FrancophonIA/ELRC3.0 huggingface dataset:
English: Caregivers administering Valtropin to their children should consider that ‘you' refers to the child.
Danish: Omsorgspersoner, som giver Valtropin til deres børn, skal tænke på, at ‘De' betyder barnet.
English: Conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism, and nutritional status for one year prior to the treatment) should have been established and should be maintained during treatment.
Danish: Konservativ behandling af nedsat nyrefunktion (hvilket inkluderer kontrol af acidose, hyperparathyroidisme og ernæringsmæssig status et år inden behandlingen) bør være etableret og bør opretholdes under behandlingen.
English: Not known: Insulin resistance
Danish: Ikke kendt: insulinresistens
English: The generation of such antibodies with low binding capacity is unlikely to be clinically relevant.
Danish: Det er usandsynligt, at dannelsen af sådanne antistoffer med lav bindingsevne har nogen klinisk relevans.
English: Dosage in paediatric population
Danish: Dosering hos pædiatrisk population
English: Tel: +49 (0) 7121 948 7756 Fax: +49 (0) 7121 346 255
Danish: Fax: +49 (0) 7121 346 255
English: Of these second tumours, in particular, brain tumours were the most common.
Danish: Af disse andre tumorer var især hjernetumorer de almindeligste.
English: Medicines should not be disposed of via waste water or household waste.
Danish: Medicinen må ikke tilføres spildevand eller husholdningsaffald.
English: Detailed instructions for the handling of the medicinal product are given at the end of the package leaflet.
Danish: Nærmere vejledning om håndtering af lægemidlet gives i slutningen af indlægssedlen.
English: The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Danish: Sprøjtens størrelse skal være lille nok til, at den ordinerede dosis kan trækkes op fra hætteglasset med rimelig nøjagtighed.
English: This dose should be gradually increased according to individual patient requirements based on the clinical response and serum IGF-1 concentrations.
Danish: Denne dosis bør gradvis øges i overensstemmelse med den enkelte patients behov baseret på klinisk respons og koncentrationerne af serum IGF-1.
English: The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Danish: Den nøjagtige væksthormondosis bør derfor kontrolleres hver 6. måned.
English: The clinical significance of this decrease is unknown.
Danish: Den kliniske betydning af denne reduktion kendes ikke.
English: The following adverse reactions and their frequencies have been observed under treatment with somatropin based on published information:
Danish: Følgende bivirkninger og deres hyppighed er observeret under behandling med somatropin baseret på den offentliggjorte information:
English: Anti-host cell protein (anti-S. cerevisiae) antibodies were uncommon in patients treated with Valtropin.
Danish: Antistoffer mod anti-værtscelleprotein (anti-S. cerevisiae protein) var usædvanlige hos patienter, der blev behandlet med Valtropin.
English: There were no relevant differences between Valtropin and the reference medicinal product with regard to height velocity and height velocity SDS.
Danish: Der var ingen relevante forskelle imellem Valtropin og referencelægemidlet, hvad angår væksthastighed og væksthastighedens SDS.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension.
Danish: I øjeblikket er der utilstrækkeligt grundlag til at vejlede den kliniske beslutningstagning hos patienter med færdigbehandlet intrakraniel hypertension.
English: Intracranial hypertension
Danish: Intrakraniel hypertension
English: Fill the syringe with air by pulling the plunger back to the level that represents your dose as prescribed by your doctor.
Danish: Fyld sprøjten med luft ved at trække stemplet tilbage til det niveau, som markerer den dosis som Deres læge har ordineret.
English: When it stimulates growth of cells in the long bones of the legs and spine, it causes an increase in height.
Danish: Når det stimulerer cellernes vækst i de lange knogler i ben og rygsøjle, øges højden.
English: Select the injection site according to the recommendation of your doctor.
Danish: Vælg injektionsstedet efter Deres læges anbefaling.
English: Syringe containing your medicine being attached to a new needle 21.
Danish: Sprøjte indeholdende Deres medicin sættes fast på en ny nål 21.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske sikkerhedsopdateringsrapport (PSUR).
English: Valtropin is synthesised in yeast cells (Saccharomyces cerevisiae).
Danish: Valtropin syntetiseres i gærceller (Saccharomyces cerevisiae).
