FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: If necessary, glucocorticoid replacement should be initiated.
Danish: Om nødvendigt skal substitutionsbehandling med glukokortikoid indledes.
English: The observed difference is likely due to slow absorption from the injection site following subcutaneous administration.
Danish: Den observerede forskel skyldes sandsynligvis langsom absorption fra injektionsstedet efter subkutan administration.
English: Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
Danish: Behandlingen bør ikke anvendes til pædiatriske patienter med en væksthastighed på mindre end 1 cm pr. år samt umiddelbart inden lukning af epifyserne.
English: Dosage should be monitored every 6 months.
Danish: Doseringen skal følges hver 6. måned.
English: Other possible side effects related to your treatment with growth hormone may include the following: You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone.
Danish: Andre bivirkninger med relation til din behandling med væksthormon kan omfatte følgende: Du (eller dit barn) kan få højt blodsukker eller nedsat niveau af skjoldbruskkirtelhormon.
English: In children
Danish: Hos børn
English: Gently swirl the vial a few times until the content is completely dissolved.
Danish: Roter hætteglasset forsigtigt et par gange, indtil indholdet er helt opløst.
English: Your doctor may need to adjust the dose of Omnitrope or of the other medicines:
Danish: Det kan være nødvendigt, at lægen justerer dosis af Omnitrope eller af de andre lægemidler:
English: As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued treatment in this situation should be weighed against the potential risks involved.
Danish: Da der ikke findes information om sikkerheden ved substitutionsbehandling med væksthormon hos akut kritisk syge patienter, bør fordelene ved fortsat behandling i denne situation afvejes mod den potentielle risiko.
English: In children such adverse reactions are uncommon.
Danish: Hos børn er denne type bivirkninger ikke almindelige.
English: Do your injection in the place you have been shown by your doctor.
Danish: Giv dig selv injektionen på det sted, din læge har vist dig.
English: • If you have Prader-Willi syndrome (a chromosomal disorder).
Danish: • Hvis du har Prader-Willis syndrom (en kromosomsygdom).
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Danish: CMPH anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne ændres.
English: All other patients will require IGF-I assay and one growth hormone stimulation test.
Danish: For alle andre patienter kræves en IGF-I-analyse og en væksthormon-stimulationstest.
English: In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
Danish: Hos patienter med PWS skal behandlingen altid kombineres med en kaloriefattig diæt.
English: * produced in Escherichia coli by recombinant DNA technology.
Danish: * Fremstillet i Escherichia coli med rekombinant dna-teknologi.
English: The clinical relevance of these findings may be limited.
Danish: Den kliniske betydning af disse fund kan være begrænset.
English: This presentation is intended for multiple use.
Danish: Produktet er til flergangsbrug.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. ml, d.v.s. den er i det væsentlige natriumfri.
English: • and tell your doctor if Omnitrope has been prescribed to stimulate growth but you have already stopped growing (closed epiphyses).
Danish: • hvis Omnitrope er blevet ordineret til stimulering af vækst, men du er holdt op med at vokse (lukkede epifyseskiver).
English: Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into the upper range of normal, not exceeding the 2 SDS.
Danish: Patienter med normale IGF-I-koncentrationer ved behandlingens start bør have væksthormon op til et IGF-I-niveau i den øvre del af normalområdet, der ikke overstiger 2 SDS.
English: To verify growth disturbance, growth should be followed for a year preceding institution of therapy.
Danish: For at verificere vækstforstyrrelse bør væksten følges 1 år, før behandling påbegyndes.
English: A small percentage of patients may develop antibodies to Omnitrope.
Danish: En lille procentdel af patienterne udvikler antistoffer mod Omnitrope.
English: In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean.
Danish: I begge tilfælde bør behandlingens mål være insulinlignende vækstfaktor (IGF-I)-koncentrationer indenfor 2 SDS fra alderskorrigeret middelværdi.
English: Somatropin must not be used for growth promotion in children with closed epiphyses.
Danish: Somatropin må ikke anvendes til at fremme væksten hos børn med lukkede epifyseskiver.
English: It is therefore not recommended to initiate treatment near onset of puberty.
Danish: Det kan derfor ikke anbefales at påbegynde behandlingen nær pubertetens start.
English: Your doctor will advise you about your individualised dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body surface area calculated from your height and weight in square metres (m2), as well as your treatment schedule.
Danish: Din læge vil informere dig om din dosis af Omnitrope i milligram (mg) ud fra enten din legemsvægt i kilo (kg) eller dit legemsoverfladeareal i kvadratmeter (m2) beregnet ud fra din højde og vægt samt din behandlingsplan.
English: Although rare, pancreatitis should be considered in somatropin-treated children who develop abdominal pain.
