natgillin/translations-raw huggingface dataset:
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 75 mg/m² i kombination med doxorubicin: 
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with doxorubicin
Docetaxel Zentiva 20 mg/1 ml sterilt koncentrat docetaxel 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel 
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Indlægseddel: Information til brugeren Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel 
Package leaflet: Information for the patient Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
• Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskredne pladecellecarcinom i hoved og hals (SCCHN) er den anbefalede dosis docetaxel 75 mg/m som en 1-times infusion, efterfulgt af 
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² i kombination med trastuzumab: 
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Metastatisk kastrationsresistent prostatakræft Den anbefalede dosis af docetaxel er 75 mg/m2. 
The recommended dose of docetaxel is 75 mg/m2.
75 mg/m til 60 mg/m 2: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter < 500 celler/mm i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati. 
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Docetaxel Zentiva 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel 
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel 
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Konstipation (alvorlig: 0,2 %); Mavesmerter (alvorlig: 1 %); 
Abdominal pain (severe: 1%);
Brug ikke Docetaxel Zentiva 
You must not be given Docetaxel Zentiva:
Mave-tarmkanalen 
Pre-Menopausal
Neutropenisk infektion (G3/4: 2,6%) 
Infection associated with G4 neutropenia (G3/4: 4.6%)
Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning. 
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion.
Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/m administreret som en 30 minutter til 
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Feber (G3/4: 1,2 %) 
Vomiting (G3/4: 1.2%)
Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år). 
1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil: 
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Koncentration af docetaxel i Docetaxel Zentiva 80 mg/4 ml er 20 mg/ml. 
In Docetaxel Zentiva 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Koncentration af docetaxel i Docetaxel Zentiva 20 mg/1 ml er 20 mg/ml. 
In Docetaxel Zentiva 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Arytmi (G3/4: 0,2 %); Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4: 
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
eller cisplatin (100 mg/m på dag 1) og 5-fluoruracil (1000 mg/m pr. dag i 5 dage). 
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Hud og subkutane væv Alopeci; Hudlidelser (G3/4: 
Alopecia (persisting: Skin disorder (G3/4:
Tabel over bivirkninger ved behandling af hoved- og halskræft med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil: 
Tabulated list of adverse reactions in head and neck cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
INFORMATION I BRAILLE SKRIFT 
Baseline cardiac assessment is recommended
Koncentrationen af docetaxel i Docetaxel Zentiva 80 mg/4 ml er 20 mg/ml 
In Docetaxel Zentiva 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil : 
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Hyppigheden kan variere alt efter kombinationen af de lægemidler, du får. 
Between infusions of Docetaxel Zentiva the following may occur, and the frequency may vary with the combinations of medicines that are received
HÆTTEGLAS ETIKET/Docetaxel Zentiva 20 mg/1 ml 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 20 mg/1 ml
HÆTTEGLAS ETIKET/Docetaxel Zentiva 160 mg/8ml 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 160 mg/8 ml
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. 
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.
TAC-armen) eller doxorubicin 50 mg/m efterfulgt af fluoruracil 500 mg/m og cyclophosphamid 500 
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² enkeltstof: 
Tabulated summary of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Antal positive lymfeknuder I alt 
Uncommon adverse reactions pneumonia, fatal in
Docetaxel Zentiva 160 mg/8 ml sterilt koncentrat docetaxel intravenøs anvendelse 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
HÆTTEGLAS ETIKET/Docetaxel Zentiva 80 mg/4ml 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 80 mg/4 ml
Revaccination: Revacciner årligt. 
Revaccination: Revaccinate annually.
Dato for første markedsføringstilladelse: 19/11/2019. 
Date of first authorisation: 19/11/2019
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. 
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.
Kaniner. 
Rabbits.
For at sikre fuld varighed af immuniteten anbefales det, i dette tilfælde, at vaccinere fra 7 ugers alderen. 
To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case.
Administrer 0,2 ml pr. dyr. 
Administer 0.2 ml per animal.
Administrer hele hætteglassets indhold. 
Administer the total contents of the vial.
En forbigående stigning i legemstemperaturen på 1-2° C kan almindeligvis opstå. 
A transient temperature increase of 1-2 °C can commonly occur.
Hver dosis (0,2 ml eller 0,5 ml) rekonstitueret vaccine indeholder: 
Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu) 
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Nylig eller latent infektion med vild myxomavirus synes i en vis udstrækning at spille en rolle i dette. 
Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
Dette ses kun hos dyr med aktiv immunitet og har ingen indflydelse på det generelle helbred, ædelysten eller dyrets adfærd. 
The scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
1 dosis 50 doser 
1 dose 50 doses
Høje niveauer af maternelle antistoffer mod myxomatosevirus og/eller RHD-virus kan potentielt reducere virkningen af produktet. 
High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product.
Rekonstitueret produkt: falmet pink eller pinkfarvet suspension. 
Reconstituted product: off-pink or pink coloured suspension.
