FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed Hospira is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Pemetrexed Hospira fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: How has Pemetrexed Hospira been studied?
Danish: Hvordan er Pemetrexed Hospira blevet undersøgt?
English: How is Pemetrexed Hospira used?
Danish: Hvordan anvendes Pemetrexed Hospira?
English: How does Pemetrexed Hospira work?
Danish: Hvordan virker Pemetrexed Hospira?
English: Everyone is different.
Danish: Alle er forskellige.
English: Bedtime is a good time because it is easy to remember.
Danish: Ved sengetid er et godt tidspunkt, da det er nemt at huske.
English: Long-term safety data are still limited.
Danish: Langtidssikkerhedsdata er stadig begrænsede.
English: Wash your hands before you continue with the next steps.
Danish: Vask dine hænder, før du fortsætter med næste trin.
English: Hands should be washed.
Danish: Hænderne vaskes.
English: - Use the solution immediately.
Danish: Brug opløsningen straks.
English: This can start during either adult life or it can continue from childhood.
Danish: Dette kan enten starte i løbet af voksenlivet eller fortsætte fra barndommen.
English: Acute critical illness
Danish: Akut kritisk sygdom
English: All products:
Danish: Alle produkter:
English: The recommended dose is for:
Danish: Den anbefalede dosis er til:
English: Patients with PWS and one or more of these risk factors may be at greater risk.
Danish: Patienter med PWS og en eller flere af disse risikofaktorer kan være mere udsatte.
English: It is also natural to have a higher level of growth hormone at night.
Danish: Det er også naturligt at have et højere niveau af væksthormon om natten.
English: 10 A-6336 Langkampfen Austria
Danish: 10 A-6336 Langkampfen Østrig
English: You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.
Danish: Du kan ryste, svede, føle dig søvnig eller “ikke dig selv”, og du kan besvime.
English: Your blood sugar level could fall too low and later rise too high.
Danish: Dit blodsukkerniveau kan blive for lavt og senere for højt.
English: This can be tested by your doctor and if necessary your doctor will prescribe the adequate treatment.
Danish: Dette kan undersøges af lægen, og hvis det er nødvendigt, vil din læge ordinere en hensigtsmæssig behandling.
English: If you forget to use a dose, have your next injection at the usual time the next day.
Danish: Hvis du har glemt at bruge en dosis, skal du tage din næste injektion til sædvanlig tid næste dag.
English: Do not attempt to inject unless you are sure you understand the procedure and requirements for the injection.
Danish: Forsøg ikke at injicere, med mindre du er helt sikker på proceduren og kravene for injektionen.
English: Scoliosis may progress in any child during rapid growth.
Danish: Skoliose kan progrediere hos alle børn i hurtig vækst.
English: When treatment with somatropin is started this deficit is rapidly corrected.
Danish: Når behandling med somatropin påbegyndes, korrigeres dette underskud hurtigt.
English: Your other hand will be free to move the plunger.
Danish: Din anden hånd skal være fri til at bevæge stemplet.
English: It also helps your fat and muscle tissues to develop in the right amounts.
Danish: Det hjælper også dit fedt- og muskelvæv til at udvikles i de rette mængder.
English: The diagnosis of PWS should be confirmed by appropriate genetic testing.
Danish: PWS-diagnosen skal bekræftes ved hjælp af passende genetisk test.
English: Contains benzyl alcohol.
Danish: Indeholder benzylalkohol.
English: • ciclosporin (a medicine that weakens the immune system after transplantation),
Danish: • Ciclosporin (medicin, der svækker immunsystemet efter transplantation),
English: It is important to continue treatment until final height is reached.
Danish: Det er vigtigt at fortsætte behandlingen, indtil sluthøjden er nået.
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Danish: DATO FOR ÆNDRING AF TEKSTEN <{MM/ÅÅÅÅ}>
English: It will also stop air going back into the pen and the needle clogging up.
Danish: Det vil også forhindre luft i at trænge tilbage i pennen og nålen i at tilstoppe.
English: Your excessive fat will decrease and your reduced muscle mass will improve.
Danish: Dit overskydende fedt vil reduceres, og din reducerede muskelmasse vil forbedres.
English: Children born smaller or lighter than expected and with growth disturbance:
Danish: Børn født mindre eller med lavere vægt end forventet og med vækstforstyrrelser:
English: Physical capacity
Danish: Fysisk kapacitet
English: Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
Danish: Kvinder kan have behov for højere doser end mænd, hvor mænd viser en stigende IGF-I-følsomhed med tiden.
English: • Treatment should be continued until you have stopped growing.
Danish: • Behandlingen bør fortsætte, indtil du er færdig med at vokse.
English: A decrease in peripheral vascular resistance may contribute to this effect.
Danish: Et fald i den perifere karmodstand kan bidrage til denne virkning.
English: It should be reconstituted with a transfer set as recommended in the information provided with the transfer set.
Danish: Det skal rekonstitueres med et overførselssæt som anbefalet i informationen, som følger med overførselssættet.
English: Turner syndrome is a genetic disorder in girls that can affect growth - your doctor will have told you if you have this.
Danish: Turners syndrom er en genetisk sygdom hos piger, der kan påvirke din vækst - din læge vil have fortalt dig, hvis du lider af det.
English: The following is a general description of the administration process.
Danish: Følgende er en generel beskrivelse af fremgangsmåden ved administration.
English: You should not use Omnitrope if you are pregnant or trying to become pregnant.
Danish: Du må ikke tage Omnitrope, hvis du er gravid eller forsøger at blive gravid.
English: Do not shake; this may cause denaturation of the active substance.
Danish: Må ikke rystes, da det kan forårsage denaturering af det aktive stof.
English: • If you are not growing properly and you do not have enough of your own growth hormone.
Danish: • Hvis du ikke vokser nok, og du ikke selv danner tilstrækkeligt meget væksthormon.
English: Growth hormone can help you grow taller if you have not been able to catch up or maintain normal growth by 4 years of age or later.
Danish: Væksthormon kan hjælpe dig med at vokse, hvis du ikke har været i stand til at indhente eller opretholde den normale vækst ved 4-års alderen eller senere.
English: Inject your growth hormone at about the same time every day.
Danish: Injicer dit væksthormon på ca. samme tidspunkt hver dag.
English: In children • Stiffness in the arms and legs
Danish: Hos børn • Stivhed i arme og ben
English: It has the same structure as natural human growth hormone which is needed for bones and muscles to grow.
Danish: Det har den samme struktur som naturligt humant væksthormon, som er nødvendigt, for at knogler og muskler kan vokse.
English: Follow the instructions given to you by your doctor.
Danish: Følg de instruktioner, du får af lægen.
English: However, no link has been made between these cases and treatment with Omnitrope.
Danish: Der er imidlertid ikke fastlagt nogen forbindelse mellem disse tilfælde og behandlingen med Omnitrope.
English: The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in a different place each time.
Danish: Huden omkring injektionsstedet kan blive ujævn, men det burde ikke ske, hvis du injicerer på forskellige steder hver gang.
English: Do not change the dosage and treatment schedule without consulting your doctor.
Danish: Du må ikke ændre dosis eller behandlingsplan uden at kontakte lægen.
English: Instructions for Use provided with SurePal).
Danish: Se instruktioner for brug, som leveres med SurePal).
English: This gives your skin and the area under your skin time to recover from one injection before it gets another one in the same place.
Danish: Dette giver huden og området under huden tid til at komme sig efter en injektion, før der gives en til på samme sted.
English: The minimum effective dose should be used.
Danish: Den mindste effektive dosis bør anvendes.
English: Date of first authorisation: 12 April 2006 Date of latest renewal: 12 April 2011
Danish: Dato for første markedsføringstilladelse: 12. april 2006 Dato for seneste fornyelse: 12. april 2011
English: As kidneys lose their ability to function normally, this can affect growth.
Danish: Når nyrerne mister evnen til at fungere normalt, kan dette påvirke væksten.
English: - Make sure you inject at least 1 cm from your last injection site and that you change the places where you inject, as you have been taught.
Danish: Vær sikker på, at du injicerer mindst 1 cm fra sidste injektionssted, og at du ændrer sted, som du har lært det.
