natgillin/translations-raw huggingface dataset:
Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema, dyspnoea), local allergic reactions at the injection site (pruritus, urticaria)
Neznana pogostnost: sistemska preobčutljivost (anafilaksija, generalizirana urtikarija, angioedem, dispneja), lokalne alergijske reakcije na mestu injiciranja (srbenje, urtikarija)
The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Presnovno delovanje IGF-1 je deloma usmerjeno k spodbujanju privzema glukoze, maščobnih kislin in aminokislin, tako da presnova oskrbuje rastoča tkiva.
In rats and rabbits reproductive toxicity was studied after intravenous but not after subcutaneous application (the normal clinical route).
Pri podganah in kuncih so vpliv na sposobnost razmnoževanja raziskovali po intravenskem dajanju, ne pa tudi po subkutanem, ki je običajni način dajanja pri klinični uporabi.
Mecasermin may lower blood sugar levels.
Mekazermin lahko zniža nivo krvnega sladkorja.
Your doctor or nurse will instruct you how to give the injection of glucagon.
Zdravnik ali medicinska sestra vas bosta poučila, kako injicirati glukagon.
Mecasermin was administered subcutaneously to Sprague Dawley rats at doses of 0, 0.25, 1, 4, and 10 mg/kg/day for up to 2 years.
Podgane vrste Sprague Dawley so do dve leti prejemale mekazermin subkutano v odmerkih 0; 0,25; 1; 4 in 10 mg/kg/dan.
Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.
Vsakega bolnika, ki začne šepati ali toži zaradi bolečin v kolkih ali kolenih, je treba ustrezno pregledati.
The MAH must ensure that, at launch, all physicians who are expected to prescribe INCRELEX are provided with a “physician information pack” containing the following:
Imetnik dovoljenja za promet mora zagotoviti, da imajo vsi zdravniki, ki bodo predvidoma predpisovali zdravilo INCRELEX, že ob prihodu zdravila na trg na voljo gradivo o zdravilu, ki vsebuje naslednje:
Figure 2: Inject air into vial
Slika 2: V vialo iztisnite zrak
Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Bolniki morajo redno hoditi na preglede in ob pojavu kliničnih simptomov je potrebno te zaplete preprečiti oziroma uvesti ustrezno zdravljenje.
During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients.
Med kliničnimi preskušanji uporabe zdravila pri drugih indikacijah, ki so bila izvedena pri vsega skupaj približno 300 bolnikih, so pri 8 % bolnikov poročali o pojavu lokalne in/ali sistemske preobčutljivosti.
Inject INCRELEX as instructed by the doctor.
Zdravilo INCRELEX injicirajte, kot vam je pokazal zdravnik.
Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
Iglo zabodite skozi gumijasti vrh viale in pritisnite na bat ter zrak iztisnite v vialo (glejte sliko 2).
Figure 4: Tip in liquid
Slika 4: Konica v tekočini
One ml contains 9 mg of benzyl alcohol.
En mililiter vsebuje 9 mg benzilalkohola.
IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons.
IGF-1 sestavlja 70 aminokislin v eni verigi s tremi intramolekularnimi disulfidnimi mostički.
Such containers should be sealed and disposed of properly in the way your doctor described.
Takšne posode morate dobro zapreti in nato ustrezno zavreči v skladu z zdravnikovimi navodili.
If you forget to use INCRELEX
Če ste pozabili uporabiti zdravilo INCRELEX
If you stop using INCRELEX
Če ste prenehali uporabljati zdravilo INCRELEX
Treatment with mecasermin is a long-term therapy.
Mekazermin je namenjen dolgotrajnemu zdravljenju.
Hypoglycaemia was the most frequently reported adverse event and a proper attention has to be given to meals in relation to dosing.
Hipoglikemija je bila najpogosteje poročani neželeni učinek, zato je posebno pozornost treba nameniti uporabi zdravila v času obrokov.
INCRELEX should be administered by subcutaneous injection shortly before or after a meal or snack.
