FrancophonIA/ELRC3.0 huggingface dataset:
English: Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low.
Danish: De kliniske data,der er beskrevet nedenfor, tyder på, at risikoen er lav for interaktioner af klinisk betydning mellem lægemidler, der administreres samtidigt.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Xelevia is 50 mg once daily.
Danish: Til patienter med moderat nyreinsufficiens (GFR ≥30 til <45 ml/min) er dosis 50 mg Xelevia en gang dagligt.
English: In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
Danish: I en 24-ugers placebokontrolleret faktoriel undersøgelse af initial behandling gav sitagliptin 50 mg to gange dagligt i kombination med metformin (500 mg eller 1.000 mg to gange dagligt) en signifikant glykæmisk forbedring sammenlignet med begge former for monoterapi.
English: Neopharmed Gentili S.p.A. Tel: +39 02891321 regulatory@neogen.it
Danish: Tel: +39 02891321 regulatory@neogen.it
English: The observed incidence of hypoglycaemia in patients treated with sitagliptin was similar to placebo.
Danish: Den observerede incidens af hypoglykæmi hos de patienter, der blev behandlet med sitagliptin var den samme som for placebo.
English: Xelevia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Danish: Xelevia indeholder det aktive stof sitagliptin, som tilhører en klasse af lægemidler, som kaldes DPP-4hæmmere (dipeptylpeptidase-4-hæmmere).
English: How to take Xelevia
Danish: Sådan skal De tage Xelevia
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to
Danish: Sammenlignet med normale raske kontrolpersoner steg sitagliptins plasma-AUC med henholdsvis ca. 1,2 gange og 1,6 gange hos patienter med let nyreinsufficiens (GFR ≥60 til <90 ml/min) og patienter med moderat nyreinsufficiens (GFR ≥45 til <60 ml/min).
English: Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Danish: Nogle patienter har oplevet følgende bivirkninger efter at sitagliptin er blevet føjet til metformin: Almindelige (kan berøre op til 1 ud af 10): Lavt blodsukker, kvalme, øget luftafgang fra tarmen, opkastning.
English: • a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Danish: • en PPAR-agonist og metformin, når anvendelse af en PPAR-agonist er hensigtsmæssig, og når diæt og motion plus dual terapi med disse lægemidler ikke giver tilstrækkelig glykæmisk kontrol.
English: The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningenefter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Danish: Nogle af disse tyder på neural toksicitet: vejrtrækning med åben mund, spytafsondring, hvid skummende opkastning, ataksi, skælven, nedsat aktivitet og/eller krum stilling.
English: Paediatric No studies with Xelevia have been performed in paediatric patients.
Danish: Børn Der er ikke udført undersøgelser med anvendelse af Xelevia til børn.
English: For adult patients with type 2 diabetes mellitus, Xelevia is indicated to improve glycaemic control:
Danish: Xelevia er indiceret til at forbedre den glykæmiske kontrol:
English: Xelevia 100 mg tablets Sitagliptin
Danish: Xelevia 100 mg tabletter sitagliptin
English: Xelevia 25 mg tablets Sitagliptin
Danish: Xelevia 25 mg tabletter sitagliptin
English: What Xelevia is and what it is used for What you need to know before you take Xelevia How to take Xelevia
Danish: Det skal De vide, før De begynder at tage Xelevia Sådan skal De tage Xelevia Bivirkninger
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Xelevia Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: Xelevia 50 mg tablets Sitagliptin
Danish: Xelevia 50 mg tabletter sitagliptin
English: EU/1/07/382/007 EU/1/07/382/008 EU/1/07/382/009 EU/1/07/382/010 EU/1/07/382/011 EU/1/07/382/012 EU/1/07/382/021 EU/1/07/382/022
Danish: EU/1/07/382/010 EU/1/07/382/011 EU/1/07/382/012 EU/1/07/382/021 EU/1/07/382/022
