FrancophonIA/ELRC3.0 huggingface dataset:
English: Special precautions for use in animals The insulin dose may need to be adjusted or discontinued in case of remission of the diabetic state in cats or after resolution of transient diabetic stages in dogs (e.g. dioestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism).
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Det kan være nødvendigt at justere eller afbryde insulindoseringen i tilfælde af remission af den diabetiske tilstand hos katte eller efter ophør af den forbigående diabetiske tilstand hos hunde (f.eks. diøstrus-induceret diabetes mellitus, diabetes mellitus sekundært til hyperadrenocorticisme).
English: Read the package leaflet before use.
Danish: Subkutan injektion Læs indlægssedlen inden brug.
English: Under clinical field conditions in diabetic dogs, time to maximal effect in lowering blood glucose concentrations (i.e. blood glucose nadir) after subcutaneous administration was not observed within 9 hours after last injection in 67.9% of dogs overall.
Danish: Efter subkutan administration er der hos diabetiske hunde under kliniske forhold ikke observeret maksimal sænkende virkning på blodglukoseskoncentrationen (blodglukoselavpunkt) inden for 9 timer efter sidste injektion hos 67,9 % af samtlige hunde (73,5% hos hunde behandlet én gang dagligt og 59,3 % hos hunde behandlet to gange daglig).
English: Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Boehringer Ingelheim Vetmedica GmbH
English: Veterinary medicinal product subject to prescription.
Danish: Det veterinære lægemiddel indgives som subkutan injektion.
English: Active substance: Insulin human*
Danish: Human insulin
English: Treatment with insulin can cause hypoglycaemia, for clinical signs and appropriate treatment, please refer to section “Overdose”, below.
Danish: For kliniske symptomer og passende behandling, se afsnit ”Overdosis (symptomer, nødforanstaltninger, modgift)” nedenfor.
English: ProZinc 40 IU/ml suspension for injection for cats and dogs
Danish: ProZinc, 40 IE/ml injektionsvæske, suspension til katte og hunde
English: ProZinc 40 IU/ml suspension for injection for dogs
Danish: ProZinc, 40 IE/ml injektionsvæske, suspension til hunde
English: The insulin dose may need to be adjusted or discontinued in case of remission of the diabetic state in cats or after resolution of transient diabetic stages in dogs (e.g. dioestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism).
Danish: Det kan være nødvendigt at justere eller afbryde insulindoseringen i tilfælde af gradvis bedring af den diabetiske tilstand hos katte eller efter ophør af den forbigående diabetiske tilstand hos hunde (f.eks. diabetes i forbindelse med løbetid eller diabetes som følge af binyrebarksygdomme (hyperadrenocorticisme)).
English: The insulin dose may need to be adjusted or discontinued after resolution of transient diabetic stages (e.g. dioestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism).
Danish: Det kan være nødvendigt at justere eller afbryde insulindoseringen efter ophør af den forbigående diabetiske tilstand (f.eks. diabetes i forbindelse med løbetid eller diabetes som følge af binyrebarksygdomme (hyperadrenocorticisme)).
English: Date of first authorisation: Date of last renewal:
Danish: Dato for første markedsføringstilladelse: 12/07/2013 Dato for seneste fornyelse af markedsføringstilladelse: 13/04/2018
English: ProZinc 40 IU/ml injection for cats and dogs insulin human as protamine zinc insulin
Danish: ProZinc, 40 IE/ml injektionsvæske til katte og hunde Human insulin som protaminzink insulin.
English: ProZinc 40 IU/ml suspension for injection for dogs insulin human
Danish: ProZinc, 40 IE/ml injektionsvæske, suspension til hunde Human insulin som protaminzink insulin.
English: Treatment with insulin can cause hypoglycaemia, for clinical signs and appropriate treatment, see section
Danish: Behandling med insulin kan forårsage hypoglykæmi.
English: ProZinc 40 IU/ml suspension for injection for cats and dogs insulin human
Danish: ProZinc, 40 IE/ml injektionsvæske, suspension til katte og hunde Human insulin som protaminzink insulin.
English: ProZinc 40 IU/ml injection for dogs insulin human as protamine zinc insulin
Danish: ProZinc, 40 IE/ml injektionsvæske til hunde Human insulin som protaminzink insulin.
