FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions reported at rates 5% higher in patients 65 years of age or greater compared to younger patients were fatigue (40.4% versus 29.8%), clinical neutropenia (24.2% versus 17.6%), asthenia (23.8% versus 14.5%), pyrexia (14.6% versus 7.6%), dizziness (10.0% versus 4.6%), urinary tract infection (9.6% versus 3.1%) and dehydration (6.7% versus 1.5%), respectively.
Danish: Bivirkninger, som blev rapporteret med hyppigheder, der var ≥5 % højere hos patienter i aldersgruppen 65 år og derover sammenlignet med yngre patienter, var træthed (40,4 % versus 29,8 %), klinisk neutropeni (24,2 % versus 17,6 %), asteni (23,8 % versus 14,5 %), pyreksi (14,6 % versus 7,6 %), svimmelhed (10,0 % versus 4,6 %), urinvejsinfektion (9,6 % versus 3,1 %) og dehydrering (6,7 % versus 1,5 %).
English: Delay treatment until improvement, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Danish: Udsæt behandling indtil der ses bedring, reducér derefter dosis af cabazitaxel fra 25 mg/m2 til 20 mg/m2
English: No specific dose adjustment for the use of cabazitaxel in elderly patients is recommended (see also sections 4.4, 4.8 and 5.2).
Danish: Der anbefales ingen specifikke dosisjusteringer for anvendelse af cabazitaxel hos ældre patienter (se også pkt.
English: JEVTANA must not be mixed with any other medicinal products than those mentioned in section 6.6.
Danish: JEVTANA må ikke blandes med andre lægemidler end dem, der er nævnt i pkt.
English: Paediatric population See section 4.2
Danish: Pædiatrisk population Se pkt.
English: Acute renal failure Renal failure Dysuria
Danish: Akut nyresvigt Nyresvigt Dysuri
English: There was a median PSA progression of 6.4 months (95%CI: 5.1-7.3) for patients in JEVTANA arm, compared to 3.1 months (95%CI: 2.2-4.4) in the mitoxantrone arm, HR 0.75 months (95%CI: 0.63-0.90), p=0.0010.
Danish: Der var en median PSA progression på 6,4 måneder (95 % CI: 5,1-7,3) for patienter i JEVTANA-armen, sammenlignet med 3,1 måned (95 % CI: 2,2-4,4) i mitoxantron-armen, HR 0,75 måneder (95 % CI: 0,63 - 0,90), p=0,0010.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindeligt (kan påvirke flere end 1 ud af 10 patienter):
English: This is common (may affect up to 1 in 10 people).
Danish: Dette er almindeligt (kan påvirke op til 1 ud af 10 patienter).
English: PVC infusion containers or polyurethane infusion sets should not be used for the preparation and administration of the infusion solution.
Danish: PVC-infusionsbeholdere eller infusionssæt i polyurethan må ikke anvendes til klargøring og indgivelse af infusionsvæsken.
English: If co-administration with a strong CYP3A inhibitor cannot be avoided, close monitoring for toxicity and a cabazitaxel dose reduction should be considered (see sections 4.2 and 4.5).
Danish: Hvis samtidig administration af en potent CYP3A-hæmmer ikke kan undgås, skal patienten observeres nøje for cabazitaxeltoksicitet og reduktion af cabazitaxeldosis bør overvejes (se pkt.
English: Co-administration with strong CYP3A inducers should be avoided since they may decrease plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Danish: Samtidig administration med potente CYP3A-induktorer bør undgås, da de kan reducere plasmakoncentrationen af cabazitaxel (se pkt.
English: Co-administration with strong CYP3A inhibitors should be avoided since they may increase the plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Danish: Samtidig administration af potente CYP3A-hæmmere bør undgås, da de kan øge plasmakoncentrationen af cabazitaxel (se pkt.
English: Once reconstituted, the resultant solution contains 10 mg/ml of cabazitaxel.
Danish: Efter rekonstitution indeholder opløsningen 10 mg cabazitaxel per ml.
English: Solvent vial
Danish: Hætteglas med solvens vial
English: Step 1.5
Danish: Trin 1.5
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: 1 ml concentrate contains 40 mg cabazitaxel.
Danish: 1 ml koncentrat indeholder 40 mg cabazitaxel.
English: Risk of renal failure
Danish: Risiko for nyresvigt
English: This overfill ensures that after initial dilution with the ENTIRE content of the solvent vial, the concentration of cabazitaxel is 10 mg/ml.
