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combined vaccine
1 Pravna redakcija
finance
CELEX: 32003L0063
- A combined vaccine contains at least two distinct vaccine antigens aimed at preventing a single or several infectious diseases.
- Kombinirano cepivo vsebuje vsaj dva različna antigena cepiva, ki sta namenjena za preprečevanje ene same ali več nalezljivih bolezni.
2 Pravna redakcija
finance
CELEX: 32003L0063
second, an assessment of the finished medicinal product (combined vaccine) containing the modified antigen which is the task of the competent authority that granted the combined vaccine marketing authorisation.
oceno končnega izdelka (kombiniranega cepiva), ki vsebuje spremenjeni antigen, kar je naloga pristojnega organa, ki je izdal dovoljenje za promet s kombiniranim cepivom.
3 Pravna redakcija
finance
CELEX: 32003L0063
The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.
Samostojni del je lahko skupen enemu ali več monovalentnim in/ali kombiniranim cepivom, ki ga predloži isti vlagatelj ali imetnik dovoljenja za promet.
4 Pravna redakcija
finance
CELEX: 32003L0063
The VAMF should serve as a stand-alone part of the marketing authorisation dossier and provide all relevant information of a biological and chemical nature related to one specific antigen, which constitutes one of the active substances of one or several combined vaccines.
Glavna dokumentacija o antigenu cepiva naj bo samostojen del dokumentacije za pridobitev dovoljenja za promet in naj vsebuje vse pomembne podatke o biološki in kemični naravi enega specifičnega antigena, ki je sestavni del ene od zdravilnih učinkovin enega ali več kombiniranih cepiv.
5 Pravna redakcija
finance
CELEX: 32003L0063
In order to simplify the existing procedures for the assessment of such vaccines, both for the granting of a first marketing authorisation and for subsequent changes to it due to modifications to the manufacturing process and testing of individual antigens involved in combined vaccines, a new system based on the concept of a vaccine antigen master file (VAMF) should be introduced.
Da se poenostavijo obstoječi postopki za oceno takih cepiv, tako pri izdaji prvega dovoljenja za promet z zdravilom kot pri vseh poznejših spremembah dovoljenja, zaradi sprememb postopka proizvodnje in preskušanja posameznih antigenov, vključenih v kombinirana cepiva, je treba uvesti nov sistem na podlagi koncepta glavne dokumentacije o antigenu cepiva (VAMF).
6 Prevajalska redakcija
RS
EMEA
Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age.
Če cepivo proti HBV ni bilo dano ob rojstvu, se lahko kombinirano cepivo prične dajati pri 8 tednih starosti.
7 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
A combined vaccine contains at least two distinct vaccine antigens aimed at preventing a single or several infectious diseases.
Kombinirano cepivo vsebuje vsaj dva različna antigena cepiva, ki sta namenjena za preprečevanje ene same ali več nalezljivih bolezni.
8 Prevajalska redakcija
RS
EMEA
In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age.
S cepljenjem s kombiniranim cepivom je v takšnih primerih potrebno pričeti pri starosti 6 tednov.
9 Prevajalska redakcija
RS
EMEA
Combined HAB vaccine (360/ 10)
Kombinirano HAB cepivo (360/ 10)
10 Prevajalska redakcija
RS
EMEA
13 In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine.
13 V prospektivni primerjalni študiji so dajanje kombiniranega DTPw- HBV cepiva primerjali s sočasnim dajanjem cepiva DTPw in cepiva HBV na različna mesta. Tako so v skupini, ki je prejela kombinirano cepivo, poročali o večji incidenci bolečine, rdečine, otekline in vročine.
11 Prevajalska redakcija
RS
EMEA
Fatigue was reported following 29.2 % doses of Ambirix, as compared to 19.3 % doses of the three dose combined vaccine.
O utrujenosti so poročali pri 29, 2 % odmerkov cepiva Ambirix v primerjavi z 19, 3 % odmerkov pri treh odmerkih kombiniranega cepiva.
