natgillin/translations-raw huggingface dataset:
In
Postmarketinško spremljanje več kot 400 milijonov odmerkov, ki so bili razdeljeni po vsem svetu v obdobju skoraj 25 let (med letoma 1978 in 2003), kaže, da o resnih neželenih učinkih kot sta encefalitis in encefalopatija še vedno redko poročajo.
7 no case has it been shown conclusively that reactions were actually caused by vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines.
V nobenem primeru ni bilo dokončno dokazano, da je neželeni učinek dejansko posledica cepiva, vendar pa podatki nakazujejo možnost, da bi nekatere od teh primerov lahko povzročilo cepivo proti ošpicam.
The results of a retrospective case-controlled study conducted by the US Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE.
Rezultati retrospektivne študije, kontrolirane s primeri, ki so jo izvedli v Centrih za kontrolo in preprečevanje bolezni (Centers for Disease Control and Prevention) v ZDA, kažejo, da je skupni učinek cepljenja proti ošpicam zaščita pred SSPE, ker preprečuje ošpice in tveganje SSPE ob njih.
Eye disorders Not known: conjunctivitis, retinitis
Očesne bolezni Neznana pogostnost: konjunktivitis, retinitis
Ear and labyrinth disorders Not known: nerve deafness
Ušesne bolezni, vključno z motnjami labirinta Neznana pogostnost: senzorinevralna gluhost
Respiratory, thoracic, and mediastinal disorders Uncommon: rhinorrhoea Not known: bronchial spasm, cough, pneumonia, pneumonitis (see section 4.3), sore throat
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasne: izcedek iz nosu Neznana pogostnost: bronhialni spazem, kašelj, pljučnica, pnevmonitis (glejte poglavje 4. 3), bolečine v žrelu
Gastrointestinal disorders Uncommon: diarrhoea or vomiting Not known: nausea
Bolezni prebavil Občasne: driska ali bruhanje Neznana pogostnost: navzea
Skin and subcutaneous tissue disorders Common: rash morbilliform or other rash Uncommon: urticaria Not known: panniculitis, purpura, skin induration, Stevens-Johnson syndrome, pruritus
Bolezni kože in podkožja Pogoste: ošpicam podoben izpuščaj ali drug izpuščaj Občasne: urtikarija Neznana pogostnost: panikulitis, purpura, zatrdlina kože, Stevens- Johnsonov sindrom, pruritus
Musculoskeletal, connective tissue and bone disorders Not known: arthritis and/ or arthralgia (usually transient and rarely chronic [see below]), myalgia
Bolezni mišično- skeletnega sistema in vezivnega tkiva Neznana pogostnost: artritis in/ ali artralgija (običajno prehodna in redko kronična [glejte v nadaljevanju]), bolečine v mišicah
Arthralgia and/ or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children.
Njihova pogostnost in resnost se razlikujeta glede na starost in spol, največji pa sta pri odraslih ženskah in najmanjši pri otrocih pred puberteto.
Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
Po cepljenju otrok so neželeni učinki v sklepih večinoma občasni (0 do 3%) in kratkotrajni.
In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12-20%), and the reactions tend to be more marked and of longer duration.
Pri ženskah so pojavne stopnje artritisa in artralgije na splošno višje kot pri otrocih (12 do 20%), neželeni učinki pa so izrazitejši in vztrajajo dalj časa.
Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/ or viral antigen isolated from body tissues.
Povezan je bil s trajno izolacijo virusa in/ ali virusnega antigena iz telesnih tkiv.
