natgillin/translations-raw huggingface dataset:
Then continue to fill the syringe with the correct volume of suspension as advised by your doctor.
Nato injekcijsko brizgo polnite naprej, da dosežete pravilno količino suspenzije, kot vam je svetoval vaš zdravnik.
These patients should undergo a single dynamic test in order to diagnose or exclude a GHD.
Ti bolniki naj opravijo en dinamični test, s katerim se bodisi dokaže bodisi izključi GHD.
Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines.
Obvestite svojega zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
After removal of the protective caps from the top of both vials the rubber stoppers should be cleaned with an alcohol swab.
Po odstranitvi zaščitnih zapork z obeh vial je treba gumijasta zamaška očistiti z alkoholno blazinico.
Insulin sensitivity
Preobčutljivost na insulin
No accumulation of hGH following multiple dosing of this medicinal product has been observed.
Kopičenja hGH po večkratnem odmerjanju tega zdravila niso opazili.
Animal studies with this medicinal product are not sufficient to fully assess the reproductive toxicity potential.
Študije na živalih za to zdravilo ne zadoščajo za celovito ocenitev možnega vpliva na sposobnost razmnoževanja.
This medicinal product is not indicated for the treatment of patients with growth failure due to Prader-Willi syndrome unless they also have a diagnosis of GHD.
To zdravilo ni indicirano za zdravljenje bolnikov, ki ne rastejo zaradi Prader-Willijevega sindroma, razen če so bili diagnosticirani tudi z GHD.
Clinical trials included approximately 530 patients treated with Somatropin Biopartners.
V kliničnih preskušanjih je bilo vključenih približno 530 bolnikov, zdravljenih z zdravilom Somatropin Biopartners.
Insert the full length of the needle into the skin fold at a right angle (90 degrees) as shown in figure 12.
V kožno gubo vstavite polno dolžino igle pod pravim kotom (90 stopinj), kot prikazuje slika 12.
The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be increased resulting in lower plasma levels of these compounds.
Očistek spojin, ki jih presnavlja citokrom P450 3A4 (npr. spolni steroidi, kortikosteroidi, antikonvulzivi in ciklosporin), se lahko poveča, kar povzroči manjše koncentracije teh spojin v plazmi.
Some patients may develop antibodies to this medicinal product.
Pri nekaterih bolnikih se lahko razvijejo protitelesa na to zdravilo.
The somatropin in this medicinal product is synthesised in yeast (Saccharomyces cerevisiae).
Somatropin v tem zdravilu se sintetizira v celicah kvasovk (Saccharomyces cerevisiae).
The binding activity of these antibodies has been low and no clinical consequences have been associated with their formation.
Vezavna dejavnost teh protiteles je bila nizka, njihov nastanek pa ni imel nobenih kliničnih posledic.
After the powder is evenly mixed with the solvent provided, this medicine is injected under the skin.
Ko je prašek enakomerno premešan s priloženim vehiklom, se zdravilo injicira pod kožo.
Safety and efficacy in adults with GHD was assessed in a phase III, double-blind, randomized, placebo-controlled, parallel-group, multicentre study.
Varnost in učinkovitost pri odraslih s pomanjkanjem rastnega hormona so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani, vzporedni, multicentrični študiji faze III.
- You must have regular thyroid function tests as this medicine can affect the amount of thyroid
- Redno morate opravljati teste delovanja ščitnice, saj lahko to zdravilo vpliva na količino
For dosage instruction, see table below.
Za navodila glede odmerjanja glejte spodnjo preglednico.
Additionally, it promotes cellular protein synthesis and nitrogen retention.
Poleg tega spodbuja celično sintezo beljakovin in zadrževanje dušika.
If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Somatropin has not been shown to increase the incidence or severity of scoliosis.
Somatropin ni povečal incidence ali resnosti skolioze.
The safety profile of Somatropin Biopartners is generally consistent with the well known safety profile of daily growth hormone treatments.
Varnostni profil zdravila Somatropin Biopartners je v glavnem v skladu z dobro znanim varnostnim profilom vsakodnevnega zdravljenja z rastnim hormonom.
In the pivotal paediatric study, antibody responses to somatropin at two or more consecutive visits were observed in 33% of the patients.
V osrednji pediatrični študiji, so opazili odzive protiteles na somatropin pri dveh ali več zaporednih obiskih pri 33 % bolnikov.
