FrancophonIA/ELRC3.0 huggingface dataset:
English: • in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon.
Danish: hos anæmiske katte med en dødelighed på ca. 60 % reduceres dødeligheden med ca. 30% ved 4, 6, 9 og 12 måneder efter behandling med interferon.
English: Slight and transient clinical signs such as hyperthermia (3-6 hours after injection) lethargy and digestive signs ( vomiting and soft faeces to mild diarrhoea, in cats only) were commonly observed in safety studies.
Danish: Lette og forbigående kliniske symptomer som hypertermi (3-6 timer efter injektion), sløvhed og symptomer fra mave/tarm (opkast og blød fæces til mild diaré, kun hos katte) var almindelige under studierne af sikkerheden.
English: Special precautions for use in animals
Danish: Specielle forholdsregler til brug hos dyr
English: Cats: as vaccination is contra-indicated in the symptomatic phase of FeLV/FIV infections, the effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Danish: Kat: Da vaccination er kontraindikeret i den symptomatiske fase af FeLV/FIV infektion, har effekten af VIRBAGEN OMEGA på kattevacciner ikke været undersøgt.
English: Dogs: Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered.
Danish: Hund: Vaccination under og efter VIRBAGEN OMEGA er kontraindikeret, indtil hunden ser ud til at være rask.
English: Shelf life after reconstitution according to directions: use immediately.
Danish: Opbevaringstid efter rekonstituering ifølge anvisning: Anvendes straks.
English: Dogs: Intravenous route Cats: Subcutaneous route
Danish: Hund: Intravenøs brug Kat: Subkutan brug
English: Pharmacotherapeutic group: Interferons ATCvet code : QL03AB
Danish: ATCvet-kode: QL03 AB
English: The import, sale, supply and/or use of VIRBAGEN OMEGA is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Danish: Indførsel, salg, levering og/eller anvendelse af VIRBAGEN OMEGA er eller kan være forbudt i visse medlemsstater på dele af eller hele deres område.
English: • in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV was reduced by 20% following treatment with interferon.
Danish: hos ikke anæmiske katte, blev en dødelighed på 50% hos katte, der er inficeret med FeLV, reduceret med 20% efter behandling med interferon.
English: Solvent: Type I glass vial of 1 ml of solvent closed with butyl elastomer rubber stopper.
Danish: Solvens: Hætteglas af type I glas med 1 ml solvens lukket med gummiprop af butylelastomer.
English: • slight sinus tachycardia.
Danish: • let sinus takykardi
English: Efficacy of the product on cats with a tumorous form of the infection by FeLV, or cats infected by FeLV or coinfected by FIV in terminal stages was not tested.
Danish: Effekten af præparatet på katte med tumorform af FeLV infektion, eller katte samtidig inficeret med FeLV og FIV i terminal fasen, er ikke undersøgt.
English: In a field study conducted, it was observed that there was : - a reduction of clinical signs during the symptomatic phase (4 months) - a reduction of mortality:
Danish: I en gennemført feltundersøgelse blev følgende observeret: - reduktion i kliniske tegn i løbet af den symptomatiske fase (4 måneder) - reduktion af dødelighed:
English: In a field study conducted, it was observed that there was: - a reduction of clinical signs during the symptomatic phase (4 months) - a reduction of mortality:
Danish: I en gennemført feltundersøgelse blev følgende observeret: - reduktion i kliniske tegn i løbet af den symptomatiske fase (4 måneder) - reduktion af dødelighed :
English: Dogs:
Danish: Hund:
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Danish: Indførsel, besiddelse, salg, levering og/eller anvendelse af dette veterinærlægemiddel er eller kan være forbudt i en medlemsstat på dele af eller hele deres område.
English: For the 10MU presentation:
Danish: For hver pakning på 10 MU:
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: EXP {month/year} The product should be used immediately after reconstitution.
Danish: EXP {måneder/år} Præparatet bør anvendes straks, efter det er rekonstitueret.
English: Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Danish: Til behandling af katte, der er inficeret med FeLV og/eller samtidig med FIV, i en ikke-kritisk klinisk tilstand, fra de er 9 uger gamle.
English: 06516 Carros, France
Danish: 06516 Carros, Frankrig
English: The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain, depending on the presentation, a limpid and colourless suspension containing 5 MU or 10 MU of recombinant interferon.
Danish: Det frysetørrede pulver skal rekonstitueres med 1 ml af det specifikke fortyndingsmiddel for at opnå, afhængig af pakningen, en klar og farveløs suspension indeholdende 5 MU eller 10 MU rekombinant interferon.
