FrancophonIA/ELRC3.0 huggingface dataset:
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravascularly.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Må ikke injiceres intravaskulært.
English: This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
Danish: Dette kan omfatte, at indehaveren af markedsføringstilladelsen forsyner hver enkelt pakning vaccine med et klistermærke med
English: A dose (0.5 ml) of the vaccine will be given.
Danish: Du skal have en dosis på 0,5 ml af vaccinen.
English: • Pain, redness, swelling or a hard lump where the injection was given, reduced movement in the Side effects from clinical studies in children
Danish: • smerte, rødmen, hævelse eller hårdhed det sted, hvor indsprøjtningen blev givet, nedsat bevægelighed i den arm, hvori indsprøjtningen blev givet
English: Very common: Injection site redness, drowsiness, irritability, loss of appetite, crying
Danish: Meget almindelig: Rødme ved injektionsstedet, døsighed, irritabilitet, appetitløshed, gråd
English: Specifically, headache, vertigo (spinning feeling), cough, feeling sick, vomiting, diarrhoea, pain in the arms or legs and tiredness were observed commonly in children and adolescents.
Danish: Specifikt blev der hyppigt set hovedpine, svimmelhed, hoste, kvalme, opkastning, diarré, smerter i arme eller ben samt træthed hos
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter anbrud af lægemidlet, se pkt.
English: A second dose of the vaccine should be given after an interval of at least three weeks.
Danish: Der gives endnu en dosis af vaccinen efter mindst tre uger.
English: Seronegative subjects at baseline (≤ 4mm 21 Days After nd
Danish: Seronegative personer ved basislinje (≤4 mm Efter 21 dage
English: Children and adolescents 6 months to 17 years of age In a clinical study the frequency and type of side effects after the first and second injection were basically similar to that seen in the adult and older population using Celvapan.
Danish: I et klinisk studie svarede hyppigheden og typen af bivirkninger efter den første og den anden indsprøjtning stort set til det, der blev set hos voksne og ældre ved brug af Celvapan.
English: In a clinical study the 7.5 µg dose of Celvapan (H1N1)v was administered to adults aged 18 to 59 years (N = 101) and older people over 60 years of age (N = 101).
Danish: I et klinisk studie blev der givet en dosis på 7,5 µg Celvapan (H1N1)v til voksne i alderen fra 18 til 59 år (N=101) og ældre over 60 år (N=101).
English: Prophylaxis of influenza caused by A(H1N1)v 2009 virus (See section 4.4).
Danish: Profylakse mod influenza forårsaget af A(H1N1)v 2009 virus.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Danish: Vaccinationen skal gives som intramuskulær injektion og helst i deltamusklen eller anterolateralt
English: The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, including older people.
Danish: Der er set følgende bivirkninger ved brug af Celvapan (H5N1)v i kliniske studier hos voksne, inklusive ældre.
English: Ask your pharmacist what to do with medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: All subjects
Danish: Alle personer
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Danish: Én pakke med 20 multidosishætteglas (type I glas) på 5 ml suspension (10 x 0,5 ml doser) med en
English: Children aged 6 to 35 months
Danish: Børn i alderen fra 6 til 35 måneder
English: CELVAPAN suspension for injection Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Danish: CELVAPAN injektionsvæske suspension Influenzavaccine (H1N1)v (hele virion, vero-celleafledt, inaktiveret)
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Danish: Tidligere anafylaktisk reaktion (dvs. livstruende) over for et af vaccinens indholdsstoffer eller spor heraf (f.eks. formaldehyd, benzonase, saccharose).
English: The immunogenicity of the vaccine containing 7.5 μg non-adjuvanted HA derived from strain A/California/07/2009 (H1N1)v has been evaluated in clinical studies in adults aged 18 years and older (N = 200), in children and adolescents aged 3 to 17 years (N = 102), and in infants and young children aged 6 to 35 months (N = 68) following a 0, 21 day schedule.
Danish: Immunogeniciteten af vaccinen indeholdende 7,5 μg non-adjuveret HA fra stamme A/California/07/2009 (H1N1)v er blevet vurderet i kliniske studier med voksne i alderen fra 18 år og ældre (N=200), med børn og unge i alderen fra 3 til 17 år (N=102) og med spædbørn og yngre børn i alderen fra 6 til 35 måneder (N=68), der fik medicinen på dag 0 og 21.
