FrancophonIA/ELRC3.0 huggingface dataset:
English: The antibody response to influenza B strains contained in Flucelvax Tetra was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage.
Danish: Antistofresponset på influenza B-stammer indeholdt i Flucelvax Tetra var superior i forhold til antistofresponset efter vaccination med TIVc, der indeholdt en influenza B-stamme fra den alternative linje.
English: Flucelvax Tetra is available in packs containing 1 pre filled syringe with needle or 10 prefilled syringes with or without needles.
Danish: Flucelvax Tetra findes i pakninger, der indeholder 1 fyldt injektionssprøjte med kanyle eller 10 fyldte injektionssprøjter med eller uden kanyler.
English: The percentage of subjects with seroconversion or significant increase in HI antibody titre is >40%, the percentage of subjects achieving an HI titre ≥1:40 is >70%.
Danish: Procentdelen af forsøgpersoner med serokonvertering eller en signifikant stigning i HI-antistoftiter er > 40%, procentdelen af forsøgspersoner, der opnåede en HI-titer ≥ 1:40, er > 70%.
English: In this study, subjects received Flucelvax Tetra (N = 1159) or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 593), or TIV2c (N = 580)].
Danish: I dette studie fik forsøgspersonerne Flucelvax Tetra (N = 1.159) eller den ene af de to formuleringer af komparatorvaccinen, cellebaseret trivalent influenzavaccine (TIVc) [TIV1c (N = 593) eller TIV2c (N = 580)].
English: GMT (95% CI) Seroconversion Ratea 77% (70%-84%)
Danish: GMT (95% CI) Serokonverteringsratea 77% (70%-84%)
English: Flucelvax Tetra has no or negligible influence on the ability to drive and use machines.
Danish: Flucelvax Tetra påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Flucelvax Tetra is used to prevent flu in adults and children from 9 years of age.
Danish: Flucelvax Tetra anvendes til at forebygge influenza hos voksne og børn fra 9 år.
English: The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2019/2020 season.
Danish: Vaccinen er rettet mod fire influenzavirusstammer efter Verdenssundhedsorganisationens (WHO's) anbefalinger for sæsonen 2019/2020.
English: The most common (≥10%) adverse reactions reported in paediatric subjects of 9 to < 18 years of age were injection site pain (58%), headache (22%), erythema (19%), fatigue (18%), myalgia (16%), and induration (15%).
Danish: De hyppigst rapporterede (≥ 10%) bivirkninger hos pædiatriske forsøgspersoner i alderen 9 til < 18 år var smerter på injektionsstedet (58%), hovedpine (22%), erytem (19%), træthed (18%), myalgi (16%) og induration (15%).
English: The immunogenicity data with TIVc are relevant to the use of Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Danish: Imunogenicitetsdata med TIVc er relevante for brugen af Flucelvax Tetra, da begge vacciner fremstilles ved anvendelse af den samme proces og har overlappende sammensætninger.
English: EU/1/18/1326/001 10 pre filled syringes without needle EU/1/18/1326/002 1 pre filled syringe with needle EU/1/18/1326/003 10 pre filled syringes with needle
Danish: EU/1/18/1326/001 10 fyldte injektionssprøjter uden kanyle EU/1/18/1326/002 1 fyldt injektionssprøjte med kanyle EU/1/18/1326/003 10 fyldte injektionssprøjter med kanyle
English: Flucelvax Tetra induces humoral antibodies against the haemagglutinins.
Danish: Flucelvax Tetra inducerer humorale antistoffer mod hæmagglutininerne.
English: Non-inferiority was established for all 4 influenza strains included in Flucelvax Tetra, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination.
Danish: Noninferioritet blev bestemt for alle 4 influenzastammer, der er indeholdt i Flucelvax Tetra, vurderet ved hjælp af forholdene mellem GMT'er og forskellene i procentdelene af forsøgspersoner, der opnåede serokonvertering 3 uger efter vaccination.
English: The available immunogenicity data in the paediatric population 4 to less than 9 years of age were obtained in trial V130_03.
Danish: De foreliggende immunogenicitetsdata for den pædiatriske population i alderen 4 til under 9 år er opnået i studie V130_03.
English: Table 3: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13)
Danish: Tabel 3: Sammenligning af virkning af TIVc i forhold til placebo mod kulturbekræftet influenza for hver undertype af influenzavirus (V58P13)
English: There are no data available on coadministration of Flucelvax Tetra with other vaccines.
Danish: Der foreligger ingen data om administration af Flucelvax Tetra sammen med andre vacciner.