English: Vial, 10 ml
Danish: Hætteglas, 10 ml
English: Vial, 20 ml
Danish: Hætteglas, 20 ml
English: ATCvet code: QI09AB04.
Danish: ATCvet kode: QI09AB04.
English: Date of last renewal: 17 September 2010
Danish: Dato for seneste fornyelse: 17. september 2010
English: DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2000
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 16. november 2000
English: Vaccination scheme:
Danish: Vaccinationsskema:
English: The vaccine should preferably be administered just behind the ear.
Danish: Vaccinen bør fortrinsvis gives lige bag øret.
English: titre2
Danish: titer2
English: ≥6.2 log2 TN titre1
Danish: ≥ 6,2 log2 TN titer1
English: Any person intending to import, sell, supply and/or use Porcilis AR-T DF must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Danish: Enhver person, som har til hensigt at indføre, sælge, levere og/eller anvende Porcilis AR-T DF, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden indførsel, salg, levering og/eller anvendelse finder sted.
English: EU/2/00/026/001 EU/2/00/026/002 EU/2/00/026/003 EU/2/00/026/004
Danish: EU/2/00/026/001 EU/2/00/026/002 EU/2/00/026/003 EU/2/00/026/004 EU/2/00/026/005 EU/2/00/026/006
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Danish: b) at den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.>
English: Pharmacotherapeutic group: inactivated bacterial vaccine.
Danish: Farmakoterapeutisk gruppe: Inaktiveret bakterievaccine.
English: In very rare cases other immediate hypersensitivity reactions, e.g. vomiting, dyspnoea and shock, may occur.
Danish: I meget sjældne tilfælde kan andre akutte hypersensitivitets reaktioner forekomme, f.eks. opkast, dyspnø og shock.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Read the package leaflet before use.
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Læs indlægssedlen inden brug.
English: The immunogens are incorporated in an adjuvant based on dl-α-tocopherol.
Danish: Antigenerne er inkorporerede i en adjuvans baseret på dl-α-tocopherol.
English: Name and address of the manufacturer of the biological active substances:
Danish: Navn og adresse på fremstilleren af de biologisk aktive stoffer
English: The first injection should be administered 6 weeks before the expected date of farrowing.
Danish: Den første vaccination bør administreres 6 uger før forventet faring.
English: Administer one dose of 2 ml by intramuscular injection to pigs of 18 weeks of age and older.
Danish: Giv en dosis af 2 ml ved intramuskulær injektion til grise, der er 18 uger gamle eller ældre.
English: Formaldehyde Water for injections
Danish: Formaldehyd Vand til injektionsvæsker
English: The import, sale, supply and/or use of Porcilis AR-T DF 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 Porcilis AR-T DF er eller kan være forbudt i visse medlemsstater på dele af eller hele deres område.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) No 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
English: Colonisation of the surface of the nasal mucosa by Pasteurella multocida is most often promoted by Bordetella bronchiseptica.
Danish: Kolonisering med Pasteurella multocida på overfladen af den nasale mukosa fremmes ofte af Bordetella bronchiseptica.
English: Apart from a higher average transient increase in body temperature on the day of vaccination or the following day, no adverse reactions other than those mentioned under section 4.6 can be expected following the administration of a double dose of vaccine.
Danish: Bortset fra en midlertidig højere gennemsnitlig legemstemperatur på vaccinationsdagen eller den følgende dag forventes ingen bivirkninger efter brug af dobbelt dosis, ud over hvad der allerede er nævnt under punkt 4.6.
English: Interaction with other medicinal products and other forms of interaction
Danish: Interaktion med andre lægemidler og andre former for interaktion:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/026/001-006
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/00/026/001-006
English: Zero days
Danish: 0 døgn
English: The vaccine contains a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.
Danish: Vaccinen indeholder et non-toksisk, rekombinant derivat af Pasteurella multocida toksinet og inaktiverede Bordetella bronchiseptica celler.
English: Vials are closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Danish: Hætteglassene er lukket med en halogenobutyl gummiprop og forseglet med en aluminiumkappe.
English: Do not mix with any other veterinary medicinal product.