12 Prevajalska redakcija
RS
EMEA
The incidence of pain and fatigue graded as severe was low and similar to that observed with the three dose combined vaccine.
Incidenca hude bolečine in utrujenosti je bila nizka ter podobna tisti po cepljenju s tremi odmerki kombiniranega cepiva.
13 Prevajalska redakcija
RS
EMEA
In situations where a booster dose of hepatitis A and/ or hepatitis B is desired, a monovalent or combined vaccine can be given.
V okoliščinah, ko je zaželen obnovitveni odmerek cepiva proti hepatitisu A in/ ali hepatitisu B, se lahko cepi z monovalentnim ali s kombiniranim cepivom.
14 Prevajalska redakcija
RS
EMEA
This combined vaccine is indicated for primary and booster vaccination of children against the viruses and bacteria mentioned above.
To kombinirano cepivo je indicirano za primarno in obnovitveno cepljenje otrok proti zgoraj omenjenim virusom in bakterijam.
15 Prevajalska redakcija
RS
EMEA
Pain was reported following 50.7 % of doses in the Ambirix group, as compared to 39.1 % of doses with the three dose combined vaccine.
5 cepivom Ambirix 66, 4 % oseb poročalo o bolečini v primerjavi s 63, 8 % oseb, ki so prejeli tri odmerke kombiniranega cepiva.
16 Prevajalska redakcija
RS
EMEA
5 combined vaccine, the only exceptions being a higher incidence of pain and fatigue on a per dose basis after Ambirix, but not on a per subject basis.
V skupini, ki je prejemala cepivo Ambirix, so poročali o bolečini pri 50, 7 % odmerkov v primerjavi z 39, 1 % odmerkov pri treh odmerkih kombiniranega cepiva.
17 Prevajalska redakcija
RS
EMEA
Bacterial and viral vaccines, combined, ATC code:
Kombinacije bakterijskih in virusnih cepiv. Oznaka ATC:
18 Prevajalska redakcija
RS
EMEA
In a study, in 300 subjects aged from 12 years up to and including 15 years, the reactogenicity profile of Ambirix was compared to that of the three-dose combined vaccine.
V študiji so pri 300 osebah, starih od 12 do vključno 15 let, primerjali pojavnost neželenih učinkov po cepljenju s cepivom Ambirix in pojavnost neželenih učinkov po prejemu treh odmerkov kombiniranega cepiva.
19 Prevajalska redakcija
RS
EMEA
The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Titri anti- HBs in anti- HAV protiteles, opaženi po osnovnem cepljenju, so primerljivi z opažanji po cepljenju z monovalentnimi cepivi.
20 Prevajalska redakcija
RS
EMEA
Bacterial and viral vaccines combined, ATC code J07CA09
Kombinacija bakterijskih in virusnih cepiv, oznaka ATC: J07CA09
21 Prevajalska redakcija
RS
EMEA
Bacterial and viral vaccines combined, ATC code J07CA12
Kombinacija bakterijskih in virusnih cepiv, oznaka ATC: J07CA12
22 Prevajalska redakcija
RS
EMEA
Bacterial and viral vaccines combined, ATC code JO7CA10
Kombinacije bakterijskih in virusnih cepiv, Oznaka ATC:
23 Prevajalska redakcija
RS
EMEA
This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three dose combined vaccine, than after a single dose of Ambirix.
V vmesnem obdobju med prejemom drugega in tretjega odmerka kombiniranega cepiva bo tako zaščiten večji odstotek oseb, kot je po enem samem odmerku cepiva Ambirix.
24 Prevajalska redakcija
RS
EMEA
Bacterial and viral vaccines combined, ATC code J07CA05.
Kombinacije bakterijskih in virusnih cepiv, oznaka ATC: J07CA05
25 Prevajalska redakcija
RS
EMEA
In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
V primerjalnem kliničnem preskušanju, ki je bilo izvedeno med osebami, starimi od 12 do vključno 15 let, jih je 142 prejelo dva odmerka cepiva Ambirix, 147 pa jih je prejelo standardno cepivo s tremi odmerki.
