FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration of therapeutic doses, doxazosin in Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets is well absorbed with peak blood levels gradually reached at 6 to 8 hours after dosing.
Danish: Efter at der gives orale terapeutiske doser, absorberes doxazosin i Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne godt med et maksimalt blodniveau, som opnås i løbet af 6 til 8 timer efter doseringen.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]has moderate influence on the ability to drive and use machines, especially at the beginning of therapy.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne har en moderat indflydelse på evnen til at føre motorkøretøj og betjene maskiner, navnlig i begyndelsen af en bestemt terapi.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should be administered with caution in patients with signs of mild to moderate hepatic impairment (see section 5.2).
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne skal gives med forsigtighed til patienter med tegn på mild eller moderat leverskade (se afsnit 5.2).
English: Do not take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]if you are pregnant or breast-feeding.
Danish: De må ikke tage Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne, hvis De er gravid eller ammer.
English: The pharmacokinetic properties of doxazosin in Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets lead to a minor variation in plasma levels.
Danish: De farmakokinetiske egenskaber for Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne og tabletter med forlænget afgivelse indebar en mindre variation i plasmaniveauet.
English: Common: frequent desire to micturate, increased micturation, delayed ejaculation Uncommon: incontinence, micturation disturbances, dysuria Rare: impotence, priapism
Danish: Almindelig: jævnligt ønske om at lade vandet, forhøjet vandladning, forsinket ejakulering Ualmindelig: inkontinens, vandladningsforstyrrelser, vandladningsbesvær Sjælden: impotens, priapisme
English: Common: constipation, dyspepsia Uncommon: anorexia, increased appetite, taste disturbances Rare: abdominal discomfort, diarrhoea, vomiting
Danish: Almindelig: forstoppelse, dyspepsi Ualmindelig: anoreksi, forhøjet appetit, smagsforstyrrelser Sjælden: mavebesvær, diarré, opkastning
English: Hepato-biliary disorders: Rare: icterus, increased liver values
Danish: Sygdomme i leer og galdeveje: Sjælden: icterus, forhøjet levertal
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is contraindicated during lactation as the medicinal product accumulates in the milk of lactating rats (see section 5.3) and there is no information about the excretion of the medicinal product into human breast milk.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne kontraindiceres ved amning, da lægemidlet akkumuleres i mælken hos diegivende rotter (se afsnit 5.3).
English: Uncommon: alopecia, oedema of the face/general oedema Rare: rash, pruritus, purpura
Danish: Ualmindelig: alopeci, ødem i ansigtet/almindeligt ødem Sjælden: udslæt, kløe, purpura
English: Common side effects, seen in more than 1 in 100 patients but less than 1in 10, include apathia muscle cramps, tiredness, a general feeling of being unwell or weakness, headache, sleepiness, problems with focussing your eyes, palpitations, chest pain, giddiness, dizziness, swelling, faintness or dizziness when standing up from a sitting or lying position (orthostatic dysregulation), shortness of breath, runny nose (rhinitis), constipation, indigestion, an increased desire or need to urinate and delayed ejaculation weakness (asthenia).
Danish: Normale bivirkninger, som ses hos mere end 1 ud af 100 patienter men mindre end 1 ud af 10, omfatter: apatiske muskelkramper, træthed, generel utilpashed eller svaghed, hovedpine, søvnighed, problemer med at se skarpt, hjertebanken, hjertesmerte, svimmelhed, hævelse, mathed eller døsighed når man står eller ligger (ortostatisk dysregulering), stakåndethed, løbende næse (rhinitis), forstoppelse, mavebesvær, øget ønske eller behov for at lade vandet og forsinket ejakuleringssvækkelse (asteni).
English: Butylhydroxytoluene (E321) Colloidal anhydrous silica Sodium stearyl fumarate
Danish: Butylhydroxytoluen (E321) Kolloid ren silika
English: Alternatively, breast-feeding must be stopped, if treatment with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is unavoidable.
Danish: Alternativt skal amningen stoppes, hvis behandling med Doxazosin Winthrop 4 mg og med forlænget afgivelse ikke kan undgås.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is not recommended for use in children and adolescents due to a lack of clinical experience.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne anbefales ikke til børn og unge på grund af manglende klinisk erfaring.
