natgillin/translations-raw huggingface dataset:
Children who received ProQuad at 4 through 6 years of age after primary immunization with Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Otroci, ki so bili cepljeni s cepivom ProQuad v starosti 4 do 6 let, po primarni imunizaciji s cepivom z živim virusom noric (Oka/ Merck) in cepivom proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
The rates and types of adverse reactions seen in the study group that received ProQuad were generally similar to those seen in the groups that received Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Deleži in vrste neželenih učinkov, ki so jih opazili v preučevani skupini, ki je bila cepljena s cepivom ProQuad, so bili na splošno podobni tistim, ki so jih opazili v skupinah, ki sta dobili cepivo z živim virusom noric (Oka/ Merck) in cepivo proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
(see section 5.1 for study description).
(glejte poglavje 5. 1 za opis študije).
The following adverse reactions were reported as vaccine related by the investigator in individuals after a single dose of ProQuad.
Po enojnem odmerku cepiva ProQuad so raziskovalci poročali o naslednjih neželenih učinkih, ki so jih opredelili kot povezane s cepljenjem.
Several adverse events were solicited in the clinical studies and are designated with the symbol (‡).
Posamezni neželeni učinki, ki so v kliničnih študijah izstopali, so označeni s simbolom (‡).
Additionally, other adverse experiences have been reported with post- marketing use of ProQuad and/ or in clinical studies and post-marketing use of either the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., the monovalent component vaccines of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or Varicella Vaccine live (Oka/ Merck).
Dodatno so na voljo podatki o neželenih učinkih iz obdobja trženja cepiva ProQuad in/ ali iz kliničnih študij in iz obdobja trženja cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., enovalentne komponente cepiv proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., in cepiva z živim virusom noric (Oka/ Merck).
These adverse effects are listed below without regard to causality or frequency (frequency not known).
Ti neželeni učinki so našteti spodaj, ne glede na vzročnost ali pogostnost pojavljanja (pogostnost pojavljanja ni znana).
6 [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/ 10000, < 1/ 1000), vključno s posamičnimi primeri; neznani (ni mogoče oceniti iz razpoložljivih podatkov)]
Infections and infestations Common: upper respiratory infection.
6 Infekcijske in parazitske bolezni Pogoste: okužba zgornjih dihal.
Uncommon: ear infection, gastroenteritis, nasopharyngitis, otitis media, pharyngitis, roseola, viral infection, viral rash.
Občasne: vnetje ušesa, gastroenteritis, nazofaringitis, vnetje srednjega ušesa, rozeola, vnetje žrela, virusna okužba, virusni izpuščaj.
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- foot- mouth disease), influenca, psevdokrup, okužba dihal, okužba kože, tonzilitis, norice ‡, virusni konjunktivitis.
Not known: aseptic meningitis (see below), atypical measles, epididymitis, herpes zoster, infection, influenza, measles, orchitis, parotitis.
Neznana pogostnost: aseptični meningitis (glejte v nadaljevanju), atipične ošpice, epididimitis, herpes zoster, okužba, gripa, ošpice, orhitis, parotitis.
Blood and the lymphatic system disorders Rare: leukocytosis, lymphadenopathy.
Bolezni krvi in limfatičnega sistema Redke: levkocitoza, limfadenopatija.
Not known: lymphadenitis, regional lymphadenopathy, thrombocytopenia.
Neznana pogostnost: limfadenitis, regionalna limfadenopatija, trombocitopenija.
Immune system disorders Rare: hypersensitivity.
Bolezni imunskega sistema Redke: hipersenzitivnost.
Not known: anaphylactoid reaction, anaphylaxis and related phenomenon such as angioneurotic oedema, facial oedema, and peripheral oedema, anaphylaxis in individuals with or without an allergic history.
Neznana pogostnost: anafilaktoidna reakcija, anafilaksija in povezani pojavi, kot so angionevrotični edem, obrazni edem in periferni edem, anafilaksija pri osebah z anamnezo alergije ali brez nje.
Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite.
