FrancophonIA/ELRC3.0 huggingface dataset:
English: Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, difficulty in concentrating; short-lasting changes in your sight.
Danish: Hovedpine, sløret tale, hurtig hjertebanken, koldsved, kold og bleg hud, kvalme, usædvanlig stor sultfornemmelse, rysten eller nervøsitet eller bekymring, unormal træthed, svaghed og døsighed, forvirring, koncentrationsbesvær, kortvarige synsforstyrrelser.
English: Flexibility in dosing time
Danish: Fleksibelt administrationsstidspunkt
English: • Periodic Safety Update Reports (PSUR)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Patients switching from more than once-daily basal or premix insulin therapy can be converted unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient's previous total daily insulin dose.
Danish: Patienter, som skifter fra behandling flere gange dagligt med basalinsulin eller færdigblandet insulin, kan konverteres enhed til enhed til Ryzodeg én eller to gange dagligt med den samme samlede insulindosis som patientens tidligere samlede daglige insulindosis.
English: Contents of the pack and other information What Ryzodeg contains
Danish: Pakningsstørrelser og yderligere oplysninger Ryzodeg indeholder:
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen After first opening or carried as a spare, the medicinal product may be stored for a maximum of 4 weeks.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen Under brug eller når medbragt som reserve kan lægemidlet opbevares i højst 4 uger.
English: Store in a refrigerator (2°C - 8°C) Do not freeze
Danish: Opbevares i køleskab (2°C - 8°C) Må ikke fryses
English: Skin changes where you use the injection (lipodystrophy): It is not known if Ryzodeg may cause lipodystrophy but such skin changes have been seen with other types of insulin.
Danish: Hyppighed ikke kendt (kan ikke bestemmes ud fra tilgængelige data) Hudforandringer på det sted, hvor du injicerer (lipodystrofi): Det vides ikke, om Ryzodeg kan give lipodystrofi, men denne type hudforandringer er set med andre typer insulin.
English: Ryzodeg (o.d.)2 Insulin users
Danish: Ryzodeg (o.d.)2 insulinbrugere
English: Patients switching from once-daily basal or premix insulin therapy can be converted unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient's previous total daily insulin dose.
Danish: Patienter, som skifter fra behandling en gang dagligt med basalinsulin eller blandingsinsulin, kan konverteres enhed til enhed til Ryzodeg én eller to gange dagligt med den samme samlede insulindosis som patientens tidligere samlede daglige insulindosis.
English: As with other basal insulin products or insulin products with a basal component, the prolonged effect of Ryzodeg may delay recovery from hypoglycaemia.
Danish: Den langvarige virkning af Ryzodeg kan som ved andre basalinsulinpræparater eller insulinpræparater med en basalkomponent forsinke normalisering af blodsukkeret efter hypoglykæmi.
English: EU/1/12/806/007 5 cartridges of 3 mL EU/1/12/806/008 10 cartridges of 3 mL
Danish: EU/1/12/806/007 5 cylinderampuller a 3 ml EU/1/12/806/008 10 cylinderampuller a 3 ml
English: • To see precisely how much insulin is left, use the dose counter:
Danish: • Brug dosistælleren til at se nøjagtigt, hvor meget insulin der er tilbage:
English: SC use
Danish: s.c. anvendelse
English: IGlar (o.d.)2 Insulin users
Danish: IGlar (o.d.)2 insulinbrugere
English: • glucocorticoids such as ‘cortisone', for inflammation
Danish: • binyrebarkhormoner, såsom kortison, mod betændelse
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a multidose disposable pre-filled pen made of polypropylene.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen 3 ml opløsning i en cylinderampul (type 1-glas) med et stempel (halobutyl) og en gummilaminatskive (halobutyl/polyisopren) i en fyldt engangspen til flergangsbrug fremstillet af polypropylen.
English: Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections
Danish: Glycerol, metacresol, phenol, natriumchlorid, zinkacetat, saltsyre og natriumhydroxid (til pHjustering) og vand til injektionsvæsker
English: in patients with type 2 diabetes mellitus.
Danish: hos patienter med type 2-diabetes mellitus.
English: Ryzodeg 100 units/mL solution for injection in cartridge 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul 3 ml opløsning i en cylinderampul (type 1-glas) med et stempel (halobutyl) og en gummilaminatskive (halobutyl/polyisopren) i en karton.
English: Ryzodeg is presented as a clear and colourless solution for injection in a cartridge (300 units per 3 mL).
Danish: Ryzodeg er en klar og farveløs injektionsvæske, opløsning i en cylinderampul (300 enheder pr. 3 ml).
English: Ryzodeg is presented as a clear and colourless solution for injection in pre-filled pen (300 units per 3 mL).
Danish: Ryzodeg er en klar og farveløs injektionsvæske, opløsning i en fyldt pen (300 enheder pr. 3 ml).
English: Ryzodeg o.d.or b.i.d demonstrated similar glycaemic control (HbA1c) compared to IGlar o.d. plus IAsp 13 times daily after 38 weeks (the estimated mean reductions are -1.17% vs -1.26%).
Danish: viste tilsvarende glykæmisk kontrol (HbA1c ) sammenlignet med IGlar o.d. plus IAsp 1-3 gange dagligt efter 38 uger (de estimerede gennemsnitlige reduktioner var -1,17% vs -1,26%).
English: Insulins and analogues for injection, intermediateor long-acting combined with fast-acting, ATC code: A10AD06.
Danish: Insuliner og analoger til injektion, mellemlang eller lang virkningstid kombineret med hurtigtvirkende.
English: Ryzodeg 100 units/mL solution for injection in cartridge After first opening or carried as a spare, the medicinal product may be stored for a maximum of 4 weeks.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul Under brug eller når medbragt som reserve kan produktet opbevares i højst 4 uger.
English: Table 3 Result of a 26-weeks' trial in type 1 diabetes mellitus with Ryzodeg given once daily
Danish: Tabel 3 Resultat af et 26-ugers studier med type 1-diabetes mellitus med Ryzodeg givet én gang dagligt
English: 10 x 3 mL
Danish: 5 x 3 ml 10 x 3 ml
English: Ryzodeg 100 units/mL solution for injection in cartridge EU/1/12/806/007
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul EU/1/12/806/007
English: • Unscrew the needle and dispose of it carefully.
Danish: • Skru nålen af, og kassér den sikkert.
English: Table 2 Result from two 26-weeks' trials in type 2 diabetes mellitus with Ryzodeg given twice daily
Danish: Tabel 2 Resultat fra to 26-ugers studier med type 2-diabetes mellitus med Ryzodeg givet to gange dagligt
English: Local reactions: Local reactions at the place you inject yourself may occur.
Danish: Almindelige bivirkninger (kan forekomme hos færre end 1 ud af 10 behandlede) Lokale reaktioner: Der kan forekomme lokale reaktioner på det sted, hvor du injicerer Ryzodeg.
English: If you experience eye problems, talk to your doctor.
Danish: Tal med din læge, hvis du oplever problemer med øjnene.
English: IGlar (o.d.)1 Insulin naïve
Danish: IGlar (o.d.)1 insulinnaive
English: In children, extra care should be taken to match insulin doses with food intake and physical activities in order to minimise the risk of hypoglycaemia.
Danish: For at reducere risikoen for hypoglykæmi skal der udvises ekstra forsigtighed med tilpasning af insulindosis til madindtag og fysisk aktivitet hos børn.
English: Flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).
Danish: Rødme og tør hud, døsighed eller træthed, mundtørhed, frugtagtig (acetonelugtende) ånde, hyppigere vandladning, tørst, appetitløshed, kvalme eller opkastning.