Zdravilo INCRELEX je treba uporabljati v obliki subkutane injekcije neposredno pred ali po obroku oziroma prigrizku.
Toxicity to reproduction
Vpliv na sposobnost razmnoževanja
Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects.
Zdravljenje akutnega prevelikega odmerjanja mekazermina mora biti usmerjeno k ublažitvi hipoglikemičnih učinkov.
Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought.
Starše in bolnike je treba opozoriti na možnost pojava tovrstnih reakcij in da morajo v primeru pojava sistemske alergijske reakcije zdravljenje takoj opustiti ter nemudoma poiskati zdravniško pomoč.
The patient information about INCRELEX should contain the following information:
Vodnik za bolnika o zdravilu INCRELEX mora vsebovati naslednje informacije:
Some signs of enlarged tonsils/adenoids include: snoring, difficulty breathing or swallowing, sleep apnoea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear.
Nekateri znaki povečanja tonzil/adenoidnega tkiva so: smrčanje, težave pri dihanju ali požiranju, apneja v spanju (začasno prenehanje dihanja med spanjem) ali tekočina v srednjem ušesu ter tudi okužbe ušesa.
INCRELEX should not be administered intravenously.
Zdravila INCRELEX se ne sme uporabljati intravensko.
Other uncommon side effects seen with mecasermin treatment include depression, nervousness.
Druga občasna neželena učinka mekazermina sta depresija in živčnost.
The most frequently occurring side effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections.
Najpogostejši neželeni učinki mekazermina so: nizek krvni sladkor (hipoglikemija), bruhanje, reakcije na mestu injiciranja, glavobol in okužba srednjega ušesa.
Clinical Trial
Klinično preskušanje
• That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects.
• Zdravilo INCRELEX je treba dati neposredno pred ali po obroku oziroma prigrizku, saj ima insulinu podobne hipoglikemične učinke.
From a microbiological point of view, once opened, the medicinal product may be stored for a maximum of 30 days at 2C to 8C.
Iz mikrobiološkega vidika se sme zdravilo po odprtju hraniti največ 30 dni pri temperaturi od 2 C - 8 C.
Chemical and physical in-use stability has been demonstrated for 30 days at 2C to 8C.
Dokazano je bilo, da je zdravilo med uporabo kemično in fizikalno stabilno 30 dni, če se ga shranjuje pri temperaturi od 2 C - 8 C.
Hypoglycaemia is a very common adverse reaction.
Hipoglikemija je zelo pogost neželeni učinek.
No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.
Okvara jeter Študije, ki bi določile vpliv okvare jeter na farmakokinetiko mekazermina, niso bile izvedene.
Increased blood sugar (hyperglycaemia) Increased blood sugar has also been observed with mecasermin treatment.
Visok krvni sladkor (hiperglikemija) Pri zdravljenju z mekazerminom so poročali tudi o zvišanju vrednosti krvnega sladkorja.
Used needle and syringe should be placed in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Uporabljeno injekcijsko iglo in brizgo morate zavreči v zabojnik za odlaganje ostrih predmetov (kot je posoda za biološko nevarne odpadke), trdo plastično posodo (kot je plastenka od detergenta) ali kovinsko posodo (kot je prazna kovinska posoda za kavo).
Mecasermin may enlarge your tonsils/adenoids.
Mekazermin lahko povzroči povečanje tonzil/adenoidnega tkiva.
Therefore, this medicinal product is not recommended in children below age of 2.
Uporaba tega zdravila pri otrocih, mlajših od 2 let, tako ni priporočljiva.
Intracranial hypertension/increased intracranial pressure occurred in 4 (0.96%) of patients from the clinical trials and occurred in 7 - 9 year old treatment naïve subjects.
Intrakranialna hipertenzija/zvišan intrakranialni tlak se je v kliničnih preskušanjih pojavil pri 4 bolnikih (0,96 %).
Pull the needle straight out and gently press on the spot where you injected you with gauze or a cotton ball for a few seconds.
