natgillin/translations-raw huggingface dataset:
Luftveje, thorax og mediastinum Rinorré
Respiratory, thoracic, and mediastinal disorders Rhinorrhoea
Der er ikke udført undersøgelser med M-M-RVAXPRO til gravide.
Studies have not been conducted with M-M-RVAXPRO in pregnant women.
Rubellavirus
Rubella virus
Det skal De vide, før De/Deres barn får M-M-RVAXPRO 3.
What you need to know before you receive M-M-RVAXPRO 3.
M-M-RVAXPRO er en vaccine, som indeholder mæslinge-, fåresyge- og røde hunde-vira, der er svækket.
M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened.
Kortvarig brænden og svien på injektionsstedet, utilpashed, papillit, perifert ødem, hævelse, ømhed, vesikler på injektionsstedet, vabler og hævelser på injektionsstedet
Burning and/or Stinging of short duration at the injection site, Malaise, Papillitis, Peripheral oedema, Swelling, Tenderness, Vesicles at the injection site, Wheal and Flare at the injection site
Anvend ikke den rekonstituerede vaccine, hvis den indeholder synlige partikler, eller hvis udseendet af solvensen eller pulveret eller den rekonstituerede vaccine adskiller sig fra ovennævnte beskrivelse.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
INSTRUCTIONS IN USE
c c. Beskrivelse af udvalgte bivirkninger
Not known see section c c. Description of selected adverse reactions
* 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.
*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.
Af hensyn til miljøet må De ikke smide vaccinerester i afløbet, toilettet eller skraldespanden.
Do not throw away any vaccines via wastewater or household waste.
Bør ikke anvendes til patienter med hereditær fructoseintolerans.
Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Dosis 1 ved 12 md. / dosis 2 ved 15 md. N= 466
Dose 1 at 12 months / Dose 2 at 15 months N = 466
Injicer hele indholdet af den fyldte sprøjte i hætteglasset, der indeholder pulveret.
Inject the entire content of the syringe into the vial containing the powder.
- 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.
- 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.
Hvis De ønsker yderligere oplysninger om M-M-RVAXPRO, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Solvens til M-M-RVAXPRO.
Solvent for M-M-RVAXPRO
Vaccinen skal injiceres intramuskulært (i.m.)
The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
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.
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.
Det anbefales derfor at monitorere disse patienter tæt efter vaccination.
Close monitoring is recommended following vaccination for the early signs of such reactions.
Solvensen er en klar, farveløs væske.
The solvent is a clear and colourless liquid.
Kontakt lægen, før De eller Deres barn får denne vaccine, hvis lægen har fortalt Dem, at De eller Deres barn ikke tåler visse sukkerarter.
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.
Yderligere information om M-M-RVAXPRO findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Mave-tarm-kanalen Diarré eller opkastning
Gastrointestinal disorders Diarrhoea or Vomiting
Brug den medfølgende solvens til rekonstituering.
To reconstitute, use the solvent supplied.
I data fra indehaveren af markedsføringstilladelsen var ”gråd” rapporteret i kliniske studier, efter markedsføring og i litteraturen i den pædiatriske population som en bivirkning.
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.
Ved indsprøjtning i en muskel foretrækkes låret normalt hos små børn, mens overarmen er det foretrukne injektionssted hos større personer.
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.
Sorbitol, natriumphosphat, kaliumphosphat, saccharose, hydrolyseret gelatine, medium 199 med Hanks salte, MEM, mononatrium-L-glutamat, neomycin, phenolrødt, natriumhydrogencarbonat, saltsyre, natriumhydroxid og vand til injektionsvæsker.
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.
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.
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.
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.
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.
• Tilstoppet næse og ondt i halsen; infektion af de øvre luftveje eller virusinfektion; næseflåd.
• Nasal congestion and sore throat; upper respiratory tract infection or viral infection; runny nose.
Deres læge vil kunne afgøre, om De bør vaccineres med M-M-RVAXPRO.
The doctor will decide if M-M-RVAXPRO should be given.
Infektioner og parasitære sygdomme Nasofaryngit, infektion eller virusinfektion i de øvre luftveje
Infections and infestations Nasopharyngitis, Upper respiratory tract infection or Viral infection
Pulveret er en kompakt lysegul, krystallinsk "kage".