Presnovne in prehranske motnje Občasne: anoreksija, zmanjšan apetit.
Rare: dehydration.
Redke: dehidracija.
Psychiatric disorders Common: irritability.
Psihiatrične motnje Pogoste: razdražljivost.
Uncommon: crying, insomnia, sleep disorder.
Občasne: jok, nespečnost, motnje spanja.
Rare: agitation, apathy, clinging, emotional changes, nervousness, restlessness.
Redke: agitacija, apatija, oklepanje, čustvene spremembe, nervoznost, nemir.
Nervous system disorders Uncommon: febrile seizure, somnolence.
Bolezni živčevja Občasne: vročinski krč, zaspanost.
Rare: ataxia, convulsion, headache, high pitched crying, hyperkinesia, hypersomnia, lethargy, tremor.
Redke: ataksija, konvulzije, glavobol, kričeč jok, hiperkinezija, hipersomnija, letargija, tremor.
Not known: afebrile convulsions or seizures, Bell’ s palsy, cerebrovascular accident, dizziness, dream abnormality, encephalitis (see below), encephalopathy (see below), Guillain-Barré syndrome, measles inclusion body encephalitis (see section 4.3), ocular palsies, paraesthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis (see below), syncope, transverse myelitis, tremor.
Neznana pogostnost: nevročinski krči ali napadi, Bellova pareza, možganskožilni dogodek, vrtoglavica, nenormalne sanje, encefalitis (glejte v nadaljevanju), encefalopatija (glejte v nadaljevanju), Guillain- Barréjev sindrom, ošpični encefalitis z inkluzijskimi telesci (glejte poglavje 4. 3), očesne pareze, parestezija, polinevritis, polinevropatija, subakutni sklerozirajoči panencefalitis (glejte v nadaljevanju), sinkopa, transverzni mielitis, tremor.
Consistent with clinical study data on the timing of fever and measles-like rash, an analysis of a post-marketing observational safety study in children (N=31,298, 99% in their second year of life) receiving their first dose of vaccine has shown that febrile seizures occurred more frequently 5-12 days following vaccination with ProQuad (n=22; 0.7 per 1000 children) when compared with data from children in a historical, age- and gender- matched, control group vaccinated with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/ Merck) concomitantly (N=31,298) before ProQuad was available (n=10; 0.3 per 1000 children).
Skladno s podatki iz klinične študije časovne pojavnosti zvišane telesne temperature in ošpicam podobnega izpuščaja, je analiza opazovalne študije varnosti pri otrocih v obdobju trženja (N=31. 298, 99% v drugem letu starosti) po prejetju prvega odmerka cepiva pokazala, da so bili vročinski krči, ki so se pojavili 5 do 12 dni po cepljenju, pri otrocih, cepljenih s cepivom ProQuad, pogostejši (n=22; 0, 7 na 1000 otrok) glede na podatke iz preteklosti, zbrane za po spolu in starosti primerljivo skupino otrok, cepljenih s cepivom proti ošpicam, mumpsu in rdečkam, izdelovalca Merck & Co., Inc., in hkrati s cepivom z živim virusom noric (Oka/ Merck) (N=31. 298) še preden je bilo na voljo cepivo ProQuad (n=10; 0, 3 na 1000 otrok).
In the 0-30 day time period following vaccination, the incidence of febrile seizures with ProQuad (n=44; 1.4 per 1000 children) was similar to that observed in children receiving the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/ Merck) concomitantly (n=40; 1.3 per 1000 children).
V obdobju od 0. do 30. dneva po cepljenju je bila pojavnost vročinskih krčev po cepljenju s cepivom ProQuad (n=44; 1, 4 na 1000 otrok) podobna tisti, ki so jo opazili pri otrocih, ki so prejeli cepivo proti ošpicam, mumpsu in rdečkam, izdelovalca Merck & Co., Inc., hkrati s cepivom z živim virusom noric (Oka/ Merck) (n=40; 1, 3 na 1000 otrok).
7 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
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 po vsem svetu (med letoma 1978 in 2005) kaže, da o resnih neželenih učinkih kot sta encefalitis in encefalopatija še vedno redko poročajo.
