FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop INCRELEX immediately and seek urgent medical advice if you develop seizures/fits or become unconscious.
Bulgarian: Du skal straks søge læge og stoppe med at tage INCRELEX, hvis du får kramper/anfald eller bliver bevidstløs.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Bulgarian: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1. Aktiv neoplasi eller mistanke om neoplasi.
English: One ml contains 9 mg of benzyl alcohol.
Bulgarian: skal være opmærksom på: 1 ml indeholder 9 mg benzylalkohol.
English: Under normal circumstances, growth hormone (GH) binds to its receptor in the liver and other tissues, and stimulates the synthesis/secretion of IGF-1.
Bulgarian: Under normale omstændigheder bindes væksthormonet (GH) til dets receptor i leveren og andre væv og stimulerer syntese/sekretion af IGF-1. I målvæv aktiveres type 1 IGF-1-receptoren, som er homolog til insulinreceptoren, af IGF-1.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Bulgarian: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.
English: A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin.
Bulgarian: Det anbefales, at der foreligger en negativ graviditetstest for alle kvinder i den fødedygtige alder forud for behandling med mercasermin.
English: The recommended starting dose of mecasermin is 0.04 mg/kg of body weight twice daily by subcutaneous injection.
Bulgarian: Den anbefalede startdosis af mecasermin er 0,04 mg pr. kg legemsvægt
English: Lymphoid tissue (e.g., tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions have been reported with the use of this medicinal product.
Bulgarian: tonsiller) forbundet med komplikationer, såsom snorken, søvnapnø og kronisk mellemøreeffusion, er rapporteret ved anvendelse af dette lægemiddel.
English: Severe hypoglycaemia may cause unconsciousness, seizures/fits or death.
Bulgarian: Meget lavt blodsukker kan medføre bevidstløshed, kramper/anfald eller død.
English: - if you develop a limp or hip or knee pain - if you have enlarged tonsils (tonsillar hypertrophy).
Bulgarian: - Hvis du har forstørrede mandler (hypertrophia tonsillarum).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INCRELEX 10 mg/ml injection mecasermin
Bulgarian: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) INCRELEX 10 mg/ml injektion mecasermin s.c.
English: The symptoms of intracranial hypertension can include visual changes, headache, nausea and/or vomiting.
Bulgarian: Symptomerne på forhøjet tryk i hjernen kan omfatte synsforstyrrelser, hovedpine, kvalme og/eller opkastning.
English: Other medicines and INCRELEX
Bulgarian: Brug af anden medicin sammen med INCRELEX
English: Clinical Trial
Bulgarian: Klinisk forsøg
English: Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Bulgarian: Reaktioner ved injektionsstedet kan undgås ved at ændre injektionssted ved hver indsprøjtning (rotation af injektionssted).
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).
Bulgarian: til 16 mg/kg (20 gange den maksimalt anbefalede humane dosis [MRHD] baseret på legemsoverfladen) og i et teratologistudie med kaniner uden påvirkning af fosteret ved doser på 0,5 mg/kg (2 gange MRHD baseret på legemsoverfladen).
English: PHARMACEUTICAL PARTICULARS
Bulgarian: FARMACEUTISKE OPLYSNINGER
English: Treatment of acute overdose of mecasermin should be directed at reversing hypoglycaemia.
Bulgarian: Behandlingen af en akut overdosering af mecasermin skal fokusere på at afhjælpe lavt blodsukker (hypoglykæmi).
English: Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass. IGF-1 increases bone density.
Bulgarian: Cirkulerende IGF-1 spiller en vigtig rolle i dannelse og opretholdelse af knoglemasse.
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).
Bulgarian: Forstørrelse af vævet (hypertrofi) og blå mærker ved injektionsstedet Dette kan undgås ved at ændre injektionssted ved hver indsprøjtning (rotation af injektionssted).
English: - if you have symptoms of increased pressure in the brain (intracranial hypertension), such as visual changes, headache, nausea and/or vomiting, contact the doctor for advice.
Bulgarian: - Hvis du har symptomer på forøget tryk i hjernen (intrakranial hypertension), såsom synsforstyrrelser, hovedpine, kvalme og/eller opkastninger.
