FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregnancy and lactation: Do not use in pregnant cats.
Danish: Drægtighed og laktation: Må ikke anvendes til drægtige katte.
English: This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most.
Danish: Denne lokale reaktion kan være i form af ødem, hævelse og knudedannelse, som forsvinder spontant inden for 3 til 4 uger.
English: Primary vaccination: - first injection in kittens from 8 weeks of age - second injection 3 or 4 weeks later.
Danish: Basisvaccination - første injektion fra killingerne er 8 uger gamle - anden injektion 3 til 4 uger senere.
English: Therefore, a test for presence of FeLV before vaccination is recommended.
Danish: Det anbefales derfor, at udføre en test for tilstedeværelse af FeLV før vaccination.
English: The vaccine can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.
Danish: Vaccinen kan anvendes til revaccination af killinger eller katte, som tidligere er vaccineret med hhv. FELIGEN RCP og LEUCOGEN.
English: PL : Polska VIRBAC Sp. z o.o.
Danish: VIRBAC Sp. z o.o.
English: The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.
Danish: Forbigående normale symptomer efter vaccination kan også observeres, såsom: hyperthermi (der sædvanligvis varer 1 til 4 dage), apati, fordøjelsesforstyrrelser.
English: Special precautions for use in animals:
Danish: Særlige forsigtighedsregler vedrørende brug til dyr:
English: The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain.
Danish: Vaccinen indeholder renset p45 FeLV-envelope antigen, fremstillet ved genetisk rekombination af E. coli-stammen.
English: Store and transport refrigerated.
Danish: Opbevares og transporteres nedkølet.
English: No adverse reactions were observed after an overdose administration (10 doses of lyophilisate and 2 doses of suspension) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Danish: Der er ikke observeret bivirkninger ved overdosering (10 doser af frysetørret pulver og 2 doser af suspension) med veterinærlægemidlet, udover de i afsnit 4.6 nævnte, bortset fra lokale reaktioner, der kan vare længere (maksimalt 5 til 6 uger).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
English: Minimum quantity of purified p45 FeLV-envelope antigen
Danish: Minimumsmængde renset p45-FeLV-envelope-antigen
English: Excipient: Stabilizing buffer containing gelatin: to
Danish: Hjælpestof: Stabiliserende buffer indeholdende gelatine, svarende til
English: The onset of immunity has been demonstrated from: - 3 weeks after the primary vaccination for the panleucopenia and leukaemia components - 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components.
Danish: Indtræden af immunitet er vist fra: - 3 uger efter endt basisvaccination for viruskomponenterne mod panleukopeni og leukæmi - 4 uger efter endt basisvaccination for calicivirus og rhinotracheitis virus.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Febrile limping syndrome reactions may occur very rarely in kittens, as reported in the literature after the use of any vaccine containing a Feline Calicivirus component.
Danish: Symptomer på 'Febrile limping syndrome´ kan i meget sjældne tilfælde ses hos killinger, som beskrevet i litteraturen efter brug af enhver vaccine indeholdende en felin calicivirus-komponent.
English: Active substance:
Danish: Aktivt stof:
English: 1 dose
Danish: 1 dosis.
English: EXP {month/year} Once reconstituted use immediately.
Danish: EXP {måneder/år} Efter rekonstitution: Anvendes straks.
English: Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination.
Danish: Maternelle antistoffer, især imod felin panleukopenivirus, kan influere negativt på immunresponset over for vaccination.
English: Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Danish: Én dosis (1 ml) af veterinærlægemidlet administreres subkutant i henhold til følgende vaccinationsprogram:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: For the leukaemia component, protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Danish: For felin leukæmi-komponenten gælder, at beskyttelse mod persisterende viræmi er vist hos 73 % af katte 3 uger efter første vaccination.
English: After the primary vaccination course, the duration of immunity lasts for one year for all components.
Danish: Efter endt basisvaccination er varigheden af immuniteten 1 år for alle komponenter.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Danish: De bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninger om dette veterinærlægemiddel.
English: 06517 Carros France service-conso@virbac.fr
Danish: FR: France VIRBAC France 13e rue LID 06517 Carros France service-conso@virbac.fr
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Danish: Vaccine mod felin viral rhinotracheitis, felin calicivirus, felin panleukopeni og felin leukæmi.
English: Excipient: Buffered isotonic solution to
Danish: Hjælpestof: Isotonisk bufferopløsning
English: Reconstitute one dose of lyophilisate with one dose of suspension, shake gently and administer immediately.