English: Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular pain, swelling of joints/arthralgia, muscle weakness
Danish: Sygdomme i bevægeapparatet, bindevæv og knogle: Ualmindelig: muskelsmerte, hævelse af led/ledsmerte, muskelsvaghed
English: If you take more Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]than you should:
Danish: Hvis De tager mere Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne end De bør:
English: Peak/trough ratio of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets is less than half that of immediate release doxazosin tablets.
Danish: Forholdet mellem top/bund for Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne og tabletter med forlænget afgivelse er mindre end halvdelen af forholdet for doxazosin-tabletter med øjeblikkelig afgivelse.
English: Each prolonged-release tablet contains 4 mg doxazosin (as mesilate).
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver depottablet indeholder 4 mg doxazosin (som mesilat).
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be taken at any time of day, during or after meals.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne kan tages på et hvilket som helst tidspunkt af dagen både sammen med eller efter et måltid.
English: The usual dose of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is one tablet taken as a single dose each day.
Danish: Den normale dosering af Doxazosin Winthrop 4 mg og tilhørende navne er en tablet en gang dagligt.
English: In patients taking Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]to treat high blood pressure (hypertension), the doxazosin works by relaxing the blood vessels so that the blood passes through them more easily and this helps to lower your blood pressure.
Danish: Hos patienter, som tager Doxazosin Winthrop 4 mg, depottabletter og dermed forbundne navne til behandling af højt blodtryk (hypertension), fungerer doxazosin ved at afslappe blodkarrene.
English: The majority of patients are controlled on the initial dose of 4 mg {Invented name}.
Danish: Flertallet af patienter kontrolleres ved en indledende dosering på 4 mg Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: On initiation of therapy or increasing of dose the patient should be monitored to minimise the potential for postural effects, e.g. hypotension and syncope.
Danish: For at minimere en eventuel postural effekt, som fx hypotension og besvimelse skal patienten overvåges ved igangsætning af terapi eller ved forhøjelse af dosering.
English: Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: [To be completed nationally]
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse [Udfyldes nationalt]
English: the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (see Annex I).
Danish: anbefaler CPMP, at der udstedes markedsføringstilladelse(r) for Doxazosin “Winthrop” 4 mg depottabletter og de tilknyttede navne.
English: Patients treated with immediate release doxazosin tablets against hypertension can be transferred to Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets and the dose titrated upwards as needed, while maintaining effect and tolerability.
Danish: De patienter, som blev behandlet for hypertension med doxazosin-tabletter med øjeblikkelig afgivelse, kansamtidig med at effekt og tolerabilitet fastholdes - overføres til Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne med forlænget afgivelse.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be taken with or after food.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne kan tages sammen med eller efter et måltid.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: De mest alvorlige bivirkninger skal anføres først for hver frekvensgruppe.
English: 1 WHAT DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]IS AND WHAT IT IS USED FOR
Danish: 1 HVAD DOXAZOSIN WINTHROP 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE ER OG KAN ANVENDES TIL
English: In patients with severe hepatic impairment clinical experience is lacking and therefore the use of doxazosin prolonged release tablets is not recommended (see section 4.4).
Danish: Derfor anbefales brugen af doxazosin-tabletter med forlænget afgivelse ikke (se afsnit 4.4).
English: If you stop taking {Invented name}: Keep taking your tablets until your doctor tells you to stop.
Danish: Hvis De holder op med at tage Doxazin Winthrop 4 mg og dermed forbundne navne Fortsæt med at tage tabletterne, indtil lægen beder Dem om at stoppe.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis De tager eller for nylig har taget anden medicin, bør De fortælle det til Deres læge eller apotek.
English: PHARMACEUTICAL FORM AND CONTENTS 28 Prolonged-release tablets 30 Prolonged-release tablets 100 Prolonged-release tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 depottabletter
English: Taking Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]with food and drink
Danish: Hvordan man tager Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne sammen med mad og drikkevarer
English: NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] Doxazosin STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 4 mg of doxazosin (as mesilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver depottablet indeholder 4 mg doxazosin (som mesilat).
English: This is the maximum dose of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I].
