotoksičnih preskušanjih in vitro in in vivo so bili testi genske mutacije in indukcije aberacije kromosomov negativni.
English: Fertility studies with Omnitrope have not been performed.
Slovenian: Študij plodnosti z zdravilom Omnitrope niso opravili.
English: • Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your breathing is interrupted during sleep), or respiratory infection before you start treatment with somatropin.
Slovenian: • Vaš zdravnik bo ocenil znake zapore zgornjih dihal, apneje med spanjem (prekinitev dihanja med spanjem) ali okužbe dihal, preden vas začne zdraviti s somatropinom.
English: There are no or limited amount of data from the use of somatropin in pregnant women.
Slovenian: Podatkov o uporabi somatropina pri nosečnicah ni oziroma so omejeni.
English: • Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of treatment)
Slovenian: • zastajanje vode (kar se kaže kot nabrekli prsti ali otekli gležnji za kratek čas po začetku zdravljenja)
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear.
Slovenian: Če jih opazite, bat narahlo povlecite nazaj; injekcijsko brizgo narahlo potolcite, pri tem pa naj bo igla obrnjena navzgor, dokler mehurčki ne izginejo.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for somatropin the CHMP is of the opinion that the benefit-risk 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: Dosage adjustment may be necessary after 6 months of treatment.
Slovenian: Morda bo treba po 6 mesecih zdravljenja prilagoditi odmerek.
English: Experience in patients above 80 years is limited.
Slovenian: Izkušnje z zdravljenjem bolnikov, starih več kot 80 let, so omejene.
English: • If you walk with a limp or if you start to limp during your growth hormone treatment, you should inform your doctor.
Slovenian: • Če šepate ali začnete šepati med zdravljenjem z rastnim hormonom, o tem obvestite svojega zdravnika.
English: Follow the instructions that come with the transfer set.
Slovenian: Upoštevajte navodila, priložena setu za prenos.
English: Remove the syringe and needle.
Slovenian: Odstranite injekcijsko brizgo in iglo.
English: • Your doctor will give you diet restrictions to follow to control your weight.
Slovenian: • Vaš zdravnik vam bo predpisal dieto za nadzor vaše telesne mase.
English: In 56 patients who were continuously treated and have reached (near) final height, the mean change from height at start of treatment was +1.90 SDS (0.033 mg/kg body weight per day) and +2.19 SDS (0.067 mg/kg body weight per day).
Slovenian: Pri 56 bolnikih, ki so jih zdravili nepretrgano in so (skoraj) dosegli končno višino, je bila srednja vrednost spremembe višine na začetku zdravljenja +1,90 SSD (0,033 mg/kg telesne mase na dan) in +2,19 SSD (0,067 mg/kg telesne mase na dan).
English: Most people do their injections into their thigh or their bottom.
Slovenian: Večina ljudi si zdravilo injicira v stegno ali zadnjico.
English: - Select the site of injection.
Slovenian: - Izberite mesto injiciranja.
English: EXP After first opening, use within 28 days.
Slovenian: EXP Uporabite v 28 dneh po prvem odpiranju.
English: What you need to know before you use Omnitrope
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Omnitrope
English: It also helps your fat and muscle tissues to develop in the right amounts.
Slovenian: Pripomore tudi k razvoju pravilne količine maščobnega in mišičnega tkiva.
English: To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are available.
Slovenian: Podatkov o končni višini bolnikov s kronično ledvično insuficienco, ki so se zdravili z zdravilom Omnitrope, ni.
English: Some of the height gain obtained with treating short children/adolescents born SGA with growth hormone may be lost if treatment is stopped before final height is reached.
Slovenian: Nekaj pridobljenih centimetrov telesne višine pri otrocih/mladostnikih, ki so se rodili MGS, s pomočjo zdravljenja z rastnim hormonom se lahko izgubi, če se zdravljenje ustavi, preden se doseže končno telesno višino.
English: However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Slovenian: Vendar pa je bila stabilnost dokazana tudi med uporabo za obdobje do 24 ur pri temperaturi od 2 °C8 °C v originalni ovojnini.
English: Elderly patients may be more sensitive to the action of Omnitrope, and therefore may be more prone to develop adverse reactions.
Slovenian: Starejši bolniki so morda bolj občutljivi na delovanje somatropina in zato bolj nagnjeni k razvoju neželenih učinkov.
English: • If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.
Slovenian: • Če se zdravite z nadomeščanjem glukokortikoidov, se morate redno posvetovati z zdravnikom, saj bo odmerek glukokortikoida morda treba prilagoditi.
English: - Carefully inspect the solution before injecting it and use only if clear and colourless.
Slovenian: - Pred injiciranjem skrbno preglejte raztopino in jo uporabite le, če je bistra in brezbarvna.
English: In the post-marketing experience rare cases of sudden death have been reported in patients affected by Prader-Willi syndrome treated with somatropin, although no causal relationship has been demonstrated.
Slovenian: Iz izkušenj v obdobju trženja so poročali o redkih primerih nenadne smrti pri bolnikih z PraderWillijevim sindromom, zdravljenih s somatropinom, čeprav vzročne povezave niso potrdili.
English: Solvent: water for injections benzyl alcohol
Slovenian: Vehikel: voda za injekcije benzilalkohol
English: When growth hormone deficiency continues into adolescence, Omnitrope should be continued until completion of physical development.
Slovenian: Če se pomanjkanje rastnega hormona nadaljuje v adolescenco, se mora zdravljenje z zdravilom Omnitrope nadaljevati do konca fizičnega razvoja.
English: - Growth disturbance associated with chronic renal insufficiency.
Slovenian: - Motnje pri rasti, povezane s kronično ledvično insuficienco.
English: All patients with PWS should have effective weight control before and during growth hormone treatment.
Slovenian: Pri vseh bolnikih s PWS je treba pred začetkom zdravljenja z rastnim hormonom in med njim učinkovito kontrolirati telesno maso.
English: Take the vial with the powder, push the needle through the rubber closure and inject the solvent slowly into the vial aiming the stream of liquid against the glass wall in order to avoid foam.
Slovenian: Vzemite vialo s praškom, potisnite iglo skozi gumijast zamašek in počasi injicirajte vehikel v stekleničko tako, da usmerite curek tekočine na stekleno steno, in tako preprečite penjenje.
English: • if you are seriously ill (for example, complications following open heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions).
Slovenian: • če ste hudo bolni (na primer zapleti po kirurškem posegu na odprtem srcu, kirurškem posegu v trebuhu, nezgodne poškodbe, akutna dihalna odpoved ali podobna stanja).
English: For storage conditions of the in-use medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6.3.
English: Important information about some of the ingredients of Omnitrope
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Omnitrope
English: Somatropin is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Somatropina ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Myalgia*
Slovenian: mialgija*
English: After reconstitution, one ml contains 15 mg benzyl alcohol.
Slovenian: Po rekonstituciji en ml vsebuje 15 mg benzilalkohola.
English: In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant effects have been observed.
Slovenian: V preskušanjih o subakutni toksičnosti in lokalni toleranci ni bilo opaziti klinično relevantnih učinkov.
English: The daily dosage should not exceed 2.7 mg.
Slovenian: Dnevni odmerek ne sme preseči 2,7 mg.
English: • medicine to treat diabetes,
Slovenian: • zdravilo za zdravljenje sladkorne bolezni,
English: Growth hormone deficiency is associated with decreased plasma and extracellular volumes.
Slovenian: Pomanjkanje rastnega hormona je povezano z zmanjšano prostornino plazme in zunajceličnih tekočin.
English: Persons above 60 years should start with a dose of 0.1-0.2 mg per day which should be slowly increased according to individual requirements.
Slovenian: Osebe, stare več kot 60 let, morajo začeti z odmerkom 0,1-0,2 mg na dan, nato pa ga počasi povečevati glede na individualne potrebe.
English: Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see section 4.4).
Slovenian: Rastni hormon zmanjša pretvorbo kortizona v kortizol, pri čemer se lahko izrazi predhodno prikrit centralni hipoadrenalizem ali pa nizki nadomestni odmerki glukokortikoidov postanejo neučinkoviti (glejte poglavje 4.4).
English: The clinical significance of this finding is unclear.
Slovenian: Klinični pomen te ugotovitve ni jasen.
English: Omnitrope is a clear and colourless solution for injection.
Slovenian: Zdravilo Omnitrope je bistra in brezbarvna raztopina za injiciranje.
English: If during treatment with somatropin patients show signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted, and a new ENT assessment performed.
Slovenian: Če imajo bolniki med zdravljenjem s somatropinom znake obstrukcije zgornjih dihal (vključno s pojavom smrčanja ali njegovega povečanja), je treba zdravljenje prekiniti in opraviti novo oceno ORL.
English: EXP After reconstitution, use within 21 days.
Slovenian: EXP Po rekonstituciji porabite v 21 dneh.
English: Injecting Omnitrope - Select the site of injection.
Slovenian: Injiciranje zdravila Omnitrope - Izberite mesto injiciranja.
English: Not Known (cannot be estimated from available data)
Slovenian: redki do zelo redki neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: Inject the solvent slowly.
Slovenian: Počasi injicirajte vehikel.
English: Somatropin increases insulin but fasting blood glucose is commonly unchanged.
Slovenian: Somatropin zveča vrednost insulina, vendar ostane navadno raven sladkorja v krvi na tešče nespremenjena.
English: Injection site reaction$
Slovenian: reakcija na mestu injiciranja$
English: The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy subjects and growth hormone deficient patients.
Slovenian: Biološka uporabnost somatropima po njegovi subkutani uporabi je tako pri zdravih ljudeh kot pri bolnikih s pomanjkanjem rastnega hormona približno 80-odstotna.
English: Omnitrope is a biosimilar medicinal product.
Slovenian: Omnitrope je biološko podobno zdravilo.
English: Read package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo!