English: The product should be used immediately after reconstitution.
Danish: Præparatet bør anvendes straks, efter det er rekonstitueret.
English: Cats:
Danish: Kat:
English: Marketing authorisation holder and manufacturer responsible for batch release
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse
English: Cardboard box containing 1 vial of lyophilisate and 1 vial with 1 ml of solvent Cardboard box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent
Danish: Papæske med 1 hætteglas med lyofilisat og 1 hætteglas med 1 ml solvens Papæske med 2 hætteglas med lyofilisat og 2 hætteglas med 1 ml solvens Papæske med 5 hætteglas med lyofilisat og 5 hætteglas med 1 ml solvens
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig for batchfrigivelse VIRBAC
English: Cats: Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Danish: Til behandling af katte der er inficeret med FeLV og/eller samtidig med FIV, i en ikke-kritisk klinisk tilstand, fra de er 9 uger gamle.
English: 06516 CARROS France
Danish: 06516 CARROS Frankrig
English: 5.2 Pharmacokinetic particulars
Danish: Farmakokinetiske egenskaber
English: Dogs: The dose is 2.5 MU/kg bodyweight.
Danish: Hund: Doseringen er 2,5 MU/kg legemsvægt.
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: Dogs: The reconstituted product should be injected intravenously once daily for 3 consecutive days.
Danish: Hund: Det rekonstituerede præparat bør injiceres intravenøst én gang daglig, 3 dage i træk.
English: VIRBAGEN OMEGA 10 MU for dogs and cats
Danish: VIRBAGEN OMEGA 10 MU til hund og kat
English: The dose is 2.5 MU/kg bodyweight.
Danish: Doseringen er 2,5 MU/kg legemsvægt.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
Danish: VIRBAGEN OMEGA 5 MU til hund og kat VIRBAGEN OMEGA 10 MU til hund og kat
English: The reconstituted product should be injected intravenously once daily for 3 consecutive days.
Danish: Det rekonstituerede præparat bør injiceres intravenøst én gang daglig, 3 dage i træk.
English: The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a suspension containing 5 MU of recombinant interferon.
Danish: Det frysetørrede pulver skal rekonstitueres med 1 ml af det specifikke fortyndingsmiddel for at opnåen suspension indeholdende 5 MU rekombinant interferon.
English: For the 10MU presentation: Cardboard box containing 1 vial of lyophilisate and 1 vial with 1 ml of solvent
Danish: For hver pakning på 10 MU: Papæske med 1 hætteglas med lyofilisat og 1 hætteglas med 1 ml solvens
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: VIRBAGEN OMEGA 5 MU for dogs and cats
Danish: VIRBAGEN OMEGA 5 MU til hund og kat
English: Cats: The dose is 1 MU/kg bodyweight.
Danish: Kat: Doseringen er 1 MU/kg legemsvægt.
English: For the 5MU presentation: Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent
Danish: For hver pakning på 5 MU: Papæske med 5 hætteglas med lyofilisat og 5 hætteglas med 1 ml solvens
English: Box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent.
Danish: Æske med 2 hætteglas lyofilisat samt 2 hætteglas indeholdende 1 ml solvens.
English: The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution containing 10 MU of recombinant interferon.
Danish: Det frysetørrede pulver skal rekonstitueres med 1 ml af det specifikke fortyndingsmiddel for at opnå en suspension indeholdende 10 MU rekombinant interferon.
English: Cats.
Danish: Kat.
English: The dose is 1 MU/kg bodyweight.
Danish: Doseringen er 1 MU/kg legemsvægt.
English: PACKAGE LEAFLET VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
Danish: INDLÆGSSEDDEL VIRBAGEN OMEGA 5 MU til hund og kat VIRBAGEN OMEGA 10 MU til hund og kat
English: VIRBAGEN OMEGA Solvent for suspension for injection
Danish: Lyofilisat og solvens til injektionsvæske, suspension
English: The reconstituted product should be injected subcutaneously once daily for 5 consecutive days.
Danish: Det rekonstituerede præparat bør injiceres subkutant en gang daglig, 5 dage i træk.
English: Box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent.
Danish: Æske med 5 hætteglas lyofilisat samt 5 hætteglas indeholdende 1 ml solvens.
English: Cats: The reconstituted product should be injected subcutaneously once daily for 5 consecutive days.
Danish: Kat: Det rekonstituerede præparat bør injiceres subkutant en gang daglig, 5 dage i træk.
