FrancophonIA/ELRC3.0 huggingface dataset:
English: Inject INCRELEX just under your skin shortly before or after a meal or snack because it may have insulinlike hypoglycaemic effects and so it may decrease blood sugar levels (see hypoglycaemia in section 4).
Slovenian: Zdravilo INCRELEX si injicirajte pod kožo neposredno pred ali po obroku oziroma prigrizku, saj ima zdravilo lahko insulinu podoben hipoglikemični učinek in lahko zniža vrednost krvnega sladkorja (glejte hipoglikemija v poglavju 4).
English: This was noted in 38 (9%) subjects, particularly in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.
Slovenian: O hipertrofiji tonzil so poročali pri 38 osebah (9 %), še posebej v prvem in drugem letu zdravljenja, v kasnejših letih pa je bila pojavnost hipertofije tonzil manjša.
English: Tissue Growth
Slovenian: Rast tkiva
English: Very common (may affect more than 1 in 10 people) Low blood sugar (hypoglycaemia)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) Nizek krvni sladkor (hipoglikemija)
English: As INCRELEX contains benzyl alcohol, it must not be given to premature babies or neonates.
Slovenian: Zdravilo INCRELEX vsebuje benzilalkohol, zato se ga ne sme dajati nedonošenčkom ali novorojenčkom.
English: Pregnancy There are no or limited amount of data for the use of mecasermin in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi mekazermina pri nosečnicah ni oziroma so omejeni.
English: The symptoms of intracranial hypertension can include visual changes, headache, nausea and/or vomiting.
Slovenian: Simptomi intrakranialne hipertenzije lahko vključujejo spremembe vida, glavobol, slabost in/ali bruhanje.
English: Mecasermin, like insulin, may lower blood sugar levels (see hypoglycaemia in section 4).
Slovenian: Mekazermin lahko, podobno kot insulin, zniža vrednost krvnega sladkorja (glejte hipoglikemija v poglavju 4).
English: Common: Skin hypertrophy, abnormal hair texture
Slovenian: Pogosti: hipertrofija kože, nenormalna tekstura las
English: Push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see Figure 6).
Slovenian: Mehurčke iztisnite s pomočjo bata in tekočino znova izvlecite, dokler ne izvlečete ustreznega odmerka (glejte sliko 6).
English: In adolescents with Primary IGFD and in healthy adults there were no apparent differences between males and females in the pharmacokinetics of INCRELEX.
Slovenian: Pri mladostnikih s primarnim pomanjkanjem IGF in pri zdravih odraslih se farmakokinetika zdravila INCRELEX med osebami moškega in ženskega spola ni pomembneje razlikovala.
English: - The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections (see section 2 "INCRELEX contains benzyl alcohol and sodium").
Slovenian: - Druge sestavine zdravila so: benzilalkohol, natrijev klorid, polisorbat 20, koncentrirana ocetna kislina (ledocet), natrijev acetat in voda za injekcije (glejte poglavje 2 “Zdravilo INCRELEX vsebuje benzilalkohol in natrij”).
English: After first use, the vial may be stored for up to 30 days at 2C to 8ºC.
Slovenian: Po prvi uporabi lahko vialo shranjujete do 30 dni pri temperaturi od 2C - 8 ºC.
English: Make sure the tip of the needle is in the liquid (see Figure 4).
Slovenian: Prepričajte se, da je konica igle v tekočini (glejte sliko 4).
English: Of these, 72 (89%) had Laron syndrome-like phenotype; 7 (9%) had GH gene deletion, 1 (1%) had neutralizing antibodies to GH and 1 (1%) had isolated genetic GH deficiency.
Slovenian: Od teh je 72 oseb (89 %) imelo fenotip, podoben Laronovemu sindromu, 7 oseb (9 %) delecijo gena za GH, 1 oseba (1 %) nevtralizirajoča protitelesa proti GH in 1 oseba (1 %) izolirano genetsko pomanjkanje GH. 46 oseb (57 %) je bilo moškega spola in 66 oseb (81 %) belcev.
English: What you need to know before you use INCRELEX 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo INCRELEX
English: Very common: Headache Common: Convulsions, dizziness, tremor
Slovenian: Zelo pogosti: glavobol Pogosti: konvulzije, omotica, tremor
English: For severe hypoglycaemia, if you are not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon.
Slovenian: V primeru hude hipoglikemije, ko se več ne odzivate in ne morete zaužiti tekočine s sladkorjem, vam morajo dati injekcijo glukagona.
English: • Immunogenicity sampling information.
Slovenian: • Informacije o vzorčenju imunogenih lastnosti.
English: The rhIGF-1 protein is synthesised in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.