English: • Injection site pain, reddening, hardening or swelling at the site of the injection
Danish: • Smerter, rødme, hårdhed eller hævelse på injektionsstedet
English: Flucelvax Tetra may be given at the same time as other vaccines.
Danish: Flucelvax Tetra kan gives samtidig med andre vacciner.
English: Flucelvax Tetra was non-inferior to TIVc.
Danish: Flucelvax Tetra var noninferior i forhold til TIVc.
English: Animal data, with cell-based trivalent influenza vaccine (TIVc), have not shown effects on female fertility.
Danish: Data fra dyrestudier med cellebaseret trivalent influenzavaccine (TIVc) har ikke vist påvirkning af fertiliteten hos hundyr.
English: Antigenically Matched Strains Overall
Danish: Stammer med match af antigener Samlet
English: Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01)
Danish: Tabel 2: Noninferioritet af Flucelvax Tetra i forhold til TIVc hos voksne i alderen 18 år og derover - Per-protokol-analysesæt (V130_01)
English: GMT (95% CI) Seroconversion Ratea 56% (48%-65%)
Danish: GMT (95% CI) Serokonverteringsratea 56% (48%-65%)
English: Currently available safety and immunogenicity data are described in sections 4.8 and 5.1 but no recommendation on posology can be made.
Danish: 4.8 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Danish: Aktive stoffer: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase), inaktiverede, fra følgende stammer*:
English: Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Danish: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase), inaktiverede, fra følgende stammer*:
English: GMT (95% CI) Seroconversion Rateb
Danish: GMT (95% CI) Serokonverterings-rateb
English: The efficacy experience with TIVc is relevant to Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Danish: Virkningserfaringen med TIVc er relevant for Flucelvax Tetra, da begge vacciner er fremstillet ved anvendelse af den samme proces og har overlappende sammensætninger.
English: Package leaflet: Information for the user Flucelvax Tetra - suspension for injection in pre-filled syringe
Danish: Indlægsseddel: Information til brugeren Flucelvax Tetra injektionsvæske, suspension i fyldt injektionssprøjte
English: Flucelvax Tetra is a clear to slightly opalescent suspension.
Danish: Flucelvax Tetra er en klar til let opaliserende suspension.
English: Immunogenicity of TIVc in children 9 to less than 18 years of age was evaluated as part of a randomised, double-blind, controlled study (V58P12) that was performed in the paediatric population 3 to less than 18 years of age.
Danish: TIVc's immunogenicitet hos børn i alderen 9 til under 18 år er blevet vurderet som en del af et randomiseret, dobbeltblindet, kontrolleret studie (V58P12), der blev udført i den pædiatriske population i alderen 3 til under 18 år.
English: Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Danish: Magnesiumchloridhexahydrat Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat Vand til injektionsvæsker
English: The safety and efficacy of Flucelvax Tetra in children from birth to less than 9 years of age has not been established.
Danish: Flucelvax Tetra's sikkerhed og virkning hos børn fra fødslen til under 9 år er ikke klarlagt.
English: Vaccine Group Difference (95% CI)
Danish: Vaccinegruppe forskel (95 % CI)
English: Flucelvax Tetra suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 2019/2020 season
Danish: Flucelvax Tetra injektionsvæske, suspension i fyldt injektionssprøjte Influenzavaccine (overfladeantigen, inaktiveret, fremstillet i cellekulturer) Sæsonen 2019/2020
English: There are no data for overdose with Flucelvax Tetra.
Danish: Der er ingen data for overdosering med Flucelvax Tetra.
English: Use of Flucelvax Tetra during breast-feeding has not been studied.
Danish: Anvendelse af Flucelvax Tetra under amning er ikke blevet undersøgt.
English: Seroconversion Rateb (95% CI)
Danish: Serokonverteringsrateb (95% CI)
English: Suspension for injection in pre-filled syringe (injection).
Danish: Injektionsvæske, suspension i fyldt injektionssprøjte (injektionsvæske).
English: Ecchymosis, Chills
Danish: Ekkymose, kulderystelser
English: The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2019/2020 season.
Danish: Vaccinen opfylder Verdensundhedsorganisationen (WHO's) anbefalinger for den nordlige halvkugle samt EU's bestemmelser for sæsonen 2019/2020.
English: Contents of the pack and other information What Flucelvax Tetra contains
Danish: Pakningsstørrelser og yderligere oplysninger Flucelvax Tetra indeholder
English: • Extensive swelling of injected limb
Danish: • kraftig hævelse af injiceret arm
English: No interaction studies have been performed with Flucelvax Tetra.