English: However, if co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis det skønnes nødvendigt med samtidig indgift af andre vacciner, skal dette ske i forskellige ekstremiteter.
English: (see section 6.
Danish: (Se pkt.
English: There is no information on administration of the vaccine Celvapan with other vaccines.
Danish: Der findes ingen data vedrørende samtidig brug af Celvapan-vaccinen og andre vacciner.
English: Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Danish: Influenzavaccine (H1N1)v (hel virus, vero-celleafledt, inaktiveret)
English: Children and adolescents (3 - 17 years of age)
Danish: Børn og unge (i alderen fra 3 - 17 år)
English: Side effects from the Pandemic Observational Study with CELVAPAN (H1N1)v Results from a clinical study done on marketed vaccine confirmed the safety profile as observed in the clinical studies.
Danish: Resultater af et klinisk studie udført med markedsført vaccine bekræftede den sikkerhedsprofil, som blev set i de kliniske studier.
English: 4.7 Effects on ability to drive and use machines Some undesirable effects mentioned under section 4.8 “Undesirable effects” may affect the ability to
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Nogle af de bivirkninger, der er nævnt i pkt.
English: There are no data on co-administration of Celvapan with other vaccines.
Danish: Der foreligger ingen data vedrørende samtidig indgift af Celvapan og andre vacciner.
English: Children and adolescents aged 5 to 17 years:
Danish: Børn og unge i alderen 5 til 17 år:
English: What Celvapan looks like and contents of the pack Celvapan is a clear to opalescent, translucent liquid.
Danish: Celvapan er en klar til opaliserende, gennemsigtig væske.
English: • Clinical trials with a version of Celvapan containing a H5N1 vaccine strain
Danish: • Kliniske studier med en version af Celvapan, som indeholder H5N1-vaccinestamme Kliniske studier blev udført med en version af Celvapan, som indeholder en H5N1-vaccinestamme (se pkt.
English: • neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
Danish: neuritis (nervebetændelse) og en slags lammelse kendt som Guillain-Barrés syndrom
English: From clinical studies limited immunogenicity and safety data are available for Celvapan (H1N1)v in healthy adult and older subjects and in children (see section 4.4, 4.8, and 5.1).
Danish: Kliniske studier har givet begrænsede immunogenicitets- og sikkerhedsdata for Celvapan (H1N1)v hos raske voksne og ældre og hos børn (se pkt.
English: Additionally, in the case of the 9 to 17 year olds pain at the injection site was very common.
Danish: Endvidere forekom smerter ved stedet for indsprøjtning meget hyppigt hos børn og unge i
English: Infants and children aged 6-35 months
Danish: Spædbørn og børn i alderen fra 6 - 35 måneder
English: • Fever, shivering, generally feeling unwell
Danish: • feber, kuldegysninger, ubehag (generel utilpashed)
English: Celvapan should be used in accordance with Official Guidance 4.2 Posology and method of administration
Danish: Celvapan bør anvendes i overensstemmelse med officielle retningslinjer.
English: Adverse reactions from pediatric clinical trials with CELVAPAN (H1N1)v are listed in the table below.
Danish: Bivirkninger fra pædiatriske kliniske studier med CELVAPAN (H1N1)v ses i nedenstående tabel.
English: Clinical Adverse Reactions (H1N1)v Studies System Organ Class (SOC)
Danish: Kliniske bivirkninger (H1N1)v-studie Systemorganklasse (SOK)
English: Immune response against a version of Celvapan containing A/H5N1 vaccine strains The immunogenicity of the vaccine containing 7.5 µg non-adjuvanted HA derived from strain A/Vietnam/1203/2004 has been evaluated in two clinical studies in adults aged 18 - 59 years (N = 312) and in older subjects aged 60 years and older (N = 272) following a 0, 21 day schedule.
Danish: Immunogeniciteten af vaccinen indeholdende 7,5 µg non-adjuveret HA udvundet fra stamme A/Vietnam/1203/2004 er blevet vurderet i to kliniske studier med voksne på 18 - 59 år (N=312) og ældre på 60 år og derover (N=272), der fik medicinen på dag 0 og dag 21.
