FrancophonIA/ELRC3.0 huggingface dataset:
English: The height velocities for years 2 through 8 remained statistically greater than baseline.
Danish: Væksthastigheden for år 2 og op til år 8 forblev statistisk større end baseline.
English: This condition is called primary IGF-1 deficiency.
Danish: Denne tilstand kaldes primær IGF-1-mangel.
English: Not known: alopecia
Danish: Ikke kendt: Alopeci
English: The next dose should be taken as usual, with a meal or snack.
Danish: Den næste dosis skal tages som sædvanligt med et måltid eller mellemmåltid.
English: This medicine has been authorised under ‘exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under “særlige vilkår”.
English: Snoring This occurred generally in the first year of treatment, and was reported in 30 subjects (7%).
Danish: Snorken Dette startede generelt i det første år af behandlingen og blev rapporteret hos 30 patienter (7 %).
English: If you develop any of these events, please follow the advice given for each event in the sections below.
Danish: Hvis du oplever noget af dette, skal du følge vejledningen for hver hændelse i afsnittene herunder.
English: Long-term overdose may result in enlargement of certain body parts (e.g., hands, feet, parts of the face) or excessive growth of the whole body.
Danish: Længerevarende overdoseringer kan medføre forstørrelse af visse kropsdele (f.eks. hænder, fødder, dele af ansigtet) eller voldsom vækst af hele kroppen.
English: Mecasermin is not a substitute for GH treatment.
Danish: Mecasermin er ikke en erstatning for GH-behandling.
English: The safety and efficacy of mecasermin in children below age of 2 have not been established (see section 5.1).
Danish: Mecasermins sikkerhed og virkning hos børn under 2 år er ikke klarlagt (se punkt 5.1).
English: Lightly pinch the skin.
Danish: Knib huden let sammen.
English: Especially tell the doctor if you take insulin or other anti-diabetes medicines.
Danish: Du skal især fortælle det til lægen, hvis du tager insulin eller andre former for medicin mod diabetes.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. det er i det væsentlige ”natriumfrit”.
English: Final report by
Danish: Sidste rapport i
English: Treatment should be reconsidered if after a year patients remain non-responsive.
Danish: Behandlingen skal tages op til ny overvejelse, hvis patienten ikke har reageret på behandlingen efter et år.
English: • Physician information about INCRELEX (information card, dosing guide, and a dose calculator)
Danish: • Lægeinformation om INCRELEX (informationskort, doseringsvejledning og en dosisberegner)
English: Release the skin (see Figure A).
Danish: Slip huden (se figur A).
English: Subcutaneous use.
Danish: Til subkutant brug.
English: Do not give the injection if you are unable to eat shortly before or after the injection.
Danish: Du må ikke give indsprøjtningen, hvis du ikke kan spise umiddelbart inden eller efter indsprøjtningen.
English: Chemical and physical in-use stability has been demonstrated for 30 days at 2C to 8C.
Danish: Den kemiske og fysiske holdbarhed under brug er påvist for 30 dage ved 2C til 8C.
English: Forty-six (57%) of the subjects were male; 66 (81%) were Caucasian.
Danish: 46 (57 %) af patienterne var af hankøn; 66 (81 %) var kaukasiske.
English: Frequency not known (frequency cannot be estimated from the available data) Serious allergic reactions (anaphylaxis)
Danish: Ukendt hyppighed (hyppigheden kan ikke vurderes ud fra de tilgængelige data) Alvorlige allergiske reaktioner (anafylaksi)
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.
Danish: Derudover vil der være en doseringsvejledning og en dosisberegner, som læger og patienter kan anvende til oplysninger om den individuelle dosisstigning for at minimere risikoen for fejlmedicinering og hypoglykæmi.
English: This reaction occurred in 71 (17%) subjects from the clinical trials and was generally associated with lack of proper rotation of injections.
Danish: Denne reaktion forekom hos 71 patienter (17 %) fra de kliniske forsøg og var oftest forbundet med mangel på korrekt rotation af injektionssted.