English: Excipients INCRELEX contains 9 mg/ml benzyl alcohol as a preservative.
Bulgarian: INCRELEX indeholder 9 mg/ml benzylalkohol
English: Enlarged thymus
Bulgarian: Forstørret thymus (brissel)
English: One ml contains 10 mg of mecasermin.
Bulgarian: En ml indeholder 10 mg mecasermin.
English: Description of selected adverse reactions
Bulgarian: Beskrivelse af udvalgte bivirkninger
English: General disorders and administration site conditions
Bulgarian: Almene symptomer og reaktioner på administrationsstedet
English: Pregnancy, breast-feeding and fertility
Bulgarian: Graviditet, amning og frugtbarhed
English: Reactions including pain, irritation, bleeding, bruising, redness and hardening have been reported with INCRELEX treatment.
Bulgarian: Der er rapporteret reaktioner såsom smerter, irritation, blødning, blå mærker, rødme og hårde områder under behandling med INCRELEX.
English: Patients who terminate treatment should also have an echocardiogram.
Bulgarian: inden behandlingen med mecasermin påbegyndes. Patienter, der afbryder behandlingen, bør også få taget et ekkokardiogram.
English: Common: Injection site pain, injection site reaction, injection site haematoma, injection site erythema, injection site induration, injection site haemorrhage, injection site irritation
Bulgarian: Hypertrofi ved injektionsstedet, blå mærker ved injektionsstedet Almindelig: Smerter på injektionsstedet, reaktioner på injektionsstedet, hæmatom på injektionsstedet, erytem på injektionsstedet, induration på injektionsstedet, blødning på injektionsstedet, irritation på injektionsstedet Ikke almindelig:
English: Dizziness and tremor have also been reported with mecasermin treatment.
Bulgarian: Svimmelhed og rysten er også rapporteret under behandling med mercasermin.
English: See section 4.
Bulgarian: Árbóc utca 6.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Bulgarian: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Height Velocity (cm/yr)
Bulgarian: Væksthastighed (cm/år)
English: Thyroid and nutritional deficiencies should be corrected before initiating mecasermin treatment.
Bulgarian: skal afhjælpes, inden en behandling med mecasermin indledes.
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.
Bulgarian: IGFBP-3 reduceres hos patienter med svær primær IGFD, hvilket resulterer
English: Mecasermin has no effects on fertility in rats using intravenous doses 0.25, 1, and 4 mg/day (up to 4 times the clinical exposure with the MRHD based on AUC).
Bulgarian: intravenøse doser på 0,25, 1 og 4 mg/dag (op til 4 gange den kliniske eksponering med MRHD baseret på AUC).
English: Make sure the tip of the needle is in the liquid (see Figure 4).
Bulgarian: Sørg for, at kanylespidsen er nede i væsken (se figur 4). Træk stemplet
English: Do not use after the expiry date (which is stated on the label after EXP and it refers to the last day of the month) or if it is cloudy or if you see bits.
Bulgarian: sidste dag i den nævnte måned), eller hvis den er uklar, eller du kan se
English: Mecasermin should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycaemic effects.
Bulgarian: inden eller efter et måltid eller mellemmåltid, da midlet kan have insulinlignende hypoglykæmiske effekter.
English: Nervous system Headache has occurred with mecasermin treatment.
Bulgarian: Nervesystemet Hovedpine er forekommet under behandling med mercasermin.
English: Do not use INCRELEX - if you are allergic to mecasermin or any of the other ingredients of this medicine (listed in section 6).
Bulgarian: - Hvis du er allergisk over for mecasermin eller et af de øvrige indholdsstoffer i INCRELEX
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.
Bulgarian: 0,12 mg/kg hos tre pædiatriske patienter med svær primær IGFD anslås til at være 5,8 timer.
English: Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi) Tel: + 39 - 02 - 39 22 41
Bulgarian: 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi)
English: Uncommon: Benign intracranial hypertension
Bulgarian: Intrakraniel hypertension/forhøjet intrakranielt
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Bulgarian: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: If the solution is cloudy, or contains particulate matter, it must not be injected.
