natgillin/translations-raw huggingface dataset:
Before taking the syringe out of the vial, draw in the same amount of air (1.5 ml) as the solvent you injected to reduce the pressure in the vial.
Preden odstranite brizgo iz viale, povlecite enako količino zraka (1,5 ml), kot ste vbrizgali vehikla, da zmanjšate tlak v viali.
Intracranial hypertension
Intrakranialna hipertenzija
At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension.
Doslej ni dokazov za vodenje postopka kliničnega odločanja pri bolnikih z odpravljeno intrakranialno hipertenzijo.
Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.
Preizkus prisotnosti protiteles proti somatropinu je treba opraviti pri vseh bolnikih, ki se ne odzivajo na zdravljenje.
Conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism, and nutritional status for one year prior to the treatment) should have been established and should be maintained during treatment.
Uvesti je treba konservativno zdravljenje ledvične insuficience (kar vključuje nadzor acidoze, hiperparatiroidizma in stanja prehranjenosti v obdobju enega leta pred uvedbo zdravljenja) in ga med zdravljenjem nadaljevati.
Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask incipient hypothyroidism.
Rastni hormon poveča pretvorbo T4 v T3 zunaj ščitnice in lahko kot tak razkrije začetni hipotiroidizem.
Your doctor or his/her assistant will tell you what size of needle to use.
Zdravnik ali medicinska sestra vam bosta povedala, katero velikost igle
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists; ATC code: H01AC01
Farmakoterapevtska skupina: hormoni in analogi hipofize in hipotalamusa, somatropin in agonisti somatropina oznaka ATC: H01AC01.
WHAT Valtropin IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO Valtropin IN ZA KAJ GA UPORABLJAMO
Paediatric population - Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.
Pediatrična populacija - Dolgoročno zdravljenje otrok (starih 2 do 11 let) in mladostnikov (starih 12 do 18 let) z zaostankom v rasti zaradi nezadostnega izločanja normalnega endogenega rastnega hormona.
Gender and dosing
Spol in odmerjanje
The MAH must ensure that the system of pharmacovigilance, as presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The clearance of compounds metabolised by cytochrome P 450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially 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.
Following reconstitution, the vial should be swirled with a GENTLE rotary motion until the contents are completely dissolved.
Po rekonstituciji je treba vialo z NEŽNIMI krožnimi gibi premešati, dokler se vsebina popolnoma ne raztopi.
There is no evidence to suspect 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.
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.
Name and address of the manufacturer of the biological active substance LG Life Sciences Ltd., Iksan Plant, 601 Yongje-dong, Iksan-si, Jeonbuk-do 570-350, South Korea Name and address of the manufacturer responsible for batch release BioPartners GmbH, Kaiserpassage 11, D-72764 Reutlingen, Germany
Ime in naslov izdelovalca biološke zdravilne učinkovine LG Life Sciences Ltd., Iksan Plant, 601 Yongje-dong, Iksan-si, Jeonbuk-do 570-350, Južna Koreja Ime in naslov izdelovalca, odgovornega za sproščanje serije BioPartners GmbH, Kaiserpassage 11 D-72764 Reutlingen, Nemčija
An increasing sensitivity to growth hormone (expressed as change in IGF-1 per growth hormone dose) over time may be observed, particularly in men.
Sčasoma lahko opazimo povečano občutljivost za rastni hormon (izraženo kot sprememba koncentracije IGF-1 v serumu na odmerek rastnega hormona), zlasti pri moških.
The total daily dose usually does not exceed 1 mg. IGF-1 concentrations need to be regularly measured and should be maintained below the upper limit of the normal range for your age and sex.
Skupni dnevni odmerek ponavadi ne presega 1 mg. Koncentracije IGF-1 je treba redno meriti ter vzdrževati pod zgornjo mejo za vašo starost in spol.
Valtropin is synthesised in yeast cells (Saccharomyces cerevisiae).
Zdravilo Valtropin se sintetizira v celicah kvasovk (Saccharomyces cerevisiae).
- Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.
- Zdravljenje zastoja v rasti pri otrocih pred puberteto s kronično ledvično insuficienco.