English: Baseline characteristics for the 81 patients evaluated in the primary and secondary efficacy analyses from the combined studies were (mean ± SD): chronological age (years): 6.8  3.8; age range (years): 1.7 to 17.5; height (cm): 84.1  15.8; height standard deviation score (SDS): -6.9  1.8; height velocity (cm/yr): 2.6  1.7; height velocity SDS: -3.4  1.6; IGF-1 (ng/ml): 24.5  27.9; IGF-1 SDS: -4.2  2.0; and bone age (years): 3.8  2.8.
Danish: Baseline-karakteristika for de 81 patienter, der blev evalueret i de primære og sekundære effektanalyser fra de kombinerede studier, var (middel ± SD): kronologisk alder (år): 6,8  3,8; aldersinterval (år): 1,7 til 17,5; højde (cm): 84,1  15,8; højde standardafvigelse score (SDS): -6,9  1,8; væksthastighed (cm/år): 2,6  1,7; væksthastighed-SDS: -3,4  1,6; IGF-1 (ng/ml): 24,5  27,9; IGF-1 SDS: -4,2  2,0; og knoglealder (år): 3,8  2,8.
English: Only use INCRELEX that is clear and colourless.
Danish: Brug kun INCRELEX, der er klar og farveløs.
English: Figure 7: Ready to inject
Danish: Figur 7: Klar til indsprøjtning
English: Lonza AG Lonzastrasse CH-3930 Visp Switzerland
Danish: Lonza AG Lonzastrasse CH-3930 Visp Schweiz
English: Call the doctor should these symptoms bother you.
Danish: Tal med lægen, hvis disse symptomer generer dig.
English: No attenuation of growth was observed as a consequence of the development of antibodies.
Danish: Der blev ikke observeret væksthæmning som følge af antistofudvikling.
English: The dose should be individualised for each patient.
Danish: Doseringen skal bestemmes individuelt for hver enkelt patient.
English: • INCRELEX should not be administered if the patient is unable to eat for any reason.
Danish: • INCRELEX må ikke indgives, hvis patienten af en eller anden årsag ikke er i stand til at spise.
English: These conditions should be monitored during INCRELEX treatment.
Danish: Disse tilstande skal monitoreres under behandling med INCRELEX.
English: Never inject it into a vein or muscle.
Danish: Indsprøjt aldrig direkte i en blodåre eller en muskel.
English: Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score
Danish: Pre-Tx = Før behandling; SD = Standardafvigelse; SDS = Standardafvigelse Score
English: In such instances, instructions for antibody testing should be considered.
Danish: I sådanne tilfælde skal vejledningen for test for antistof følges.
English: Excess mortality secondary to IGF-1 induced hypoglycaemia was observed in the carcinogenesis studies.
Danish: En større dødelighed sekundært til IGF-1-induceret hypoglykæmi blev observeret i karcinogenicitetsstudierne.
English: Active or suspected neoplasia.
Danish: Aktiv neoplasi eller mistanke om neoplasi.
English: Toxicity to reproduction
Danish: Toksicitet i forbindelse med reproduktion
English: Glucagon raises the blood sugar when it is injected.
Danish: Glukagon hæver blodsukkeret, når det indsprøjtes.
English: Annual results for height velocity, height velocity SDS, and height SDS until year 8 are shown in Table 2.
Danish: De årlige resultater for væksthastighed, væksthastighed-SDS og højde-SDS indtil år 8 er vist i tabel 2.
English: Inject INCRELEX as instructed by the doctor.
Danish: Indsprøjt INCRELEX som anvist af lægen.
English: IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons.
Danish: IGF-1 består af 70 aminosyrer i en enkelt kæde med tre intramolekylære disulfid-broer og en molekylvægt på 7649 dalton.
English: Tell the doctor immediately if you have any of these symptoms.
Danish: Tal straks med lægen, hvis du får nogen af disse symptomer.
English: Do not inject your dose of INCRELEX if you cannot eat for any reason.
Danish: Du må ikke injicere din dosis INCRELEX hvis du af en eller anden årsag ikke kan spise.
English: Table 1 contains very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000, < 1/100) adverse reactions which occurred in clinical trials.
Danish: Tabel 1 indeholder meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10) og ikke almindelige (≥ 1/1.000 til < 1/100) bivirkninger, som er forekommet i kliniske forsøg.
English: - It is used to treat children and adolescents from 2 to 18 years old who are very short for their age because their bodies do not make enough IGF-1.
