natgillin/translations-raw huggingface dataset:
The immunogenicity of a single dose of an earlier formulation of ProQuad was comparable to the immunogenicity of a single dose of its individual component vaccines (Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.), currently used in routine vaccination in some countries.
Imunogenost enojnega odmerka predhodne oblike cepiva ProQuad je bila primerljiva z imunogenostjo enojnega odmerka posameznih komponent cepiva (cepivo z živim virusom noric (Oka/ Merck) ter cepivo proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.), ki se trenutno v nekaterih državah uporabljajo za rutinsko cepljenje.
Clinical trials involving 6987 subjects who received ProQuad demonstrated detectable immune responses to measles, mumps, rubella, and varicella in a high proportion of individuals.
Klinične študije pri 6987 preiskovancih, ki so dobili cepivo ProQuad, so dokazale zaznaven imunski odziv na ošpice, mumps, rdečke in norice pri velikem deležu posameznikov.
The presence of detectable antibody was assessed by an appropriately sensitive enzyme-linked immunosorbent assay (ELISA) for measles, mumps (wild-type and vaccine-type strains), and rubella, and by gpELISA for varicella.
Prisotnost zaznavnih protiteles so ocenili z ustrezno občutljivim encimsko- imunskim testom (ELISA) za ošpice, mumps (divji in cepilni sevi) in rdečke ter z gpELISA za norice.
Following a single dose of ProQuad, the vaccine response rates were 97.7% for measles, 10 96.3% to 98.8% for mumps, and 98.8% for rubella.
Po enem odmerku cepiva ProQuad je znašal delež odziva na cepljenje 97, 7% za ošpice, 96, 3% do 98, 8% za mumps ter 98, 8% za rdečke.
While the seroconversion rate for varicella was uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate well with protection.
Medtem ko je bil delež serokonverzije za norice konstantno visok (97, 9% do 99, 8% v vseh študijah), pa se zanjo ni pokazalo, da bi dobro sovpadala z zaščito.
The vaccine response rate was 90.9% (range 80.8% to 94.5%) for varicella based on a post-vaccination antibody titer ≥ 5 gpELISA units/ ml (an antibody titer that has been shown to be highly correlated with long-term protection).
Delež odziva na cepljenje s post- vakcinacijskim titrom protiteles ≥ 5 gpELISA enot/ ml (titer protiteles, ki dokazano dobro sovpada z dolgoročno zaščito), je znašal 90, 9% (razpon od 80, 8% do 94, 5%).
These results were similar to the immune response rates induced by concomitant administration of a single dose of Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at separate injection sites.
10 živim virusom noric (Oka/ Merck) ter cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., na različnih vbodnih mestih.
Children who received a second dose of ProQuad In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
Otroci, ki so dobili drugi odmerek cepiva ProQuad V 2 kliničnih študijah je 1035 preiskovancev dobilo drugi odmerek cepiva ProQuad približno 3 mesece po prvem cepljenju.
The vaccine response rates were 99.4% for measles, 99.9% for mumps, 98.3% for rubella, and 99.4% for varicella (≥ 5 gpELISA Units/ ml).
Odzivni deleži na cepivo so znašali 99, 4% za ošpice, 99, 9% za mumps, 98, 3% za rdečke in 99, 4% za norice (≥ 5 gpELISA enot/ ml).
The geometric mean titers (GMTs) following the second dose of ProQuad increased approximately 2 fold each for measles, mumps, and rubella, and approximately 41 fold for varicella (for safety information, see section 4.8).
Geometrična povprečja titrov (GMT = geometric mean titers) protiteles proti ošpicam, mumpsu in rdečkam so se po drugem odmerku cepiva ProQuad približno podvojila, proti noricam pa so se povečala za približno 41- krat (za podatke o varnosti glejte poglavje 4. 8).
Children who received ProQuad at 4 through 6 years of age after primary vaccination with Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Otroci, ki so dobili cepivo ProQuad v starosti 4 do 6 let, po primarnem cepljenju s cepivom z živim virusom noric (Oka/ Merck) in cepivom proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
The immunogenicity and safety of ProQuad were evaluated in a clinical trial involving 799 subjects 4 through 6 years of age who had received Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at least 1 month prior to study entry.