26 Prevajalska redakcija
RS
EMEA
Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 90 % of children administered four doses of a combined vaccine containing the same HBs antigen as 7 Infanrix Penta.
Zaščitna protitelesa proti hepatitisu B so dokazano prisotna vsaj še 3, 5 leta pri več kot 90 % otrok, ki dobijo štiri odmerke kombiniranega cepiva z enakim antigenom HBs, kot ga vsebuje Infanrix Penta.
27 Prevajalska redakcija
RS
EMEA
Twinrix Adult is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Twinrix za odrasle je kombinirano cepivo, pripravljeno iz posameznih pripravkov prečiščenega, inaktiviranega virusa hepatitisa A (HA) in prečiščenega površinskega antigena virusa hepatitisa B (HBsAg), ki sta ločeno adsorbirana na aluminijev hidroksid in aluminijev fosfat.
28 Prevajalska redakcija
RS
EMEA
In both studies, subjects received either a two dose schedule of Ambirix or a three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
V obeh študijah so osebe prejele bodisi cepivo Ambirix po shemi dveh odmerkov bodisi tri odmerke kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
29 Prevajalska redakcija
RS
EMEA
Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Twinrix za otroke je kombinirano cepivo, pripravljeno iz posameznih pripravkov prečiščenega, inaktiviranega virusa hepatitisa A (HA) in prečiščenega površinskega antigena virusa hepatitisa B (HBsAg), ki sta ločeno adsorbirana na aluminijev hidroksid in aluminijev fosfat.
30 Prevajalska redakcija
RS
EMEA
If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
V primeru potrebe po hitri zaščiti pred hepatitisom B je priporočljiva standardna shema treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
31 Prevajalska redakcija
RS
EMEA
This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
To kombinirano cepivo se uporablja za primarno in obnovitveno cepljenje otrok proti davici, tetanusu, oslovskemu kašlju, vsem znanim podtipom virusa hepatitisa B, otroški ohromelosti in invazivnim okužbam s Haemophilus influenzae tipa b.
32 Prevajalska redakcija
RS
EMEA
In this study, the immune response to both antigen components was comparable to that seen after a 3-dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10µg of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml.
V tej študiji je bil odziv na obe antigenski komponenti primerljiv tistemu po 3- odmernem režimu dajanja kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 µg rekombinantnega površinskega antigena virusa hepatitisa B v odmerku 0, 5 ml.
33 Prevajalska redakcija
RS
EMEA
In a comparative trial in subjects aged 1-11 years, the incidences of local and general solicited symptoms in the Ambirix group were similar to those seen with the three-dose combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
V primerjalnem preskušanju pri osebah, starih od 1 do 11 let, je bila incidenca lokalnih in generaliziranih simptomov v skupini, ki je prejemala Ambirix, podobna tisti po prejemu treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
34 Prevajalska redakcija
RS
EMEA
The percentages of vaccinees reporting any solicited symptom graded as severe during a two-dose regimen of Ambirix or a three dose regimen with the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen, were not statistically different.
Odstotki poročil, o katerem koli resnem simptomu med cepljenjem z dvema odmerkoma cepiva Ambirix ali s tremi odmerki kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B, se statistično niso razlikovali.
35 Prevajalska redakcija
RS
EMEA
• If your child has had an allergic reaction to eggs or anything that contained egg. • If your child has a history or family history of allergies or of convulsions (fits). • If your child has had a side effect after vaccination with measles, mumps, or rubella (in a single vaccine or combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or ProQuad) that involved easy bruising or bleeding for longer than usual. • If your child has infection with Human Immunodeficiency Virus (HIV) but does not show symptoms of HIV disease.