Danish: Må ikke blandes med andre veterinære lægemidler til dyr.
English: Excipient: Formaldehyde
Danish: Hjælpestof: Formaldehyd
English: INDICATION(S) Vaccine against progressive atrophic rhinitis.
Danish: INDIKATION(ER) Vaccine mod progressiv atrofisk rhinitis.
English: Active substances: - Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin)
Danish: Aktive stoffer - Protein dO (non-toksisk deleteret derivat af Pasteurella multocida dermonekrotisk toksin)
English: Incompatibilities Do not mix with any other veterinary medicinal products.
Danish: Uforligeligheder: Må ikke blandes med andre veterinære lægemidler.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis AR-T DF
Danish: VETERINÆRLÆGEMIDLETS NAVN Porcilis AR-T DF
English: Dermonecrotic toxin producing Pasteurella multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis.
Danish: Dermonekrotisk toksinproducerende Pasteurella multocida er det patogen, som forårsager turbinal atrofi ved progressiv atrofisk rhinitis.
English: Special precautions to be taken by the person administering the medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Revaccination: a single injection of one dose (2 ml) should be carried out 2 to 4 weeks prior to each subsequent farrowing.
Danish: Revaccination: En enkelt vaccination med en dosis (2 ml) bør gives 2 - 4 uger før hver efterfølgende faring.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Intervet International B.V.
English: To stimulate active immunity in order to provide passive immunity to the progeny against progressive atrophic rhinitis.
Danish: Til stimulering af aktiv immunitet med henblik på dannelse af passiv immunitet hos afkommet mod progressiv atrofisk rhinitis.
English: Shelf life after first opening the vial: 10 hours.
Danish: Opbevaringstid efter første åbning af beholderen: 10 timer.
English: 20 ml (10 doses) Glass vial 50 ml (25 doses) Glass vial 20 ml (10 doses) PET vial 50 ml (25 doses) PET vial 100 ml (50 doses) PET vial 250 ml (125 doses) PET vial
Danish: 20 ml (10 doser) hætteglas 50 ml (25 doser) hætteglas 20 ml (10 doser) hætteglas (PET) 50 ml (25 doser) hætteglas (PET) 100 ml (50 doser) hætteglas (PET) 250 ml (125 doser) hætteglas (PET)
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO ≥5.5 log2 Aggl.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Pr. dosis af 2 ml: ≥ 6,2 log2 TN titer Protein dO ≥ 5,5 log2 Aggl.
English: Can be used during pregnancy (see details under section 4.9).
Danish: (Se detaljer i afsnit 4.9).
English: Cardboard box containing one glass vial (Hydrolytic Type I) of 20 ml or 50 ml.
Danish: Kartonæske indeholdende 1 hætteglas (hydrolytisk Type I glas) af 20 ml eller 50 ml.
English: A mean transient increase in body temperature of 1.5°C, in some pigs up to 3 °C, which could lead to an abortion, can generally be measured on the day of vaccination or the following day.
Danish: En forbigående stigning i kropstemperaturen på gennemsnitlig 1,5°C men op til 3°C i enkelte grise kan almindeligvis måles på vaccinationsdagen eller den følgende dag.
English: Shake vigorously before and at intervals during use.
Danish: Ryst grundigt før og under brug.
English: Cardboard box containing one PET vial of 20 ml, 50 ml, 100 ml or 250 ml.
Danish: Kartonæske indeholdende 1 hætteglas (PET) af 20 ml, 50 ml, 100 ml eller 250 ml..
English: Marketing authorisation holder and manufacturer: Intervet International B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller af batchfrigivelse: Intervet International B.V.
English: 4.2 Indications for use, specifying the target species For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til reduktion af de kliniske symptomer på progressiv atrofisk rhinitis hos grise gennem passiv oral immunisering via kolostrum fra moderdyr, som er aktivt immuniserede med vaccinen.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: 150 mg dl-α-tocopherol acetate
Danish: 150 mg dl-α-tocopherolacetat
English: ADVICE ON CORRECT ADMINISTRATION Before use, allow the vaccine to reach room temperature.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Lad vaccinen opnå stuetemperatur inden brug.