English: Recombinant Omega interferon of feline origin 5 MU* 10 MU presentation:
Danish: Rekombinant Omega interferon fra dyr af katteslægten 5 MU* 10 MU pakning:
English: Lyophilisate: Recombinant Omega interferon of feline origin
Danish: Lyofilisat: Rekombinant Omega interferon fra dyr af katteslægten 10 MU*
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Indlægssedlen eller etiketten bør vises til lægen.
English: Dispose of waste material in accordance with local requirements
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer
English: Once reconstituted use immediately.
Danish: Anvendes straks efter rekonstitution.
English: EXP: {month/year} Once reconstituted use immediately.
Danish: EXP {måneder/år} Anvendes straks efter rekonstitution.
English: Recombinant Omega interferon of feline origin 5 MU*/ ml * MU: Million Units
Danish: Rekombinant Omega interferon fra dyr af katteslægten 5 MU*/ ml *MU: Million enheder
English: Box containing 1 vial of lyophilisate and 1 vial with 1 ml of solvent.
Danish: Æske med 1 hætteglas lyofilisat samt 1 hætteglas indeholdende 1 ml solvens.
English: Recombinant Omega interferon of feline origin 10 MU*/ ml * MU: Million Units
Danish: Rekombinant Omega interferon fra dyr af katteslægten 10 MU*/ ml *MU: Million enheder
English: Recombinant Omega interferon of feline origin 10 MU* *MU : Million Units
Danish: Rekombinant Omega interferon fra dyr af katteslægten 10 MU* *MU: Million enheder
English: Cardboard box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent Not all pack sizes may be marketed.
Danish: Papæske med 2 hætteglas med lyofilisat og 2 hætteglas med 1 ml solvens Papæske med 5 hætteglas med lyofilisat og 5 hætteglas med 1 ml solvens
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer) Toray industries, Inc.
English: Isotonic sodium chloride solution
Danish: Isotonisk saltvandsopløsning
English: Excipients:
Danish: Lyofilisat:
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGS-TILLADELSEN
English: This summary was last updated in 08-2016.
Danish: Dette sammendrag blev sidst ajourført i 08-2016.
English: IDflu is a vaccine.
Danish: IDflu er en vaccine.
English: The immunogenicity and safety of subsequent formulations of the vaccine have also been examined in
Danish: Immunogeniciteten af og sikkerheden ved efterfølgende formuleringer af vaccinen er også blevet
English: This is a summary of the European public assessment report (EPAR) for IDflu.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for IDflu.
English: influenza vaccine (split virion, inactivated)
Danish: Influenzavaccine (split virion, inaktiveret)
English: IDflu contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type).
Danish: IDflu indeholder 15 mikrogram af hver af tre forskellige stammer (varianter) af influenzavirus (en H1N1-undertype, A/California/7/2009, NYMC X-179A; en H3N2-undertype, A/Hong Kong/4801/2014, NYMC X-263B; og en type B, B/Brisbane/60/2008, vildtype).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om,
English: What measures are being taken to ensure the safe and effective use of IDflu?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af IDflu?
English: Why has IDflu been approved?
Danish: Hvorfor blev IDflu godkendt?
English: The European Commission granted a marketing authorisation valid throughout the EU for IDflu on 24
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for IDflu den 24. februar 2009.
English: IDflu must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9.
Danish: IDflu må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for de aktive stoffer, over for nogen af indholdsstofferne eller over for nogen af komponenterne, som kan forekomme i meget små mængder, såsom æg (ovalbumin, kyllingeproteiner), neomycin, formaldehyd eller octoxinol 9.
English: The ability of IDflu to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people.
Danish: IDflus evne til at udløse dannelsen af antistoffer (immunogenicitet) blev først vurderet i fem hovedundersøgelser, som omfattede næsten 9 000 personer.
English: What is the risk associated with IDflu?
Danish: Hvilken risiko er der forbundet med IDflu?
English: IDflu is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease.
Danish: IDflu anvendes til at vaccinere personer i alderen 60 år og derover mod influenza, navnlig de, der har øget risiko for at udvikle komplikationer af sygdommen.
English: The most common side effects with IDflu (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Danish: De hyppigste bivirkninger ved IDflu (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, muskelsmerter og lokale reaktioner på vaccinationsstedet (rødme, hævelse, dannelse af hård hud, smerte og kløe).
English: When a person is given the vaccine, the immune system recognises the virus fragments as ‘foreign' and makes antibodies against them.
Danish: Når vaccinen gives til en person, opfatter immunsystemet virusfragmenterne som "fremmede" og danner antistoffer mod dem.
English: The antibodies will then help to protect against the disease caused by these strains of flu virus.
Danish: Antistofferne medvirker efterfølgende til at beskytte mod sygdom forårsaget af disse influenzavirusstammer.