Danish: Der er ikke udført interaktionsstudier med Flucelvax Tetra.
English: Flucelvax Tetra was noninferior to TIVc in children 4 to less than 18 years of age.
Danish: Flucelvax Tetra var noninferior i forhold til TIVc hos børn i alderen 4 til under 18 år.
English: Injection site pain, Fatigue1,
Danish: Smerter på injektionsstede t, træthed1, erytem, induration1
English: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Danish: Flucelvax Tetra - injektionsvæske, suspension i fyldt injektionssprøjte Influenzavaccine (overfladeantigen, inaktiveret, fremstillet i cellekulturer)
English: This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.
Danish: Sådanne reaktioner opstår dog kun sjældent, men de kan forekomme med Flucelvax Tetra ligesom med alle andre vacciner, der indsprøjtes.
English: The safety of Flucelvax Tetra in adults 18 years and older was evaluated in a randomised, controlled study (V130_01), in which 1334 subjects received Flucelvax Tetra.
Danish: Flucelvax Tetra's sikkerhed hos voksne i alderen 18 år og derover er blevet vurderet i et randomiseret, kontrolleret studie (V130_01), hvor 1.334 forsøgspersoner fik Flucelvax Tetra.
English: Suspension for injection in pre-filled syringe 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with needle 10 pre-filled syringes (0.5 ml) with needle
Danish: Injektionsvæske, suspension i fyldt injektionssprøjte 10 fyldte injektionssprøjter (0,5 ml) uden kanyle 1 fyldt injektionssprøjte (0,5 ml) med kanyle 10 fyldte injektionssprøjter (0,5 ml) med kanyle
English: For egg-derived influenza vaccines larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
Danish: For æg-afledte influenzavacciner foreligger der et større datasæt om sikkerheden for det andet og tredje trimester sammenlignet med det første trimester.
English: Flucelvax Tetra may be used during lactation.
Danish: Flucelvax Tetra kan anvendes under amning.
English: The safety of Flucelvax Tetra in children 4 to less than 18 years of age was evaluated in a randomised, controlled study (V130_03).
Danish: Flucelvax Tetra's sikkerhed hos børn i alderen 4 til under 18 år er blevet vurderet i et randomiseret, kontrolleret studie (V130_03).
English: TIVc = cell-based trivalent influenza vaccine; TIVeA = egg-based trivalent influenza vaccine (Agrippal); TIVeF = egg-based trivalent influenza vaccine (Fluvirin) a Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
Danish: TIVc = cellebaseret trivalent influenzavaccine, TIVeA = ægbaseret trivalent influenzavaccine (Agrippal), TIVeF = ægbaseret trivalent influenzavaccine (Fluvirin) a Serokonverteringsrate = procentdel af forsøgspersoner med enten en prævaccinations-HI-titer på < 1:10 og en postvaccinations-HI-titer på ≥ 1:40 eller med en prævaccinations-HI-titer på ≥ 1:10 og en mindst 4-gange stigning i postvaccinations-HI-antistoftiter.
English: There are no reproductive and developmental toxicology studies with Flucelvax Tetra.
Danish: Der foreligger ingen studier af reproduktions- eller udviklingstoksikologi med Flucelvax Tetra.
English: Flucelvax Tetra is not indicated for use in children less than 9 years of age, see section 4.2.
Danish: Flucelvax Tetra er ikke indiceret til anvendelse til børn under 9 år, se pkt.
English: Immunogenicity of Flucelvax Tetra was evaluated in children 9 to less than 18 years of age as part of a randomised, double-blind, controlled study (V130_03) that was performed in the paediatric population 4 to less than 18 years of age.
Danish: Flucelvax Tetra's immunogenicitet blev vurderet hos børn i alderen 9 til under 18 år som en del af et randomiseret, dobbeltblindet, kontrolleret studie (V130_03), der blev udført i den pædiatriske population i alderen 4 til under 18 år.
English: or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 677) or TIV2c (N = 669)].
Danish: I dette studie fik forsøgspersonerne Flucelvax Tetra (N = 1.334) eller den ene af de to formuleringer af komparatorvaccinen, cellebaseret trivalent influenzavaccine (TIVc) [TIV1c (N = 677) eller TIV2c (N = 669)].
English: Immunogenicity of Flucelvax Tetra was evaluated in adults 18 years of age and older in a randomised, double-blind, controlled study (V130_01).