Danish: Én dosis frysetørret pulver (lyofilisat) rekonstitueres med én dosis suspension, rystes let og administreres umiddelbart efter.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Live attenuated feline calicivirus (strain F9)
Danish: Levende, svækket felin calicivirus (stamme F9)
English: Per dose of 1 ml:
Danish: Dosis svarende til 1 ml indeholder:
English: Suspension for LEUCOFELIGEN FeLV/RCP, for cats
Danish: Suspension til LEUCOFELIGEN FeLV/RCP, til katte
English: Incompatibilities:
Danish: Uforligeligheder:
English: Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Danish: Natriumchlorid Dinatriumfosfat, vandfri Kaliumdihydrogenphosphat Aluminiumhydroxid gel Quillaja saponaria Vand til injektionsvæsker
English: Box of 10 or 50 lyophilisate vials and 10 or 50 suspension vials
Danish: Æske med 10 eller 50 hætteglas med lyofilisat og 10 eller 50 hætteglas med suspension
English: The antigenic suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.
Danish: Til antigenopløsningen er der anvendt aluminiumhydroxidgel og renset ekstrakt af Quillaja saponaria som adjuvans.
English: Visual aspect:
Danish: Udseende:
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr I tilfælde af selvinjektion ved hændeligt uheld, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: WITHDRAWAL PERIOD(S)
Danish: TILBAGEHOLDELSESTID(er)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: In this case, since annual revaccination is required for calicivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of FELIGEN RCP can be used annually.
Danish: I sådanne tilfælde kan en enkelt dosis FELIGEN RCP gives hvert år, da årlig revaccination er nødvendig for calicivirus-, rhinotracheitisvirus- og panleucopenivirus-komponenterne.
English: 1.3 ml before freeze-drying
Danish: 1,3 ml før frysetørring foretages.
English: The feline calicivirus and feline panleucopenia virus vaccine strains can spread.
Danish: Vaccinestammerne med felin calicivirus og felin panleukopenivirus kan spredes.
English: Lyophilisate and suspension for suspension for injection.
Danish: Lyofilisat og suspension til injektionsvæske, suspension.
English: Shelf life after reconstitution: use immediately.
Danish: Opbevaringstid efter rekonstituering: Anvendes straks
English: Live attenuated feline viral rhinotracheitis virus (strain F2)
Danish: Levende, svækket felin viral rhinotracheitisvirus (stamme F2)
English: Disposal: read package leaflet.
Danish: Bortskaffelse: Læs indlægssedlen
English: Name and address of the manufacturers of the biological active substances
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer)
English: Live attenuated feline panleucopenia virus (strain LR 72)
Danish: Levende, svækket felin panleucopenivirus (stamme LR 72)
English: Marketing authorisation holder and manufacturer responsible for the batch release:
Danish: Indehaver af markedsføringstilladelsen og fremstiller af batchfrigivelse:
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig for batchfrigivelse
English: LEUCOFELIGEN FeLV/RCP, lyophilisate for cats
Danish: LEUCOFELIGEN FeLV/RCP, lyofilisat til katte
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Read the package leaflet before use Subcutaneous use
Danish: Læs indlægssedlen inden brug.
English: Plastic or cardboard box of 10 lyophilisate vials and 10 suspension vials.
Danish: Plast- eller papæske med 10 hætteglas med lyofilisat og 10 hætteglas med suspension.
English: Potassium hydroxide Lactose monohydrate Glutamic acid
Danish: Kaliumhydroxid Lactosemonohydrat Glutaminsyre
English: Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years for the leukaemia component.
Danish: Efter en boostervaccination givet 1 år efter endt basisvaccination kan efterfølgende vaccinationer gives med intervaller på 3 år gældende for viruskomponenten mod leukæmi.
English: Plastic or cardboard box of 50 lyophilisate vials and 50 suspension vials.
Danish: Plast- eller papæske med 50 hætteglas med lyofilisat og 50 hætteglas med suspension.
English: A type I glass vial containing one dose (1 ml) of the adjuvanted liquid vaccine, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Danish: Et hætteglas af glas type I indeholdende en dosis (1 ml) vaccinesuspension lukket med en 13 mmdiameter prop af butylelastomer, fastgjort med en aluminiumskapsel.
English: - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs, - feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Danish: - felin calicivirus til reduktion af kliniske symptomer, - felin viral rhinotracheitis til reduktion af kliniske symptomer og virusudskillelse, - felin panleukopeni til forebyggelse af leukopeni og reduktion af kliniske symptomer, - felin leukæmi til forebyggelse af vedvarende viræmi og kliniske symptomer på sygdommen.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: Type I glass vial containing one dose (1 ml) of the adjuvanted liquid, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Danish: Et hætteglas af glas type I indeholdende en dosis (1 ml) suspension lukket med en 13 mm-diameter prop af butylelastomer, fastgjort med en aluminiumskapsel
English: Reconstitute one dose of lyophilisate with one dose (1ml) of suspension, shake gently and administer immediately.
Danish: Én dosis af frysetørret pulver (1 ml) og én dosis suspension blandes, rystes let og gives umiddelbart efter.
English: - feline calicivirosis to reduce clinical signs, - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs,
Danish: - felin calicivirus til reduktion af kliniske symptomer, - felin viral rhinotracheitis til reduktion af kliniske symptomer og virusudskillelse, - felin panleukopeni til forebyggelse af leukopeni og reduktion af kliniske symptomer, - felin leukæmi til forebyggelse af persisterende viræmi og kliniske symptomer på sygdommen.
English: A type I glass vial containing one dose of freeze-dried attenuated live viral components with a butyl elastomer stopper.
Danish: Et hætteglas af glas type I indeholdende en dosis frysetørrede, svækkede, levende viruskomponenter lukket med en prop af butylelastomer.
English: PACKAGE LEAFLET: LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
Danish: INDLÆGSSEDDEL: LEUCOFELIGEN FeLV/RCP, lyofilisat og suspension til injektionvsæke, suspension til katte
English: 103.7-104.5 CCID50*
Danish: CCID50* CCID50* CCID50*
English: Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated for the leukaemia component.
Danish: Efter en boostervaccination givet 1 år efter endt basisvaccination er det vist, at varigheden af immunitet er 3 år for viruskomponenten mod leukæmi.
English: Potassium dihydrogen phosphate Dipotassium phosphate Water for injections
Danish: Kaliumdihydrogenphosphat Dikaliumphosphat Vand til injektionsvæsker Natriumchlorid Dinatriumphosphat, vandfri
English: LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
Danish: LEUCOFELIGEN FeLV/RCP, lyofilisat og suspension til injektionsvæske, suspension til katte.
English: SUSPENSION VIAL
Danish: 10. TILBAGEHOLDELSESTID
English: Lyophilisate: White color.
Danish: Frysetørret pulver: Hvid farve Suspension: Opaliserende væske
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: ère avenue 2065 m LID 06516 Carros France
Danish: ère avenue 2065 m LID 06516 Carros Frankrig
English: Sodium chloride
Danish: Tørstof (lyofilisat):
English: Gelatin
Danish: PRODUKTRESUME
English: Suspension: Opalescent liquid.
Danish: Frysetørret pulver: Hvid pellet Suspension: Opaliserende væske
English: not known not known
Danish: ikke kendt ikke kendt
English: Absolute bioavailability is greater than 80%.
Danish: Den absolutte biotilgængelighed er større end 80 %.
English: In particular, patients have experienced the following serious side effects:
Danish: Patienter har især oplevet følgende alvorlige bivirkninger:
English: These patients may be at risk of pregnancy.
Danish: Disse patienter risikerer derfor at blive gravide.
English: if you drink alcohol excessively (either every day or only from time to time).
Danish: - hvis De har et overdrevent alkoholforbrug (enten hver dag eller fra tid til anden).
English: This is to check that your liver is working normally.
Danish: Dette sker for at kontrollere, at Deres lever fungerer normalt.
English: County Wicklow Ireland
Danish: County Wicklow Irland
English: Absorption is not influenced by food intake.
Danish: Absorptionen påvirkes ikke af fødeindtagelse.
English: The potential risk for humans is unknown.
Danish: Den eventuelle risiko for mennesker kendes ikke.
English: if you have or have ever had bladder cancer.
Danish: - hvis De har eller nogensinde har haft blærekræft.
English: 28065 Cerano (NO) Italy
Danish: 28065 Cerano (NO) Italien
English: Date of first authorisation: 11 December 2007 Date of latest renewal: 10 November 2017
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 11. december 2007 Dato for seneste fornyelse: 10. november 2017
English: The data presented during the current reporting period did not provide new information that would allow for further reduction, mitigation, or characterisation of these risks.
Danish: De præsenterede data fra indeværende rapporteringsperiode, har ikke tilvejebragt nye oplysninger, som ville tillade yderligere reduktion, afbødning eller karakterisering af disse risici.
English: Two-year clinical studies have shown maintenance of this effect.
Danish: Kliniske studier af en varighed på to år har vist, at denne effekt bibeholdes.
English: However, this did not lead to an increase in mortality in this study.
Danish: Dette førte imidlertid ikke til øget dødelighed i dette studie.
English: The recommended dose is one tablet taken twice daily.
Danish: Den anbefalede dosis er én tablet to gange daglig.
English: If necessary your doctor may tell you to take a different dose.
Danish: Efter behov kan Deres læge give Dem besked om at tage en anden dosis.
English: Previous anti-diabetic medicinal products were discontinued for 12 weeks prior to baseline measurements.
Danish: Tidligere antidiabetiske lægemidler blev afbrudt i 12 uger inden baseline-målingerne.
English: Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Danish: Visse epidemiologiske studier har tydet på en lignende øget risiko for frakturer hos både mænd og kvinder.
English: Package leaflet: Information for the patient
Danish: Indlægsseddel: information til patienten
English: The level of sugar in your blood or urine should be checked regularly.
Danish: Deres niveau af sukker i urinen skal kontrolleres regelmæssigt.
English: As a consequence, the conditions or restrictions with regards to the safe and effective use of the medicinal product should be updated to remove the additional risk minimisation measures.
Danish: Derfor bør betingelserne eller begrænsningerne med hensyn til sikker og effektiv anvendelse af lægemidlet opdateres, så de yderligere risikominimeringsforanstaltninger fjernes.
English: if you have blood in your urine that your doctor has not checked.
Danish: - hvis De har blod i urinen, og Deres læge ikke har undersøgt årsagen.
English: Aluminium/aluminium blisters.
Danish: Aluminium/aluminium-blisterpakninger.
English: In addition, increased fatty deposition and infiltration were observed.
Danish: Derudover blev der observeret øget fedtaflejring og -infiltration.
English: Talk to your doctor before stopping this treatment.
Danish: Tal med lægen, før De stopper behandlingen.
English: The presence of microcrystals exacerbated the hyperplastic response but was not considered to be the primary cause of hyperplastic changes.
Danish: Tilstedeværelse af mikrokrystaller forværrede det hyperplastiske respons, men ansås ikke for at være den primære årsag til de hyperplastiske forandringer.
English: Although in very rare cases fatal outcome has been reported, causal relationship has not been established.
Danish: Selvom der i meget sjældne tilfælde har været rapporteret tilfælde med letal udgang, er der ikke blevet fastslået en kausal sammenhæng.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Danish: Forsøgspopulationen havde en gennemsnitsalder på 62 år, og den gennemsnitlige varighed af diabetes var 9,5 år.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Danish: Patienten bør informeres, og der bør udføres hyppigere monitorering af blodsukker, specielt i begyndelsen af behandlingen.
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Danish: Den højeste rapporterede dosis på 120 mg/dag i fire dage og derefter 180 mg/dag i syv dage var ikke associeret med nogen symptomer.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Danish: Efter en oral dosis var den genfundne ikke-absorberede fraktion i fæces 20-30 %.
English: In some cases weight increase may be a symptom of cardiac failure; therefore weight should be closely monitored.
Danish: I nogle tilfælde kan vægtøgning være et symptom på hjertesvigt; derfor bør vægten monitoreres nøje.
English: This check should be repeated at intervals.
Danish: Denne kontrol bør udføres løbende.
English: On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
Danish: På dette grundlag er M-IV's bidrag til effekten omkring tre gange pioglitazons, mens den relative effekt af M-II er minimal.
English: Immune System Disorders hypersensitivity and allergic reactions1
Danish: Immunsystemet overfølsomhed og allergiske reaktioner1
English: Hypromellose Macrogol 8000
Danish: Filmovertræk Hypromellose Macrogol 8000
English: The mean Vd ranged between 63-276 L.
Danish: Det gennemsnitlige fordelingsvolumen (Vd) var mellem 63-276 l.
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy Lilly S.A., Avda.
Danish: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Irland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italien Lilly S.A., Avda.
English: Take Glubrava daily as prescribed.
Danish: Tag Glubrava dagligt som foreskrevet.
English: At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working normally.
Danish: Mindst en gang om året (oftere, hvis De er en ældre person eller har nyreproblemer) vil Deres læge kontrollere, at Deres nyrer fungerer normalt.
English: However if you miss a dose, skip the missed dose and just carry on with the next dose as normal.
Danish: Hvis De glemmer en dosis, skal De springe den glemte dosis over og blot fortsætte med den næste dosis som normalt.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glubrava.
Danish: Der kan være større sandsynlighed for at blive gravid, fordi De kan få ægløsning igen, når De tager Glubrava.
English: Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea.
Danish: Omkring en tredjedel af patienterne fik insulin i kombination med metformin og/eller sulfonylurinstof.
English: See section 4.
Danish: Se afsnit punkt 4.