FrancophonIA/ELRC3.0 huggingface dataset:
English: *These side effects were reported with the use of M-M-RVAXPRO or with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or with its monovalent (single) components, during post-marketing use and/or during clinical studies.
Danish: * Disse bivirkninger er indberettet i forbindelse med brug af M-M-RVAXPRO eller mæslinge-, fåresyge- eller røde hunde-vaccine fremstillet af Merck & Co., Inc. eller vaccinens monovalente (enkelt)komponenter efter markedsføring og/eller under kliniske studier.
English: Do not throw away any vaccines via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide vaccinerester i afløbet, toilettet eller skraldespanden.
English: Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Danish: Bør ikke anvendes til patienter med hereditær fructoseintolerans.
English: Dose 1 at 12 months / Dose 2 at 15 months N = 466
Danish: Dosis 1 ved 12 md. / dosis 2 ved 15 md. N= 466
English: Inject the entire content of the syringe into the vial containing the powder.
Danish: Injicer hele indholdet af den fyldte sprøjte i hætteglasset, der indeholder pulveret.
English: - If you or your child have a family history of congenital or hereditary immunodeficiency, unless the immune competence of you or your child is demonstrated.
Danish: - Hvis De eller Deres barn har en familiær medfødt eller arvelig immundefekt, med mindre De eller Deres barn har fået bevist, at De har et funktionsdygtigt immunforsvar.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om M-M-RVAXPRO, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Solvent for M-M-RVAXPRO
Danish: Solvens til M-M-RVAXPRO.
English: The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
Danish: Vaccinen skal injiceres intramuskulært (i.m.)
English: However, since M-M-RVAXPRO has been shown to have safety and immunogenicity profiles similar to the previous formulation of the combined measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., experience with this vaccine can be considered.
Danish: Men da det er påvist, at M-M-RVAXPRO har samme sikkerheds- og immunogenicitetsprofil som den tidligere formulering af den kombinerede mæslinge-, parotitis- og rubellavaccine fremstillet af Merck & Co., Inc., kan erfaring med denne vaccine tages i betragtning.
English: Close monitoring is recommended following vaccination for the early signs of such reactions.
Danish: Det anbefales derfor at monitorere disse patienter tæt efter vaccination.
English: The solvent is a clear and colourless liquid.
Danish: Solvensen er en klar, farveløs væske.
English: If you have been told by your doctor that you or your child have an intolerance to some sugars, inform your doctor before you or your child receive this vaccine.
Danish: Kontakt lægen, før De eller Deres barn får denne vaccine, hvis lægen har fortalt Dem, at De eller Deres barn ikke tåler visse sukkerarter.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om M-M-RVAXPRO findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Gastrointestinal disorders Diarrhoea or Vomiting
Danish: Mave-tarm-kanalen Diarré eller opkastning
English: To reconstitute, use the solvent supplied.
Danish: Brug den medfølgende solvens til rekonstituering.
English: The MAH presented an analysis of reports with PT (preferred term) “Crying” From the data provided by the MAH “crying” was reported during clinical trials, post marketing source and literature report in paediatric population as an ADR.
Danish: I data fra indehaveren af markedsføringstilladelsen var ”gråd” rapporteret i kliniske studier, efter markedsføring og i litteraturen i den pædiatriske population som en bivirkning.
English: M-M-RVAXPRO should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm. Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site.
Danish: Ved indsprøjtning i en muskel foretrækkes låret normalt hos små børn, mens overarmen er det foretrukne injektionssted hos større personer.
English: Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.
Danish: Sorbitol, natriumphosphat, kaliumphosphat, saccharose, hydrolyseret gelatine, medium 199 med Hanks salte, MEM, mononatrium-L-glutamat, neomycin, phenolrødt, natriumhydrogencarbonat, saltsyre, natriumhydroxid og vand til injektionsvæsker.
English: Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Danish: Vurdering af immunogenicitet og klinisk virkning En sammenlignende undersøgelse af 1 279 personer, som fik M-M-RVAXPRO eller den tidligere formulering af mæslinge-, parotitis- og rubellavaccine (fremstillet med humant serumalbumin) fremstillet af Merck & Co., Inc. påviste ens immunogenicitet og sikkerhed af de 2 produkter.