Danish: Flucelvax Tetra's immunogenicitet blev vurderet hos voksne i alderen 18 år og derover i et randomiseret, dobbeltblindet, kontrolleret studie (V130_01).
English: Carton box for syringe(s) with needle: - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle Carton box for syringe(s) without needle: - 10 pre-filled syringes (0.5 ml) without needle
Danish: Kartonæske til injektionssprøjte(r) uden kanyle: - 10 fyldte injektionssprøjter (0,5 ml) uden kanyle Kartonæske til injektionssprøjte(r) med kanyle: - 1 fyldt injektionssprøjte (0,5 ml) med kanyle - 10 fyldte injektionssprøjter (0,5 ml) med kanyle
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Danish: 6.1 eller over for mulige sporrester, såsom beta-propiolacton, cetyltrimethylammoniumbromid og polysorbat 80.
English: Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).
Danish: Flucelvax Tetra er en injektionsvæske, suspension i en fyldt injektionssprøjte (brugsklar sprøjte).
English: Male fertility has not been assessed in animals.
Danish: Der foreligger ingen dyrestudier vedrørende påvirkning af fertiliteten hos handyr.
English: b Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
Danish: b Serokonverteringsrate = procentdel af forsøgspersoner med enten en prævaccinations-HI-titer < 1:10 og en postvaccinations-HI-titer ≥ 1:40 eller med en prævaccinations-HI-titer ≥ 1:10 og en mindst 4 gange stigning i postvaccinations-HI-antistoftiter.
English: Mild side effects
Danish: Lette bivirkninger
English: Pack of 1 pre-filled syringe, with needle
Danish: Pakning med 1 fyldt injektionssprøjte med kanyle.
English: How Flucelvax Tetra is given
Danish: Sådan gives Flucelvax Tetra
English: Other medicines and Flucelvax Tetra
Danish: Brug af anden medicin sammen med Flucelvax Tetra
English: Immunogenicity of Flucelvax Tetra in Children and Adolescents 9 to less than 18 Years of Age
Danish: Flucelvax Tetra's immunogenicitet hos børn og unge i alderen 9 til under 18 år
English: Immunogenicity of Flucelvax Tetra in Adults 18 years of age and older
Danish: Flucelvax Tetra's immunogenicitet hos voksne i alderen 18 år og derover
English: Immunogenicity of Flucelvax Tetra in children 4 to less than 9 years of age
Danish: Flucelvax Tetra's immunogenicitet hos børn i alderen 4 til under 9 år
English: Frequency not known3
Danish: Ikke kendt3
English: • Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.
Danish: • Der kan forekomme besvimmelse efter eller endog før en kanyleinjektion.
English: The immunogenicity endpoints were geometric mean antibody titres (GMTs) of haemagglutination inhibition (HI) antibodies response and percentage of subjects who achieved seroconversions, defined as a pre-vaccination HI titre of <1:10 with a post vaccination titre ≥1:40 or with a prevaccination HI titre of ≥10 and a minimum 4-fold increase in serum HI antibody titre.
Danish: Endepunkterne for immunogenicitet var geometriske middelantistoftitre (GMT'er) for hæmagglutination-inhibition (HI)-antistofrespons og procentdel af forsøgspersoner, der opnåede serokonverteringer, defineret som en prævaccinations-HI-titer på < 1:10 med en postvaccinationstiter på ≥ 1:40 eller med en prævaccinations-HI-titer på ≥ 1:10 og en mindst 4 gange stigning i serum-HIanstoftiter.
English: The immunogenicity endpoints were GMTs of HI antibodies response and percentage of subjects who achieved seroconversions (seroconversion rate), defined as a pre-vaccination HI titre of <1:10 with a post-vaccination titre ≥1:40 or with a pre-vaccination HI titre ≥ 1:10 and a minimum 4-fold increase in serum HI antibody titre.
Danish: Endepunkterne for immunogenicitet var GMT'er for HI-antistofrespons og procentdel af forsøgspersoner, der opnåede serokonverteringer (serokonverteringsrate), defineret som en prævaccinations-HI-titer på < 1:10 med en postvaccinationstiter på ≥ 1:40 eller en prævaccinationsHI-titer på ≥ 1:10 og en mindst 4 gange stigning i serum-HI-anstoftiter.
English: Seqirus Netherlands B.V. Paasheuvelweg 28
Danish: Paasheuvelweg 28
English: Vaccine Group Ratio (95% CI)
Danish: Vaccinegruppe forhold (95 % CI)
English: Extensive swelling of injected limb
Danish: Kraftig hævelse af injiceret ekstremitet
English: In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.