Danish: Selvom det er sjældent, skal pancreatitis overvejes hos somatropinbehandlede børn, som får abdominalsmerter.
English: In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate.
Danish: Hos børn med utilstrækkeligt endogent væksthormon, stimulerer somatropin lineær vækst og forøger væksthastigheden.
English: • Your doctor will check your blood sugar and insulin levels before the start of treatment and every year during treatment.
Danish: • Din læge vil måle dit blodsukker og insulinniveau, inden behandlingen påbegyndes og hvert år under behandlingen.
English: Your doctor may need to adjust the dose of these medicines or the dose of somatropin.
Danish: Det kan være nødvendigt, at lægen justerer dosis af disse lægemidler eller dosis af somatropin.
English: The clearance of compounds metabolised by cytochrome P 450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in lower plasma levels of these compounds.
Danish: Clearance af stoffer, som metaboliseres af cytokrom P 450 3A4 (f.eks. kønshormoner, kortikosteroider, antikonvulsiva og ciclosporin), kan især øges og medføre lavere plasmaniveauer af disse stoffer.
English: Serum concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Danish: Serumkoncentrationerne af IGF-I (insulinlignende vækstfaktor I) og IGFBP3 (insulinlignende vækstfaktorbindingsprotein 3) øges af somatropin.
English: Other adverse drug reactions may be considered somatropin class effects, such as possible hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign intra-cranial hypertension.
Danish: Andre bivirkninger kan anses for at være klassevirkninger for somatropin, såsom mulig hyperglykæmi forårsaget af nedsat insulinfølsomhed, nedsat niveau af frit tyroxin og benign intrakraniel hypertension.
English: Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations.
Danish: Væksthormon forøger den ekstratyroidale omdannelse af T4 til T3, hvilket kan medføre reduktion i serum-T4 og stigning i serum-T3.
English: Data from an interaction study performed in growth hormone deficient adults suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Danish: Data fra et interaktionsstudie med voksne patienter med væksthormonmangel tyder på, at somatropinadministration kan øge clearance af stoffer, som metaboliseres af cytokrom P450isoenzymer.
English: Paediatric population The posology and administration schedule should be individualised.
Danish: Pædiatrisk population Dosering og administrationsplan er individuel.
English: • synthetic adrenal hormones (corticosteroids).
Danish: • Syntetiske binyrebarkhormoner (kortikosteroider).
English: • If you are receiving somatropin for growth hormone deficiency following a previous tumour (cancer), you should be examined regularly for recurrence of the tumour or any other cancer.
Danish: • Hvis du får somatropin for væksthormonmangel på grund af tidligere svulster (kræft), skal du undersøges regelmæssigt for tilbagevenden af svulster eller andre kræftformer.
English: To avoid this, use a slightly different place for your injection each time.
Danish: For at undgå dette skal du give injektionen på lidt forskellige steder hver gang.
English: Follow the Instructions for Use of the pen injector.
Danish: Følg instruktionen for brug af pen injektor.
English: METHOD AND ROUTE OF ADMINISTRATION Use only clear solution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Brug kun en klar opløsning.
English: Fatty tissue of the skin can shrink at the site of injection.
Danish: Fedtvævet i huden kan skrumpe ind på injektionsstedet.
English: Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
Danish: Mens de perifere thyroideahormonniveauer har ligget inden for referenceværdierne for raske personer, kan hypotyreoidisme teorestisk set opstå hos personer med subklinisk hypotyreoidisme.
English: The powder is white and the solvent is a clear, colourless solution.
Danish: Pulveret er hvidt og solvensen er en klar, farveløs opløsning.
English: Remove the syringe and needle.
Danish: Fjern sprøjte og nål.
English: - Childhood onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Danish: - Start i barndommen: Patienter, der havde væksthormonmangel i barndommen, der skyldtes medfødte, genetiske, erhvervede eller idiopatiske årsager.
English: Preparation
Danish: Forberedelse
English: Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope.
Danish: Samtidig behandling med glukokortikoider hæmmer de vækstfremmende virkninger af Omnitrope.
English: At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.
Danish: På nuværende tidspunkt foreligger der ikke tilstrækkelig dokumentation til at rådgive specifikt om fortsættelse af væksthormonbehandling hos patienter med ophørt intrakraniel hypertension.
English: Experience in initiating treatment in SGA patients near onset of puberty is limited.
Danish: Erfaring med at igangsætte behandling af SGA-patienter nær pubertetsstarten er begrænset.
English: It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and thus do not require dose escalation.
Danish: Det vides, at der er patienter med væksthormonmangel, som ikke normaliserer deres IGF-I-niveauer på trods af et godt klinisk respons og derfor ikke behøver dosisøgning.
