FrancophonIA/ELRC3.0 huggingface dataset:
English: Confirm completion & dispose
Norwegian Bokmål: VEDLEGG I PREPARATOMTALE
English: The combination of Imraldi and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Norwegian Bokmål: Kombinasjonen av Imraldi og anakinra er ikke anbefalt (se pkt.
English: Biogen Idec Limited (UK) Tel: +44 (0)20 360 886 22
Norwegian Bokmål: Tel: +44 (0)20 360 886 22
English: Keep the syringe in the outer carton in order to protect from light.
Norwegian Bokmål: Oppbevar sprøyten i ytteremballasjen for å beskytte mot lys.
English: • low blood potasium.
Norwegian Bokmål: • lavt kaliumnivå i blodet.
English: Biogen Austria GmbH Tel: + 43 (0)1 267 51 42
Norwegian Bokmål: Tel: + 43 (0)1 267 51 42
English: Table 23 Maintenance of Clinical Remission and Response (Percent of Patients)
Norwegian Bokmål: Tabell 23 Vedlikehold av klinisk remisjon og respons (Prosent av pasientene)
English: • facial oedema;
Norwegian Bokmål: • svekket heling.
English: The recommended dose of Imraldi for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Norwegian Bokmål: Anbefalt startdose av Imraldi til voksne pasienter er 80 mg gitt subkutant etterfulgt av 40 mg subkutant etter en uke, og deretter 40 mg annenhver uke.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
Norwegian Bokmål: Det er viktig at du informerer legen om du har symptomer på infeksjon, som for eksempel feber, sår, tretthet, problemer med tennene.
English: - Not applicable
Norwegian Bokmål: Ikke kjent
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Norwegian Bokmål: Gastrointestinal blødning, dyspepsi, refluksøsofagitt (GERD), Sjøgrens syndrom Mindre vanlige Pankreatitt, dysfagi, ansiktsødem
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/ml during the induction period.
Norwegian Bokmål: Hos pasienter med ulcerøs kolitt var «trough»-nivået for serumkonsentrasjon av adalimumab i induksjonsperioden ca. 12 mikrog/ml med induksjonsdose 160 mg adalimumab ved uke 0, etterfulgt av 80 mg adalimumab ved uke 2.
English: Ewopharma d.o.o Tel: + 385 (0)1 777 64 37
Norwegian Bokmål: Tel: + 385 (0)1 777 64 37
English: Adolescent hidradenitis suppurativa
Norwegian Bokmål: Hidrosadenitt (hidradenitis suppurativa, HS) hos ungdom
English: • Throw away your used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Norwegian Bokmål: • Kast hetteglasset i en spesialbeholder slik lege, sykepleier eller apotek har fortalt deg.
English: Pharma.MT Ltd Tel: + 356 27 78 15 79
Norwegian Bokmål: Tel: + 356 27 78 15 79
English: Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 513 33 33
Norwegian Bokmål: Tel: +353 (0)1 513 33 33
English: If you dropped your pen with the cap OFF, do not use it.
Norwegian Bokmål: Hvis du mistet pennen med kanylehetten AV, må du ikke bruke den. Kanylen kan ha blitt skitten eller skadet.
English: • rash;
Norwegian Bokmål: • kløe,
English: Syringe storage
Norwegian Bokmål: Karsykdommer
English: Contents of the pack and other information
Norwegian Bokmål: Hvordan du oppbevarer Imraldi Innholdet i pakningen og ytterligere informasjon Instruksjoner for bruk
English: Imraldi Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Norwegian Bokmål: Imraldidosering for pasienter med entesittrelatert artritt Kroppsvekt
English: Adalimumabb N=113
Norwegian Bokmål: Adalimumab b N = 113
English: • scar;
Norwegian Bokmål: • slag,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIAL PACK)
Norwegian Bokmål: OPPLYSNINGER SOM SKAL ANGIS PÅ DEN YTRE EMBALLASJE YTRE ESKE (HETTEGLASSPAKNING)
English: • pulmonary fibrosis (scarring of the lung);
Norwegian Bokmål: • lungefibrose (arrdannelse i lungene),
English: Each 0.8 ml pre-filled pen contains 40 mg adalimumab.