Ensure the solution is at room temperature.
Raztopina mora biti na sobni temperaturi.
At the end of the new expiry date, the medicinal product should have been used or be disposed of.
Ob poteku novega roka uporabnosti je treba zdravilo porabiti ali zavreči.
After reconstitution with the solvent provided, Valtropin has a pH of approximately 7.5 and an osmolality of approximately 320 mOsm/kg.
Po rekonstituciji s priloženim vehiklom ima zdravilo Valtropin pH približno 7,5, njegova osmolalnost pa je približno 320 mOsm/kg.
If you are injecting this medicine yourself you will be instructed how to prepare and give the injection.
Če si zdravilo injicirate sami, vam bo zdravnik dal navodila za pripravo in injiciranje.
If you become pregnant, tell your doctor immediately.
Če zanosite, takoj obvestite zdravnika.
- If you have injected Valtropin by mistake into the muscle instead of under the skin, your blood sugar may become too low (hypoglycaemia).
- Če so vam zdravilo Valtropin pomotoma injicirali v mišico, namesto pod kožo, se lahko raven sladkorja v krvi preveč zniža (hipoglikemija).
When using other medicines the dose of Valtropin or of the other medicine may need to be adjusted (see section 2, ‘Using other medicines').
Pri sočasni uporabi drugih zdravil bo morda treba odmerek zdravila Valtropin ali drugega zdravila prilagoditi (glejte poglavje 2, "Uporaba drugih zdravil").
If necessary, your doctor will gradually increase this dose according to your individual requirements based on the clinical outcome and measurement of your blood levels of a so called “growth factor” (known as IGF-1).
Po potrebi vam bo zdravnik postopno povečeval odmerek glede na potrebe, pri čemer bo upošteval klinični učinek in meritev ravni tako imenovanega "rastnega faktorja" v krvi (znanega kot IGF-1).
• Do not use Valtropin after the expiry date which is stated on the labels and the carton after EXP.
• Zdravila Valtropin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli poleg oznake Uporabno do/EXP.
The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Prostornina brizge mora biti dovolj majhna, da lahko iz viale dovolj natančno vzamete predpisani odmerek.
If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Če se zdravljenje z rastnim hormonom ponovno uvede, je nujno treba skrbno spremljati simptome intrakranialne hipertenzije.
Your doctor will tell you how much to use.
Zdravnik vam bo povedal, koliko zdravila si odmerite.
Turner syndrome
Turnerjev sindrom
Pack size of 1 vial and 1 pre-filled syringe.
Velikost pakiranja - 1 viala in 1 napolnjena injekcijska brizga.
Long-term overdose could result in signs and symptoms of acromegaly consistent with the known effects of excess human growth hormone.
Dolgotrajno preveliko odmerjanje ima lahko za posledico znake in simptome akromegalije, kar ustreza znanim učinkom presežka humanega rastnega hormona.
If you use more Valtropin than you should In case more Valtropin was used than recommended, please consult your doctor.
Če ste uporabili večji odmerek zdravila Valtropin, kot bi smeli Če ste uporabili več zdravila Valtropin, kot vam je bilo priporočeno, se posvetujte z zdravnikom.
The accuracy of the Valtropin dose should be checked every 6 months by your doctor.
Natančnost odmerka zdravila Valtropin mora zdravnik preveriti vsakih 6 mesecev.
The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Natančnost odmerka rastnega odmerka je treba torej preveriti vsakih 6 mesecev.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 3.1 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Cleanse the injection site with an alcohol swab and wait for the area to dry.
Mesto injiciranja očistite z alkoholno blazinico in počakajte, da se posuši.
Sensitivity to metacresol
Preobčutljivost na metakrezol
If the patient has had a brain tumour, the patient should be re-examined frequently to make sure that the tumour has not come back.
Če je imel bolnik tumor na možganih, ga je treba pogosto pregledovati in zagotoviti, da se tumor ni vrnil.
Dispose the used syringe in a closed container.
Uporabljeno brizgo zavrzite v zaprto posodo.
The date of refrigerator removal and the new expiry date should be written on the outer carton.