English: However, the in-use stability has been demonstrated for up to 24 hours at 2°C
Slovenian: Vendar pa je bila stabilnost dokazana tudi med uporabo za obdobje do 24 ur pri temperaturi od
English: Somatropin stimulates the turnover of skeletal bone.
Slovenian: Somatropin spodbuja presnovo skeletne kosti.
English: Children with hypopituitarism may experience fasting hypoglycaemia.
Slovenian: Otroci s hipopituitarizmom imajo lahko hipoglikemijo na tešče.
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).
Slovenian: Pri ženskah na peroralnem estrogenskem nadomestnem zdravljenju bo za dosego cilja zdravljenja morda potreben večji odmerek rastnega hormona (glejte poglavje 4.4).
English: Your doctor should have already shown you how to use Omnitrope.
Slovenian: Vaš zdravnik bi vam moral že pokazati, kako se uporablja zdravilo Omnitrope.
English: Subcutaneous use after reconstitution
Slovenian: Za subkutano uporabo po rekonstituciji
English: Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Slovenian: Bolnike z že izraženo sladkorno boleznijo, intoleranco za glukozo ali dodatnimi dejavniki tveganja za sladkorno bolezen je treba med zdravljenjem s somatropinom skrbno spremljati.
English: In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be observed.
Slovenian: Na splošno se pri bolnikih s pomanjkanjem rastnega hormona zaradi uporabe somatropina zmanjšata serumski koncentraciji LDL in apolipoproteina B. Zmanjša se lahko tudi serumska vrednost skupnega holesterola.
English: • Water retention (which shows as puffy fingers or swollen ankles)
Slovenian: • zastajanje vode (kar se kaže kot nabrekli prsti ali otekli gležnji)
English: Long-term overdose could result in signs and symptoms consistent with the known effects of human growth hormone excess.
Slovenian: Dolgotrajno preveliko odmerjanje povzroči pojav znakov in simptomov, ki so podobni tistim pri čezmernem izločanju rastnega hormona pri ljudeh.
English: Reconstituting Omnitrope - Remove the protective caps from the two vials in the box.
Slovenian: Priprava zdravila Omnitrope - Odstranite zaščitni zaporki z obeh vial v škatlici.
English: However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.)
Slovenian: Vendar pa ni dokazov, da je pogostnost levkemije povečana pri prejemnikih rastnega hormona brez predispozicijskih dejavnikov.)
English: In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay attention to signs of relapse of the malignancy.
Slovenian: Pri pomanjkanju rastnega hormona, ki je posledica zdravljenja maligne bolezni, je priporočljivo posvetiti pozornost znakom ponovitve maligne bolezni.
English: Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected.
Slovenian: Apnejo v spanju je treba pred začetkom zdravljenja z rastnim hormonom oceniti s priznanimi metodami, kot sta polisomnografija ali nočna oksimetrija, bolnike pa je treba nadzorovati, če obstaja sum na apnejo v spanju.
English: In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Slovenian: Tudi v preskušanjih o splošni toksičnosti somatropina, njegovi lokalni toleranci in reprodukcijski toksičnosti ni bilo opaziti klinično relevantnih učinkov.
English: Aim the stream of liquid against the glass wall in order to avoid foam.
Slovenian: Curek tekočine usmerite na stekleno steno, da preprečite penjenje.
English: Each vial must be reconstituted with the accompanying solvent only.
Slovenian: Vsebino viale je treba pripraviti le z vehiklom, ki je priložen.
English: In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended.
Slovenian: Pri bolnikih s hudim ali ponavljajočim se glavobolom, motnjami vida, slabostjo in/ali bruhanjem se priporoča fundoskopija za odkrivanje edema papile.
English: Signs of scoliosis should be monitored during treatment.
Slovenian: Med zdravljenjem je treba spremljati znake skolioze.
English: • During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
Slovenian: • Če se med zdravljenjem razvije okužba pljuč, to povejte zdravniku, da bo lahko okužbo zdravil.
English: However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Slovenian: Vendar pa ni dokazov, da je incidenca levkemije povečana pri prejemnikih rastnega hormona brez predispozicijskih dejavnikov.
English: • After starting somatropin treatment some patients may need to start thyroid hormone replacement.
Slovenian: • Po uvedbi zdravljenja s somatropinom potrebujejo nekateri bolniki nadomestno zdravljenje s ščitničnim hormonom.
English: Wash your hands before you continue with the next steps.
Slovenian: Preden postopek nadaljujete, si umijte roke.
English: • If you have chronic renal (kidney) insufficiency.
Slovenian: • če imate kronično renalno (ledvično) odpoved.
English: Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated with somatropin (regarding patients undergoing substitution therapy, see section 4.4).
Slovenian: S somatropinom se ne sme zdraviti bolnikov z akutno kritično boleznijo, ki imajo zaplete po operaciji na odprtem srcu, v trebuhu, z večkratnimi nezgodnimi poškodbami, z akutno odpovedjo dihanja ali podobnimi stanji (o bolnikih, ki imajo nadomestno zdravljenje, glejte poglavje 4.4).