Danish: Vaccinen må ikke administreres, hvis der observeres urenheder i form af partikler og/eller variation i fysisk beskaffenhed.
English: * propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown); ** haemagglutinin
Danish: hvori influenzavirus er dyrket) ** hæmagglutinin
English: What you need to know before you receive Flucelvax Tetra 3.
Danish: Virkning og anvendelse Det skal du vide, før du får Flucelvax Tetra Sådan gives Flucelvax Tetra Bivirkninger
English: Pre-filled syringe label
Danish: Etiket på fyldt injektionssprøjte
English: • Tiredness
Danish: • Kulderystelser
English: Seqirus Netherlands B.V. Netherlands Tél: +31 (0) 20 204 6900
Danish: Netherlands Tél: +31 (0) 20 204 6900
English: antibody titre.
Danish: CI = konfidensinterval.
English: Seqirus Netherlands B.V. Netherlands Tél/Tel: +31 (0) 20 204 6900
Danish: Netherlands Tél/Tel: +31 (0) 20 204 6900
English: Seqirus Netherlands B.V. Alankomaat Puh/Tel: +31 (0) 20 204 6900
Danish: Alankomaat Puh/Tel: +31 (0) 20 204 6900
English: Seqirus Netherlands B.V. Nederland Tlf: +31 (0) 20 204 6900
Danish: Nederland Tlf: +31 (0) 20 204 6900
English: Studies 301 and 202
Danish: Studierne 301 og 202
English: What is MPS VII
Danish: Hvad er MPS VII
English: Reports to be submitted as part of the annual reassessment
Danish: Rapporter skal fremsendes som en del af den årlige revurdering
English: Appropriate clinical treatment should be immediately sought.
Danish: Der skal omgående søges passende klinisk behandling.
English: Date of first authorisation: 23 August 2018
Danish: TILLADELSEN Dato for første markedsføringstilladelse: 23. august 2018
English: Compatibility with other medicinal products has not been evaluated.
Danish: Kompatibilitet med andre lægemidler er ikke blevet undersøgt.
English: The posology in the paediatric population is the same as in adults.
Danish: Doseringen til den pædiatriske population er den samme som til voksne.
English: - Do not use this medicine if you notice particles.
Danish: - Brug ikke lægemidlet, hvis du bemærker partikler.
English: From a microbiological safety point of view, the diluted product should be used immediately.
Danish: Ud fra et mikrobiologisk sikkerhedssynspunkt skal det fortyndede produkt anvendesstraks.
English: - The medicine has to be diluted before being given.
Danish: - Lægemidlet skal fortyndes, før det gives.
English: - These sugars are re-cycled all the time - new ones are made and old ones are broken down.
Danish: - Disse sukkerstoffer genbruges hele tiden - der dannes nye, og gamle nedbrydes.
English: The dose you will receive is based on how much you weigh.
Danish: Den dosis, du vil få, er baseret på din vægt.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Fortæl det omgående til lægen, hvis du bemærker nogle af følgende bivirkninger - du kan have behov for omgående lægehjælp:
English: (mL/h)
Danish: (ml/t)
English: - You may have side effects while you are being given Mepsevii or for up to a day afterwards.
Danish: - Du kan få bivirkninger, mens du får Mepsevii eller i op til en dag bagefter.
English: These problems can be signs of the illness and may be caused by pressure on your spinal cord.
Danish: Disse problemer kan være tegn på sygdommen og kan forårsages af tryk på din rygmarv.
English: - Each infusion will be given over about 4 hours.
Danish: - Hver infusion vil blive givet i løbet af ca. 4 timer.
English: This is because there is no experience on the use of Mepsevii during pregnancy.
Danish: Årsagen hertil er, at der ikke erfaring med brugen af Mepsevii under graviditet.
English: They may include an allergic reaction (see section 4).
Danish: De kan omfatte en allergisk reaktion (se pkt.
English: He or she will check that the correct dose has been given and take action as needed.
Danish: Lægen vil kontrollere, at den rette dosis er givet og tage forholdsregler efter behov.
English: Starting treatment early in children may stop the illness getting worse and reduce permanent damage.
Danish: Hvis behandlingen påbegyndes tidligt hos børn, kan det forhindre, at sygdommen forværres og reducere permanent skade.
English: No alternative dose regimen is recommended in these patients.
Danish: Intet alternativt dosisregimen anbefales til disse patienter.