FrancophonIA/ELRC3.0 huggingface dataset:
English: - oestrogen taken orally or other sex hormones - medicines to treat epilepsy - cyclosporine: a medicine to suppress the immune system
Danish: - østrogen taget oralt (gennem munden) eller andre kønshormoner - medicin til behandling af epilepsi - ciclosporin: en medicin til at hæmme immunsystemet
English: Continue to fill the syringe with the correct volume of the solvent for injection, as described in the text of figure 4 above.
Danish: Fortsæt med at fylde sprøjten med den korrekte mængde solvens til injektionsvæske som beskrevet i teksten til figur 4 ovenfor.
English: There is no antidote for somatropin overdose.
Danish: Der findes ingen kendt antidot mod overdosering med somatropin.
English: Hold the syringe firmly by the finger grip.
Danish: Hold godt fast om sprøjten med fingrene.
English: Common: Nausea
Danish: Almindelig: Kvalme
English: With regard to antibodies against host cell proteins, low anti-S. cerevisiae protein antibody titres similar to levels in the normal untreated population were found in some patients treated with this medicinal product.
Danish: Med hensyn til antistoffer mod værtcelleproteiner blev der fundet lave anti-S.cerevisiae protein antistoftitere hos nogle patienter, der blev behandlet med dette lægemiddel.
English: The weekly dose of 0.5 mg of somatropin per kilogram of body weight should not be exceeded due to limited experience with higher doses in children.
Danish: Den ugentlige dosis på 0,5 mg somatropin pr. kg. legemsvægt bør ikke overskrides pga. begrænset erfaring med højere doser hos børn.
English: Inject the medicine as instructed by your doctor who will also tell you what dose to use and how to inject this dose with the vials you have been prescribed.
Danish: Injicer medicinen som anvist af din læge, som også vil fortælle dig, hvilken dosis, du skal bruge og hvordan, du skal injicere denne dosis med de hætteglas, du har fået ordineret.
English: In a randomized, parallel-group, multicentre Phase III study, 178 children between 3 and 12 years of age with organic and/or idiopathic GHD were randomised to receive either weekly administered Somatropin Biopartners (0.5 mg/kg/week) or daily administered recombinant hGH (0.03 mg/kg/day) for 12 months.
Danish: I et randomiseret, parallelgruppe, multicenter, fase III-studie blev 178 børn mellem 3 og 12 år med organisk og/eller idiopatisk GHD randomiseret til at få enten ugentligt administreret Somatropin Biopartners (0,5 mg/kg/uge) eller dagligt administreret rekombinant hGH (0,03 mg/kg/dag) i 12 måneder.
English: The results showed weekly administered Somatropin Biopartners to be non inferior to daily administered recombinant hGH with respect to the primary endpoint of height velocity after 12 months.
Danish: Resultaterne viste, at ugentligt administreret Somatropin Biopartners var lige så godt som dagligt administreret rekombinant hGH med hensyn til det primære endepunkt for højdehastighed efter 12 måneder.
English: Somatropin Biopartners is not recommended during pregnancy.
Danish: Somatropin Biopartners anbefales ikke under graviditeten.
English: Vigorously swirl the vial without touching the rubber top with your fingers until the content is completely mixed.
Danish: Sving hætteglasset kraftigt uden at berøre gummitoppen med fingrene, indtil indholdet er helt blandet.
English: You should not use Somatropin Biopartners if you are pregnant or are trying to become pregnant.
Danish: Du bør ikke bruge Somatropin Biopartners, hvis du er gravid eller prøver på at blive gravid.
English: Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with GHD.
Danish: Diagnose og behandling med dette lægemiddel skal indledes og overvåges af læger med tilstrækkelig erfaring inden for diagnosticering og håndtering af patienter med GHD.
English: Somatropin Biopartners has given rise to the formation of antibodies in approximately 4% of adult patients.
Danish: Somatropin Biopartners har ført til dannelse af antistoffer hos ca. 4% af voksne patienter.
English: It is recommended that a maximum injection volume of 1 mL per injection site, corresponding to a dose of 20 mg of somatropin, should not be exceeded.
Danish: Det anbefales ikke at overskride en maksimal injektionsvolumen på 1 ml pr. injektionssted, svarende til en dosis på 20 mg somatropin.
English: After accidental intramuscular injection, hypoglycaemia may occur.