Danish: Det er den maksimale dosering af Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne [Se Bilag I] Doxazosin
English: Administration of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]to patients with prostatic hyperplasia results in a significant improvement in urodynamics and symptoms as a result of a selective blockade of alpha-adrenoceptors located in the prostatic muscular stroma, capsule and bladder neck.
Danish: Ved at give Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne til patienter med prostatahyperplasi opnås en signifikant forbedring af urodynamik og symptomer.
English: What Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]contains:
Danish: Hvad Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne indeholder
English: 3 HOW TO TAKE DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]
Danish: 3 HVORDAN DE TAGE DOXAZOSIN WINTHROP 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be used as sole agent or in combination with another medicinal product e.g. a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Danish: Det kan også kombineres med et andet lægemiddel som eksempelvis en thiazid-diuretikum, betaadrenoceptor blokeringsagent, kalciumantagonist eller en ACE-inhibitor.
English: 2 BEFORE YOU TAKE DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]
Danish: 1 LÆGEMIDLETS NAVN Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne [Se Bilag I]
English: Do not take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Danish: De bør ikke tage Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne
English: Always take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]exactly as your doctor has told you.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne bør altid tages i nøje overensstemmelse med Deres læges instruktioner.
English: Take special care with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Danish: Vær særlig forsigtig med at tage Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne
English: • if you are breast feeding.
Danish: • Hvis De ammer
English: The procedure started on 18 October 2007.
Danish: Proceduren indledtes den 18. oktober 2007.
English: London, 6 October 2008 Doc.
Danish: London, den 6. oktober 2008 Dok.
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008.
Danish: Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 28. januar 2008.
English: A Decision was issued by the European Commission on 6 October 2008.
Danish: Europa-Kommissionen traf en afgørelse den 6. oktober 2008.
English: Zyrtec and associated names, 10 mg film coated tablets, 10 mg/ml oral drops, 1 mg/ml oral solution, is an anti-allergic drug indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of chronic idiopathic urticaria.
Danish: Zyrtec og tilknyttede navne, 10 mg filmovertrukne tabletter, 10 mg/ml orale dråber, 1 mg/ml oral opløsning, er et lægemiddel mod allergi til lindring af næse- og øjensymptomer på sæsonbetinget og tilbagevendende allergisk rhinitis og til lindring af kronisk idiopatisk urticaria.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.
Danish: Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Zyrtec og tilknyttede navne i EU-medlemsstaterne, især med hensyn til indikationer, dosering, kontraindikationer og særlige advarsler.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Zyrtec and associated names International Non-Proprietary Name (INN): cetirizine
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Zyrtec og tilknyttede navne Internationalt fællesnavn (INN): cetirizin
English: On 9 October 2007 the Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Zyrtec and associated names.
Danish: Den 9. oktober 2007 indbragte Kommissionen en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, med henblik på harmonisering af de nationalt godkendte produktresuméer, etikettering og indlægsseddel for lægemidlet Zyrtec og tilknyttede navne.
English: During its May 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Danish: På sit møde i maj 2008 var CHMP på baggrund af alle de foreliggende oplysninger og de faglige drøftelser i udvalget af den opfattelse, at forslaget om harmonisering af produktresumé, etikettering og indlægsseddel var acceptabelt, og at ændringerne burde foretages.
English: The CHMP gave a positive opinion on 30 May 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Zyrtec and associated names.
Danish: CHMP afgav den 30. maj 2008 en positiv udtalelse, hvori udvalget anbefalede harmonisering af produktresumé, etikettering og indlægsseddel for Zyrtec og tilknyttede navne.
English: Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009
Danish: Dato for første tilladelse: 13. august 1999 Dato for seneste fornyelse: 27. juli 2009
English: Let stand for 20 minutes.
Danish: Skal stå i 20 minutter.
English: Justification for not including Braille accepted.
Danish: Begrundelse for ikke at inkludere braille er accepteret
English: However in-use stability has been demonstrated for 3 hours at 20 - 24oC.
Danish: Der er imidlertid vist stabilitet under anvendelse i 3 timer ved 20-24C.
English: In vitro studies of antiviral activity
Danish: In vitro studier af antiviral aktivitet
English: For example, for a baby with a body weight of 3 kg, the calculation becomes:
Danish: For eksempel, for en baby der vejer 3 kg, bliver udregningen:
English: 04011 Campoverde di Aprilia (LT) Italy
Danish: 04011 Campoverde di Aprilia (LT) Italien
English: Where possible, the first dose should be administered prior to commencement of the RSV season.