Iglo izvlecite naravnost in na mesto injiciranja za nekaj sekund rahlo pritisnite z gazo ali kosmom vate.
Common: Sleep apnoea syndrome, adenoidal hypertrophy, tonsillar hypertrophy, snoring
Pogosti: sindrom apneje v spanju, adenoidna hipertrofija, tonzilarna hipertrofija, smrčanje
Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
Mekazermin je humani insulinu podoben rastni faktor-1 (rhIGF-1), pridobljen s tehnologijo rekombinantne DNA.
• Product information
• Informacije o zdravilu
Echocardiogram is recommended before initiation of mecasermin treatment in all patients.
Pred začetkom zdravljenja z mekazerminom je pri vseh bolnikih priporočljiva uporaba ehokardiograma.
If you use more INCRELEX than you should
Če ste uporabili večji odmerek zdravila INCRELEX, kot bi smeli
Infections Infections of the middle ear have been observed in children with mecasermin treatment.
Okužbe Pri zdravljenju z mekazerminom so pri otrocih poročali o okužbah srednjega ušesa.
Do not give the injection if you are unable to eat shortly before or after the injection.
Če neposredno pred ali po injiciranju ne morete jesti, zdravila ne injicirajte.
The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
Najnižji odmerek, ki je povezan s pomembnim povečanjem rasti pri posameznem bolniku, je 0,04 mg/kg dvakrat na dan.
Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass. IGF-1 increases bone density.
Cirkulirajoči IGF-1 ima pomembno vlogo pri večanju in vzdrževanju kostne mase.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih ali genotoksičnosti ne kažejo posebnega tveganja za človeka.
If more INCRELEX than recommended was injected, contact your doctor immediately.
Če ste injicirali večji odmerek zdravila INCRELEX od priporočenega, se nemudoma posvetujte z zdravnikom.
Olbrachtova 2006/9,
Olbrachtova 2006/9, CZ-140 00 Praha 4
Glucagon raises the blood sugar when it is injected.
Glukagon po injiciranju dvigne količino sladkorja v krvi.
IGFBP-3 is reduced in subjects with severe Primary IGFD, resulting in increased clearance of IGF-1 in these subjects relative to healthy subjects.
Pri osebah s hudim primarnim pomanjkanjem IGF je koncentracija IGFBP-3 manjša, posledično je pri njih očistek IGF-1 večji kot pri zdravih osebah.
The height velocities at a given year of treatment were compared by paired t-tests to the pre-treatment height velocities of the same subjects completing that treatment year.
Pri osebah, ki so dokončale enoletno zdravljenje, so hitrost rasti v danem letu zdravljenja s parnim t-testom primerjali s hitrostjo rasti pred začetkom zdravljenja.
The amino acid sequence of the product is identical to that of endogenous human IGF-1.
Aminokislinsko zaporedje zdravila je enako endogenemu humanemu IGF-1.
Hypoacusis (hearing loss)
Hipakuza (naglušnost)
What INCRELEX contains - The active substance is mecasermin.
Kaj vsebuje zdravilo INCRELEX - Učinkovina je mekazermin.
Hair loss has also been reported following mecasermin use.
Izpadanje las (alopecija) Poročali so o izpadanju las po uporabi mekazermina.
Treatment of acute overdose of mecasermin should be directed at reversing hypoglycaemia.
Zdravljenje akutnega prevelikega odmerka mekazermina mora biti usmerjeno k ublažitvi hipoglikemije.
Injection site hypertrophy (tissue at injection site increases in size) and bruising These can be avoided by changing the injection site at each injection (injection site rotation).
Hipertrofija na mestu injiciranja (povečanje tkiva na mestu injiciranja) in modrice na mestu injiciranja Pojavu hipertrofije in modric na mestu injiciranja se lahko izognete tako, da zdravilo vsakič injicirate na drugo mesto (rotacija mesta injiciranja).
Increased pressure in the brain (intracranial hypertension) INCRELEX can sometimes cause a temporary increase in pressure within the brain.