English: • Experience in patients above 80 years is limited.
Danish: • Der er begrænset erfaring hos patienter over 80 år.
English: In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be observed.
Danish: Generelt medfører administration af somatropin til patienter med væksthormonmangel et fald i serum LDL og apolipoprotein B. Der kan også ses en reduktion i totalt kolesterolindhold i serum.
English: Fertility studies with Omnitrope have not been performed.
Danish: Der er ikke udført fertilitetsstudier med Omnitrope.
English: In addition to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores.
Danish: Ud over forøget lipolyse nedsætter somatropin optagelsen af triglycerider i kroppens fedtdepoter.
English: This dosage should be gradually increased according to blood test results as well as clinical response and side effects.
Danish: Denne dosis skal forøges gradvist i overensstemmelse med blodprøveresultater samt klinisk respons og bivirkninger.
English: Even higher doses have been used.
Danish: Højere doser er anvendt.
English: • Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome)
Danish: • Smerter eller brændende fornemmelse i hænder eller på underarme (karpaltunnelsyndrom)
English: In adults as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.
Danish: Hos voksne, såvel som hos børn, opretholder somatropin en normal kropssammensætning ved at øge kvælstofretention og stimulere skeletmuskelvækst og fedtmobilisering.
English: With your other hand, hold the syringe as you would a pencil.
Danish: Med den anden hånd holder du injektionssprøjten, som var det en blyant.
English: - Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
Danish: - Vækstforstyrrelse (nuværende standardafvigelsescore (SDS) for højde < -2,5 og forældrejusteret højde-SDS < -1) hos børn/unge med lav højde, som er født små i forhold til deres gestationsalder (SGA), med en fødselsvægt og/eller -længde under -2 standardafvigelser (SD), som ikke ved 4-årsalderen eller senere har vist catch-up-vækst (væksthastighed (HV)-SDS < 0) i løbet af det seneste år.
English: In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended.
Danish: I tilfælde af alvorlig eller tilbagevendende hovedpine, synsforstyrrelser, kvalme og/eller opkastning anbefales det at foretage fundoskopi med henblik på papilødem.
English: The daily dosage should not exceed 2.7 mg.
Danish: Den daglige dosis bør ikke overstige 2,7 mg.
English: Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
Danish: Indledning af behandling med somatropin kan medføre hæmning af 11βHSD-1 og reducerede serumkoncentrationer af kortisol.
English: Your doctor should have already shown you how to use Omnitrope.
Danish: Din læge bør allerede have vist dig, hvordan du tager Omnitrope.
English: In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population.
Danish: Hos patienter med endokrine forstyrrelser, inklusive væksthormonmangel, kan hofteskred forekomme hyppigere end generelt i befolkningen.
English: The effects of somatropin on recovery were studied in two placebo controlled trials involving 522 critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.
Danish: Somatropins virkning på restitution blev undersøgt i 2 placebokontrollerede studier med 522 kritisk syge voksne patienter med komplikationer efter åben hjertekirurgi, abdominalkirurgi, multiple accidentelle traumer eller akut respirationssvigt.
English: Mortality was higher in patients treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%.
Danish: Mortaliteten var højere hos patienter behandlet med 5,3 mg eller 8 mg somatropin dagligt end hos patienter behandlet med placebo, hhv. 42 % og 19 %.
English: This means that it is injected through a short injection needle into the fatty tissue just under your skin.
Danish: Det betyder, at det injiceres ved hjælp af en kort injektionsnål i fedtvævet lige under huden.
English: During this period, conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism and nutritional status) should have been established and should be maintained during treatment.
Danish: I løbet af denne periode bør konservativ behandling af nyresvigt (omfattende kontrol af acidose, hyperparatyreoidisme og ernæringsstatus) være iværksat, og den bør opretholdes under behandlingen.
English: In all patients developing other or similar acute critical illness, the possible benefit of treatment with somatropin must be weighed against the potential risk involved.
Danish: Hos alle patienter, som udvikler anden eller lignende akut kritisk sygdom, bør de potentielle fordele ved behandling med somatropin afvejes mod den potentielle risiko.
English: Medical treatment for your kidney should be continued.
Danish: Den medicinske behandling af din nyresygdom bør fortsætte.
English: Patients limping during treatment with somatropin should be examined clinically.
Danish: Patienter, som halter under behandling med somatropin, bør undersøges klinisk.
English: Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increased hepatic clearance.
Danish: Det er blevet rapporteret, at somatropin reducerer serumcortisolniveauerne, muligvis ved at påvirke bærerproteiner eller ved øget hepatisk clearance.
English: If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Danish: Hvis væksthormonbehandling genoptages, er det nødvendigt omhyggeligt at kontrollere for symptomer på intrakraniel hypertension.