Slovenian: Sinteza proteina rhIGF-1 poteka v bakterijah (E. coli), ki imajo vstavljen gen za humani IGF-1.
English: Organ growth: treatment of IGF-1 deficient rats with rhIGF-1 results in whole body and organ growth.
Slovenian: Rast organov: pri dajanju rhIGF-1 podganam s pomanjkanjem IGF-1 so zasledili rast tako celotnega telesa kot organov.
English: In this case INCRELEX cannot help you grow and should not be used.
Slovenian: V tem primeru vam zdravljenje z zdravilom INCRELEX ne bo koristilo, zato zdravila ne smete uporabljati.
English: 65, quai Georges Gorse 92100 Boulogne-Billancourt France
Slovenian: 65, quai Georges Gorse 92100 Boulogne-Billancourt Francija
English: There were also reports of systemic hypersensitivity from post-marketing use, of which some cases were indicative of anaphylaxis.
Slovenian: O sistemski preobčutljivosti so poročali tudi v obdobju po začetku trženja zdravila, nekatera od teh poročil pa so kazala na anafilaksijo.
English: INCRELEX contains benzyl alcohol and sodium
Slovenian: Zdravilo INCRELEX vsebuje benzilalkohol in natrij
English: It is also recommended that all women of childbearing potential use adequate contraception during treatment.
Slovenian: Za vse ženske v rodni dobi je priporočljivo, da med zdravljenjem uporabljajo učinkovito kontracepcijo.
English: At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Slovenian: Na začetku zdravljenja je potrebno starše poučiti o znakih, simptomih in zdravljenju hipoglikemije, vključno z injiciranjem glukagona.
English: A small number of cases indicative of anaphylaxis requiring hospitalisation have been reported.
Slovenian: V majhnem številu primerov so poročali o anafilaksiji, pri kateri je bilo potrebno zdravljenje v bolnišnici.
English: Before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the prescribed dose.
Slovenian: Preden iglo zabodete v vialo, bat brizge izvlecite nazaj in brizgo napolnite z zrakom do oznake, ki ustreza predpisanemu odmerku zdravila.
English: Throw them away properly 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).
Slovenian: Po uporabi ju ustrezno zavrzite 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).
English: Tonsillar hypertrophy
Slovenian: Hipertrofija tonzil
English: Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema, dyspnoea), local allergic reactions at the injection site (pruritus, urticaria)
Slovenian: Neznana pogostnost: sistemska preobčutljivost (anafilaksija, generalizirana urtikarija, angioedem, dispneja), lokalne alergijske reakcije na mestu injiciranja (srbenje, urtikarija)
English: 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.
Slovenian: Presnovno delovanje IGF-1 je deloma usmerjeno k spodbujanju privzema glukoze, maščobnih kislin in aminokislin, tako da presnova oskrbuje rastoča tkiva.
English: In rats and rabbits reproductive toxicity was studied after intravenous but not after subcutaneous application (the normal clinical route).
Slovenian: 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.
English: Mecasermin may lower blood sugar levels.
Slovenian: Mekazermin lahko zniža nivo krvnega sladkorja.
English: Your doctor or nurse will instruct you how to give the injection of glucagon.
Slovenian: Zdravnik ali medicinska sestra vas bosta poučila, kako injicirati glukagon.
English: 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.
Slovenian: Podgane vrste Sprague Dawley so do dve leti prejemale mekazermin subkutano v odmerkih 0; 0,25; 1; 4 in 10 mg/kg/dan.
English: Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.
Slovenian: Vsakega bolnika, ki začne šepati ali toži zaradi bolečin v kolkih ali kolenih, je treba ustrezno pregledati.
English: 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:
Slovenian: 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:
English: Figure 2: Inject air into vial
Slovenian: Slika 2: V vialo iztisnite zrak
English: Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Slovenian: Bolniki morajo redno hoditi na preglede in ob pojavu kliničnih simptomov je potrebno te zaplete preprečiti oziroma uvesti ustrezno zdravljenje.
English: During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients.
Slovenian: 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.
English: Inject INCRELEX as instructed by the doctor.
Slovenian: Zdravilo INCRELEX injicirajte, kot vam je pokazal zdravnik.
English: Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
Slovenian: Iglo zabodite skozi gumijasti vrh viale in pritisnite na bat ter zrak iztisnite v vialo (glejte sliko 2).
English: Figure 4: Tip in liquid
Slovenian: Slika 4: Konica v tekočini
English: One ml contains 9 mg of benzyl alcohol.
Slovenian: En mililiter vsebuje 9 mg benzilalkohola.
English: IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons.
