FrancophonIA/ELRC3.0 huggingface dataset:
English: • To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
Slovenian: • Navodila za poročanje zdravniku o pojavu šepanja ali bolečinah v kolku ali kolenu, da bi bilo mogoče stanje oceniti.
English: Elderly The pharmacokinetics of INCRELEX have not been studied in subjects greater than 65 years of age.
Slovenian: Starostniki Pri osebah, starejših od 65 let, farmakokinetika zdravila INCRELEX ni bila raziskana.
English: P-value for change from pre-Tx [1]
Slovenian: Povprečje (SD) za spremembo iz pre-Tx P-vrednost za spremembo iz pre-Tx [1] SDS telesne višine N Povprečje (SD)
English: Therefore there is insufficient medical information to determine whether there are significant risks to a foetus.
Slovenian: Razpoložljivi zdravstveni podatki tako ne zadostujejo za oceno stopnje tveganja za plod.
English: Data was also collected from post-marketing sources.
Slovenian: Podatke o neželenih učinkih so zbirali tudi v obdobju po začetku trženja zdravila.
English: You should have examinations periodically.
Slovenian: V tem primeru so potrebni redni zdravniški pregledi.
English: Excipients INCRELEX contains 9 mg/ml benzyl alcohol as a preservative.
Slovenian: Zdravilo INCRELEX vsebuje kot konzervans 9 mg/ml benzilalkohola.
English: Pull the plunger to withdraw the correct dose into the syringe (see Figure 5).
Slovenian: Povlecite za bat in v brizgo izvlecite ustrezni odmerek (glejte sliko 5).
English: • To report the onset of severe headache, blurred vision and associated nausea and vomiting to their physician.
Slovenian: • Navodila za poročanje zdravniku o pojavu hudega glavobola, zamegljenega vida in s tem povezane slabosti ter bruhanja.
English: INCRELEX 10 mg/ml solution for injection Mecasermin
Slovenian: INCRELEX 10 mg/ml raztopina za injiciranje mekazermin
English: This reaction occurred in 71 (17%) subjects from the clinical trials and was generally associated with lack of proper rotation of injections.
Slovenian: V kliničnih preskušanjih se je hipertrofija na mestu injiciranja pojavila pri 71 osebah (17 %) in je običajno bila posledica nedoslednega menjavanja mesta injiciranja.
English: Str. Grigore Alexandrescu nr. 59, clădirea HQ Sector 1, 010623, Bucureşti, România
Slovenian: Sector 1, 010623, Bucureşti, România
English: Excess mortality secondary to IGF-1 induced hypoglycaemia was observed in the carcinogenesis studies.
Slovenian: Pri študijah karcinogenosti so opazili večjo umrljivost zaradi hipoglikemije, povzročene z IGF-1.
English: Carbohydrate Metabolism
Slovenian: Presnova ogljikovih hidratov
English: Do not recap the syringe.
Slovenian: Brizge ne pokrivajte več.
English: Acute overdose could lead to hypoglycaemia.
Slovenian: Pri akutnem prevelikem odmerjanju se lahko pojavi hipoglikemija.
English: 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).
Slovenian: 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).
English: Serious allergic reactions have also been reported with INCRELEX.
Slovenian: Pri uporabi zdravila INCRELEX so poročali tudi o pojavu resnih alergijskih reakcij.
English: The dose of INCRELEX should not be doubled to make up for one or more omitted doses.
Slovenian: Odmerka zdravila INCRELEX ni dovoljeno podvojiti, če je bil izpuščen en ali več odmerkov.
English: Acute overdose could lead to hypoglycaemia (low blood sugar).
Slovenian: V primeru enega samega prevelikega odmerka (akutni preveliki odmerek) se lahko pojavi hipoglikemija (nizek nivo krvnega sladkorja).
English: Post-marketing reports
Slovenian: Poročila po prihodu zdravila na trg
English: INCRELEX should be administered using sterile disposable syringes and injection needles.
Slovenian: Pri injiciranju zdravila INCRELEX je treba uporabljati sterilno injekcijsko brizgo in iglo za enkratno uporabo.
English: Mecasermin may be started again after the episode is over.
Slovenian: Mekazermin lahko spet začnete uporabljati, ko stanje mine.
English: - 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.
Slovenian: - 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.
English: MARKETING AUTHORISATION HOLDER Ipsen Pharma
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma
English: 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.
Slovenian: 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).
English: No subject discontinued the studies due to adverse events.
