natgillin/translations-raw huggingface dataset:
Because of the presence of benzyl alcohol the medicinal product must not be given to premature babies or neonates.
Zaradi vsebnosti benzilalkohola se zdravila ne sme dajati nedonošenčkom ali novorojencem.
Keep a note of any missed injections and tell your doctor at your next check-up.
Zabeležite si morebitne izpuščene injekcije in to ob naslednjem pregledu predložite svojemu zdravniku.
This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na ml, kar v bistvu pomeni »brez natrija«.
• thyroid hormones,
• ščitnične hormone,
Children born small or too light at birth
Otroci, ki se rodijo premajhni ali prelahki
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.
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.
At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.
Trenutno ni dovolj dokazov za pripravo priporočil glede nadaljevanja zdravljenja z rastnim hormonom pri bolnikih z odpravljeno intrakranialno hipertenzijo.
The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you.
Odmerek je odvisen od vaše velikosti, bolezni, zaradi katere se zdravite, in od učinka, ki ga ima rastni hormon na vas.
Nevertheless, corticosteroid replacement therapy should be optimised before initiation of therapy.
Kljub temu pa je treba pred uvedbo zdravljenja optimirati nadomestno zdravljenje s kortikosteroidom.
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.
Ali se somatropin izloča v mleko, ni znano, toda verjetnost absorpcije nespremenjene beljakovine iz dojenčkovih prebavil je izjemno majhna.
Mortality was higher in patients treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%.
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 %).
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.
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.
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.
Koža okoli mesta injiciranja lahko postane neravna ali bulasta, toda če si zdravilo injicirate vsakič na drugo mesto, se to ne bi smelo zgoditi.
• During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.
• Med zdravljenjem vas bo zdravnik pregledal, da ugotovi morebitne znake skolioze, vrste deformacije hrbtenice.
Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01.
Farmakoterapevtska skupina: hormoni sprednjega režnja hipofize in sorodne učinkovine, oznaka ATC: H01AC01.
- Growth disturbance associated with Turner syndrome.
- Motnje pri rasti, povezane s Turnerjevim sindromom.
Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
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).
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.
V tem času je treba začeti konzervativno zdravljenje ledvične insuficience (ki vključuje nadzor acidoze, hiperparatiroidizma in prehranjenosti) in ga nadaljevati med zdravljenjem.
Scoliosis is common in patients with PWS.
Skolioza je pri bolnikih s PWS pogosta.
- If the solution is cloudy (and the cloudiness does not disappear within ten minutes) or contains particles, it should not be used.
- Če je raztopina motna (in motnost ne izgine v 10 minutah) ali vsebuje delce, je ne smete uporabiti.
Consequently monitoring of thyroid function should therefore be conducted in all patients.
Posledično je treba pri vseh bolnikih nadzirati delovanje ščitnice.
In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
Pri bolnikih s PWS mora biti zdravljenje vedno v kombinaciji s prehrano z manjšim vnosom kalorij.
Both are rapidly increased after treatment with somatropin.
Obe vrednosti se po zdravljenju s somatropinom hitro zvečata.
Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
Uvedba zdravljenja s somatropinom lahko povzroči zaviranje 11βHSD-1 in zmanjšanje koncentracij kortizola v serumu.
In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean.
V obeh primerih je cilj zdravljenja doseči koncentracijo insulinu podobnega rastnega dejavnika (IGFI) znotraj 2 SDS s starostno korekcijo srednje vrednosti.
some of whom have been treated with somatropin.
pri čemer so bili nekateri zdravljeni s somatropinom.
• oestrogen taken orally or other sex hormones,
• estrogen, ki se ga jemlje peroralno, ali drugi spolni hormoni,
- Insert the needle into the skin in the way your doctor has taught you.
- Iglo zapičite v kožo tako, kot vam je pokazal zdravnik.
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.
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.
In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.
Pri otrocih, ki so preživeli raka, so poročali o povečanem tveganju za sekundarne novotvorbe pri bolnikih, zdravljenih s somatropinom po svoji prvi novotvorbi.
- 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.
- 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.
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.
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.
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.
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.
This dosage should be gradually increased according to blood test results as well as clinical response and side effects.
Ta odmerek se lahko postopoma povečuje glede na rezultate krvnih preiskav, klinični odziv in neželene učinke.
Patients limping during treatment with somatropin should be examined clinically.
Bolnike, ki med zdravljenjem s somatropinom šepajo, je treba klinično pregledati.
- 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.
- 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.
Do not use if the solution is cloudy or contains particles.