English: TARGET SPECIES Pigs (sows and gilts)
Danish: DYREARTER Svin (søer og gylte)
English: Primary vaccination: inject one dose (2 ml) per pig, followed by a second injection 4 weeks after the first injection.
Danish: Basisvaccination: Der gives en dosis (2 ml) pr. gris efterfulgt af endnu en injektion 4 uger senere.
English: 50 ml (25 doses)
Danish: 20 ml (10 doser) 50 ml (25 doser)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN FOR UDLEVERING OG BRUG
English: Reduced activity and lack of appetite on the day of vaccination very commonly occurs and/or a transient swelling (max diameter: 10 cm) for up to two weeks may arise at the site of injection.
Danish: Nedsat aktivitet og mangel på ædelyst er meget almindeligt på vaccinationsdagen og/eller en forbigående hævelse (maks.
English: Sodium chloride Phosphate buffer Simethicone Polysorbate 80
Danish: Natriumchlorid Phosphatbuffer Simeticon
English: Shake vigorously before use and at intervals during use.
Danish: Ryst grundigt inden brug og regelmæssigt under brug.
English: For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Danish: Til reduktion af kliniske symptomer på progressiv atrofisk rhinitis hos grise gennem passiv oral immunisering via kolostrum fra moderdyr, som er aktivt immunisrede med vaccinen.
English: Use during pregnancy, lactation or lay Can be used during pregnancy
Danish: Anvendelse under drægtighed og laktation: Kan anvendes under drægtighed.
English: EXP {month/year} Once broached, use within 10 hours.
Danish: Efter anbrud/åbning anvendes inden 10 timer.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS [20 and 50 ml vials]
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER (20 ml og 50 ml)
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Wim de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis AR-T DF suspension for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Porcilis AR-T DF injektionsvæske, suspension til svin
English: PACKAGE SIZE 100 ml (50 doses) 250 ml (125 doses)
Danish: PAKNINGSSTØRRELSE 100 ml (50 doser) hætteglas 250 ml (125 doser) hætteglas
English: titre inactivated B. bronchiseptica cells dl-α-tocopherol acetate
Danish: titer1 inaktiverede B. bronchiseptica celler dl-α-tocopherolacetat
English: PACKAGE LEAFLET Porcilis AR-T DF suspension for injection for pigs
Danish: INDLÆGSSEDDEL Porcilis AR-T DF injektionsvæske, suspension til svin
English: - Inactivated Bordetella bronchiseptica cells
Danish: Inaktiverede Bordetella bronchiseptica celler
English: Shelf life of the veterinary medicinal product as packaged for sale: 5 years Shelf life after first opening the vial: 10 hours.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 5 år.
English: Before use, allow the vaccine to reach room temperature.
Danish: Lad vaccinen opnå stuetemperatur inden brug.
English: Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.
Danish: Nyfødte grise opnår passiv immunitet via optagelse af kolostrum fra vaccinerede søer/gylte.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE [100 and 250 ml vials]
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE (100 ml og 250 ml hætteglas)
English: Name and address of the manufacturer responsible for batch release:
Danish: Navn og adresse på fremstilleren, der er ansvarlig for batchfrigivelse
English: Adjuvant: dl-α-tocopherol acetate
Danish: Adjuvans: dl-α-tocopherolacetat
English: 1 Mean toxin neutralising titre obtained after repeated vaccination of a half dose in rabbits.
Danish: 1 Middel titer for neutralisering af toksin opnået efter gentagen vaccination af kaniner med halv dosis.
English: 2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits
Danish: 2 Middel agglutinations titer opnået efter en enkelt vaccination af kaniner med ½ dosis.
English: 4.6 Adverse reactions (frequency and seriousness) A mean transient increase in body temperature of 1.5 °C, in some pigs up to 3 °C, which could lead to an abortion, can generally be measured on the day of vaccination or the following day.
Danish: En forbigående stigning i kropstemperaturen på gennemsnitlig ca. 1,5°C men op til 3°C i enkelte grise kan almindeligvis måles på vaccinationsdagen eller den følgende dag.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) ≥5.5 log2 Aggl.
Danish: Pr. dosis af 2 ml: - ≥ 6,2 log2 TN titer Protein dO (non-toksisk deleteret derivat af Pasteurella multocida dermonekrotisk toksin) - ≥ 5,5 log2 Aggl.