English: The safety profile of Valtropin observed in these clinical studies was consistent with that reported with the reference medicinal product used in these studies and other somatropin containing medicinal products.
Danish: Valtropins sikkerhedsprofil, som er observeret i disse kliniske forsøg, svarede til den, der er rapporteret for referencelægemidlet, som blev anvendt i disse forsøg, og andre lægemidler, som indeholder somatropin.
English: Dizziness (vertigo)
Danish: Svimmelhed (vertigo)
English: It has the same structure as the growth hormone that the body produces in the pituitary glands (glands located at the base of the brain).
Danish: Det har den samme struktur som det væksthormon, kroppen selv producerer i hypofysen (kirtler der sidder nederst på hjernen).
English: The most prominent effect of somatropin is that it stimulates the growth plates of long bones.
Danish: Somatropins mest fremherskende effekt er, at det stimulerer de lange knoglers vækstplader.
English: If the patient has had a brain tumour, the patient should be re-examined frequently to make sure that the tumour has not come back.
Danish: Hvis patienten har haft en hjernetumor, bør patienten undersøges hyppigt for at sikre, at tumoren ikke er kommet tilbage.
English: Children with Turner syndrome
Danish: Børn med Turner's syndrom
English: Monitoring of thyroid function should therefore be conducted in all patients.
Danish: Monitorering af thyreoideafunktionen bør derfor foretages hos alle patienter.
English: Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask incipient hypothyroidism.
Danish: Væksthormon øger den ekstrathyreoideale omdannelse af T4 til T3 og kan som sådan afsløre begyndende hypothyroidisme.
English: There are no specific local tolerance studies in animals after subcutaneous injection of Valtropin.
Danish: Der eksisterer ingen specifikke undersøgelse af lokal tolerance hos dyr efter subkutan injektion af Valtropin.
English: If not used immediately, in-use storage times and conditions prior to use would normally not be longer than 24 hours at 2°C - 8°C (refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes omgående, overstiger opbevaringstid ogbetingelser før brug normalt ikke 24 timer ved 2°C-8°C (i køleskab), medmindre rekonstitution har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Solvent: metacresol (see leaflet for further information) and water for injections.
Danish: Solvens: metacresol (se indlægssedlen for yderligere information) og vand til injektionsvæske.
English: After reconstitution with the solvent provided: can be stored for 21 days in a refrigerator.
Danish: Efter rekonstitution med den medfølgende solvens: kan opbevares i 21 dage i køleskab.
English: The efficacy and safety of Valtropin has been assessed in a randomised, double-blind, parallel, controlled Phase III study in children with growth hormone deficiency.
Danish: Valtropins effekt og sikkerhed er vurderet i et randomiseret, dobbeltblindt, parallelt, kontrolleret fase III-forsøg hos børn med væksthormonmangel.
English: Push the plunger slowly back up to the correct dose.
Danish: Skub stemplet langsomt tilbage til den korrekte dosis.
English: During clinical studies 128 children (98 children with growth hormone deficiency and 30 with Turner syndrome) were exposed to Valtropin.
Danish: Under kliniske forsøg fik 128 børn (98 børn med væksthormonmangel og 30 med Turner's syndrom) Valtropin.
English: In this leaflet the patient is addressed as ‘you'.
Danish: I denne indlægsseddel tiltales patienten med ‘De'.
English: If there is bleeding, cover the injection site with an adhesive plaster.
Danish: Hvis det bløder, dækkes injektionsstedet med hæfteplaster.
English: Your doctor may need to adjust the dose of Valtropin or of the other medicine.
Danish: Det kan måske være nødvendigt, at Deres læge justerer dosen af Valtropin eller af det andet lægemiddel.
English: Withdrawing the right volume of your medicine with the help of the syringe markings 19.
Danish: Trække den rette mængde medicin op ved hjælp af markeringerne på sprøjten 19.
English: - for growth promotion in children who have already stopped growing - if you have had a serious heart or abdominal operation - if you are being treated for more than one injury following a serious accident - if you have sudden serious breathing problems
Danish: - til at fremskynde vækst hos børn, der allerede er holdt op med at vokse - hvis De har haft en alvorlig hjerte- eller maveoperation - hvis De behandles for mere end en kvæstelse efter et alvorligt uheld - hvis De får pludselige, alvorlige vejrtrækningsproblemer
English: Long-term overdose could result in signs and symptoms of acromegaly consistent with the known effects of excess human growth hormone.
Danish: Langvarig overdosering kan resultere i tegn og symptomer på akromegali i overensstemmelse med den kendte virkning af overskud af humant væksthormon.
English: Please read the instructions carefully and follow them step by step.
Danish: Læs instruktionen omhyggeligt og følg den punkt for punkt.
English: - If you have injected Valtropin by mistake into the muscle instead of under the skin, your blood sugar may become too low (hypoglycaemia).
Danish: - Hvis De ved en fejl har injiceret Valtropin i musklen i stedet for under huden, kan Deres blodsukker blive for lavt (hypoglykæmi).
English: Before and after every injection, the septum of the vial should be wiped with alcohol to prevent contamination of the contents by repeated needle insertions.
Danish: Før og efter hver injektion skal hætteglassets prop tørres af med sprit for at forhindre kontaminering af indholdet ved gentagne kanyleindstik.
English: It is advisable not to exceed the recommended dosage in view of the potential risks of acromegaly, hyperglycaemia, and glucosuria.
Danish: Det tilrådes, at den anbefalede dosis ikke overskrides i betragtning af den potentielle risiko for akromegali, hyperglykæmi og glukosuri.
English: - Valtropin should not be used for growth promotion in children with closed epiphyses.
Danish: - Valtropin må ikke anvendes til at fremme væksten hos børn med lukkede epifyser.
English: During or after serious illness - If you have had a brain tumour, you should be re-examined frequently to make sure that the tumour has not come back.
Danish: Under eller efter alvorlig sygdom - Hvis De har haft en hjernetumor, skal De undersøges ofte for at sikre, at tumoren ikke er kommet tilbage.
English: Hold the syringe in your hand as you would hold a pencil.
Danish: Hold sprøjten i hånden, som om det var en blyant.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Bortskaffelse Ikke anvendte lægemidler samt affald heraf bør bortskaffes i overensstemmelse med lokale krav.
English: Subcutaneous administration of 0.073 mg/kg body weight of Valtropin resulted in a Cmax of 43.97 ng/ml and an AUC0-24 h of 369.90 ng·h/ml.
Danish: Subkutan indgivelse af 0,073 mg/kg legemsvægt Valtropin gav en Cmax på 43,97 ng/ml og en AUC0-24 t på 369,90 ng·h/ml.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists; ATC code: H01AC01
Danish: Farmakoterapeutisk klassifikation: Hypofyse- og hypothalamus-hormoner og analoger, somatropin og somatropin-agonister; ATC-kode: H01AC01
English: Animal studies are insufficient with respect to effects on pregnancy, embryofoetal development, parturition or postnatal development (see section 5.3).
Danish: De udførte dyreforsøg er utilstrækkelige med hensyn til virkningerne for graviditeten, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: A double-blind, randomised, single dose, crossover study in 24 healthy volunteers showed that the pharmacokinetic profile of Valtropin was comparable to that of the reference medicinal product.
Danish: Et dobbeltblindt, randomiseret, enkeltdosis overkrydsningsforsøg med 24 raske frivillige viste, at Valtropins farmakokinetiske profil var sammenligneligt med referencelægemidlet.
English: Squeeze a big skin fold between your thumb and index finger.
Danish: Klem en stor hudfold imellem tommel- og pegefinger.
English: If necessary, your doctor will gradually increase this dose according to your individual requirements based on the clinical outcome and measurement of your blood levels of a so called “growth factor” (known as IGF-1).
Danish: Om nødvendigt vil Deres læge gradvist øge denne dosis efter Deres individuelle behov på basis af klinisk behandlingsresultat og målinger af koncentrationen i Deres blod af en såkaldt “vækstfaktor” (kaldet IGF-1).
English: Cleanse the injection site with an alcohol swab and wait for the area to dry.
Danish: Rens injektionsstedet med en spritserviet og vent, til området tørrer.
English: This hurts less than pushing the needle in slowly.
Danish: Det gør mindre ondt end at presse kanylen langsomt ind. 30.
