qanastek/EMEA-V3 huggingface dataset:
Official recommendations may vary regarding the duration of the waiting period that is recommended for avoiding pregnancy following vaccination.
Rakkommandazzjonijiet uffiċjali jistgħu jvarjaw dwar it- tul tal- perjodu ta ’ stennijja li huwa rrakkommandat għall- evitar ta 'tqala wara l- vaċċinazzjoni.
Postpartum Women It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period.
Nisa wara l- Ħlas Instab li ħafna drabi, huwa konvenjenti li jsir tilqim ta ’ nisa li huma suxxettibbli għall- ħosba Ġermaniża f’ dak il- perjodu eżatt wara l- ħlas.
Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants.
Studji wrew li nisa li jreddgħu wara l- ħlas u li ġew imlaqqma bil- vaċċin tal- ħosba Ġermaniża tat- tip ħaj attenwat jistgħu jerħu l- virus fil- ħalib u jitrassmettuh lit- trabi li jkunu qed irreddgħu.
In the infants with serological evidence of rubella infection, none had symptomatic disease.
Fi trabi b’ evidenza seroloġika t’ infezzjoni b’ ħosba Ġermaniża, l- ebda minnhom ma kellhom sintomi tal - marda.
It is not known whether measles or mumps vaccine virus is secreted in human milk; therefore, caution should be exercised when M-M-RVAXPRO is administered to a breast-feeding woman.
M’ huwiex magħruf jekk il- virus tal- vaċċin tal- ħosba jew tal- gattone jinħariġx fil- ħalib tas - sider; għalhekk l- għoti ta ’ M- M- RVAXPRO lil mara li qed tredda 'għandu jsir b’ kawtela.
In clinical trials, M-M-RVAXPRO was administered to 1965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Fi prova klinika, M- M- RVAXPRO ingħata lil 1965 tifel u tifla (ara sezzjoni 5. 1), u l- profil tas- sigurtà ġenerali kien komparabbli mal- formolazzjoni preċedenti tal- ħosba, gattone u ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc.
In a clinical trial, 752 children received M-M-RVAXPRO, either intramuscularly or subcutaneously.
Fi prova klinika, 752 tifel u tifla rċevew M- M- RVAXPRO, jew ġol- muskoli jew taħt il- ġilda.
6 although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Il- profil ġenerali tas- sigurtà taż- żewġ rotot ta ’ amministrazzjoni kienu komparabbli, għalkemm ir- reazzjonijiet tal- post ta ’ l- injezzjoni kienu inqas frekwenti fil- grupp IM (15. 8%) meta mqabbla ma ’ dawk tal- grupp SC (25. 8%).
All adverse reactions were evaluated in 1940 children.
Ir- reazzjonijiet mhux mixtieqa ġew evalwati fl- 1940 tifel u tifla.
Among these children, the following vaccine-related adverse reactions were observed in individuals following vaccination with M-M-RVAXPRO (excluding isolated reports with frequency < 0.2%).
Fost dawn it- tfal, ir- reazzjonijiet mhux mixtieqa li ġejjin ġew osservati f' individwi wara tilqima b’ M- M- RVAXPRO (rapporti iżolati bi frekwenza < 0. 2% ma ġewx ikkunsidrati)
In comparison to the first dose, a second dose of M-M-RVAXPRO is not associated with an increase in the incidence and severity of clinical symptoms including those suggestive of hypersensitivity reaction.
Meta mqabbla ma ’ l- ewwel doża, it- tieni doża ta ’ M- M- RVAXPRO mhijiex assoċjata ma ’ żieda fl - inċidenza u s- severità ta ’ sintomi kliniċi fosthom dawk li jissuġġerixxu reazzjoni ta ’ sensittività eċċessiva.
Additionally, other adverse experiences reported with post-marketing use of M-M-RVAXPRO and/ or in clinical studies and post-marketing use of previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck & Co., Inc. without regard to causality or frequency are available and are summarised below (frequency not known).
