FrancophonIA/ELRC3.0 huggingface dataset:
English: Then continue to fill the syringe with the correct volume of suspension as advised by your doctor.
Danish: Fortsæt dernæst med at fylde sprøjten med den korrekte mængde suspension som anvist af din læge.
English: Conversion from patient body weight to dose, number of vials, total injection volume and number of injections in paediatric patients
Danish: Konvertering fra patientlegemsvægt til dosis, antal hætteglas, samlet injektionsvolumen og antal injektioner hos pædiatriske patienter
English: The safety profile of Somatropin Biopartners is generally consistent with the well known safety profile of daily growth hormone treatments.
Danish: Sikkerhedsprofilen for Somatropin Biopartners er generelt overensstemmende med den velkendte sikkerhedsprofil for daglige væksthormonbehandlinger.
English: If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Danish: Hvis behandlingen med væksthormon genoptages, er det nødvendigt at foretage en nøje monitorering for symptomer på intrakraniel hypertension.
English: This medicince is injected once a week.
Danish: Denne medicin injiceres én gang ugentligt.
English: With the exception of injection site related reactions and the formation of antibodies to rhGH which were reported more frequently in children than in adults the safety profile of Somatropin Biopartners is similar for children and adults.
Danish: Bortset fra reaktioner på injektionsstedet og dannelsen af antistoffer mod rhGH, som blev rapporteret hyppigere hos børn end hos voksne, er sikkerhedsprofilen for Somatropin Biopartners den samme for børn og voksne.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
English: • Somatropin treatment must not be started in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure or similar conditions.
Danish: • Behandling med Somatropin må ikke påbegyndes hos patienter med akut, kritisk sygdom på grund af komplikationer efter åben hjertekirurgi eller abdominalkirurgi, multiple traumatiske ulykkesbetingede læsioner, eller patienter med akut respirationssvigt eller lignende tilstande.
English: - if you are being treated for more than one injury following a serious accident; - if you experience sudden serious breathing problems.
Danish: - hvis du er i behandling for mere end en kvæstelse efter et alvorligt uheld; - hvis du får pludselige og alvorlige vejrtrækningsproblemer.
English: Caution should be exercised when this medicinal product is administered to breast-feeding women.
Danish: Der skal udvises forsigtighed, når dette lægemiddel administreres til ammende kvinder.
English: In particular, inform your doctor if you are taking or have recently taken any of the following medicines.
Danish: Fortæl især din læge, hvis du tager noget af følgende medicin eller har gjort det for nylig.
English: For children and adolescents aged 2 to 18 years somatropin
Danish: Til børn og unge i alderen 2-18 år somatropin
English: If you are heavier than 40 kg, two vials must be used.
Danish: Hvis du vejer over 40 kg, skal der anvendes 2 hætteglas.
English: There are no specific studies which address local tolerance in animals after subcutaneous injection, but data available from the repeated-dose toxicity studies revealed swelling and inflammatory infiltrate at the injection sites.
Danish: Der er ingen specifikke studier, der omhandler lokal tolerance hos dyr efter subkutan injektion, men data fra studier af toksicitet efter gentagne doser viste hævelse og inflammatorisk infiltrat på injektionsstederne.
English: Animal studies with other somatropin formulations have shown adverse effects but the available nonclinical data are considered insufficient to draw firm conclusions on the use in humans (see section
Danish: Dyreforsøg med andre somatropinpræparater har påvist bivirkninger, men de foreliggende prækliniske data anses for at være utilstrækkelige til at drage faste konklusioner om anvendelse hos mennesker (se pkt.
English: Somatropin Biopartners contains human growth hormone, also called somatropin.
Danish: Somatropin Biopartners indeholder et humant væksthormon, også kaldet somatropin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2013
Danish: Dato for første markedsføringstilladelse: 05. august 2013
English: The subcutaneous injection should always be administered at the same time of the day to increase compliance and the site of injection must be varied to prevent lipoatrophy.
Danish: Den subkutane injektion bør altid indgives på samme tidspunkt af dagen for at øge komplians og injektionsstedet skal varieres for at undgå lipoatrofi.
English: The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be increased resulting in lower plasma levels of these compounds.
Danish: Clearance af stoffer, som metaboliseres af cytokrom P450 3A4 (f.eks. kønssteroider, kortikosteroider, antikonvulsiva og ciclosporin), kan øges og medføre lavere plasmaniveauer af disse stoffer.
English: The somatropin in this medicinal product is a polypeptide hormone of recombinant DNA origin.
Danish: Somatropin i dette lægemiddel er et polypeptidhormon af rekombinant DNA-oprindelse.
English: Your doctor will stop your treatment with this medicine if there is evidence of cancerous growth; - if you are ill due to a serious heart or stomach operation;
Danish: Din læge vil standse behandlingen med denne medicin, hvis der er tegn på kræftspredning; - hvis du er syg på grund af en alvorlig hjerte- eller maveoperation;
English: The binding activity of these antibodies has been low and no clinical consequences have been associated with their formation.
Danish: Disse antistoffer har en lav bindingsevne, og der er ikke associeret nogen kliniske konsekvenser med deres dannelse.
English: Female (on oral oestrogen)
Danish: Kvinde (i behandling med oral østrogen)
English: The recommended weekly dose in children (i.e. 0.5 mg/kg/week) should not be exceeded as there is limited experience with higher doses in this patient group.
Danish: Den anbefalede ugentlige dosis hos børn (d.v.s. 0,5 mg/kg/uge) bør ikke overskrides, da der er begrænset erfaring med højere doser i denne patientgruppe.
English: Very common: Mild hyperglycaemia*
Danish: Meget almindelig: Mild hyperglykæmi*
English: The apparent terminal half-life was about 7.4 h in children, presumably reflecting slow absorption from the site of injection.
Danish: Den tilsyneladende terminale halveringstid var ca. 7,4 t hos børn, hvilket sandsynligvis skyldes langsom absorption fra injektionsstedet.
English: previous dose Dose change at a time
Danish: Handling for tidligere dosis Dosisændring ad gangen
English: Put an adhesive plaster on the injection site.
Danish: Sæt et hæfteplaster på injektionsstedet.
English: Withdraw the syringe and discard it.
Danish: Træk sprøjten ud og bortskaf den.
English: Additional reports based on published information for daily growth hormone treatments are listed with asterisks.
Danish: Yderligere rapporteret baseret på offentliggjort information om daglige væksthormonbehandlinger er anført med stjernemarkering.
English: Slowly withdraw the suspension.
Danish: Træk langsomt suspensionen ud.
English: Very common: Headache
Danish: Meget almindelig: Hovedpine
English: - If you have an abnormal curving of the spine your doctor will monitor you for worsening of this
Danish: - Hvis du har en unormal rygsøjlekrumning, vil din læge overvåge dig for forværring af denne tilstand.
English: The powder is white to almost white, the solvent is a clear liquid.
Danish: Pulveret er hvidt til næsten hvidt, solvensen er en klar væske.
English: If not used immediately, the suspension must be reconstituted again by swirling immediately before injection.
Danish: Hvis suspensionen ikke anvendes omgående, skal den rekonstitueres igen ved at svinge hætteglasset umiddelbart før injektion.
English: The recommended and maximum dose is 0.5 mg/kg / week and should not be exceeded.
Danish: Den anbefalede og maksimale dosis er 0,5 mg/kg/uge og bør ikke overskrides.
English: After 6 months of weekly treatment with Somatropin Biopartners, there was a statistically significant reduction of 1.6 kg in fat mass in the Somatropin Biopartners group compared to the placebo group.
Danish: Efter 6 måneders ugentlig behandling med Somatropin Biopartners var der en statistisk signifikant reduktion på 1,6 kg i fedtmassen i Somatropin Biopartners gruppen sammenlignet med placebogruppen.
English: In older or overweight patients, lower doses may be necessary.
Danish: Det kan være nødvendigt med lavere doser til ældre eller overvægtige patienter.
English: If the flow stops or bubbles appear, gently tap the syringe with your fingers.
Danish: Hvis strømmen stopper, eller der kommer bobler, kan du banke let på sprøjten med fingrene.
English: It is not known if this medicine passes into breast milk.
Danish: Det er ukendt, om denne medicin udskilles i human mælk.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and agonists, ATC code: H01AC01
Danish: Farmakoterapeutisk klassifikation: Hypofyse- og hypothalamus-hormoner og analoger, somatropin og agonister, ATC-kode: H01AC01
English: A similar improvement was observed for the secondary efficacy endpoints namely increase in lean body mass, serum IGF-I and IGF-I SDS.
Danish: En tilsvarende forbedring blev observeret for de sekundære virkningsendepunkter, nemlig en stigning i muskelmasse, serum IGF-I og IGF-I SDS.
English: Very common: Formation of antibodies against growth hormone (33%), see section “Descriptions of selected adverse reactions”, under “Immunogenicity”.
Danish: Meget almindelig: Dannelse af antistoffer mod væksthormonet (33%), se punktet ”Beskrivelse af udvalgte bivirkninger” under “Immunogenicitet”.
English: In cases of severe or recurrent headache, visual problems, nausea, and/or vomiting, a fundoscopy for papilloedema is recommended.
Danish: I tilfælde af svær eller gentagen hovedpine, synsproblemer, kvalme og/eller opkastning anbefales det at foretage en fundoskopi for papillødem.
English: Use immediately, as the suspension may settle if left standing.
Danish: Brug opløsningen omgående, da suspensionen kan bundfælde sig, hvis den får lov at stå hen.
English: Once a normal peak bone mass is attained patients should be switched to Somatropin Biopartners for adults, if clinically indicated, and the dosing recommendation for adults should be followed.
Danish: Når en normal peak-knoglemasse er nået, bør patienterne skiftes over til Somatropin Biopartners for voksne, hvis det er klinisk indiceret, og doseringsvejledningen for voksne bør følges.
English: Generally, 2 mg once a week for all patients apart from female patients receiving oral oestrogen therapy who should receive 3 mg once a week.
Danish: Sædvanligvis 2 mg en gang ugentligt til alle patienter, bortset fra kvindelige patienter, der får oral østrogenbehandling.
English: Malignancies/tumours
Danish: Maligniteter/tumorer
English: Similar results were achieved for all other parameters assessed including height SDS (standard deviation score), bone maturation, IGF-I and IGF BP-3.
Danish: Lignende resultater blev opnået for alle andre vurderede parametre, inklusive højde-SDS (standardafvigelsesscore), knoglemodning, IGF-I og IGF BP-3.
English: For women taking oral oestrogens the starting dose is usually 3 mg injected once a week.
Danish: For kvinder, der tager østrogen oralt, er startdosis sædvanligvis 3 mg injiceret en gang ugentligt.
English: Few patients discontinued treatment due to injections site reactions.
Danish: Få patienter seponerede behandling på grund af reaktioner på injektionsstedet.
English: There is an increased risk that paediatric patients with prior malignancies may develop second neoplasm when treated with growth hormone, especially if treatment of the primary malignancy involved radiotherapy.
Danish: Der er en øget risiko for, at pædiatriske patienter med tidligere maligniteter kan udvikle sekundær neoplasme ved behandling med væksthormon, især hvis behandling af den primære malignitet involverede strålebehandling.
English: If the symptoms leading to the dose reduction disappear, at the judgment of the physician, the dose may be maintained at the decreased level or increased according to the dose adjustment scheme described above.
Danish: Hvis symptomerne, der førte til dosisreduktion, forsvinder, kan dosis vedligeholdes på det nedsatte niveau eller øges i overensstemmelse med den ovenfor beskrevne dosisjusteringsplan efter lægens vurdering.
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: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Danish: Akut overdosering kan føre til først hypoglykæmi og derefter hyperglykæmi.
English: The most frequently reported adverse reactions in children were injection site related reactions, most of them being mild to moderate in intensity.
Danish: De hyppigst rapporterede bivirkninger hos børn var reaktioner relateret til injektionsstedet, og de fleste var milde til moderate i sværhedsgrad.
English: Non-clinical data revealed no specific hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity.
Danish: Prækliniske data viste ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser og genotoksicitet.
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 papillødem bekræftes, bør diagnosen benign intrakraniel hypertension overvejes, og, hvis relevant, bør behandlingen med væksthormon seponeres.
English: Experience with somatropin treatment in patients above 60 years of age is limited.
Danish: Der er begrænset erfaring med somatropin-behandling hos patienter over 60 år.
English: Development of new tumours or reappearance of previously existing tumours has been reported during treatment with growth hormones.
Danish: Udvikling af nye svulster eller genopdukken af tidligere eksisterende svulster er blevet indberettet under behandling med væksthormoner.
English: Safely dispose of all used injection needles and syringes after a single use.
Danish: Bortskaf alle brugte kanyler og sprøjter på sikker vis efter en enkelt anvendelse.
English: The tmax was later and the half-life longer following the administration of Somatropin Biopartners than when immediate release products had been previously administered once daily to the same subjects reflecting the slower and more prolonged release of hGH from the site of injection of Somatropin Biopartners.
Danish: tmax var senere og halveringstiden længere efter administration af Somatropin Biopartners, end når produkter til øjeblikkelig frigivelse tidligere blev administreret en gang dagligt til de samme patienter, hvilket skyldes hGHs langsommere og mere langvarige frigivelse fra injektionsstedet med Somatropin Biopartners.
English: Somatropin has not been shown to increase the incidence or severity of scoliosis.
Danish: Det er ikke påvist, at somatropin øger forekomsten eller sværhedsgraden af skoliose.
English: Inject the suspension over a period of 5 seconds by gently pushing the plunger until the syringe is empty.
Danish: Injicer suspensionen over en periode på 5 sekunder ved forsigtigt at trykke stemplet, indtil sprøjten er tom.
English: Shelf-life after reconstitution with solvent
Danish: Opbevaringstid efter rekonstitution med solvens
English: The treatment goal should be IGF-I concentrations within -0.5 and +1.5 SDS of the age corrected mean.
Danish: Behandlingsmålet bør være IGF-I-koncentrationer inden for -0,5 og +1,5 SDS fra alderskorrigeret middelværdi.
English: Preparing the suspension
Danish: Tilberedning af suspensionen
English: In paediatric patients there is no evidence that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in patients with a history of pituitary pathology.
Danish: Hos pædiatriske patienter er der ingen tegn på, at væksthormonsubstitution påvirker recidivraten eller genvækst af intrakranielle neoplasmer, men standard klinisk praksis kræver regelmæssig scanning af hypofysen hos patienter med hypofysepatologi i anamnesen.
English: This medicine is used to treat adults with a lack (deficiency) of growth hormone who - already had growth hormone deficiency when they were children or - do not have enough growth hormone during adulthood.
Danish: Dette lægemiddel anvendes til at behandle voksne med væksthormonmangel som - allerede havde væksthormonmangel, da de var børn eller - ikke har nok væksthormon i voksenalderen.
English: If a drop of blood appears, maintain the pressure for a
Danish: Hvis der kommer en dråbe blod, vedligeholdes trykket i et øjeblik.
English: Where childhood-onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
Danish: Når GHD opstået i barndommen fortsætter i puberteten bør behandlingen fortsættes for at opnå fuldstændig somatisk udvikling (f.eks. kropssammensætning og knoglemasse).
English: It is unlikely that the antibody responses to treatment with Somatropin Biopartners are of clinical relevance.
Danish: Det er usandsynligt, at antistofresponser på behandling med Somatropin Biopartners har klinisk relevans.
English: Side effects very commonly reported (may affect more than 1 in 10 people) were injection site swelling and development of substances (antibodies) in the blood that bind to growth hormone.
Danish: Bivirkninger, der forekom hyppigt (kan forekomme hos flere end 1 ud af 10 personer) var hævelse på injektionsstedet og udvikling af stoffer(antistoffer) i blodet, der binder til væksthormonet.
English: The injection site should be cleaned with an alcohol swab and the suspension injected over a period of 5 seconds.
Danish: Injektionsstedet skal rengøres med en spritserviet, og suspensionen injiceres i løbet af 5 sekunder.
English: No information in patients with renal or hepatic impairment is available and particular dose recommendations cannot be given.