Norwegian Bokmål: Hver ferdigfylte penn inneholder 40 mg adalimumab i 0,8 ml.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré
Norwegian Bokmål: Multippel sklerose, demyeliniseringsforstyrrelser (f. eks.
English: Continued therapy should be carefully considered in a subject not responding by week 12.
Norwegian Bokmål: Fortsettelse av behandlingen hos pasienter som ikke responderer innen uke 12, bør vurderes nøye.
English: • intestinal perforation;
Norwegian Bokmål: • leddinfeksjoner,
English: Insomnia
Norwegian Bokmål: Svimmelhet
English: • liver failure;
Norwegian Bokmål: • leversvikt,
English: Uncommon Deafness, tinnitus
Norwegian Bokmål: Mindre vanlige Døvhet, øresus
English: The recommended dose of Imraldi for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Norwegian Bokmål: Anbefalt startdose av Imraldi til voksne pasienter med uveitt er 80 mg etterfulgt av 40 mg etter en uke, og deretter 40 mg annenhver uke.
English: Each 0.8 ml vial contains 40 mg adalimumab.
Norwegian Bokmål: Hvert hetteglass inneholder 40 mg adalimumab i 0,8 ml.
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Norwegian Bokmål: Vedlegg I Liste over navn, legemiddelformer, legemidlenes styrker, administrasjonsveier, innehavere av markedsføringstillatelser i medlemsstatene
English: Parenteral use
Norwegian Bokmål: Parenteral bruk
English: Abrunheira 2710-089 Sintra Portugal
Norwegian Bokmål: 2710-089 Sintra Portugal
English: Oral use Intravenous use
Norwegian Bokmål: Oral bruk Intravenøs bruk
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande,
Norwegian Bokmål: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira
English: Amsterdam GK - 1081 The Netherlands
Norwegian Bokmål: Amsterdam GK - 1081
English: Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark
Norwegian Bokmål: Pharmacosmos A/S Roervangsvei 30 Holbaek DK-4300 Denmark
English: IBD3 Pharma Consulting Immeuble l'Orient 10, place Charles Béraudier
Norwegian Bokmål: IBD3 Pharma Consulting Immeuble l'Orient 10, place Charles Béraudier 69003 Lyon
English: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy sodium ferric gluconate complex
Norwegian Bokmål: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy natriumjernglukonatkompleks
English: Czech Republic
Norwegian Bokmål: Den tsjekkiske republikk
English: Solution for infusion
Norwegian Bokmål: Infusionslösung
English: Pharmamatch B.V.
Norwegian Bokmål: Nederland Pharmamatch B.V.
