FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil :
English: Between infusions of Docetaxel Zentiva the following may occur, and the frequency may vary with the combinations of medicines that are received
Danish: Hyppigheden kan variere alt efter kombinationen af de lægemidler, du får.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 20 mg/1 ml
Danish: HÆTTEGLAS ETIKET/Docetaxel Zentiva 20 mg/1 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 160 mg/8 ml
Danish: HÆTTEGLAS ETIKET/Docetaxel Zentiva 160 mg/8ml
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Danish: I studiet GEICAM9805 fortsatte alopeci, som forekom i løbet af behandlingsperioden, ind i opfølgningsperioden og blev fortsat observeret hos 49 patienter (9,2 %) i TAC-armen og hos 35 patienter (6,7 %) i FAC-armen.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Danish: TAC-armen) eller doxorubicin 50 mg/m efterfulgt af fluoruracil 500 mg/m og cyclophosphamid 500
English: Tabulated summary of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² enkeltstof:
English: Uncommon adverse reactions pneumonia, fatal in
Danish: Antal positive lymfeknuder I alt
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
Danish: Docetaxel Zentiva 160 mg/8 ml sterilt koncentrat docetaxel intravenøs anvendelse
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 80 mg/4 ml
Danish: HÆTTEGLAS ETIKET/Docetaxel Zentiva 80 mg/4ml
English: Revaccination: Revaccinate annually.
Danish: Revaccination: Revacciner årligt.
English: Date of first authorisation: 19/11/2019
Danish: Dato for første markedsføringstilladelse: 19/11/2019.
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: De aktive substanser som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet, falder ikke inden for anvendelsesområdet af Forordning (EF) nr. 470/2009.
English: Rabbits.
Danish: Kaniner.
English: To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case.
Danish: For at sikre fuld varighed af immuniteten anbefales det, i dette tilfælde, at vaccinere fra 7 ugers alderen.
English: Administer 0.2 ml per animal.
Danish: Administrer 0,2 ml pr. dyr.
English: Administer the total contents of the vial.
Danish: Administrer hele hætteglassets indhold.
English: A transient temperature increase of 1-2 °C can commonly occur.
Danish: En forbigående stigning i legemstemperaturen på 1-2° C kan almindeligvis opstå.
English: Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Danish: Hver dosis (0,2 ml eller 0,5 ml) rekonstitueret vaccine indeholder:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu)
English: Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
Danish: Nylig eller latent infektion med vild myxomavirus synes i en vis udstrækning at spille en rolle i dette.
English: The scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
Danish: Dette ses kun hos dyr med aktiv immunitet og har ingen indflydelse på det generelle helbred, ædelysten eller dyrets adfærd.
English: 1 dose 50 doses
Danish: 1 dosis 50 doser
English: High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product.
Danish: Høje niveauer af maternelle antistoffer mod myxomatosevirus og/eller RHD-virus kan potentielt reducere virkningen af produktet.
English: Reconstituted product: off-pink or pink coloured suspension.
Danish: Rekonstitueret produkt: falmet pink eller pinkfarvet suspension.
English: Pharmacotherapeutic group: Immunologicals for Leporidae, live viral vaccine for rabbits ATC-vet code: QI08AD
Danish: Farmakoterapeutisk gruppe: Immunologica til kaniner, levende virale vacciner, ATCvet-kode: QI08AD
English: Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Danish: Må ikke blandes med lægemidler til dyr undtaget solvens der leveres til brug med dette veterinærlægemiddel.
English: Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet (lyofilisatet) i salgspakning: 2 år.
English: Therefore, the vaccination of breeding bucks is not recommended.
Danish: Det anbefales derfor ikke at vaccinere hankaniner til avl.
English: Primary vaccination: Administer one dose to rabbits from 5 weeks of age onwards.
Danish: Basisvaccination: Administrer 1 dosis vaccine til kaniner fra 5 ugers alderen og opefter.
English: A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Danish: En lille ikke smertefuld hævelse (maximalt 2 cm i diameter) på injektionsstedet ses almindeligtt i de første to uger efter vaccination.
English: For proper reconstitution of the multidose vial, use the following procedure:
Danish: For at opnå korrekt rekonstitution af flerdosis hætteglasset, følges proceduren nedenfor:
English: EXP {month/year} Once reconstituted use within 4 hours.
Danish: EXP {måned/år} Efter rekonstitution: anvendes inden for 4 timer.
English: After infection with virulent field myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Danish: Efter infektion med virulent myxomavirus vil nogle vaccinerede dyr udvikle nogle få meget små hævelser, specielt på hårløse områder af kroppen.
English: The vector technology used to develop the vaccine strains allows the RHD virus components to be produced in vitro instead of using live rabbits for cultivation.