Barra minn hekk, esperjenzi avversi oħra rrappurtati bl- użu wara t- tqegħid fis- suq ta ’ M- M- RVAXPRO u/ jew fi studji kliniċi u l- użu wara t- tqegħid fis- suq ta 'formulazzjonijiet preċedenti ta' vaċċini monovalenti u tal- vaċċini kombinati kontra l- ħosba, il- gattone, u r- rubella żviluppati minn Merck & Co., Inc. mingħajr ma jitqiesu l- kawżalità u l- frekwenza huma disponibbli u miġbura fil - qosor hawn taħt (il- frekwenza mhix magħrufa).
These data were reported based on more than 400 million doses distributed worldwide.
Din id- dejta ġiet irrappurtata fuq il- bażi ta 'aktar minn 400 miljun doża mqassmin madwar id- dinja.
[Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to ≤ 1/ 100); not known (cannot be estimated from the available data)]
[Komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa ≤1/ 100); mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)]
Infections and infestations Uncommon: nasopharyngitis, upper respiratory tract infection or viral infection Not known: aseptic meningitis (see below), atypical measles, epididymitis, orchitis, otitis media, parotitis, rhinitis, subacute sclerosing panencephalitis (see below)
Infezzjonijiet u infestazzjonijiet Mhux komuni: nasofarinġite, infezzjoni fil- parti ta 'fuq ta' l- apparat respiratorju jew infezzjoni virali Mhux magħruf: meninġite asettika (ara taħt), ħożba atipika, epididimite, orkite, otite tal- widna tan - nofs, parotite, rinite, panenċefalite bi sclerosing subakut (ara taħt)
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination.
Ġew irrappurtati każijiet ta 'meninġite asettika wara tilqim 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 tipi oħra ta 'vaċċin kontra l- gattone u l- meninġite asettika, m' hemmx evidenza li torbot il- vaċċin kontra l- gattone Jeryl Lynn™ mal- meninġite asettika.
Blood and the lymphatic system disorders Not known: regional lymphadenopathy, thrombocytopenia
6 Disturbi tad- demm u tas- sistema limfatika Mhux magħruf: limfadenopatija reġjonali, tromboċitopenja
Immune system disorders Not known: anaphylactoid reaction, anaphylaxis and related phenomenon such as angioneurotic oedema, facial oedema, and peripheral oedema
Disturbi fis- sistema immuni Mhux magħruf: reazzjoni anaphylactoid, anafilassi u fenomenu relatat bħal edema anġjonewrotika, edema fil- wiċċ, u edema periferali
Psychiatric disorders Not known: irritability
Disturbi psikjatriċi Mhux magħruf: irritabilità
Nervous system disorders Not known: afebrile convulsions or seizures, ataxia, dizziness, encephalitis (see below), encephalopathy (see below), febrile convulsion (in children), Guillain-Barre syndrome, headache, measles inclusion body encephalitis (MIBE) (see section 4.3), ocular palsies, optic neuritis, paraesthesia, polyneuritis, polyneuropathy, retrobulbar neuritis, syncope
Disturbi fis- sistema nervuża Mhux magħruf: konvulżjonijiet jew aċċessjonijiet bla deni, atassja, sturdament, enċefalite (ara taħt), enċefalopatija (ara taħt), konvulżjoni bid- deni (fit- tfal), is- sindrome ta 'Guillain- Barre, uġigħ ta' ras, measles inclusion body encephalitis (MIBE) (ara sezzjoni 4. 3), paraliżi fl- għajnejn, nevrite ottika, parasteżija, polinevrite, polinewropatija, nevrite retrobulbari, sinkope
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 enċefalopatija, bl- esklużjoni tal- panenċefalite bi sclerosing subakut (SSPE), ġew irrappurtati bejn wieħed u ieħor darba kull 3 miljun doża tal- vaċċini li fihom il- ħosba żviluppati minn Merck & Co., Inc.
In
Is- sorveljanza wara t- tqegħid fis- suq ta 'l- aktar min 400 miljun doża li tqassmu madwar id- dinja tul kważi 25 sena (1978- 2003) tindika li episodji avversi serji bħall- enċefalite u l - enċefalopatija għadhom jiġu rrappurtati b' mod rari.
7 no case has it been shown conclusively that reactions were actually caused by vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines.