English: Intravenous use intramuscular use
Norwegian Bokmål: Intravenøs bruk intramuskulær bruk
English: Pharmachemie B.V. Haarlem - 2031 GA The Netherlands
Norwegian Bokmål: Haarlem - 2031 GA The Netherlands
English: Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex
Norwegian Bokmål: Brüningstrasse 50, D-65926 Frankfurt am Main Germany natriumjernglukonatkompleks
English: Target Pharma Ltd Menandrou 54 Athens 10431
Norwegian Bokmål: Target Pharma Ltd Menandrou 54
English: Solution for perfusion
Norwegian Bokmål: PARA PERFUSION
English: Óxido Férrico Sacarosado Farmoz
Norwegian Bokmål: Jernsukrose-kompleks Óxido Férrico Sacarosado Farmoz
English: FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion
Norwegian Bokmål: Jernsukrose-kompleks FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion
English: Czech Republic sodium ferric gluconate complex
Norwegian Bokmål: Czech Republic natriumjernglukonatkompleks
English: FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)
Norwegian Bokmål: Jernsukrose-kompleks FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)
English: Óxido Férrico Sacarosado Normon
Norwegian Bokmål: Jernsukrose-kompleks Óxido Férrico Sacarosado Normon
English: VENOFER INJECTION 100MG IRON/5ML
Norwegian Bokmål: Jernsukrose-kompleks VENOFER INJECTION 100MG IRON/5ML
English: 61352 Bad Homburg Germany
Norwegian Bokmål: 61352 Bad Homburg
English: Concentrate for solution for infusion/solution for injection
Norwegian Bokmål: INJECTION/CONCENTR ATE FOR SOLUTION FOR INFUSION
English: FER ACTAVIS 100 mg/5 ml, solution injectable
Norwegian Bokmål: Jernsukrose-kompleks FER ACTAVIS 100 mg/5 ml, solution injectable
English: IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie
Norwegian Bokmål: Jernsukrose-kompleks IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie
English: Óxido Férrico Sacarosado Combino
Norwegian Bokmål: Jernsukrose-kompleks Óxido Férrico Sacarosado Combino
English: FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion
Norwegian Bokmål: Jernsukrose-kompleks FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion
English: ENDOREM 11,2 mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION
Norwegian Bokmål: Jernsukrose-kompleks ENDOREM 11,2 mg FE/ml CONCENTRADO
English: FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion
Norwegian Bokmål: Jernsukrose-kompleks FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion
English: Athens-Lamia, 14565 Greece
Norwegian Bokmål: Athens 14564 Greece
English: Concentrate for suspension for infusion
Norwegian Bokmål: Konsentrat til infusjonsvæske, suspensjon
English: Ferrologic 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje
Norwegian Bokmål: Jernsukrose-kompleks Ferrologic 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje
English: Venofer 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje
Norwegian Bokmål: Jernsukrose-kompleks Venofer 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje
English: Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie
Norwegian Bokmål: Jernsukrose-kompleks Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie
English: FERRO SACCARATO FME
Norwegian Bokmål: Jernsukrose-kompleks FERRO SACCARATO FME
English: Venofer 20 mg FR / ml Injektionslösung
Norwegian Bokmål: Jernsukrose-kompleks Venofer 20 mg FR / ml Injektionslösung
English: SUCRO-FER
Norwegian Bokmål: Jernsukrose-kompleks SUCRO-FER
English: FERINJECT 50 mg fer/ml
Norwegian Bokmål: Jernkarboksymaltose FERINJECT 50 mg fer/ml
English: IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie
Norwegian Bokmål: Jernsukrose-kompleks IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie
English: FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung
Norwegian Bokmål: FERINJECT 50 mg Eisen/ml Injektionsund Infusionslösung
English: VENOFER 20mg/ml, solution injectable
Norwegian Bokmål: Jernsukrose-kompleks VENOFER 20mg/ml, solution injectable