Danish: - Det anvendes til at behandle børn og unge mellem 2 og 18 år, som er meget lave af vækst i forhold til deres alder, fordi deres krop ikke danner tilstrækkeligt IGF-1.
English: As INCRELEX contains benzyl alcohol, it must not be given to premature babies or neonates.
Danish: Da INCRELEX indeholder benzylalkohol, må det ikke gives til præmature spædbørn eller nyfødte.
English: INCRELEX should not be administered intravenously.
Danish: INCRELEX bør ikke indgives intravenøst.
English: Five clinical studies (4 open-label and 1 double-blind, placebo-controlled) were conducted with INCRELEX.
Danish: Der har været gennemført fem kliniske studier (4 åbne og 1 dobbeltblind, placebokontrolleret undersøgelse) med INCRELEX.
English: Uncommon: Depression, nervousness
Danish: Ikke almindelig: Depression, nervøsitet
English: Data was also collected from post-marketing sources.
Danish: Data blev også indsamlet efter markedsføringen.
English: IGF-1 has mitogenic activity that leads to an increased number of cells in the body.
Danish: IGF-1 har mitogen aktivitet, som fører til et øget antal celler i kroppen.
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:
Danish: Ved markedsføring skal MAH sørge for, at alle læger, der forventes at ordinere INCRELEX, får udleveret en “informationspakke til læger”, som indeholder følgende:
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:
Danish: Gennemførelse af en længerevarende sikkerhedsundersøgelse, hvor behandling med mecasermin iværksættes i den tidlige barndom og fortsættes til voksenalderen, så man kan undersøge:
English: The injection site should be dry before you inject.
Danish: Indgivelsesstedet skal være tørt, før du indsprøjter.
English: The patient information about INCRELEX should contain the following information:
Danish: Patientinformationen om INCRELEX skal indeholde følgende information:
English: These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during mecasermin treatment.
Danish: Disse tilstande og andre symptomer og tegn, som generelt er forbundet med GH-behandling, skal monitoreres under behandling med mecasermin.
English: INCRELEX should not be given to pregnant or nursing women.
Danish: INCRELEX bør ikke gives til gravide eller ammende kvinder.
English: If a dose is skipped, the next dose should not be made larger to compensate.
Danish: Hvis du glemmer en dosis skal den næste dosis ikke laves større for at kompensere.
English: In rats and rabbits reproductive toxicity was studied after intravenous but not after subcutaneous application (the normal clinical route).
Danish: Reproduktionstoksicitet er undersøgt hos rotter og kaniner efter intravenøs men ikke efter subkutan anvendelse (den normale kliniske indgivelsesvej).
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.
Danish: Under normale omstændigheder bindes væksthormonet (GH) til dets receptor i leveren og andre væv og stimulerer syntese/sekretion af IGF-1.
English: • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
Danish: • Eksklusion af sekundære former for IGF-1-mangel, såsom fejlernæring, hypotyroidisme, eller kronisk behandling med farmakologiske doser af antiinflammatoriske steroider.
English: Figure A: Lightly pinch the skin and inject as instructed
Danish: Figur A: Knib huden let sammen, og indsprøjt ifølge vejledningen
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.
Danish: Ud af disse havde 72 (89 %) Larons syndrom-lignende fænotype; 7 (9 %) havde GHgentab, 1 (1 %) havde neutraliserende antistoffer over for GH, og 1(1 %) havde isoleret genetisk GH-mangel.
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.
Danish: Dette blev registreret hos 38 patienter (9 %), især i de første 1 til 2 år af behandlingen, med en mindre tonsillær vækst i de efterfølgende år.
English: 5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).
Danish: 5 ml hætteglas (type I glas) lukket med en prop (bromobutyl/isoprenpolymer) og en forsegling (lakeret plast).
English: The effects of mecasermin on the unborn child have not been studied.
Danish: Virkningen af mecasermin på det ufødte barn er ikke blevet undersøgt.
English: Figure 1: Wipe top with alcohol
Danish: Figur 1: Tør toppen af med alkohol
English: Your doctor may perform an echocardiogram before, during and after mecasermin treatment.
Danish: Din læge kan foretage et ekkokardiogram inden, under og efter behandling med mecasermin.
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.