Fl- ebda każ ma ntwera b' mod konklużiv li r - reazzjonijiet fil- fatt kienu kkawżati mill- vaċċin; madankollu, id- data tissuġġerixxi l- possibilità li xi wħud minn dawn il- każijiet setgħu kienu kkawżati mill- vaċċini tal- ħosba.
There is no evidence that measles vaccine can cause SSPE.
M' hemmx evidenza li l- vaċċin tal- ħosba jista 'jikkawża 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 wild- type iżda li rċevew il- vaċċin 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 jista ’ jkun li rriżultaw minn ħosba mhux rikonoxxuta fl- ewwel sena tal- ħajja jew possibbilment mit- tilqima tal- ħosba.
The results of a retrospective case-controlled study conducted by the US Centers for Disease Control and Prevention suggest 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 retrospettiv bil- każi kkontrollati mwettaq miċ- Ċentri ta ’ l- US għall- Kontroll u l- Prevenzjoni tal- Mard jissuġġerixxu li l- effett globali tal- vaċċin tal- ħosba kien li jipproteġi kontra s- SSPE billi jimpedixxi l- ħosba bir- riskju inerenti tagħha ta 'SSPE.
Eye disorders Not known: conjunctivitis, retinitis
Disturbi fl- għajnejn Mhux magħruf: konġuntivite, retinite
Ear and labyrinth disorders Not known: nerve deafness
Disturbi fil- widnejn u fis- sistema labirintika Mhux magħruf: truxija tan- nervi
Respiratory, thoracic, and mediastinal disorders Uncommon: rhinorrhoea Not known: bronchial spasm, cough, pneumonia, pneumonitis (see section 4.3), sore throat
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: mħat Mhux magħruf: spażmu tal- bronki, sogħla, pnewmonja, pnewmonite (ara sezzjoni 4. 3), uġigħ fil - griżmejn
Gastrointestinal disorders Uncommon: diarrhoea or vomiting Not known: nausea
Disturbi gastro- intestinali Mhux komuni: dijarea jew rimettar Mhux magħruf: dardir
Skin and subcutaneous tissue disorders Common: rash morbilliform or other rash Uncommon: urticaria Not known: panniculitis, purpura, skin induration, Stevens-Johnson syndrome, pruritus
Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda Komuni: raxx bl- infafet jew raxx ieħor Mhux komuni: urtikarja Mhux magħruf: pannikulite. purpura, twebbis tal- ġilda, sindrome ta' Stevens- Johnson, ħakk
Musculoskeletal, connective tissue and bone disorders Not known: arthritis and/ or arthralgia (usually transient and rarely chronic [see below]), myalgia
Disturbi muskolu- skeltrali, tal- connective tissue u tal- għadam Mhux magħruf: artrite u/ jew artralġja (ġeneralment għaddiena u rarament kroniċi [ara taħt]), uġigħ fil - muskoli
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 sex, being greatest in adult females and least in prepubertal children.
7 L- artralġja u/ jew l- artrite (ġeneralment għaddiena u rarament kroniċi), u l- polinevrite huma karatteristiċi ta 'infezzjoni b' rubella wild- type u jvarjaw fil- frekwenza u s- severità ma' l- età u s- sess tal - persuna, l- akbar ikunu f' nisa adulti u l- anqas ikunu fi tfal ta 'qabel il- pubertà.
Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
Wara tilqima fit- tfal, ir - reazzjonijiet fil- ġogi ġeneralment mhumiex komuni (0- 3%) u ma tantx idumu.
Symptoms may persist for a matter of months or on rare occasions for years.
Fin- nisa, ir- rati ta 'l - inċidenza għall- artrite u l- artralġja huma ġeneralment ogħla minn dawk li jidhru fit- tfal (12- 20%), u r - reazzjonijiet għandhom tendenza li jkunu aktar evidenti u jdumu aktar.
In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.
Fil- bniet adoloxxenti, ir - reazzjonijiet jidhru li huma ta 'inċidenza intermedja bejn dawk li jidhru fit- tfal u f' nisa adulti.
Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Anki f' nisa ta 'età akbar (35- 45 sena), dawn ir- reazzjonijiet ġeneralment huma ttollerati sewwa u rari jinterferixxu ma' l- 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.