English: People who have fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Danish: Personer med feber eller akutte (kortvarige) infektioner bør ikke vaccineres, før de er raske.
English: Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season.
Danish: Verdenssundhedsorganisationen (WHO) udsender hvert år anbefalinger for, hvilke influenzastammer der bør være indeholdt i vacciner til den efterfølgende influenzasæson.
English: The shoulder is the recommended site of injection.
Danish: Det foretrukne injektionssted er skulderen.
English: The vaccine contains fragments of influenza (flu) viruses that have been inactivated (treated to prevent them causing infection).
Danish: Vaccinen indeholder brudstykker af influenzavira, som er blevet inaktiveret (behandlet således, at de ikke forårsager infektion).
English: IDflu contains fragments from three different strains of flu virus.
Danish: IDflu indeholder brudstykker fra tre forskellige influenzavirusstammer.
English: The CHMP decided that IDflu's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved IDflu opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for IDflu.
English: IDflu is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system.
Danish: IDflu gives som én "intradermal" indsprøjtning i det øverste hudlag ved hjælp af et særligt mikroinjektionssystem.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Danish: Derefter vil immunsystemet hurtigere kunne danne antistoffer, når det udsættes for en af disse virusstammer.
English: Three studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength.
Danish: Tre undersøgelser omfattede personer i alderen 60 år og derover, som var blevet vaccineret med styrken på 15 mikrogram.
English: Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in IDflu before the
Danish: Fragmenter af de virusstammer, der ifølge anbefalingerne fra WHO for den nordlige halvkugle og fra Den Europæiske Union (EU) forventes at forårsage influenza i den kommende sæson, skal være indeholdt i IDflu, inden vaccinen
English: How does IDflu work?
Danish: Hvordan virker IDflu?
English: In one study in people aged 60 years and over, IDflu was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response).
Danish: I en undersøgelse af personer i alderen 60 år og derover blev IDflu sammenlignet med en influenzavaccine, der indeholder en adjuvans (en forbindelse, som tilføjes for at give en bedre immunrespons).
English: In all studies, IDflu was compared with another flu vaccine given by injection into a muscle.
Danish: I alle undersøgelserne blev IDflu sammenlignet med en anden influenzavaccine indgivet ved injektion i en muskel.
English: In the five original studies, both IDflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Danish: I de fem oprindelige undersøgelser bevirkede både IDflu og sammenligningsvaccinen dannelse af tilstrækkelige mængder beskyttende antistoffer mod alle tre influenzastammer.
English: Later seasonal formulations of IDflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
Danish: Senere sæsoners formuleringer af IDflu har vist sig at fremkalde lignende antistofreaktioner mod de tre influenzastammer, som er indeholdt i vaccinen, svarende til reaktionerne i hovedundersøgelsen.
English: The other two studies looked at use of a lower strength in people under the age of 60.
Danish: De to andre undersøgelser omfattede personer under 60 år, der var blevet vaccineret med en lavere styrke.
English: In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the comparator vaccines.
Danish: Hos personer i alderen 60 år og derover gav styrken på 15 mikrogram en lige så god beskyttelse som
English: The use of the vaccine should be based on
Danish: Anvendelsen af vaccinen bør ske i overensstemmelse med officielle retningslinjer.
English: The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before
Danish: I undersøgelserne sammenlignedes vaccinernes evne til at fremkalde antistofdannelse (immunogenicitet) ved at sammenholde antistofindholdet før injektionen og tre uger efter.
English: The full EPAR for IDflu can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for IDflu findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Hvis du ønsker yderligere oplysninger om behandling med IDflu, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din
English: IDflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Danish: IDflu er en vaccine, der leveres som injektionsvæske (suspension) i en fyldt sprøjte.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of IDflu have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af IDflu.
English: What benefit has IDflu shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved IDflu?
English: For the full list of all side effects reported with IDflu, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved IDflu fremgår af
English: The following other side effects have also been reported:
Danish: Følgende andre bivirkninger er også blevet rapporteret:
English: Median OS (months)
Danish: Median OS (måneder)
English: The risk for humans is thus unknown.
Danish: Risikoen for mennesker kendes derfor ikke.
English: You may need urgent treatment.
Danish: Der kan være behov for omgående behandling.
English: This is because there may be a risk that an unborn baby is harmed.
Danish: Det skyldes, at der kan være en risiko for at skade et ufødt barn.
English: These elevations were mainly transient and did not lead to discontinuation.
Danish: Disse forhøjelser var hovedsagelig forbigående og medførte ikke seponering.