Danish: Den rekombinante teknologi som er anvendt til at udvikle vaccine stammerne tillader RHDviruskomponenterne at blive fremstillet in vitro frem for at anvende levende kaniner til kultiveringen.
English: These scabs usually disappear within 2 weeks.
Danish: På disse steder vil der hurtigt dannes sårskorper, som almindeligvis forsvinder inden for to uger.
English: Multi-dose vial (50 doses)
Danish: Flerdosis hætteglas (50 doser)
English: Ensure that the lyophilisate is completely reconstituted before use.
Danish: Kontroller at lyofilisatet er helt rekonstitueret før brug.
English: Use the vaccine suspension within 4 hours of reconstitution.
Danish: Vaccinesuspensionen skal anvendes inden for 4 timer efter rekonstitution.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX (SOLVENT ONLY)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (Kun solvens)
English: Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits
Danish: Nobivac Myxo-RHD PLUS lyofilisat og solvens til injektionsvæske, suspension til kaniner
English: In pet rabbits, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur in very rare cases.
Danish: Hos kæledyrskaniner kan der i meget sjældne tilfælde opstå lokale reaktioner på injektionsstedet som nekrose, sårskorpe, skorpedannelse eller hårtab.
English: Shelf life of the solvent as packaged for sale: 4 years.
Danish: Opbevaringstid for solvensen i salgspakning: 4 år.
English: Any unused veterinary medicinal product or waste materials derived from such medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: *Focus Forming Units For the full list of excipients, see section 6.1.
Danish: * Focus Forming Units Alle hjælpestoffer er anført under pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: Solvent: No special precautions for storage.
Danish: Solvens: Kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Shelf life after reconstitution according to directions: 4 hours.
Danish: Opbevaringstid efter rekonstitution ifølge anvisning: 4 timer.
English: Name and address of the manufacturer of the biological active substances Intervet International B.V.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Intervet International B.V.
English: Lyophilisate: off-white or cream-coloured pellet.
Danish: Lyofilisat: råhvide eller creme-farvede pellets.
English: For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).
Danish: Til aktiv immunisering af kaniner fra 5-ugers alderen for at nedsætte dødelighed og kliniske symptomer ved myxomatose og rabbit heamorrhagic disease (RHD) forårsaget af klassisk RHD-virus (RDHV1) og RHD-virus type 2 (RHDV2).
English: Solvent for Nobivac Myxo-RHD PLUS
Danish: Solvens til Nobivac Myxo-RHD PLUS
English: 5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine
Danish: 5 x 1 dosis vaccine inklusive solvens 25 x 1 dosis vaccine inklusive solvens 10 x 50 doser vaccine
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: − Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER SOLVENS ETIKET
English: The appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination in very rare cases.
Danish: I meget sjældne tilfælde kan lette kliniske symptomer på myxomatose ses i op til 3 uger efter vaccination.
English: Serious hypersensitivity reactions, which may be fatal, may occur after vaccination in very rare cases.
Danish: I meget sjældne tilfælde kan der efter vaccination opstå alvorlige overfølsomhedsreaktioner, som kan være dødelige.
English: The vaccine is intended to stimulate immunity against myxoma virus and rabbit haemorrhagic disease viruses in rabbits.
Danish: Vaccinen er beregnet til at stimulere immunitet over for myxomavirus og rabbit haemorrhagic disease vira hos kaniner.
English: Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop an adequate immune response against rabbit haemorrhagic disease following vaccination.
Danish: Kaniner, der tidligere er vaccinerede med anden vaccine mod myxomatose eller har gennemgået naturlig smitte, udvikler ikke nødvendigvis et acceptabelt immunrespons mod rabbit haemorrhagic disease efter vaccination.
English: Add 1 -2 ml of solvent to the 50-dose vaccine vial and ensure that the lyophilisate is fully dissolved.
Danish: Tilsæt 1-2 ml solvens til 50-dosis hætteglasset og kontroller at lyofilisatet er helt opløst.
English: No special storage conditions.
Danish: Ingen særlige opbevaringsbetingelser.
English: No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Danish: Der er ikke udført sikkerhedsstudier vedrørende reproduktion hos hankaniner.
English: Lyophilisate: Type I clear glass vial of 1 or 50 doses closed with a chlorobutyl rubber stopper and aluminium cap.
Danish: Hætteglas af Type I klart glas indeholdende 1 eller 50 doser lukket med chlorbutyl gummiprop og aluminiumshætte.
English: Cardboard box with 10 x 10 ml solvent vials (glass)
Danish: Papæske med 10 x 10 ml solvens i hætteglas (glas)
English: As a consequence, rabbits are immunised against myxoma virus and both classical and type 2 RHD viruses.
Danish: Som konsekvens heraf immuniseres kaninerne mod myxomavirus og både klassisk og type 2 RHD-vira.