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) Povišan tlak v možganih (intrakranialna hipertenzija) Zdravilo INCRELEX lahko včasih povzroči prehodno zvišanje tlaka v možganih.
Studies have not been conducted with mecasermin in breast-feeding mothers.
Študije z mekazerminom pri doječih materah niso bile izvedene.
Systemic hypersensitivity included symptoms such as anaphylaxis, generalized urticaria, angioedema and dyspnoea.
Sistemska preobčutljivost, vključno s simptomi, kot so anafilaksija, generalizirana urtikarija, angioedem in dispneja.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP in se nanaša na zadnji dan navedenega meseca.
Wash your hands before getting INCRELEX ready for your injection.
Preden začnete s pripravo zdravila INCRELEX za injiciranje, si umijte roke.
For subjects with bone age available for at least 6 years after treatment initiation, the mean increase in bone age was comparable to the mean increase in chronological age; for these subjects, there does not appear to be any clinically significant advance of bone age relative to chronological age.
Pri osebah z znano zrelostjo kosti za vsaj 6 let po uvedbi zdravljenja je bilo povprečno povečanje zrelosti kosti primerljivo s povprečnim povečanjem kronološke starosti.
Women of childbearing potential / Contraception in males and females A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin.
Ženske v rodni dobi/Kontracepcija pri moških in ženskah Pri vseh ženskah v rodni dobi je pred začetkom zdravljenja z mekazerminom priporočljivo izvesti test nosečnosti, ki mora biti negativen.
Children The pharmacokinetics of INCRELEX have not been studied in subjects younger than 12 years of age.
Otroci Pri osebah, mlajših od 12 let, farmakokinetika zdravila INCRELEX ni bila raziskana.
Oral glucose or food should be consumed.
Bolnik mora peroralno zaužiti glukozo ali hrano.
Other ingredients: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections.
Pomožne snovi so: benzilalkohol, natrijev klorid, polisorbat 20, koncentrirana ocetna kislina (ledocet), natrijev acetat in voda za injekcije.
• To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
• Navodila za poročanje zdravniku o pojavu šepanja ali bolečinah v kolku ali kolenu, da bi bilo mogoče stanje oceniti.
Elderly The pharmacokinetics of INCRELEX have not been studied in subjects greater than 65 years of age.
Starostniki Pri osebah, starejših od 65 let, farmakokinetika zdravila INCRELEX ni bila raziskana.
P-value for change from pre-Tx [1]
Povprečje (SD) za spremembo iz pre-Tx P-vrednost za spremembo iz pre-Tx [1] SDS telesne višine N Povprečje (SD)
Therefore there is insufficient medical information to determine whether there are significant risks to a foetus.
Razpoložljivi zdravstveni podatki tako ne zadostujejo za oceno stopnje tveganja za plod.
Data was also collected from post-marketing sources.
Podatke o neželenih učinkih so zbirali tudi v obdobju po začetku trženja zdravila.
You should have examinations periodically.
V tem primeru so potrebni redni zdravniški pregledi.
Excipients INCRELEX contains 9 mg/ml benzyl alcohol as a preservative.
Zdravilo INCRELEX vsebuje kot konzervans 9 mg/ml benzilalkohola.
Pull the plunger to withdraw the correct dose into the syringe (see Figure 5).
Povlecite za bat in v brizgo izvlecite ustrezni odmerek (glejte sliko 5).
• To report the onset of severe headache, blurred vision and associated nausea and vomiting to their physician.
• Navodila za poročanje zdravniku o pojavu hudega glavobola, zamegljenega vida in s tem povezane slabosti ter bruhanja.
INCRELEX 10 mg/ml solution for injection Mecasermin
INCRELEX 10 mg/ml raztopina za injiciranje mekazermin
This reaction occurred in 71 (17%) subjects from the clinical trials and was generally associated with lack of proper rotation of injections.