Raztopine ne uporabljajte, če je motna ali vsebuje delce.
Somatropin must not be used when there is any evidence of activity of a tumour.
Somatropina se ne sme uporabljati, če obstajajo znaki dejavnega tumorja.
What Omnitrope is and what it is used for
Kaj je zdravilo Omnitrope in za kaj ga uporabljamo
Do not pass it on to others.
Svojega peresnika ne dajajte drugim.
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.
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.
Do your injection in the place you have been shown by your doctor.
Injicirajte si ga na mesto, ki vam ga pokaže zdravnik.
Water and mineral metabolism
Presnavljanje vode in mineralov
Follow the Instructions for Use of the pen injector.
Upoštevajte navodila za uporabo peresnika za injiciranje.
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.
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.
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.
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).
• For single use only.
• Samo za enkratno uporabo.
- Pull the needle straight out of the skin.
- Nato iglo izvlecite iz kože.
Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth.
Pri bolnikih s pomanjkanjem ACTH je treba nadomestno zdravljenje z glukokortikoidi skrbno prilagoditi, da bi preprečili kakršen koli zaviralni učinek na rast.
Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
Zdravila se ne sme dajati pediatričnim bolnikom, ki na leto zrastejo manj kot 1 cm in pri katerih so se epifize že skoraj zaprle.
The observed difference is likely due to slow absorption from the injection site following subcutaneous administration.
Razlika je verjetno posledica počasne absorpcije z mesta injiciranja po subkutani uporabi zdravila.
Omnitrope has given rise to the formation of antibodies in approximately 1% of patients.
Zdravilo Omnitrope povzroči nastajanje protiteles pri približno 1 % bolnikov.
The absolute bioavailability of somatropin seems to be similar in males and females following subcutaneous administration.
Absolutna biološka uporabnost somatropina je videti po njegovi subkutani uporabi pri ženskah in moških podobna.
Do not massage the injection site.
Mesta injiciranja ne masirajte.
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
Pri kronični ledvični insuficienci mora biti pred uvedbo zdravljenja delovanje ledvic manjše od 50 odstotkov normalnega delovanja.
As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
Ker se normalno fiziološko nastajanje rastnega hormona z leti zmanjšuje, se po potrebi zmanjša tudi njegov odmerek.
- Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).
- Menjavajte mesta injiciranja, da boste tako čim bolj zmanjšali nevarnost lokalne lipoatrofije (lokalnega zmanjšanja maščobnega tkiva pod kožo).
• 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.
• 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.
Gently swirl the vial a few times until the content is completely dissolved.
Vialo nekajkrat narahlo zavrtite, dokler se vsebina povsem ne raztopi.
Higher doses can be used.
Uporabiti je možno višje odmerke.
In adult patients adverse reactions related to fluid retention, such as peripheral oedema, musculoskeletal stiffness, arthralgia, myalgia and paraesthesia are common.
Neželene reakcije pri odraslih, ki so povezane z zastajanjem tekočin, kot so periferni edem, mišično-skeletna okorelost, artralgija, mialgija in parestezija, se pojavijo pogosto.
Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope.
Sočasno zdravljenje z glukokortikoidi zavre učinke spodbujanja rasti zdravila Omnitrope.
• Leukaemia (This has been reported in a small number of growth hormone deficiency patients,
• levkemija (O njej so poročali pri majhnem številu bolnikov s pomanjkanjem rastnega hormona,
There have been rare cases of sudden death in patients with Prader-Willi syndrome.
Obstajajo redki primeri nenadne smrti pri bolnikih s Prader-Willijevim sindromom.
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.
S tem koži in predelu pod kožo omogočite, da po injiciranju okreva, preden si zdravilo naslednjič injicirate na isto mesto.
• Your doctor should examine your kidney function and your growth rate before starting somatropin.
• Vaš zdravnik mora preveriti delovanje vaših ledvic in stopnjo rasti pred začetkom zdravljenja s somatropinom.
In SGA children/adolescents it is recommended to measure the IGF-I level before start of treatment and twice a year thereafter.
Pri otrocih/mladostnikih, ki so MGS, se priporoča merjenje ravni IGF-I pred začetkom zdravljenja in nato dvakrat na leto.
Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD).
Dojenčki, otroci in mladostniki - Motnje rasti zaradi nezadostnega izločanja rastnega hormona (pomanjkanje rastnega hormona, PRH).
• 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.
• 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.
EXP After reconstitution, use within 24 hours.
EXP Po rekonstituciji porabite v 24 urah.
With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of chromosome aberrations have been negative.