Datum odvzema iz hladilnika in nov rok uporabnosti je treba napisati na zunanjo škatlo.
Pancreatitis in children
Pankreatitis pri otrocih
Withdraw the needle quickly and apply pressure over the injection site with a dry gauze or cotton pad for several seconds.
Iglo hitro izvlecite in na mesto injiciranja nekaj sekund pritiskajte s suho gazo ali bombažno blazinico.
After reconstitution with the solvent provided: can be stored for 21 days in a refrigerator.
Po rekonstituciji s priloženim vehiklom: v hladilniku lahko shranjujete 21 dni.
After accidental intramuscular injection, hypoglycaemia may appear.
Po nenamernem intramuskularnem injiciranju se lahko pojavi hipoglikemija.
The dosage and administration schedule should be individualised for each patient.
Odmerjanje in urnik dajanja je treba prilagoditi posameznemu bolniku.
Solvent: metacresol (see leaflet for further information) and water for injections.
Vehikel: metakrezol (dodatne informacije so v navodilu za uporabo) in voda za injekcije.
Total daily dose usually does not exceed 1 mg. IGF-1 concentrations should be maintained below the upper limit of the age-specific normal range.
Skupni dnevni odmerek navadno ne presega 1 mg. Koncentracije IGF-1 je treba vzdrževati pod zgornjo mejo za starost značilnega normalnega razpona.
However, in single and repeat-dose general toxicity studies no adverse reactions at the injection sites were reported.
Vendar v študijah splošne toksičnosti pri posameznih in ponavljajočih se odmerkih niso poročali o neželenih učinkih na mestu injiciranja.
Interruption or early stopping of treatment with Valtropin may impair the success of the growth hormone therapy.
Prekinitev ali prezgodnje prenehanje zdravljenja z zdravilom Valtropin lahko ogrozi uspešnost zdravljenja z rastnim hormonom.
Do not use Valtropin if you notice that the solvent or the reconstituted solution is cloudy or discoloured or if contains particulate matters.
Ne uporabljajte zdravila Valtropin, če opazite, da sta vehikel ali rekonstituirana raztopina motna ali obarvana ali če vsebuje delce.
For further information on reconstitution and administration see section 6.6.
Za dodatne informacije o rekonstituciji in uporabi glejte poglavje 6.6.
Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin.
Bolniki s hudim pomanjkanjem rastnega hormona 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.
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 upoštevati tudi možnost diagnoze benigne intrakranialne hipertenzije in po potrebi prekiniti zdravljenje z rastnim hormonom.
Valtropin should not be used during pregnancy unless clearly necessary.
Zdravila Valtropin se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno.
What Valtropin looks like and contents of the pack
Izgled zdravila Valtropin in vsebina pakiranja
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Akutno preveliko odmerjanje lahko sprva vodi v hipoglikemijo in nato v hiperglikemijo.
For handling the vial see ‘Injecting the solution', step 32.
Za odstranjevanje viale glejte 32. korak
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.
In contrast to bacteria (E. coli), yeast has not been described to elicit adjuvant effects modifying the immunological response.
V nasprotju z bakterijami (E. coli) pri kvasovkah niso opazili dodatnih učinkov, ki bi spremenili imunski odziv.
Push the plunger slowly back up to the correct dose.
Bat počasi potisnite nazaj do ustreznega odmerka.
This means that after reconstitution of the powder with the solvent provided the solution is injected with a short needle into the fatty tissue just under the skin.
To pomeni, da se po rekonstituciji praška s priloženim vehiklom raztopina s kratko iglo injicira v maščobno tkivo tik pod kožo.
Detailed instructions for subcutaneous administration are provided with this leaflet (see section ‘Information on how to self-inject Valtropin' at the end of this leaflet).
Natančna navodila za subkutano injiciranje so v tem navodilu za uporabo (glejte poglavje "Informacije za samoinjiciranje zdravila Valtropin" na koncu tega navodila).
- Valtropin can affect the amount of thyroid hormone in the blood, so you must have thyroid function tests from time to time.
- Zdravilo Valtropin lahko vpliva na količino hormonov ščitnice v krvi, zato morate občasno opraviti preizkuse delovanja ščitnice.