The powder is a light yellow compact crystalline cake.
dpoc_czechslovak@merck.com
dpoc_czechslovak@merck.com hungary_msd@merck.com
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.
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.
Anafylaktoid reaktion, anafylakse og relaterede fænomener, såsom angioneurotisk ødem, facialt ødem og perifert ødem
Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema
Subakut skleroserende panencefalit (SSPE)
Subacute sclerosing panencephalitis
Kaliumphosphat
Potassium phosphate
Hjælpestoffer, som behandleren skal være opmærksom på: Vaccinen indeholder 14,5 mg sorbitol.
The vaccine contains 14.5 mg of sorbitol.
Graviditet.
Pregnancy.
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).
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)
Det skal de vide, før De/Deres barn får M-M-RVAXPRO
What you need to know before you receive M-M-RVAXPRO
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.
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).
Før pulveret blandes med solvens er det en kompakt lysegul, krystallinsk "kage".
Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
2 Wistar RA 27/3 stamme (levende, svækket)
Rubella virus Wistar RA 27/3 strain (live attenuated)
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.
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.
eller s.c. anvendelse.
IM or SC use
Se også punkt 3 Sådan får De/Deres barn M-M-RVAXPRO.
See also section 3 How to use M-M-RVAXPRO.
• Tåreflåd og kløende øjne med sammenklistrede øjenlåg (øjenbetændelse).
• Discharge and itching of the eyes with crusting of eyelids (conjunctivitis).
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).
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).
- Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
- If you have any further questions, ask your doctor or your pharmacist.
Vaccinen er et pulver til injektionsvæske, suspension, i et enkeltdosishætteglas.
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided.
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).
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).
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.
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.
Det er dog fastslået, at vaccinen i brug er holdbar i 8 timer ved opbevaring i køleskab ved 2-8° C.
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.
Ryst forsigtigt for at opløse pulveret fuldstændigt.
Gently agitate to dissolve completely.
Parotitisvirus
Mumps virus
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/1/06/337/003 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
Almene symptomer og reaktioner på administrationsstedet Feber (38,5 °C eller derover), erytem på injektionsstedet, smerter på injektionsstedet og hævelser på injektionsstedet
General disorders and administration site conditions Fever (38.5°C or higher), Injection site erythema,
1 Jeryl Lynn™ stamme [niveau B]) (levende, svækket) ikke under 12,5x10 3 CCID50*
1 Jeryl Lynn™ [Level B] strain (live, attenuated)………not less than 12.5x10 3 CCID50*
† , febrile konvulsioner (hos børn), Guillain-Barres syndrom, hovedpine, mæslingeencefalitis (MIBE) (se pkt.
†, 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
M-M-RVAXPRO anvendes på følgende måde: Én dosis gives på en bestemt dato, som regel fra 12-måneders alderen.
One dose is given at an elected date usually from 12 months of age.
M-M-RVAXPRO pulver til injektionsvæske, suspension.
M-M-RVAXPRO powder for suspension for injection
Sådan får De/Deres barn M-M-RVAXPRO 4.
How to use M-M-RVAXPRO 4.
Overførsel af rubellavaccinevirus til spædbørn via modermælken uden holdepunkter for klinisk sygdom er dog dokumenteret (se pkt.
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).
FYLDT SPRØJTE MED SOLVENS
PRE-FILLED SYRINGE OF SOLVENT
Dosis 1 ved 9 md. / dosis 2 ved 12 md. N= 527
Dose 1 at 9 months / Dose 2 at 12 months
M-M-RVAXPRO kan under særlige omstændigheder gives til spædbørn fra 9-måneders alderen (se pkt.
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).
1 - Jeryl Lynn™-stamme [niveau B](levende, svækket) ikke under 12,5 x 10 3 CCID50*
1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x10 3 CCID50*
Bronkospasme, hoste, pneumoni, pneumonit (se pkt.
Bronchial spasm, Cough, Pneumonia, Pneumonitis (see section 4.3), Sore throat
ikke under 1 x 10 3 CCID50* Parotitisvirus - Jeryl Lynn™-stamme [niveau B](levende, svækket) ikke under 12,5 x 10 3 CCID50*
3 CCID50* Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) not less than 12,5 x10
10 enkeltdosishætteglas (pulver) + 10 hætteglas (solvens).
10 single dose vials (powder) + 10 vials (solvent).
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.
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.
Pulver og solvens til injektionsvæske, suspension i fyldt sprøjte.