English: Frequency1
Danish: Foretrukket MedDRA-term Hyppighed1
English: Children and adolescents 3 to 17 years of age
Danish: Børn og unge i alderen fra 3 til 17 år
English: SPECIAL STORAGE CONDITIONS Store in refrigerator.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER
English: After first opening, the vial is to be used within a maximum of 3 hours.
Danish: Efter første åbning skal indholdet bruges inden 3 timer.
English: Children and adolescents aged 6 months to 17 years of age:
Danish: Børn og unge i alderen fra 6 måneder til 17 år:
English: Adverse reactions from clinical trials with Celvapan (H1N1)v in a healthy adult and older people are listed in the table below.
Danish: Bivirkninger fra kliniske studie med Celvapan (H1N1)v hos raske voksne og raske ældre ses i nedenstående tabel.
English: Whole virus influenza vaccine, inactivated containing antigen of strain*:
Danish: Influenzavaccine, hele virion, inaktiveret, indeholder antigen af stamme*:
English: The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in children aged 6 to 35 months were as follows:
Danish: Seroprotektionsværdi, serokonversionsværdi og serokonversionsfaktor for anti-HA-antistof, målt med enkelt radial hæmolyse (SRH) hos børn i alderen fra 6 til 35 måneder, var som følger:
English: Detailed information on this medicinal product is available on the website of the European Medicines
Danish: Du kan finde yderligere oplysninger om Celvapan på Det Europæiske Lægemiddelagenturs
English: Persistence of anti-HA antibodies 180 days after the first vaccination as measured by single radial haemolysis (SRH) and microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above was as follows:
Danish: Forekomst af anti-HA-antistoffer 180 dage efter den første vaccination, målt med enkelt radial hæmolyse (SRH) og mikroneutraliseringsanalyse (MN) hos voksne i alderen 18 til 59 år og hos ældre personer på 60 år og derover, var som følger:
English: Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization assay (MN) in infants and young children aged 6 to 35 months was as follows:
Danish: Forekomst af anti-HA-antistoffer 180 dage og 360 dage efter den første vaccination, målt med enkelt radial hæmolyse (SRH) og mikroneutraliseringsanalyse (MN) hos spædbørn og yngre børn i alderen 6 til 35 måneder, var som følger:
English: After first opening the vial is to be used within a maximum of 3 hours.
Danish: Efter at være åbnet første gang skal indholdet i hætteglasset anvendes inden højst 3 timer.
English: The vaccine may be used during breast-feeding.
Danish: Du må gerne få vaccinen, mens du ammer.
English: Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization (MN) assay in children and adolescents
Danish: Forekomst af anti-HA-antistoffer 180 dage og 360 dage efter den første vaccination, målt med enkelt radial hæmolyse (SRH) og mikroneutraliseringsanalyse (MN) hos børn og unge i alderen 3 til 17 år,
English: Clinical Trial Adverse Reactions H1N1v studies
Danish: Kliniske bivirkninger (H1N1)v-studie
English: The dose recommendations take into account available data from clinical studies in healthy subjects who received two doses of Celvapan (H1N1)v.
Danish: Den anbefalede dosis tager hensyn til data fra igangværende kliniske studier hos raske personer,
English: After vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Danish: Efter vaccination var seroprotektionsværdi, serokonversionsværdi og serokonversionsfaktor for anti-HA-antistof, målt med enkelt radial hæmolyse (SRH) hos voksne i alderen fra 18 til 59 år og ældre på 60 år og derover, som følger:
English: Very common Common Common Common
Danish: Meget almindelig Almindelig Almindelig Almindelig
English: The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in children and adolescents aged 3 to 17 years were as
Danish: Seroprotektionsværdi, serokonversionsværdi og serokonversionsfaktor for anti-HA-antistof, målt med enkelt radial hæmolyse (SRH) hos børn og unge i alderen fra 3 til 17 år, var som følger:
English: • Injection site pain
Danish: Reaktioner ved injektionsstedet
English: Very common: Redness where the injection was given, drowsiness, irritability, loss of appetite, crying
Danish: Meget almindelig: Rødme det sted, hvor indsprøjtningen blev givet, døsighed, irritabilitet,
English: Seronegative subjects at baseline 21 Days After nd
Danish: Seronegative personer ved basislinje (<1:10) Efter 21 dage
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children and adolescents aged 3 to 17 years were as follows:
Danish: Efter vaccination var tallene for personer med neutraliserende antistoftitre ≥40, serokonversionsværdi og serokonversionsfaktor, målt med mikroneutraliseringsanalyse (MN) hos børn og unge i alderen fra 3 til 17 år, som følger:
English: 18 to 59 years
Danish: 9 - 17 år
English: 6.6 Special precautions for disposal and other handling
Danish: 6.4 Særlige opbevaringsforhold
English: Very common: Injection site pain, injection site redness, muscle pain
Danish: Meget almindelig: Smerte ved injektionsstedet, rødme ved injektionsstedet, muskelsmerter Ikke almindelig: Influenzalignende sygdom
English: NERVOUS SYSTEM DISORDERS Headache Dizziness
Danish: PSYKISKE FORSTYRRELSER Søvnforstyrrelser
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Danish: Efter vaccination var tallene for personer med neutraliserende antistoftitre ≥40, serokonversionsværdi og serokonversionsfaktor, målt med mikroneutraliseringsanalyse (MN) hos voksne i alderen fra 18 til 59 år og ældre på 60 år og derover, som følger:
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children aged 6 to 35 months
Danish: Efter vaccination var tallene for personer med neutraliserende antistoftitre ≥40, serokonversionsværdi og serokonversionsfaktor, målt med mikroneutraliseringsanalyse (MN) hos børn i alderen
English: INFECTIONS AND INFESTATIONS Nasopharyngitis
Danish: Nasopharyngitis
English: See section 6.5 for the number of doses per vial.
Danish: Se antal doser pr. hætteglas under pkt.
English: Check with your doctor or nurse before you are given Celvapan if
Danish: Lægen eller sygeplejersken vil være ekstra forsigtig med at behandle dig med Celvapan:
English: Clinical trials were conducted with a version of Celvapan containing a H5N1 vaccine strain (see section 5.1) in approximately 3700 subjects (ranging in age from 18 to 60 years and above), and in special risk groups of approximately 300 subjects each, consisting of immune-compromised subjects and patients with chronic disease conditions.
Danish: hos ca. 3.700 personer (i alderen fra 18 til 60 år og derover) og hos særlige risikogrupper, bestående af immunkompromitterede personer og patienter med kroniske sygdomstilstande, med
English: If you have any further questions, ask your doctor or nurse.
Danish: Spørg lægen eller sygeplejersken, hvis der er mere, du vil vide.
English: Influenza-like illness
Danish: INFEKTIONER OG PARASITÆRE SYGDOMME
English: PSYCHIATRIC DISORDERS
Danish: Antistofforekomst
English: The following additional adverse reactions have been reported in the post-marketing experience in adults and children receiving Celvapan (H1N1)v.
Danish: Følgende yderligere bivirkninger er blevet rapporteret efter markedsføringen hos voksne og børn,
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm²; > 4-fold increase in MN titer;
Danish: ** enten SRH-område > 25 mm², hvis basislinjeprøven er negativ, eller 50 % stigning i SRH-område, hvis basislinjeprøven > 4 mm²; > 4-dobbelt stigning i MN-titer;
English: Common Common Common
Danish: Almindelig Almindelig Almindelig
English: Common Common Common Common Common Common
Danish: Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig
English: ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline
Danish: ** enten SRH-område > 25 mm² hvis basislinjeprøven er negativ eller 50 % stigning i
English: Dose st
Danish: Se pkt.
English: Common Common Common Common Common
Danish: Almindelig Almindelig Almindelig Almindelig Almindelig
English: The side effects listed below have occurred with Celvapan (H1N1)v in adults and children during the
Danish: Nedenstående bivirkninger er set hos voksne og børn, der har fået Celvapan (H1N1)v under vaccinationsprogrammet med pandemisk influenzavaccination.
English: * SRH area > 25 mm² ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
Danish: ** enten SRH-område > 25 mm² hvis basislinjeprøven er negativ eller 50 % stigning i SRH-område, hvis basislinjeprøven > 4 mm²
English: Dose
Danish: Hyppighed
English: SRH Assay
Danish: SRH-analyse
English: <EMA procedure number> <MA (EU) number>
Danish: <EMA's procedurenr.> <MF (EU)-nummer>
English: powder: 90 mg; solvent: 2 ml
Danish: Pulver: 90 mg; solvens: 2 ml
English: 60 vials powder + 60 vials solvent + 60 3 ml syringes + 60 1 ml syringes + 180 alcohol swabs
Danish: 60 hætteglas pulver + 60 hætteglas solvens + 60 3 ml sprøjter + 60 1 ml sprøjter +
English: <Content (concentration)>
Danish: Styrke Lægemiddelform Administration Emballage <Indhold (Koncentration)>
English: (Invented) name Strength Pharmaceutical form
Danish: (Særnavn) Navn
English: Subcutaneous use powder: vial (glass); solvent: vial (glass)
Danish: Hætteglas (glas); solvens:
English: Immediate Packaging
Danish: spritservietter
English: These measures will help protect the environment.