Patient bodyweight (kg)
Telesna masa bolnika (kg)
If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
Če je edem papile potrjen, je treba razmisliti o diagnozi benigne intrakranialne hipertenzije in, če je potrebno, prekiniti zdravljenje z rastnim hormonom.
Long term over-dosing could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of hGH excess.
Dolgotrajno preveliko odmerjanje lahko povzroči pojav znakov in simptomov gigantizma in/ali akrogemalije, ki so podobni tistim pri čezmernem izločanju hGH.
Malignancies/tumours
Malignosti/tumorji
Somatropin Biopartners contains human growth hormone, also called somatropin.
Zdravilo Somatropin Biopartners vsebuje humani rastni hormon, imenovan tudi somatropin.
No information in patients with renal or hepatic impairment is available and particular dose recommendations cannot be given.
Podatkov o bolnikih z okvarjenim delovanjem ledvic ali jeter ni, zato posebnih priporočil o odmerjanju ni mogoče dati.
If the flow stops or bubbles appear, gently tap the syringe with your fingers.
Če se tok ustavi ali se pojavijo mehurčki, s prsti nežno potrkajte po injekcijski brizgi.
The injection site should be cleaned with an alcohol swab and the suspension injected over a period of 5 seconds.
Mesto injiciranja očistite z alkoholno blazinico in injicirajte suspenzijo v obdobju 5 sekund.
*produced in Saccharomyces cerevisiae by recombinant DNA technology For the full list of excipients, see section 6.1.
*Izdelanega v celicah Saccharomyces cerevisiae z metodo rekombinantne DNA Za celoten seznam pomožnih snovi glejte poglavje 6.1.
BioPartners GmbH Kaiserpassage 11 D-72764 Reutlingen Germany
BioPartners GmbH Kaiserpassage 11 D-72764 Reutlingen Nemčija
A similar improvement was observed for the secondary efficacy endpoints namely increase in lean body mass, serum IGF-I and IGF-I SDS.
Podobno izboljšanje so opazili za sekundarne opazovane parametre učinkovitosti, namreč povečanje puste telesne mase, serumskega IGF-I in SDS IGF-I.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
EXP After reconstitution, use immediately.
EXP Uporabite takoj po rekonstituciji.
Somatropin Biopartners is administered subcutaneously once a week.
Zdravilo Somatropin Biopartners se daje subkutano enkrat na teden.
• Somatropin must not be used when there is any evidence of tumour activity.
• Somatropina se ne sme uporabljati, če obstajajo znaki dejavnega tumorja.
Treatment with growth hormone may facilitate the development of adrenal insufficiency and potentially fatal adrenal crises in patients with organic GHD or idiopathic panhypopituitarism.
Zdravljenje z rastnim hormonom lahko pospeši razvoj insuficience nadledvične žleze in morebitnih smrtnih adrenalnih kriz pri bolnikih z organskim GHD ali idiopatičnim panhipopituitarizmom.
Where childhood-onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
Kjer se GHD, ki se je začelo v otroštvu, nadaljuje tudi v adolescenci, je treba z zdravljenjem nadaljevati, da dosežemo popoln somatski razvoj (npr. telesna sestava, kostna masa).
Animal studies with other somatropin formulations have shown adverse effects but the available nonclinical data are considered insufficient to draw firm conclusions on the use in humans (see section
Študije na živalih z drugimi oblikami somatropina so pokazale neželene učinke, vendar razpoložljivi predklinični podatki ne zadoščajo za sklepanje o uporabi pri ljudeh (glejte poglavje 5.3).
It is unknown whether somatropin or its metabolites are excreted in human breast milk; however, absorption of intact protein from the gastrointestinal tract of the infant is unlikely.
Ni znano, ali se somatropin ali njegovi presnovki izločajo v materino mleko, vendar pa ni verjetno, da bi se nepoškodovane beljakovine absorbirale iz prebavil dojenčkov.
During normal pregnancy, levels of pituitary growth hormone fall markedly after 20 weeks of gestation, being replaced almost entirely by placental growth hormone by 30 weeks.
Med normalno nosečnostjo ravni hipofiznega rastnega hormona po 20 tednih nosečnosti močno padejo, do 30 tedna pa jih skoraj v celoti nadomesti rastni hormon posteljice.
Not all pack sizes may be available in your country.
Na trgu v vaši državi morda ni vseh navedenih pakiranj.
Accidental injection of this medicine into the muscle instead of under the skin may result in blood sugar levels becoming too low.
Če si po pomoti injicirate zdravilo v mišico namesto v kožo, lahko to povzroči prenizke ravni krvnega sladkorja.
