FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.
Danish: Dosis bør øges eller nedsættes gradvist i overensstemmelse med patientens behov, bestemt af IGF-I-koncentrationen.
English: The treatment should be discontinued at renal transplantation.
Danish: Behandlingen bør afbrydes ved nyretransplantation.
English: Somatropin stimulates the turnover of skeletal bone.
Danish: Somatropin stimulerer knogleomsætningen.
English: Pack sizes of 1, 5 and 10.
Danish: Pakningsstørrelser: 1, 5 og 10.
English: In patients above 60 years, therapy should start with a dose of 0.1 - 0.2 mg per day and should be slowly increased according to individual patient requirements.
Danish: Hos patienter over 60 år bør behandling starte med en dosis på 0,1 - 0,2 mg dagligt, der langsomt øges i overensstemmelse med individuelle patientbehov.
English: Solvent: water for injections
Danish: Solvens: vand til injektionsvæsker
English: In another study with somatropin, no increase in chromosomal abnormalities was found in the lymphocytes of patients who had received long-term somatropin therapy.
Danish: I et andet studie med somatropin fandtes kromosomforandringer i lymfocytterne ikke hyppigere hos patienter, som havde været i langtidsbehandling med somatropin.
English: Each vial must be reconstituted with the accompanying solvent only.
Danish: Hvert hætteglas skal rekonstitueres udelukkende med den medfølgende opløsning.
English: - The residual solution, vials, and injection materials intended for single use must be discarded.
Danish: Resten af opløsning, hætteglas og injektionsmateriale beregnet til engangsbrug skal kasseres.
English: Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins.
Danish: Somatropin er et potent stofskiftehormon med betydning for fedt-, kulhydrat- og proteinmetabolismen.
English: Omnitrope is a clear and colourless solution for injection.
Danish: Omnitrope er en klar og farveløs injektionsvæske, opløsning.
English: In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required.
Danish: Hos patienter, som behandles med somatropin, kan hidtil ikkediagnosticeret central (sekundær) hypoadrenalisme afsløres, og det kan være nødvendigt med substitutionsbehandling med glukokortikoid.
English: If you continue Omnitrope after treatment during childhood you should start with 0.2-0.5 mg per day.
Danish: Hvis du fortsætter med Omnitrope efter behandling i barndommen, skal du starte med 0,2-0,5 mg dagligt.
English: ≥ 1/100 to
Danish: Almindelig ≥ 1/100 til
English: Indication mg/kg body weight dose per day mg/m² body surface area dose per day
Danish: Indikation mg/kg kropsvægt pr. dag mg/m² legemsoverflade pr. dag
English: Remove the pen needle and dispose of it in accordance with local requirements.
Danish: Fjern kanylen til pen og bortskaf i henhold til lokale retningslinjer.
English: Clinical trials in adults with GHD
Danish: Kliniske studier hos voksne med GHD
English: - After reconstitution, Omnitrope is given as an injection under the skin.
Danish: - Efter tilberedning gives Omnitrope som en injektion under huden.
English: - Insert the needle into the skin in the way your doctor has taught you.
Danish: - Stik nålen i huden, som du har lært det.
English: • If you have raised intracranial pressure (which causes symptoms, such as strong headache, visual disturbances or vomiting) you should inform your doctor about it.
Danish: • Hvis du har øget tryk i hjernen (som forårsager symptomer som kraftig hovedpine, synsforstyrrelser eller opkastning), skal du fortælle det til lægen.
English: Administer the appropriate dose by subcutaneous injection using a sterile pen needle.
Danish: 10. Administrer den passende dosis ved subkutan injektion ved brug af en steril nål til pen.
English: • Water retention (which shows as puffy fingers or swollen ankles)
Danish: • Væskeophobning (viser sig som opsvulmede fingre eller hævede ankler)
English: Follow the instructions that come with the transfer set.
Danish: Følg instruktionen for overførselssættet.
English: In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.
Danish: Hos patienter, der har overlevet børnecancer, er der blevet rapporteret om en øget risiko for sekundære tumorer, hvis de blev behandlet med somatropin efter den første neoplasme.
English: Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth.
Danish: Patienter med væksthormonmangel, der starter i barndommen, bør reevalueres for sekretorisk kapacitet af væksthormon, efter den longitudinale vækst er afsluttet.
English: • If you walk with a limp or if you start to limp during your growth hormone treatment, you should inform your doctor.
Danish: • Hvis du halter eller begynder at halte under behandlingen med væksthormon, skal du fortælle det til lægen.
English: In patients who continue growth hormone therapy after childhood GHD, the recommended dose to restart is 0.2 - 0.5 mg per day.
Danish: Hos patienter, som fortsætter behandlingen med væksthormon efter væksthormonmangel i barndommen, er den anbefalede dosis til genstart 0,2-0,5 mg dagligt.
English: What Omnitrope contains
Danish: Omnitrope indeholder
English: Growth hormone deficient adult patients
Danish: Væksthormonmangel hos voksne patienter
English: Elderly patients may be more sensitive to the action of Omnitrope, and therefore may be more prone to develop adverse reactions.
Danish: Ældre patienter kan være mere følsomme for virkningen af Omnitrope, og derfor kan de have en større tendens til at udvikle bivirkninger.
English: Clinical trials in children with SGA
Danish: Kliniske studier hos børn med SGA
English: Rarely, an inflammation of the pancreas has been reported in patients treated with growth hormone.
Danish: Der er i sjældne tilfælde blevet rapporteret betændelse i bugspytkirtlen hos patienter i behandling med væksthormon.
English: In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/kg body weight per day have been used for treatment until final height is reached.
Danish: I kliniske studier med SGA-børn/unge med lav højde har doser på 0,033 og 0,067 mg/kg/dag været anvendt, indtil sluthøjde er opnået.
English: The top of the vials should be wiped with an antiseptic solution to prevent contamination of the contents.
Danish: Toppen af hætteglassene bør aftørres med en antiseptisk opløsning for at undgå kontaminering af indholdet.
English: Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
Danish: I tilfælde, hvor væksthormonmangel, der starter i barndommen, varer ved i puberteten, skal behandlingen fortsættes for at opnå fuldstændig somatisk udvikling (f.eks. kropssammensætning, knoglemasse).
English: After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel.
Danish: Når nålen er inde, kan du fjerne hånden, som du holdt huden med, og bruge den til at holde injektionssprøjtens cylinder med.
English: • Store in the original package in order to protect from light.
Danish: • Opbevares i den originale yderpakning for at beskytte mod lys.
English: Solution for injection in a cartridge for SurePal 5, SurePal 10, SurePal 15.
Danish: Injektionsvæske, opløsning i en cylinderampul til SurePal 5, SurePal 10, SurePal 15.
English: Before initiation of treatment with somatropin patients with PWS should be evaluated for upper airway obstruction, sleep apnoea or respiratory infections should be assessed.
Danish: Før somatropin-behandling påbegyndes bør patienter med PWS undersøges for tegn på øvre luftvejsobstruktion, søvnapnø eller luftvejsinfektioner.
English: Use only with Omnitrope Pen 5.
Danish: Må kun anvendes med Omnitrope Pen 5.
English: Use only with Omnitrope Pen 10.
Danish: Må kun anvendes med Omnitrope Pen 10.
English: - Be sure that the tip of the syringe is in the Omnitrope reconstituted solution.
Danish: Vær sikker på, at spidsen af nålen er i den færdigblandede opløsning med Omnitrope.
English: Clinical trials in children with Turner syndrome Table 2
Danish: Kliniske studier hos børn med Turners syndrom Tabel 2
English: In addition, patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses, following initiation of somatropin treatment (see section 4.5).
Danish: Derudover kan patienter i substitutionsbehandling med glukokortikoid mod tidligere diagnosticeret hypoadrenalisme have behov for en dosisøgning af deres vedligeholdelses- eller stressdosis efter indledning af behandling med somatropin (se pkt.
English: If during treatment with somatropin patients show signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted, and a new ENT assessment performed.
Danish: Hvis patienterne viser tegn på øvre luftvejsobstruktion (herunder øget tendens til at snorke) under behandling med somatropin, bør behandlingen afbrydes og en ny øre-næse-halsvurdering bør udføres.
English: - Check for air bubbles in the syringe.
Danish: Kontroller for luftbobler i injektionssprøjten.
English: • and tell your doctor if you have an active tumour (cancer).
Danish: • hvis du har aktive svulster (kræft).
English: In adults Omnitrope is used to
Danish: Hos voksne anvendes Omnitrope til at:
English: Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected.
Danish: Søvnapnø skal vurderes ved brug af anerkendte metoder, som fx polysomnografi eller oximetri natten over, før behandling med væksthormon påbegyndes, og monitoreres, hvis der er mistanke om søvnapnø.
English: Do not use Omnitrope
Danish: Brug ikke Omnitrope
English: Musculoskeletal stiffness*
Danish: Muskuloskeletal stivhed*
English: • thyroid hormones,
Danish: • Skjoldbruskkirtelhormoner,
English: Clean the injection site with an alcohol swab and administer Omnitrope by subcutaneous injection.
Danish: Rens injektionsstedet med en desinficerende serviet og administrer Omnitrope ved subkutan injektion.
English: In addition, patients already receiving glucocorticoid replacement therapy may need to have the dose of their replacement therapy adjusted, after somatropin treatment is initiated.
Danish: Derudover kan det være nødvendigt for patienter, som allerede får substitutionsbehandling med glukokortikoid, at få justeret dosis af deres substitutionsbehandling efter indledning af behandling med somatropin.
English: Common to < 1/10
Danish: Ikke almindelig til < 1/100
English: - Before you make an injection, clean your skin well with an alcohol swab.
Danish: Inden du foretager en injektion, skal du rense huden med en desinficerende serviet.
English: Use only with Omnitrope Pen L. Read package leaflet before use.
Danish: Må kun anvendes med Omnitrope Pen L. Læs indlægssedlen inden brug.
English: Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.
Danish: De hyppigste sekundære tumorer var intrakranielle tumorer, især meningiomer, hos patienter, der fik strålebehandling i hovedet for deres første neoplasme.
English: Arthralgia* Myalgia*
Danish: Artralgi* Myalgi*
English: Prader-Willi syndrome
Danish: Prader-Willis syndrom
English: The top of the vial and of the cartridge should be wiped with an antiseptic solution in order to prevent contamination of the contents.
Danish: Toppen af hætteglasset og patronen bør aftørres med en antiseptisk opløsning for at undgå kontaminering af indholdet.
English: In SGA children/adolescents it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter.
Danish: Det anbefales, at SGA-børn/unge får målt deres fasteinsulin og blodsukker inden behandlingsstart og derefter årligt.
English: The reconstituted solution should be administered using sterile, disposable syringes.
Danish: Den rekonstituerede opløsning bør administreres ved brug af sterile engangssprøjter.
English: • During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
Danish: • Under behandlingen skal du fortælle lægen, hvis du får en lungeinfektion, så infektionen kan behandles.
English: Adults - Replacement therapy in adults with pronounced growth hormone deficiency.
Danish: Voksne - Erstatningsterapi hos voksne med udtalt væksthormonmangel.
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of 1.3 mg powder
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 1 hætteglas med 1,3 mg pulver
English: • For single use only.
Danish: • Kun til engangsbrug.
English: • medicines to control epilepsy (anticonvulsants),
Danish: • Medicin til behandling af epilepsi,
English: Arthralgia*
Danish: Artralgi*
English: If during the evaluation of upper airway obstruction, pathological findings are observed, the child should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the respiratory disorder prior to initiating growth hormone treatment.
Danish: Hvis der observeres patologiske fund under evalueringen af øvre luftvejsobstruktion, bør barnet henvises til en øre-næse-halsspecialist for behandling og afklaring af luftvejslidelsen før behandling med væksthormon påbegyndes.
English: Intracranial tumours must be inactive and anti-tumour therapy must be completed prior to starting GH therapy.
Danish: Intrakranielle tumorer skal være inaktive, og antitumorbehandlingen skal være afsluttet, før væksthormonbehandling iværksættes.
English: - Growth disturbance associated with chronic renal insufficiency.
Danish: - Vækstforstyrrelse forbundet med kronisk nedsat nyrefunktion.
English: The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
Danish: Injektionen skal gives subkutant på forskellige steder for at undgå lipoatrofi.
English: Shelf life after first use
Danish: Opbevaringstid efter første brug
English: The incidence of these adverse effects is related to the administered dose, the age of the patients, and possibly inversely related to the age of the patients at the onset of growth hormone deficiency.
Danish: Forekomsten af disse bivirkninger er relateret til den administrerede dosis, patienternes alder og muligvis omvendt relateret til patienternes alder, når væksthormonmanglen sætter ind.
English: • Temporary reddening, itchiness or pain at the injection site
Danish: • Forbigående rødme, kløe eller smerter på injektionsstedet
English: The following instructions explain how to inject Omnitrope yourself.
Danish: Den følgende instruktion forklarer, hvordan du selv injicerer Omnitrope.
English: ‡ Clinical significance is unknown
Danish: ‡ Den kliniske signifikans er ikke kendt.
English: • Increased intracranial pressure (which causes symptoms such as strong headache, visual disturbances or vomiting)
Danish: • Øget tryk i hjernen (forårsager symptomer såsom kraftig hovedpine, synsforstyrrelser eller opkastning)
English: If the solution is cloudy or contains particulate matter, it should not be used.
Danish: Hvis opløsningen er uklar eller indeholder partikler, bør den ikke anvendes.
English: Somatropin induces the retention of sodium, potassium and phosphorus.
Danish: Somatropin inducerer natrium-, kalium- og fosforretention.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Omnitrope (water for injections with 1.5% benzyl alcohol) Subcutaneous use.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Solvens til Omnitrope (vand til injektionsvæsker med 1,5 % benzylalkohol) Til subkutan anvendelse.
English: • Reddening, itchiness or pain at the injection site
Danish: • Rødme, kløe eller smerter på injektionsstedet
English: There have been no clinical studies conducted with somatropin containing products in breast-feeding women.
Danish: Der er ikke udført kliniske studier med somatropin-præparater hos ammende kvinder.
English: Children born small or too light at birth
Danish: Børn født små eller med lav fødselsvægt
English: The maintenance dose in these patients seldom exceeds 0.5 mg per day.
Danish: Vedligeholdelsesdosis hos disse patienter overstiger sjældent 0,5 mg dagligt.
English: Talk to your doctor before using Omnitrope.
Danish: Kontakt lægen, før du bruger Omnitrope
English: It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Danish: Benzylalkohol kan give forgiftningsreaktioner og anafylaktoide reaktioner hos spædbørn og børn op til 3 år.
English: Long-term treatment and improvement of body composition of children with growth disturbance due to Prader-Willi syndrome
Danish: Langvarig behandling og forbedring af kropssammensætning hos børn med vækstforstyrrelse pga. Prader-Willis syndrom
English: Powder and solvent for solution for injection (powder in a vial (1.3 mg), solvent in a vial (1 ml)).
Danish: Pulver og solvens til injektionsvæske (pulver i et hætteglas (1,3 mg), solvens i et hætteglas (1 ml)).
English: The content must be clear and colourless after reconstitution.
Danish: Indholdet skal være klart og farveløst efter rekonstitution.
English: Omnitrope 5 mg/ml is supplied in a vial containing the active substance as a powder and the solvent filled in a cartridge.
Danish: Omnitrope 5 mg/ml leveres i et hætteglas indeholdende det aktive indholdsstof som pulver samt solvens i en patron.
English: Clinical trials in children with Turner syndrome
Danish: Kliniske studier hos børn med Turners syndrom
English: - With one hand, pitch a fold of loose skin.
Danish: Lav en fold med løs hud med den ene hånd.
English: - Turn the vial with the solvent upside down and withdraw all the solvent from the vial.
Danish: Vend bunden i vejret på hætteglasset med solvens og træk hele mængden af solvens ud af hætteglasset.
English: The solution is for single use only.
Danish: Opløsningen er udelukkende til engangsbrug.
English: • If you are receiving treatment with thyroid hormones it may become necessary to adjust your thyroid hormone dose.
Danish: • Hvis du får behandling med skjoldbruskkirtelhormoner, kan det blive nødvendigt at justere din dosis af skjoldbruskkirtelhormon.
English: Children with growth hormone deficiency:
Danish: Børn med væksthormonmangel:
English: To setup the pen dial the dose.
Danish: For at klargøre pennen, drejes dosen.
English: For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin therapy is instituted.
Danish: Hos patienter med diabetes mellitus kan justering af insulindosis være nødvendig, når somatropinterapi påbegyndes.
English: This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects.
Danish: Denne dosis skal øges eller reduceres gradvist i henhold til blodprøveresultater samt efter, hvordan medicinen virker, og hvilke bivirkninger du får.
English: Solution for injection.
Danish: Efter injektion
English: Conversely, if a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be reduced to avoid excess of growth hormone and/or side effects (see section 4.5).