Danish: Når det er muligt, bør den første dosis gives inden starten på RSV-sæsonen.
English: On this basis, the absolute risk reduction is 5.8% which means the number needed to treat is 17 to prevent one hospitalisation.
Danish: På basis af dette er den absolutte risiko reduktion 5,8%, hvilket betyder, at det nødvendige antal at behandle er 17 for at forebygge én indlæggelse.
English: unusual bruising or groups of tiny red spots on the skin.
Danish: Usædvanlige blå mærker eller grupper af små røde pletter på huden.
English: If your child misses an injection, you should contact your doctor as soon as possible.
Danish: Hvis dit barn mangler at få en injektion, skal du kontakte din læge så hurtigt som muligt.
English: No medical consequences were identified in these instances.
Danish: Der blev i disse tilfælde ikke konstateret nogen medicinske følger.
English: Store in a refrigerator (2ºC to 8ºC).
Danish: Opbevares i køleskab (2C til 8C).
English: Synagis is not indicated for use in adults.
Danish: Synagis er ikke indiceret til anvendelse til voksne.
English: These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg.
Danish: Disse doser var 20,25 mg/kg, 21,1 mg/kg og 22,27 mg/kg.
English: In the first study, all 153 premature infants received both formulations in different sequences.
Danish: I det første studie, fik alle 153 præmature spædbørn begge formuleringer i forskellig rækkefølge.
English: The injection should be given using standard aseptic technique.
Danish: Injektionen skal gives ved brug af standard aseptisk teknik.
English: In clinical studies, three children received an overdose of more than 15 mg/kg.
Danish: I kliniske studier fik tre børn en dosis på mere end 15 mg/kg.
English: No significant findings were observed.
Danish: Der blev ikke påvist signifikante forandringer.
English: The majority of clinical RSV isolates tested (n=96) were collected from subjects in the United States.
Danish: Størstedelen af de testede kliniske RSV-isolater (n=96) blev indsamlet fra forsøgspersoner i USA.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af,at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Do not dilute the product.
Danish: Fortynd ikke produktet.
English: In some cases, fatalities have been reported (see section 4.8).
Danish: I visse tilfælde er dødsfald rapporteret (se pkt.
English: The appearance of the reconstituted solution is clear to slightly opalescent.
Danish: Udseendet på den rekonstituerede opløsning er klart til let opaliserende.
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR -2D-STREGKODE
English: Your child can then go back to the original planned injections.
Danish: Derefter kan dit barn vende tilbage til de oprindelig planlagte injektioner.
English: Therefore, anti-drug antibody (ADA) responses appear to be of no clinical relevance.
Danish: Derfor synes anti-lægemiddel-antistof-reaktioner ikke at have klinisk relevans.
English: Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections.
Danish: I denne gruppe fik 1.250 af de medvirkende børn 6 injektioner, 183 børn fik 7 injektioner, og 27 børn fik enten 8 eller 9 injektioner.
English: The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies.
Danish: Hyppigheden af disse “bivirkninger”, som er vist i tabellen herunder, blev estimeret ved brug af sikkerhedsdata fra de to kliniske registreringsstudier.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Danish: I tilfælde af overdosering anbefales det, at patienten overvåges for eventuelle tegn eller symptomer på utilsigtede hændelser eller bivirkninger og passende symptomatisk behandling straks påbegyndes.
English: Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.
Danish: Derfor skal diagnostiske testresultater altid bruges sammen med kliniske fund som vejledning for medicinske beslutninger.
English: The neutralization titre (50% effective concentration [EC50]) is expressed as the antibody concentration required to reduce detection of RSV antigen by 50% compared with untreated virus-infected cells.
Danish: Neutralisationstiter (50% effektiv koncentration [EC50]) udtrykkes som den antistofkoncentration, der er nødvendig for at reducere detektion af RSV-antigen med 50% sammenlignet med ubehandlede virus-inficerede celler.
English: • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
Danish: • Børn under 2 år, som inden for de sidste 6 måneder har krævet behandling for bronkopulmonal dysplasi.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid dette lægemiddel nøjagtigt som angivet af lægen eller apotekspersonalet.