For women taking oral oestrogens the starting dose is usually 3 mg injected once a week.
Za ženske, ki jemljejo peroralne estrogene, je začetni odmerek običajno 3 mg, injiciranih enkrat na teden.
The dosage of somatropin should be decreased in cases of persistent oedema or severe paraesthesia, in order to avoid the development of carpal tunnel syndrome.
Odmerjanje somatropina je treba zmanjšati v primerih vztrajnega edema ali hude parestezije, da se prepreči razvoj sindroma karpalnega kanala.
Adults with childhood-onset of GHD
Odrasli z začetkom GHD v otroštvu
For monitoring, the attainment of a normal peak bone mass defined as a T score > - 1 (i.e. standardised to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account gender and ethnicity) is one of the therapeutic objectives during the transition period.
Pri bolniku se spremlja doseg normalne največje kostne mase, opredeljene kot rezultat T > - 1 (tj. standardizirano na povprečno najvišjo kostno maso pri odraslih, izmerjeno z dvoenergijsko rentgensko absorpciometrijo ob upoštevanju spola in narodnosti), ki je en od terapevtskih ciljev v prehodnem obdobju.
There are no specific studies which address local tolerance in animals after subcutaneous injection, but data available from the repeated-dose toxicity studies revealed swelling and inflammatory infiltrate at the injection sites.
Specifičnih študij lokalnega prenašanja pri živalih po subkutani injekciji ni, vendar so podatki iz študij toksičnosti pri ponavljajočem se odmerjanju pokazali otekline in vnetne infiltrate na mestu injiciranja.
The treatment goal should be IGF-I concentrations within -0.5 and +1.5 SDS of the age corrected mean.
Cilj zdravljenja je doseči koncentracije IGF-I znotraj -0,5 in +1,5 SDS s starostno korekcijo srednje vrednosti.
In the children receiving Somatropin Biopartners a higher incidence of (non-serious) injection site reactions and a higher rate of formation of (non-neutralising) antibodies against somatropin as compared to children with daily administered recombinant growth hormone were observed (see also sections 4.4 and 4.8).
Pri otrocih, ki so prejemali zdravilo Somatropin Biopartners, so opazili višjo incidenco (ne-resnih) reakcij na mestu injiciranja in višjo pogostnost nastajanja (ne-nevtralizirajočih) protiteles proti somatropinu, kot pri otrocih, ki so dnevno prejemali rekombinantni rastni hormon (glejte tudi poglavji 4.4 in 4.8).
Slowly withdraw the required volume of solvent.
Počasi izvlecite potrebno količino vehikla.
In older or overweight patients, lower doses may be necessary.
Pri starejših bolnikih in bolnikih s prekomerno telesno težo bo morda potreben manjši začetni odmerek.
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 imata koža in del pod kožo čas, da okrevata od injiciranja, preden si zdravilo ponovno injicirate na istem mestu.
In paediatric patients there is no evidence that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in patients with a history of pituitary pathology.
Pri pediatričnih bolnikih ni dokazov, zaradi katerih bi lahko sumili, da nadomeščanje rastnega hormona vpliva na stopnjo ponovitve ali ponovne rasti intrakranialnih novotvorb, vendar standardna klinična praksa pri bolnikih s patologijo hipofize v anamnezi zahteva redno slikanje hipofize.
You should not use Somatropin Biopartners if you are pregnant or are trying to become pregnant.
Zdravila Somatropin Biopartners ne uporabljajte, če ste noseči ali poskušate zanositi.
Prolonged overdose may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone.
Če preveliko odmerjanje poteka daljše obdobje, lahko to povzroči večjo rast ušes, nosu, ustnic, jezika in ličnic, kot je normalno.
Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with GHD.
Diagnozo in zdravljenje s tem zdravilom morajo začeti in spremljati zdravniki, ki imajo ustrezne izkušnje pri diagnosticiranju in zdravljenju bolnikov z GHD.
After 6 months of weekly treatment with Somatropin Biopartners, there was a statistically significant reduction of 1.6 kg in fat mass in the Somatropin Biopartners group compared to the placebo group.
Po 6 mesecih tedenskega zdravljenja z zdravilom Somatropin Biopartners je prišlo do statistično značilnega 1,6-kilogramskega zmanjšanja maščobne mase v skupini, ki je prejemala zdravilo Somatropin Biopartners, v primerjavi s skupino s placebom.