Danish: Der foreligger ingen data for patienter med nedsat nyre- eller leverfunktion, og der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Because human growth hormone (hGH) may induce a state of insulin resistance and hyperglycaemia, patients treated with this medicinal product should be monitored for evidence of glucose intolerance.
Danish: Da humant væksthormon (hGH) kan forårsage en tilstand med insulinresistens og hyperglykæmi, bør patienter behandlet med dette lægemiddel monitoreres for tegn på glukoseintolerans.
English: Because hGH may induce a state of insulin resistance, an adjustment of the insulin dose may be required.
Danish: Da hGH kan fremkalde en tilstand af insulinresistens, kan det være nødvendigt at justere insulindosen.
English: Vials and solvent required for preparation of one dose*
Danish: Hætteglas og solvens påkrævet til tilberedning af én dosis*
English: Fatty tissue under the skin can shrink at the site of injection on repeated administration at the same site.
Danish: Fedtvæv under huden kan krympe på injektionsstedet ved gentagen indgivelse på det samme sted.
English: Insert the full length of the needle into the skin fold at a right angle (90 degrees) as shown in figure 12.
Danish: Før kanylen i hele dens længde ind i hudfolden i en højrevinkel (90 grader) som vist i figur 12.
English: Large doses of somatropin may impair glucose tolerance.
Danish: Store doser somatropin kan hæmme glukosetolerancen.
English: Hypothyroidism may develop in patients with central subclinical hypothyroidism after initiating therapy with growth hormone.
Danish: Hypothyroidisme kan udvikles hos patienter med central subklinisk hypothyroidisme efter iværksættelse af behandling med væksthormon.
English: This medicine is used to treat failure to grow normally (growth deficiency) in children and adolescents aged 2 to 18 years with insufficient secretion of growth hormone.
Danish: Dette lægemiddel anvendes til at behandle manglende evne til at vokse normal (vækstmangel) hos børn og unge i alderen 2-18 år med utilstrækkelig udskillelse af væksthormon.
English: Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin.
Danish: Debut i voksenalderen: Patienter med GHD i voksenalderen defineres som patienter med kendt hypothalamisk-hypofysær patologi og mindst en yderligere kendt mangel på et hypofysehormon, som ikke er prolactin.
English: If you 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 har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du bruger dette lægemiddel.
English: Remove the protective caps from the top of both vials as seen in figure 3a.
Danish: Tag de beskyttende låg af toppen af begge hætteglas som vist i figur 3a.
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 øger den ekstrathyreoideale omdannelse af T4 til T3, som kan føre til en reduktion i serumkoncentrationen af T4 og en stigning i serumkoncentrationen af T3.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Somatropin Biopartners is administered subcutaneously once a week.
Danish: Somatropin Biopartners indgives subkutant en gang ugentligt.
English: The dosage of somatropin should be decreased in cases of persistent oedema or severe paraesthesia, in order to avoid the development of carpal tunnel syndrome.
Danish: Dosering af somatropin bør nedsættes i tilfælde af vedvarende ødem eller svær paræstesi for at undgå udviklingen af karpaltunnelsyndrom.
English: Cases of malignant and benign tumour recurrences, de-novo and secondary tumours have been reported in temporal relationship with somatropin therapy.
Danish: Tilfælde af recidiv af maligne og benigne tumorer, de-novo og sekundære tumorer er rapporteret i et tidsmæssigt forhold med somatropin-behandling.
English: Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective.
Danish: Væksthormon nedsætter omdannelse af kortison til kortisol og kan afsløre tidligere, uopdaget central hypoadrenalisme eller gøre lave glukokortikoidsubstitutionsdoser ineffektive.
English: The powder should be homogenously suspended in the injection vehicle prior to administration.
Danish: Pulveret skal være ensartet suspenderet i injektionen før administration.
English: • Somatropin must not be used when there is any evidence of tumour activity.
Danish: • Somatropin må ikke anvendes, hvis der er tegn på tumoraktivitet.
English: In the pivotal paediatric study, antibody responses to somatropin at two or more consecutive visits were observed in 33% of the patients.
Danish: I det pivotale pædiatriske studie blev der observeret antistofresponser på somatropin ved to eller flere konsekutive besøg hos 33% af patienterne.