Slovenian: IGF-1 sestavlja 70 aminokislin v eni verigi s tremi intramolekularnimi disulfidnimi mostički.
English: Such containers should be sealed and disposed of properly in the way your doctor described.
Slovenian: Takšne posode morate dobro zapreti in nato ustrezno zavreči v skladu z zdravnikovimi navodili.
English: If you forget to use INCRELEX
Slovenian: Če ste pozabili uporabiti zdravilo INCRELEX
English: If you stop using INCRELEX
Slovenian: Če ste prenehali uporabljati zdravilo INCRELEX
English: Treatment with mecasermin is a long-term therapy.
Slovenian: Mekazermin je namenjen dolgotrajnemu zdravljenju.
English: Hypoglycaemia was the most frequently reported adverse event and a proper attention has to be given to meals in relation to dosing.
Slovenian: Hipoglikemija je bila najpogosteje poročani neželeni učinek, zato je posebno pozornost treba nameniti uporabi zdravila v času obrokov.
English: INCRELEX should be administered by subcutaneous injection shortly before or after a meal or snack.
Slovenian: Zdravilo INCRELEX je treba uporabljati v obliki subkutane injekcije neposredno pred ali po obroku oziroma prigrizku.
English: Toxicity to reproduction
Slovenian: Vpliv na sposobnost razmnoževanja
English: Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects.
Slovenian: Zdravljenje akutnega prevelikega odmerjanja mekazermina mora biti usmerjeno k ublažitvi hipoglikemičnih učinkov.
English: 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.
Slovenian: 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.
English: The patient information about INCRELEX should contain the following information:
Slovenian: Vodnik za bolnika o zdravilu INCRELEX mora vsebovati naslednje informacije:
English: 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.
Slovenian: 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.
English: INCRELEX should not be administered intravenously.
Slovenian: Zdravila INCRELEX se ne sme uporabljati intravensko.
English: Other uncommon side effects seen with mecasermin treatment include depression, nervousness.
Slovenian: Druga občasna neželena učinka mekazermina sta depresija in živčnost.
English: The most frequently occurring side effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections.
Slovenian: Najpogostejši neželeni učinki mekazermina so: nizek krvni sladkor (hipoglikemija), bruhanje, reakcije na mestu injiciranja, glavobol in okužba srednjega ušesa.
English: Clinical Trial
Slovenian: Klinično preskušanje
English: • That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects.
Slovenian: • Zdravilo INCRELEX je treba dati neposredno pred ali po obroku oziroma prigrizku, saj ima insulinu podobne hipoglikemične učinke.
English: 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.
Slovenian: Iz mikrobiološkega vidika se sme zdravilo po odprtju hraniti največ 30 dni pri temperaturi od 2 C - 8 C.
English: Chemical and physical in-use stability has been demonstrated for 30 days at 2C to 8C.
Slovenian: 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.
English: Hypoglycaemia is a very common adverse reaction.
Slovenian: Hipoglikemija je zelo pogost neželeni učinek.
English: No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.
Slovenian: Okvara jeter Študije, ki bi določile vpliv okvare jeter na farmakokinetiko mekazermina, niso bile izvedene.
English: Ipsen Farmaceutica B.V. Taurusavenue 33 B NL-2132 LS Hoofddorp Tel: + 31 23 55 41 600
Slovenian: Taurusavenue 33 B NL-2132 LS Hoofddorp Tel: + 31 23 55 41 600
English: Increased blood sugar (hyperglycaemia) Increased blood sugar has also been observed with mecasermin treatment.
Slovenian: Visok krvni sladkor (hiperglikemija) Pri zdravljenju z mekazerminom so poročali tudi o zvišanju vrednosti krvnega sladkorja.
English: 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).
Slovenian: 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).
English: Mecasermin may enlarge your tonsils/adenoids.
Slovenian: Mekazermin lahko povzroči povečanje tonzil/adenoidnega tkiva.
English: Therefore, this medicinal product is not recommended in children below age of 2.
Slovenian: Uporaba tega zdravila pri otrocih, mlajših od 2 let, tako ni priporočljiva.
English: 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.
Slovenian: Intrakranialna hipertenzija/zvišan intrakranialni tlak se je v kliničnih preskušanjih pojavil pri 4 bolnikih (0,96 %).
English: 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.
Slovenian: Iglo izvlecite naravnost in na mesto injiciranja za nekaj sekund rahlo pritisnite z gazo ali kosmom vate.
English: Common: Sleep apnoea syndrome, adenoidal hypertrophy, tonsillar hypertrophy, snoring
Slovenian: Pogosti: sindrom apneje v spanju, adenoidna hipertrofija, tonzilarna hipertrofija, smrčanje
English: Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
Slovenian: Mekazermin je humani insulinu podoben rastni faktor-1 (rhIGF-1), pridobljen s tehnologijo rekombinantne DNA.
English: • Product information
Slovenian: • Informacije o zdravilu
English: Echocardiogram is recommended before initiation of mecasermin treatment in all patients.
Slovenian: Pred začetkom zdravljenja z mekazerminom je pri vseh bolnikih priporočljiva uporaba ehokardiograma.
English: If you use more INCRELEX than you should
Slovenian: Če ste uporabili večji odmerek zdravila INCRELEX, kot bi smeli
English: Infections Infections of the middle ear have been observed in children with mecasermin treatment.
Slovenian: Okužbe Pri zdravljenju z mekazerminom so pri otrocih poročali o okužbah srednjega ušesa.
English: Do not give the injection if you are unable to eat shortly before or after the injection.
Slovenian: Če neposredno pred ali po injiciranju ne morete jesti, zdravila ne injicirajte.
English: The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
Slovenian: Najnižji odmerek, ki je povezan s pomembnim povečanjem rasti pri posameznem bolniku, je 0,04 mg/kg dvakrat na dan.
English: Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass. IGF-1 increases bone density.
Slovenian: Cirkulirajoči IGF-1 ima pomembno vlogo pri večanju in vzdrževanju kostne mase.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih ali genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: If more INCRELEX than recommended was injected, contact your doctor immediately.
Slovenian: Če ste injicirali večji odmerek zdravila INCRELEX od priporočenega, se nemudoma posvetujte z zdravnikom.
English: Olbrachtova 2006/9,
Slovenian: Olbrachtova 2006/9, CZ-140 00 Praha 4
English: Glucagon raises the blood sugar when it is injected.
Slovenian: Glukagon po injiciranju dvigne količino sladkorja v krvi.
English: IGFBP-3 is reduced in subjects with severe Primary IGFD, resulting in increased clearance of IGF-1 in these subjects relative to healthy subjects.
Slovenian: Pri osebah s hudim primarnim pomanjkanjem IGF je koncentracija IGFBP-3 manjša, posledično je pri njih očistek IGF-1 večji kot pri zdravih osebah.
English: 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.
Slovenian: 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.
English: The amino acid sequence of the product is identical to that of endogenous human IGF-1.
Slovenian: Aminokislinsko zaporedje zdravila je enako endogenemu humanemu IGF-1.
English: Hypoacusis (hearing loss)
Slovenian: Hipakuza (naglušnost)
English: What INCRELEX contains - The active substance is mecasermin.
Slovenian: Kaj vsebuje zdravilo INCRELEX - Učinkovina je mekazermin.
English: Hair loss has also been reported following mecasermin use.
Slovenian: Izpadanje las (alopecija) Poročali so o izpadanju las po uporabi mekazermina.
English: Treatment of acute overdose of mecasermin should be directed at reversing hypoglycaemia.
Slovenian: Zdravljenje akutnega prevelikega odmerka mekazermina mora biti usmerjeno k ublažitvi hipoglikemije.
English: 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).
Slovenian: 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).
English: Increased pressure in the brain (intracranial hypertension) INCRELEX can sometimes cause a temporary increase in pressure within the brain.
Slovenian: 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.
English: Studies have not been conducted with mecasermin in breast-feeding mothers.
Slovenian: Študije z mekazerminom pri doječih materah niso bile izvedene.
English: Brodišče 32 SI-1236 Trzin Tel: + 386 1 236 47 00
Slovenian: SI-1236 Trzin Tel: + 386 1 236 47 00
English: Systemic hypersensitivity included symptoms such as anaphylaxis, generalized urticaria, angioedema and dyspnoea.
Slovenian: Sistemska preobčutljivost, vključno s simptomi, kot so anafilaksija, generalizirana urtikarija, angioedem in dispneja.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Slovenian: 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.
English: Wash your hands before getting INCRELEX ready for your injection.
Slovenian: Preden začnete s pripravo zdravila INCRELEX za injiciranje, si umijte roke.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Children The pharmacokinetics of INCRELEX have not been studied in subjects younger than 12 years of age.
Slovenian: Otroci Pri osebah, mlajših od 12 let, farmakokinetika zdravila INCRELEX ni bila raziskana.
English: Oral glucose or food should be consumed.
Slovenian: Bolnik mora peroralno zaužiti glukozo ali hrano.
English: Other ingredients: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections.
Slovenian: Pomožne snovi so: benzilalkohol, natrijev klorid, polisorbat 20, koncentrirana ocetna kislina (ledocet), natrijev acetat in voda za injekcije.