Imunogenost in varnost cepiva ProQuad so ocenjevali v klinični študiji s 799 otroci, starimi 4 do 6 let, ki so bili najmanj 1 mesec pred vstopom v študijo cepljeni s cepivom z živim virusom noric (Oka/ Merck) in cepivom proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
Following the dose of ProQuad, GMTs for measles, mumps, rubella, and varicella were similar to those following a second dose of Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. administered concomitantly at separate injection sites.
Po cepljenju s cepivom ProQuad so bila GMT za ošpice, mumps, rdečke in norice podobna kot po drugem odmerku cepiva z živim virusom noric (Oka/ Merck) ter cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc, s katerima so bili cepljeni sočasno na različnih vbodnih mestih.
Additionally, GMTs for measles, mumps, and rubella were similar to those following a second dose of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. given concomitantly with placebo (for safety information, see section 4.8).
Poleg tega so bila GMT za ošpice, mumps in rdečke podobna kot po drugem odmerku cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., danega sočasno s placebom (za podatke o varnosti glejte poglavje 4. 8).
Persistence of Immune Response The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2108 subjects who were involved in 1 clinical trial.
Trajanje imunskega odziva Vztrajanje protiteles 1 leto po cepljenju so ocenjevali pri podskupini 2. 108 preiskovancev, ki so sodelovali v eni klinični študiji.
The antibody persistence rates 1 year postvaccination in recipients of a single dose of ProQuad were 98.9% (1722/ 1741) for measles, 96.7% (1676/ 1733) for mumps, 99.6% (1796/ 1804) for rubella, and 97.5% (1512/ 1550) for varicella (≥ 5 gpELISA Units/ ml).
Eno leto po cepljenju so pri 98, 9% (1. 722/ 1. 741) prejemnikov enega odmerka cepiva ProQuad vztrajala protitelesa proti ošpicam, pri 96, 7% (1. 676/ 1. 733) so vztrajala protitelesa proti mumpsu, pri 99, 6% (1. 796/ 1. 804) so vztrajala proti rdečkam in pri 97, 5% (1. 512/ 1. 550) prejemnikov so vztrajala protitelesa proti noricam (≥ 5 gpELISA enot/ ml).
In clinical studies involving healthy subjects who received 1 dose of Varicella Vaccine live (Oka/ Merck), detectable varicella antibodies were present in most individuals tested for up to 10 years postvaccination.
V kliničnih študijah zdravih preiskovancev, ki so dobili 1 odmerek cepiva z živim virusom noric (Oka/ Merck), so bila protitelesa proti noricam zaznavna pri večini pregledanih preiskovancev do 10 let po cepljenju.
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 SPC.
Običajne predklinične študije varnosti niso bile opravljene, ni pa predkliničnih zadržkov, ki bi jih smatrali za pomembne za klinično varnost, razen podatkov, vključenih v drugih odstavkih Povzetka glavnih značilnosti zdravil.
Powder Sucrose
Prašek saharoza hidrolizirana želatina natrijev klorid sorbitol
11 Hydrolysed gelatin Sodium chloride Sorbitol Monosodium glutamate Sodium phosphate Sodium bicarbonate Potassium phosphate Potassium chloride Medium 199 with Hanks’ Salts Minimum Essential Medium, Eagle (MEM) Neomycin Phenol red Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH) Urea
11 mononatrijev glutamat natrijev fosfat natrijev hidrogenkarbonat kalijev fosfat kalijev klorid medij 199 s Hanksovimi solmi minimalni esencialni medij, Eagle (MEM) neomicin fenol rdeče klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH) sečnina
However, the in-use stability has been demonstrated for 30 minutes between 20°C and 25°C.
Bila pa je dokazana 30- minutna stabilnost pri temperaturi od 20 °C do 25 °C.
Store and transport refrigerated (2°C-8°C).
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).
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 pakiranjih po 1 in 10.
It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one individual to another.
Pomembno je, da za vsakogar uporabite drugo sterilno brizgo in iglo, da preprečite prenos okužb z ene osebe na drugo.
12 Reconstitution instructions Withdraw the entire volume of solvent into a syringe.
Navodilo za pripravo cepiva Celotno količino vehikla povlecite v brizgo.
IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.
12 PRIPOROČAMO, DA CEPIVO UPORABITE TAKOJ PO PRIPRAVI, DA SE IZOGNETE IZGUBI UČINKOVITOSTI.
DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.
ČE PRIPRAVLJENEGA CEPIVA NE UPORABITE V 30 MINUTAH, GA ZAVRZITE.