Slovenian: Zaradi neželenih učinkov iz študij ni bila izključena nobena oseba.
English: Figure 3: Prepare for extraction
Slovenian: Slika 3: Priprava na odvzem odmerka iz viale
English: Snoring This occurred generally in the first year of treatment, and was reported in 30 subjects (7%).
Slovenian: O smrčanju so poročali pri 30 osebah (7 %).
English: Please ask the doctor for advice before stopping the treatment.
Slovenian: Preden prenehate z zdravljenjem, se posvetujte z zdravnikom.
English: When injections were properly dispersed, the condition resolved.
Slovenian: Po ustreznem menjavanju mest injiciranja se je stanje izboljšalo.
English: Treatment should be reconsidered if after a year patients remain non-responsive.
Slovenian: Če po enoletnem zdravljenju pri bolniku ni napredka, je treba zdravljenje ponovno ovrednotiti.
English: IGF-1 has inhibitory effects on insulin secretion.
Slovenian: IGF-1 zavira izločanje insulina.
English: Very common: Vomiting, upper abdominal pain
Slovenian: Zelo pogosti: bruhanje,bolečina v zgornjem delu abdomna Pogosti: abdominalna bolečina
English: Inject INCRELEX just below the skin in your upper arm, upper leg (thigh), stomach area (abdomen), or buttocks.
Slovenian: Zdravilo INCRELEX si injicirajte neposredno pod kožo nadlakti, stegna, trebuha (abdomna) ali zadnjice.
English: 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).
Slovenian: Tako boste preprečili onesnaženje viale z mikrobi, do katerega bi lahko prišlo pri ponavljajočem se prebadanju z iglo (glejte sliko 1).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: One multi-use vial of 4 ml.
Slovenian: Ena viala s 4 ml za večkratno uporabo.
English: If a dose is skipped, the next dose should not be made larger to compensate.
Slovenian: Če ste pozabili uporabiti odmerek, naslednjič ne smete uporabiti večjega odmerka, da bi tako nadomestili pozabljeni odmerek.
English: Slipped capital femoral epiphysis (with the potential to lead to avascular necrosis) and progression of scoliosis can occur in patients who experience rapid growth.
Slovenian: Pri bolnikih s hitro rastjo lahko pride do zdrsa epifize glavice stegnenice (z možnostjo povzročitve avaskularne nekroze) in napredovanja skolioze.
English: Very common: Hypoglycaemia Common: Hypoglycaemic seizure, hyperglycaemia
Slovenian: Zelo pogosti: hipoglikemija Pogosti: hipoglikemični krči, hiperglikemija
English: Funduscopic examination is recommended at the initiation, periodically during the course of mecasermin therapy and at the occurrence of clinical symptoms.
Slovenian: Na začetku zdravljenja z mekazerminom je priporočljivo opraviti pregled očesnega ozadja in ga nato redno ponavljati med zdravljenjem ali v primeru pojava kliničnih simptomov.
English: Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Slovenian: Pojav reakcij na mestu injiciranja lahko preprečite tako, da zdravilo vsakič injicirate na drugo mesto (rotacija mesta injiciranja).
English: Seventy-four (91%) of the subjects were prepubertal at baseline.
Slovenian: 74 oseb (91 %) je bilo v izhodišču v obdobju pred začetkom spolnega dozorevanja.
English: Decide on an injection area - upper arm, thigh, buttock, or abdomen (see below).
Slovenian: Izberite mesto injiciranja - nadlaket, stegno, zadnjico ali trebuh (glejte spodaj).
English: Instructions on the administration of glucagon should severe hypoglycaemia occur.
Slovenian: Navodila o dajanju glukagona v primeru pojava hude oblike hipoglikemije.
English: If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycaemic effects.
Slovenian: Če se pojavi nezavest, bo bolnik za prekinitev hipoglikemičnega učinka morda moral prejeti glukozo intravensko ali glukagon parenteralno.
English: Local allergic reactions at the injection site (itching, hives) have also been reported.
Slovenian: Poročali so tudi o pojavu lokalnih alergijskih reakcij na mestu injiciranja (srbenje, koprivnica).
English: The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea.
Slovenian: V primerih, ki so nakazovali na anafilaksijo, so simptomi vključevali urtikarijo, angioedem in dispnejo.
English: 140 00 Praha 4 Tel: + 420 242 481 821
Slovenian: Tel: + 420 242 481 821
English: Reactions observed from the post-marketing environment
Slovenian: Neželeni učinki, opaženi v obdobju po prihodu zdravila na trg
English: Common (may affect up to 1 in 10 people) Seizures
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) Krči
English: Mecasermin therapy should be discontinued if pregnancy occurs.