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Akutno preveliko odmerjanje lahko najprej povzroči hipoglikemijo, pozneje pa hiperglikemijo.
There have been reports of sleep apnoea and sudden death after initiating growth hormone therapy in patients with Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Obstajajo poročila o apneji v spanju in nenadni smrti po uvedbi zdravljenja z rastnim hormonom pri bolnikih s Prader-Willijevim sindromom, ki so imeli enega ali več od naslednjih dejavnikov tveganja: huda debelost, obstrukcija zgornjih dihal ali apneja v spanju v anamnezi ali neidentificirana okužba dihal.
Infections and infestations Common: Herpes simplex
Infekcijske in parazitske bolezni pogosti: herpes simplex
- if you are being treated for more than one injury following a serious accident; - if you experience sudden serious breathing problems.
- če se zdravite zaradi več kot ene poškodbe po hudi nesreči.
The generation of such antibodies with low binding activity is unlikely to be clinically relevant.
Ni verjetno, da bi bilo nastajanje teh protiteles z nizko vezavno dejavnostjo klinično pomembno.
The apparent terminal half-life was about 7.4 h in children, presumably reflecting slow absorption from the site of injection.
Navidezni končni razpolovni čas je bil za otroke približno 7,4 ure, kar verjetno kaže na počasno absorpcijo z mesta injiciranja.
IGF-I SDS lower than -1
SDS IGF-I nižji kot -1
Doses in excess of human therapeutic doses have shown adverse effects on reproductive function in male and female rats and male dogs, possibly through disruption of hormonal regulation.
Odmerki, višji od terapevtskih odmerkov pri ljudeh, so pokazali neželene učinke na sposobnost razmnoževanja pri podganjih samcih in samicah in pasjih samcih, morda zaradi prekinitve reguliranja hormonov.
Long term carcinogenicity studies with Somatropin Biopartners have not been conducted.
Dolgoročnih študij kancerogenosti z zdravilom Somatropin Biopartners niso izvajali.
Clean the rubber stopper of both vials with an alcohol swab (figure 3b).
Gumijasti zamašek obeh vial očistite z alkoholno blazinico (slika 3b).
Preparing the suspension
Priprava suspenzije
Immune system disorders Common: Formation of antibodies against growth hormone
Bolezni imunskega sistema pogosti: nastanek protiteles proti rastnemu hormonu
Somatropin may induce insulin resistance.
Somatropin lahko povzroči rezistenco na insulin.
Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin.
Začetek v odrasli dobi: Bolniki z GHD v odrasli dobi so opredeljeni kot bolniki z znano patologijo osi hipotalamus-hipofiza in z vsaj enim dodatno znanim pomanjkanjem hipofiznega hormona, ki ni prolaktin.
The solvent vial should be warmed to room temperature and the powder vial should be tapped and shaken to ensure the powder is moving freely.
Vialo z vehiklom je treba ogreti na sobno temperaturo, na vialo s praškom pa je treba potrkati in jo stresti, da se prašek prosto premika.
The tmax was later and the half-life longer following the administration of Somatropin Biopartners than when immediate release products had been previously administered once daily to the same subjects reflecting the slower and more prolonged release of hGH from the site of injection of Somatropin Biopartners.
tmax je bil kasnejši, razpolovni čas pa daljši po dajanju zdravila Somatropin Biopartners kot pri dajanju zdravil s takojšnjim sproščanjem, ki so jih prej dajali istim osebam enkrat na dan, kar kaže na počasnejše in podaljšano sproščanje hGH z mesta injiciranja zdravila Somatropin Biopartners.
- If you have an abnormal curving of the spine your doctor will monitor you for worsening of this
- Če imate nenormalno ukrivljeno hrbtenico, vas bo zdravnik spremljal, da se to stanje ne
Very limited data on exposure to other somatropin preparations during early pregnancy did not indicate an adverse pregnancy outcome.
Podatkov o uporabi tega zdravila pri nosečnicah ni. Zelo omejeni podatki o izpostavljenosti drugim pripravkom somatropina v zgodnji nosečnosti ne kažejo na neželene izide nosečnosti.
The apparent terminal half-life was about 16.8 h in adults, presumably reflecting slow absorption from the site of injection.
Navidezni končni razpolovni čas je bil za odrasle približno 16,8 ur, kar verjetno kaže na počasno absorpcijo z mesta injiciranja.
Apply gentle pressure to the injection site with a dry gauze or cotton pad.
Na mesto injiciranja nežno pritiskajte s suho gazo ali bombažnim kosmičem.