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the vaccine differs from that described above.
Pripravljenega cepiva ne smete uporabiti, če v njem opazite delce snovi ali če se videz cepiva razlikuje od prej opisanega.
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.
Measles, mumps, rubella and varicella vaccine (live).
ProQuad prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi Cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo).
Measles virus1 Enders’ Edmonston strain (live, attenuated).................. not less than 3.00 log10 CCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)............. not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)......................... not less than 3.00 log10 CCID50* Varicella virus3 Oka/ Merck strain (live, attenuated).............................. not less than 3.99 log10 PFU**
Virus ošpic1, sev Enders ’ Edmonston (živ, oslabljen) najmanj.............................. 3, 00 log10 CCID50 * Virus mumpsa1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen) najmanj...................... 4, 30 log10 CCID50 * Virus rdečk2, sev Wistar RA 27/ 3 (živ, oslabljen) najmanj..................................... 3, 00 log10 CCID50 * Virus varicella- zoster3, sev Oka/ Merck (živ, oslabljen) najmanj............................. 3, 99 log10 PFU **
Powder and solvent for suspension for injection in a pre-filled syringe.
Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi.
ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella, and varicella in individuals from 12 months of age.
Cepivo ProQuad je indicirano za hkratno cepljenje proti ošpicam, mumpsu, rdečkam in noricam v starosti od 12 mesecev dalje.
Note: applicable official recommendations may vary regarding the interval between doses and the need for two or one doses of measles, mumps and rubella and of varicella-containing vaccine.
Opomba: ustrezna uradna priporočila se lahko razlikujejo glede na interval med odmerkoma in potrebnost cepljenja z dvema odmerkoma ali enim odmerkom cepiva proti ošpicam, mumpsu in rdečkam ter cepiva, ki vsebuje virus noric.
14 Method of administration The vaccine is to be injected by the subcutaneous route in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
14 Način uporabe Cepivo je treba injicirati pod kožo (subkutano) v področje deltoidne mišice nadlahti ali v zgornje anterolateralno področje stegna.
Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad as Reye's syndrome has been reported following the use of salicylates during wild-type varicella infection.
Prejemniki cepiva se morajo 6 tednov po cepljenju s cepivom ProQuad izogibati jemanju salicilatov, saj so pri uporabi salicilatov med okužbo z divjim sevom noric poročali o Reyevem sindromu.
15 As for any vaccine, vaccination with ProQuad may not result in protection in all vaccine recipients.
15 Kot pri drugih cepivih, tudi pri cepljenju s cepivom ProQuad, zaščita vseh cepljenih posameznikov lahko ni popolna.
There are no reports of transmission of the more attenuated Enders’ Edmonston strain of measles virus or the Jeryl Lynn ™ strain of mumps virus from vaccine recipients to susceptible contacts.
Ni poročil o prenosu bolj oslabljenega seva Enders 'Edmonston virusa ošpic ali seva Jeryl Lynn™ virusa mumpsa s cepljenih oseb na kontaktne osebe, dovzetne za okužbe z virusom ošpic in mumpsa.
16 Post-exposure prophylaxis No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or varicella.
16 Ni kliničnih podatkov o cepljenju s cepivom ProQuad po izpostavitvi ošpicam, mumpsu, rdečkam ali noricam.
17 Note: official recommendations may vary regarding the duration of the waiting period that is recommended for avoiding pregnancy following vaccination.
Opomba: uradna priporočila lahko navajajo različna obdobja, ko se je po cepljenju treba izogibati nosečnosti.
Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.
17 Študije so pokazale, da lahko doječe matere, ki so bile po porodu cepljene z živim oslabljenim cepivom proti rdečkam, izločajo virus v mleku in ga prenesejo na dojenčke.
The only vaccine-related systemic adverse reactions reported at a significantly greater rate in individuals who received the earlier formulation of ProQuad compared to individuals who received the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/ Merck) were fever (≥ 38.9°C oral equivalent or abnormal) and measles-like rash.
Edina s cepljenjem povezana sistemska neželena učinka, o katerih so značilno pogosteje poročali pri otrocih, ki so dobili predhodno obliko cepiva ProQuad, v primerjavi s posamezniki, ki so prejeli cepivo proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc. in cepivo z živim virusom noric (Oka/ Merck), sta bila zvišana telesna temperatura (≥ 38, 9 °C merjeno v ustih ali nenormalna) ter ošpicam podoben izpuščaj.