English: Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains: Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU * Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU* *Focus Forming Units
Danish: Hver dosis (0,2 ml eller 0,5 ml) rekonstitueret vaccine indeholder: Levende myxoma rekombinant RHD virus stamme 009: 103,0 - 105,8 FFU* Levende myxoma rekombinant RHD virus stamme MK1899: 103,0 - 105,8 FFU* * Focus Forming Units
English: In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after administration of a ten-fold overdose.
Danish: Foruden de bivirkninger, der ses efter en enkelt vaccination, kan der inden for de første tre dage efter administration af 10-fold overdosis ses en let hævelse af de lokale lymfeknuder.
English: Read package leaflet before use.
Danish: Læs indlægssedlen før brug.
English: In addition to the signs observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after the administration of a ten-fold overdose.
Danish: Foruden de bivirkninger, der ses efter en enkelt vaccination, kan der indenfor de første tre dage efter administration af 10-fold overdosis ses en let hævelse af de lokale lymfeknuder.
English: Ensure that the resulting vaccine suspension in the solvent vial is properly mixed.
Danish: Det skal sikres at vaccinekoncentratet og solvensen er blandet omhyggeligt.
English: The vaccine strains are myxoma viruses expressing the capsid protein gene of classical or type 2 RHD viruses.
Danish: Vaccinestammerne er myxomavira, der udtrykker kapselproteingenet fra klassisk eller type 2 RHDvira.
English: Multi-dose vial
Danish: Flerdosis hætteglas
English: Solvent: Type I clear glass vial of 0.5 ml or 10 ml closed with a bromobutyl rubber stopper and aluminium cap.
Danish: Hætteglas af Type I klart glas indeholdende 0,5 ml eller 10 ml lukket med brombutyl gummiprop og aluminiumshætte.
English: Reconstitute a multi-dose vial containing lyophilisate with 10 ml of the supplied solvent.
Danish: Rekonstituer et flerdosis hætteglas indeholdende lyofilisat med 10 ml af den tilhørende solvens.
English: Live myxoma vectored RHD viruses
Danish: Levende myxoma rekombinant RHD-vira
English: Name and address of the manufacturer responsible for batch release Intervet International B.V.
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Intervet International B.V.
English: The swelling will resolve completely by 3 weeks after vaccination.
Danish: 3 uger efter vaccination vil hævelsen være helt forsvundet.
English: 0.5 ml and 10 ml glass vial
Danish: 0,5 ml og 10 ml hætteglas i glas
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse Intervet International B.V.
English: − very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Danish: − Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling)
English: Any reconstituted vaccine remaining at the end of this time should be discarded.
Danish: der på dette tidspunkt endnu ikke er anvendt, skal bortskaffes.
English: − common (more than 1 but less than 10 animals in 100 animals treated)
Danish: − Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr)
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate
Danish: Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat Vand til injektionsvæsker
English: No special precautions for storage.
Danish: Kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU* Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU*
Danish: Levende myxoma rekombinant RHD-virus stamme 009: 103,0 -105,8 FFU* Levende myxoma rekombinant RHD-virus stamme MK1899: 103,0 -105,8 FFU*
English: Reconstitute a single dose vial containing lyophilisate with 0.5 ml of the supplied solvent.
Danish: Rekonstituer et enkeltdosis hætteglas indeholdende lyofilisat med 0,5 ml af den tilhørende solvens.
English: Withdraw the reconstituted vaccine concentrate from the vial and inject it back into the solvent vial.
Danish: Overfør det nu opblandede vaccinekoncentrat fra vaccinehætteglasset til hætteglasset med solvens.
English: WITHDRAWAL PERIODS
Danish: 10. TILBAGEHOLDELSESTID
English: Intervet International B.V. Wim de Körverstraat 35
Danish: Intervet International B.V.
English: Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU/dose.
Danish: Levende myxoma rekombinant RHD virus stamme 009: 103,0 -1055,8 FFU/dosis Levende myxoma rekombinant RHD virus stamme MK1899: 103,0 - 105,8 FFU/dosis
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VACCINE GLASS VIAL LABEL - 1 dose / 50 doses glass vial
Danish: VACCINE HÆTTEGLAS (GLAS) ETIKET - 1 dosis / 50 doser i glas hætteglas
English: Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 vials containing 0.5 ml of solvent.
Danish: Pakningsstørrelser: - Plastikæske med 5 x 1 dosis vaccine i hætteglas og 5 hætteglas indeholdende 0,5 ml solvens.
English: {MM/YYYY}
Danish: {DD / MM / ÅÅÅÅ}
English: - Plastic box with 25 x 1 dose vials of vaccine and 25 vials containing 0.5 ml of solvent.
Danish: - Plastikæske med 25 x 1 dosis vaccine i hætteglas og 25 hætteglas indeholdende 0,5 ml solvens.