L- artrite kronika ġiet assoċjata ma 'infezzjoni tar- rubella wild- type u ġiet assoċjata ma' virus persistenti u/ jew antiġen virali iżolat mit- tessuti tal- ġisem.
Only rarely have vaccine recipients developed chronic joint symptoms.
F' każijiet rari biss ir- riċevituri tal- vaċċin żviluppaw sintomi kroniċi fil- ġogi.
8 General disorders and administration site conditions Very common: fever (38.5°C or higher), injection site erythema, injection site pain, and injection site swelling Common: injection site bruising Uncommon: injection site rash Not known: burning and/ or stinging of short duration at the injection site, fever (38.5°C or higher), malaise, papillitis, peripheral oedema, swelling, tenderness, vesicles at the injection site, wheal and flare at the injection site
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata Komuni ħafna: deni (38. 5°C jew ogħla), eritema fil- post ta' l- injezzjoni, uġigħ fil- post ta 'l- injezzjoni, u nefħa fil- post ta' l- injezzjoni Komuni: tbenġil fil- post ta 'l- injezzjoni Mhux komuni: raxx fil- post ta' l- injezzjoni Mhux magħruf: ħruq u/ jew tingiż li ma tantx idum fil- post ta 'l- injezzjoni, deni (38. 5°C jew ogħla), malesseri, papillite, edema periferali, nefħa, sensittività, infafet fil- post ta' l- injezzjoni, tbenġil u nirien fil- post ta 'l- injezzjoni
Vascular disorders Not known: vasculitis
Disturbi vaskulari Mhux magħruf: vaskulite
Overdose has been reported rarely and was not associated with any serious adverse reactions.
Rari li ġiet irrapportata doża eċċessiva u din ma kinitx assoċjata ma ’ effetti negattivi serji.
Pharmacotherapeutic group:
Vaċċin virali, Kodiċi ATC:
Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Evalwazzjoni ta ’ l- immunoġeniċità u ta 'l- effikaċja klinika Studju komparattiv f’ 1279 persuna li rċevew M- M- RVAXPRO jew il- formolazzjoni preċedenti (mmanifatturata minn albumina tas- serum uman) tal- ħosba, gattone jew ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc. wera immunoġeniċità u sigurtà simili bejn iż- żewġ prodotti.
Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. is highly immunogenic and generally well tolerated.
Studji kliniċi fuq 284 tifel u tifla li kienu negattivi fis- serum għal tlett darbiet, ta ’ età bejn 11- il xahar sa 7 snin, urew li l- formolazzjoni preċedenti tal- vaċċin tal- ħosba, gattone u ħosba Ġermaniża mmanifatturat minn Merck & Co., Inc. hija immunoġenika ħafna u ġeneralment tollerata sew.
In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralising antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons.
F’ dawn l- istudji, injezzjoni waħda tal- vaċċin kienet il- kawża ta ’ antikorpi ta 'inibizjoni ta' hemagglutination (HI) tal- ħosba f’ 95%, antikorpi li jinnewtralizzaw il- gattone f’ 96% u antikorpi (HI) għall- ħosba Ġermaniża f’ 99% tal- persuni suxxettibbli.
A comparative study in 752 subjects who received M-M-RVAXPRO either by intramuscular route or subcutaneous route demonstrated a similar immunogenicity profile between both administration routes.
Studju komparattiv f’ 752 suġġett li rċevew M- M- RVAXPRO jew ġol- muskoli jew taħt il- ġilda wera profil ta ’ immunoġeniċità simili bejn iż- żewġ rotot ta ’ għoti.
The efficacy of the components of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. was established in a series of double-blind controlled field trials, which demonstrated a high degree of protective efficacy afforded by the individual vaccine components.
L- effikaċja tal- komponenti tal- vaċċin tal- formolazzjoni preċedenti tal- ħosba, gattone u ħosba Ġermaniża mmanifatturat minn Merck & Co., Inc. ġiet stabbilita f’ serje ta ’ provi kliniċi double- blind ikkontrollati, li wrew grad għoli ta ’ effikaċja protettiva mogħtija mill- komponenti tal- vaċċin
These studies also established that seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
Dawn l- istudji wrew ukoll li s- serokonverżjoni b’ rispons għat- tilqima kontra l- ħosba, il - gattone u l- ħosba Ġermaniża hija parallela ma ’ protezzjoni minn dan il- mard.
