qanastek/EMEA-V3 huggingface dataset:
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.
Filwaqt li r- rata ta 'serokonverżjoni għall- ġidri r- riħ kienet għolja b' mod uniformi (97. 9% għal 99. 8% tul l- istudji kollha), is- serokonverżjoni ma ntweritex li tikkorrelata tajjeb mal- protezzjoni.
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).
Ir- rata tar- rispons tal- vaċċin kienet ta '90. 9% (medda 80. 8% sa 94. 5%) għall - ġidri r- riħ fuq il- bażi ta' titer ta 'antikorp ta' wara t- tilqima ≥ 5 gpELISA units/ ml (titer ta 'antikorp li ntwera li kien korrelatat ferm ma' protezzjoni fit- tul).
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.
Dawn ir- riżultati kienu simili għar- rati ta 'risposta ta' l- immunità indotti b' għoti fl- istess ħin ta 'doża waħda ta' Varicella Vaccine live (Oka/ Merck) u l- vaċċin tal- ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. f' postijiet ta 'injezzjoni separati.
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.
Tfal li ħadu t- tieni doża ta ’ ProQuad F' 2 provi kliniċi, 1035 suġġett ġew mogħtija tieni doża ta 'ProQuad bejn wieħed u ieħor 3 xhur wara l - ewwel doża.
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).
Ir- rati ta 'rispons tal- vaċċin kienu 99. 4% għall- ħosba, 99. 9% għall- gattone, 98. 3% għar - rubella, u 99. 4% għall- ġidri r- riħ (≥ 5 gpELISA Units/ 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).
It- titer medjo ġejometriku (GMTs) wara t - tieni doża ta 'ProQuad żdiedu b' bejn wieħed u ieħor darbtejn kull wieħed għall- ħosba, gattone, u rubella, u bejn wieħed u ieħor 41 darba għall - ġidri r- riħ (għal informazzjoni dwar is- sigurtà, ara sezzjoni 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.
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 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.
L- immunoġenicità u s- sigurtà ta 'ProQuad ġew evalwati fi prova klinika li kienet tinvolvi 799 suġġett ta ’ 4 sa 6 snin t' età li kienu rċevew Varicella Vaccine live (Oka/ Merck) u l- vaċċin tal- ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. għallinqas xahar qabel id- daħliet ta' l- istudju.
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.
Wara d - doża ta 'ProQuad, GMTs għall- ħosba, gattone, rubella, u ġidri r- riħ kienu simili għal dawk wara tieni doża ta' Varicella Vaccine live (Oka/ Merck) u tal- vaċċin tal- ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. mogħti fl- istess ħin f' postijiet t' injezzjoni separati.
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).
Barra minn hekk, GMTs għall- ħosba, gattone, u rubella kienu simili għal dawk wara tieni doża tal- vaċċin tal- ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. mogħti fl- istess ħin ma 'plaċebo (għal informazzjoni dwar is- sigurtà, ara sezzjoni 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.
Persistenza tar- Rispons ta 'Immunità Il- persistenza ta' antikorp f' sena waħda wara t- tilqima ġiet evalwata f' subsett ta '2108 suġġett li kienu involuti fi prova klinika.
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).
Ir- rata ta 'persistenza ta' l- antikorpi, sena wara t- tilqima f' riċevituri ta 'doża waħda ta' ProQuad kienet 98. 9% (1722/ 1741) għall- ħosba, 96. 7% (1676/ 1733) għall- gattone, 99. 6% (1796/ 1804) għar- rubella, u 97. 5% (1512/ 1550) għall- ġidri r- riħ (≥ 5 gpELISA Units/ ml).
Experience with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrates that antibodies to measles, mumps, and rubella viruses are still detectable in most individuals 11 to 13 years after primary vaccination.
L- esperjenza bil- vaċċin tal- ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. turi li antikorpi għall- virus tal- ħosba, gattone, u rubella għadhom jiġu osservat f' ħafna individwi 11 sa 13- il sena wara l- ewwel tilqima.
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.
Fi studji kliniċi li jinvolvu suġġetti b' saħħithom li rċevew doża 1 ta 'Varicella Vaccine live (Oka/ Merck), kien hemm preżenti antikorpi tal- ġidri r- riħ f' ħafna mill - individwi ttestjati sa 10 snin wara t- tilqima.
Evaluation of pharmacokinetic properties is not required for vaccines.
Evalwazzjoni tat- tagħrif farmakokinetiku m' huwiex meħtieġ għat- tilqim.
5.3 Preclinical safety data
11 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
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.
Ma sarux studji mhux kliniċi tradizzjonali, iżda m' hemm ebda tħassib mhux kliniku relevanti għas - sigurtà klinika barra mill- informazzjoni inkluża f' sezzjonijiet oħra tal- SPC.
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
Trab Sucrose Hydrolysed gelatin Sodium chloride Sorbitol Monosodium glutamate Sodium phosphate Sodium bicarbonate Potassium phosphate Potassium chloride Medium 199 b' Hanks ’ Salts Minimum Essential Medium, Eagle (MEM) Neomycin Phenol red Hydrochloric acid (għall- aġġustament tal- pH) Sodium hydroxide (għall- aġġustament tal- pH) Urea
In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
After reconstitution, the vaccine should be used immediately.
Wara rikonstituzzjoni, il- vaċċin għandu jintuża minnufih.
However, the in-use stability has been demonstrated for 30 minutes between 20°C and 25°C.
Madankollu, l- istabbilità waqt l- użu ntweriet għal 30 minuta meta maħżun bejn 20°C u 25°C.
Store and transport refrigerated (2°C-8°C).
Aħżen u ġorr imkessaħ (2°C- 8°C).
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta 'ħażna tal- prodott mediċinali rikonstitwit, ara sezzjoni 6. 3.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a vial (Type 1 glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Trab f' kunjett (ħġieġ ta 'Tip I) b' tapp (butyl rubber) u solvent f' kunjett (ħġieġ ta' Tip I) b' tapp (chlorobutyl rubber) f' pakkett ta 'daqs 1 u 10.
6.6 Special precautions for disposal and other handling
12 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u maniġġ ieħor
To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substances, which might inactivate the vaccine.
Biex tirrikonstitwixxi l- vaċċin, uża biss is- solvent provdut, minħabba li ma għandux preservattivi jew sostanzi antivirali, li jistgħu jinattivaw il- vaċċin.
ProQuad, when reconstituted, is clear pale yellow to light pink liquid.
ProQuad, meta rikonstitwit, huwa likwidu safrani ċar għal roża ċar.
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.
Huwa importanti li tintuża siringa u labra sterelizzata separata għal kull individwu sabiex tkun impeduta t- trasmissjoni ta 'aġenti t' infezzjoni minn individwu għal ieħor.
ProQuad must not be mixed in a syringe with other vaccines.
ProQuad ma għandux jintuża f' siringa ma 'vaċċini oħrajn.
12 Reconstitution instructions Withdraw the entire volume of solvent into a syringe.
Struzzjonijiet ta 'rikonstituzzjoni Iġbed il- volum kollu f' siringa ta' solvent f' siringa.
Inject the entire content of the syringe into the vial containing the powder.
Injetta l- kontenut kollu tas- siringa fil- kunjett li fih it- trab.
Withdraw the entire content of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.
Iġbed il- kontenut kollu tal- vaċċin rikonstitwit mill- kunjett fl- istess siringa u injetta l- volum kollu.
IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.
HUWA RRAKKOMANDAT LI L- VAĊĊIN JINGĦATA MINNUFIH WARA RIKOSTITUZZJONI, SABIEX TNAQQAS IT- TELF TA L- POTENZA.
DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.
ARMI L- VAĊĊIN RIKONSTITWIT JEKK MA JINTUŻAX FI ŻMIEN 30 MINUTA.
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.
Il- vaċċin rikonstitwit ma għandux jintuża jekk tiġi nnotata xi materja ta 'partikulati jew jekk id- dehra tal- vaċċin tkun differenti minn dik deskritta fuq.
SANOFI PASTEUR MSD SNC 8 rue Jonas Salk F-69007 Lyon France
SANOFI PASTEUR MSD SNC 8 rue Jonas Salk F- 69007 Lyon Franza
ProQuad powder and solvent for suspension for injection in a pre-filled syringe.
ProQuad trab u solvent għal sospensjoni għall- injezzjoni f' siringa mimlija għal- lest.
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 tal- gattone1 razza Jeryl Lynn™ (Livell B) (ħaj, attenwat) mhux inqas minn 4. 30 log10 CCID50 * Virus tar- rubella2 razza Wistar RA 27/ 3, (ħaj, attenwat) mhux inqas minn 3. 00 log10 CCID50 * Virus tal- ġidri r- riħ1, razza Oka/ Merck, (ħaj, attenwat)
Powder and solvent for suspension for injection in a pre-filled syringe.
Trab u solvent għal sospensjoni għall- injezzjoni f' siringa mimlija għal- lest.
ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella, and varicella in individuals from 12 months of age.
ProQuad huwa indikat għal tilqim simultanju kontra ħosba, gattone, rubella, u ġidri r- riħ f' individwu minn 12- il xahar 'il fuq.
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 Metodu ta 'amministrazzjoni Il- vaċċin għandu jiġi injettat taħt il- ġilda fir- reġjun tal- muskolu deltojd fin- naħa ta ’ fuq ta ’ l- id jew fil - ġenb ta ’ quddiem fil- parti ta ’ fuq tal- koxxa.
In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
F’ individwi li kienu severament immunokompromessi u li mingħajr ma jafu ġew injettati bil- vaċċin li fih il- virus tal- ħosba, ġie rrappurtat li kien hemm enċefalite tal- ġisem inkluża tal - ħosba pulmonite u riżultati fatali, konsegwenza iretta ta ’ tixrid ta ’ l- infezzjoni bil- virus tal- vaċċin tal - ħosba.
Vaccination should be postponed during any illness with fever > 38.5°C.
It- tilqim għandu jiġi pospost waqt mard b' deni li jitla '> 38. 5C.
This vaccine contains 16 mg of sorbitol as an excipient.
Dan il- vaċċin fih 16mg ta ’ sorbitol bħala sustanza mhux attiva.
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.
15 Riċevituri tal- vaċċin għandhom jevitaw l- użu ta ’ salicylates għal 6 ġimgħat wara t- tilqima bi ProQuad, għaliex is- sindromu ta 'Reye ġie rrapportat wara l- użu ta' salicylates waqt infezzjoni tal- ġidri tip mhux attenwat.
15 As for any vaccine, vaccination with ProQuad may not result in protection in all vaccine recipients.
Bħal b' kull tilqima oħra, it- tilqim b' ProQuad jista 'ma jirriżultax fi protezzjoni fir- riċevituri kollha tat - tilqima.
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 'tromboċitopenja f' individwi mlaqqmin bi ProQuad.
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- immunodefiċenzamingħajr evidenza ta ’ immunosuppressjoni.
Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine.
16 Tfal taħt trattament għat- tuberkulożi ma esperjenzawx taħrix ta ’ din il- marda meta ġew imlaqqma bil - vaċċin tal- virus tal- ħosba tat- tip ħaj.
16 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.
5 months for VZIG).
Mandakollu, 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).
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 '15- 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 ħadu
17 Note: official recommendations may vary regarding the duration of the waiting period that is recommended for avoiding pregnancy following vaccination.
17 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.
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.
There is no evidence that varicella vaccine virus is excreted in breast milk.
Fi trabi li kellhom evidenza seroloġika ta ’ infezzjoni tar- rubella, ħadd minnhom ma wera sintomi tal- marda.
It is not known whether measles or mumps vaccine virus is secreted in human milk.
M’ hemmx evidenza li l- vaċċin tal- ġidri r- riħ jgħaddi fil- ħalib ta ’ l- omm.
Therefore, caution should be exercised when considering whether to administer ProQuad to a breast-feeding woman.
M' huwiex magħruf jekk il- virus tal- vaċċin tal - ħosba u tal- gattone jgħaddix fil- ħalib tal- bniedem.
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 ebda vaċċin ieħor lil 6038 tifel/ tifla ta 'bejn 12 u 23 xahar.
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.
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.
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 18 (Oka/ Merck).
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)]
[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)]
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).
19 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).
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.
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..
Not known: arthritis and/ or arthralgia (usually transient and rarely chronic [see below]), musculoskeletal pain, myalgia, pain of the hip, leg, or neck, swelling.
20 Mhux magħruf: artrite u/ jew artralġja (normalment temporanja u rarament kronika [ara taħt]), uġigħ muskuloskeletali, mijalġja, uġigħ fil- ġenbejn, saqajn jew għonq, nefħa.
Following vaccination in children, reactions
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.
20 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.
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.
21 riċevituri ta ’ Varicella Vaccine live (Oka/ merck) mingħajr raxx bħal tal- ġidri r- riħ, ġiet irrapportati iżda ma ġietx ikkonfermata.
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.
22 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.
While the seroconversion rate for varicella was
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.
22 uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate well with protection.
Filwaqt li r- rata ta 'serokonverżjoni għall- ġidri r- riħ kienet għolja b' mod uniformi (97. 9% għal 99. 8% tul l- istudji kollha), is- serokonverżjoni ma ntweritex li tikkorrelata tajjeb mal- protezzjoni.
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).
Ir- rata tar- rispons tal- vaċċin kienet ta '90. 9% (medda 80. 8% sa 94. 5%) għall - ġidri r- riħ fuq il- bażi ta' titer ta 'antikorp ta' wara t- tilqima ≥5 gpELISA units/ ml (titer ta 'antikorp li ntwera li kien korrelatat ferm ma' protezzjoni fit- tul).
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.
L- immunoġenicità u s- sigurtà ta 'ProQuad ġew evalwati fi prova klinika li kienet tinvolvi 799 suġġett ta' 4 sa 6 snin t' età li kienu rċevew Varicella Vaccine live (Oka/ Merck) u l- vaċċin tal- ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. għallinqas xahar qabel id- daħliet ta 'l- istudju.
Experience with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrates that antibodies to measles, mumps, and rubella viruses are still detectable in most individuals 11 to 13 years after primary vaccination.
L- esperjenza bil- vaċċin tal- ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. turi li antikorpi għall- virus tal- ħosba, gattone, u rubella għadhom jiġu osservati f' ħafna individwi 11 sa 13- il sena wara l- ewwel tilqima.
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
Trab Sucrose Hydrolysed gelatin Sodium chloride Sorbitol Monosodium glutamate Sodium phosphate Sodium bicarbonate Potassium phosphate Potassium chloride Medium 199 b' Hanks ’ Salts Minimum Essential Medium, Eagle (MEM) Neomycin Phenol red Hydrochloric acid (għall- aġġustament tal- pH) Sodium hydroxide (għall- aġġustament tal- pH) Urea
Store and transport refrigerated (2°C-8°C).
Aħżen u ttrasporta mkessaħ (2°C- 8°C).
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type 1 glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber) in a pack size of 1 and 10.
Trab f' kunjett (ħġieġ ta 'Tip I) b' tapp (butyl rubber) u solvent f' siringa mimlija għal- lest (ħġieġ ta' Tip I) b' labra mwaħħla bi stopper tal- planġer (chlorobutyl rubber) u bi protezzjoni għal- labra (gomma naturali) f' pakkett ta 'daqs 1 u 10.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type 1 glass) with plunger stopper and tip cap (chlorobutyl rubber), without needle, in a pack size of 1, 10 and 20.
Trab f' kunjett (ħġieġ ta 'Tip I) b' tapp (butyl rubber) u solvent f' siringa mimlija għal- lest (ħġieġ ta' Tip I) bi stopper tal- planġer u kappa tat- tarf (chlorobutyl rubber), mingħajr labra f' pakkett ta 'daqs 1, 10, u 20.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type 1 glass) with plunger stopper and tip cap (chlorobutyl rubber), with one or two unattached needles, in a pack size of 1, 10 and 20.
24 Trab f' kunjett (ħġieġ ta 'Tip I) b' tapp (butyl rubber) u solvent f' siringa mimlija għal- lest (ħġieġ ta' Tip I) bi stopper tal- planġer u kappa tat- tarf (chlorobutyl rubber), b' labra waħda jew tnejn mhux imqabbdin, f' pakkett ta 'daqs 1, 10, u 20.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u maniġġ ieħor
24 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.
Huwa importanti li tintuża siringa u labra sterelizzata separata għal kull individwu sabiex tkun impeduta t- trasmissjoni ta 'aġenti t' infezzjoni minn individwu għal ieħor.
Reconstitution instructions Inject the entire content of the syringe into the vial containing the powder.
Struzzjonijiet ta 'rikostituzzjoni Injetta l- kontenut kollu tas- siringa fil- kunjett li fih it- trab.
B CONDITIONS OF THE MARKETING AUTHORISATION
DATA TA 'META ĠIET RIVEDUTA L- KITBA
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
BOX 581, 2003 PC Haarlem The Netherlands
BOX 581, 2003 PC Haarlem L- Olanda
ProQuad - Powder in vial and solvent in vial - Pack of 1, 10
ProQuad - Trab f' kunjett u solvent f' kunjett - Pakkett ta '1, 10
ProQuad powder and solvent for suspension for injection Measles, mumps, rubella and varicella vaccine (live)
ProQuad trab u solvent għal sospensjoni għall- injezzjoni Vaċċin (ħaj) tal- ħosba, gattone, rubella u ġidri r- riħ
After reconstitution, one dose (0.5 ml) contains (live, attenuated):
Wara rikonstituzzjoni, doża waħda (0. 5 ml) fiha (ħaj, attenwat):
Measles virus Enders’ Edmonston strain..................................... ≥ 3.00 log10 CCID50* Mumps virus Jeryl Lynn™ (Level B) strain................................ ≥ 4.30 log10 CCID50* Rubella virus Wistar RA 27/ 3 strain............................................ ≥ 3.00 log10 CCID50* Varicella virus Oka/ Merck strain................................................ .≥ 3.99 log10 PFU**
Virus tal- ħosba razza Enders ’ Edmonston............................................. ≥ 3. 00 log10 CCID50 * Virus tal- gattone razza Jeryl Lynn™ (Livell B).................................... ≥ 4. 30 log10 CCID50 * Virus tar- rubella Wistar RA 27/ 3........................................................... ≥ 3. 00 log10 CCID50 * Virus tal- ġidri r- riħ razza Oka/ Merck..................................................... ≥ 3. 99 log10 PFU **
Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, neomycin, phenol red, HCl, NaOH.
Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 b' Hanks ’ Salts, MEM, neomycin, phenol red, HCl, NaOH.
Pack of 1 single dose vial (powder) + 1 vial (solvent).
Pakkett ta 'kunjett wieħed ta' doża waħda (trab) + kunjett wieħed (solvent).
Pack of 10 single dose vials (powder) + 10 vials (solvent).
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 kunjetti (solvent).
STORE AND TRANSPORT REFRIGERATED.
ŻOMM MKESSAĦ WAQT IL- ĦAŻNA U L- ĠARR.
Keep the vial of powder in the outer carton to protect from light.
Żomm il- kunjett tat- trab fil- kaxxa tal- kartun biex tipproteġih mid- dawl.
After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.
Wara rikonstituzzjoni, uża minnufih jew fi żmien 30 minuta jekk maħżun f' 20°C u 25°C.
Read the package leaflet for disposal of medicines no longer required.
Aqra l- fuljett tal- pakkett dwar kif għandek tarmi l- mediċini li mhumiex aktar meħtieġa.
EU/ 1/ 05/ 323/ 001 - pack of 1 EU/ 1/ 05/ 323/ 002 - pack of 10
EU/ 1/ 05/ 323/ 001 - pakkett ta '1 EU/ 1/ 05/ 323/ 002 - pakkett ta' 10
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- PAKKETTI Ż- ŻGĦAR EWLENIN
ProQuad powder for suspension for injection
ProQuad trab għal sospensjoni għall- injezzjoni
32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- PAKKETTI Ż- ŻGĦAR EWLENIN
Solvent for ProQuad Water for injections
Solvent għal ProQuad Ilma għall- injezzjonijiet
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ProQuad - Powder in vial and solvent in pre-filled syringe with attached needle - Pack of 1, 10
ProQuad - - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' labra mwaħħla - Pakkett ta '1, 10
ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)
Trab u solvent ProQuad għal sospensjoni għall- injezzjoni f' siringa mimlija għal- lest Vaċċin (ħaj) tal- ħosba, gattone, rubella u ġidri r- riħ
Measles virus Enders’ Edmonston strain..................................... ≥ 3.00 log10 CCID 50* Mumps virus Jeryl Lynn™ (Level B) strain................................ ≥ 4.30 log10 CCID50* Rubella virus Wistar RA 27/ 3 strain............................................ ≥ 3.00 log10 CCID50* Varicella virus Oka/ Merck strain................................................ .≥ 3.99 log10 PFU**
Virus tal- ħosba razza Enders ’ Edmonston............................................. ≥ 3. 00 log10 CCID50 * Virus tal- gattone razza Jeryl Lynn™ (Livell B).................................... ≥ 4. 30 log10 CCID50 * Virus tar- rubella Wistar RA 27/ 3........................................................... ≥ 3. 00 log10 CCID50 * Virus tal- ġidri r- riħ razza Oka/ Merck..................................................... ≥ 3. 99 log10 PFU **
Pack of 1 single dose vial (powder) + 1 pre-filled syringe with attached needle (solvent).
Pakkett ta 'kunjett ta' doża waħda (trab) + siringa waħda mimlija għal- lest b' labra mwaħħla (solvent).
Pack of 10 single dose vials (powder) + 10 pre-filled syringes with attached needle (solvent).
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest b' labra mwaħħla (solvent).
EU/ 1/ 05/ 323/ 003 – pack of 1 EU/ 1/ 05/ 323/ 004 – pack of 10
EU/ 1/ 05/ 323/ 003 - pakkett ta '1 EU/ 1/ 05/ 323/ 004 - pakkett ta' 10
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ProQuad - Powder in vial and solvent in pre-filled syringe without needle - Pack of 1, 10, 20
ProQuad - - Trab f' kunjett u solvent f' siringa mimlija għal- lest mingħajr labra mwaħħla - Pakkett ta '1, 10, 20
Pack of 1 single dose vial (powder) + 1 pre-filled syringe without needle (solvent).
Pakkett ta 'kunjett wieħed ta' doża waħda (trab) + siringa waħda mimlija għal- lest mingħajr labra (solvent).
Pack of 10 single dose vials (powder) + 10 pre-filled syringes without needle (solvent).
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest mingħajr labra (solvent).
Pack of 20 single dose vials (powder) + 20 pre-filled syringes without needle (solvent).
Pakkett ta '20 kunjett ta' doża waħda (trab) + 20 siringa mimlijin għal- lest mingħajr labra (solvent).
Keep the vial of powder in the outer carton to protect from light.
Żomm il- kunjett fil- kaxxa tal- kartun biex tipproteġih mid- dawl.
After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.
Wara rikonstituzzjoni, uża minnufih jew fi żmien 30 minuta jekk maħżun bejn 20°C u 25°C.
EU/ 1/ 05/ 323/ 005 – pack of 1 EU/ 1/ 05/ 323/ 006 – pack of 10 EU/ 1/ 05/ 323/ 007 – pack of 20
EU/ 1/ 05/ 323/ 005 - pakkett ta '1 EU/ 1/ 05/ 323/ 006 - pakkett ta' 10 EU/ 1/ 05/ 323/ 004 - pakkett ta '20
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ProQuad - Powder in vial and solvent in pre-filled syringe with 1 unattached needle - Pack of 1, 10, 20
ProQuad - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' labra waħda mhux imwaħħla - Pakkett ta '1, 10, 20
ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)
ProQuad trab u solvent għal sospensjoni għall- injezzjoni f' siringa mimlija għal- lest Vaċċin (ħaj) tal- ħosba, gattone, rubella u ġidri r- riħ
Pack of 1 single dose vial (powder) + 1 pre-filled syringe (solvent)+ 1 unattached needle.
Pakkett ta 'kunjett ta' doża waħda (trab) + siringa waħda mimlija għal- lest (solvent) + labra waħda labra mhux imwaħħla.
Pack of 10 single dose vials (powder) + 10 pre-filled syringes (solvent)+ 10 unattached needles.
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest (solvent) + 10 labriet mhux imwaħħlin.
Pack of 20 single dose vials (powder) + 20 pre-filled syringes (solvent)+ 20 unattached needles.
Pakkett ta '20 kunjett ta' doża waħda (trab) + 20 siringa mimlijin għal- lest (solvent) + 20 labra mhux imwaħħla.
Keep the vial of powder in the outer carton to protect from light.
ŻOMM MKESSAĦ WAQT IL- ĦAŻNA U L- ĠARR Żomm il- kunjett fil- kaxxa tal- kartun biex tipproteġih mid- dawl.
EU/ 1/ 05/ 323/ 008 – pack of 1 EU/ 1/ 05/ 323/ 009 – pack of 10 EU/ 1/ 05/ 323/ 012 – pack of 20
EU/ 1/ 05/ 323/ 008 - pakkett ta '1 EU/ 1/ 05/ 323/ 009 - pakkett ta' 10 EU/ 1/ 05/ 323/ 012 - pakkett ta '20
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ProQuad - Powder in vial and solvent in pre-filled syringe with 2 unattached needles - Pack of 1, 10, 20
ProQuad - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' żewġ labriet mhux imwaħħlin - Pakkett ta '1, 10, 20
Pack of 1 single dose vial (powder) + 1 pre-filled syringe (solvent)+ 2 unattached needles.
Pakkett ta 'kunjett ta' doża waħda (trab) + siringa waħda mimlija għal- lest (solvent) + 2 labriet mhux imwaħħlin.
Pack of 10 single dose vials (powder) + 10 pre-filled syringes (solvent)+ 20 unattached needles.
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest (solvent) + 20 labra mhux imwaħħla.
Pack of 20 single dose vials (powder) + 20 pre-filled syringes (solvent)+ 40 unattached needles.
Pakkett ta '20 kunjett ta' doża waħda (trab) + 20 siringa mimlijin għal- lest (solvent) + 40 labra mhux imwaħħla.
EU/ 1/ 05/ 323/ 010 – pack of 1 EU/ 1/ 05/ 323/ 011 – pack of 10 EU/ 1/ 05/ 323/ 013 – pack of 20
EU/ 1/ 05/ 323/ 010 - pakkett ta '1 EU/ 1/ 05/ 323/ 011 - pakkett ta' 10 EU/ 1/ 05/ 323/ 013 - pakkett ta '20
41 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL OF POWDER
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- PAKKETTI Ż- ŻGĦAR EWLENIN
ProQuad powder for suspension for injection SC
ProQuad trab għal sospensjoni għall- injezzjoni SC
42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- PAKKETTI Ż- ŻGĦAR EWLENIN
SYRINGE OF SOLVENT
SIRINGA TA 'SOLVENT
Solvent for ProQuad Water for injections
Solvent għal ProQuad Ilma għall- injezzjonijiet.
44 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
ProQuad Powder and solvent for suspension for injection Measles, mumps, rubella and varicella vaccine (live)
ProQuad Trab u solvent għal sospensjoni għall- injezzjoni Vaċċin (ħaj) tal- ħosba, gattone, rubella u ġidri r- riħ
Read all of this leaflet before your child is vaccinated.
Aqra dan il- fuljett kollu qabel it- tifel/ tifla tiegħek jitlaqqam/ titlaqqam.
- This vaccine has been prescribed for your child.
- Din il- mediċina ġiet mogħtija lit- tifel/ tifla tiegħek.
What ProQuad is and what it is used for 2.
X’ inhu ProQuad u għalxiex jintuża 2.
Before you use ProQuad 3.
Qabel ma tuża ProQuad 3.
How to use ProQuad 4.
Kif tuża ProQuad 4.
How to store ProQuad 6.
Kif taħżen ProQuad 6.
WHAT ProQuad IS AND WHAT IT IS USED FOR
X’ INHU ProQuad U GĦALXIEX JINTUŻA
ProQuad is a vaccine containing measles, mumps, rubella, and varicella (chickenpox) viruses that have been weakened.
ProQuad huwa vaċċin li fih il- virus tal- ħosba, tal- gattone, tar- rubella, u tal- ġidri r- riħ (chickenpox) li ġew imdgħajjfa.
When a person is given the vaccine, the immune system (the body ’ s natural defences) will make antibodies against the measles, mumps, rubella, and varicella viruses.
Meta persuna tingħata l- vaċċin, is- sistema ta 'l- immunità (id- difiża naturali tal- ġisem) tagħmel antikorpi kontra l- virus tal- ħosba, tal- gattone, tar- rubella, u tal- ġidri r- riħ.
The antibodies help protect against diseases caused by these viruses.
L- anti korpi jgħinu fil- protezzjoni kontra l- mard ikkawżat minn dawn il- virusijiet.
ProQuad is given to help protect your child against measles, mumps, rubella, and varicella (chickenpox).
ProQuad jingħata sabiex jgħin lit- tifel/ tifla tiegħek fil- protezzjoni kontra l- ħosba, gattone, rubella, u ġidri r- riħ (chickenpox).
The vaccine may be administered to persons from 12 months of age.
Il- vaċċin jista 'jingħata lil persuni minn 12- il xahar' il fuq.
Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or varicella (chickenpox) in healthy people.
Għalkemm ProQuad fih virusijiet ħajjin, huma dgħajjfa wisq biex jikkawżaw il- ħosba, gattone, rubella, jew ġidri r- riħ (chickenpox) f' nies b' saħħithom.
BEFORE YOU USE ProQuad
QABEL MA TUŻA ProQuad
Do not use ProQuad
Tużax ProQuad
• If your child is allergic (hypersensitive) to any of the components of ProQuad (including neomycin or any of the ingredients listed under “ other ingredients” -see section 6, Further information). • If your child has a blood disorder or any type of cancer that affects the immune system. • If your child is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy). • If your child has a weakened immune system because of a disease (including AIDS). • If your child has a family history of congenital or hereditary immunodeficiency, unless the immune competence of your child is demonstrated. • If your child has active untreated tuberculosis. • If your child has any illness with fever higher than 38.5°C; however, low-grade fever itself is not a reason to delay vaccination. • If your child is pregnant (in addition, pregnancy should be avoided for 3 months after vaccination, see Pregnancy and breast-feeding).
• Jekk it- tifel/ tifla tiegħek huwa/ hija allerġiku/ a (ibati/ tbati minn sensittività eċċessiva) għal xi sustanza tal- vaċċin ProQuad (inkluż neomycin jew xi ingredjent elenkat taħt “ ingredjenti oħra ” - ara sezzjoni 6, Aktar informazzjoni). • Jekk it- tifel/ tifla tiegħek ibati/ tbati minn xi disturbi tad- demm jew minn xi tip ta 'kanċer li jaffettwa s- sistema ta' l- immunità. • Jekk it- tifel/ tifla tiegħek qed jirċievi/ tirċievi trattament jew qed jieħu/ tieħu mediċini li jistgħu jdgħajjfu s- sistema ta 'l- immunità (għajr terapija ta' doża baxxa ta 'kortikosterojdi għall- ażżma jew terapija ta' sostituzzjoni). • Jekk it- tifel/ tifla tiegħek għandha sistema ta 'immunità mdgħajjfa minħabba marda (inkluż AIDS). • Jekk it- tifel/ tifla tiegħek għandha storja familjari ta' immunodefiċjenza konġenitali jew ereditarja, sakemm ma tintweriex il- kompetenza ta 'l- immunità tat- tifel/ tifla tiegħek. • Jekk it- tifel/ tifla tiegħek għandu/ għandha tuberkolożi attiva mhux trattata. • Jekk it- tifel/ tifla tiegħek għandu/ għandha marda b' deni ogħla minn 38. 5°C; madankollu, deni baxxa m' huwiex raġuni l- għala t- tilqima għandha ddum biex tingħata.
45 Take special care with ProQuad
Oqgħod attent ħafna bi ProQuad
If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before ProQuad is given:
Jekk il- persuna li għandha tieħu t- tilqima esperjenzat xi waħda minn dawn li ġejjin, kellem lit- tabib jew lill- ispiżjar tiegħek qabel ma jingħata ProQuad:
• If your child has had an allergic reaction to eggs or anything that contained egg. • If your child has a history or family history of allergies or of convulsions (fits). • If your child has had a side effect after vaccination with measles, mumps, or rubella (in a single vaccine or combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or ProQuad) that involved easy bruising or bleeding for longer than usual. • If your child has infection with Human Immunodeficiency Virus (HIV) but does not show symptoms of HIV disease.
• Jekk it- tifel/ tifla tiegħek kellu/ kellha reazzjoni għall- bajd jew għal xi ħaġa li fiha l- bajd. • Jekk it- tifel/ tifla tiegħek għandu/ għandha storja jew storja familjari ta 'allerġiji jew ta' konvulżjoni/ aċċessjoni (fits). • Jekk it- tifel/ tifla tiegħek kellu/ kellha xi effett sekondarju wara t- tilqima bil- ħosba, gattone, jew rubella (f' tilqima singola jew f' tilqima kombinata, bħat- tilqima tal- ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. jew ProQuad) li kien jinvolvi tbenġil malajr jew fsad itwal min- normal. • Jekk it- tifel/ tifla tiegħek huwa/ hija infettat/ a bi Human Immunodeficiency Virus (HIV) iżda ma turix sintomi tal- marda tal- HIV.
However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).
Madankollu, it- tilqima tista 'tkun inqas effettiva milli fuq persuni mhux infettati (ara Tużax ProQuad).
Once vaccinated, your child should attempt to avoid for up to 6 weeks following vaccination, whenever possible, close association with the following individuals:
Ladarba mlaqqam/ mlaqma, it- tifel/ it- tifla tiegħek għandu jevita/ għandha tevita għal 6 ġimgħat wara t - tilqima, kull meta possibbli, assoċjazzjoni mill- qrib ma 'l- individwi li ġejjin:
• Individuals with a lowered resistance to diseases. • Pregnant women who have either not had chickenpox or have not been vaccinated against chickenpox. • Newborn infants of mothers who have either not had chickenpox or have not been vaccinated against chickenpox.
• Individwu b' reżistenza iktar baxxa għall- mard. • Nisa tqal li jew ikunu għadhom ma ħadux il- ġidri r- riħ jew li jkunu għadhom ma ġewx imlaqqmin kontra l- ġidri r- riħ. • Trabi li jkunu għadhom kif twieldu li jew ikunu għadhom ma ħadux il- ġidri r- riħ jew li jkunu għadhom ma ġewx imlaqqmin kontra l- ġidri r- riħ.
Tell your doctor if there is anyone who falls into one of the categories above and is expected to be in contact with your vaccinated child.
Għid lit- tabib tiegħek jekk hemmx xi ħadd li jaqa 'taħt waħda mill- kategoriji msemmija fuq u huwa mistenni li jiġi f' kuntatt mat- tifel/ tifla tiegħek imlaqqam/ imlaqqma.
As with other vaccines, ProQuad may not completely protect all persons who are vaccinated.
Bħal ħafna tilqim ieħor, ProQuad mhux bilfors jagħti protezzjoni totali lill- persuni kollha li jieħdu t - tilqima.
Also, if the person to be vaccinated has already been exposed to the measles, mumps, rubella, or varicella virus but is not yet ill, ProQuad may not be able to prevent the illness from appearing.
Ukoll, jekk il- persuna li se tiġi mlaqqma diġà ġiet esposta għall- virus tal- ħosba, gattone, rubella, jew ġidri r- riħ iżda għadha mhux marida, ProQuad jista 'ma jkunx kapaċi jimpedixxi milli tfeġġ il- marda.
Using other medicines and other vaccines
Meta tuża mediċini oħra u tilqim ieħor
The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulin (IG), or varicella zoster immune globulin (VZIG).
It- tabib jista 'jdewwem it- tilqima għal mill- inqas 3 xhur wara t- trasfużjonijiet ta ’ - demm jew plażma, jew l- għoti ta' globulin immun (IG), jew ġidri r- riħ globulin taz- zoster immun( VZIG).
After vaccination with ProQuad, IG or VZIG should not be given for 1 month, unless your doctor tells you otherwise.
Wara tilqim bi ProQuad, IG jew VZIG ma għandhomx jingħataw għal xahar, sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 4 to 6 weeks after vaccination with ProQuad.
Jekk għandu jsir test tat- tuberkulin, dan għandu jsir jew f' xi ħin qabel, fl- istess ħin ta ', jew 4 sa 6 ġimgħat wara t- tilqima bi ProQuad.
Tell the doctor if your child has recently received a vaccine or if one is scheduled to be given in the near future.
Għid lit- tabib tiegħek jekk it- tifel/ tifla tiegħek ikun ħa/ tkun ħadet tilqima jew jekk hemm il- ħsieb li jieħu/ tieħu waħda fil- qarib.
The doctor will determine when ProQuad may be given.
It- tabib tiegħek jiddeċiedi meta ProQuad għandu jingħata.
The use of salicylates (for example, acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever) should be avoided for 6 weeks following vaccination with ProQuad.
L- użu ta 'salicylates (eżempju, acetylsalicylic acid, sostanza preżenti f' ħafna mediċini wżati għas - serħan mill- uġigħ u biex tbaxxi d- deni) għandu jiġi evitata għal 6 ġimgħat wara t- tilqima bi ProQuad.
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines (or other vaccines) including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk it- tifel/ tifla tiegħek qed jieħu/ tieħu jew ħa/ ħadet dan l- aħħar xi mediċini oħra (jew tilqim ieħor), anki dawk mingħajr riċetta.
ProQuad should not be given to pregnant females.
47 ProQuad ma għandux jingħata lil nisa tqal.
46 Persons who are breast-feeding or who intend to breast-feed should tell the doctor.
Persuni li qegħdin ireddgħu jew li għandhom l- intenzjoni li jreddgħu għandhom javżaw lit- tabib.
The doctor will decide if ProQuad should be given.
It - tabib tiegħek jiddeċiedi jekk ProQuad għandux jingħata.
Important information about some of the ingredients of ProQuad
Tagħrif importanti dwar is- sustanzi ta 'ProQuad
ProQuad contains sorbitol.
ProQuad fih sorbitol.