English: Paediatric population - Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.
Danish: Pædiatrisk population - Langtidsbehandling af børn (2 - 11 år) og unge (12 - 18 år) med hæmmet vækst på grund af utilstrækkelig sekretion af normalt, endogent væksthormon.
English: Animal studies with Valtropin are not sufficient to assess the reproductive toxicity potential.
Danish: Dyreforsøg med Valtropin er ikke tilstrækkelige til at vurdere midlets toksicitetspotentiale ved reproduktion.
English: Your medicine is called Valtropin.
Danish: Navnet på Deres lægemiddel er Valtropin.
English: Important information about some of the ingredients of Valtropin The accompanying solvent of Valtropin contains metacresol.
Danish: Vigtige oplysninger om nogle af indholdsstofferne i Valtropin Den medfølgende Valtropin-solvens indeholder metacresol.
English: The clinical significance of this is unknown.
Danish: De kliniske konsekvenser heraf er ukendte.
English: Common: Hypothyroidism
Danish: Almindelig: hypothyroidisme
English: The binding capacity of these antibodies was low and there was no effect on growth rate.
Danish: Disse antistoffers havde en lav bindingsevne, og vækstraten blev ikke påvirket.
English: In contrast to bacteria (E. coli), yeast has not been described to elicit adjuvant effects modifying the immunological response.
Danish: I modsætning til bakterier (E. coli) er det for gær ikke beskrevet at det udløser adjuvante effekter, som påvirker den immunologiske respons.
English: Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.
Danish: Test for antistoffer mod somatropin bør udføres hos alle patienter, som ikke responderer på behandlingen.
English: Please contact your doctor for further advice.
Danish: Kontakt lægen for få yderligere råd.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE Læs indlægssedlen før brug.
English: The clearance of compounds metabolised by cytochrome P 450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased resulting in lower plasma levels of these compounds.
Danish: Udskillelsen af stoffer metaboliseret af cytokrom P450 3A4 (f.eks. kønssteroider, kortikosteroider, antikonvulsiva og cyclosporin) kan blive forøget, hvilket kan give lavere plasmaniveauer for disse stoffer.
English: Non-clinical data reveal no special hazard for humans based on conventional studies with Valtropin of repeated dose toxicity, genotoxicity and reproductive toxicity studies.
Danish: De ikke-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser med Valtropin af gentagen dosistoksicitet, genotoksicitet og toksicitet i forbindelse med reproduktion.
English: After reconstitution with the solvent provided, Valtropin has a pH of approximately 7.5 and an osmolality of approximately 320 mOsm/kg.
Danish: Efter rekonstitution med den medfølgende solvens har Valtropin en pH på cirka 7,5 og en osmolalitet på cirka 320 mOsm/kg.
English: If you use more Valtropin than you should In case more Valtropin was used than recommended, please consult your doctor.
Danish: Hvis De anvender mere Valtropin, end De bør: Hvis der er anvendt mere Valtropin end anbefalet, skal De søge læge.
English: The accuracy of the Valtropin dose should be checked every 6 months by your doctor.
Danish: Den nøjagtige dosis Valtropin bør derfor kontrolleres hver 6. måned af Deres læge.
English: Somatropin is a polypeptide hormone of recombinant DNA origin.
Danish: Somatropin er et polypeptidhormon af rekombinant DNA-oprindelse.
English: What Valtropin contains
Danish: Hvad Valtropin indeholder
English: - Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.
Danish: - Behandling af manglende højde hos børn med Turner's syndrom, bekræftet af kromosomanalyse.
English: The injection sites should be varied in order to avoid lipo-atrophy.
Danish: Der bør skiftes imellem injektionsstederne for at undgå lipoatrofi.
English: Therefore Valtropin should not be used during pregnancy unless clearly necessary.
Danish: Valtropin bør derfor ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Do not use Valtropin if you notice that the solvent or the reconstituted solution is cloudy or discoloured or if contains particulate matters.
Danish: De må ikke anvende Valtropin, hvis De ser, at solvensen eller den rekonstituerede opløsning er uklar eller misfarvet, eller hvis den indeholder partikler.