English: Omnitrope (MAH: Sandoz), Zomacton and associated names (MAH: Ferring), Norditropin and associated names (MAH: Novo Nordisk), Genotropin and associated names (MAH: Pfizer)
Danish: Omnitrope (MAH: Sandoz), Zomacton og associerede navne (MAH: Ferring), Norditropin og associerede navne (MAH: Novo Nordisk), Genotropin og associerede navne (MAH: Pfizer)
English: The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you.
Danish: Dosis afhænger af din størrelse, den sygdom du behandles for, og hvor godt væksthormon virker på dig.
English: Somatropin also increases cardiac output, but the mechanism has yet to be clarified.
Danish: Somatropin øger også hjertets slagvolumen, men mekanismen er endnu ikke klarlagt.
English: Dosage adjustment may be necessary after 6 months of treatment.
Danish: Doseringsjustering kan være nødvendig efter 6 måneders behandling.
English: If you inject much more than you should, contact your doctor or pharmacist as soon as possible.
Danish: Hvis du injicerer meget mere, end du skal, skal du kontakte lægen eller apoteket snarest muligt.
English: • if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of Omnitrope.
Danish: • hvis du er allergisk (overfølsom) over for somatropin eller et af de øvrige indholdsstoffer i Omnitrope.
English: $ Transient injection site reactions in children have been reported.
Danish: $ Forbigående reaktioner på injektionsstedet er blevet rapporteret hos børn.
English: These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency.
Danish: Disse patienter skal gennemgå en passende dynamisk test for at diagnosticere eller udelukke væksthormonmangel.
English: • Your doctor will give you diet restrictions to follow to control your weight.
Danish: • Din læge vil give dig kostmæssige begrænsninger, som du skal følge for at kontrollere din vægt.
English: Based on this information, these types of patients should not be treated with somatropin.
Danish: På baggrund i denne information bør disse patientgrupper ikke behandles med somatropin.
English: Type 2 diabetes mellitus
Danish: Diabetes mellitus type II
English: The binding capacity of these antibodies is low and there is no effect on growth rate.
Danish: Bindingskapaciteten af disse antistoffer er lav, og der er ingen virkning på vækstraten.
English: • If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor for specific advice relating to puberty and treatment with this medicine.
Danish: • Hvis du var for lille eller vejede for lidt ved fødslen, og du er mellem 9 og 12 år, skal du spørge lægen om specifik rådgivning angående behandling med denne medicin i puberteten.
English: Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates.
Danish: Behandling bør afbrydes, hvis væksthastigheden er < 2 cm/år, og såfremt bekræftelse er nødvendig, knoglealderen er > 14 år (piger) eller > 16 år (drenge), svarende til lukning af epifyseskiverne.
English: - Prader-Willi syndrome (PWS), for improvement of growth and body composition.
Danish: - Prader-Willis syndrom (PWS), til forbedring af vækst og kropssammensætning.
English: Literature data from untreated SGA children/adolescents without early spontaneous catch-up suggest a late growth of 0.5 SDS.
Danish: Data fra litteraturen om ubehandlede SGA-børn/unge uden tidlig spontan catch-up angiver en sen vækst på 0,5 SDS.
English: Clinical response and side effects may also be used as guidance for dose titration.
Danish: Klinisk respons og bivirkninger kan også bruges som rettesnor for dosistitrering.
English: - Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).
Danish: - Skift injektionssted for at minimere risikoen for lokal lipoatrofi (nedsat mængde fedtlag under huden).
English: • If you were small or too light at birth.
Danish: • Hvis du var lille eller vejede for lidt ved fødslen.
English: You should only be given this medicine by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.
Danish: Du bør kun få denne medicin af en læge med erfaring i behandling med væksthormoner, som har bekræftet din diagnose.
English: Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis.
Danish: Rekonstitution skal udføres i overensstemmelse med reglerne for god praksis, især med hensyn til aseptik.
English: Keep a note of any missed injections and tell your doctor at your next check-up.
Danish: Registrer alle glemte injektioner og fortæl det til lægen ved din næste kontrol.
English: There are no or limited amount of data from the use of somatropin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af somatropin til gravide kvinder.
English: Consequently monitoring of thyroid function should therefore be conducted in all patients.
Danish: Derfor bør thyroideafunktionen monitoreres hos alle patienter.