Post-exposure vaccination Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours after exposure.
Tilqim wara espożizzjoni It- tilqim ta ’ individwi li ġew esposti għall- ħosba tat- tip selvaġġ jista 'jipprovdi xi ftit protezzjoni jekk dan jingħata fi żmien 72 siegħa wara l- espożizzjoni.
If, however, the vaccine is given a few days before exposure, substantial protection may be afforded.
Madankollu, jekk il- vaċċin jingħata ftit jiem qabel l- espożizzjoni, għandha tingħata protezzjoni sostanzjali.
There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.
M’ hemmx evidenza konklussiva li tilqima fuq individwi li riċentament ġew esposti għall- gattone tat- tip selvaġġ jew ħosba Ġermaniża tat- tip selvaġġ se tipprovdi protezzjoni.
9 Effectiveness More than 400 million doses of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2003).
Effettività Iktar minn 400 miljun doża tal- formolazzjoni preċedenti tal- ħosba, gattone jew ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc. tqassmu madwar id- dinja (1978- 2003).
Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a > 99% reduction in the incidence of each of the 3 targeted diseases.
Użu mifrux ta 'skeda ta' tilqim b' 2 dożi fl- Istati Uniti u f' pajjiżi bħalma huma l- Finlandja u l- Iżvezja wassal għal tnaqqis ta '> 99% fl- inċidenza tat- 3 mardiet fil- mira.
Non-pregnant adolescent and adult females Vaccination of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see sections 4.4 and 4.6).
Adoloxxenti u nisa adulti li m’ humiex tqal Tilqim ta ’ adoloxxenti u nisa adulti suxxetibbli li m’ humiex tqal iżda ta ’ età li jista 'jkollhom it- tfal, bil- vaċċin tal- ħosba Ġermaniża tat- tip ħaj attenwat huwa indikat jekk jiġu osservati ċertu prekawzjonijiet.
Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which, in turn, prevents infection of the foetus and consequent congenital rubella injury.
Tilqim fuq nisa suxxetibbli wara l- pubertà jagħti protezzjoni individwali kontra li mara takkwista infezzjoni tal- ħosba Ġermaniża waqt it- tqala, li b' hekk, tipprevjeni milli l- fetu jinfetta ruħu u b’ konsegwenza jseħħ korriment konġenitali bil- ħosba Ġermaniża.
Previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella-containing vaccine (such as M-M-RVAXPRO or a monovalent rubella vaccine) to reduce the risk of exposure of the pregnant woman.
Tfal li qatt ma ġew imlaqqma li għandhom iktar minn 12- il xahar, li huma f’ kuntatt ma ’ nisa tqal suxxettibbli għandhom jieħdu vaċċin tal- ħosba Ġermaniża tat- tip ħaj attenwat (bħal M- M- RVAXPRO jew vaċċin monovalenti tal- ħosba Ġermaniża) biex inaqqsu r- riskju ta ’ espożizzjoni tan- nisa tqal.
Individuals likely to be susceptible to mumps and rubella M-M-RVAXPRO is preferred for vaccination of persons likely to be susceptible to mumps and rubella.
Individwi li hemm ċans li jkunu suxxettibbli għall- gattone u ħosba Ġermaniża M- M- RVAXPRO huwa preferut għat- tilqim ta 'persuni li għandhom ċans kbir li jkunu suxxettibbli għall- gattone u ħosba Ġermaniża.
Individuals who require vaccination against measles can receive M-M-RVAXPRO regardless of their immune status to mumps or rubella if a monovalent measles vaccine is not readily available.
Individwi li għandhom bżonn tilqima kontra l- ħosba jistgħu jieħdu M- M- RVAXPRO mingħajr ma jagħtu kas ta 'l- istatus immuni tagħhom għall- gattone jew ħosba Ġermaniża jekk vaċċin tal- ħosba monovalenti ma jkunx disponibbli.