Danish: Dette overskud sikrer, at koncentrationen af cabazitaxel efter den initiale fortynding med HELE indholdet af hætteglasset med solvens er 10 mg/ml.
English: Step 2.4
Danish: Trin 2.4
English: The safety of JEVTANA in combination with prednisone or prednisolone was evaluated in 371 patients with metastatic castration resistant prostate cancer who were treated with 25 mg/m2
Danish: Sikkerheden ved JEVTANA i kombination med prednison eller prednisolon blev evalueret hos 371 patienter med metastatisk kastrationsresistent prostatacancer, der blev behandlet med 25 mg/m2 cabazitaxel en gang hver tredje uge i et randomiseret, åbent, kontrolleret fase III-studie.
English: Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN) (see sections 4.3, 4.4 and 5.2).
Danish: Cabazitaxel bør ikke gives til patienter med svært nedsat leverfunktion (total-bilirubin >3 x ULN) (se pkt.
English: Neuropathy peripheral Peripheral sensory neuropathy Dizziness Headache Paraesthesia Lethargy
Danish: Dysgeusi Perifer neuropati Perifer sensorisk neuropati
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er angivet i pkt.
English: Step 2.3
Danish: Trin 2.3
English: BATCH NUMBER Batch:
Danish: Batch:
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindeligt (kan påvirke op til 1 ud af 100 patienter):
English: Upper respiratory tract infection Herpes zoster Candidiasis
Danish: Herpes zoster Candidiasis
English: 13.4 (12.19 to 14.88)
Danish: 4.4, 4.8 og 5.2).
English: Back pain Arthralgia Pain in extremity
Danish: Rygsmerter Arthralgi Smerter i ekstremitet Muskelkramper Myalgi
English: PVC infusion containers and polyurethane infusion sets should not be used.
Danish: 6.6 Brug ikke PVC infusionsbeholdere og infusionssæt i polyurethan.
English: Cardiac arrhythmias have been reported, most commonly tachycardia and atrial fibrillation (see section 4.8).
Danish: Risiko for hjertearytmi Der er indberettet tilfælde af hjertearytmi, oftest takykardi og atrieflimren (se pkt.
English: One ml of concentrate contains 40 mg cabazitaxel.
Danish: En ml koncentrat indeholder 40 mg cabazitaxel.
English: What JEVTANA looks like and contents of the pack JEVTANA is a concentrate and solvent for solution for infusion (sterile concentrate).
Danish: JEVTANA er et koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: What you need to know before you are given JEVTANA
Danish: Det skal du vide, før du begynder at få JEVTANA 3.
English: Vertigo
Danish: Tinnitus Vertigo
English: Cabazitaxel is extensively metabolised by the liver.
Danish: Cabazitaxel metaboliseres i udtalt grad i leveren.
English: • Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml).
Danish: • Solvens: 4,5 ml koncentrat i et 15 ml gennemsigtigt hætteglas (type I), der er lukket med en grå gummiprop af chlorbutyl og forseglet med en guldfarvet aluminiumshætte, der er dækket af en farveløs flip-off hætte af plastik.
English: Step 1.4
Danish: Trin 1.4
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Danish: JEVTANA 60 mg koncentrat og solvens til infusionsvæske, opløsning cabazitaxel
English: Cabazitaxel is minimally excreted through the kidney.
Danish: Cabazitaxels udskillelse gennem nyrerne er minimal.
English: Common (may affect up to 1 in 10 people):
Danish: Almindeligt (kan påvirke op til 1 ud af 10 patienter):
English: This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel.
Danish: Dette overskud sikrer, at der efter fortynding med HELE indholdet af det medfølgende hætteglas med solvens, fremstår en opløsning indeholdende 10 mg cabazitaxel per ml.
English: Each 1.5 ml vial of concentrate contains 60 mg cabazitaxel.
Danish: Hvert 1,5 ml hætteglas med koncentrat indeholder 60 mg cabazitaxel.
English: Patients under treatment with cabazitaxel should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop.
Danish: Hvis der under behandling med cabazitaxel opstår symptomer på neuropati så som smerte, brændende fornemmelse, snurren, følelsesløshed eller svaghed, bør patienterne rådgives om at informere deres læge, før behandlingen fortsættes.
English: Febrile neutropenia
Danish: Klinisk neutropeni Febril neutropeni
English: Step 1.2
Danish: Trin 1.2
English: Neutropeniaa*
Danish: Hjerte*
English: 14.5 (13.47 to 15.28)
Danish: 4.3, 4.4 og 5.2).