English: EU/1/07/382/013 14 film-coated tablets EU/1/07/382/014 28 film-coated tablets EU/1/07/382/023 30 film-coated tablets EU/1/07/382/015 56 film-coated tablets EU/1/07/382/016 84 film-coated tablets EU/1/07/382/024 90 film-coated tablets EU/1/07/382/017 98 film-coated tablets EU/1/07/382/018 50 x 1 film-coated tablets
Danish: EU/1/07/382/013 14 filmovertrukne tabletter EU/1/07/382/014 28 filmovertrukne tabletter EU/1/07/382/023 30 filmovertrukne tabletter EU/1/07/382/015 56 filmovertrukne tabletter EU/1/07/382/016 84 filmovertrukne tabletter EU/1/07/382/024 90 filmovertrukne tabletter EU/1/07/382/017 98 filmovertrukne tabletter EU/1/07/382/018 50 x 1 filmovertrukne tabletter
English: EU/1/07/382/007 14 film-coated tablets EU/1/07/382/008 28 film-coated tablets EU/1/07/382/021 30 film-coated tablets EU/1/07/382/009 56 film-coated tablets EU/1/07/382/010 84 film-coated tablets EU/1/07/382/022 90 film-coated tablets EU/1/07/382/011 98 film-coated tablets EU/1/07/382/012 50 x 1 film-coated tablets
Danish: EU/1/07/382/007 14 filmovertrukne tabletter EU/1/07/382/008 28 filmovertrukne tabletter EU/1/07/382/021 30 filmovertrukne tabletter EU/1/07/382/009 56 filmovertrukne tabletter EU/1/07/382/010 84 filmovertrukne tabletter EU/1/07/382/022 90 filmovertrukne tabletter EU/1/07/382/011 98 filmovertrukne tabletter EU/1/07/382/012 50 x 1 filmovertrukne tabletter
English: Xelevia 100 mg film-coated tablets Sitagliptin
Danish: Xelevia 100 mg filmovertrukne tabletter sitagliptin
English: EU/1/07/382/001 14 film-coated tablets EU/1/07/382/002 28 film-coated tablets EU/1/07/382/019 30 film-coated tablets EU/1/07/382/003 56 film-coated tablets EU/1/07/382/004 84 film-coated tablets EU/1/07/382/020 90 film-coated tablets EU/1/07/382/005 98 film-coated tablets EU/1/07/382/006 50 x 1 film-coated tablets
Danish: EU/1/07/382/001 14 filmovertrukne tabletter EU/1/07/382/002 28 filmovertrukne tabletter EU/1/07/382/019 30 filmovertrukne tabletter EU/1/07/382/003 56 filmovertrukne tabletter EU/1/07/382/004 84 filmovertrukne tabletter EU/1/07/382/020 90 filmovertrukne tabletter EU/1/07/382/005 98 filmovertrukne tabletter EU/1/07/382/006 50 x 1 filmovertrukne tabletter
English: Xelevia 100 mg film-coated tablets
Danish: Xelevia 100 mg filmovertrukne tabletter
English: Xelevia 25 mg film-coated tablets
Danish: Xelevia 25 mg filmovertrukne tabletter
English: Xelevia 25 mg film-coated tablets Sitagliptin
Danish: Xelevia 25 mg filmovertrukne tabletter sitagliptin
English: Xelevia 50 mg film-coated tablets
Danish: Xelevia 50 mg filmovertrukne tabletter
English: Xelevia 50 mg film-coated tablets Sitagliptin
Danish: Xelevia 50 mg filmovertrukne tabletter sitagliptin
English: Uncommon angioedema
Danish: Natriumstearylfumarat
English: This product contains genetically modified organisms (GMOs).
Danish: Produktet indeholder genetisk modificerede organismer GMO'er).
English: ** CCID50: 50% Cell Culture Infectious Dose.
Danish: **CCID50: 50 % infektionsdosis i cellekultur.
English: Chimeric yellow fever dengue virus serotype 1* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 2* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 3* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 4* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** * Produced in Vero cells by recombinant DNA technology.
Danish: Kimær gul feber denguevirus-serotype 1 (levende, svækket)*..........................................4,5 - 6,0 log10 CCID50/dosis** Kimær gul feber denguevirus-serotype 2 (levende, svækket)*..........................................4,5 - 6,0 log10 CCID50/dosis** Kimær gul feber denguevirus-serotype 3 (levende, svækket)*..........................................4,5 - 6,0 log10 CCID50/dosis** Kimær gul feber denguevirus-serotype 4 (levende, svækket)*..........................................4,5 - 6,0 log10 CCID50/dosis** *Produceret i Vero-celler ved rekombinant DNA-teknologi.