Danish: Af de 115 patienter (28 %), som havde en eller flere episoder med hypoglykæmi, oplevede 6 patienter hypoglykæmiske krampeanfald ved en eller flere lejligheder.
English: Some patients may develop antibodies to mecasermin.
Danish: Nogle patienter kan udvikle antistoffer over for mecasermin.
English: Seventy-four (91%) of the subjects were prepubertal at baseline.
Danish: 74 (91 %) af patienterne var præpubertale ved baseline.
English: Oral glucose or food should be consumed.
Danish: Oral glukose eller føde skal indtages.
English: Common: Melanocytic naevus
Danish: Almindelig: Melanocytisk naevus
English: For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
Danish: Til langvarig behandling af vækstmangel hos børn og unge fra 2 til 18 år med svær primær insulinlignende vækstfaktor 1-mangel (primær IGFD).
English: Long-term overdose may result in signs and symptoms of acromegaly or gigantism.
Danish: Overdosering over længere tid kan medføre tegn og symptomer på akromegali eller gigantisme.
English: Use a new disposable needle and syringe every time you give a dose.
Danish: Brug en ny engangskanyle og en engangssprøjte, hver gang du giver en dosis.
English: If the patient is unable to eat, for any reason, this medicinal product should be withheld.
Danish: Hvis patienten af en eller anden årsag ikke kan spise, bør dette lægemiddel ikke indgives.
English: Patients who terminate treatment should also have an echocardiogram.
Danish: Patienter, der afbryder behandlingen, bør også få taget et ekkokardiogram.
English: The bioavailability of mecasermin after subcutaneous administration in healthy subjects has been reported to be approximately 100%.
Danish: Biotilgængeligheden af mecasermin efter subkutan indgivelse til raske personer er rapporteret til ca. 100 %.
English: [1] P-values for comparison versus pre-Tx values were computed using paired t-tests.
Danish: [1] P-værdier for sammenligning kontra pre-Tx-værdier blev beregnet ved hjælp af parvise t-tests.
English: Reactions at the injection site
Danish: Reaktioner ved injektionsstedet
English: Mecasermin should not be used for growth promotion in patients with closed epiphyses.
Danish: Mecasermin må ikke anvendes til vækststimulering hos patienter med lukkede epifyser.
English: Figure 5: Extract correct dose
Danish: Figur 5: Træk den korrekte dosis op
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningsliner.
English: INCRELEX should be administered using sterile disposable syringes and injection needles which could be provided by your doctor, pharmacist or nurse.
Danish: INCRELEX skal indgives ved brug af sterile engangssprøjter og injektionskanyler, som kan fås af din læge, farmaceut eller sygeplejerske.
English: Eighty-three (83) out of 92 patients were naïve to INCRELEX at baseline and 81 completed at least one year of INCRELEX treatment.
Danish: 83 ud af 92 patienter var INCRELEX-naive ved baseline, og 81 gennemførte mindst et års behandling med INCRELEX.
English: Treatment with mecasermin is a long-term therapy.
Danish: Behandling med mecasermin er en længerevarende behandling.
English: The doctor or nurse will instruct you how to give the injection.
Danish: Lægen eller sygeplejersken vil vise dig, hvordan du skal give indsprøjtningen.
English: Call the doctor as soon as possible if you get a localised rash.
Danish: Kontakt lægen så hurtigt som muligt, hvis du får et lokalt udslæt.
English: Figure 6: Remove air bubbles and refill syringe
Danish: Figur 6: Fjern luftbobler og fyld sprøjten op igen
English: Organ growth: treatment of IGF-1 deficient rats with rhIGF-1 results in whole body and organ growth.
Danish: Organvækst: behandling af IGF-1-insufficiente rotter med rhIGF-1 medfører hel krops- og organvækst.
English: Serious allergic reactions have also been reported with INCRELEX.
Danish: Der har også været tilfælde af alvorlige allergiske reaktioner med INCRELEX.
English: A dose adjustment may be needed for these medicines.
Danish: Det kan være nødvendigt at justere dosis af denne type medicin.
English: Injecting the dose:
Danish: Indsprøjtning af dosis:
English: IGF-1 has inhibitory effects on insulin secretion.
Danish: IGF-1 har en hæmmende effekt på insulinsekretionen.