English: Ryzodeg 100 units/mL solution for injection in cartridge The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul Cylinderampullen (Penfill) er beregnet til anvendelse sammen med Novo Nordisk dispenseringssystemer (udstyr til gentagen brug, medfølger ikke i pakningen) og NovoFine/NovoTwist engangsnåle med en længde på op til 8 mm.
English: Mean change
Danish: Middelændring
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Before first use:
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen Før ibrugtagning:
English: Package leaflet: Information for the patient Ryzodeg 100 units/mL solution for injection in pre-filled pen
Danish: Indlægsseddel: Information til patienten Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen
English: Table 1 Result from two 26-weeks' trials in type 2 diabetes mellitus with Ryzodeg given once daily
Danish: Tabel 1 Resultat fra to 26-ugers studier hos type 2-diabetes mellitus med Ryzodeg givet én gang dagligt
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen En fyldt pen indeholder 300 enheder insulin degludec/insulin aspart i 3 ml opløsning.
English: After subcutaneous injection, soluble and stable multi-hexamers of insulin degludec are formed creating a depot of insulin in the subcutaneous tissue, while not interfering with the rapid release of insulin aspart monomers into the circulation.
Danish: Efter subkutan injektion dannes opløselige og stabile multihexamerer af insulin degludec, hvorved der opstår et depot af insulin i det subkutane væv.
English: Each pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Danish: Hver fyldt pen indeholder 300 enheder insulin degludec/insulin aspart i 3 ml opløsning.
English: Start by checking your pen to make sure that it contains Ryzodeg 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.
Danish: og se derefter på nedenstående illustrationer, så du kan lære de forskellige dele af pennen og nålen at kende.
English: Each cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Danish: Hver cylinderampul indeholder 300 enheder insulin degludec/insulin aspart i 3 ml opløsning.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen Den fyldte pen (FlexTouch) er beregnet til anvendelse sammen med NovoFine/NovoTwist engangsnåle op til en længde på 8 mm.
English: Ryzodeg (o.d.)1 Insulin naïve
Danish: Ryzodeg (o.d.)1 insulinnaive
English: Ryzodeg 100 units/mL solution for injection in cartridge Ryzodeg comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul Ryzodeg leveres i en cylinderampul (Penfill), som er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist engangsnåle.
English: Keep the cartridges in the outer carton in order to protect from light.
Danish: Opbevar cylinderampullen i den ydre karton for at beskytte mod lys.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg 100 units/mL solution for injection in cartridge
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul
English: Package leaflet: Information for the patient Ryzodeg 100 units/mL solution for injection in cartridge
Danish: Indlægsseddel: Information til patienten Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul
English: Instructions on how to use Ryzodeg 100 units/mL solution for injection in pre-filled pen (FlexTouch)
Danish: Brugervejledning til Ryzodeg pen 100 enheder/ml injektionsvæske, opløsning i fyldt pen (FlexTouch)
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen Ryzodeg leveres i en fyldt pen (FlexTouch), som er beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen Injektionsvæske, opløsning (FlexTouch).
English: What Ryzodeg is and what it is used for
Danish: • hvor meget Ryzodeg du har behov for hver dag og til hvilke måltider
English: • Pull off the inner needle cap and throw it away.
Danish: • Fjern den indre nålehætte og kassér den.
English: • danazol, for endometriosis
Danish: • danazol, lægemiddel, der virker på ægløsning
English: Frequency Adverse reaction
Danish: Hyppighed Bivirkning
English: IDegAsp 0.8 U/kg
Danish: Tid efter injektion (timer) Behandling IDegAsp 0,8 enheder/kg
English: Degradation of insulin degludec and insulin aspart is similar to that of human insulin; all metabolites formed are inactive.
Danish: Nedbrydningen af insulin degludec og insulin aspart ligner humant insulins.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (100 units/mL cartridge (Penfill))
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET (100 enheder/ml cylinderampul (Penfill))
English: Keep the cap on the pen in order to protect from light.
Danish: Opbevar pennen med hætten på for at beskytte mod lys.
English: After first opening: Can be stored in a refrigerator (2°C - 8°C).
Danish: Under brug: Kan opbevares i et køleskab (2°C - 8°C).
English: Ryzodeg 100 units/mL solution for injection 70% insulin degludec / 30% insulin aspart FlexTouch
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning 70% insulin degludec / 30% insulin aspart FlexTouch
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL cartridge (Penfill))
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (100 enheder/ml cylinderampul (Penfill))
English: Ryzodeg 100 units/mL solution for injection in cartridge Solution for injection (Penfill).
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul Injektionsvæske, opløsning (Penfill).
English: Ryzodeg 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul En cylinderampul indeholder 300 enheder insulin degludec/insulin aspart i 3 ml opløsning.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (100 units/mL pre-filled pen (FlexTouch))
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PENETIKET (100 enheder/ml fyldt pen (FlexTouch))
English: How to store Ryzodeg
Danish: Sådan skal du tage Ryzodeg
English: Ryzodeg 100 units/mL solution for injection in cartridge Before first use:
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul Før ibrugtagning:
English: For detailed instructions for use, see the package leaflet.
Danish: Se indlægssedlen for detaljeret brugsvejledning.
English: In one trial in type 2 diabetes mellitus Ryzodeg o.d. was compared to insulin glargine (IGlar) o.d. plus IAsp o.d. After 26 weeks of treatment the Ryzodeg dose could be split into b.i.d.
Danish: I et studie med type 2-diabetes mellitus blev Ryzodeg o.d. sammenlignet med insulin glargin (IGlar) o.d. plus IAsp o.d.
English: If you use more Ryzodeg than you should
Danish: Hvis du har taget for meget Ryzodeg
English: Non-fatal MI
Danish: Ikke-dødelig apopleksi Ikke-dødelig MI Alle dødsårsager
English: Ryzodeg 100 units/mL solution for injection 70% insulin degludec / 30% insulin aspart Penfill
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning 70% insulin degludec / 30% insulin aspart Penfill
English: • Check the name and strength on the label of the pen to make sure it is Ryzodeg 100 units/mL.
Danish: • Kontrollér navnet og styrken på pennens etiket for at sikre dig, at det er Ryzodeg
English: Dose counter Dose pointer
Danish: Dosistæller Dosismarkør
English: Not known Lipodystrophy General disorders and administration site conditions Common
Danish: Almene symptomer og reaktioner på administrationsstedet
English: It demonstrates superior improvements in fasting plasma glucose levels compared to patients treated with BIAsp 30.
Danish: Ryzodeg viste signifikant bedre faste-plasmaglucose, end patienter, som behandledes med BIAsp 30 og resulterede i lavere forekomst af generel og natlig hypoglykæmi (tabel
English: Each mL of solution contains 100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Danish: Hver ml af opløsningen indeholder 100 enheder insulin degludec/insulin aspart i forholdet 70/30 (svarende til 2,56 mg insulin degludec og 1,05 mg insulin aspart).
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING INNER CARTON FOR MULTIPACK (100 units/mL pre-filled pen (FlexTouch))
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE INDRE KARTON FOR MULTIPAKNING (100 enheder/ml fyldt pen (FlexTouch))
English: • In all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: • Alle børn og unge med type 2-diabetes mellitus (se pkt.
English: One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution 1 mL solution contains 100 units of insulin degludec/insulin aspart in the ration of 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart)
Danish: Én fyldt pen indeholder 300 enheder insulin degludec/insulin aspart i 3 ml opløsning 1 ml af opløsningen indeholder 100 enheder insulin degludec/insulin aspart i forholdet 70/30 (svarende til 2,56 mg insulin degludec og 1,05 mg insulin aspart)
English: 1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Danish: 1 ml af opløsningen indeholder 100 enheder insulin degludec/insulin aspart* i forholdet 70/30 (svarende til 2,56 mg insulin degludec og 1,05 mg insulin aspart).
English: Non-fatal Stroke
Danish: Ikke almindelig Perifert ødem
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL pre-filled pen (FlexTouch))
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (100 enheder/ml fyldt pen (FlexTouch))
English: One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution 1 mL solution contains 100 units of insulin degludec/insulin aspart in the ratio of 70/30 (equivalent to 2.56 mg insulin degludec and1.05 mg insulin aspart)
Danish: Én cylinderampul indeholder 300 enheder insulin degludec/insulin aspart i 3 ml opløsning 1 ml af opløsningen indeholder 100 enheder insulin degludec/insulin aspart i forholdet 70/30 (svarende til 2,56 mg insulin degludec og 1,05 mg insulin aspart)
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen 70% insulin degludec / 30% insulin aspart
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i fyldt pen 70% insulin degludec / 30% insulin aspart
English: Ryzodeg 100 units/mL solution for injection in cartridge 70% insulin degludec / 30% insulin aspart
Danish: Ryzodeg 100 enheder/ml injektionsvæske, opløsning i cylinderampul 70% insulin degludec / 30% insulin aspart
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL (100 units/mL pre-filled pen (FlexTouch))
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON FOR MULTIPAKNING (100 enheder/ml fyldt pen (FlexTouch))
English: End of trial Mean change
Danish: Forsøgsafslutning Middelændring
English: What Ryzodeg looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold af lægemidlet under brug, se pkt.
English: This summary was last updated in 02-2011.
Danish: Dette sammendrag blev sidst ajourført i 04-2017.
English: This means that they are fixed onto aluminium compounds to help stimulate a better response.
Danish: Det betyder, at de fæstner sig til aluminiumforbindelser for at hjælpe med at stimulere en bedre respons.
English: Vaccination should be postponed for people with a severe illness with fever.
Danish: Vaccinationen skal udsættes hos personer med en alvorlig sygdom med feber.
English: The full EPAR for HBVaxPro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for HBVaxPro findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the viruses.
Danish: Herefter vil immunsystemet være i stand til at producere antistoffer hurtigere, når personen senere bliver naturligt udsat for viraene.
English: The surface antigens are also ‘adsorbed'.
Danish: Overfladeantigenerne bliver også "adsorberet".
English: This is a summary of the European public assessment report (EPAR) for HBVaxPro.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for HBVaxPro.
English: This helps to protect against infection with the hepatitis B virus.
Danish: Dette hjælper med at beskytte imod infektion med hepatitis B-virus.
English: Therefore, the Committee decided that HBVaxPro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved HBVaxPro opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: HBVaxPro is available in two strengths (10 and 40 micrograms/ml).
Danish: HBVaxPro fås i to styrker (10 og 40 mikrogram/ml).
English: The timing of injections depends on the patient's age, strength of the immune system, response to vaccination and likelihood of exposure to the hepatitis B virus.
Danish: Tidspunktet for injektionerne afhænger af patientens alder, styrken af dennes immunsystem, reaktion på vaccination og sandsynligheden for, at han/hun bliver udsat for hepatitis B-virus.
English: A course of vaccination should include at least three injections of HBVaxPro.
Danish: Et vaccinationsforløb bør omfatte mindst tre injektioner med HBVaxPro.
English: The medicine can only be obtained with a prescription.
Danish: Vaccinen udleveres kun efter recept.
English: The CHMP concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Danish: CHMP konkluderede, at fjernelse af thiomersal fra vacciner ikke reducerede deres effektivitet med hensyn til at beskytte mod infektion med hepatitis B-virus, men reducerede risiciene.
English: Because the active substance used in HBVaxPro was already authorised for use in the EU, there have been no formal studies with HBVaxPro.
Danish: Fordi det aktive stof i HBVaxPro allerede var godkendt til brug i EU, har der ikke været foretaget nogen formelle undersøgelser af HBVaxPro.