English: Do not use JEVTANA if:
Danish: Det skal du vide, før du begynder at få JEVTANA Du må ikke få JEVTANA hvis:
English: Septic shock Sepsis Cellulitis Urinary tract infection
Danish: Septisk shock Sepsis
English: Step 1.3
Danish: Trin 1.3
English: • Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml).
Danish: • Koncentrat: 1,5 ml koncentrat i et 15 ml gennemsigtigt hætteglas (type I), der er lukket med en grå gummiprop af chlorbutyl og forseglet med en aluminiumshætte, der er dækket af en lysegrøn flip-off hætte af plastik.
English: Step 2.2
Danish: Trin 2.2
English: mitoxantrone + prednisone n=377
Danish: Mitoxantron + prednison cabazitaxel + prednison
English: Solution for IV infusion after final dilution (see package leaflet).
Danish: Infusionsvæske til i.v.-administration efter sidste fortynding (se indlægssedlen) Påfyldt et overskud
English: Delay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m2 to
Danish: Udsæt behandlingen indtil bedring eller ophør og reducer derpå dosis af cabazitaxel fra 25 mg/m2 til 20 mg/m2.
English: • blood clot in the leg
Danish: • blodprop i benet
English: Step 1.1
Danish: Trin 1.1
English: • feeling anxious
Danish: • stakåndethed
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION JEVTANA 60 mg sterile concentrate cabazitaxel
Danish: JEVTANA 60 mg cabazitaxel som sterilt koncentrat cabazitaxel
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single-use vials.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Suomi/Finland Sanofi Oy
Danish: Suomi/Finland
English: One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover, containing 4.5 ml (nominal volume) solvent.
Danish: - Et engangshætteglas med 4,5 ml (nominelt volumen) solvens i et gennemsigtigt hætteglas, der er lukket med en grå gummiprop af chlorbutyl og forseglet med en guldfarvet aluminiumshætte, der er dækket af en farveløs flip-off hætte af plastik.
English: System Organ Class Adverse reaction
Danish: MedDRAsystemorganklasser
English: p-value 1HR estimated using Cox model; a hazard ratio of less than 1 favours JEVTANA
Danish: 1HR estimeret ved hjælp af Cox-modellen.
English: Each vial of concentrate contains 60 mg cabazitaxel.
Danish: Hvert hætteglas med koncentrat indeholder 60 mg cabazitaxel.
English: Clinical neutropenia
Danish: Knoglemarvsdepression
English: Preparation and administration precautions
Danish: Forholdsregler ved klargøring og indgivelse
English: A.
Danish: herunder
English: Thrombocytopeniaa 176 (47.4) Febrile neutropenia
Danish: Leukopenia Trombocytopenia Febril neutropeni
English: Studies in animals have shown reproductive toxicity at maternotoxic doses (see section 5.3) and that cabazitaxel crosses the placenta barrier (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet ved toksiske doser hos mater (se pkt.
English: Hypoaesthesia Sciatica
Danish: Hovedpine Paræstesi Letargi Hypoæstesi Ischias
English: One single useclear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover, containing 1.5 ml (nominal volume) concentrate.
Danish: En pakke JEVTANA indeholder: - Et engangshætteglas med 1,5 ml (nominelt volumen) koncentrat i et gennemsigtigt hætteglas, der er lukket med en grå gummiprop af chlorbutyl og forseglet med en aluminiumshætte, der er dækket af en lysegrøn flip-off hætte af plastik.
English: Psychiatric disorders Anxiety Confusional state Nervous system Dysgeusia
Danish: Psykiske forstyrrelser Angst Konfusion
English: • muscle discomfort, aches or pain
Danish: • smerter eller ubehag i muskler
English: Muscle spasms Myalgia Musculoskeletal chest pain Flank pain
Danish: Muskuloskeletale smerter i brystet Flankesmerter
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion.
Danish: JEVTANA 60 mg koncentrat og solvens til infusionsvæske, opløsning.
English: Fatigue
Danish: Vægttab
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate and solvent for solution for infusion.
Danish: Koncentrat og solvens til infusionsvæske, opløsning.
English: Decreased appetite Vomiting
Danish: Appetitløshed Opkastning
English: • rectal bleeding
Danish: • rektal blødning
English: This includes medicines obtained without a prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SOLVENT for JEVTANA
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: Musculoskeletal and connective tissue disorders
Danish: Cellulitis Urinvejsinfektion
English: Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to
Danish: Febril neutropeni eller neutropenisk infektion Udsæt behandlingen indtil bedring eller ophør og indtil neutrofiltallet er >1.500 celler/mm3.