English: --¹ After reconstitution, one dose (0.5 mL) contains:
Danish: Efter rekonstitution indeholder én dosis (0,5 ml):
English: 5 sets of 2 vials (1 with powder + 1 with solvent, 5 doses each)
Danish: 5 sæt med 2 hætteglas (1 med pulver og 1 med solvens, 5 doser i hver)
English: Powder: 5 doses; solvent: 2.5 ml
Danish: Pulver: 1 dosis Solvens: 0,5 ml
English: Subcutaneous use powder: vial (glass); solvent: vial (glass)
Danish: 10 hætteglas + 10 fyldte injektionssprøjter pulver: hætteglas (glas), solvens: hætteglas (glas)
English: 10 vials + 10 pre-filled syringes + 20 needles
Danish: 10 hætteglas + 10 fyldte injektionssprøjter + 20 kanyler
English: 1 vial + 1 pre-filled syringe
Danish: 1 hætteglas + 1 fyldt injektionssprøjte
English: This is to be expected and is not a cause for concern.
Danish: Dette kan forventes og bør ikke give anledning til bekymring.
English: Some bubbles may be present, but this is normal.
Danish: Der kan være nogle bobler til stede, men det er normalt.
English: Wash your hands carefully.
Danish: Vask dine hænder omhyggeligt.
English: Before reconstitution 3 years.
Danish: Før rekonstitution 3 år.
English: - thoughts about threatening the life of others.
Danish: - tanker om at true andre på livet.
English: Date of first authorisation: 29 May 2000 Date of latest renewal: 29 May 2010
Danish: Dato for første markedsføringstilladelse: 29. maj 2000 Dato for seneste fornyelse: 29. maj 2010
English: - The contents should now be completely dissolved.
Danish: - Indholdet skulle nu være fuldstændigt opløst.
English: The frequency of such re-activation appears to be low.
Danish: Hyppigheden af denne slags reaktivering forekommer at være lav.
English: Inject this medicine once each week on the same day.
Danish: Indsprøjt dette lægemiddel en gang om ugen på den samme ugedag.
English: Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Danish: Derfor skal dit blod kontrolleres regelmæssigt for at være sikker på, at hiv-infektionen ikke forværres.
English: Injecting it at the same time of day each week will help you not to forget to take it.
Danish: Indsprøjtning på det samme tidspunkt af dagen hver uge vil hjælpe dig til ikke at glemme at bruge den.
English: Please read the instructions carefully and follow them step by step.
Danish: Læs venligst vejledningerne omhyggeligt og følg den trin for trin.
English: Ribavirin can be very damaging to an unborn baby.
Danish: Ribavirin kan være yderst skadelig for et ufødt barn.
English: Another approximately 2 % had a transient decrease below the lower limit of normal.
Danish: Omtrent 2 % havde et forbigående fald til under den nedre normalgrænse.
English: Your other hand will be free to move the plunger.
Danish: Din anden hånd vil være fri til at bevæge stemplet.
English: There is, however, only a modest increase in biologic activity as measured by a bioassay.
Danish: Der er imidlertid kun en beskeden stigning i biologisk aktivitet målt ved et bioassay.
English: The potential risk in humans is unknown.
Danish: Den potentielle risiko for mennesker er ukendt.
English: % (number) of patients
Danish: % (antal) af patienter
English: - are allergic to any interferon.
Danish: - er allergisk over for et hvilket som helst interferon.
English: From a microbiological point of view, the product is to be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal præparatet anvendes straks.
English: If necessary, the dose may be changed during treatment.
Danish: Om nødvendigt kan dosis blive ændret under behandlingen.
English: The solution may appear cloudy or bubbly for a few minutes.
Danish: Opløsningen kan forekomme uklar eller boblefyldt i et par minutter.
English: • Look in the window.
Danish: • Kig gennem pennens vindue.
English: - have had severe heart problems.
Danish: - har haft alvorlige hjerteproblemer.
English: Any or all of these activities may contribute to interferon's therapeutic effects.
Danish: Nogle eller alle af disse reaktioner kan være medvirkende til interferons terapeutiske virkninger.
English: Additional 5 seconds ensures complete dose delivery.
Danish: Yderligere 5 sekunder vil sikre, at hele dosen er indgivet.
English: Other side effects that have been reported in adults include:
Danish: Andre bivirkninger rapporteret hos voksne inkluderer:
English: Your doctor will monitor you for signs and symptoms of these conditions.
Danish: Din læge vil følge dig for tegn og symptomer på disse tilstande.
English: Use this solution immediately.
Danish: Anvend opløsningen straks.
English: • TSH level must be within normal limits
Danish: • TSH-niveau skal være inden for normalområdet
English: • Wash your hands well with soap and warm water.