English: The total daily dose usually does not exceed 1 mg. IGF-1 concentrations need to be regularly measured and should be maintained below the upper limit of the normal range for your age and sex.
Danish: Den samlede daglige dosis overstiger som regel ikke 1 mg. IGF-1 koncentrationerne skal måles regelmæssigt og bør vedligeholdes under den øvre grænse for normalområdet for Deres alder og køn.
English: DO NOT aim it at the white powder at the bottom of the vial.
Danish: Ret den IKKE mod det hvide pulver i bunden af hætteglasset.
English: Valtropin should not be used during pregnancy unless clearly necessary.
Danish: Valtropin bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Pancreatitis in children
Danish: Pankreatitis hos børn
English: From reproductive toxicity studies performed with other somatropin medicinal products there is no evidence of an increased risk of adverse reactions for the embryo or foetus.
Danish: Baseret på reproduktive toksicitetsforsøg med andre somatropin-holdige lægemidler er der ingen tegn på øget risiko for bivirkninger for embryoet eller fostret.
English: Reconstitution with the solvent provided
Danish: Rekonstitution med den leverede solvens
English: Valtropin has no or negligible influence on the ability to drive and use machines.
Danish: Valtropin har ingen eller ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
English: After accidental intramuscular injection, hypoglycaemia may appear.
Danish: Efter en utilsigtet intramuskulær injektion kan der opstå hypoglykæmi.
English: Uncommon: Personality disorder
Danish: Ikke almindelig: personlighedsforstyrrelser
English: Gender and dosing
Danish: Køn og dosering
English: Experience of prolonged treatment (over 5 years) with somatropin in adults is limited.
Danish: Der er begrænsede erfaringer med langvarig behandling (over 5 år) med somatropin hos voksne.
English: Total daily dose usually does not exceed 1 mg. IGF-1 concentrations should be maintained below the upper limit of the age-specific normal range.
Danish: Den samlede daglige dosis overstiger som regel ikke 1 mg. IGF-1-koncentrationerne bør vedligeholdes under den øverste grænse for det aldersspecifikke normalområde.
English: If you have used too much Valtropin over a longer period, this may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone (acromegaly).
Danish: Hvis De har anvendt for meget Valtropin over en længere periode, kan det forårsage en større vækst end normalt af ører, næse, læber, tunge og kindben (akromegali).
English: Do not inject Valtropin yourself if you are not sure about the dose.
Danish: De må ikke selv injicere Valtropin, hvis De ikke er sikker på dosis.
English: Any unused solution should be discarded.
Danish: Eventuel ubrugt opløsning skal kasseres.
English: When empty, discard the vial as well.
Danish: Når hætteglasset er tomt, bortskaffes dette også.
English: The MAH must ensure that the system of pharmacovigilance, as presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer, før og mens lægemidlet markedsføres.
English: • The non-reconstituted medicine can be kept at room temperature (not above 25°C) for one single period of up to 4 weeks before use.
Danish: • Det ikke-rekonstituerede lægemiddel kan opbevares ved stuetemperatur (ikke over 25°C) i en enkelt periode i op til 4 uger før brug.
English: If you have used too much Valtropin, initially your blood sugar may decrease and become too low (hypoglycaemia) and subsequently increase and become too high (hyperglycaemia).
Danish: Hvis De har anvendt for meget Valtropin, kan Deres blodsukker først falde og blive for lavt (hypoglykæmi) og derefter stige og blive for højt (hyperglykæmi).
English: For handling the vial see ‘Injecting the solution', step 32.
Danish: Vedrørende håndtering af hætteglasset, se ‘Injektion af opløsning', trin 32.
English: Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin.
Danish: Patienter med svær væksthormonmangel i voksenalderen defineres som patienter med kendt hypothalamisk-hypofysær patologi og mindst en yderligere kendt mangel på et hypofysehormon, som ikke er prolactin.
English: Please do not change the dosage without consulting your doctor.
Danish: De må ikke ændre dosis uden at tale med Deres læge om det først.
English: - Patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or patients having acute respiratory failure.
Danish: - Patienter med akut, kritisk sygdom på grund af komplikationer efter operative indgreb i hjerte eller abdomen, multiple traumatiske læsioner fra uheld eller patienter med akut vejrtrækningsbesvær.