Danish: Det vil hjælpe med at beskytte miljøet.
English: Open the bottle.
Danish: Åben flasken.
English: Age also had an influence on both parameters.
Danish: Alder havde også en indflydelse på begge parametre.
English: After first opening: 7 months
Danish: Efter første åbning: 7 måneder
English: Two minor metabolites were also identified.
Danish: To mindre metabolitter blev også identificeret.
English: Date of first authorisation: 5 December 2011 Date of latest renewal: 08 August 2016
Danish: Dato for første markedsføringstilladelse: 5. december 2011 Dato for seneste fornyelse: 8. august 2016
English: Oral absolute bioavailability is close to
Danish: Den absolutte orale biotilgængelighed er næsten
English: Nevertheless, the concentration of this metabolite remains low.
Danish: Ikke desto mindre vedbliver koncentrationen af denne metabolit at være lav.
English: He/she may decide if your dose should be adjusted.
Danish: Han/hun kan beslutte om din dosis skal justeres.
English: The results are consistent across age group.
Danish: Resultaterne er konsistente på tværs af aldersgrupper.
English: Suicide
Danish: Selvmord
English: Your doctor will establish the best possible treatment of overdose.
Danish: Din læge vil fastlægge den bedst mulige behandling af overdosering.
English: The mechanism of this risk is not known.
Danish: Mekanismen bag denne risiko er ikke kendt.
English: This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
Danish: Dette fald er mere udtalt i tredje trimester (op til 60 % af baseline-koncentrationen før graviditet).
English: In the elderly, the half-life is increased by about 40% (10 to 11 hours).
Danish: Hos ældre er halveringstiden øget med ca. 40 % (10 til 11 timer).
English: The lowest effective dose should be used.
Danish: Den laveste effektive dosis bør anvendes.
English: This is more likely at the beginning of treatment or after an increase in the dose.
Danish: Dette er mere sandsynligt i begyndelsen af behandlingen eller efter forøgelse af dosis.
English: Contact your doctor if you have missed one or more doses.
Danish: Kontakt lægen, hvis du har glemt en eller flere doser.
English: The elimination half-life was approximately 5 hours.
Danish: Elimineringshalveringstiden var tilnærmelsesvis 5 timer.
English: Food and alcohol
Danish: Mad og alkohol
English: Dose and frequency
Danish: Dosis og hyppighed
English: Be sure to drink the whole contents of the glass.
Danish: Vær sikker på at du drikker hele glassets indhold.
English: [140-age (years)] x weight (kg)
Danish: [140-alder (år)] x vægt (kg)
English: Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: The primary metabolite is inactive.
Danish: Den primære metabolit er inaktiv.
English: Elderly (65 years and older)
Danish: Ældre (65 år og ældre)
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
Danish: • encefalopati (se underafsnittet ”Kontakt omgående lægen” for en detaljeret beskrivelse af symptomer);
English: Then CLcr is adjusted for body surface area (BSA) as follows:
Danish: Derefter justeres CLcr for legemsoverfladeareal (BSA) på følgende måde:
English: Other unidentified components accounted only for 0.6% of the dose.
Danish: Andre uidentificerede komponenter udgjorde kun 0,6 % af dosis.
English: • Do not stop your treatment without your doctor's advice as this could increase your seizures.
Danish: • Stop ikke behandlingen uden lægens anbefaling, da dette kan øge antallet af anfald.
English: However, current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays.
Danish: De nuværende epidemiologiske undersøgelser (med ca. 100 børn) tyder imidlertid ikke på øget risiko for neuroudviklingsmæssige forstyrrelser eller forsinkelser.
English: This dose can be started on the first day of treatment.
Danish: Man kan starte med denne dosering fra den første behandlingsdag.