Danish: • Vask hænderne grundigt med vand og sæbe.
English: Doses up to 10.5 times the intended dose have been reported.
Danish: Der er set doser op til 10,5 gange den tilsigtede dosis.
English: The study results are summarized in Table 15.
Danish: Undersøgelsens resultater er sammenfattet i Tabel 15.
English: Take/administer the dose of this medicine as soon as you remember, but only if within 1-2 days after the forgotten dose.
Danish: Tag/giv dosis af dette lægemiddel, så snart du husker det, men kun hvis det er inden for 1-2 dage efter den glemte dosis.
English: While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Danish: Selv om disse virkninger almindeligvis er reversible, tog fuldstændig restitution hos nogle få patienter op til tre uger.
English: Signs, Symptoms, and Treatment Mechanism and Risk Factors
Danish: Tegn, symptomer og behandling Mekanisme og risikofaktorer
English: Pull back the plunger very slightly with one hand.
Danish: Træk stemplet en smule tilbage med den ene hånd.
English: You are now ready to inject the dose.
Danish: Du er nu klar til at indsprøjte dosis.
English: Note: The pre-filled pen will make a clicking sound for up to 10 seconds - depending on your dose.
Danish: Bemærk: Den fyldte pen vil give en klikkende lyd i op til 10 sekunder - afhængigt af din dosis.
English: There was no improvement in terms of fibrosis observed in this study.
Danish: Der var ingen bedring i relation til fibrose observeret i undersøgelsen.
English: Decrease in mean height percentile at year 1 of long-term follow-up was most prominent in prepubertal age children.
Danish: Fald i gennemsnitlig højde-percentil i 1. år af langtidsopfølgningen var mest fremtrædende hos præpubertale børn.
English: Overall population*
Danish: Samlet population*
English: Transient rashes do not necessitate interruption of treatment.
Danish: Forbigående udslæt kræver ikke afbrydelse af behandlingen.
English: This medicine is injected into your body to work with your immune system.
Danish: Dette lægemiddel indsprøjtes i din krop for at arbejde sammen med dit immunsystem.
English: Some children did not reach their projected height within 1-5.5 years after completing treatment.
Danish: Nogle børn nåede ikke den forventede højde inden for 1-5,5 år efter behandlingen.
English: - have heart disease that has not been well controlled during the past 6 months.
Danish: - har en hjertesygdom, som ikke har været velbehandlet gennem de seneste 6 måneder.
English: Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Danish: Særligt hos patienter på en høj dosis methadon bør risikoen for forlængelse af QTc overvejes.
English: Number of capsules (200 mg)
Danish: Antal kapsler (200 mg)
English: Standard methods to increase elimination of the medicinal product, e.g., dialysis, have not been shown to be useful.
Danish: Standardmetoder til at øge udskillelsen af lægemidlet, f.eks. dialyse, har ikke vist sig at være brugbare.
English: 327 patients completed at least 5 years of long-term follow-up and only 3 out of 366 sustained responders relapsed during the study.
Danish: 327 patienter fuldførte mindst 5 års langtidsopfølgning og kun 3 ud af 366 vedvarende responderende fik recidiv under undersøgelsen.
English: These studies were limited to four weeks due to the appearance of anti-interferon antibodies in most monkeys.
Danish: Disse studier var begrænset til fire uger på grund af fremkomsten af anti-interferon antistoffer hos de fleste aber.
English: Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking this medicine.
Danish: Kør ikke bil og betjen ikke værktøj eller maskiner, hvis du føler dig træt, søvnig eller forvirret, mens du tager dette lægemiddel.
English: Bilirubin - indirect
Danish: Bilirubin - indirekte
English: Monitoring of lipid levels is, therefore, recommended.
Danish: Derfor anbefales monitorering af lipidniveauer.
English: Dose reduction of boceprevir is not recommended.
Danish: Dosisreduktion af boceprevir anbefales ikke.
English: These events may also be more severe.
Danish: Denne bivirkning kan også være mere alvorlig.
English: In studies in pregnant animals, interferons have sometimes caused miscarriage.
Danish: I studier med drægtige dyr har interferoner sommetider forårsaget abort.
English: When this medicine is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Danish: Når dette lægemiddel anvendes alene, er sandsynligheden for nogle af bivirkningerne mindre og nogle forekommer slet ikke.
English: If it is very close to your next injection, do not double the dose to make up for the forgotten dose, but continue your treatment as usual.