• Če je imel vaš otrok alergijsko reakcijo na jajca ali na karkoli, kar vsebuje jajca. • Če je imel vaš otrok ali kdo iz njegove družine kdaj konvulzije (krče). • Če je imel vaš otrok kdaj neželen učinek po cepljenju proti ošpicam, mumpsu ali rdečkam (pri cepljenju z enovalentnim ali kombiniranim cepivom, kot je cepivo proti ošpicam, mumpsu in rdečkam, izdelovalca Merck & Co., Inc., ali ProQuad), pri katerem so se hitro pojavljale modrice ali je krvavitev trajala dlje kot ponavadi. • Če je vaš otrok okužen s človeškim virusom imunske pomanjkljivosti (HIV), a ne kaže znakov bolezni HIV.
36 Prevajalska redakcija
RS
EMEA
A clinical trial was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 486 healthy adult volunteers.
Pri 486 zdravih odraslih prostovoljcih so opravili klinično preskušanje s cepivom proti sevu H5N1, kombiniranim z adjuvansom MF59C. 1.
37 Prevajalska redakcija
RS
EMEA
In combined clinical trials of a single dose of Varicella Vaccine live (Oka/ Merck) in healthy children, the protective efficacy of the vaccine against all severities of varicella disease ranged from 81 % to 100 %.
V kombiniranih kliničnih študijah enojnega odmerka cepiva z živim virusom noric (Oka/ Merck) pri zdravih otrocih je znašala učinkovitost zaščite cepiva proti vsem stopnjam noric od 81 % do 100 %.
38 Prevajalska redakcija
RS
EMEA
During post-marketing surveillance with the three dose combined vaccine containing either 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml (recommended for subjects 1 year up to and including 15 years of age) or 720 ELISA Units of formalin inactivated hepatitis A virus and 20 micrograms of recombinant hepatitis B surface antigen in a dose volume of 1 ml (recommended from the age of 16 years onwards), the following adverse reactions have been reported.
Med postmarketinškim spremljanjem cepljenja s tremi odmerki kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B v odmerku 0, 5 ml (priporočeno za osebe, stare od 1 do vključno 15 let) ali 720 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 20 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B v odmerku 1 ml (priporočeno za osebe, stare 16 let in več) so poročali o naslednjih neželenih reakcijah:
39 Prevajalska redakcija
RS
EMEA
However, since M-M-RVAXPRO has been shown to have safety and immunogenicity profiles similar to the previous formulation of the combined measles, mumps, 5 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.
40 Prevajalska redakcija
RS
EMEA
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1)
Pri sočasnem vendar ločenem injiciranju cepiva Ambirix in mešanega cepiva proti davici, tetanusu, oslovskemu kašlju – acelularno, otroški ohromelosti – inaktivirano in Haemophilusu influenzae tipa b (DTPa- IPV/ Hib) ali mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, je bil imunski odziv na vse antigene zadovoljiv (glejte poglavje 5. 1).
41 Prevajalska redakcija
RS
EMEA
When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Če se je prvi odmerek cepiva Ambirix dal sočasno z obnovitvenim odmerkom mešanega cepiva proti davici, tetanusu, oslovskemu kašlju – acelularno, otroški ohromelosti – inaktivirano in Haemophilusu influenzae tipa b (DTPa- IPV/ Hib) ali s prvim odmerkom mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, so bili imunski odzivi na vse antigene zadovoljivi.
42 Prevajalska redakcija
RS
EMEA
In a trial of booster vaccination against Hib and MenC, Menitorix was administered concomitantly (into opposite thighs) with a first dose of combined measles, mumps and rubella (MMR) vaccine.
V preskušanju obnovitvenega cepljenja proti Hib in MenC, so osebe cepivo Menitorix prejele sočasno (v drugo stegno) s prvim odmerkom kombiniranega cepiva proti ošpicam, mumpsu in rdečkam (MMR).
43 Prevajalska redakcija
RS
EMEA
However, the frequency of irritability was statistically higher after all three injections of PROCOMVAX combined and after the first injection of PROCOMVAX compared to the monovalent vaccines.