Danish: Efter en utilsigtet intramuskulær injektion kan der opstå hypoglykæmi.
English: There have been reports of sleep apnoea and sudden death after initiating growth hormone therapy in patients with Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Danish: Der er rapporteret om søvnapnø og pludseligt dødsfald efter påbegyndt væksthormonbehandling hos patienter med Prader-Willi syndrom, som havde en eller flere af følgende risikofaktorer: svær fedme, kendt øvre luftvejsobstruktion eller søvnapnø, eller uidentificeret luftvejsinfektion.
English: The generation of such antibodies with low binding activity is unlikely to be clinically relevant.
Danish: Det er usandsynligt, at dannelsen af sådanne antistoffer med lav bindingsevne har nogen klinisk relevant.
English: For children heavier than 40 kg, two vials (a 10 mg and a 20 mg vial or two vials of 20 mg) can be used according to the body weight as indicated in the table below.
Danish: Hos børn, der vejer over 40 kg, kan der anvendes to hætteglas (et hætteglas med 10 mg og et hætteglas med 20 mg eller to hætteglas med 20 mg) i henhold til legemsvægten angivet i nedenstående tabel.
English: Dosage reductions may be necessary: - in patients above 60 years of age - in patients who develop long lasting tissue swelling caused by fluid retention or who develop abnormal sensations such as prickling, tingling and itchiness - to avoid the development of carpal tunnel syndrome, where the nerve running through the wrist
Danish: Dosisreduktioner kan være nødvendige: - hos patienter over 60 år - hos patienter, der får langvarig vævshævelse forårsaget af væskeophobning eller der får unormale fornemmelser, f.eks. prikken, snurren og kløe - for at undgå udvikling af karpaltunnelsyndrom, hvor nerven, der løber gennem håndleddet
English: Growth hormone increases the extrathyroidal conversion of thyroxin (T4) to triiodothyronine (T3) and may unmask central hypothyroidism.
Danish: Væksthormon øger den ekstrathyroidale omdannelse af thyroxin (T4) til triiodothyronin (T3) og kan afsløre central hypothyroidisme.
English: Non-clinical pharmacokinetic and pharmacodynamic studies in dogs and juvenile monkeys showed that Somatropin Biopartners released recombinant hGH in a prolonged manner and increased serum IGF-I for an extended period up to 5-6 days.
Danish: Prækliniske farmakokinetiske og farmakodynamiske studier hos hunde og unge aber viste, at Somatropin Biopartners frigav rekombinant hGH over længere tid og øgede serum IGF-I i en længere periode op til 5-6 dage.
English: It is therefore crucial to assess baseline and stress doses of glucocorticoids which may need to be adjusted when growth hormone therapy is initiated.
Danish: Det er derfor kritisk at vurdere udgangsværdien og stressdoser af glukokortikoider, der muligvis skal justeres, når behandling med væksthormoner iværksættes.
English: Doses in excess of human therapeutic doses have shown adverse effects on reproductive function in male and female rats and male dogs, possibly through disruption of hormonal regulation.
Danish: Doser over human-terapeutiske doser har påvist bivirkninger på den reproduktive funktion hos han- og hunrotter og hanhunde, muligvis gennem forstyrrelse af hormonreguleringen.
English: From reproductive toxicity studies performed with other somatropin products there is no evidence of an increased risk of adverse reactions to the embryo or foetus.
Danish: Baseret på dyreforsøg om reproduktionstoksicitet med andre somatropin-holdige lægemidler er der ingen tegn på øget risiko for bivirkninger for embryoet eller fostret.
English: Adults with childhood-onset of GHD
Danish: Voksne med GHD med debut i barndommen
English: This pivotal phase III study comprised 151 adult patients with GHD of adult- or childhood-onset and lasted 6 months.
Danish: Dette pivotale fase III-studie bestod af 151 voksne patienter med GHD med debut i voksenalderen eller i barndommen og varede 6 måneder.
English: Somatropin may induce insulin resistance.
Danish: Somatropin kan forårsage insulinresistens.
English: Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein (HDL)-cholesterols, and decreases total plasma cholesterol.
Danish: Somatropin stimulerer lipidmetabolismen, øger fedtsyrer i plasma og HDL-kolesteroler og reducerer det totale plasmakolesterol.
English: Common: Conjunctivitis, visual acuity reduced
Danish: Almindelig: Conjunctivitis, nedsat syn
English: Common: Hypercortisolism (7.7%), hypothyroidism (2.2%), adrenal cortical insufficiency (3.3%), hypothyreosis secondary to TSH deficiency (2.6%), decreased free thyroxine (4.4%), increased blood TSH (2.2%)
Danish: Almindelig: Hyperkortisolisme (7,7%), hypothyroidisme (2,2%), binyreinsufficiens (3,3%), hypothyreose sekundært til TSH-mangel (2,6%), nedsat frit thyroxin (4,4%), øget TSH i blodet (2,2%)
English: The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data):
Danish: Hyppigheden af bivirkningerne herunder er angivet efter følgende regler: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
English: Patients taking insulin for diabetes mellitus should be carefully monitored during treatment with somatropin.
Danish: Patienter, som tager insulin for diabetes mellitus, bør monitoreres nøje under behandlingen med somatropin.
English: Any suspension remaining after the injection should
Danish: Eventuel resterende suspension efter injektionen skal bortskaffes.
English: Long term carcinogenicity studies with Somatropin Biopartners have not been conducted.
Danish: Der er ikke udført langtidsstudier af carcinogenicitet med Somatropin Biopartners.
English: Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like growth factor-I (IGF-I) concentrations (< -2 standard deviation score (SDS)), who may be considered for one test.
Danish: Debut i barndommen: Hos patienter med isoleret GHD med debut i barndommen (ingen tegn på hypothalamisk-hypofysær sygdom eller kraniel bestråling), bør to dynamiske tests anbefales, undtagen hos patienter med lave insulinlignende vækstfaktor-I (IGF-I)-koncentrationer (< -2 standardafvigelsesscore (SDS)), som kan komme i betragtning til én test. Cut-off point for den dynamiske test skal være nøjagtigt.
English: Your doctor will stop your treatment with this medicine if there is evidence of cancerous growth; - if you are a child that has already stopped growing; - if you are ill due to a serious heart or stomach operation; - if you are being treated for more than one injury following a serious accident; - if you experience sudden serious breathing problems.
Danish: Din læge vil standse behandlingen med denne medicin, hvis der er tegn på kræftspredning; - hvis du er et barn, der allerede er holdt op med at vokse; - hvis du er syg på grund af en alvorlig hjerte- eller maveoperation; - hvis du er i behandling for mere end en kvæstelse efter et alvorligt uheld; - hvis du får pludselige og alvorlige vejrtrækningsproblemer.
English: Clean the rubber stopper of both vials with an alcohol swab (figure 3b).
Danish: Rengør gummiproppen på begge hætteglas med en spritserviet (figur 3b).
English: Uncommon, may affect up to 1 in 100 people - enlargement of the male breast
Danish: Ikke almindelig, kan påvirke op til 1 ud af 100 personer - forstørrelse af det mandlige bryst
English: Side effects were generally transient and mild to moderate.
Danish: Bivirkningerne var generelt forbigående og milde til moderate i sværhedsgrad.
English: The recommended dose is 0.5 mg of somatropin per kilogram of body weight injected once a week.
Danish: Den anbefalede dosis er 0,5 mg somatropin pr. kg legemsvægt injiceret én gang ugentligt.
English: The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data):
Danish: Hyppigheden af bivirkningerne herunder er angivet efter følgende regler: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
English: Common: Hypertension,increased blood pressure
Danish: Almindelig: Hypertension, højt blodtryk
English: Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with growth hormone deficiency (GHD).
Danish: Diagnose og behandling med dette lægemiddel skal indledes og overvåges af læger med tilstrækkelig erfaring inden for diagnosticering og håndtering af patienter med væksthormonmangel (GHD).
English: Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Danish: Patienter med diabetes, glukoseintolerans eller andre risikofaktorer for diabetes skal monitoreres nøje under somatropin-behandlingen.
English: Somatropin has no or negligible influence on the ability to drive and use machines.
Danish: Somatropin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Injecting the suspension
Danish: Injektion af suspensionen
English: However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Danish: Der er dog intet der tyder på, at hyppigheden af leukæmi er højere hos væksthormon-patienter, der ikke er prædisponerede.
English: A baseline scan is recommended in these patients before instituting growth hormone replacement therapy.
Danish: En baselinescanning anbefales hos disse patienter inden iværksættelse af substitutionsbehandling med væksthormon.
English: Common: injection site pain (9.9%), injection site discolouration (8.8%), injection site erythema (7.7%), injection site nodule (4.4%), injection site reaction (1.1%), injection site warmth (1.1%), pyrexia (2.6%), oedema (local and generalised)*
Danish: Meget almindelig: Hævelse på injektionsstedet (30,8%) Almindelig: Smerte på injektionsstedet (9,9%), misfarvning af injektionsstedet (8,8%), erytem på injektionsstedet (7,7%), nodul på injektionsstedet (4,4%), reaktion på injektionsstedet (1,1%), varme på injektionsstedet (1,1%), pyreksi (2,6%), ødem (lokalt og generaliseret)*
English: Patients receiving concomitant glucocorticoid therapy should have their dose carefully adjusted to avoid an inhibitory effect on growth.
Danish: Patienter i samtidig glukokortikoidbehandling bør have deres dosis nøje justeret for at undgå en hæmmende virkning på vækst.
English: In women taking oral oestrogens, a higher dose of somatropin may be required to achieve the treatment goal, see section 4.2.
Danish: Hos kvinder, som tager østrogen oralt, kan det være nødvendigt at øge dosen af somatropin for at nå behandlingsmålet, se pkt.
English: In patients with an already manifest diabetes mellitus, the anti-diabetic therapy might require adjustment when somatropin treatment is initiated.
Danish: Hos patienter med en allerede tydelig diabetes mellitus, kan det være nødvendigt at justere den antidiabetiske behandling, når somatropin-behandlingen iværksættes.
English: The recommended starting dose is 2 mg of somatropin injected once a week.
Danish: Den anbefalede startdosis er 2 mg somatropin injiceret en gang ugentligt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, d.v.s. den er i det væsentlige ‘natriumfri'.
English: This means that after preparation, the suspension is injected with a short needle into the fatty skin tissue.
Danish: Det betyder, at suspensionen injiceres med en kort nål i fedtvævet efter tilberedningen.
English: Treatment with growth hormone may facilitate the development of adrenal insufficiency and potentially fatal adrenal crises in patients with organic GHD or idiopathic panhypopituitarism.
Danish: Behandling med væksthormon kan lette udviklingen af binyreinsufficiens og potentielt dødelige binyrekriser hos patienter med organisk GHD eller idiopatisk nedsat hypofysefunktion.
English: The amino acid sequence of the active substance is identical to that of hGH of pituitary origin.
Danish: Det aktive stofs aminosyresekvens er identisk med hGH af hypofysær oprindelse.
English: - You must have regular thyroid function tests as this medicine can affect the amount of thyroid
Danish: - Du skal have regelmæssige tests af skjoldbruskkirtelfunktionen, da denne medicin kan påvirke mængden af skjoldbruskkirtelhormon i blodet.
English: * Each vial contains an overfill of somatropin powder to allow the withdrawal of the required amount of somatropin when reconstituted (see section 6.6).
Danish: * Hvert hætteglas indeholder en overfyldning af somatropinpulver, hvilket tillader udtrækning af den nødvendige mængde somatropin efter rekonstitution (se punkt 6.6).
English: Paediatric patients with endocrine disorders, including GHD, may develop slipped capital femoral epiphyses more frequently.
Danish: Hos pædiatriske patienter med endokrine forstyrrelser, inklusiv GHD, kan hofteskred forekomme hyppigere end generelt i befolkningen.
English: Clean the injection site with an unused alcohol swab.
Danish: Rengør injektionsstedet med en ubrugt spritserviet.
English: After the injection, wait a few seconds, then quickly withdraw the needle with the plunger still pushed down.
Danish: Vent et par sekunder efter injektionen, og træk dernæst forsigtigt kanylen ud med stemplet stadigvæk trykket i bund.
English: Somatropin Biopartners has given rise to the formation of antibodies in approximately 33% of the paediatric patients.
Danish: Somatropin Biopartners har ført til dannelse af antistoffer hos ca. 33% af pædiatriske patienter.
English: 3 mg (9 IU)
Danish: 3 mg (9 IE)
English: Warm the solvent vial to room temperature by gently rolling it between your hands.
Danish: Opvarm hætteglasset med solvens til stuetemperatur ved at rulle det forsigtigt mellem hænderne.
English: Side effects very commonly reported in adults (may affect more than 1 in 10 people) were tissue swelling due to fluid retention, mild increase in blood sugar and headache.
Danish: Bivirkninger, der forekom hyppigt hos voksne (kan forekomme hos flere end 1 ud af 10 personer) var vævshævelse på grund af væskeretention, mild stigning i blodsukkeret og hovedpine.
English: When adverse reactions occurred, they tended to be transient and severity was generally mild to moderate.
Danish: Når bivirkninger opstod, var de forbigående og sværhedsgraden var generelt mild til moderat.
English: Young adult patients with closed epiphyses who have previously been treated as children for GHD should be re-evaluated for GHD using the criteria for adult patients (see section 4.1) before replacement therapy is commenced at the doses recommended for adults.
Danish: Unge voksne patienter med lukkede epifyser, som tidligere er blevet behandlet som børn for GHD, bør evalueres igen for GHD med anvendelse af kriterierne for voksne patienter (se pkt.
English: The swirling should only be stopped once the suspension appears uniform, white and all the powder on the bottom is dispersed.
Danish: Denne svingende bevægelse bør kun stoppes, når suspensionen ser ensartet ud og er hvid, og alt pulveret i bunden er opløst.
English: For the treatment of children and adolescents aged 2 to 18 years the 10 mg and 20 mg vials of this medicinal product should be used.
Danish: Til behandling af børn og unge i alderen 2-18 år bør der anvendes hætteglas på 10 mg og 20 mg af lægemidlet.
English: Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis.
Danish: Da somatropin øger vækstraten, bør patienter med skoliose i anamnesen, som er i behandling med somatropin, monitoreres for progression af skoliose.
English: The biological effects of somatropin are equivalent to those of hGH of pituitary origin.
Danish: Somatropins biologiske effekt svarer til hGH af hypofysær oprindelse.
English: Clean the rubber stopper again with an unused alcohol swab.
Danish: Rengør gummiproppen igen med en ubrugt spritserviet.
English: Your doctor may need to adjust the dose of Somatropin Biopartners or of the other medicines: - corticosteroids, such as cortisone or prednisolone: medicines to reduce inflammation or immune system activity, to prevent organ transplant rejection or to treat asthma - thyroxine: a medicine to treat reduced thyroid gland function - insulin: a medicine to lower blood sugar levels
Danish: Din læge vil muligvis justere dosis af Somatropin Biopartners eller af den anden medicin: - kortikosteroider, f.eks. kortison eller prednisolon: medicin, der reducerer betændelse eller immunsystemaktivitet, for at forhindre afstødning af organtransplantat eller til behandling af astma - thyroxin: en medicin til behandling af nedsat skjoldbruskkirtelfunktion - insulin: en medicin til at sænke sukkerniveauet i blodet
English: Somatropin therapy has a beneficial effect on body composition in patients with -GHD, in that body fat stores are reduced and lean body mass is increased.
Danish: Somatropin-behandling har en gavnlig virkning på kroppens sammensætning hos patienter med GHD, fordi fedtdepoterne reduceres, og muskelmassen øges.
English: • Periodic safety update reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Very rare, may affect up to 1 in 1,000 people - sleeplessness - enlargement of the male breast
Danish: Meget sjælden, kan påvirke op til 1 ud af 1.000 personer - søvnighed - forstørrelse af det mandlige bryst
English: Adrenal function
Danish: Binyrefunktion
English: Somatropin Biopartners has no or negligible effects on the ability to drive and use machines.
Danish: Somatropin Biopartners påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Long-term therapy in growth hormone-deficient patients increases bone mineral density.
Danish: Langvarig behandling af patienter med væksthormonmangel øger knoglemineraldensiteten.
English: Special populations
Danish: Særlige populationer Ældre personer
English: Common: Increased blood phosphorus, increased or decreased IGF Description of selected adverse reactions
Danish: Almindelig: Øget fosfor i blodet, nedsat eller øget IGF Beskrivelse af udvalgte bivirkninger
English: Due to the prolonged-release characteristics of this medicinal product peak levels of growth hormone can be expected approximately 15 hours after injection, see section 5.2.
Danish: Topniveauer af væksthormonet kan forventes ca. 15 timer efter injektionen på grund af dette lægemiddels depotkarakteristika, se pkt.