V kliničnih preskušanjih se je hipertrofija na mestu injiciranja pojavila pri 71 osebah (17 %) in je običajno bila posledica nedoslednega menjavanja mesta injiciranja.
Str. Grigore Alexandrescu nr. 59, clădirea HQ Sector 1, 010623, Bucureşti, România
Sector 1, 010623, Bucureşti, România
Excess mortality secondary to IGF-1 induced hypoglycaemia was observed in the carcinogenesis studies.
Pri študijah karcinogenosti so opazili večjo umrljivost zaradi hipoglikemije, povzročene z IGF-1.
Carbohydrate Metabolism
Presnova ogljikovih hidratov
Do not recap the syringe.
Brizge ne pokrivajte več.
Acute overdose could lead to hypoglycaemia.
Pri akutnem prevelikem odmerjanju se lahko pojavi hipoglikemija.
Mecasermin has been tested in a rat teratology study with no effects on fœtus up to 16 mg/kg (20 fold the maximum recommended human dose (MRHD) based on body surface area) and in a rabbit teratology with no effects on foetus at dose of 0.5 mg/kg (2 fold the MRHD based on body surface area).
Teratogeno delovanje mekazermina so raziskovali v študiji pri podganah v odmerkih do 16 mg/kg (20-kratni največji priporočeni odmerek za človeka na osnovi telesne površine) in kuncih v odmerkih 0,5 mg/kg (2-kratni največji priporočeni odmerek za človeka na osnovi telesne površine).
Serious allergic reactions have also been reported with INCRELEX.
Pri uporabi zdravila INCRELEX so poročali tudi o pojavu resnih alergijskih reakcij.
The dose of INCRELEX should not be doubled to make up for one or more omitted doses.
Odmerka zdravila INCRELEX ni dovoljeno podvojiti, če je bil izpuščen en ali več odmerkov.
Acute overdose could lead to hypoglycaemia (low blood sugar).
V primeru enega samega prevelikega odmerka (akutni preveliki odmerek) se lahko pojavi hipoglikemija (nizek nivo krvnega sladkorja).
Post-marketing reports
Poročila po prihodu zdravila na trg
INCRELEX should be administered using sterile disposable syringes and injection needles.
Pri injiciranju zdravila INCRELEX je treba uporabljati sterilno injekcijsko brizgo in iglo za enkratno uporabo.
Mecasermin may be started again after the episode is over.
Mekazermin lahko spet začnete uporabljati, ko stanje mine.
- INCRELEX is a liquid that contains mecasermin which is a man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
- Zdravilo INCRELEX je na voljo v obliki tekočine in vsebuje mekazermin, ki je sintezni insulinu podoben rastni faktor-1 (IGF-1), podoben IGF-1, ki ga proizvaja človeško telo.
MARKETING AUTHORISATION HOLDER Ipsen Pharma
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma
The total IGF-1 volume of distribution (mean ± SD) after subcutaneous administration of INCRELEX in 12 subjects with severe Primary IGFD is estimated to be 0.257 (± 0.073) l/kg at a mecasermin dose of 0.045 mg/kg, and is estimated to increase as the dose of mecasermin increases.
Pri 12 osebah s hudim primarnim pomanjkanjem IGF so ocenili, da je skupni volumen porazdelitve IGF-1 po subkutanem dajanju zdravila INCRELEX v odmerku 0,045 mg/kg mekazermina 0,257 (± 0,073) l/kg (povprečna vrednost ± SD).
No subject discontinued the studies due to adverse events.
Zaradi neželenih učinkov iz študij ni bila izključena nobena oseba.
Figure 3: Prepare for extraction
Slika 3: Priprava na odvzem odmerka iz viale
Snoring This occurred generally in the first year of treatment, and was reported in 30 subjects (7%).
O smrčanju so poročali pri 30 osebah (7 %).
Please ask the doctor for advice before stopping the treatment.
Preden prenehate z zdravljenjem, se posvetujte z zdravnikom.
When injections were properly dispersed, the condition resolved.