English: TARGET SPECIES Pigs (sows and gilts).
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Svin (søer og gylte)
English: EXPIRY DATE EXP {month/year} Once broached, use within 10 hours.
Danish: 10. UDLØBSDATO EXP Måned/år
English: B. bronchiseptica cells
Danish: titer inaktiverede B. bronchiseptica celler
English: WITHDRAWAL PERIOD Zero days
Danish: 10. TILBAGEHOLDELSESTID 0 døgn.
English: (2015/2016 season)
Danish: (Sæsonen 2015/2016)
English: In such cases, the Western blot method is negative.
Danish: I sådanne tilfælde er Western blot-metoden negativ.
English: Component of a multipack, can't be sold separately.
Danish: Del af en flerstykspakning, kan ikke sælges separat.
English: Adults from the age of 18 years:
Danish: Voksne fra 18 år:
English: Therefore, the vaccine may work less effectively.
Danish: Vaccinen kan derfor være mindre effektiv.
English: BEFORE receiving the vaccine
Danish: FØR De får vaccinen
English: Outer carton box will include “Blue Box”.
Danish: Den ydre karton vil inkludere ”Blå Boks”.
English: - Fever greater than 39.0°C
Danish: - Feber over 39,0 °C
English: - Allergic reactions, in very rare cases leading to shock
Danish: - Allergiske reaktioner, som i meget sjældne tilfælde har ført til shock
English: These reactions are usually mild and only last a few days.
Danish: Disse reaktioner er som regel milde og varer kun et par dage.
English: Rare to <1/1000
Danish: Sjældne til < 1/1.000
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De får denne vaccine, da den indeholder vigtige oplysninger.
English: Vaccine Efficacy*
Danish: Vaccinens virkning*
English: • if you have an acute illness associated with fever.
Danish: • hvis De har en akut sygdom, som er forbundet med feber.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Danish: Disse forbigående falsk positive resultater kan skyldes produktion af IgM som reaktion på vaccinen.
English: ** Thrombocytopenia (some very rare cases were severe with platelet counts less than 5000 per mm3)
Danish: ** Trombocytopeni (visse meget sjældne tilfælde var alvorlige med trombocyttal under 5.000 pr. mm3)
English: * These reactions usually disappeared within 1-2 days without treatment.
Danish: * Disse reaktioner forsvandt som regel inden for 1-2 dage efter vaccinationen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Vaccine Efficacy = (1 - Relative Risk) x 100 %
Danish: Vaccinens virkning = (1 - relativ risiko) x 100 %
English: Among the overall study population enrolled, the mean age was 33 years, 55% were female, 84% were Caucasian, 7% were Black, 7% were Hispanic, and 2% were of other ethnic origin.
Danish: I den samlede, indskrevne studiepopulation var gennemsnitsalderen 33 år, 55 % var kvinder, 84 % var kaukasiere, 7 % var sorte, 7 % var af latinamerikansk oprindelse, og 2 % var af anden etnisk oprindelse.
English: Optaflu was well tolerated and immunogenic in mice and ferrets.
Danish: Optaflu var veltolereret og immunogent hos mus og fritter.
English: Optaflu has not been studied in the paediatric population and therefore, data on immune response are not available for this age group.
Danish: Optaflu er ikke blevet undersøgt i den pædiatriske population, og der er derfor ingen tilgængelige data vedrørende immunrespons i denne aldersgruppe.
English: - Thrombocytopenia**
Danish: - Trombocytopeni**
English: Optaflu should be used in accordance to Official guidance.
Danish: Optaflu skal anvendes i overensstemmelse med de officielle retningslinjer.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optaflu (2015/2016 season)
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Optaflu (Sæsonen 2015/2016)
English: Immunisation shall be postponed in patients with febrile illness or acute infection.
Danish: Immunisering skal udskydes hos patienter med febersygdom eller akut infektion.
English: The safety of Optaflu has been assessed in seven randomized, active controlled clinical trials performed as part of the development program.
Danish: Optaflus sikkerhed er blevet vurderet i syv randomiserede, aktivt kontrollerede kliniske studier, der er udført som en del af udviklingsprogrammet.