8 General disorders and administration site conditions Very common: fever (38.5°C or higher), injection site erythema, injection site pain, and injection site swelling Common: injection site bruising Uncommon: injection site rash Not known: burning and/ or stinging of short duration at the injection site, fever (38.5°C or higher), malaise, papillitis, peripheral oedema, swelling, tenderness, vesicles at the injection site, wheal and flare at the injection site
Občasne: izpuščaj na mestu injiciranja Neznana pogostnost: kratkotrajen pekoč občutek in/ ali zbadanje na mestu injiciranja, zvišana telesna temperatura (38, 5 ºC ali več), slabo počutje, papilitis, periferni edem, oteklina, občutljivost, mehurčki na mestu injiciranja, gnojni mehurčki s širjenjem na mestu injiciranja
Vascular disorders Not known: vasculitis
Žilne bolezni Neznana pogostnost: vaskulitis
Overdose has been reported rarely and was not associated with any serious adverse reactions.
O prevelikih odmerkih so poročali redko; ti niso bili povezani s kakršnimikoli resnimi neželenimi učinki.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: virusna cepiva; oznaka ATC:
Viral vaccine, ATC code J07BD52
J07BD.
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.
Ocena imunogenosti in klinične učinkovitosti Primerjalna študija s 1279 preiskovanci, ki so bili cepljeni z M- M- RVAXPRO ali prejšnjim cepivom (izdelanim s humanim serumskim albuminom) proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc., je pokazala, da sta imunogenost in varnost teh dveh cepiv podobni.
Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. is highly immunogenic and generally well tolerated.
Klinične študije pri 284 trojno seronegativnih otrocih, starih od 11 mesecev do 7 let, so pokazale veliko imunogenost in dobro prenašanje prejšnjega cepiva proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc.
In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralising antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons.
V teh študijah je eno cepljenje induciralo protitelesa HI (protitelesa, ki zavirajo hemaglutinacijo) proti ošpicam pri 95%, nevtralizirajoča protitelesa proti mumpsu pri 96% in protitelesa HI proti rdečkam pri 99% dovzetnih oseb.
A comparative study in 752 subjects who received M-M-RVAXPRO either by intramuscular route or subcutaneous route demonstrated a similar immunogenicity profile between both administration routes.
Primerjalna študija pri 752 posameznikih, ki so prejemali M- M- RVAXPRO, intramuskularno ali subkutano, je pokazala, da je imunogenosti pri obeh načinih apliciranja podobna.
The efficacy of the components of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. was established in a series of double-blind controlled field trials, which demonstrated a high degree of protective efficacy afforded by the individual vaccine components.
Učinkovitost komponent prejšnjega cepiva proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc., je bila dokazana v seriji dvojno slepih, kontroliranih področnih študij, ki so dokazale visoko
Post-exposure vaccination Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours after exposure.
Poekspozicijsko cepljenje Cepljenje oseb, ki so bile izpostavljene divjemu sevu ošpic, je lahko v določeni meri zaščitno, če ga je mogoče izvesti v 72 urah po izpostavitvi.
If, however, the vaccine is given a few days before exposure, substantial protection may be afforded.
Če je oseba cepljena nekaj dni pred izpostavitvijo, je možna precejšnja zaščita.
There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.
Ni prepričljivih dokazov, da je cepljenje oseb, nedavno izpostavljenih divjemu sevu mumpsa ali rdečk, zaščitno.
9 Effectiveness 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).
Učinkovitost Po svetu so med letoma 1978 in 2003 razdelili več kot 400 milijonov odmerkov cepiva proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc.
Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a > 99% reduction in the incidence of each of the 3 targeted diseases.
Razširjena uporaba cepljenja z 2 odmerkoma v ZDA in državah, kot sta Finska in Švedska, je vodila v več kot 99- odstotno zmanjšanje pojavnosti vsake od teh treh bolezni.
Non-pregnant adolescent and adult females Vaccination of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see sections 4.4 and 4.6).
Mladostnice in odrasle ženske, ki niso noseče Cepljenje dovzetnih mladostnic in odraslih žensk v rodni dobi, ki niso noseče, z oslabljenim živim virusnim cepivom proti rdečkam je indicirano ob upoštevanju nekaterih previdnostnih ukrepov (glejte poglavji 4. 4 in 4. 6).
Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which, in turn, prevents infection of the foetus and consequent congenital rubella injury.
Cepljenje dovzetnih žensk po puberteti daje individualno zaščito pred prihodnjo okužbo z rdečkami v nosečnosti, kar preprečuje tudi okužbo ploda in prirojene rdečke.
Previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella-containing vaccine (such as M-M-RVAXPRO or a monovalent rubella vaccine) to reduce the risk of exposure of the pregnant woman.
M- M- RVAXPRO ali enovalentno cepivo proti rdečkam), da se tako zmanjša tveganje izpostavitve nosečnice.
Individuals likely to be susceptible to mumps and rubella M-M-RVAXPRO is preferred for vaccination of persons likely to be susceptible to mumps and rubella.
Osebe, ki so verjetno dovzetne za mumps in rdečke Pri cepljenju oseb, ki so verjetno dovzetne za mumps in rdečke, ima prednost M- M- RVAXPRO.
Individuals who require vaccination against measles can receive M-M-RVAXPRO regardless of their immune status to mumps or rubella if a monovalent measles vaccine is not readily available.
Osebe, ki jih je treba cepiti proti ošpicam, lahko prejmejo M- M- RVAXPRO ne glede na njihovo stanje imunosti proti mumpsu ali rdečkam, če enovalentnega cepiva proti ošpicam ni takoj na voljo.
Evaluation of pharmacokinetic properties is not required for vaccines.
Ocena farmakokinetičnih lastnosti za cepiva ni potrebna.
Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics.
Običajne predklinične študije varnosti niso bile opravljene, ni pa predkliničnih zadržkov, ki bi jih imeli za pomembne za klinično varnost, razen podatkov, vključenih v drugih odstavkih Povzetka glavnih značilnosti zdravil.
Powder Sorbitol Sodium phosphate Potassium phosphate Sucrose Hydrolysed gelatin Medium 199 with Hanks’ salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin
Prašek sorbitol natrijev fosfat kalijev fosfat saharoza hidrolizirana želatina medij 199 s Hanksovimi solmi minimalni esencialni medij, Eagle (MEM) natrijev L- glutamat neomicin
10 Phenol red Sodium bicarbonate Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH)
9 fenol rdeče natrijev bikarbonat klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at2°C-8°C.
V primeru shranjevanja rekonstituiranega cepiva v hladilniku pri temperaturi od 2 °C - 8 °C je bila dokazana 8 urna stabilnost.
Store and transport refrigerated (2°C – 8°C).
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).
Protect from light.
Varujte pred svetlobo.
For storage conditions of the reconstituted medicinal product, see section 6.3
Za pogoje shranjevanja rekonstituiranega cepiva glejte poglavje 6. 3.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a vial (Type 1 glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Prašek v viali (steklo tipa 1) z zamaškom (butilna guma) in vehikel v viali (steklo tipa 1) z zamaškom (klorobutilna guma) v pakiranju po 1 in 10.
Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Preden ga zmešamo z vehiklom, je prašek bledorumen kompakten kristalni skupek.
Withdraw the entire volume of solvent into the syringe to be used for reconstitution.
Za pripravo cepiva potegnite celoten volumen vehikla v brizgo.
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Pripravljenega cepiva ne smete uporabiti, če v njem opazite delce snovi ali če se videz vehikla, praška ali cepiva razlikuje od prej opisanega.
11 Any unused product or waste material should be disposed of in accordance with local requirements.
Morebitno neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon France
SANOFI PASTEUR MSD SNC 8 rue Jonas Salk F- 69007 Lyon Francija
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe.
M- M- RVAXPRO prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi
Measles, mumps, and rubella vaccine (live).
cepivo proti ošpicam, mumpsu in rdečkam (živo)
Powder and solvent for suspension for injection in pre-filled syringe.
Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi
Infants between 6 months and less than 12 months
12 Dojenčki, stari od 6 do 12 mesecev
14 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.
Pri imunsko hudo oslabljenih osebah, ki so jih pomotoma cepili s cepivom proti ošpicam, so poročali o ošpičnem encefalitistu z inkluzijskimi telesci, o pnevmonitisu in smrti kot neposredni posledici razsejane okužbe s cepilnim virusom ošpic.
15 Other Individuals who are known to be infected with human immunodeficiency viruses and are not immunocompromised may be vaccinated.
Drugo Osebe, za katere vemo, da so okužene z virusom HIV, in nimajo oslabljene imunosti, lahko cepimo.
Transmission Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
14 Pri večini cepljenih, za rdečke dovzetnih posameznikov je 7 do 28 dni po cepljenju prišlo do izločanja majhnih količin živega oslabljenega virusa rdečk iz nosu ali grla.
16 and rubella vaccine manufactured by Merck & Co., Inc., experience with this vaccine can be considered.
Ker pa ima M- M- RVAXPRO dokazano podoben profil varnosti in imunogenosti kot prejšnja oblika kombiniranega cepiva proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc., lahko upoštevamo izkušnje s tem cepivom.
Therefore, the vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for 3 months following vaccination (see sections 4.3 and 4.4).
Poleg tega naj ženska 3 mesece po cepljenju ne zanosi (glejte poglavje 4. 3 in 4. 4).
There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy.
15 Ustreznih študij o oslabljenem (cepilnem) sevu virusa ošpic v nosečnosti ni.
In a clinical trial, 752 children received M-M-RVAXPRO, either intramuscularly or subcutaneously.
V kliničnem preskušanju je bilo s cepivom M- M- RVAXPRO intramuskularno (IM) ali subkutano (SC) cepljenih 752 otrok.
17 although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Splošni profil varnosti po obeh načinih injiciranja je bil primerljiv, čeprav so bile reakcije na mestu vboda manj pogoste pri i. m. uporabi (15%) v primerjavi s s. c. uporabo (25, 8%).
Additionally, other adverse experiences 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 below (frequency not known).
Dodatno so na voljo podatki o neželenih učinkih iz obdobja trženja cepiva M- M- RVAXPRO in/ ali iz kliničnih študij in iz obdobja trženja prejšnjih oblik enovalentnih in kombiniranih cepiv proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc. in so, ne glede na vzročnost ali pogostnost pojavljanja, našteti spodaj (pogostnost pojavljanja ni znana).
Blood and the lymphatic system disorders Not known: regional lymphadenopathy, thrombocytopenia
16 Neznana pogostnost: regionalna limfadenopatija, trombocitopenija
18 no case has it been shown conclusively that reactions were actually caused by vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines.
V nobenem primeru ni bilo dokončno dokazano, da je neželeni učinek dejansko posledica cepiva, vendar pa podatki nakazujejo možnost, da bi nekatere od teh primerov lahko povzročilo cepivo proti ošpicam.
19 General disorders and administration site conditions Very common: fever (38.5°C or higher), injection site erythema, injection site pain, and injection site swelling Common: injection site bruising Uncommon: injection site rash Not known: burning and/ or stinging of short duration at the injection site, fever (38.5°C or higher), malaise, papillitis, peripheral oedema, swelling, tenderness, vesicles at the injection site, wheal and flare at the injection site
Občasne: izpuščaj na mestu injiciranja Neznana pogostnost: kratkotrajen pekoč občutek in/ ali zbadanje na mestu injiciranja, zvišana telesna temperatura (38, 5 ºC ali več), slabo počutje, papilitis, periferni edem, oteklina, občutljivost, mehurčki na mestu injiciranja, gnojni mehurčki s širjenjem na mestu injiciranja
Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. is highly immunogenic and generally well tolerated.
Klinične študije pri 284 trojno seronegativnih otrocih, starih od 11 mesecev do 7 let, je pokazala veliko imunogenost in dobro prenašanje prejšnjega cepiva proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc.