English: Genericos Espanoles Laboratorio S.A.Cólquide, 6 - Portal 2, 1 Oficina F.Las Rozas 28230 MADRID Spain
Norwegian Bokmål: Oficina F.Las Rozas 28230 MADRID Spain
English: 4230 Skaelskoer Denmark
Norwegian Bokmål: Alternova A/S Lodshusvej 11 4230 Skaelskoer Denmark
English: Fermed-100mg/5ml
Norwegian Bokmål: Jernsukrose-kompleks Fermed-100mg/5ml
English: Jerndextran "Pharmacosmos" 50mg/ml
Norwegian Bokmål: Jerndextran "Pharmacosmos"
English: Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule
Norwegian Bokmål: Jernsukrose-kompleks Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule
English: Óxido Férrico Sacarosado Generis
Norwegian Bokmål: Jernsukrose-kompleks Óxido Férrico Sacarosado Generis
English: Intermed ABEE Kalyftaki 27 Athens 14564 Greece
Norwegian Bokmål: Intermed ABEE Kalyftaki 27
English: Ferric (III) hydroxide dextran complex
Norwegian Bokmål: Jern(III)hydroksiddek stran-kompleks
English: IRON SUCROSE PHARMABIDE 20 MG/ML
Norwegian Bokmål: Jernsukrose-kompleks IRON SUCROSE PHARMABIDE 20
English: Belgium VIFOR France SA 7-13 Boulevard Paul Emile Victor
Norwegian Bokmål: Storbritannia VIFOR France SA 7-13 Boulevard Paul Emile Victor
English: Sweden VIFOR France SA 7-13 Boulevard Paul Emile Victor
Norwegian Bokmål: Nederland VIFOR France SA 7-13 Boulevard Paul Emile Victor
English: Finland Pharmacosmos A/S Roervangsvej 30
Norwegian Bokmål: Nederland Pharmacosmos A/S Roervangsvej 30
English: Germany Pharmacosmos A/S Roervangsvej 30
Norwegian Bokmål: Storbritannia Pharmacosmos A/S Roervangsvej 30
English: FERMED 100 mg/ 5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION
Norwegian Bokmål: Jernsukrose-kompleks FERMED 100 mg/ 5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA
English: FERINJECT 50 mg ijzer/ ml, oplossing voor injectie/infusie
Norwegian Bokmål: Jernkarboksymaltose FERINJECT 50 mg ijzer/ ml, oplossing voor injectie/infusie
English: FERINJECT 50 mg iron/ml solution for injection/infusion
Norwegian Bokmål: Jernkarboksymaltose FERINJECT 50 mg iron/ml solution for injection/infusion
English: Oral solution or solution for infusion
Norwegian Bokmål: Oral oppløsning eller infusjonsvæske, oppløsning
English: Sodium ferric gluconate complex
Norwegian Bokmål: Jernsukrose-kompleks FERRINEMIA
English: Injectafer-50mg/l
Norwegian Bokmål: Jernkarboksymaltose Injectafer-50mg/l
English: Injectafer
Norwegian Bokmål: PERFUSION
English: FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie
Norwegian Bokmål: Jernsukrose-kompleks FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie
English: FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION
Norwegian Bokmål: Jernkarboksymaltose FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION
English: Ferric carboxymaltose complex
Norwegian Bokmål: Jernkarboksymaltose Injectafer
English: Iron (III) isomaltoside complex
Norwegian Bokmål: Jern(III)isomaltosidekompleks
English: HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION
Norwegian Bokmål: Jernsukrose-kompleks FERIV 20mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA
English: HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION
Norwegian Bokmål: Jernsukrose-kompleks VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA
English: Nefro-Fer
Norwegian Bokmål: Jernsukrose-kompleks Nefro-Fer
English: Ferrologic-20mg/ml
Norwegian Bokmål: Jernsukrose-kompleks Ferrologic-20mg/ml
English: FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion
Norwegian Bokmål: Jernsukrose-kompleks FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion
English: FERROLOGIC 20 MG/ML
Norwegian Bokmål: Jernsukrose-kompleks FERROLOGIC 20 MG/ML 20 mg/ml
English: FERINJECT 50 mg/ml, solution injectable/pour perfusion
Norwegian Bokmål: Jernkarboksymaltose FERINJECT 50 mg/ml, solution injectable/pour perfusion
English: FerroLogic
Norwegian Bokmål: Jernsukrose-kompleks Ferrologic
English: Ferrologic