Vendar pa je bila pogostnost razdražljivosti po vseh treh injekcijah cepiva PROCOMVAX skupaj in po prvi injekciji cepiva PROCOMVAX v primerjavi z monovalentnima cepivoma statistično večja.
44 Prevajalska redakcija
RS
EMEA
Based upon combined data from REST and the FES, the reduction up to 3 years post-vaccination in the rate of hospitalisations and emergency department visits for RV gastroenteritis was 94.4% (95% CI:
Na podlagi kombiniranih podatkov iz REST in FES je bilo zmanjšanje deleža hospitalizacij in obiskov nujne zdravniške pomoči zaradi RV gastroenteritisa v obdobju 3 let po cepljenju 94, 4 % (95- odstotni IZ:
45 Prevajalska redakcija
RS
EMEA
Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Hepatitis B virus, polio virus and Haemophilus influenzae type b.
Hexavac je heksavalentno cepivo, ki vsebuje kombinirane antigene, pridobljene iz Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virusa hepatitisa B, poliovirusa in Haemophilus influenzae tipa b.
46 Prevajalska redakcija
RS
EMEA
The Committee for Medicinal products for Human Use (CHMP) decided that M-M-RVAXPRO’ s benefits are greater than its risks for the combined vaccination against measles, mumps, and rubella in individuals 12 months or older.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so za hkratno cepljenje proti ošpicam, mumpsu in rdečkam v starosti od 12 mesecev dalje, koristni učinki cepiva M- M- RVAXPRO večji od tveganja, povezanega z zdravilom.
47 Prevajalska redakcija
RS
EMEA
Additional side effects that have been reported very rarely (less than 1 in 10,000 doses of vaccine) in the days or weeks after vaccination with very similar combined or individual hepatitis A and hepatitis B vaccines, include:
Dodatni neželeni učinki, o katerih so zelo redko (manj kot 1 od 10. 000 odmerkov cepiva) poročali več dni ali tednov po cepljenju in so zelo podobni tako za kombinirana kot za posamična cepiva proti hepatitisu A in hepatitisu B, vključujejo:
48 Prevajalska redakcija
RS
EMEA
Menitorix can be given at the same time as vaccines intended to protect against one or more of diphtheria, tetanus, whooping cough, polio, hepatitis B, pneumococcal conjugate vaccine and combined vaccines against measles, mumps and rubella (MMR).
Cepivo Menitorix se lahko uporablja sočasno z enim ali več konjugiranimi cepivi proti davici, tetanusu, oslovskemu kašlju, otroški ohromelosti, hepatitisu B ali pneumokokom in kombiniranimi cepivi proti ošpicam, mumpsu in rdečkam (MMR).
49 Prevajalska redakcija
RS
EMEA
The data from SPCs, literature and generated during clinical development combined with recent surveillance data from the United Kingdom and Canada suggest that vaccine effectiveness remained high in unprimed subjects who had been vaccinated in their second year of life with a single dose.
Podatki iz povzetka glavnih značilnosti zdravila in literature ter podatki, do katerih so prišli med kliničnim razvojem v kombinaciji z zadnjimi podatki spremljanja iz Združenega kraljestva in Kanade, kažejo, da je učinkovitost cepiva ostala visoka pri osebah, ki niso prejele osnovnega cepljenja in ki so se cepile v drugem letu življenja z enim samim odmerkom.
50 Prevajalska redakcija
RS
EMEA
Instead, you/ your child will probably need to have three injections of a combined hepatitis A and hepatitis B vaccine that has a lower content in each dose of the active substances (360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen).
Namesto tega boste/ bo vaš otrok verjetno potrebovali/ potreboval tri odmerke kombiniranega cepiva proti hepatitisu A in hepatitisu B z manjšo vsebnostjo zdravilne učinkovine v vsakem odmerku (360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B).
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combined vaccine