The efficacy of the components of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. was established in a series of double-blind controlled field trials, which demonstrated a high degree of protective efficacy afforded by the individual vaccine components.
V teh študijah je bila serokonverzija kot
These studies also established that seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
18 odziv na cepljenje proti ošpicam, mumpsu in rdečkam vzporedna zaščiti po vsaki od teh prebolelih bolezni.
20 Effectiveness 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).
Učinkovitost Po svetu so med letoma 1978 in 2003 razdelili več kot 400 milijonov odmerkov cepiva proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc.
5.2 Pharmacokinetic properties
5. 3 Farmakokinetične lastnosti
Powder Sorbitol Sodium phosphate Potassium phosphate Sucrose Hydrolysed gelatin Medium 199 with Hanks’ salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin
Prašek sorbitol natrijev fosfat kalijev fosfat saharoza hidrolizirana želatina medij 199 s Hanksovimi solmi minimalni esencialni medij, Eagle (MEM) natrijev L- glutamat neomicin fenol rdeče
21 Phenol red Sodium bicarbonate Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH)
19 natrijev bikarbonat klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
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.
V primeru shranjevanja rekonstituiranega cepiva v hladilniku pri temperaturi od 2 °C - 8 °C je bila dokazana 8 urna stabilnost.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type 1 glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle-shield (natural rubber) in a pack size of 1 and 10.
Prašek v viali (steklo tipa 1) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo tipa 1) z batnim zamaškom (klorobutilna guma) in z iglo z zaščito (iz naravne gume) v pakiranju po 1 in 10.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type 1 glass) with plunger stopper and tip cap (chlorobutyl rubber), without needle, in pack size 1, 10, and 20.
Prašek v viali (steklo tipa 1) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo tipa 1) z batnim zamaškom in pokrovčkom (klorobutilna guma), brez igle, v pakiranju po 1, 10 in 20.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type 1 glass) with plunger stopper and tip cap (chlorobutyl rubber), with one or two unattached needles, in pack size 1, 10 and 20.
Prašek v viali (steklo tipa 1) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo tipa 1) z batnim zamaškom in pokrovčkom (klorobutilna guma), z eno ali dvema nepritrjenima iglama, v pakiranju po 1, 10 in 20.
22 Reconstitution instructions
Navodilo za pripravo cepiva
IThe reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Pripravljenega cepiva ne smete uporabiti, če v njem opazite delce snovi ali če se videz vehikla, praška ali cepiva razlikuje od prej opisanega.
Any unused product or waste material should be disposed of in accordance with local requirements.
20 Morebitno neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
23 ANNEX II
21 DODATEK II
Sumneytown Pike PO Box 4 West Point Pennsylvania 19486 USA
Sumneytown Pike PO Box 4 West Point Pennsylvania 19486 ZDA
Waarderweg 39 2031 BN Haarlem The Netherlands
2031 BN Haarlem Nizozemska
25 ANNEX III
23 DODATEK III
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
25 PODATKI NA ZUNANJI OVOJNINI
M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
M- M- RVAXPRO – prašek v viali in vehikel v viali – pakiranje po 1, 10
M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps, and rubella vaccine (live)
M- M- RVAXPRO Prašek in vehikel za suspenzijo za injiciranje cepivo proti ošpicam, mumpsu in rdečkam (živo)
Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/ 3 strain (live attenuated)
Po pripravi cepiva en odmerek (0, 5 ml) vsebuje: najmanj 1 x 103 CCID50 * Virus ošpic, sev Enders ’ Edmonston (živ, oslabljen) najmanj 12, 5 x 103 CCID50 Virus mumpsa, sev Jeryl Lynn™ [nivo B] (živ, oslabljen) najmanj 1 x 103 CCID50 Virus rdečk, sev Wistar RA 27/ 3 (živ, oslabljen)
not less than 1 x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*
* 50- odstotni infektivni odmerek na celični kulturi