Farmakoterapeutisk gruppe: Immunologica til kaniner, levende virale vacciner, ATCvet-kode: QI08AD 
Pharmacotherapeutic group: Immunologicals for Leporidae, live viral vaccine for rabbits ATC-vet code: QI08AD
Må ikke blandes med lægemidler til dyr undtaget solvens der leveres til brug med dette veterinærlægemiddel. 
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Opbevaringstid for veterinærlægemidlet (lyofilisatet) i salgspakning: 2 år. 
Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.
Det anbefales derfor ikke at vaccinere hankaniner til avl. 
Therefore, the vaccination of breeding bucks is not recommended.
Basisvaccination: Administrer 1 dosis vaccine til kaniner fra 5 ugers alderen og opefter. 
Primary vaccination: Administer one dose to rabbits from 5 weeks of age onwards.
En lille ikke smertefuld hævelse (maximalt 2 cm i diameter) på injektionsstedet ses almindeligtt i de første to uger efter vaccination. 
A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
For at opnå korrekt rekonstitution af flerdosis hætteglasset, følges proceduren nedenfor: 
For proper reconstitution of the multidose vial, use the following procedure:
EXP {måned/år} Efter rekonstitution: anvendes inden for 4 timer. 
EXP {month/year} Once reconstituted use within 4 hours.
Efter infektion med virulent myxomavirus vil nogle vaccinerede dyr udvikle nogle få meget små hævelser, specielt på hårløse områder af kroppen. 
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.
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. 
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.
På disse steder vil der hurtigt dannes sårskorper, som almindeligvis forsvinder inden for to uger. 
These scabs usually disappear within 2 weeks.
Flerdosis hætteglas (50 doser) 
Multi-dose vial (50 doses)
Kontroller at lyofilisatet er helt rekonstitueret før brug. 
Ensure that the lyophilisate is completely reconstituted before use.
Vaccinesuspensionen skal anvendes inden for 4 timer efter rekonstitution. 
Use the vaccine suspension within 4 hours of reconstitution.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (Kun solvens) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX (SOLVENT ONLY)
Nobivac Myxo-RHD PLUS lyofilisat og solvens til injektionsvæske, suspension til kaniner 
Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits
Hos kæledyrskaniner kan der i meget sjældne tilfælde opstå lokale reaktioner på injektionsstedet som nekrose, sårskorpe, skorpedannelse eller hårtab. 
In pet rabbits, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur in very rare cases.
Opbevaringstid for solvensen i salgspakning: 4 år. 
Shelf life of the solvent as packaged for sale: 4 years.
Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer. 
Any unused veterinary medicinal product or waste materials derived from such medicinal product should be disposed of in accordance with local requirements.
* Focus Forming Units Alle hjælpestoffer er anført under pkt. 
*Focus Forming Units For the full list of excipients, see section 6.1.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Solvens: Kræver ingen særlige forholdsregler vedrørende opbevaringen. 
Solvent: No special precautions for storage.
Opbevaringstid efter rekonstitution ifølge anvisning: 4 timer. 
Shelf life after reconstitution according to directions: 4 hours.
Navn og adresse på fremstilleren af det biologisk aktive stof Intervet International B.V. 
Name and address of the manufacturer of the biological active substances Intervet International B.V.
Lyofilisat: råhvide eller creme-farvede pellets. 
Lyophilisate: off-white or cream-coloured pellet.
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). 
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).
Solvens til Nobivac Myxo-RHD PLUS 
Solvent for Nobivac Myxo-RHD PLUS
5 x 1 dosis vaccine inklusive solvens 25 x 1 dosis vaccine inklusive solvens 10 x 50 doser vaccine 
5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine
− Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter) 
− very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER SOLVENS ETIKET 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
I meget sjældne tilfælde kan lette kliniske symptomer på myxomatose ses i op til 3 uger efter vaccination. 
The appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination in very rare cases.
I meget sjældne tilfælde kan der efter vaccination opstå alvorlige overfølsomhedsreaktioner, som kan være dødelige. 
Serious hypersensitivity reactions, which may be fatal, may occur after vaccination in very rare cases.
Vaccinen er beregnet til at stimulere immunitet over for myxomavirus og rabbit haemorrhagic disease vira hos kaniner. 
The vaccine is intended to stimulate immunity against myxoma virus and rabbit haemorrhagic disease viruses in rabbits.
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. 
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.
Tilsæt 1-2 ml solvens til 50-dosis hætteglasset og kontroller at lyofilisatet er helt opløst. 
Add 1 -2 ml of solvent to the 50-dose vaccine vial and ensure that the lyophilisate is fully dissolved.
Ingen særlige opbevaringsbetingelser. 
No special storage conditions.
Der er ikke udført sikkerhedsstudier vedrørende reproduktion hos hankaniner. 
No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Hætteglas af Type I klart glas indeholdende 1 eller 50 doser lukket med chlorbutyl gummiprop og aluminiumshætte. 