Evaluation of pharmacokinetic properties is not required for vaccines.
Evalwazzjoni ta ’ karatteristiċi farmakokinetiċi m’ huwiex meħtieġ għal vaċċini.
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 Summary of Product Characteristics.
Tradizzjonalment, ma sarux studji li m' humiex kliniċi, iżda m’ hemm l- ebda tħassib mhux kliniku meqjus relevanti għas- sigurtà klinika iktar mit- tagħrif li ġie inkluż f' sezzjonijiet oħra tas- Sommarju tal- Karatteristiċi tal- Prodott.
Powder Sorbitol Sodium phosphate Potassium phosphate Sucrose Hydrolysed gelatin Medium 199 with Hanks’ salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin
Trab Sorbitol Sodium phosphate Potassium phosphate Sucrose Hydrolysed gelatin Medium 199 b' Hanks ’ salts Minimum Essential Medium, Eagle (MEM)
10 Phenol red Sodium bicarbonate Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH)
9 Monosodium L- glutamate Neomycin Phenol red Sodium bicarbonate Hydrochloric acid (biex jaġġusta l- pH) Sodium hydroxide (biex jaġġusta l- pH)
After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at2°C-8°C.
Wara rikostituzzjoni, il- vaċċin irid jintuża minnufih; madankollu, l- istabbilità waqt l- użu intweriet għal 8 sigħat fi friġġ f’ temperatura ta '2 °C- 8 °C.
Store and transport refrigerated (2°C – 8°C).
Żomm kiesaħ waqt il- ħażna u l- ġarr (2 °C – 8 °C).
Protect from light.
Ipproteġi mid- dawl.
For storage conditions of the reconstituted medicinal product, see section 6.3
Għall- kundizzjonijiet ta ’ ħżin tal- prodott rikostitwit ara s- 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 1) b' tapp (gomma tal- butyl) u solvent f' kunjett (ħġieġ ta ’ Tip 1) b' tapp (gomma tal- chlorobutyl) f’ pakkett ta ’ 1 u 10.
To reconstitute, use the solvent supplied.
Biex tirrikostitwixxi, uża s- solvent ipprovdut miegħu.
The solvent is a clear colourless liquid.
Dan is- solvent huwa likwidu ċar u bla kulur.
Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Qabel ma tħallat mas- solvent, it- trab huwa kejk kristallin kumpatt isfar ċar.
When completely reconstituted, the vaccine is a clear yellow liquid.
Meta jkun rikostiwit għal kollox, il- vaċċin huwa likwidu isfar trasparenti.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
Huwa importanti li tintuża siringa u labra sterelizzata separata għal kull pazjent sabiex tkun impeduta t- trasmissjoni ta 'aġenti t' infezzjoni minn individwu għal ieħor.
Reconstitution instructions
Struzzjonijiet għar- rikostituzzjoni
Withdraw the entire volume of solvent into the syringe to be used for reconstitution.
Iġbed il- volum kollu tas- solvent għal ġos- siringa li tkun se tintuża għar- rikostituzzjoni.
Inject the entire content of the syringe into the vial containing the powder.
Injetta l - kontenut kollu tas- siringa ġol- kunjett li fih it- trab.
Gently agitate to mix thoroughly.
Ħawwad bil- mod biex jitħallat sew.
Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume.
Neħħi l - kontenut kollhu tal- kunjett tal- vaċċin rikostitwit għal ġos- siringa u injetta l- volum kollu.
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Il- vaċċin rikostitwit ma jistax jintuża jekk jidher xi frak jew jekk l- apparenza tas- solvent jew tat- trab jew tal- vaċċin rikostitwit tkun differenti minn kif ġie deskritt hawn fuq.
11 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe.
M- M- RVAXPRO Trab u solvent għal suspensjoni għal injezzjoni f' siringa mimlija għal- lest.
Measles, mumps, and rubella vaccine (live).
Vaċċin tal- ħosba, gattone, u ħosba Ġermaniża (ħaj).
Powder and solvent for suspension for injection in pre-filled syringe.
Trab u solvent għal suspensjoni għal injezzjoni f' siringa mimlija għal- lest.
13 Individuals 12 months or older
Individwi ta ’ 12- il xahar jew akbar
Infants between 6 months and less than 12 months
12 Trabi bejn 6 xhur u iżgħar minn 12- il xahar
14 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 huma immunokompromessi b’ mod gravi li b’ nuqqas ta ’ attenzjoni ġew imlaqqma b’ vaċċin li fih il- ħosba, ġew rappurtati measles inclusion body encephalitis, pnewmonite u riżultati fatali bħala konsegwenza diretta ta ’ tixrid ta ’ l - infezzjoni tal- virus tal- vaċċin tal- ħosba.
Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions.
13 Adulti u adoloxxenti bi storja ta ’ allerġiji jistgħu potenzjalment ikunu f’ riskju akbar ta ’ anafilassi jew ta ’ reazzjonijiet anafilaktojde.
Therefore caution needs to be exercised when using any product containing rHA in individuals who previously showed signs of hypersensitivity to rHA.
Għalhekk għandha tingħata kull attenzjoni dovuta meta jintuża kwalunkwe prodott li fih rHA f’ individwi li xi darba wrew sensittività eċċessiva għal rHA.
15 Other Individuals who are known to be infected with human immunodeficiency viruses and are not immunocompromised may be vaccinated.
Oħrajn Individwi magħrufin li huma nfettati bl- HIV u li m’ humiex immunokompromessi jistgħu jiġu imlaqqma.
There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
M’ hemmx evidenza kkonfermata li tindika li virus bħal dan huwa trasmess lil persuni suxxettibbli li jiġu f’ kuntatt ma ’ individwi mlaqqma.
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).
14 personali, għalkemm aċċettata bħala possibilità teoretika, m' hijiex meqjusa bħala riskju sinifikanti; madankollu, it- trasmissjoni tal- virus tal- vaċċin tal- ħosba Ġermaniża lil trabi mill- ħalib tas- sider ġiet dokumentata mingħajr evidenza ta ’ mard kliniku (ara sezzjoni 4. 6).
16 and rubella vaccine manufactured by Merck & Co., Inc., experience with this vaccine can be considered.
Iżda, minħabba li ntwera li M- M- RVAXPRO għandu profili ta 'sigurtà u ta' immuniġeniċità li huma simili ħafna għall- formolazzjoni preċedenti tal- vaċċin kombinat tal- ħosba, gattone u ħosba Ġermaniża mmanifatturat minn Merck & Co., Inc., esperjenza b’ dan il- vaċċin tista ’ tiġi kkunsidrata.
There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy.
15 adekwati fuq ir- razza attenwata tal- virus tal- ħosba fi tqala.
17 although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Il- profil ġenerali tas- sigurtà taż- żewġ rotot ta ’ amministrazzjoni kienu komparabbli, għalkemm ir- reazzjonijiet tal- post ta ’ l- injezzjoni kienu inqas frekwenti fil- grupp IM (15. 8%) meta mqabbla ma ’ dawk tal- grupp SC (25. 8%).
In comparison to the first dose, a second dose of M-M-RVAXPRO is not associated with an increase in the incidence and severity of clinical symptoms including those suggestive of hypersensitivity reaction.
Meta mqabbla ma ’ l- ewwel doża, it- tieni doża ta ’ M- M- RVAXPRO mhijiex assoċjata ma ’ żieda fl - inċidenza u s- severità ta ’ sintomi kliniċi fosthom dawk li jisuġġerixxu reazzjoni ta ’ sensittività eċċessiva.
Infections and infestations Uncommon: nasopharyngitis, upper respiratory tract infection or viral infection Not known: aseptic meningitis (see below), atypical measles, epididymitis, orchitis, otitis media, parotitis, rhinitis, subacute sclerosing panencephalitis (see below)
Infezzjonijiet u infestazzjonijiet Mhux komuni: rinofarinġite, infezzjoni fil- parti ta 'fuq ta' l- apparat respiratorju jew infezzjoni virali Mhux magħruf: meninġite asettika (ara taħt), ħożba atipika, epididimite, orkite, otite tal- widna tan - nofs, parotite, rinite, panenċefalite bi sclerosing subakut (ara taħt)
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 tipi oħra ta 'vaċċin kontra l- ħosba u l- meninġite asettika, m' hemmx evidenza li torbot il- vaċċin kontra l- ħosba Jeryl Lynn™ mal- meninġite asettika.