Slovenian: V primeru nosečnosti je treba zdravljenje z mekazerminom prekiniti.
English: An increased incidence of adrenal medullary hyperplasia and pheochromocytoma was observed in male rats at doses of 1 mg/kg/day and above ( 1 times the clinical exposure with the maximum recommended human dose [MRHD] based on AUC) and female rats at all dose levels ( 0.3 times the clinical exposure with the MRHD based on AUC).
Slovenian: Pri samcih podgan so pri odmerkih 1 mg/kg/dan in več ( 1-kratna izpostavljenost človeka pri klinični uporabi najvišjega priporočenega odmerka na osnovi AUC) in pri samicah podgan pri vseh odmerkih ( 0,3-kratna izpostavljenost človeka pri klinični uporabi najvišjega priporočenega odmerka na osnovi AUC) opazili večjo pojavnost hiperplazije sredice nadledvične žleze in feokromocitoma.
English: Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of mecasermin treatment, until a welltolerated dose of INCRELEX has been established.
Slovenian: Bolniki se morajo 2 do 3 ure po uporabi odmerka izogibati vseh visoko tveganih dejavnosti, še posebej na začetku zdravljenja z mekazerminom, dokler se ne določi odmerek zdravila INCRELEX, ki ga bolnik dobro prenaša.
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced for diabetic subjects using this medicinal product.
Slovenian: Pri osebah s sladkorno boleznijo bo med zdravljenjem s tem zdravilom morda treba zmanjšati odmerek insulina ali drugih antidiabetikov ali obojega.
English: Stop INCRELEX immediately and seek urgent medical advice if you develop a serious allergic reaction.
Slovenian: V primeru pojava resne alergijske reakcije takoj prenehajte uporabljati zdravilo INCRELEX in nemudoma poiščite nujno zdravniško pomoč.
English: These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during mecasermin treatment.
Slovenian: Splošno pravilo je, da je treba med zdravljenjem z mekazerminom ta stanja in druge simptome in znake, za katere je znano, da so povezani z zdravljenjem z GH, spremljati.
English: Bone/Mineral Metabolism
Slovenian: Presnova kosti/mineralov
English: An enlarged thymus (a specialized organ of the immune system) has been observed with mecasermin treatment.
Slovenian: Pri zdravljenju z mekazerminom so poročali o povečanju priželjca (specializirani organ imunskega sistema).
English: A swelling at the back of the eye (due to increased pressure within the brain) may be observed by a doctor or optician during mecasermin treatment.
Slovenian: Med zdravljenjem z mekazerminom lahko zdravnik ali okulist opazi oteklino očesnega ozadja (zaradi povečanega pritiska v možganih).
English: The mean terminal t1/2 of total IGF-1 after single subcutaneous administration of 0.12 mg/kg in three paediatric subjects with severe Primary IGFD is estimated to be 5.8 hours.
Slovenian: Pri treh otrocih s hudim primarnim pomanjkanjem IGF je bilo ocenjeno, da je po enkratnem subkutanem odmerku 0,12 mg/kg povprečni končni razpolovni čas (t1/2) celokupnega IGF-1 5,8 ur.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INCRELEX 10 mg/ml injection mecasermin
Slovenian: IME ZDRAVILA IN POT(I) UPORABE INCRELEX 10 mg/ml injekcija mekazermin s.c.
English: Get medical help immediately if you have a generalised allergic reaction (hives, trouble breathing, faintness or collapse and feeling generally unwell).
Slovenian: Če se pojavi splošna alergijska reakcija (koprivnica, oteženo dihanje, omedlevica ali kolaps ter splošno slabo počutje), nemudoma poiščite najbližjo zdravniško pomoč.
English: How to use INCRELEX
Slovenian: Kako uporabljati zdravilo INCRELEX
English: If it is present, your doctor may decide to temporarily reduce or discontinue mecasermin therapy.
Slovenian: Če bo ugotovil, da gre za intrakranialno hipertenzijo, lahko začasno zniža odmerek mekazermina ali zdravljenje prekine.
English: One ml contains 10 mg of mecasermin.
Slovenian: En ml vsebuje 10 mg mekazermina.
English: This may be through the production of anti-IGF-1 IgEs, sustaining antibodies or neutralizing antibodies respectively.