In no case has it been shown conclusively that reactions were actually caused by the 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 kažejo na možnost, da je 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 show 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 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.
Not known: oedema of the eyelid, irritation, optic neuritis, retinitis, retrobulbar neuritis.
Neznana pogostnost: edem vek, draženje, optični nevritis, retinitis, retrobulbarni nevritis.
Ear and labyrinth disorders Rare: ear pain.
Ušesne bolezni, vključno z motnjami labirinta Redke: bolečina v ušesu.
Not known: nerve deafness.
Neznana pogostnost: senzorinevralna gluhost.
Vascular disorders Rare: flushing, pallor.
Žilne bolezni Redke: zardevanje, bledica.
Not known: extravasation.
Neznana pogostnost: ekstravazacija.
Respiratory, thoracic, and mediastinal disorders Uncommon: cough, nasal congestion, respiratory congestion, rhinorrhoea.
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasne: kašelj, kongestija nosu, kongestija dihal, izcedek iz nosu.
Rare: asthma, pulmonary congestion, sinus disorder, sneezing, wheezing.
Redke: astma, plučna kongestija, bolezni obnosnih votlin, kihanje, piskanje.
Not known: bronchial spasm, bronchitis, epistaxis, pneumonitis (see section 4.3), pneumonia, pulmonary congestion, rhinitis, sinusitis, sore throat.
Neznana pogostnost: bronhialni spazem, bronhitis, epistaksa, pnevmonitis (glejte poglavje 4. 3), pljučnica, pljučna kongestija, rinitis, sinusitis, bolečine v grlu.
Gastrointestinal disorders Common: diarrhoea, vomiting.
Bolezni prebavil Pogoste: driska, bruhanje.
Rare: abdominal pain upper, abnormal faeces, constipation, flatulence, nausea, salivation increase, stomatitis, teething.
Redke: bolečine v zgornjem delu trebuha, nenormalno blato, zaprtje, vetrovi, navzea, povečano slinjenje, stomatitis, dobivanje zob.
Not known: abdominal pain, haematochezia, mouth ulcer.
Neznana pogostnost: bolečine v trebuhu, hemohezija, razjeda v ustih.
Skin and subcutaneous tissue disorders Common: measles-like rash ‡, rash, varicella-like rash ‡,.
Bolezni kože in podkožja Pogoste: ošpicam podoben izpuščaj ‡, izpuščaj, noricam podoben izpuščaj ‡.
Uncommon: dermatitis (including contact, atopic, and diaper rash), heat rash, rubella-like rash ‡, urticaria, viral exanthema, eczema, erythema.
Občasne: dermatitis (vključno s kontaktnim in atopijskim dermatitisom ter pleničnim izpuščajem), vročinski izpuščaj, rdečkam podoben izpuščaj ‡, koprivnica, virusni izpuščaj, ekcem, eritem.
Rare: acne, clammy skin, exfoliative dermatitis, drug eruption, exanthema, livedo reticularis, papular rash, pruritus, skin discoloration, skin lesion, zosteriform rash.
Redke: akne, lepljiva koža, eksfoliativni dermatitis, izpuščaj zaradi zdravil, ekzantem, livedo reticularis, mozoljasti izpuščaj, srbenje, razbarvanje kože, kožne lezije, pasavcu podoben izpuščaj.
Not known: erythema multiforme, Henoch-Schönlein purpura, herpes simplex, impetigo, panniculitis, purpura, skin induration, Stevens-Johnson syndrome, sunburn.
Neznana pogostnost: multiformni eritem, Henoch- Schönleinova purpura, herpes simplex, impetigo, panikulitis, purpura, zatrdlina kože, Stevens- Johnsonov sindrom, sončna opeklina.
Musculoskeletal, connective tissue and bone disorders Rare: arm pain, musculoskeletal stiffness.
Bolezni mišično- skeletnega sistema in vezivnega tkiva Redke: bolečina v rokah, mišično- skeletna okorelost.