18 [Very common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000), including isolated reports; not known (cannot be estimated from the available data)]
[Zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1000), vključno s posamičnimi primeri; neznani (ni mogoče oceniti iz razpoložljivih podatkov)]
Infections and infestations Common: upper respiratory infection.
18 Infekcijske in parazitske bolezni Pogoste: okužba zgornjih dihal.
Rare: bronchiolitis, candida nappy rash, candidiasis, cellulitis, infectious croup, viral gastroenteritis, hand-foot-mouth disease, influenza, pseudocroup, respiratory infection, skin infection, tonsillitis, varicella ‡, viral conjunctivitis.
Redke: bronhiolitis, kandidiazni plenični izpuščaj, kandidiaza, celulitis, infekcijski krup, virusni gastroenteritis, virusna okužba rok- stopal- ust (hand- food- mouth disease), influenca, psevdokrup, okužba dihal, okužba kože, tonzilitis, norice ‡, virusni konjunktivitis.
19 Encephalitis and encephalopathy (excluding subacute sclerosing panencephalitis [SSPE]) have been reported approximately once for every 3 million doses of the measles-containing vaccines manufactured by Merck & Co., Inc.
O encefalitisu in encefalopatiji (razen subakutnega sklerozirajočega panencefalitisa [SSPE]) so poročali približno enkrat na 3 milijone odmerkov cepiva, ki vsebuje cepivo proti ošpicam izdelovalca Merck & Co., Inc.
Post-marketing surveillance of the more than 428 million doses that have been distributed worldwide (1978 to 2005) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.
Postmarketinško spremljanje več kot 428 milijonov odmerkov, ki so bili razdeljeni
Eye disorders Rare: conjunctivitis, eye discharge, eyelid inflammation, eye irritation, eye swelling, ocular hyperaemia, tearing, visual discomfort.
Očesne bolezni Redke: konjunktivitis, izcedek iz oči, vnetje očesne veke, draženje oči, otekanje oči, hiperemija zrkla, solzenje, neprijeten občutek v očeh.
Rare: asthma, pulmonary congestion, sinus disorder, sneezing, wheezing.
Redke: astma, pljučna kongestija, bolezni obnosnih votlin, kihanje, piskanje.
Rare: abdominal pain upper, abnormal faeces, constipation, flatulence, nausea, salivation increase, stomatitis, teething.
Neznana pogostnost: bolečine v trebuhu, hemohezija, razjeda v ustih.
Not known: abdominal pain, haematochezia, mouth ulcer.
Redke: bolečine v zgornjem delu trebuha, nenormalno blato, zaprtje, vetrovi, navzea, povečano slinjenje, stomatitis, dobivanje zob.
Not known: arthritis and/ or arthralgia (usually transient and rarely chronic [see below]), musculoskeletal pain, myalgia, pain of the hip, leg, or neck, swelling.
Neznana pogostnost: artritis in/ ali artralgija (običajno prehodna in redko kronična [glejte v nadaljevanju]), mišično- skeletne bolečine, mialgija v mišicah, bolečine v kolku, nogi ali vratu, oteklina.
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 gender, being greatest in adult females and least in prepubertal children.
Artralgija in/ ali artritis (običajno prehodna in redko kronična) ter polinevritis so značilni za okužbo z divjim sevom rdečk.
Following vaccination in children, reactions
Njihova pogostnost in resnost se razlikujeta glede na starost in spol, največji pa sta pri odraslih ženskah in najmanjši pri otrocih pred puberteto.
20 in joints are generally uncommon (0 to 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 to 20%), and the reactions tend to be more marked and of longer duration.
Pri ženskah so pojavne stopnje artritisa in artralgije na splošno večje kot pri otrocih (12 do 20%), neželeni učinki pa so izrazitejši in trajajo dalj
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.
Kronični artritis so povezovali z okužbo z divjim sevom rdečk in je bil povezan z izolacijo perzistentnega virusa in/ ali virusnega antigena iz telesnih tkiv.
Uncommon: asthenia/ fatigue, injection-site haemorrhage, injection-site induration or warmth, injection-site mass, malaise.
Občasne: astenija/ utrujenost, krvavitev na mestu injiciranja, zatrdlina ali toplota na mestu injiciranja, oteklina na mestu injiciranja ‡, slabo počutje.