Norwegian Bokmål: Jernsukrose-kompleks FerroLogic
English: Ferrologic 20mg/ml
Norwegian Bokmål: Jernsukrose-kompleks Ferrologic 20mg/ml
English: Ferion 20 mg/ml
Norwegian Bokmål: Jernsukrose-kompleks FERION 20 MG/ML
English: FERION 20 MG/ML
Norwegian Bokmål: Jernsukrose-kompleks Ferion 20 mg/ml
English: DEXTRIFER-S
Norwegian Bokmål: Jernsukrose-kompleks DEXTRIFER-S
English: Denmark Fresenius Medical Care Nephrologica Deutschland GmbH
Norwegian Bokmål: Nederland Fresenius Medical Care Nephrologica Deutschland GmbH
English: Concentrate for solution for injection
Norwegian Bokmål: Konsentrat til injeksjonsvæske, oppløsning
English: NEPHROFEROL
Norwegian Bokmål: Jernsukrose-kompleks NEPHROFEROL
English: Germany Fresenius Medical Care Nephrologica Deutschland GmbH
Norwegian Bokmål: Storbritannia Fresenius Medical Care Nephrologica Deutschland GmbH
English: EU/1/14/969/001
Norwegian Bokmål: EU/1/14/969/001 Scenesse
English: 16 mg Implant
Norwegian Bokmål: 16 mg Implantat
English: Subcutaneous use vial (glass)
Norwegian Bokmål: Hetteglass (glass)
English: Scenesse
Norwegian Bokmål: Pakningsstørrelse
English: Pack size
Norwegian Bokmål: Subkutan bruk
English: Strength Pharmaceutical Form
Norwegian Bokmål: Legemidlets navn Styrke Legemiddelform Administrasjonsmåte Indre emballasje
English: These are not, however, recommendations for storage.
Norwegian Bokmål: Dette er imidlertid ikke anbefalinger for oppbevaring.
English: Animal reproduction studies have not been conducted.
Norwegian Bokmål: Reproduksjonsstudier på dyr er ikke utført.
English: Other side effects are reported very rarely:
Norwegian Bokmål: Andre bivirkninger rapporteres svært sjelden:
English: Do not use this vaccine after the expiry date which is stated on the label.
Norwegian Bokmål: Bruk ikke denne vaksinen etter utløpsdatoen som er angitt på etiketten.
English: See sections 4.3, 4.4 and 4.8.
Norwegian Bokmål: 4.3, 4.4 og 4.8.
English: Individuals less than 16 years of age:
Norwegian Bokmål: Dosering for individer under 16 år:
English: Booster:
Norwegian Bokmål: Boosterdose:
English: Common (≥1/100 to, <1/10)
Norwegian Bokmål: Vanlige (≥ 1/100 til < 1/10)
English: Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours.
Norwegian Bokmål: Kumulative gjentatte uttak mellom 0 °C og 2 °C er også tillatt så lenge den totale tiden mellom 0 °C og 2 °C ikke overskrider 72 timer.
English: The doctor or nurse will give the vaccine as an injection into muscle.
Norwegian Bokmål: Legen eller sykepleieren gir vaksinen som en injeksjon i muskelen.
English: HBVAXPRO should be administered as soon as possible after being removed from refrigeration.
Norwegian Bokmål: HBVAXPRO skal administreres så snart som mulig etter uttak fra kjøleskapet.
English: Two primary immunisation schedules can be recommended:
Norwegian Bokmål: To tidsskjemaer for primærvaksinasjon kan anbefales:
English: Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Norwegian Bokmål: Ytterligere doser kan måtte vurderes for personer som ikke responderer, eller som har en suboptimal respons på vaksinasjonen.
English: Adsorbants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
Norwegian Bokmål: Adsorbenter er stoffer som er tilsatt visse vaksiner for å akselerere, forbedre og/eller forlenge den beskyttende effekten av vaksinen.
English: If these conditions exist, the product should not be administered.
Norwegian Bokmål: Dersom slikt forekommer, skal ikke legemidlet administreres.
English: Special dosage recommendations:
Norwegian Bokmål: Spesielle doseringsanbefalinger:
English: Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant.
Norwegian Bokmål: Amorft aluminiumhydroksyfosfatsulfat er inkludert i denne vaksinen som en adsorbent.
English: Latex rubber may cause severe allergic reactions.
Norwegian Bokmål: Lateksgummi kan forårsake alvorlige allergiske reaksjoner.
English: HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours.
Norwegian Bokmål: HBVAXPRO kan administreres dersom den totale tiden (kumulative gjentatte uttak) utenfor kjøleskap (ved temperaturer mellom 8 °C og 25 °C) ikke overskrider 72 timer.
English: Immunocompetent vaccinees
Norwegian Bokmål: Immunkompetente vaksinemottakere
English: Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95 % as compared to the infection rate in untreated historical controls.
Norwegian Bokmål: Blant 130 vaksinerte barn var den forventede effektiviteten når det gjelder forebygging av kronisk hepatitt B-infeksjon, 95 % sammenlignet med infeksjonsrate i en ubehandlet historisk kontrollgruppe.
English: The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Norwegian Bokmål: Vaksinen skal kun brukes under graviditet dersom mulige fordeler oppveier den potensielle risikoen for fosteret.
English: This leaflet was last approved in {MM/YYYY}
Norwegian Bokmål: Dette pakningsvedlegget ble sist oppdatert {MM/ÅÅÅÅ}
English: The following undesirable effects have been reported following the widespread use of the vaccine.
Norwegian Bokmål: Følgende bivirkninger er rapportert etter omfattende bruk av vaksinen.
English: Fertility: HBVAXPRO has not been evaluated in fertility studies.
Norwegian Bokmål: Fertilitet HBVAXPRO er ikke evaluert i fertilitetsstudier.
English: This includes any possible side effects not listed in this leaflet.
Norwegian Bokmål: inkludert mulige bivirkninger som ikke er nevnt i dette pakningsvedlegget.
English: The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity (see section 4.8).
Norwegian Bokmål: Den potensielle risikoen for apné og behovet for respiratorisk overvåking i 48 til 72 timer bør vurderes ved primærvaksinasjon til svært premature spedbarn (født ≤ 28 uke i svangerskapet) og spesielt for de med en tidligere historie av respiratorisk umodenhet (se pkt.
English: Shake well before use.
Norwegian Bokmål: Ristes godt før bruk.
English: • Inflammation of the eye which causes pain and redness
Norwegian Bokmål: • Betennelse i øyet som gir rødhet og smerte
English: The following information is intended for medical or health care professionals only:
Norwegian Bokmål: Påfølgende informasjon er bare beregnet på helsepersonell:
English: The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.
Norwegian Bokmål: Hvilke risikogrupper som skal vaksineres, avgjøres på bakgrunn av offentlige anbefalinger.
English: Dizziness and Fainting
Norwegian Bokmål: svimmelhet og besvimelse
English: Do not inject intravascularly.
Norwegian Bokmål: Må ikke gis intravaskulært.
English: • Low blood pressure, Blood vessel inflammation
Norwegian Bokmål: • Lavt blodtrykk, blodårebetennelse
English: This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process.
Norwegian Bokmål: Denne vaksinen kan inneholde spor av formaldehyd og kaliumtiocyanat som brukes i fremstillingsprosessen.
English: No studies on the effects on the ability to drive and use machines have been performed.
Norwegian Bokmål: Det er ikke utført studier vedrørende påvirkning av evnen til å kjøre bil og bruke maskiner.
English: This vaccine should never be given into a blood vessel.
Norwegian Bokmål: Vaksinen skal aldri gis i en blodåre.
English: - if you or your child has a severe illness with fever
Norwegian Bokmål: - dersom du eller barnet ditt har en alvorlig sykdom med feber.
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Norwegian Bokmål: Hos spedbarn som er svært premature (født ved 28. svangerskapsuke eller tidligere) kan det gå lengre mellomrom enn normalt mellom åndedrett i 2 til 3 dager etter vaksinasjonen.
English: Instructions
Norwegian Bokmål: Instruksjoner
English: Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01
Norwegian Bokmål: Farmakoterapeutisk gruppe: virusvaksine, ATC-kode: J07BC01.
English: Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.
Norwegian Bokmål: Hepatitt B-vaksine er anerkjent som den første kreftvaksinen siden den kan hindre utvikling av primær leverkreft.