Po ustreznem menjavanju mest injiciranja se je stanje izboljšalo.
Treatment should be reconsidered if after a year patients remain non-responsive.
Če po enoletnem zdravljenju pri bolniku ni napredka, je treba zdravljenje ponovno ovrednotiti.
IGF-1 has inhibitory effects on insulin secretion.
IGF-1 zavira izločanje insulina.
Very common: Vomiting, upper abdominal pain
Zelo pogosti: bruhanje,bolečina v zgornjem delu abdomna Pogosti: abdominalna bolečina
Inject INCRELEX just below the skin in your upper arm, upper leg (thigh), stomach area (abdomen), or buttocks.
Zdravilo INCRELEX si injicirajte neposredno pod kožo nadlakti, stegna, trebuha (abdomna) ali zadnjice.
Wipe the rubber stopper of the vial with an alcohol swab to prevent contamination of the vial by germs that may be introduced by repeated needle insertions (see Figure 1).
Tako boste preprečili onesnaženje viale z mikrobi, do katerega bi lahko prišlo pri ponavljajočem se prebadanju z iglo (glejte sliko 1).
Clearance of total IGF-1 is inversely proportional to serum IGFBP-3 levels and total IGF-1 systemic clearance (CL/F) is estimated to be 0.04 l/hr/kg at 3 mg/l IGFBP-3 in 12 subjects.
Pri 12 bolnikih s serumsko koncentracijo IGFBP-3 3 mg/l je bil sistemski očistek (CL/F) celokupnega IGF-1 0,04 l/h/kg.
You should avoid engaging in any high-risk activities (e.g., driving, etc.) within 2-3 hours after dosing, particularly at the start of INCRELEX treatment, until a dose of INCRELEX has been found which does not cause side effects that make these activities risky.
2 do 3 ure po uporabi odmerka se morate izogibati visoko tveganih dejavnosti (npr. vožnje, itd.), še posebej na začetku zdravljenja z zdravilom INCRELEX, dokler se ne določi odmerek zdravila INCRELEX, pri katerem se neželeni učinki, ki bi lahko imeli negativen vpliv na tovrstne aktivnosti, ne pojavijo.
One multi-use vial of 4 ml.
Ena viala s 4 ml za večkratno uporabo.
If a dose is skipped, the next dose should not be made larger to compensate.
Če ste pozabili uporabiti odmerek, naslednjič ne smete uporabiti večjega odmerka, da bi tako nadomestili pozabljeni odmerek.
Slipped capital femoral epiphysis (with the potential to lead to avascular necrosis) and progression of scoliosis can occur in patients who experience rapid growth.
Pri bolnikih s hitro rastjo lahko pride do zdrsa epifize glavice stegnenice (z možnostjo povzročitve avaskularne nekroze) in napredovanja skolioze.
Very common: Hypoglycaemia Common: Hypoglycaemic seizure, hyperglycaemia
Zelo pogosti: hipoglikemija Pogosti: hipoglikemični krči, hiperglikemija
Funduscopic examination is recommended at the initiation, periodically during the course of mecasermin therapy and at the occurrence of clinical symptoms.
Na začetku zdravljenja z mekazerminom je priporočljivo opraviti pregled očesnega ozadja in ga nato redno ponavljati med zdravljenjem ali v primeru pojava kliničnih simptomov.
Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Pojav reakcij na mestu injiciranja lahko preprečite tako, da zdravilo vsakič injicirate na drugo mesto (rotacija mesta injiciranja).
Seventy-four (91%) of the subjects were prepubertal at baseline.
74 oseb (91 %) je bilo v izhodišču v obdobju pred začetkom spolnega dozorevanja.
Decide on an injection area - upper arm, thigh, buttock, or abdomen (see below).
Izberite mesto injiciranja - nadlaket, stegno, zadnjico ali trebuh (glejte spodaj).
Instructions on the administration of glucagon should severe hypoglycaemia occur.
Navodila o dajanju glukagona v primeru pojava hude oblike hipoglikemije.