V genotoksičnih preskušanjih in vitro in in vivo so bili testi genske mutacije in indukcije aberacije kromosomov negativni.
Fertility studies with Omnitrope have not been performed.
Študij plodnosti z zdravilom Omnitrope niso opravili.
• 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.
• Vaš zdravnik bo ocenil znake zapore zgornjih dihal, apneje med spanjem (prekinitev dihanja med spanjem) ali okužbe dihal, preden vas začne zdraviti s somatropinom.
There are no or limited amount of data from the use of somatropin in pregnant women.
Podatkov o uporabi somatropina pri nosečnicah ni oziroma so omejeni.
• Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of treatment)
• zastajanje vode (kar se kaže kot nabrekli prsti ali otekli gležnji za kratek čas po začetku zdravljenja)
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear.
Če jih opazite, bat narahlo povlecite nazaj; injekcijsko brizgo narahlo potolcite, pri tem pa naj bo igla obrnjena navzgor, dokler mehurčki ne izginejo.
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
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.
Dosage adjustment may be necessary after 6 months of treatment.
Morda bo treba po 6 mesecih zdravljenja prilagoditi odmerek.
Experience in patients above 80 years is limited.
Izkušnje z zdravljenjem bolnikov, starih več kot 80 let, so omejene.
• If you walk with a limp or if you start to limp during your growth hormone treatment, you should inform your doctor.
• Če šepate ali začnete šepati med zdravljenjem z rastnim hormonom, o tem obvestite svojega zdravnika.
Follow the instructions that come with the transfer set.
Upoštevajte navodila, priložena setu za prenos.
Remove the syringe and needle.
Odstranite injekcijsko brizgo in iglo.
• Your doctor will give you diet restrictions to follow to control your weight.
• Vaš zdravnik vam bo predpisal dieto za nadzor vaše telesne mase.
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).
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).
Most people do their injections into their thigh or their bottom.
Večina ljudi si zdravilo injicira v stegno ali zadnjico.
- Select the site of injection.
- Izberite mesto injiciranja.
EXP After first opening, use within 28 days.
EXP Uporabite v 28 dneh po prvem odpiranju.
What you need to know before you use Omnitrope
Kaj morate vedeti, preden boste uporabili zdravilo Omnitrope
It also helps your fat and muscle tissues to develop in the right amounts.
Pripomore tudi k razvoju pravilne količine maščobnega in mišičnega tkiva.
To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are available.
Podatkov o končni višini bolnikov s kronično ledvično insuficienco, ki so se zdravili z zdravilom Omnitrope, ni.
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.
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.
However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Vendar pa je bila stabilnost dokazana tudi med uporabo za obdobje do 24 ur pri temperaturi od 2 °C8 °C v originalni ovojnini.
Elderly patients may be more sensitive to the action of Omnitrope, and therefore may be more prone to develop adverse reactions.
Starejši bolniki so morda bolj občutljivi na delovanje somatropina in zato bolj nagnjeni k razvoju neželenih učinkov.
• If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.
• Če se zdravite z nadomeščanjem glukokortikoidov, se morate redno posvetovati z zdravnikom, saj bo odmerek glukokortikoida morda treba prilagoditi.
- Carefully inspect the solution before injecting it and use only if clear and colourless.
- Pred injiciranjem skrbno preglejte raztopino in jo uporabite le, če je bistra in brezbarvna.
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.
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.
Solvent: water for injections benzyl alcohol
Vehikel: voda za injekcije benzilalkohol
When growth hormone deficiency continues into adolescence, Omnitrope should be continued until completion of physical development.
Če se pomanjkanje rastnega hormona nadaljuje v adolescenco, se mora zdravljenje z zdravilom Omnitrope nadaljevati do konca fizičnega razvoja.
- Growth disturbance associated with chronic renal insufficiency.
- Motnje pri rasti, povezane s kronično ledvično insuficienco.
All patients with PWS should have effective weight control before and during growth hormone treatment.
Pri vseh bolnikih s PWS je treba pred začetkom zdravljenja z rastnim hormonom in med njim učinkovito kontrolirati telesno maso.
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.
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.
• if you are seriously ill (for example, complications following open heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions).
• 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).
For storage conditions of the in-use medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6.3.
Important information about some of the ingredients of Omnitrope
Pomembne informacije o nekaterih sestavinah zdravila Omnitrope
Somatropin is not recommended during pregnancy and in women of childbearing potential not using contraception.
Somatropina ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
After reconstitution, one ml contains 15 mg benzyl alcohol.
Po rekonstituciji en ml vsebuje 15 mg benzilalkohola.