Bulgarian: Opløsningen må ikke injiceres, hvis den er uklar eller indeholder partikler.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Bulgarian: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen
English: 140 00 Praha 4 Tel: + 420 242 481 821
Bulgarian: Tel: + 420 242 481 821
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).
Bulgarian: inden eller efter et måltid eller mellemmåltid, da det kan have insulinlignende hypoglykæmiske virkninger og derfor kan sænke sukkerniveauet i blodet (se hypoglykæmi i afsnit 4). Du må ikke injicere din dosis INCRELEX hvis du af en eller anden årsag ikke kan spise.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Bulgarian: skal bortskaffes i henhold til lokale retningsliner.
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.
Bulgarian: til 8C. Fra et mikrobiologisk synspunkt kan lægemidlet opbevares i maks.
English: - If you have any further questions, ask your doctor or pharmacist.
Bulgarian: Er du i tvivl, så spørg lægen eller på apoteket.
English: If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycaemic effects.
Bulgarian: skal rettes mod afhjælpning af hypoglykæmiske effekter. Oral glukose eller føde skal indtages. Hvis overdoseringen medfører bevidstløshed, kan det være nødvendigt at indgive intravenøs glukose eller parenteral glukagon for at modvirke de hypoglykæmiske effekter.
English: Mecasermin may cause hypoglycaemia (very common side effect, see section 4) that may impair your ability to drive and use machines because your ability to concentrate or react may be reduced.
Bulgarian: Mecasermin kan forårsage for lavt blodsukker (en meget almindelig bivirkning, se punkt 4), som kan påvirke din evne
English: When injections were properly dispersed, the condition resolved.
Bulgarian: Tilstanden forsvandt, når injektionerne blev spredt ud.
English: The use of this medicine has not been studied in children under 2 years of age and is therefore not recommended.
Bulgarian: ikke blevet undersøgt hos børn under 2 år, og INCRELEX bør derfor ikke anvendes til denne patientgruppe.
English: Cell growth: IGF-1 receptors are present on most types of cells and tissues.
Bulgarian: Cellevækst: IGF-1-receptorer findes på de fleste celle- og vævstyper. IGF-1 har mitogen aktivitet, som fører til et øget antal celler i kroppen.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Bulgarian: BILAG I PRODUKTRESUME
English: Excess mortality secondary to IGF-1 induced hypoglycaemia was observed in the carcinogenesis studies.
Bulgarian: til IGF-1-induceret hypoglykæmi blev observeret
English: - Keep this leaflet.
Bulgarian: - Gem indlægssedlen.
English: Musculoskeletal and connective Very common: Arthralgia, pain in tissue disorders extremity Common: Scoliosis, myalgia
Bulgarian: Meget almindelig: Artralgi, ekstremitetssmerter Almindelig: Skoliose, myalgi
English: Slowly push in the plunger of the syringe all the way, making sure you have injected all the liquid.
Bulgarian: Skub forsigtigt sprøjtestemplet helt ind, og sørg for, at du har indsprøjtet al væsken. Træk kanylen lige ud, og tryk forsigtigt et par sekunder på det
English: Digestive system Vomiting and pain in the upper belly have occurred with mecasermin treatment.
Bulgarian: Fordøjelsessystemet Opkastning og smerter i den øvre del af maven er opstået under behandling med mercasermin.
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.
Bulgarian: Dette blev registreret hos 38 patienter (9 %), især i de første 1
English: In rats and rabbits reproductive toxicity was studied after intravenous but not after subcutaneous application (the normal clinical route).
Bulgarian: Reproduktionstoksicitet er undersøgt hos rotter og kaniner efter intravenøs men
English: See the end of section 4 for how to report side effects.
Bulgarian: Du kan hjælpe ved at indberette alle de bivirkninger, du får. Se sidst i punkt 4, hvordan du indberetter bivirkninger.
English: • To perform a routine funduscopic examination prior to beginning treatment and periodically during treatment or at the occurrence of clinical symptoms.
Bulgarian: og med regelmæssige mellemrum under behandlingen eller ved forekomst af kliniske symptomer.
English: INCRELEX 10 mg/ml solution for injection Mecasermin
Bulgarian: INCRELEX 10 mg/ml injektionsvæske Mecasermin
English: Reactions including rash, swelling and fatty lumps have been reported with INCRELEX treatment.