English: Formation of antibodies to the injected growth hormone but these do not seem to stop the growth hormone from working.
Danish: Dannelse af antistoffer mod det injicerede væksthormon, men det virker ikke som om, det får væksthormonet til at holde op med at virke.
English: Persons above 60 years should start with a dose of 0.1-0.2 mg per day which should be slowly increased according to individual requirements.
Danish: Personer over 60 år bør starte med en dosis på 0,1-0,2 mg dagligt, som bør øges langsomt i henhold til individuelle behov.
English: If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
Danish: Hvis papilødem bekræftes, bør diagnosen benign intrakraniel hypertension overvejes, og væksthormonbehandlingen bør i givet fald afbrydes.
English: In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
Danish: Ved kronisk nedsat nyrefunktion bør nyrefunktionen være under 50 % af det normale, før behandling påbegyndes.
English: This will keep the Omnitrope solution sterile and prevent leaking.
Danish: Dette vil holde Omnitrope-opløsningen steril og forhindre udsivning.
English: Water and mineral metabolism
Danish: Vand og mineralmetabolisme
English: The mean terminal half-life of somatropin after intravenous administration in growth hormone deficient adults is about 0.4 hours.
Danish: Somatropins gennemsnitlige halveringstid efter intravenøs administration hos voksne patienter med væksthormonmangel er ca. 0,4 timer.
English: The best sites for injection are tissues with a layer of fat between skin and muscle, such as the thigh or belly (except the navel or waistline).
Danish: Det bedste sted til injektion er væv med et lag fedt mellem hud og muskel som f.eks. låret eller maven (undgå navle og talje).
English: There have been rare cases of sudden death in patients with Prader-Willi syndrome.
Danish: Der har været sjældne tilfælde af pludselig død hos patienter med Prader-Willis syndrom.
English: Somatropin increases insulin but fasting blood glucose is commonly unchanged.
Danish: Somatropin øger insulinniveauet, men fasteblodsukkerniveauet er normalt uforandret.
English: Push up the plunger slowly back to the correct dose.
Danish: Skub langsomt stemplet tilbage til den rette dosis.
English: In patients with increased risk for diabetes mellitus (e.g. familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed.
Danish: Hos patienter med øget risiko for diabetes mellitus (f.eks. familiær anamnese for diabetes, fedme, svær insulinresistens, acanthosis nigricans) bør oral glucosetoleranstest (OGTT) foretages.
English: - Growth disturbance associated with Turner syndrome.
Danish: - Vækstforstyrrelse forbundet med Turners syndrom.
English: • Stiffness in the arms and legs, muscle pain
Danish: • Stivhed i arme og ben, muskelsmerter.
English: Important information about some of the ingredients of Omnitrope
Danish: Vigtig information om nogle af de øvrige indholdsstofer i Omnitrope
English: • If you have diabetes, you should closely monitor your blood sugar level during treatment with somatropin and discuss the results with your doctor to determine whether you need to change the dose of your medicines to treat diabetes.
Danish: • Hvis du har diabetes, skal du måle dit blodsukkerniveau nøje under somatropinbehandlingen og diskutere resultaterne med lægen for at finde ud af, om det er nødvendigt, at du ændrer dosis af din diabetesmedicin.
English: Omnitrope has given rise to the formation of antibodies in approximately 1% of patients.
Danish: Omnitrope har givet anledning til dannelse af antistoffer hos ca. 1 % af patienterne.
English: An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken from patients after long term treatment with somatropin and following the addition of the radiomimetic drug bleomycin.
Danish: En øget kromosomfragilitet er observeret i et in vitro-studie med lymfocytter fra patienter efter langtidsbehandling med somatropin og efter tilføjelse af det radiomimetiske lægemiddel bleomycin.
English: The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy subjects and growth hormone deficient patients.
Danish: Biotilgængeligheden af subkutant administreret somatropin er ca. 80 % både hos både raske studiepersoner og patienter med væksthormonmangel.
English: Do not use if the solution is cloudy or contains particles.
Danish: Brug ikke opløsningen, hvis den er uklar eller indeholder partikler.
English: EXP After reconstitution, use within 21 days.
Danish: EXP Efter rekonstitution, anvendes inden for 21 dage.
English: Clinical trials in PWS
Danish: Kliniske studier af PWS
English: Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01.
Danish: Farmakoterapeutisk klassifikation: Hypofyseforlapshormoner og analoger, ATC-kode: H 01 AC 01.
English: In SGA children/adolescents it is recommended to measure the IGF-I level before start of treatment and twice a year thereafter.
Danish: Hos SGA-børn/unge anbefales det at måle IGF-I-niveauet før behandlingsstart og herefter 2 gange årligt.