Valtropin is intended for subcutaneous use after reconstitution.
Zdravilo Valtropin je namenjeno za subkutano uporabo po rekonstituciji.
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Če vidite mehurčke, povlecite bat malo nazaj in potrkajte po brizgi - pri tem naj bo igla obrnjena navzgor -, dokler mehurčki ne izginejo.
- Patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or patients having acute respiratory failure.
- Bolniki z akutno kritično boleznijo zaradi zapletov po operaciji na odprtem srcu ali operaciji trebuha, bolniki z mnogovrstnimi nezgodnimi poškodbami ali bolniki z akutno respiratorno odpovedjo.
In patients with severe liver dysfunction a reduction of somatropin clearance has been noted.
Pri bolnikih s hudo disfunkcijo jeter so opazili zmanjšanje očistka somatropina.
These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency.
Ti bolniki naj opravijo posamezni dinamični test, s katerim se bodisi dokaže bodisi izključi pomanjkanje rastnega hormona.
Tell especially your doctor if you are taking - adrenal steroid hormone such as cortisone or prednisolone - insulin - oral oestrogen - sex hormones, medicines to treat stress response or inflammation (corticosteroids), medicines to treat epilepsy (e.g. carbamazepin)or cyclosporine (a medicine to suppress the immune system).
Zdravniku povejte zlasti, če uporabljate - steroidne hormone nadledvične žleze, kot sta kortizon ali prednizolon - insulin - peroralni estrogen - spolne hormone, zdravila za zdravljenje odziva na stres ali vnetje (kortikosteroide), zdravila za zdravljenje epilepsije (npr. karbamazepin) ali ciklosporin (zdravilo za zaviranje imunskega sistema).
Your doctor or his/her assistant will instruct you how to self-inject Valtropin.
Zdravnik ali medicinska sestra vam bosta razložila, kako si sami injicirate zdravilo Valtropin.
Withdrawing the right volume of your medicine with the help of the syringe markings 19.
Odmerjanje ustrezne prostornine zdravila s pomočjo oznak na brizgi 19.
Take the injection syringe and the needle supplied by your pharmacy or hospital, to withdraw the solution of medicine.
Vzemite injekcijsko brizgo in iglo, ki ste ju dobili v lekarni ali bolnišnici, ter izvlecite raztopino zdravila.
The solvent should be injected into the vial by aiming the stream of liquid against the glass wall.
Vehikel je treba injicirati v vialo tako, da curek tekočine usmerite proti stekleni steni viale.
Uncommon: Personality disorder
Občasni: osebnostne motnje
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.
Poročali so o apneji med spanjem in nenadni smrti po uvedbi zdravljenja z rastnim hormonom pri bolnikih s PraderWillijevim sindromom, ki so imeli enega ali več od naslednjih dejavnikov tveganja: zelo veliko prekomerno telesno težo, anamnezo obstrukcije zgornjih dihalnih poti ali apnejo med spanjem ter neopredeljeno okužbo dihal.
Wash your hands thoroughly with soap and water before preparing the medicine.
Pred pripravo zdravila si roke temeljito umijte z vodo in milom.
Take a new needle (one that is suitable for subcutaneous injection) and place it firmly onto the tip of the syringe.
Vzemite drugo iglo (ustrezno za subkutano injiciranje) in jo trdno pritrdite na vrh brizge.
Uncommon: Anaemia
Občasni: anemija
Please contact your doctor for further advice.
Za dodatne nasvete vprašajte zdravnika.
The MAH should submit an updated Risk Management Plan reflecting: New neoplasm, Second neoplasm in childhood cancer survivors and Intracranial aneurysm and Intracranial haemorrhage as potential risk.
Imetnik dovoljenja za promet z zdravilom bo predložil posodobljen načrt za obvladovanje tveganj, ki bo prikazoval: nove novotvorbe, drugo novotvorbo pri otrocih, ki so preživeli raka, in intrakranialno anevrizmo ter intrakranialno krvavitev kot možno tveganje.
Fill the syringe with air by pulling the plunger back to the level that represents your dose as prescribed by your doctor.