English: Grade ≥ 3 thrombocytopenia
Danish: INFORMATION I BRAILLESKRIFT
English: What you need to know before you use <product name>, and 3.
Danish: Det skal du vide, før du begynder at bruge <produktnavn>, og 3.
English: Posology and method of administration, and/or 4.4.
Danish: Dosering og administration, og/eller 4.4.
English: Other side effects which have been observed with XELJANZ are listed below.
Danish: Øvrige bivirkninger, der er observeret med XELJANZ, er anført nedenfor.
English: Tofacitinib - Angioedema (EPITT no 18904)
Danish: Tofacitinib - angioødem (EPITT nr. 18904)
English: Insulin (pre-filled pens and cartridges): insulin aspart; insulin bovine; insulin degludec; insulin degludec, insulin aspart; insulin degludec, liraglutide; insulin detemir; insulin glargine; insulin glulisine; insulin human (rDNA); insulin human, insulin isophane; insulin lispro; insulin porcinePotential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia (EPITT no 18893)
Danish: Insulin (fyldte penne og cylinderampuller): insulin aspart; bovint insulin; insulin degludec; insulin degludec, insulin aspart; insulin degludec, liraglutid; insulin detemir; insulin glargin; insulin glulisin; human insulin (rDNA); human insulin, isophaninsulin; insulin lispro; porcint insulin - muligvis øget risiko for medicineringsfejl, der er forbundet med optrækning af insulin fra fyldte penne og cylinderampuller, og som kan føre til dysglykæmi (EPITT nr. 18893)
English: Adopted at the 27-30 November 2017 PRAC
Danish: Vedtaget på PRAC's møde den 27.-30. november 2017
English: In post-marketing experience, cases of hypersensitivity associated with tofacitinib administration have been reported.
Danish: Der er efter markedsføring rapporteret om tilfælde af overfølsomhed forbundet med administration af tofacitinib.
English: Frequency ‘not known': hypersensitivity; angioedema; urticaria
Danish: Hyppighed "ikke kendt": overfølsomhed, angioødem, urticaria
English: Special warnings and precautions for use
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Overfølsomhed
English: If any serious allergic or anaphylactic reaction occurs, tofacitinib should be discontinued immediately.
Danish: Hvis der forekommer alvorlige allergiske eller anafylaktiske reaktioner, bør tofacitinib seponeres øjeblikkeligt.
English: Allergic reactions included angioedema and urticaria; serious reactions have occurred.
Danish: Allergiske reaktioner omfattede angioødem og urticaria; der er observeret alvorlige tilfælde.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/611010/2017
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/813967/2017
English: Special precautions for disposal and other handling The following text and any related package leaflet text should be removed: ‘If the <pen / infusion pump> malfunctions (see instructions for using the pen / infusion pump), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.'
Danish: Følgende tekst og eventuel relateret tekst i indlægssedler bør fjernes: "Hvis <pennen/infusionspumpen> ikke fungerer (se vejledningen i brug af pennen/infusionspumpen), kan opløsningen trækkes fra cylinderampullen op i en sprøjte (der er egnet til en insulin med 100 enheder/ml) og injiceres".
English: Not known (frequency cannot be estimated from the available data): hives (itchy, bumpy rash)
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): nældefeber (kløende udslæt med knopper)
English: <If administration by syringe, <intravenous injection> or <infusion pump> is necessary, a vial should be used.>>
Danish: <Hvis det er nødvendigt at anvende en sprøjte, <intravenøs injektion> eller <infusionspumpe> til administrationen, bør et hætteglas anvendes.>>
English: Special warnings and precautions for use <<Product name in cartridges> is only suitable for subcutaneous injections from a reusable pen.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen <<Produktnavn i cylinderampuller> er kun egnet til subkutan injektion fra en genanvendelig pen.
English: Standard (100 units/mL) and lower (< 100 units/mL) strength insulin products The text to be adapted to individual products is in bold.
Danish: Insulinprodukter med standardstyrke (100 enheder/ml) og lavere styrke (< 100 enheder/ml)
English: <Product name in pre-filled pen> is only suitable for injecting just under the skin.
Danish: <Produktnavn i fyldte penne> er kun egnet til indsprøjtning lige under huden.
English: <<Product name in pre-filled pen> is only suitable for subcutaneous injections.
Danish: <<Produktnavn i fyldte penne> er kun egnet til subkutan injektion.
English: How to use <product name> <Product name in cartridges> is only suitable for injecting just under the skin using a reusable pen.