English: Based on clinical studies with the quadrivalent measles, mumps, rubella and varicella vaccine and with the previous formulation of the combined measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., M-M-RVAXPRO can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine.
Danish: Baseret på kliniske studier med den firvalente mæslinge-, parotitis-, rubella- og varicellavaccine og med den tidligere formulering af den kombinerede mæslinge-, parotitis- og rubellavaccine fremstillet af Merck & Co., Inc. kan M-M-RVAXPRO indgives samtidig (men på separate injektionssteder) med Prevenar og/eller hepatitis-A-vaccine.
English: • Nasal congestion and sore throat; upper respiratory tract infection or viral infection; runny nose.
Danish: • Tilstoppet næse og ondt i halsen; infektion af de øvre luftveje eller virusinfektion; næseflåd.
English: The doctor will decide if M-M-RVAXPRO should be given.
Danish: Deres læge vil kunne afgøre, om De bør vaccineres med M-M-RVAXPRO.
English: Infections and infestations Nasopharyngitis, Upper respiratory tract infection or Viral infection
Danish: Infektioner og parasitære sygdomme Nasofaryngit, infektion eller virusinfektion i de øvre luftveje
English: The powder is a light yellow compact crystalline cake.
Danish: Pulveret er en kompakt lysegul, krystallinsk "kage".
English: dpoc_czechslovak@merck.com hungary_msd@merck.com
Danish: dpoc_czechslovak@merck.com
English: For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated individuals older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1.
Danish: Til anvendelse ved udbrud af mæslinger, til vaccination efter udsættelse for smitte samt til anvendelse hos ikke tidligere vaccinerede personer over 9 måneder, som er i kontakt med modtagelige gravide kvinder, og hos personer, som sandsynligvis er modtagelige for parotitis og rubella, se pkt.
English: Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema
Danish: Anafylaktoid reaktion, anafylakse og relaterede fænomener, såsom angioneurotisk ødem, facialt ødem og perifert ødem
English: Subacute sclerosing panencephalitis
Danish: Subakut skleroserende panencefalit (SSPE)
English: Potassium phosphate
Danish: Kaliumphosphat
English: The vaccine contains 14.5 mg of sorbitol.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Vaccinen indeholder 14,5 mg sorbitol.
English: Pregnancy.
Danish: Graviditet.
English: Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Danish: Sorbitol, natriumphosphat, kaliumphosphat, saccharose, hydrolyseret gelatine, medium 199 med Hanks salte, MEM, mononatrium-L-glutamat, neomycin, phenolrødt, natriumhydrogencarbonat, saltsyre (til justering af pH) og natriumhydroxid (til justering af pH).
English: What you need to know before you receive M-M-RVAXPRO
Danish: Det skal de vide, før De/Deres barn får M-M-RVAXPRO
English: More than 400 million doses of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2003).
Danish: Der er på verdensplan (1978-2003) blevet distribueret over 400 mio. doser af den tidligere formulering af mæslinge-, parotitis- og rubellavaccine fremstillet af Merck & Co., Inc.
English: Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Danish: Før pulveret blandes med solvens er det en kompakt lysegul, krystallinsk "kage".
English: Rubella virus Wistar RA 27/3 strain (live attenuated)
Danish: 2 Wistar RA 27/3 stamme (levende, svækket)
English: It has been reported that live attenuated measles, mumps, and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
Danish: Ved separat indgivelse af de enkelte levende svækkede mæslinge-, parotitis- og rubellavacciner er der rapporteret tilfælde, hvor huden kortvarigt har vist nedsat følsomhed over for tuberkulin.
English: IM or SC use
Danish: eller s.c. anvendelse.
English: See also section 3 How to use M-M-RVAXPRO.
Danish: Se også punkt 3 Sådan får De/Deres barn M-M-RVAXPRO.
English: • Discharge and itching of the eyes with crusting of eyelids (conjunctivitis).
Danish: • Tåreflåd og kløende øjne med sammenklistrede øjenlåg (øjenbetændelse).
English: After 2 doses, the seroprotection rates against measles were 98.1% when the first dose was given at 11 months compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective met).
Danish: Efter 2 doser var serobeskyttelsesraterne over for mæslinger 98,1 %, når første dosis blev givet ved 11 måneder sammenlignet med 98,9 %, når første dosis blev givet ved 12 måneder (formålet med ikke-inferioritetsstudiet opfyldt).
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided.
Danish: Vaccinen er et pulver til injektionsvæske, suspension, i et enkeltdosishætteglas.
English: After two doses, the seroprotection rates against measles were 94.6% when the first dose was given at 9 months compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective not met).
Danish: Efter 2 doser var serobeskyttelsesraterne over for mæslinger 94,6 %, når første dosis blev givet ved 9 måneder sammenlignet med 98,9 %, når første dosis blev givet ved 12 måneder (effektmålet for noninferioritetsstudiet ikke opfyldt).
English: In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Danish: Hos svært immunkompromitterede personer, der ved en fejl er blevet vaccineret med vaccine indeholdende mæslingevirus, er der indberettet mæslingeencefalitis (measles inclusion body encephalitis - MIBE), pneumonitis og dødelig udgang som en direkte følge af dissemineret infektion med mæslingevaccinevirus (se pkt.
English: After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at 2°C-8°C.
Danish: Det er dog fastslået, at vaccinen i brug er holdbar i 8 timer ved opbevaring i køleskab ved 2-8° C.
English: Gently agitate to dissolve completely.
Danish: Ryst forsigtigt for at opløse pulveret fuldstændigt.
English: Mumps virus
Danish: Parotitisvirus
English: EU/1/06/337/003 EU/1/06/337/004 EU/1/06/337/005 EU/1/06/337/006 EU/1/06/337/007 EU/1/06/337/008 EU/1/06/337/009 EU/1/06/337/010 EU/1/06/337/011 EU/1/06/337/012 EU/1/06/337/013
Danish: EU/1/06/337/003 EU/1/06/337/004 EU/1/06/337/005 EU/1/06/337/006 EU/1/06/337/007 EU/1/06/337/008
English: General disorders and administration site conditions Fever (38.5°C or higher), Injection site erythema,
Danish: Almene symptomer og reaktioner på administrationsstedet Feber (38,5 °C eller derover), erytem på injektionsstedet, smerter på injektionsstedet og hævelser på injektionsstedet
English: 1 Jeryl Lynn™ [Level B] strain (live, attenuated)………not less than 12.5x10 3 CCID50*
Danish: 1 Jeryl Lynn™ stamme [niveau B]) (levende, svækket) ikke under 12,5x10 3 CCID50*
English: †, Febrile convulsion (in children), Guillain-Barre syndrome, Headache, Measles inclusion body encephalitis (MIBE) (see section 4.3), Ocular palsies, Optic neuritis, Paraesthesia, Polyneuritis, Polyneuropathy, Retrobulbar neuritis, Syncope
Danish: † , febrile konvulsioner (hos børn), Guillain-Barres syndrom, hovedpine, mæslingeencefalitis (MIBE) (se pkt.
English: One dose is given at an elected date usually from 12 months of age.
Danish: M-M-RVAXPRO anvendes på følgende måde: Én dosis gives på en bestemt dato, som regel fra 12-måneders alderen.
English: M-M-RVAXPRO powder for suspension for injection
Danish: M-M-RVAXPRO pulver til injektionsvæske, suspension.
English: How to use M-M-RVAXPRO 4.
Danish: Sådan får De/Deres barn M-M-RVAXPRO 4.
English: Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
Danish: Overførsel af rubellavaccinevirus til spædbørn via modermælken uden holdepunkter for klinisk sygdom er dog dokumenteret (se pkt.
English: PRE-FILLED SYRINGE OF SOLVENT
Danish: FYLDT SPRØJTE MED SOLVENS
English: Dose 1 at 9 months / Dose 2 at 12 months
Danish: Dosis 1 ved 9 md. / dosis 2 ved 12 md. N= 527
English: M-M-RVAXPRO can be administered to infants from 9 months of age under special circumstances (see sections 4.2, 4.4 and 5.1).
Danish: M-M-RVAXPRO kan under særlige omstændigheder gives til spædbørn fra 9-måneders alderen (se pkt.
English: Merck Sharp & Dohme Cyprus Limited.
Danish: Malta Merck Sharp & Dohme Cyprus Limited., Tel:
English: 1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x10 3 CCID50*
Danish: 1 - Jeryl Lynn™-stamme [niveau B](levende, svækket) ikke under 12,5 x 10 3 CCID50*
English: Bronchial spasm, Cough, Pneumonia, Pneumonitis (see section 4.3), Sore throat
Danish: Bronkospasme, hoste, pneumoni, pneumonit (se pkt.
English: 3 CCID50* Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) not less than 12,5 x10
Danish: ikke under 1 x 10 3 CCID50* Parotitisvirus - Jeryl Lynn™-stamme [niveau B](levende, svækket) ikke under 12,5 x 10 3 CCID50*
English: 10 single dose vials (powder) + 10 vials (solvent).
Danish: 10 enkeltdosishætteglas (pulver) + 10 hætteglas (solvens).
English: Warnings and precautions Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have experienced any of the following: - If you or your child have an allergic reaction to eggs or anything that contained egg - If you or your child have a history or family history of allergies or of convulsions (fits) - If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising or bleeding for longer than usual - If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før De/Deres barn får M-M-RVAXPRO: - Hvis De eller Deres barn har haft en allergisk reaktion på æg eller noget der indeholder æg.
English: Powder and solvent for suspension for injection in pre-filled syringe.
Danish: Pulver og solvens til injektionsvæske, suspension i fyldt sprøjte.
English: EU/1/06/337/011 - pack of 1 EU/1/06/337/012 - pack of 10 EU/1/06/337/013 - pack of 20
Danish: EU/1/06/337/011 - pakning a 1 stk. EU/1/06/337/012 - pakning a 10 stk. EU/1/06/337/013 - pakning a 20 stk.
English: Solvent: water for injections
Danish: Opløsningsmiddel: Vand til injektionsvæsker.
English: Additionally, other adverse reactions reported with post-marketing use of M-M-RVAXPRO and/or in clinical studies and post-marketing use of previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck & Co., Inc. without regard to causality or frequency are available and are summarised in section b. The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Danish: Hertil kommer, at andre bivirkninger er rapporteret under anvendelse efter markedsføring af M-MRVAXPRO og/eller i kliniske forsøg efter markedsføringen af tidligere formuleringer af monovalente og kombinerede mæslinge-, parotitis- og rubellavacciner fremstillet af Merck & Co., Inc. uden hensyntagen til kausalitet eller hyppighed.
English: In clinical trials, M-M-RVAXPRO was administered to 1965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Danish: 5.1), og den generelle sikkerhedsprofil var sammenlignelig med den tidligere formulering af mæslinge-, parotitis- og rubellavaccine fremstillet af Merck & Co., Inc.
English: M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
Danish: M-M-RVAXPRO Pulver og solvens til injektionsvæske, suspension, Mæslinge-, parotitis- og rubellavaccine (levende)
English: M-M-RVAXPRO powder for suspension for injection in pre-filled syringe
Danish: M-M-RVAXPRO pulver til injektionsvæske, suspension, i en fyldt sprøjte.
English: EU/1/06/337/005 - pack of 1 EU/1/06/337/006 - pack of 10 EU/1/06/337/007 - pack of 20
Danish: EU/1/06/337/005 - pakning a 1 stk. EU/1/06/337/006 - pakning a 10 stk. EU/1/06/337/007 - pakning a 20 stk.
English: 20 single dose vials (powder) + 20 prefilled syringes (solvent) without needle.
Danish: 20 enkeltdosishætteglas (pulver) + 20 fyldte sprøjter (solvens) uden kanyle.
English: Measles virus
Danish: Mæslingevirus
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in pack size 1, 10 and 20.
Danish: Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i fyldt sprøjte (glas) med stempelprop (chlorbutylgummi) og hætte (styren butadiengummi), med en eller to separate kanyler i pakningsstørrelser på 1, 10 og 20 stk.
English: M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live)
Danish: M-M-RVAXPRO Pulver og solvens til injektionsvæske, suspension, i fyldt sprøjte Mæslinge-, parotitis- og rubellavaccine (levende)
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in pack size 1, 10, and 20.
Danish: Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i fyldt sprøjte (glas) med stempelprop (chlorbutylgummi)og hætte (styren butadiengummi), uden kanyle i pakningsstørrelser på 1, 10 og 20 stk.
English: 20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 40 needles.
Danish: 20 enkeltdosishætteglas (pulver) + 20 fyldte sprøjter (solvens) + 40 kanyler.
English: M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
Danish: M-M-RVAXPRO - Pulver i hætteglas og solvens i hætteglas - Pakning a 1, 10 stk.
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a vial (glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Danish: Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i hætteglas (glas) med en prop (chlorbutyl) i pakningsstørrelser på 1 og 10 stk.
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle-shield (natural rubber) in a pack size of 1 and 10.
Danish: Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i fyldt sprøjte (glas) med påsat kanyle med stempelprop (chlorbutylgummi) og kanylebeskyttelse (naturgummi) i pakningsstørrelser på 1 og 10 stk.
English: Withdraw the entire volume of solvent into a syringe.
Danish: Træk hele mængden af solvens op i en sprøjte (unødvendigt, hvis der anvendes fyldt sprøjte).
English: not less than 1 x10
Danish: ikke under 1 x 10 3 CCID50*
English: After reconstitution,1 dose (0.5 ml) contains: Measles virus Enders' Edmonston strain (live attenuated)
Danish: Mæslingevirus - Enders' Edmonston-stamme (levende, svækket)
English: 10 single dose vials (powder) + 10 pre-filled syringes (solvent) + 20 needles.
Danish: 10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) + 20 kanyler.
English: Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients; therefore, some of these patients may acquire measles, mumps, or rubella in case of contact, despite appropriate vaccine administration.
Danish: Derfor kan nogle af disse patienter få mæslinger, parotitis og rubella i tilfælde af kontakt til trods for passende administration af vaccinen.
English: EU/1/06/337/003 - pack of 1 EU/1/06/337/004 - pack of 10
Danish: EU/1/06/337/003 - pakning a 1 stk. EU/1/06/337/004 - pakning a 10 stk.
English: • Rash (including measles-like rash).
Danish: • Udslæt (herunder mæslingelignende udslæt).
English: 10 single dose vials (powder) + 10 prefilled syringes (solvent) without needle.
Danish: 10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) uden kanyle.
English: M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needlesPack of 1, 10, 20
Danish: M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte med 2 separate kanyler - Pakning a 1, 10, 20 stk.
English: 2 Wistar RA 27/3 strain (live, attenuated) …………….….not less than 1x10 3 CCID50*
Danish: 2 - Wistar RA 27/3 stamme ikke under 1 x 10 3 CCID50*
English: 10 single dose vials (powder) + 10 prefilled syringes (solvent) with needle.
Danish: 10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) med kanyle.
English: *50% cell culture infectious dose produced in chick embryo cells.
Danish: * Cellekultur infektiøs dosis 50 %.
English: N = 527
Danish: / dosis 2 ved 12 md. N= 527
English: M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needlePack of 1, 10, 20
Danish: M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte uden kanyle - Pakning a 1, 10, 20 stk.
English: Vascular disorders Vasculitis
Danish: Vaskulære sygdomme Vaskulit
English: EU/1/06/337/008 - pack of 1 EU/1/06/337/009 - pack of 10 EU/1/06/337/010 - pack of 20
Danish: EU/1/06/337/009 - pakning a 10 stk. EU/1/06/337/010- pakning a 20 stk.
English: EU/1/06/337/001 - pack of 1 EU/1/06/337/002 - pack of 10
Danish: EU/1/06/337/001 - pakning a 1 stk. EU/1/06/337/002 - pakning a 10 stk.