Povlecite bat in napolnite brizgo z zrakom do oznake, ki predstavlja odmerek, ki vam ga je predpisal
After reconstitution with the solvent provided, chemical and physical in-use stability has been demonstrated for 21 days at 2°C - 8°C (refrigerator).
Dokazano je, da je zdravilo po rekonstituciji s priloženim vehiklom kemijsko in fizikalno stabilno ter primerno za uporabo 21 dni pri temperaturi 2 °C - 8 °C (v hladilniku).
Therapy with Valtropin should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with growth hormone deficiency.
Zdravljenje z zdravilom Valtropin morajo začeti in spremljati zdravniki, ki imajo ustrezne izkušnje pri diagnosticiranju in zdravljenju bolnikov s pomanjkanjem rastnega hormona.
If you have used too much Valtropin over a longer period, this may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone (acromegaly).
Če ste dalj časa uporabljali preveč zdravila Valtropin, lahko pride do povečane rasti ušes, nosu, ustnic, jezika in ličnic (akromegalije).
An open single-arm Phase III study investigating the efficacy and safety of treatment with Valtropin in girls with short stature associated with Turner syndrome showed a significant effect of study treatment on height velocity.
V odprti enokračni študiji faze III, pri kateri so raziskovali učinkovitost in varnost zdravljenja pri deklicah nizke rasti, povezane s Turnerjevim sindromom, z zdravilom Valtropin, so pokazali pomemben učinek uporabljenega zdravljenja na hitrost rasti.
Check that the correct dose of Valtropin solution is in the syringe.
Prepričajte se, da je v brizgi ustrezen odmerek raztopine zdravila Valtropin.
In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test.
Pri bolnikih z izoliranim pomanjkanjem rastnega hormona od otroštva dalje (brez dokazov bolezni osi hipotalamus-hipofiza ali obsevanja glave) je treba priporočiti dva dinamična testa, razen pri tistih z nizkimi koncentracijami insulinu podobnega rastnega dejavnika 1 (IGF-1, Insulin-Like Growth Factor-1) (< 2 standardna odklona (SDS, Standard Deviation Score)), pri katerih zadošča en test. Mejna točka dinamičnega testa mora biti strogo določena.
Please read the following instructions carefully before using Valtropin.
Pred uporabo zdravila Valtropin podrobno preberite naslednja navodila.
Single case of acute allergic reaction involving itching and swelling similar to insect stings and itching Severe reduction of insulin effects (insulin resistance)
Neznana pogostnost en primer akutne alergijske reakcije s srbenjem in oteklostjo, podobno piku žuželke in srbenju hudo zmanjšanje učinka insulina (rezistenca na insulin)
- Too much growth hormone can cause greater than normal growth of ears, nose, lips, tongue and cheekbone (acromegaly), high blood sugar (hyperglycaemia) and presence of sugar in the urine (glucosuria).
- Preveč rastnega hormona lahko povzroči povečano rast ušes, nosu, jezika in ličnic (akromegalijo), povišano raven sladkorja v krvi (hiperglikemijo) in prisotnost sladkorja v urinu (glukozurijo).
Detailed instructions for the handling of the medicinal product are given at the end of the package leaflet.
Podrobna navodila za ravnanje z zdravilom so navedena na koncu navodila za uporabo.
One pack contains: - 5 mg of white to almost white powder in a glass vial closed with a rubber stopper and a cap - 1.5 ml of solvent in a pre-filled syringe closed with a tip cap, for reconstitution as a clear solution.
Eno pakiranje vsebuje: - 5 mg belega do skoraj belega praška v stekleni viali, zaprti z gumijastim zamaškom in zaporko - 1,5 ml vehikla v napolnjeni injekcijski brizgi, zaprti z zaporko, za rekonstitucijo v obliki bistre raztopine.
Patients with co-existing adrenocorticotropic hormone (ACTH) deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth.
Pri bolnikih s soobstoječim pomanjkanjem adrenokortikotropina (ACTH, Adrenocorticotropic Hormone) je treba skrbno prilagoditi odmerek nadomestnega glukokortikoida, s čimer se lahko izognemo zaviralnemu učinku na rast.