Danish: Hvis det er meget tæt på din næste dosis, må du ikke tage en dobbeltdosis som erstatning for den glemte dosis, men fortsætte din behandling som sædvanligt.
English: The mechanisms involved in clearance of interferons in man have not yet been fully elucidated.
Danish: De mekanismer, der er involveret i udskillelsen af interferoner hos mennesker, er ikke blevet fuldstændigt belyst.
English: Do not inject into this site; withdraw the needle and repeat the procedure.
Danish: Sprøjt ikke ind på dette sted, træk kanylen ud og gentag proceduren.
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SmPC).
Danish: Mekanismen bag denne bivirkning er ikke kendt (se punkterne 4.3, 4.4 og 4.5 i SPC for telbivudin).
English: Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Danish: Kaukasiske patienter havde en højere vedvarende virologisk responsrate end de afroamerikanske.
English: Clear and colourless solvent.
Danish: Klar og farveløs solvens.
English: Be sure the solution is at room temperature up to 25°C.
Danish: Vær sikker på, at opløsningen har stuetemperatur op til 25 °C.
English: - if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom.
Danish: - hvis du er en mand, der bruger ribavirin: så hav ikke samleje med en gravid kvinde, medmindre du bruger kondom.
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5-year observational follow-up study.
Danish: Selvom data er begrænsede, blev der ikke set tegn på langtidsvirkning på kønsmodningen i det 5-årige opfølgende observationsstudie.
English: This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Danish: Dette forårsager svær anæmi, og symptomer på dette vil omfatte usædvanlig træthed og mangel på energi.
English: If it gets worse, your doctor will decide whether or not your ribavirin treatment needs to be changed.
Danish: Hvis den bliver værre, vil lægen beslutte, hvorvidt din ribavirin behandling skal ændres.
English: The average molecular mass is approximately 31,300 daltons of which the protein moiety constitutes approximately 19,300.
Danish: Den gennemsnitlige molekylevægt er omkring 31.300 dalton, hvoraf proteindelen udgør cirka 19.300.
English: Bilirubin - direct
Danish: Bilirubin - direkte
English: This includes adults also infected with clinically stable HIV (Human Immunodeficiency Virus).
Danish: Dette omfatter også voksne som er smittet med klinisk stabilt hiv (humant immundefekt-virus).
English: If the solution is cold, warm the syringe between your palms.
Danish: Hvis opløsningen er kold, så varm sprøjten mellem dine håndflader.
English: - are planning to become pregnant, discuss this with your doctor before starting to use this medicine.
Danish: - planlægger at blive gravid, så diskuter dette med din læge før start af behandling med dette lægemiddel.
English: Fluid replacement may be necessary.
Danish: Væsketilførsel kan være nødvendigt.
English: Ask a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Danish: Bed et familiemedlem eller en nær ven om at hjælpe dig med at være opmærksom på tegn på depression eller ændringer i din opførsel.
English: Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Danish: Pres på indsprøjtningsstedet med en lille forbinding eller steril gaze om nødvendigt i adskillige sekunder.
English: In all three treatment groups, sustained virologic response rates were similar.
Danish: I alle tre behandlingsgrupper var den vedvarende virologiske responsrate ens.
English: Growth rate decrease (height and/or weight decrease for age)
Danish: Nedsat væksthastighed (mindre højde og/eller nedsat vægt i forhold til alderen)
English: This decline was significant among responders (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Danish: Dette fald var signifikant blandt de responderende (-0,3 for Metavir og -1,2 for Ishak) og stabilt (-0,1 for Metavir og -0,2 for Ishak) blandt de ikke-responderende.
English: The best sites for injection are tissues with a layer of fat between skin and muscle.
Danish: De bedste steder til indsprøjtning er væv med et fedtlag mellem hud og muskel.
English: With your other hand, hold the syringe as you would a pencil.
Danish: Hold sprøjten med din anden hånd, som du ville holde en blyant.
English: (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Danish: (%)) hos tidligere ubehandlede børn og unge med genotype og behandlingsvarighed - Alle forsøgspersoner n = 107 24 uger
English: This should be discussed with your doctor.
Danish: Du bør diskutere dette med lægen.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8ºC.
Danish: Kemisk og fysisk holdbarhed under brug er påvist for 24 timer ved 2 °C - 8 ºC.
English: Children and adolescents This medicine is not recommended for use in patients under the age of 3 years.
Danish: Børn og unge Dette lægemiddel anbefales ikke til patienter på under 3 år.