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, 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
Njihova pogostnost in resnost se razlikujta glede na starost in spol, največji pa sta pri odraslih ženskah in najmanjši pri otrocih pred puberteto.
8 greatest in adult females and least in prepubertal children.
8 časa.
Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Simptomi lahko vztrajajo več mesecev, v redkih primerih nekaj let.
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 perzistentega virusa in/ ali virusnega antigena iz telesnih tkiv.
General disorders and administration site conditions Very common: fever ≥ 38.9°C (oral equivalent or abnormal )‡, erythema‡ or pain/ tenderness/ soreness‡ at the injection site.
Splošne težave in spremembe na mestu aplikacije Zelo pogoste: zvišana telesna temperatura ≥ 38, 9 °C (oralni ekvivalent ali nenormalna) ‡, eritem ‡ ali bolečina/ občutljivost/ bolečnost ‡ na mestu injiciranja.
Common: ecchymosis or swelling ‡ at the injection site, injection-site rash‡.
Pogoste: ekhimoza ali oteklina ‡ na mestu injiciranja, izpuščaj na mestu injiciranja ‡.
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.
Občasne: astenija/ utrujenost, krvavitev na mestu injiciranja, zatrdlina ali toplota na mestu injiciranja, oteklina na mestu injiciranja ‡, slabo počutje, 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.
Not known: injection site complaints (burning and/ or stinging of short duration, eczema, oedema/ swelling, hive-like rash, hematoma, induration, lump, vesicles, wheal and flare), inflammation, lip abnormality, papillitis, roughness/ dryness, stiffness, trauma, varicella-like rash, venipuncture site haemorrhage, warm sensation, warm to touch.
Neznana pogostnost: reakcije na mestu injiciranja (kratkotrajen pekoč občutek in/ ali zbadanje, ekcem, edem/ oteklina, koprivnici podoben izpuščaj, hematom, zatrdlina, bula, mehurčki, gnojni mehurčki s širjenjem), vnetje, nenormalnost ustnice, papilitis, hrapava/ suha koža, otrdelost, poškodba, noricam podoben izpuščaj, krvavitev na mestu venepunkcije, občutek toplote, toplota na dotik.
Investigations Rare: weight loss.
Preiskave Redke: izguba teže.
Injury and poisoning, and procedural complications Rare: contusion, non-venomous bite/ sting.
Poškodbe in zastrupitve Redke: udarnina, nestrupen pik/ ugriz.
Social circumstances Rare: activities of daily living impaired.
Socialne okoliščine Redke: motene vsakodnevne dejavnosti.
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 1 leto.
Surveillance data on varicella vaccinated individuals for up to nine years suggest no increase in the frequency of herpes zoster in this population.
Podatki o spremljanju otrok do 9 let po cepljenju s cepivom proti noricam ne kažejo na povečanje pojavnosti pasavca pri tej populaciji.
There are no long term data currently available for ProQuad.
Za cepivo ProQuad dolgoročnejših podatkov ni na voljo.
Transmission The varicella vaccine virus may rarely be transmitted to contacts of recipients of Varicella Vaccine live (Oka/ Merck) who develop a varicella-like rash (see section 4.4).
Prenos Cepilni virus noric se redko lahko prenese na kontaktne osebe prejemnikov cepiva z živim virusom noric (Oka/ Merck), pri katerih se pojavi noricam podoben izpuščaj (glejte poglavje 4. 4).
In particular, this kind of transmission has been documented 3 times out of more than 40 million doses of Varicella Vaccine live (Oka/ Merck) that have been distributed.
Tak prenos je bil opisan v 3 primerih med več kot 40 milijoni razdeljenih odmerkov cepiva z živim virusom noric (Oka/ Merck).
Transmission of varicella vaccine virus from recipients of Varicella Vaccine live (Oka/ Merck) without a varicella-like rash has been reported but has not been confirmed.
O prenosu cepilnega virusa noric s prejemnikov cepiva z živim virusom noric (Oka/ Merck) brez noricam podobnega izpuščaja so sicer poročali, ni pa bil potrjen.