Bulgarian: tilfælde af reaktioner såsom udslæt, hævelse og fedtholdige buler ved behandling med INCRELEX.
English: The typical dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day.
Bulgarian: Den sædvanlige dosis er 0,04 til 0,12 mg/kg legemsvægt
English: Uncommon: Cardiomegaly, ventricular hypertrophy, mitral valve incompetence, tricuspid valve incompetence
Bulgarian: Ikke almindelig: Kardiomegali, ventrikulær hypertrofi, mitralklapinsufficiens, trikuspidalklapinsufficiens
English: Local allergic reactions at the injection site (itching, hives) have also been reported.
Bulgarian: tilfælde af lokale allergiske reaktioner ved injektionsstedet (kløe og udslæt).
English: Elderly The pharmacokinetics of INCRELEX have not been studied in subjects greater than 65 years of age.
Bulgarian: ikke undersøgt hos patienter over 65 år.
English: To perform one long-term safety study where mecasermin treatment is initiated in early phase of childhood and continued to adulthood in order to investigate:
Bulgarian: Gennemførelse af en længerevarende sikkerhedsundersøgelse, hvor behandling med mecasermin iværksættes i den
English: Follow the doctor's instructions for throwing away the needle and syringe.
Bulgarian: Følg din læges anvisninger for bortskaffelse af kanyle og sprøjte. Sæt ikke hætten tilbage på sprøjten.
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.
Bulgarian: Mercasermin kan forstørre dine mandler/polypper. Tegn på forstørrede mandler/polypper kan være snorken, besvær med at trække vejret eller synke, søvnapnø (en tilstand, hvor du kortvarigt holder op med at trække vejret, mens du sover), væske i mellemøret og mellemørebetændelse.
English: Before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the prescribed dose.
Bulgarian: tilbage for at trække den mængde luft ind i sprøjten, som svarer
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).
Bulgarian: Mecasermin blev indgivet subkutant til Sprague Dawley-rotter ved doser på 0, 0,25, 1, 4 og 10 mg/kg/dag i op til 2 år. En øget forekomst af adrenal medullær hyperplasi og pheochromocytom blev observeret hos hanrotter ved doser på 1 mg/kg/dag og derover ( 1 gange den kliniske eksponering med den maksimale anbefalede humane dosis [MRHD], baseret på AUC) og hunrotter ved alle dosisniveauer ( 0,3 gange den kliniske eksponering med MRHD baseret på AUC).
English: A disruption or early ending of treatment with mecasermin may impair the success of the growth therapy.
Bulgarian: Hvis du holder op med at tage INCRELEX Afbrydelse eller for tidligt ophør med behandlingen med mercasermin kan påvirke vækstbehandlingens udfald. Tal med lægen, inden du holder op med behandlingen.
English: Tel. + 370 37 337854
Bulgarian: LT-48100 Kaunas Tel. + 370 37 337854
English: If more INCRELEX than recommended was injected, contact your doctor immediately.
Bulgarian: Kontakt straks lægen, hvis du har indsprøjtet mere INCRELEX end anbefalet.
English: Heart abnormalities A fast heart rate and abnormal heart sounds have been reported with mecasermin treatment.
Bulgarian: Der er rapporteret en hurtig hjerterytme (puls) og unormale hjertelyde under behandling med mercasermin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 10 mg of mecasermin.
Bulgarian: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml indeholder 10 mg mecasermin Hvert hætteglas indeholder 40 mg mecasermin
English: The safety and efficacy of mecasermin in children below age of 2 have not been established (see section 5.1).
Bulgarian: Mecasermins sikkerhed og virkning hos børn under 2 år er
English: Pre-treatment height velocity data were available for 75 subjects.
Bulgarian: til rådighed for 75 patienter.
English: Therefore there is insufficient medical information to determine whether there are significant risks to a foetus.
Bulgarian: signifikant risiko for et foster.
English: Five clinical studies (4 open-label and 1 double-blind, placebo-controlled) were conducted with INCRELEX.