English: It is recombinant meaning it is not made from human or animal tissue.
Danish: Det er rekombinant, hvilket betyder, at det ikke er dannet fra væv fra mennesker eller dyr.
English: Treatment should be discontinued after the first year if you are not responding or if you have reached your final height and stopped growing.
Danish: Behandlingen bør afsluttes efter det første år, hvis du ikke reagerer på behandlingen, eller hvis du har nået din sluthøjde og er holdt op med at vokse.
English: Long-term overdose could result in signs and symptoms consistent with the known effects of human growth hormone excess.
Danish: Lang tids overdosering kan resultere i tegn og symptomer i overensstemmelse med den kendte virkning af overskud af humant væksthormon.
English: - Pull the needle straight out of the skin.
Danish: Træk nålen lige ud af huden.
English: Omnitrope has no or negligible influence on the ability to drive and use machines.
Danish: Omnitrope påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: However, there is no evidence of an increased risk of leukaemia without predisposition factors, such as radiation to the brain or head.
Danish: Der er imidlertid intet bevis for en øget risiko for leukæmi uden prædisponerende faktorer, såsom strålingbehandling af hjerne eller hoved.
English: Growth hormone will help you grow taller if you are still growing, and will also improve your body composition.
Danish: Væksthormon vil hjælpe dig med at vokse, hvis du stadig vokser, og det vil også forbedre din kropssammensætning.
English: Insert the needle into the pinched skin at an angle of 45° to 90°.
Danish: Sæt nålen i huden med en vinkel på 45°-90°.
English: As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
Danish: Da den normale fysiologiske væksthormonproduktion falder med alderen, kan dosisbehovet mindskes.
English: • If you have Turner syndrome.
Danish: • Hvis du har Turners syndrom.
English: • After reconstitution, from a microbiological point of view, the product should be used immediately.
Danish: • Produktet skal, ud fra et mikrobiologisk synspunkt, bruges straks efter rekonstitution.
English: If on repeated measurements IGF-I levels exceed +2 SD compared to references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to consider dose adjustment.
Danish: Hvis IGF-I-niveauet ved gentagne målinger overstiger +2 SD, sammenlignet med referencen for alder og pubertetsstatus, kan IGF-I/IGFBP-3 forholdet tages i betragtning ved overvejelse af dosisjustering.
English: In children Omnitrope is used to treat the following growth disturbances:
Danish: Hos børn anvendes Omnitrope til at behandle følgende vækstforstyrrelser:
English: In particular, inform your doctor if you are taking or have recently taken any of the following medicines.
Danish: Det er særlig vigtigt, at du fortæller lægen, hvis du tager eller for nylig har taget nogle af følgende lægemidler.
English: - The solution should be clear after removal from the refrigerator.
Danish: Opløsningen skal være klar efter fjernelse fra køleskabet.
English: Omnitrope is a recombinant human growth hormone (also called somatropin).
Danish: Omnitrope er rekombinant humant væksthormon (også kaldet somatropin).
English: All patients with PWS should have effective weight control before and during growth hormone treatment.
Danish: Alle patienter med PWS bør underlægges effektiv vægtkontrol før og under behandlingen med væksthormon.
English: Both are rapidly increased after treatment with somatropin.
Danish: Begge øges hurtigt efter somatropinbehandling.
English: Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or incomplete.
Danish: Information om somatropins farmakokinetik i geriatriske og pædiatriske populationer, hos forskellige racer og hos patienter med nyre-, lever- eller hjerteinsufficiens er enten ufuldstændig eller mangler.
English: This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated.
Danish: Dette medfører en risiko for, at kvinder er underbehandlede, især kvinder i oral østrogenerstatningsbehandling, mens mænd er overbehandlede.
English: Treatment should not be used in children who have almost stopped growing after puberty.
Danish: Behandlingen bør ikke anvendes til børn, som næsten er færdige med at vokse efter puberteten.
English: Tables 1-6 show the adverse reactions ranked under headings of System Organ Class and frequency 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); very rare (<1/10,000); not known (cannot be estimated from the available data) for each of the indicated conditions.
Danish: Tabel 1-6 viser bivirkningerne klassificeret i henhold til systemorganklasse og hyppighed ved hjælp af følgende konvention: 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), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data) for hvert indikationsområde:
English: In addition, the following actions have been demonstrated.