Danish: Omvendt kan det være nødvendigt at reducere dosis af somatropin, hvis en kvinde, som tager somatropin, stopper med oral østrogenbehandling, for at undgå for meget væksthormon og/eller bivirkninger (se pkt.
English: Use only with SurePal 10.
Danish: Må kun anvendes med SurePal 10.
English: - If the solution is cloudy (and the cloudiness does not disappear within ten minutes) or contains particles, it should not be used.
Danish: Hvis opløsningen er uklar (og den ikke bliver klar indenfor 10 minutter) eller indeholder partikler, må den ikke bruges.
English: The manufacturer's instructions with each individual transfer set and pen must be followed for reconstituting Omnitrope 5 mg/ml powder for solution for injection, loading the cartridge, attaching the injection needle and for the administration.
Danish: Fremstillerens instruktioner, som følger med hvert enkelt overførselssæt og pen skal følges ved rekonstitution af Omnitrope 5 mg/ml pulver til injektionsvæske, når patronen påfyldes blandingen, ved påsætning af injektionsnålen og ved administration.
English: Powder and solvent for solution for injection (powder in a vial (5 mg), solvent in a cartridge (1 ml)) Pack sizes of 1 and 5.
Danish: Pulver og solvens til injektionsvæske (pulver i et hætteglas (5 mg), solvens i en cylinderampul (1 ml)) Pakningsstørrelser: 1 og 5.
English: Growth disturbance in short children/adolescents born small for gestational age (SGA) A dose of 0.035 mg/kg body weight per day (1 mg/m2 body surface area per day) is usually recommended until final height is reached (see section 5.1).
Danish: Vækstforstyrrelse hos børn/unge med lav højde født små i forhold til deres gestationsalder (SGA) En dosis på 0,035 mg/kg kropsvægt pr. dag (1 mg/m2 legemsoverflade pr. dag) anbefales normalt indtil sluthøjde er nået (se pkt.
English: Pack sizes of 1 and 5.
Danish: Pakningsstørrelser: 1 og 5
English: - a pen needle for subcutaneous injection.
Danish: - En pennenål til subkutan injektion.
English: However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Danish: Det er imidlertid ikke bevist, at forekomsten af leukæmi er forøget hos patienter uden prædisponerende faktorer, der får væksthormon.
English: Do not massage the injection site.
Danish: Masser ikke på injektionsstedet.
English: 1 vial of 5 mg powder 1 cartridge of 1 ml solvent 5 vials of 5 mg powder 5 cartridges of 1 ml solvent
Danish: 1 hætteglas med 5 mg pulver 1 cylinderampul med 1 ml solvens 5 hætteglas med 5 mg pulver 5 cylinderampuller med 1 ml solvens
English: Bring the syringe to the correct dose needed.
Danish: Anbring stemplet på den korrekte dosis.
English: Somatropin 5 mg (15 IU)/ml in a vial.
Danish: Somatropin 5 mg (15 IE)/ml i et hætteglas.
English: - Take the needle off the pen using the outer needle cap, and discard the needle.
Danish: - Tag nålen af pennen ved at bruge den ydre nålehætte og kasser nålen.
English: If you stop using Omnitrope
Danish: Hvis du holder op med at bruge Omnitrope
English: - a vial with solvent (liquid) for Omnitrope 1.3 mg/ml.
Danish: Et hætteglas med solvens (opløsningsmiddel) til Omnitrope 1,3 mg/ml.
English: In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Danish: generel toksicitet, lokal tolerance og reproduktionstoksicitet er der ikke observeret klinisk relevante effekter.
English: In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant effects have been observed.
Danish: subakut toksicitet og lokal tolerance er der ikke observeret kliniske relevante effekter.
English: Omnitrope 5 mg/1.5 ml solution for injection: One ml contains 9 mg benzyl alcohol.
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning: 1 ml indeholder 9 mg benzylalkohol.
English: Always use this medicine exactly as your doctor or pharmacist or nurse has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.
Danish: Patienter og plejepersonale skal modtage passende undervisning og instruktioner fra læger eller andet kvalificeret sundhedspersonale i korrekt anvendelse af Omnitrope cylinderampullerne og pennen.
English: If you forget to use Omnitrope
Danish: Hvis du har glemt at bruge Omnitrope
English: Arthralgia* Myalgia* Musculoskeletal stiffness*
Danish: Artralgi* Myalgi* Muskuloskeletal stivhed*