Slovenian: Lahko se tvorijo protitelesa anti-IGF-1 razreda IgE, protitelesa, ki se vežejo na učinkovino, oziroma nevtralizirajoča protitelesa.
English: Other adverse reactions have been identified during post approval use of INCRELEX.
Slovenian: O drugih neželenih učinkih so poročali v obdobju po začetku trženja zdravila INCRELEX.
English: Of the 115 (28%) subjects who experienced one or more episode of hypoglycaemia, 6 subjects experienced a hypoglycaemic seizure on one or more occasion.
Slovenian: O pojavu ene ali več epizod hipoglikemije so poročali pri 115 osebah (28 %).
English: Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with severe Primary IGFD.
Slovenian: Pri otrocih s hudim primarnim pomanjkanjem IGF ni zadostnih podatkov z odmerki, višjimi od 0,12 mg/kg dvakrat na dan.
English: Dizziness and tremor have also been reported with mecasermin treatment.
Slovenian: Pri zdravljenju z mekazerminom so poročali tudi o omotici in tremorju.
English: - if you develop a limp or hip or knee pain - if you have enlarged tonsils (tonsillar hypertrophy).
Slovenian: - če imate povečane tonzile (tonzilarna hipertrofija).
English: Each vial of 4 ml contains 40 mg of mecasermin*.
Slovenian: Ena viala s 4 ml vsebuje 40 mg mekazermina*.
English: You should always have a source of sugar such as orange juice, glucose gel, sweets, or milk available in case symptoms of hypoglycaemia occur.
Slovenian: Zaradi možnega pojava simptomov hipoglikemije morate vedno imeti na voljo vir sladkorja, kot so pomarančni sok, sladkorni sirup, sladkarije ali mleko.
English: The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined.
Slovenian: Pri osebah s hudim primarnim pomanjkanjem IGF absolutna biološka uporabnost mekazermina po subkutanem injiciranju ni bila določena.
English: Common: Injection site pain, injection site reaction, injection site haematoma, injection site erythema, injection site induration, injection site haemorrhage, injection site irritation
Slovenian: Zelo pogosti: hipertrofija na mestu injiciranja, modrica na mestu injiciranja Pogosti: bolečina na mestu injiciranja, reakcija na mestu injiciranja, hematom na mestu injiciranja, rdečina na mestu injiciranja, zatrdlina na mestu injiciranja, krvavitev na mestu injiciranja, draženje na mestu injiciranja
English: In blood, IGF-1 is bound to six IGF binding proteins (IGFBPs), with ~80% bound as a complex with IGFBP-3 and an acid-labile subunit.
Slovenian: Približno 80 % IGF-1 je vezanega v kompleksu z IGFBP-3 in acidolabilno podenoto.
English: Uncommon: Cardiomegaly, ventricular hypertrophy, mitral valve incompetence, tricuspid valve incompetence
Slovenian: Pogosti: srčni šum, tahikardija Občasni: kardiomegalija, ventrikularna hipertrofija, insuficienca mitralne zaklopke, insuficienca trikuspidalne zaklopke
English: Weight increase Weight increase has been observed with mecasermin treatment.
Slovenian: Ocenjeno je bilo, da se skupni volumen porazdelitve povečuje z zviševanjem odmerka mekazermina.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) Bistra in brezbarvna vodna raztopina.
English: NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection
Slovenian: IME ZDRAVILA INCRELEX 10 mg/ml raztopina za injiciranje
English: Limited information is available on the concentration of unbound IGF-1 after the administration of INCRELEX.
Slovenian: Podatki o koncentraciji nevezanega IGF-1 po dajanju zdravila INCRELEX so pomanjkljivi.
English: Pain in muscles has also been seen with mecasermin treatment.
Slovenian: Pri zdravljenju z mekazerminom so poročali tudi o bolečinah v mišicah.
English: Sugarcontaining fluids or food should be consumed.
Slovenian: V tem primeru morate zaužiti tekočino ali hrano, ki vsebuje sladkor.
English: *Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
Slovenian: *Mekazermin je insulinu podoben rastni faktor-1 (IGF-1), pridobljen s tehnologijo rekombinantne DNA na kulturi celic Escherichia coli.
English: These conditions should be monitored during INCRELEX treatment.
Slovenian: Med zdravljenjem z zdravilom INCRELEX je treba to stanje nadzorovati.
English: INCRELEX should not be given to pregnant or nursing women.
Slovenian: Nosečnice ali doječe matere zdravila INCRELEX ne smejo uporabljati.
English: Patients who terminate treatment should also have an echocardiogram.