Danish: Herudover er følgende virkninger påvist:
English: It is best to use your growth hormone regularly.
Danish: Det er bedst at tage væksthormon regelmæssigt.
English: The maximum recommended daily dose should not be exceeded (see section 4.2).
Danish: Den anbefalede maksimale daglige dosis bør ikke overskrides (se pkt.
English: Scoliosis is common in patients with PWS.
Danish: Skoliose er almindeligt forekommende hos patienter med PWS.
English: Muscle strength and physical exercise capacity are improved after long-term treatment with somatropin.
Danish: Muskelstyrke og fysisk arbejdskapacitet forbedres efter langtidsbehandling med somatropin.
English: Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Danish: Behandlingen bør afbrydes efter det første behandlingsår, hvis SDS for væksthastigheden er under + 1.
English: The following is a general description of the reconstitution and administration process.
Danish: Følgende er en generel beskrivelse af fremgangsmåden ved rekonstitution og administration.
English: Omnitrope is a biosimilar medicinal product.
Danish: Omnitrope er et biosimilært lægemiddel.
English: - Carefully inspect the solution before injecting it and use only if clear and colourless.
Danish: - Kontroller opløsningen nøje inden injektion og brug den kun, hvis den fremstår klar og farveløs.
English: Experience in patients above 80 years is limited.
Danish: Erfaringen hos patienter over 80 år er begrænset.
English: • Type 2 diabetes • A decrease in the levels of the hormone Cortisol in your blood
Danish: • Type II diabetes (sukkersyge) • Et nedsat niveau af hormonet kortisol i blodet
English: Experience in patients with Silver-Russell syndrome is limited.
Danish: Erfaring med patienter med Silver-Russells syndrom er begrænset.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Data fra dyrestudier er utilstrækkelige, hvad angår reproduktionstoksicitet (se pkt.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for somatropin, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for somatropin er CHMP nået frem til følgende videnskabelige konklusioner:
English: The absolute bioavailability of somatropin seems to be similar in males and females following subcutaneous administration.
Danish: Somatropins absolutte biotilgængelighed synes at være ens hos mænd og kvinder efter subkutan administration.
English: Eliminate air bubbles if necessary.
Danish: Fjern alle luftbobler om nødvendigt.
English: Dose recommendations in paediatric patients
Danish: Anbefalede doser hos pædiatriske patienter
English: Use only clear solution.
Danish: Brug kun en klar opløsning.
English: System Organ Class
Danish: Systemorgan klasse
English: Pull back the plunger very slightly with one hand.
Danish: Træk stemplet tilbage meget langsomt med en hånd.
English: Higher doses may be necessary if the rate of growth is too low.
Danish: Højere doser kan være nødvendige, hvis væksthastigheden er for lav.
English: Wait for the area to dry.
Danish: Vent til huden er tør.
English: Most people do their injections into their thigh or their bottom.
Danish: De fleste personer giver sig selv injektionen i låret eller i bagdelen.
English: Not Known (cannot be estimated from available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhånden værende data)
English: Somatropin may reduce insulin sensitivity.
Danish: Somatropin kan reducere insulinsensitiviteten.
English: In adults
Danish: Hos voksne
English: Do not use Omnitrope if you notice that the solution is cloudy.
Danish: Brug ikke Omnitrope, hvis du opdager, at opløsningen er uklar.
English: - SurePal, an injection device specifically developed for use with
Danish: - SurePal, en injektionsanordning specielt udviklet til brug af
English: Symptoms: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Danish: Symptomer: Akut overdosering kan initialt medføre hypoglykæmi og derefter hyperglykæmi.
English: Higher doses can be used.
Danish: Højere doser kan anvendes.
English: Experience with prolonged treatment in adults and in patients with PWS is limited.
Danish: Erfaring med langvarig behandling af voksne og patienter med PWS er begrænset.
English: It is not known if somatropin is excreted into breast milk, but absorption of intact protein from the gastrointestinal tract of the infant is extremely unlikely.
Danish: Det er ukendt, om somatropin udskilles i human mælk, men absorption af intakt protein fra barnets mave-tarmkanal er yderst usandsynlig.