Lyophilisate: Type I clear glass vial of 1 or 50 doses closed with a chlorobutyl rubber stopper and aluminium cap.
Papæske med 10 x 10 ml solvens i hætteglas (glas) 
Cardboard box with 10 x 10 ml solvent vials (glass)
Som konsekvens heraf immuniseres kaninerne mod myxomavirus og både klassisk og type 2 RHD-vira. 
As a consequence, rabbits are immunised against myxoma virus and both classical and type 2 RHD viruses.
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 
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
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. 
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.
Læs indlægssedlen før brug. 
Read package leaflet before use.
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. 
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.
Det skal sikres at vaccinekoncentratet og solvensen er blandet omhyggeligt. 
Ensure that the resulting vaccine suspension in the solvent vial is properly mixed.
Vaccinestammerne er myxomavira, der udtrykker kapselproteingenet fra klassisk eller type 2 RHDvira. 
The vaccine strains are myxoma viruses expressing the capsid protein gene of classical or type 2 RHD viruses.
Flerdosis hætteglas 
Multi-dose vial
Hætteglas af Type I klart glas indeholdende 0,5 ml eller 10 ml lukket med brombutyl gummiprop og aluminiumshætte. 
Solvent: Type I clear glass vial of 0.5 ml or 10 ml closed with a bromobutyl rubber stopper and aluminium cap.
Rekonstituer et flerdosis hætteglas indeholdende lyofilisat med 10 ml af den tilhørende solvens. 
Reconstitute a multi-dose vial containing lyophilisate with 10 ml of the supplied solvent.
Levende myxoma rekombinant RHD-vira 
Live myxoma vectored RHD viruses
3 uger efter vaccination vil hævelsen være helt forsvundet. 
The swelling will resolve completely by 3 weeks after vaccination.
0,5 ml og 10 ml hætteglas i glas 
0.5 ml and 10 ml glass vial
Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse Intervet International B.V. 
Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
− Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) 
− very common (more than 1 in 10 animals treated displaying adverse reaction(s))
der på dette tidspunkt endnu ikke er anvendt, skal bortskaffes. 
Any reconstituted vaccine remaining at the end of this time should be discarded.
− Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) 
− common (more than 1 but less than 10 animals in 100 animals treated)
Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat Vand til injektionsvæsker 
Disodium phosphate dihydrate Potassium dihydrogen phosphate
Kræver ingen særlige forholdsregler vedrørende opbevaringen. 
No special precautions for storage.
Levende myxoma rekombinant RHD-virus stamme 009: 103,0 -105,8 FFU* Levende myxoma rekombinant RHD-virus stamme MK1899: 103,0 -105,8 FFU* 
Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU* Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU*
Rekonstituer et enkeltdosis hætteglas indeholdende lyofilisat med 0,5 ml af den tilhørende solvens. 
Reconstitute a single dose vial containing lyophilisate with 0.5 ml of the supplied solvent.
Overfør det nu opblandede vaccinekoncentrat fra vaccinehætteglasset til hætteglasset med solvens. 
Withdraw the reconstituted vaccine concentrate from the vial and inject it back into the solvent vial.
10. TILBAGEHOLDELSESTID 
WITHDRAWAL PERIODS
Intervet International B.V. 
Intervet International B.V. Wim de Körverstraat 35
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 
Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU/dose.
VACCINE HÆTTEGLAS (GLAS) ETIKET - 1 dosis / 50 doser i glas hætteglas 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VACCINE GLASS VIAL LABEL - 1 dose / 50 doses glass vial
Pakningsstørrelser: - Plastikæske med 5 x 1 dosis vaccine i hætteglas og 5 hætteglas indeholdende 0,5 ml solvens. 
Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 vials containing 0.5 ml of solvent.
{DD / MM / ÅÅÅÅ} 
{MM/YYYY}
- Plastikæske med 25 x 1 dosis vaccine i hætteglas og 25 hætteglas indeholdende 0,5 ml solvens. 
- Plastic box with 25 x 1 dose vials of vaccine and 25 vials containing 0.5 ml of solvent.
- Papæske med 10 x 50 doser vaccine i hætteglas + karton med 10 x 10 ml solvens i hætteglas. 
- Cardboard box with 10 x 50 doses vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
- Plastikæske med 5 x 1 dosis vaccine i hætteglas og 5 hætteglas indeholdende 0,5 ml solvens. 
- Plastic box with 5 x 1 dose vials of vaccine and 5 vials containing 0.5 ml of solvent.
Plastikæske med 25 x 1 dosis vaccine i hætteglas og 25 hætteglas (glas) indeholdende 0,5 ml solvens. 
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
Tidligere kendt som Zevtera. 
1 Previously known as Zevtera.
Hvad er Zeftera? 
What is Zeftera?
EMA/476149/2010 EMEA/H/C/000883 
18 February 2010 EMA/83783/2010 EMEA/H/C/883
Virksomheden, som ansøgte om tilladelse, er Janssen-Cilag International N.V. 
The company that applied for the authorisation is Janssen-Cilag International N.V.