Slovenian: Ehokardiogram naj opravijo tudi bolniki, ki prenehajo z zdravljenjem.
English: Uncommon: Increased weight
Slovenian: Občasni: povečanje telesne mase
English: Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with mecasermin, as has been reported with therapeutic GH administration.
Slovenian: Pri bolnikih, ki so se zdravili z mekazerminom, so poročali o intrakranialni hipertenziji (IH) s papiledemom, motnjami vida, glavoboli, navzeo in/ali bruhanjem, podobno kot pri zdravljenju z GH.
English: Use a new disposable needle and syringe every time you give a dose.
Slovenian: Pri vsakem injiciranju odmerka uporabite novo injekcijsko brizgo in iglo za enkratno uporabo.
English: Injection sites should be rotated to a different site with each injection.
Slovenian: Zdravilo je treba vsakič injicirati na drugo mesto.
English: Tell the doctor immediately if you have any of these symptoms.
Slovenian: V primeru pojava teh simptomov o tem nemudoma obvestite zdravnika.
English: Thyroid and nutritional deficiencies should be corrected before initiating mecasermin treatment.
Slovenian: Pred začetkom zdravljenja z mekazerminom je treba odpraviti motnje delovanja ščitnice in podhranjenost.
English: Renal impairment No studies have been conducted in children with renal impairment.
Slovenian: Okvara ledvic Pri otrocih z okvaro ledvic študije niso bile izvedene.
English: The injection site should be changed for each injection (rotate the injection site).
Slovenian: Mesto injiciranja morate pri vsakem naslednjem injiciranju zamenjati (rotiranje mesta injiciranja).
English: Postmarketing reports of local allergic reactions were also received.
Slovenian: V obdobju po začetku trženja zdravila so poročali tudi o pojavu lokalne preobčutljivosti.
English: Reproductive system Breast enlargement has been observed with mecasermin treatment.
Slovenian: Reproduktivni sistem Pri zdravljenju z mekazerminom so poročali o povečanju dojk.
English: The vial contains 4 ml of solution.
Slovenian: Viala vsebuje 4 ml raztopine.
English: The injection site should be dry before you inject.
Slovenian: Ob injiciranju mora biti mesto injiciranja suho.
English: Common: Melanocytic naevus
Slovenian: Pogosti: melanocitni nevus
English: Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1.
Slovenian: GH in IGF-1 neposredno spodbujata rast in presnovo celic epifiznih plošč.
English: Common: Thymus hypertrophy
Slovenian: Pogosti: hipertrofija timusa
English: Each vial contains 40 mg of mecasermin.
Slovenian: Ena viala vsebuje 40 mg mekazermina.
English: Injection site hypertrophy
Slovenian: Hipertrofija na mestu injiciranja
English: Intracranial hypertension/increased intracranial pressure This occurred in 4 subjects (0.96%); in two subjects INCRELEX was discontinued and not restarted; in two subjects the event did not recur after restarting INCRELEX at a reduced dose.
Slovenian: Pri dveh osebah so zdravljenje z zdravilom INCRELEX prekinili in ga nato niso več uvedli, pri dveh osebah pa se neželeni učinek po ponovni uvedbi zdravljenja z zdravilom INCRELEX v zmanjšanem odmerku ni ponovil.
English: If you take INCRELEX, you should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment.
Slovenian: Med zdravljenjem z zdravilom INCRELEX se morate 2 do 3 ure po injiciranju zdravila INCRELEX izogibati zelo tveganih dejavnosti (npr. intenzivna telesna aktivnost), še posebej na začetku zdravljenja z zdravilom INCRELEX.
English: Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score
Slovenian: Povprečje (SD) za spremembo iz pre-Tx P-vrednost za spremembo iz pre-Tx [1] Pre-Tx = pred zdravljenjem, SD = standardna deviacija, SDS = vrednost standardnega odklona [1] P-vrednosti za primerjanje z vrednostmi pre-Tx so bile izračunane s pomočjo parnega t-testa.
English: If you develop any of these events, please follow the advice given for each event in the sections below.
Slovenian: V primeru pojava kateregakoli od navedenih neželenih učinkov upoštevajte navodila, navedena v nadaljevanju.
English: Common: Papilloedema
Slovenian: Pogosti: papiledem
English: Uncommon: Injection site rash, injection site swelling, lipohypertrophy
Slovenian: Občasni: izpuščaj na mestu injiciranja, oteklina na mestu injiciranja, lipohipertrofija
English: Papilloedema
Slovenian: Nadlaket