- oestrogen taken orally or other sex hormones - medicines to treat epilepsy - cyclosporine: a medicine to suppress the immune system
- peroralni estrogeni ali drugi spolni hormoni - zdravila za zdravljenje epilepsije - ciklosporin: zdravilo za zaviranje imunskega sistema ali zdravljenje drugih bolezni
Do not use any remaining solvent for a second preparation!
Preostalega vehikla ne uporabite za naslednjo pripravo zdravila!
Your doctor will check your levels of adrenal hormones (glucocorticoids) which may require adjustment once growth hormone therapy begins.
Vaš zdravnik bo preveril ravni hormonov nadledvične žleze (glukokortikoidov), ki jih bo morda treba prilagoditi, ko boste začeli zdravljenje z rastnim hormonom.
If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Če se zdravljenje z rastnim hormonom ponovno začne, je treba bolnika skrbno spremljati, da bi zaznali simptome intrakranialne hipertenzije.
The frequency of adverse reactions listed below is defined 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), not known (cannot be estimated from the available data):
Pogostnost neželenih učinkov je navedena 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov):
Injection site related reactions, mostly swelling at the injection site, were reported in approximately 43% of the paediatric patients.
Reakcije, povezane z mestom injiciranja, običajno oteklina na mestu injiciranja, so poročali pri približno 43 % pediatričnih bolnikov.
Because hGH may induce a state of insulin resistance, an adjustment of the insulin dose may be required.
hGH lahko povzroči odpornost na insulin, zato bo morda treba prilagoditi odmerek insulina.
This means that after preparation, the suspension is injected with a short needle into the fatty skin tissue.
To pomeni, da se pripravljena suspenzija s kratko iglo injicira v maščobno kožno tkivo.
The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data):
Pogostnost neželenih učinkov je navedena 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):
After the injection, wait a few seconds, then quickly withdraw the needle with the plunger still pushed down.
Po injiciranju počakajte nekaj sekund, nato pa iglo hitro izvlecite z batom pritisnjenim navzdol.
The recommended and maximum dose is 0.5 mg/kg/week and should not be exceeded.
Priporočeno in največje odmerjanje je 0,5 mg/kg enkrat na teden in ga ni dovoljeno prekoračiti.
Large doses of somatropin may impair glucose tolerance.
Visoki odmerki somatropina lahko okvarijo toleranco za glukozo.
The solvent is a clear, oily liquid.
Vehikel je bistra, oljna tekočina.
Slowly release the skin during the injection.
Med injiciranjem počasi spuščajte kožo.
It is unlikely that the antibody responses to treatment with Somatropin Biopartners are of clinical relevance.
Ni verjetno, da bi bil odziv protiteles na zdravljenje z zdravilom Somatropin Biopartners klinično pomemben.
The subcutaneous injection should always be administered at the same time of the day to increase compliance and the site of injection must be varied to prevent lipoatrophy.
Subkutano injiciranje je treba opraviti ob istem času dneva za povečanje skladnosti, mesto injiciranja pa je treba spreminjati, da se prepreči lipoatrofija.
If you are breast-feeding only use this medicine if your doctor indicates it is clearly necessary.
Če dojite, to zdravilo uporabite le, če zdravnik meni, da je to nujno potrebno.
There is an increased risk that paediatric patients with prior malignancies may develop second neoplasm when treated with growth hormone, especially if treatment of the primary malignancy involved radiotherapy.
Obstaja povečano tveganje, da se pri pediatričnih bolnikih pri uporabi rastnega hormona s predhodnimi malignostmi razvijejo sekundarne novotvorbe, zlasti če so se primarne malignosti zdravile tudi z radioterapijo.
If not used immediately, the suspension must be reconstituted again by swirling immediately before injection.
Če suspenzije ne uporabite takoj, jo morate tik pred injiciranjem rekonstituirati z vrtenjem.
If a drop of blood appears, maintain the pressure for a
Če se pojavi kapljica krvi, pritiskajte še nekaj trenutkov.
Dose (mg)
Odmerek (mg)
This medicine is used to treat adults with a lack (deficiency) of growth hormone who - already had growth hormone deficiency when they were children or - do not have enough growth hormone during adulthood.
To zdravilo se uporablja za odrasle s pomanjkanjem rastnega hormona, ki - so že imeli pomanjkanje rastnega hormona kot otroci ali - ki v odrasli dobi nimajo dovolj rastnega hormona.