Viral Vaccine; ATC code:
9 Farmakoterapevtska skupina: virusna cepiva; oznaka ATC:
Efficacy Formal studies to evaluate the efficacy of ProQuad have not been performed.
Učinkovitost Formalne študije za oceno učinkovitosti cepiva ProQuad niso bile izvedene.
However, the efficacy of Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. has been demonstrated in numerous studies.
V številnih študijah pa so dokazali učinkovitost cepiva z živim virusom noric (Oka/ Merck) in cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
Efficacy of the measles, mumps, and rubella components of ProQuad was previously established in a series of double-blind controlled field trials with the monovalent vaccines manufactured by Merck & Co., Inc., which demonstrated a high degree of protective efficacy.
Učinkovitost komponent cepiva ProQuad proti ošpicam, mumpsu in rdečkam je bila predhodno dokazana v seriji dvojno slepih, kontroliranih področnih študij z enovalentnimi cepivi izdelovalca Merck & Co., Inc., ki so dokazale visoko stopnjo učinkovitosti zaščite.
More than 428 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2005).
Po svetu so med letoma 1978 in 2005 razdelili več kot 428 milijonov odmerkov cepiva proti ošpicam, mumpsu in rdečkam izdelovalca 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.
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%.
In a large case-control study, the vaccine was estimated to be 85% effective against all forms of varicella and 97% effective against moderately severe and severe disease.
V obsežni s primerom nadzorovani študiji so ocenili, da je cepivo 85% učinkovito proti vsem oblikam noric ter 97% učinkovito proti zmerno hudi in hudi bolezni.
In a study comparing 1 dose (N=1114) to 2 doses (N=1102) of Varicella Vaccine live (Oka/ Merck), the estimated vaccine efficacy against all severities of varicella disease for the 10-year observation period was 94% for 1 dose and 98% for 2 doses (p < 0.001).
V študiji, ki je primerjala 1 odmerek (n = 1114) z 2 odmerkoma (n = 1102) cepiva z živim virusom noric (Oka/ Merck), je ocenjena učinkovitost cepiva proti vsem stopnjam noric v 10- letnem opazovalnem obdobju znašala 94% za 1 odmerek in 98% za 2 odmerka (p < 0, 001).
Over the 10-year observation period, the cumulative rate of varicella was 7.5% after 1 dose and 2.2% after 2 doses.
V 10- letnem obdobju opazovanja je znašal kumulativni delež noric 7, 5% po 1 odmerku in 2, 2% po 2 odmerkih.
Antibody responses against varicella virus ≥ 5 gpELISA Units/ ml in the glycoprotein enzyme-linked immunosorbent assay (gpELISA, a highly sensitive assay which is not commercially available) have been shown to be highly correlated with long-term protection.
Protitelesni odziv proti virusu noric ≥ 5 gpELISA enot/ ml pri gp- ELISA- testu (iz ang. glycoprotein enzyme- linked immunosorbent assay – zelo občutljiv test, ki ni komercialno dostopen) je pokazal veliko sovpadanje z dolgoročno zaščito.
Clinical studies have shown that immunization with ProQuad elicits rates of antibody responses against varicella virus ≥ 5 gpELISA Units/ ml similar to those observed after vaccination with Varicella Vaccine live (Oka/ Merck).
Klinične študije so pokazale, da cepljenje s cepivom ProQuad vzpodbudi raven protitelesnega odziva proti virusu noric ≥ 5 gpELISA enot/ ml, ki je podobna kot po cepljenju s cepivom z živim virusom noric (Oka/ Merck).
Immunogenicity Immunogenicity was studied in children 12 through 23 months of age with a negative clinical history of measles, mumps, rubella, and varicella who participated in 5 randomized clinical trials. The immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier formulation of ProQuad six weeks after a single dose of the vaccine.
Imunogenost obstoječe oblike stabilne v hladilniku je bila primerljiva z imunogenostjo predhodne oblike cepiva ProQuad šest tednov po enojnem odmerku cepiva.