Rare: influenza-like illness, injection-site desquamation, injection-site discoloration, injection-site pruritus, injection-site rash non-specific, injection-site reaction, injection-site scar, hyperthermia, pain, pain/ tenderness/ soreness.
Redke: influenci podobna bolezen, luščenje kože na mestu injiciranja, razbarvanje na mestu injiciranja, srbečica na mestu injiciranja, nespecifični izpuščaj na mestu injiciranja, reakcija na mestu injiciranja, brazgotina na mestu injiciranja, hipertermija, bolečina, bolečina/ občutljivost/ bolečnost.
Cases of herpes zoster in clinical studies In a clinical trial, 2 cases of herpes zoster were reported in 2108 healthy subjects 12 through 23 months of age who were vaccinated with one dose of ProQuad and followed for 1 year.
Primeri pasavca (herpes zoster) v kliničnih študijah V klinični študiji so poročali o 2 primerih pasavca med 2108 zdravimi otroci, starimi 12 do 23 mesecev, ki so jih cepili z enim odmerkom cepiva ProQuad in spremljali eno leto.
Viral Vaccine; ATC code:
21 Farmakoterapevtska skupina: virusna cepiva; oznaka ATC:
Following a single dose of ProQuad, the vaccine response rates were 97.7% for measles, 96.3% to 98.8% for mumps, and 98.8% for rubella.
Po enem odmerku cepiva ProQuad je znašal delež odziva na cepljenje 97, 7% za ošpice, 96, 3% do 98, 8% za mumps ter 98, 8% za rdečke.
22 uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate well with protection.
Medtem ko je bil delež serokonverzije za norice konstantno visok (97, 9% do 99, 8% v vseh študijah), pa se zanjo ni pokazalo, da bi dobro sovpadala z zaščito.
The vaccine response rate was 90.9% (range 80.8% to 94.5%) for varicella based on a postvaccination antibody titer ≥ 5 gpELISA units/ ml (an antibody titer that has been shown to be highly correlated with long-term protection).
Delež odziva na cepljenje s post- vakcinacijskim titrom protiteles ≥ 5 gpELISA enot/ ml (titer protiteles, ki dokazano dobro sovpada z dolgoročno zaščito), je znašal 90, 9% (razpon od 80, 8% do 94, 5%).
These results were similar to the immune response rates induced by concomitant administration of a single dose of Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at separate injection sites.
22 živim virusom noric (Oka/ Merck) ter cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., na različnih vbodnih mestih.
Additionally, GMTs for measles, mumps, and rubella were similar to those following a second dose of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. given concomitantly with placebo (for safety information, see section 4.8).
Poleg tega so bila GMT za ošpice, mumps in rdečke podobna kot po drugem odmerku cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc, danega sočasno s placebom (za podatke o varnosti glejte poglavje 4. 8).
The antibody persistence rates 1 year postvaccination in recipients of a single dose of ProQuad were 98.9% (1722/ 1741) for measles, 96.7% (1676/ 1733) for mumps, 99.6% (1796/ 1804) for rubella, and 97.5% (1512/ 1550) for varicella (≥ 5 gpELISA Units/ ml).
Eno leto po cepljenju so pri 98, 9% (1722/ 1741) prejemnikov enega odmerka cepiva ProQuad vztrajala protitelesa proti ošpicam, pri 96, 7% (1. 676/ 1. 733) so vztrajala protitelesa proti mumpsu, pri 99, 6% (1. 796/ 1. 804) so vztrajala proti rdečkam in pri 97, 5% (1. 512/ 1. 550) prejemnikov so vztrajala protitelesa proti noricam (≥ 5 gpELISA enot/ ml).
Powder Sucrose Hydrolysed gelatin Sodium chloride
Prašek saharoza hidrolizirana želatina natrijev klorid sorbitol
23 Sorbitol Monosodium glutamate Sodium phosphate Sodium bicarbonate Potassium phosphate Potassium chloride Medium 199 with Hanks’ Salts Minimum Essential Medium, Eagle (MEM) Neomycin Phenol red Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH) Urea
23 mononatrijev glutamat natrijev fosfat natrijev hidrogenkarbonat kalijev fosfat kalijev klorid medij 199 s Hanksovimi solmi minimalni esencialni medij, Eagle (MEM) neomicin fenol rdeče klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH) sečnina