Danish: Sådan skal du bruge <produktnavn> <Produktnavn i cylinderampuller> er kun egnet til indsprøjtning lige under huden ved hjælp af en genanvendelig pen.
English: Rabbits need to be revaccinated every year.
Danish: Kaninerne skal vaccineres igen hvert år.
English: Protection starts at three weeks and lasts for one year.
Danish: Beskyttelsen begynder efter tre uger og varer et år.
English: It is given to rabbits from five weeks of age as a single injection under the skin.
Danish: Vaccinen gives til kaniner fra de er 5 uger gamle som en enkelt injektion under huden.
English: Antibody levels increased for up to six weeks following vaccination and stayed at this level for 12 months.
Danish: Antallet af antistoffer steg i op til seks uger efter vaccinationen og holdt sig på det niveau i 12 måneder.
English: When the rabbit comes into contact with these or similar viruses, these antibodies,
Danish: Når kaninen kommer i kontakt med disse eller en lignende virus, vil disse antistoffer sammen med andre
English: The swelling resolves completely by 3 weeks after vaccination.
Danish: Hævelsen vil være fuldstændig væk 3 uger efter vaccinationen.
English: The virus causes swelling and discharge from the eyes, nose and bottom with most rabbits dying within 10 - 14 days.
Danish: Virussen medfører hævelser og sekretionsdannelse fra øjne, næse og kønsåbning, og de fleste kaniner dør inden for 10-14 dage.
English: together with other components of the immune system, will be able to kill the viruses and help protect against the diseases.
Danish: komponenter i immunsystemet være i stand til at dræbe virussen og hjælpe med at beskytte mod sygdommen.
English: Four laboratory studies were conducted in young rabbits that showed protection began three weeks after vaccination and lasted 12 months against RHDV1 and RHDV2.
Danish: Der blev gennemført fire laboratoriestudier hos unge kaniner, som viste, at beskyttelse begyndte at virke tre uger efter vaccinationen og varede i 12 måneder mod RHDV1 og RHDV2.
English: RHD, caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2), leads to blood clots in major organs such as the heart, lungs and kidneys leading to heart and respiratory failure when the heart and lungs do not work properly.
Danish: RHD forårsages af klassisk RHV-virus (RHDV1) og RHD type 2-virus (RHDV2) og fører til blodpropper i vigtige organer såsom hjertet, lungerne og nyrerne og dermed til hjerte- og vejrtrækningssvigt, når hjertet og lungerne ikke fungerer, som de skal.
English: For myxoma virus, rabbits were tested for antibodies only.
Danish: Ved myxomavirus blev kaninerne kun testet for antistoffer.
English: The withdrawal period for meat from rabbits treated with Nobivac Myxo-RHD Plus is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra kaniner, der behandles med Nobivac Myxo-RHD Plus, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: When a rabbit is given the vaccine, the immune system recognises the weakened viruses in the vaccine as ‘foreign' and makes antibodies against both the myxoma virus and the RHD virus proteins.
Danish: Når en kanin vaccineres, opfatter immunsystemet det svækkede virus i vaccinen som "fremmed" og danner antistoffer både mod myxomavirus og RHD-virusproteiner.
English: Further information on Nobivac Myxo-RHD Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/nobivac-myxo-rhd-plus.
Danish: Yderligere information om Nobivac Myxo-RHD Plus findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/nobivac-myxo-rhd-plus.
English: Myxomatosis is caused by the myxoma virus and is spread between rabbits by close contact and biting insects such as fleas and mosquitoes.
Danish: Myxomatose forårsages af myxomavirus og spredes mellem kaniner ved tæt kontakt og i forbindelse med bidende insekter såsom lopper og myg.
English: These viruses have been modified so that they also produce proteins from the outer coat of either RHDV1 (strain 009) or RHDV2 (strain MK1899).
Danish: Disse vira er blevet modificeret, så de også producerer proteiner fra overfladen af enten RHDV1 (stamme 009) eller RHDV2 (stamme MK1899).
English: These studies showed that rabbits that were vaccinated with Nobivac Myxo-RHD had fewer signs of myxomatosis, more antibodies against RHDV1 virus in their blood and a lower death rate than unvaccinated rabbits.
Danish: Disse studier viste, at kaniner, der blev vaccineret med Nobivac Myxo-RHD, havde færre symptomer på myxomatose, flere antistoffer mod RHDV1-virus i blodet og en lavere dødelighed end kaniner, der ikke var vaccineret.
English: Nobivac Myxo-RHD Plus is a vaccine.
Danish: Nobivac Myxo-RHD Plus er en vaccine.