Bulgarian: Der har været gennemført fem kliniske studier (4 åbne og 1 dobbeltblind, placebokontrolleret undersøgelse) med INCRELEX. Subkutane doser af mecasermin, generelt varierende fra 60 til 120 g/kg indgivet
English: Each vial of 4 ml contains 40 mg of mecasermin*.
Bulgarian: 1 hætteglas på 4 ml indeholder 40 mg mecasermin*.
English: Each ml contains 10 mg of mecasermin*.
Bulgarian: 1 ml indeholder 10 mg mecasermin*.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Bulgarian: Følgende bivirkninger er set i dyrestudier efter eksponering ved plasmakoncentrationer, der svarer til humane terapeutiske doser.
English: The vial contains 4 ml of solution.
Bulgarian: Hætteglasset indeholder 4 ml opløsning.
English: • To avoid engaging in any high-risk activities (such as vigorous physical activity) within 2 - 3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well-tolerated dose of INCRELEX has been established.
Bulgarian: Patienten skal undgå høj-risiko-aktiviteter (såsom voldsom fysisk aktivitet) i 2-3 timer efter doseringen, indtil en veltolereret dosis af INCRELEX er fastlagt.
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced (see section 4.4).
Bulgarian: skal muligvis reduceres (se pkt. 4.4).
English: One multi-use vial of 4 ml.
Bulgarian: Et hætteglas med 4 ml til flergangsbrug.
English: • Possible occurrence of malignancies as well as other risks The interim reports will be submitted every two years until the final patient is followed for 5 years.
Bulgarian: De foreløbige rapporter skal indsendes hvert 2. år, indtil den
English: 6.5 Nature and contents of container
Bulgarian: 6.5 Emballagetype og pakningsstørrelser
English: • That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects.
Bulgarian: inden eller efter et måltid eller mellemmåltid, da midlet har insulinlignende hypoglykæmiske effekter.
English: Very common: Hypoglycaemia Common: Hypoglycaemic seizure, hyperglycaemia
Bulgarian: Hypoglykæmiske kramper, hyperglykæmi
English: In addition there will be a dosing guide, and a dose calculator, for use by physician and patients to include information on the individualised dose escalation to minimise the risk of medication errors and hypoglycaemia.
Bulgarian: individuelle dosisstigning for at minimere risikoen for fejlmedicinering og hypoglykæmi.
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Bulgarian: ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet, fordi det anvendes til en sjælden sygdom.
English: A dose adjustment may be needed for these medicines.
Bulgarian: skal muligvis reduceres hos diabetikere, der får dette lægemiddel.
English: Always use this medicine exactly as your doctor has told you.
Bulgarian: Sådan skal du tage INCRELEX Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: Height Velocity SDS
Bulgarian: Væksthastighed SDS
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Bulgarian: Bivirkningerne præsenteres efter frekvens med angivelse af de alvorligste bivirkninger først indenfor hver frekvensgruppe.
English: It is recommended that the dose be individualised for each patient as described under posology
Bulgarian: Det anbefales, at dosis tilpasses individuelt for hver patient
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Bulgarian: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: Possible side effects
Bulgarian: Disse bivirkninger er
English: Funduscopic examination is recommended at the initiation, periodically during the course of mecasermin therapy and at the occurrence of clinical symptoms.
Bulgarian: i løbet af behandlingen med mecasermin og ved forekomst af kliniske symptomer.
English: Common (may affect up to 1 in 10 people) Seizures
Bulgarian: til 1 ud af 10 patienter) Kramper
English: The dose of mecasermin should never be increased to make up for one or more omitted doses.
Bulgarian: ikke indgives. Mecasermin-dosis må aldrig øges for at erstatte en eller flere glemte doser. Der skal skiftes injektionssted ved hver injektion.
English: Reporting of suspected adverse reactions
Bulgarian: Indberetning af formodede bivirkninger
English: In post-marketing experience in patients treated with INCRELEX, cases of hypersensitivity, urticaria, pruritus and erythema have been reported.
Bulgarian: tilfælde af hypersensitivitet, urticaria, pruritus og erytem hos patienter behandlet med INCRELEX.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Bulgarian: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning.
English: Cardiac disorders
Bulgarian: Afvigelser i hjertefunktionen