English: Tissue Growth
Danish: Vævsvækst
English: • INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops.
Danish: • INCRELEX er kontraindiceret ved aktiv eller mistænkt neoplasi, og behandlingen skal seponeres, hvis der udvikles tegn på neoplasi.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Data fra dyrestudier er utilstrækkelige hvad angår reproduktionstoksicitet (se pkt.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists, ATC code: H01AC03
Danish: Farmakoterapeutisk klassifikation: Hypofyse- og hypothalamushormoner og analoger, somatropin og somatropinagonister, ATC-kode: H01AC03
English: IH-associated signs and symptoms resolved after interruption of dosing.
Danish: IH-associerede tegn og symptomer forsvandt efter seponering af dosis.
English: Patients were enrolled in the studies on the basis of extreme short stature, slow growth rates, low IGF-1 serum concentrations, and normal GH secretion.
Danish: Patienterne blev rekrutteret til studierne ud fra en meget lille højde, langsom vækst, lave IGF-1serumkoncentrationer og normal GH-sekretion.
English: For the 21 treatment naïve subjects with near-adult height, the mean (± SD) of the difference between observed increase in height versus that expected from Laron was approximately 13 cm (± 8 cm) after an average of 11 years of treatment.
Danish: For de 21 behandlingsnaive patienter med næsten voksenhøjde var middelforskellen (± SD) mellem observeret højdeforøgelse versus den, der forventes i henhold til Larons syndrom, ca. 13 cm (± 8 cm) efter gennemsnitligt 11 års behandling.
English: Cell growth: IGF-1 receptors are present on most types of cells and tissues.
Danish: Cellevækst: IGF-1-receptorer findes på de fleste celle- og vævstyper.
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.
Danish: Mecasermin kan forårsage for lavt blodsukker (en meget almindelig bivirkning, se punkt 4), som kan påvirke din evne til at føre motorkøretøj og betjene maskiner fordi din evne til at koncentrere dig og reagere kan være nedsat.
English: • Immunogenicity sampling information.
Danish: • Information om immunogenicitetsprøvetagning.
English: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100 Dreux France
Danish: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100 Dreux Frankrig
English: In some patients treated with mecasermin, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle and abnormalities of heart valve function.
Danish: Hos visse patienter, der blev behandlet med mecasermin, viste en ultralydsundersøgelse af hjertet (ekkokardiogram) en forstørrelse af hjertemusklen og afvigelser i hjerteklappernes funktion.
English: Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone.
Danish: Knoglevæksten opnås ved epifyseskiverne ved enderne af en knogle i vækst.
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.
Danish: rhIGF-1-proteinet er syntetiseret i bakterier (E. coli), som er modificeret ved at tilføje genet for human IGF-1.
English: The physician information about INCRELEX should contain the following key elements:
Danish: Lægeinformationen om INCRELEX skal indeholde følgende nøgleelementer:
English: Among all subjects included for safety evaluation (n=92), 83% of the subjects reported at least one adverse event during the course of the studies.
Danish: Blandt alle patienter, der blev inkluderet til sikkerhedsvurdering (n=92), rapporterede 83 % af patienterne mindst en bivirkning i løbet af studierne.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Placental transfer of mecasermin was not studied.
Danish: Placental overførsel af mecasermin er ikke undersøgt.
English: Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.
Danish: Behandling med mecasermin skal styres af læger med erfaring i diagnosticering og behandling af patienter med vækstforstyrrelser.
English: Pregnancy There are no or limited amount of data for the use of mecasermin in pregnant women.
Danish: Graviditet Der er ingen eller utilstrækkelige data fra anvendelse af mecasermin til gravide kvinder.
English: Limited information is available on the concentration of unbound IGF-1 after the administration of INCRELEX.
Danish: Der er begrænsede oplysninger til rådighed om koncentrationen af ubundet IGF-1 efter indgivelse af INCRELEX.
English: Special attention should be paid to young children, children with a history of hypoglycaemia and children with inconsistent food intake.
Danish: Især skal man være opmærksom på små børn, børn med tidligere tilfælde af hypoglykæmi og børn med uregelmæssig fødeindtag.
English: Benzyl alcohol Sodium chloride Polysorbate 20
Danish: Benzylalkohol Natriumchlorid Polysorbat 20