Powder and solvent for suspension for injection in pre-filled syringe.
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.
EU/1/06/337/011 - pack of 1 EU/1/06/337/012 - pack of 10 EU/1/06/337/013 - pack of 20
Opløsningsmiddel: Vand til injektionsvæsker.
Solvent: water for injections
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.
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.
5.1), og den generelle sikkerhedsprofil var sammenlignelig med den tidligere formulering af mæslinge-, parotitis- og rubellavaccine fremstillet af Merck & Co., Inc.
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.
M-M-RVAXPRO Pulver og solvens til injektionsvæske, suspension, Mæslinge-, parotitis- og rubellavaccine (levende)
M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
M-M-RVAXPRO pulver til injektionsvæske, suspension, i en fyldt sprøjte.
M-M-RVAXPRO powder for suspension for injection in pre-filled syringe
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.
EU/1/06/337/005 - pack of 1 EU/1/06/337/006 - pack of 10 EU/1/06/337/007 - pack of 20
20 enkeltdosishætteglas (pulver) + 20 fyldte sprøjter (solvens) uden kanyle.
20 single dose vials (powder) + 20 prefilled syringes (solvent) without needle.
Mæslingevirus
Measles virus
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.
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.
M-M-RVAXPRO Pulver og solvens til injektionsvæske, suspension, i fyldt sprøjte Mæslinge-, parotitis- og rubellavaccine (levende)
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live)
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.
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.
20 enkeltdosishætteglas (pulver) + 20 fyldte sprøjter (solvens) + 40 kanyler.
20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 40 needles.
M-M-RVAXPRO - Pulver i hætteglas og solvens i hætteglas - Pakning a 1, 10 stk.
M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i hætteglas (glas) med en prop (chlorbutyl) i pakningsstørrelser på 1 og 10 stk.
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.
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.
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.
Træk hele mængden af solvens op i en sprøjte (unødvendigt, hvis der anvendes fyldt sprøjte).
Withdraw the entire volume of solvent into a syringe.
ikke under 1 x 10 3 CCID50*
not less than 1 x10
Mæslingevirus - Enders' Edmonston-stamme (levende, svækket)
After reconstitution,1 dose (0.5 ml) contains: Measles virus Enders' Edmonston strain (live attenuated)
10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) + 20 kanyler.
10 single dose vials (powder) + 10 pre-filled syringes (solvent) + 20 needles.
Derfor kan nogle af disse patienter få mæslinger, parotitis og rubella i tilfælde af kontakt til trods for passende administration af vaccinen.
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.
EU/1/06/337/003 - pakning a 1 stk. EU/1/06/337/004 - pakning a 10 stk.
EU/1/06/337/003 - pack of 1 EU/1/06/337/004 - pack of 10
• Udslæt (herunder mæslingelignende udslæt).
• Rash (including measles-like rash).
10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) uden kanyle.
10 single dose vials (powder) + 10 prefilled syringes (solvent) without needle.
M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte med 2 separate kanyler - Pakning a 1, 10, 20 stk.
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needlesPack of 1, 10, 20
2 - Wistar RA 27/3 stamme ikke under 1 x 10 3 CCID50*
2 Wistar RA 27/3 strain (live, attenuated) …………….….not less than 1x10 3 CCID50*
10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) med kanyle.
10 single dose vials (powder) + 10 prefilled syringes (solvent) with needle.
* Cellekultur infektiøs dosis 50 %.
*50% cell culture infectious dose produced in chick embryo cells.
/ dosis 2 ved 12 md. N= 527
N = 527
M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte uden kanyle - Pakning a 1, 10, 20 stk.
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needlePack of 1, 10, 20
Vaskulære sygdomme Vaskulit
Vascular disorders Vasculitis
EU/1/06/337/009 - pakning a 10 stk. EU/1/06/337/010- pakning a 20 stk.
EU/1/06/337/008 - pack of 1 EU/1/06/337/009 - pack of 10 EU/1/06/337/010 - pack of 20
EU/1/06/337/001 - pakning a 1 stk. EU/1/06/337/002 - pakning a 10 stk.
EU/1/06/337/001 - pack of 1 EU/1/06/337/002 - pack of 10
Efter rekonstitution skal vaccinen anvendes straks eller inden for 8 timer, hvis den opbevares i køleskab.
Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator