qanastek/EMEA-V3 huggingface dataset:
There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Għad mhemmx evidenza kkonfermata li tindika li persuni mlaqqma jistgħu jagħtu l- virus lil persuni suxxettibbli li jiġu f' kuntatt ma 'dawn il- persuni li rċevew il- vaċċin.
Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
Konsegwentament, trasmissjoni b’ kuntatt viċin personali, waqt li aċċettata bħala tejoretikament possibli, ma titqiesx bħala riskju sinifikanti; madankollu ġie ddokumentat li l- virus tar- rubella fil- vaċċin ġie trasmess lit- trabi mill- ħalib tas- sider mingħajr evidenza ta ’ mard kliniku (ara sezzjoni 4. 6).
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.
M’ hemmx rapporti ta ’ trasmissjoni tal- virus tal- ħosba tar- razza Enders ’ Edmonston li huwa aktar attenwat jew tal- virus tal- gattone tar- razza Jeryl Lynn™ mir- riċevituri tal- vaċċin għal kuntatti suxxettibbli.
Post-licensing experience with Varicella Vaccine live (Oka/ Merck) suggests that transmission of varicella vaccine virus may rarely occur between healthy vaccine recipients who develop a varicella- like rash and contacts susceptible to varicella, as well as high-risk individuals susceptible to varicella (see section 4.8).
Esperjenza wara l- liċenzjar b' Varicella Vaccine live (Oka/ Merck) tissuġġerixxi li t- trasmissjoni tal - virus tal- vaċċin tal- ġidri r- riħ, rari tiġri bejn riċevituri b’ saħħithom li jiżviluppaw raxx li jixbah lil dak tal- ġidri r- riħ u kuntatti suxxettibbli għall- ġidri r- riħ, kif ukoll individwi b’ riskju għoli ta 'suxxettibilità għall- ġidri r- riħ (ara sezzjoni 4. 8).
High-risk individuals susceptible to varicella include:
Individwi b’ riskju għoli ta 'suxxettibilità għall- virus jinkludu:
• immunocompromised individuals (see section 4.3), • pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection, • newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection.
• individwi immunokompromessi (ara sezzjoni 4. 3), • nisa tqal mingħajr storja pożittiva dokumentata ta 'ġidri r- riħ jew evidenza laboratorja ta ’ infezzjoni li ttieħdet qabel, • trabi tat- twelid ta ’ ommijiet mingħajr storja pożittiva dokumentata ta' ġidri r- riħ jew evidenza laboratorja ta ’ infezzjoni li ttieħdet qabel.
Vaccine recipients should attempt to avoid, whenever possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination.
Ir- riċevituri tal- vaċċin iridu jippruvaw jevitaw, kemm jista 'jkun, assoċjazzjoni mill- qrib ma' persuni b’ riskju għoli ta ’ suxxettibilità għall- ġidri r- riħ sa 6 ġimgħat wara t- tilqima.
In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus.
F’ ċirkostanzi fejn kuntatt ma 'persuni li huma f’ riskju għoli li jieħdu l- virus tal- ġidri r- riħ huwa inevitabbli, ir- riskju potenzjali ta ’ trasmissjoni tal- virus tal- ġidri r- riħ tal- vaċċin għandu jiġi miżun kontra r- riskju li wieħed jista ’ tieħu u jittrasmetti it- tip mhux attenwat tal- virus tal- ġidri r- riħ.
Thrombocytopenia No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad.
Tromboċitopenja Għad m’ hemmx tagħrif kliniku fuq l- iżvilupp jew iggravar ta 'thromboċitopenja f' individwi mlaqqmin bi ProQuad.
However, post-marketing experience with live measles, mumps, and rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Madankollu, l- esperjenza ta 'wara t- tqegħid fis- suq b' vaċċini ħajjin tal- ħosba, rubella u gattone, tindika li persuni bi tromboċitopenja jistgħu jiżviluppaw tromboċitopenja iktar serja wara li jieħdu l- vaċċin.
In addition, individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses.
Barra minn hekk, individwi li jesperjenzaw tromboċitopenja wara l- ewwel doża tal - vaċċin ħaj tal- ħosba, rubella, u gattone, jistgħu jiżviluppaw tromboċitopenja b’ dożi ripetuti.
Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
L- istatus seroloġiku jista 'jiġi evalwat biex wieħed jistabbilixxi jekk hemmx bżonn ta ’ iktar dożi tal- vaċċin.
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad in such cases (see section 4.8).
Il - proporzjon bejn ir- riskju potenzjali u l- benifiċċju għandu jiġi evalwat bl- ikbar attenzjoni qabel wieħed jikkunsidra tilqim bi ProQuad f’ każijiet bħal dawn (ara sezzjoni 4. 8).
Other No clinical data are available for ProQuad in individuals who are known to be infected with human immunodeficiency viruses without evidence of immunosuppression.
Oħrajn Għad m’ hemmx tagħrif kliniku għal ProQuad f’ individwi li huma infettati bil- virus ta ’ l- HIV( virus uman ta ’ l- immunodefiċenza) mingħajr evidenza ta ’ immunosuppressjoni.
Careful risk-to-benefit evaluation should be done for these subjects (see section 4.3).
F’ dawn il- każijiet ir- riskju jrid jiġi evalwat kontra l- benefiċċju bir- reqqa (ara sezzjoni 4. 3).
Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine.
4 Tfal taħt trattament għat- tuberkulożi ma esperjenzawx taħrix ta ’ din il- marda meta ġew imlaqqma bil - vaċċin tal- virus tal- ħosba tat- tip ħaj.
No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis (see section 4.3).
S' issa għad ma ġewx rapportati studji li juru l- effett tal- vaċċin tal- virus tal- ħosba fuq tfal li għandhom it- tuberkulożi u li m' hix qed tiġi ttrattata (ara sezzjoni 4. 3).
4 Post-exposure prophylaxis No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or varicella.
Prevenzjoni wara espożizzjoni għall- virus M’ hemmx tagħrif kliniku disponibbli għal ProQuad amministrat wara espożizzjoni għal ħosba, gattone, rubella jew ġidri r- riħ.
However, post-exposure prophylaxis for varicella and measles has been demonstrated with Varicella Vaccine live (Oka/ Merck) and the measles-containing vaccines manufactured by Merck & Co., Inc., respectively.
Madankollu, profilassi wara espożizzjoni għall- ġidri r- riħ jew ħosba ġiet murija bil- Varicella Vaccine live (Oka/ Merck) u l- vaċċini li fihom il- ħosba mmanifatturati minn Merck & Co., Inc., rispettivament.
At least 1 month should elapse between receipt of a live virus vaccine and ProQuad.
Irid ikun għadda mill- inqas xahar bejn ir- riċeviment ta 'tilqima b' virus ħaj u ProQuad.
Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see section 4.4).
Riċevituri tal- vaċċin iridu jevitaw l- użu ta ’ salicylates għal 6 ġimgħat wara t- tilqima bi ProQuad (ara section 4. 4).
Do not give immunoglobulin (IG) or Varicella Zoster Immune Globulin (VZIG) concomitantly with ProQuad.
Tagħtix Immunoglobulin (IG) jew Varicella Zoster Immune Globulin (VZIG) fl- istess ħin ta 'ProQuad.
Administration of immune globulins concomitantly with ProQuad may interfere with the expected immune response.
Għoti ta 'immuno globulini fl- istess ħin ta' ProQuad jista 'jinterferixxi mar- rispons ta' l- immunità mistenni.
Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).
Il- vaċċin ma jistax jittieħed qabel tlett xhur wara trasfużjoni tad- demm jew plażma, jew wara għoti ta ’ immunoglobulini (IG).
5 months for VZIG).
Madankollu, l- intervall issuġġerit bejn trasfużjoni jew amministrazzjoni ta ’ IG u tilqima tvarja skond it- tip ta 'trasfużjoni jew l- indikazzjoni għal, u d- doża ta ’ IG (eżempju 5 xhur għal VZIG).
Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of ProQuad may reduce the immune response to the vaccine and hence reduce its protective efficacy.
Għoti ta ’ prodotti tad- demm li fihom antikorpi tal- virus tal- varicella zoster, inklużi VZIG jew preparazzjonijiet ta ’ immunoglobulini oħrajn, fi żmien xahar mid- doża ta ’ ProQuad, jista 'jnaqqas ir - risons immuni lejn il- vaċċin u b’ hekk inaqqas l- effikaċja protettiva tiegħu.
Therefore, administration of any of these products should be avoided within 1 month after a dose of ProQuad unless considered to be essential.
Għalhekk, l- għoti ta ’ kwalunkwe prodott minn dawn għandu jiġi evitat matul l- ewwel xahar minn meta jkun ingħata ProQuad sakemm dan ma jkunx jitqies bħala ħaġa essenzjali.
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
Kien hemm rapporti li meta l- vaċċini ħajjin tal- virus tal- ħosba, gattone u rubella jingħataw individwalment, dan jista ’ jwassal għal tnaqqis temporanju fis- sensittività tal- ġilda għat- tuberkulina.
Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after immunization with ProQuad.
Għalhekk, jekk għandu jsir test tat- tuberkulina, dan għandu jingħata jew f' xi ħin qabel, fl- istess ħin ta ', jew għallinqas 4 sa 6 ġimgħat wara t- tilqima bi ProQuad.
There are insufficient data to support the use of ProQuad with any other vaccines.
M’ hemmx biżżejjed tagħrif biex ProQuad jintuża ma ’ xi vaċċini oħra.
Studies have not been conducted with ProQuad in pregnant women.
Ma sarux studji fuq ProQuad f' nisa tqal.
It is not known whether ProQuad can cause foetal harm when administered to a pregnant woman or affect reproduction capacity.
M' huwiex magħruf jekk ProQuad jistax jikkawża ħsara għall - fetu meta mogħti lil mara tqila jew jistax jaffettwa l- kapaċità riproduttiva.
Therefore, ProQuad should not be administered to pregnant females; furthermore, pregnancy should be avoided for 3 months following vaccination (see sections 4.1, 4.3 and 4.4).
Għalhekk, ProQuad m' għandux jingħata lil nisa tqal; u l- mara m' għandhiex toħroġ tqila fi żmien tlett xhur mit- tilqima (ara sezzjonijiet 4. 1, 4. 3 u 4. 4).
In order to advise women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months after vaccination, the physician should be aware of the following:
Biex ikun jista 'jingħata parir lil dawk in- nisa li ngħataw il- vaċċin meta kienu tqal, jew ħarġu tqal fi żmien tlett xhur minn meta jkunu ħadu il- vaċċin, it- tabib irid ikun jaf dan li ġej:
(1) Reports have indicated that contracting of wild-type measles during pregnancy enhances foetal risk.
(1) Rapporti indikaw li jekk tieħu l- virus tal- ħosba tat- tip mhux attenwat waqt it- tqala, jikber ir - riskju fuq il- fetu.
Increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity have been observed subsequent to wild-type measles during pregnancy.
Ġew osservati rati ikbar ta ’ abort spontanju, twelid ta 'trabi mejta, difetti konġenitali u twelid qabel iż - żmien, meta ikun hemm virus tal- ħosba tat- tip mhux attenwat fit- tqala.
There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy.
Ma sarux studji adegwati fuq ir- razza tat- tip attenwata tal- virus tal- ħosba fit- tqala.
However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse foetal effects; (2) Mumps infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Madankollu, ikun prudenti li wieħed jassumi li l - virus tal- vaċċin hu wkoll kapaċi jikkaġuna ħsara fuq il- fetu; (2) Infezzjoni tal- gattone waqt l- ewwel tlett xhur tat- tqala tista 'żżid ir- rata ta ’ l - abbort spontanju.
Although mumps vaccine virus has been shown to infect the placenta and foetus, there is no evidence that it causes congenital malformations in humans; (3) In a 15-year survey involving over 1100 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 635 received the Wistar RA 27/ 3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome; and (4) Wild-type varicella is known to cause foetal harm, and is associated with an increased risk of herpes zoster in the first year of life and severe varicella in the newborn infant.
Għalkemm il- vaċċin tal- virus tal- gattone wera li jinfetta l- plaċenta u l- fetu, m’ hemmx evidenza li dan il- virus jikkawża malformazzjonijiet konġenitali fl- umani; (3) Fi stħarriġ li sar fuq medda ta 'ħmistax- il sena, li kien jinvolvi iktar min 1100 mara tqila li ħadu l- vaċċin tar- rubella fi żmien tlett xhur qabel jew wara konċepiment (minn dawn, 635
5 Note: official recommendations may vary regarding the duration of the waiting period that is recommended for avoiding pregnancy following vaccination.
5 ħadu l- virus tar- razza Wistar RA 27/ 3), l- ebda tarbija minn dawn ma kellha abnormalitajiet kompatibbli mas- sindromu tar- rubella konġenitali; u (4) huwa magħruf li l- ġidri r- riħ tat- tip mhux attenwat jagħmel ħsara lill- fetu u huwa assoċjat ma 'riskju akbar ta ’ herpes zoster fl- ewwel sena ta ’ ħajja u ġidri r- riħ qawwi fit- tarbija tat- twelid.
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.
Nota: rakommandazzjonijiet uffiċjali jistgħu jvarjaw fuq kemm għandu jkun twil il- perjodu ta ’ stennija rakkomandat li fih għanda tiġi evitata t- tqala wara li jittieħed il- vaċċin.
In the infants with serological evidence of rubella infection, none had symptomatic disease.
Studji juru li nisa li qed ireddgħu u li ħadu l- vaċċin tar- rubella tat- tip attenwat, jistgħu jgħaddu l- virus fil- ħalib tas- sider u b’ hekk jittrasmettuh lit- trabi. li jieħdu ħalib tas- sider Fi trabi li kellhom evidenza seroloġika ta ’ infezzjoni tar- rubella, ħadd minnhom ma wera sintomi tal- marda.
There is no evidence that varicella vaccine virus is excreted in breast milk.
M’ hemmx evidenza li l- vaċċin tal- ġidri r- riħ jgħaddi fil- ħalib ta ’ l- omm.
It is not known whether measles or mumps vaccine virus is secreted in human milk.
M' huwiex magħruf jekk il- virus tal- vaċċin tal - ħosba u tal- gattone jgħaddix fil- ħalib tal- bniedem.
Therefore, caution should be exercised when considering whether to administer ProQuad to a breast-feeding woman.
Għalhekk, id- deċiżjoni jekk ProQuad għandux jingħata lil mara li qegħda tredda 'għanda ssir b’ attenzjoni kbira.
No studies on the affects on the ability to drive or use machinery have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age.
• F’ 5 provi kliniċi, ProQuad ġie amministrat mingħajr l- ebda vaċċin ieħor lil 6038 tifel/ tifla ta 'bejn 12 u 23 xahar.
The children in these studies received either the current refrigerator-stable formulation or an earlier formulation of ProQuad.
It- tfal ta ’ dan l- istudju ħadu l- formolazzjoni kurrenti li hija stabbli fil- friġġ jew formolazzjoni oħra preċedenti ta ’ ProQuad.
Children in these studies were monitored for six weeks post vaccination.
It- tfal f’ dawn l- istudji ġew osservati għal 6 ġimgħat wara li ngħataw it- tilqima.
The safety profiles were comparable for the two different formulations after a single dose.
Il- profili ta 'sigurtà ta' dawn iż- żewġ formolazzjonijiet differenti kienu komparabbli wara doża waħda.
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.
L- uniċi effetti avversi sistemiċi relatati mal- vaċċin li ġew irrapportati b' rata ferm ikbar f’ individwi li ħadu l- vaċċin tal- ħosba, gattone jew rubella mmanifatturata minn Merck & Co., Inc. u Varicella Vaccine live (Oka/ Merck) kien deni ta ’ (≥ 38. 9°C orali, equivalenti jew anormali) u raxx bħal dak tal- ħosba.
Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short duration and resolved with no long-term sequelae.
Kemm id- deni kif ukoll ir- raxx bħal tal- ħosba seħħew fi żmien 5 sa 12- il ġurnata wara li ngħatat it- tilqima, u dawn damu żmien qasir mingħajr konsegwenzi fit- tul.
Pain/ tenderness/ soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad.
Uġigħ u tenerezza fil- post ta ’ l- injezzjoni kienu rrapportati b' rata statistikament inqas f’ individwi li ħadu ProQuad.
The only vaccine related injection-site adverse reaction that was more frequent among recipients of ProQuad than among recipients of Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co.
L- unika reazzjoni negattiva li għanda x’ taqsam mal- post ta ’ l- injezzjoni li kienet iktar frekwenti fost dawk li ħadu Varicella Vaccine live (Oka/ Merck) u l- vaċċin tal- ħosba, gattone, u tal- ġidri r- riħ immanifatturat minn Merck & Co.
Inc. was rash at the injection site.
Inc. kien raxx fil- post ta 'l- injezzjoni.
Children who received a second dose of ProQuad The rates of adverse reactions after a second dose of ProQuad were generally similar to, or lower than, those seen with the first dose.
Tfal li ħadu t- tieni doża ta ’ ProQuad Ir- rati ta 'effetti avversi wara t- tieni doża ta ’ ProQuad kienu ġeneralment simili ħafna għal, jew inqas minn, dawk osservati fl- ewwel doża.
The fever rate was lower after the second dose than after the first dose (see section 5.1 for study description).
Ir- rata tad- deni kienet inqas wara t- tieni doża milli wara l- ewwel doża (ara sezzjoni 5. 1 għal deskrizzjoni ta 'l- istudju).
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.
Tfal ta ’ età bejn l- 4 u s- 6 snin li ħadu ProQuad wara l- ewwel tilqima bil- Varicella Vaccine live (Oka/ Merck) u l- vaċċin tal- ħosba, gattone jew rubella mmanifatturata minn 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.
Ir- rati u t- tipi ta reazzjonijiet avversi fil- grupp ta 'studju li rċieva ProQuad kienu ġeneralment simili għal dawk osservati fil- gruppi li rċevew Varicella Vaccine live (Oka/ Merck) u l- vaċċin tal- ħosba, gattone jew rubella mmanifatturat minn Merck & Co., Inc.
(see section 5.1 for study description).
(ara sezzjoni 5. 1 għal deskrizzjoni ta 'l - istudju).
No specific studies have been conducted in individuals from 2 years of age who had not previously received measles, mumps, rubella, and varicella vaccines.
Ma sar l- ebda studju speċifiku fuq individwi minn sentejn 'il fuq li qabel, kienu għadhom ma ħadux il - vaċċin tal- ħosba, gattone jew rubella.
The following adverse reactions were reported as vaccine related by the investigator in individuals after a single dose of ProQuad.
• Dawn li ġejjin huma r- reazzjonijiet avversi li ġew irrapportati bħala dawk relatati mal- vaċċin mill- investigatur wara l- ewwel doża ta ’ ProQuad.
Several adverse events were solicited in the clinical studies and are designated with the symbol (‡).
Fl- istudji kliniċi ħarġu bosta każijiet avversi u dawn huma indikati bis- simbolu (‡).
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).
Barra minn hekk, ġew irrapportati esperjenzi avversi oħrajn ma ’ l- użu wara t- tqegħid fis- suq ta ’ ProQuad u/ jew fi studji kliniċi u użu wara t- tqegħid fis- suq tat- tilqima tal - ħosba, gattone u rubella ffabbrikata minn Merck & Co., Inc., jew il- Vaċċin tal- Variċella ħaj
These adverse effects are listed below without regard to causality or frequency (frequency not known).
Dawn l- effetti avversi huma elenkati hawn taħt mingħajr ma titqies il- kaswalità jew il - frekwenza (frekwenza mhux magħrufa).
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)]
[Komuni ħafna (≥ 1/ 10); Komuni (≥ 1/ 100, < 1/ 10); Mhux komuni (≥ 1/ 1, 000, < 1/ 100); Rari (≥ 1/ 10, 000, < 1/ 1, 000), inkluż rapporti iżolati; mhux magħruf (ma jistax jiġi stmat mid- data disponibbli)]
Infections and infestations Common: upper respiratory infection.
Infezzjonijiet u infestazzjonijiet Komuni: infezzjoni fil- parti ta 'fuq ta' l- apparat respiratorju.
Uncommon: ear infection, gastroenteritis, nasopharyngitis, otitis media, pharyngitis, roseola, viral infection, viral rash.
Mhux komuni: infezzjoni fil- widnejn, gastro- enterite, infjammazzjoni ta ’ l- imnieħer u tal- farinġi, otite medja, farinġite, roseola, infezzjoni virali, raxx virali.
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.
Rari: bronkjolite, raxx tal- ħrieqi mill- candida, candidite, ċellulitis, krupp infettiva, gastro- enterite virali, marda ta 'l- idejn- saqajn- ħalq, influwenza, pswedokrupp, infezzjoni respiratorja, infezzjoni tal - ġilda, tonsillite, ġidri r- riħ ‡, konġuntivite virali.
Not known: aseptic meningitis (see below), atypical measles, epididymitis, herpes zoster, infection, influenza, measles, orchitis, parotitis.
Mhux magħruf: meninġite settika (ara taħt), ħosba atipika, epididimite, herpes zoster, infezzjoni, influwenza, ħosba, orkite, parotite.
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination.
Każijiet ta ’ meninġite asettika ġew irrapportati wara t- tilqima ta ’ kontra l- ħosba, gattone u rubella.
Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.
Għalkemm intweriet relazzjoni kawżali bejn razez oħrajn tal- vaċċin tal- gattone u meninġite asettika, ma kien ebda evidenza li tirrelata t- tilqima ta ’ kontra l- gattone ta ’ Jeryl Lynn™ ma ’ meninġite asettika.
Blood and the lymphatic system disorders Rare: leukocytosis, lymphadenopathy.
Disturbi tad- demm u tas- sistema limfatika Rari: lukoċistosi, limfoadenopatija.
Not known: lymphadenitis, regional lymphadenopathy, thrombocytopenia.
Mhux magħruf: limfadenite, limfadenopatija, fadenite, limfadenopatija reġjonali, tromboċitopenja.
Immune system disorders Rare: hypersensitivity.
Disturbi fis- sistema immunitarja Rari: sensittività eċċessiva.
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.
Mhux magħruf: reazzjoni anafilaktojde, anafilassi u fenomeni relatati bħal edema anġjonewrotika, edema periferali, anafilassi f’ individwi bi jew mingħajr storja allerġika.
Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite.
Disturbi fil- metaboliżmu u n- nutrizzjoni Mhux komuni: anoreksja, tnaqqis fl- aptit.
Rare: dehydration.
Rari: deidratazzjoni.
Psychiatric disorders Common: irritability.
Disturbi psikjatriċi Komuni: irritabilità.
Uncommon: crying, insomnia, sleep disorder.
Mhux komuni: biki, diffikultà fl- irqad, mard ta ’ l- irqad.
Rare: agitation, apathy, clinging, emotional changes, nervousness, restlessness.
Rari: aġitazzjoni, apatija, tibdil fl- emozzjonijiet, nervi, bla kwiet.
Nervous system disorders Uncommon: febrile seizure, somnolence.
Disturbi fis- sistema nervuża Mhux komuni: attakk tad- deni, ngħas.
Rare: ataxia, convulsion, headache, high pitched crying, hyperkinesia, hypersomnia, lethargy, tremor.
Rari: atassja, konvulżjoni, uġigħ ta ’ ras, biki sfrenat, iperkinesja, ipersomnja, letarġija, rogħda.
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.
Mhux magħruf: konvulżjonijiet jew aċċessjonijiet bid- deni, Bell’ s palsy, inċident ċerebrovaskulari, sturdament, anormalità fil- ħolm, enċefalite (ara taħt), enċefalopatija (ara taħt), is- sindrome ta ’ Guillain- Barré, enċfalite tal- korp ta ’ inklużjoni tal- ħosba (ara sezzjoni 4. 3), palsies okulari, paraestesija, polinewrite, polinewuropatija, subacute sclerosing panencephalitis (ara taħt), sinkope, majelite trasversa, rogħda.
Febrile seizures have been reported in children receiving ProQuad.
Attakki ta ’ deni ġew irrapportati fi tfal li rċevew ProQuad.
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).
Fil- perjodu
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).
7 ta ’ żmien ta ’ 0- 30 jum wara t- tilqima, l- inċidenza ta ’ attakki ta ’ deni bi ProQuad (n=44; 1. 4 għal kull 1000 tifel/ tifla) kienet simili għal dik osservata fi tfal li kienu qed jirċievu l- vaċċin tal- ħosba, gattone u rubella immanifatturat minn Merck & Co., Inc., u bil- Vaċċin tal- Variċella ħaj (Oka/ Merck) fl- istess ħin (n=40; 1. 3 għal kull 1000 tifel/ tifla).
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.
Enċefalite u enċefalopatika (għajr subacute sclerosing panencephalitis [SSPE]) ġew irrapportati f’ bejn wieħed u ieħor darba kull 3 miljun doża tat- tilqim li fihom il- ħosba mmanifatturati minn 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.
Sorveljanza ta ’ wara t- tqegħid fis- suq ta ’ aktar minn 428 miljun doża li tqassmu madwar id- dinja (1978 to 2005) tindika li episodji avversi serji bħal enċefalite u enċefalopatija jibqgħu jiġu rrapportati b’ mod rari.
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.
F’ ebda każ ma ntwera b’ mod konklussiv li r- reazzjonijiet kienu fil- fatt ikkawżati mit - tilqima; madankollu, id- data tissuġġerixxi l- possibbiltà li xi wħud minn dawn il- każijiet setgħu ġew ikkawżati mit- tilqim tal- ħosba.
There is no evidence that measles vaccine can cause SSPE.
Ma hemm ebda evidenza li t- tilqima tal- ħosba tista ’ tikkawża SSPE.
There have been reports of SSPE in children who did not have a history of infection with wild-type measles but did receive measles vaccine.
Kien hemm rapporti ta ’ SSPE fi tfal li ma kellhomx storja ta ’ infezzjoni b’ ħosba tat- tip selvaġġ iżda rċievew it- tilqima tal- ħosba.
Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.
Xi wħud minn dawn il- każijiet setgħu rriżultaw mill- ħosba mhux rikonoxxuta fl- ewwel sena tal- ħajja jew possibbilment mit- tilqima kontra l- kosba.
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.
Ir- riżultati ta ’ studju bil- każ ikkontrollat retrospettivament immexxi miċ- Ċentri ta ’ l- US għall- Kontroll u l- Prevenzjoni tal- Mard juru li l- effett ġenerali tat- tilqima ta ’ kontra l- ħosba kien dak li jipproteġi kontra SSPE billi jimpedixxi ħosba bir- riskju inerenti tiegħu ta ’ SSPE.
Eye disorders Rare: conjunctivitis, eye discharge, eyelid inflammation, eye irritation, eye swelling, ocular hyperaemia, tearing, visual discomfort.
Disturbi f l- għajnejn Rari: konġuntivite, tnixxija mill- għajn, infjammazjoni fil- kappell ta ’ l- għajn, irritazzjoni fl- għajnejn, nefħa tal- għajnejn, iperimja okulari, għajnejn idemmgħu, skumdità fil- viżta.
Not known: oedema of the eyelid, irritation, optic neuritis, retinitis, retrobulbar neuritis.
Mhux magħruf: edema tal- kappell ta ’ l- għajn, irritazzjoni, newrite ottika, retinite, newrite retrobulbari.
Ear and labyrinth disorders Rare: ear pain.
Disturbi fil- widnejn u fis- sistema labirintika Rari: uġigħ fil- widnejn.
Not known: nerve deafness.
Mhux magħruf: truxija tan- nervituri
Vascular disorders Rare: flushing, pallor.
Disturbi vaskulari Rari: ħmura fil- wiċċ, pallidità.
Not known: extravasation.
Mhux magħruf: ekstravażazzjoni.
Respiratory, thoracic, and mediastinal disorders Uncommon: cough, nasal congestion, respiratory congestion, rhinorrhoea.
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: sogħla, konġestjoni fl- imnieħer, konġestjoni fis- sistema respiratorja, rinoreja.
Rare: asthma, pulmonary congestion, sinus disorder, sneezing, wheezing.
Rari: ażma, konġestjoni fil- pulmun, sinużite, għatis, tħarħir.
Not known: bronchial spasm, bronchitis, epistaxis, pneumonitis (see section 4.3), pneumonia, pulmonary congestion, rhinitis, sinusitis, sore throat.
Mhux magħruf: spasmu bronkjali, bronkite, epistassi, pnewmonite (ara sezzjoni 4. 3), pnewmonja, konġestjoni pulmonari, rinite, sinusite, uġigħ fil- griżmejn.
Gastrointestinal disorders Common: diarrhoea, vomiting.
Disturbi gastro- intestinali Komuni: dijarea, rimettar Rari:
Rare: abdominal pain upper, abnormal faeces, constipation, flatulence, nausea, salivation increase, stomatitis, teething.
Uġigħ addominali, fil- parti ta ’ fuq ta ’ l- addome fl- ippurgar, stitikezza, gass, dardir, żieda fil - bżieq, stomatite, uġigħ fis- snien.
Not known: abdominal pain, haematochezia, mouth ulcer.
Mhux magħruf: uġigħ addominali, ematokeżija, ulċera fil- ħalq.
Skin and subcutaneous tissue disorders Common: measles-like rash ‡, rash, varicella-like rash ‡,.
Disturbi fil- ġilda u tat- tessuti ta 'taħt il- ġilda Komuni: raxx bħal tal- ħosba ‡, raxx bħal tal- ġidri r- riħ ‡,.
Uncommon: dermatitis (including contact, atopic, and diaper rash), heat rash, rubella-like rash ‡, urticaria, viral exanthema, eczema, erythema.
Mhux komuni: dermatite (inklużi dawk ta ’ kuntatt, atopiċi u raxx tal- ħrieqi), raxx tas- sħana, raxx bħal tar- rubella ‡, urtikarja, exantema virali, ekżema, eritema.
Rare: acne, clammy skin, exfoliative dermatitis, drug eruption, exanthema, livedo reticularis, papular rash, pruritus, skin discoloration, skin lesion, zosteriform rash.
Rari: acne, ġilda umda, dermatite bil- qxur, żbroff ta ’ drogi, exantema virali, livedo reticularis, infafet, prurite, tibdil fil- kulur tal- ġilda, qasma fil- ġilda, raxx zosteriform.
Not known: erythema multiforme, Henoch-Schönlein purpura, herpes simplex, impetigo, panniculitis, purpura, skin induration, Stevens-Johnson syndrome, sunburn.
Mhux magħruf: eritema multiformi, purpura Henoch- Schönlein, ħerpes simplex, impetigo, pannikulite, purpura, indurazzjoni tal- ġilda, sindromu ta ’ Stevens- Johnson, ħarqa bix- xemx.
Musculoskeletal, connective tissue and bone disorders Rare: arm pain, musculoskeletal stiffness.
Disturbi muskolu- skeltrali, tat- tessut konnettiv Rari: uġigħ fl- idejn, twebbis muskolu- skeletrali.
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
8 Mhux magħruf: artrite u/ jew artralġja (normalment temporanja u rarament kronika [ara taħt]), uġigħ muskuloskeletali, mijalġja, uġigħ fil- ġenbejn, saqajn jew għonq, nefħa.
8 greatest in adult females and least in prepubertal children.
Artralġja u/ jew artrite (normalment temporanji u rarament kroniċi) u polinewrite huma karatteristiċi ta ’ infezzjoni ma ’ rubella ta ’ tip selvaġġ u jvarjaw fil- frekwenza u fis- severità ma ’ l- età u s- sess, bl- aktar komuni jkunu fin- nisa adulti u l- anqas fi tfal prepubertali.
Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Wara tilqima fit- tfal, ir- reazzjonijiet fil- ġogi huma ġeneralment mhux komuni (0 sa 3%) u jdumu ftit.
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.
Fin- nisa, ir- rati ta ’ inċidenza għall- artrite u għall- artralġja huma ġeneralment ogħla minn dawk fit- tfal (12 sa 20%), u hemm it- tendenza li r - reazzjonijiet ikunu aktar sinjifikanti u jdumu aktar.
Symptoms may persist for a matter of months or on rare occasions for years.
Is- sintomi jistgħu jippersistu għal xi xhur jew f’ każijiet rari għal xi snin.
In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.
Fi bniet adoloxxenti, ir- reazzjonijiet jidhru li jkunu intermedji fl- inċidenza bejn dawk li jidhru fit- tfal u fin- nisa adulti.
Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Anki f’ nisa akbar fl- età (35 sa 45 sena), dawn ir - reazzjonijiet huma ġeneralment ittollerati sewwa u rarament jinterferixxu ma ’ attivitajiet normali.
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.
Artrite kronika ġiet assoċjata ma ’ infezzjoni tar- rubella tat- tip selvaġġ u kienet relatata ma ’ virus persistenti u/ jew antiġen virali iżolat minn tessut tal- ġisem.
Only rarely have vaccine recipients developed chronic joint symptoms.
Huwa rarament biss li r- riċevituri tal - vaċċin żviluppaw sintomi kroniċi tal- ġogi.
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.
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna: deni ≥ 38. 9°C (ekwivalenti orali jew abnormali) ‡, eritema ‡ jew uġigħ/ tenerezza/ ħruxija ‡ fil- post ta ’ l- injezzjoni.
Common: ecchymosis or swelling ‡ at the injection site, injection-site rash‡.
Komuni: ekimożi jew nefħa ‡ fil- post ta ’ l- injezzjoni jew raxx fil- post ta ’ l- injezzjoni ‡.
Uncommon: asthenia/ fatigue, injection-site haemorrhage, injection-site induration or warmth, injection-site mass, malaise.
Mhux komuni: astjena/ għejja, emmoraġija fis- sit ta 'l- injezzjoni, għebusija jew sħana fil- post ta' l - injezzjoni, massa fil- post ta 'l- injezzjoni, telqa tal- ġisem.
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.
Rari: mard li jixbah l- influwenza, tqaxxir fil- post ta 'l- injezzjoni, telf tal- kulur fil- post ta' l- injezzjoni, ħakk fil- post ta 'l- injezzjoni, raxx mhux speċifiku fil- post ta' l- injezzjoni, reazzjoni fil- post ta 'l - injezzjoni, ċikatriċi fil- post ta' l- injezzjoni, ipertermja, uġigħ, uġigħ/ tenerezza/ ħruxija.
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.
Mhux magħruf: ilmenti fis- sit ta ’ injezzjoni (ħruq u/ jew tingiż li ma jdumx biex jgħaddi, ekżema, edema/ nefħa, raxx simili għal ħorriqija, ematoma, twebbis, formazzjoni ta ’ boċċi, bżieżaq bl- ilma, wheal u fwawar), infjammazzjoni, anormalità fix- xoffa, papillite, ħruxija/ nixfa, ebusija, trawma, raxx simili variċella, emorraġija tas- sit tal- venipuntura, sensazzjoni ta ’ sħana, sensazzjoni sħuna, sens tas - sħana mal- mess.
Investigations Rare: weight loss.
Investigazzjonijiet Rari: tnaqqis fil- piż.
Injury and poisoning, and procedural complications Rare: contusion, non-venomous bite/ sting.
Korriment, avvelenament, u kumplikazzjonijiet ta ’ xi proċedura Rari: kontużjoni, gidma/ tingiża mhux velenuża.
Social circumstances Rare: activities of daily living impaired.
Ċirkustanzi soċjali Rari: diffikultà biex twettaq attivitajiet ta 'kuljum.
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.
Każijiet ta ’ herpes zoster fi studji kliniċi Fi prova klinika, 2 każijiet ta ’ herpes zoster ġew rappurtati f’ 2108 persuna f’ saħħithom ta ’ età bejn 12 u 23 xahar li ġew imlaqqma b’ doża waħda ta ProQuad u segwiti għal sena.
Both cases were unremarkable and no sequelae were reported.
Ma ġara xejn rimarkabbli fiż- żewġ każijiet u l- ebda konsegwenza ma ġiet rappurtata.
Surveillance data on varicella vaccinated individuals for up to nine years suggest no increase in the frequency of herpes zoster in this population.
Informazzjoni ta 'sorveljanza li nġabret fuq medda ta ’ 9 snin fuq individwi li ħadu l- vaċċin tal- ġidri r - riħ, tissuġġerixxi li din ma żżidx il- frekweza ta ’ herpes zoster f’ din il- popolazzjoni.
However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Madankollu l - effett tal- vaċċin tal- ġidri r- riħ fuq l- inċidenza tal- herpes zoster fuq żmien twil għadha mhux magħrufa.
There are no long term data currently available for ProQuad.
Bħalissa m’ hemmx tagħrif fuq żmien twil disponibbli għal ProQuad.
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).
Trasmissjoni Huwa rari li l- virus tal- vaċċin tal- ġidri r- riħ, jiġi trasmess lil min ġie f’ kuntatt ma 'riċevituri ta Varicella Vaccine live (Oka/ Merck) li żviluppaw raxx bħal tal- ġidri r- riħ (ara sezzjoni 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.
B' mod partikolari, din it- tip ta 'trasmissjoni ġiet dokumentata 3 darbiet minn fost aktar minn 40 miljun doża ta ’ Varicella Vaccine live (Oka/ Merck) li ġew imqassma.
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.
It- trasmissjoni tal- virus tal- ġidri r- riħ minn 9 riċevituri ta ’ Varicella Vaccine live (Oka/ merck) mingħajr raxx bħal tal- ġidri r- riħ, ġiet irrapportati iżda ma ġietx ikkonfermata.
Viral Vaccine; ATC code:
Vaċċin Virali; Kodiċi ATC:
Efficacy Formal studies to evaluate the efficacy of ProQuad have not been performed.
Effikaċja Ma sarux studji formali sabiex l- effikaċja ta 'ProQuad tiġi evalwata.
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.
Madankollu, l- effikaċja ta 'Varicella Vaccine live (Oka/ Merck) u tal- vaċċin tal- ħosba, gattone, u tar- rubella mmanifatturati minn Merck & Co., Inc. ġiet murija b' bosta studji.
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.
L- effikaċja tal- komponenti tal- ħosba, gattone, u rubella ta 'ProQuad ġiet preċedentament stabbilita f' serje ta' provi fil- qasam, ikkontrollati u fejn iż- żewġ partijiet ma jafux xi trattament qed jieħdu, bil - vaċċini monovalenti immanifatturati minn Merck & Co., Inc., li wrew livell għoli ta 'effikaċja protettiva.
In these studies seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
F' dawn l- istudji, serokonverżjoni b' risposta għat- tilqima kontra l- ħosba, gattone, u rubella offriet protezzjoni parallela minn dan il- mard.
ProQuad elicits rates of antibody responses against measles, mumps, and rubella similar to those observed after vaccination with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
ProQuad jiġbed rati ta 'risposti ta' antikorpi kontra l - ħosba, gattone, u rubella simili għal dawk osservati wara t- tilqima bil- vaċċin tal- ħosba, gattone, u tar - rubella mmanifatturat minn Merck & Co., Inc.
More than 428 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2005).
Aktar minn 428 miljun doża tal- vaċċin tal- ħosba, gattone, u rubella mmanifatturati minn Merck & Co., Inc. tqassmu madwar id- dinja (1978 sa l- 2005).
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%.
Fi provi kliniċi kkombinati ta 'doża waħda ta' Varicella Vaccine live (Oka/ Merck) fi tfal b' saħħithom, l- effikaċja tal- protezzjoni tal- vaċċin kontra s- severitajiet kollha tal- marda tal - ġidri r- riħ kellha medda ta 'bejn 81% u 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.
Fi studju kbir ta 'kontroll tal- każ, il- vaċċin kien stmat li kien 85% effettiv kontra l- forom kollha ta' ġidri r- riħ u 97% effettiv kontra mard moderatament sever u sever.
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).
Fi studju li jqabbel doża 1 (N=1114) sa 2 dożi (N=1102) ta 'Varicella Vaccine live (Oka/ Merck), l - effikaċja stmata tal- vaċċin kontra s- severitajiet kollha tal- marda tal- ġidri r- riħ għall- perjodu t' osservazzjoni ta' 10 snin kienet ta '94% għal doża 1 u 98% għal 2 dożi (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.
Fuq il- perjodu t' osservazzjoni ta '10 snin, ir- rata kumulattiva ta' ġidri r- riħ kienet ta '7. 5% wara doża 1 u 2. 2% wara 2 dożi.
Most cases of varicella reported in recipients of 1 dose or 2 doses of vaccine were mild.
Ħafna mill- każijiet ta 'ġidri r- riħ irrapportati f' riċevituri ta' doża 1 jew ta '2 dożi tal- vaċċin kienu ħfief.
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.
Ir- risponsi ta 'antikorpi kontra l- virus tal- ġidri r- riħ ≥ 5 gpELISA Units/ ml fl- assaġġ immunosorbenti tal- glikoproteina f’ għaqda mal- enzimi (gpELISA, assaġġ sensittiv ferm li mhuwiex disponibbli fis - suq) intwerew li kienu korrelatati ferm ma' protezzjoni fit- tul.
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).
Studji kliniċi wrew li l - immunizzazzjoni bi ProQuad tiġbed rati ta 'risponsi ta' antikorpi kontra l- virus tal- ġidri r- riħ virus ≥ 5 gpELISA Units/ ml simili għal dawk osservati wara t- tilqima b' Varicella Vaccine live (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.
L- immunoġeniċità tal - formulazzjoni kurrenti stabbli fil- friġġ ntweriet li kienet simili għall- immunoġeniċità tal- formolazzjoni aktar bikrija ta 'ProQuad sitt ġimgħat wara doża waħda tal- vaċċin.
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.
10 komponent individwali ta 'doża waħda (Varicella Vaccine live (Oka/ Merck) u l- vaċċin tal- ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc.), użat fil- preżent f' tilqim ta' rutina f' xi pajjiżi.
Clinical trials involving 6987 subjects who received ProQuad demonstrated detectable immune responses to measles, mumps, rubella, and varicella in a high proportion of individuals.
Provi kliniċi li nvolvew 6987 suġġett li rċevew ProQuad urew risponsi ta 'immunità li jistgħu jiġu osservati għall- ħosba, gattone, rubella, u ġidri r- riħ f' ħafna mill- individwi.
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.
Il- preżenza ta 'antikorpi li jistgħu jiġu osservati ġiet stmata b' assaġġ immunosorbenti ta ’ għaqda ma l- enzimi (ELISA) sensittiv kif meħtieġ għall- ħosba, gattone (tipi salvaġġ u tal- vaċċin), u rubella, u b' gpELISA għall- ġidri r- riħ.
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.
Wara doża waħda ta 'ProQuad, ir- rati ta' rispons tal- vaċċin kienu 97. 7% għall- ħosba, 96. 3% sa 98. 8% għall- gattone, u 98. 8% għar- rubella.