English: - Cardboard box with 10 x 50 doses vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
Danish: - Papæske med 10 x 50 doser vaccine i hætteglas + karton med 10 x 10 ml solvens i hætteglas.
English: - Plastic box with 5 x 1 dose vials of vaccine and 5 vials containing 0.5 ml of solvent.
Danish: - Plastikæske med 5 x 1 dosis vaccine i hætteglas og 5 hætteglas indeholdende 0,5 ml solvens.
English: Plastic box with 5 x 1 dose vials of vaccine and 5 x 0.5 ml solvent vials (glass) Plastic box with 25 x 1 dose vials of vaccine and 25 x 0.5 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Danish: Plastikæske med 25 x 1 dosis vaccine i hætteglas og 25 hætteglas (glas) indeholdende 0,5 ml solvens.
English: 1 Previously known as Zevtera.
Danish: Tidligere kendt som Zevtera.
English: What is Zeftera?
Danish: Hvad er Zeftera?
English: 18 February 2010 EMA/83783/2010 EMEA/H/C/883
Danish: EMA/476149/2010 EMEA/H/C/000883
English: The company that applied for the authorisation is Janssen-Cilag International N.V.
Danish: Virksomheden, som ansøgte om tilladelse, er Janssen-Cilag International N.V.
English: This prevents the bacteria from building the walls that surround their cells, which kills the bacteria.
Danish: Det forhindrer bakterierne i at opbygge de vægge, som omgiver deres celler, hvilket dræber bakterierne.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has t might affect the response to treatment.
Danish: "Kompliceret" betyder, at infektionen er vanskelig at behandle, fordi den har bredt sig til det dybe væv under huden, operativ behandling kan være nødvendig, eller fordi patienten har andre tilstande, der påvirker responsen på behandlingen.
English: It works by attaching to certain types of protein on the surface of the bacteria cells.
Danish: Det virker ved at sætte sig på visse typer proteiner på overfladen af bakteriecellerne.
English: What was Zeftera expected to be used for?
Danish: Hvad forventedes Zeftera anvendt til?
English: How is Zeftera expected to work?
Danish: Hvordan forventes Zeftera at virke?
English: On 18 February 2010, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product for the treatment of adults with complicated skin and soft-tissue infections.
Danish: Den 18. februar 2010 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Zeftera til behandling af komplicerede hud- og bløddelsinfektioner hos voksne.
English: Refusal of the marketing authorisation for ZefteraF F (ceftobiprole) EMA/83783/2010
Danish: Afslag på markedsføringstilladelse for ZefteraF F (ceftobiprol) EMA/476149/2010
English: The active substance in Zeftera, ceftobiprole, is an antibiotic that belongs to the group ‘cephalosporins'.
Danish: Det aktive stof i Zeftera, ceftobiprol, er et antibiotikum, som tilhører gruppen "cefalosporiner".
English: In bo effectiveness was the number of patients whose infection had been cured at the
Danish: I begge undersøgelser var det primære effektmål antallet af patienter, hvis infektion var blevet kureret ved behandlingens afslutning.
English: The company informed the CHMP that that there are no consequences for patients in clinical trials with Zeftera and that there are no compassionate use programmes in progress with Zeftera.
Danish: Virksomheden har informeret CHMP om, at afslaget ikke vil få nogen konsekvenser for patienter, som deltager i kliniske undersøgelser med Zeftera, og at der ikke er nogen igangværende programmer med særlig udleveringstilladelse.
English: Zeftera was expected to be used to treat adults with complicated infections of th other conditions tha
Danish: Zeftera forventedes anvendt til behandling af voksne med komplicerede hud- og bløddelsinfektioner.
English: Refusal of the marketing authorisation for Zeftera
Danish: Afslag på markedsføringstilladelse for Zeftera (ceftobiprol)
English: is active against several types of bacteria, including methicillin-resistant Staphylococcus d in humans.
Danish: Ceftobiprol er aktivt imod adskillige typer bakterier, herunder methicillin-resistent Staphylococcus aureus (MRSA).
English: The first study compared Zeftera with vancomycin (another an ceftazidime (another cephalosporin antibiotic) in 828 patients.
Danish: I den første undersøgelse sammenlignedes Zeftera med vancomycin (et andet antibiotikum, der er aktivt imod MRSA) hos 784 patienter, og i den anden undersøgelse sammenlignedes det med en kombination af vancomycin og ceftazidim (et andet cefalosporinantibiotikum) hos 828 patienter.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Zeftera eller i programmer for anvendelse af Zeftera med særlig udleveringstilladelse?
English: The Commi therefore recommended that, in light of the uncertainty surrounding the results, th not be granted marketing authorisation.
Danish: I betragtning af de usikkerheder, der omgav resultaterne, anbefalede CHMP således, at der ikke skulle udstedes markedsføringstilladelse for lægemidlet.