Blood and the lymphatic system disorders Not known: regional lymphadenopathy, thrombocytopenia
16 Disturbi tad- demm u tas- sistema limfatika Mhux magħruf: limfadenopatija reġjonali, tromboċitopenja
18 no case has it been shown conclusively that reactions were actually caused by vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines.
Fl- ebda każ ma ntwera b' mod konklużiv li r - reazzjonijiet fil- fatt kienu kkawżati mill- vaċċin; madankollu, id- data tissuġġerixxi l- possibilità li xi wħud minn dawn il- każijiet setgħu kienu kkawżati mill- vaċċini tal- ħosba.
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 sex, being greatest in adult females and least in prepubertal children.
17 L- artralġja u/ jew l- artrite (ġeneralment għaddiena u rarament kroniċi), u l- polinevrite huma karatteristiċi ta 'infezzjoni b' rubella wild- type u jvarjaw fil- frekwenza u s- severità ma' l- età u s- sess tal - persuna, l- akbar ikunu f' nisa adulti u l- anqas ikunu fi tfal ta 'qabel il- pubertà.
19 General disorders and administration site conditions Very common: fever (38.5°C or higher), injection site erythema, injection site pain, and injection site swelling Common: injection site bruising Uncommon: injection site rash Not known: burning and/ or stinging of short duration at the injection site, fever (38.5°C or higher), malaise, papillitis, peripheral oedema, swelling, tenderness, vesicles at the injection site, wheal and flare at the injection site
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata Komuni ħafna: deni (38. 5°C jew ogħla), eritema fil- post ta' l- injezzjoni, uġigħ fil- post ta 'l- injezzjoni, u nefħa fil- post ta' l- injezzjoni Komuni: tbenġil fil- post ta 'l- injezzjoni Mhux komuni: raxx fil- post ta' l- injezzjoni Mhux magħruf: ħruq u/ jew tingiż li ma tantx idum fil- post ta 'l- injezzjoni, deni (38. 5°C jew ogħla), malesseri, papillite, edema periferali, nefħa, sensittività, infafet fil- post ta' l- injezzjoni, tbenġil u nirien fil- post ta 'l- injezzjoni
Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Evalwazzjoni ta ’ i- immunoġeniċità u ta 'l- effikaċja klinika Studju komparattiv f’ 1279 persuna li rċevew M- M- RVAXPRO jew il- formolazzjoni preċedenti (mmanifatturata minn albumina tas- serum uman) tal- ħosba, gattone jew ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc. wera immunoġeniċità u sigurtà simili bejn iż- żewġ prodotti.
20 Effectiveness More than 400 million doses of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2003).
Effettività Iktar minn 400 miljun doża tal- formolazzjoni preċedenti tal- ħosba, gattone jew ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc. tqassmu madwar id- dinja (1978- 2003).
21 Phenol red Sodium bicarbonate Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH)
19 Monosodium L- glutamate Neomycin Phenol red Sodium bicarbonate Hydrochloric acid (biex jaġġusta l- pH) Sodium hydroxide (biex jaġġusta l- pH)
After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at 2°C-8°C.
Wara rikostituzzjoni, il- vaċċin irid jintuża minnufih; madankollu, l- istabbilità waqt l- użu intweriet għal 8 sigħat fi friġġ f’ temperatura ta '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 1) b' tapp (gomma tal- butyl) u solvent f' siringa mimlija għal- lest (Ħġieġ ta' Tip 1) b' labra mwaħħla u bi plunger stopper (gomma tal- chlorobutyl) u għata għal- labra (gomma naturali) f' pakkett ta '1 u ta' 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 pack size 1, 10, and 20.
Trab f' kunjett (Ħġieġ ta 'Tip 1) b' tapp (gomma tal- butyl) u solvent f' siringa mimlija għal- lest (Ħġieġ ta' Tip 1) bi plunger stopper u b' għata għall- ponta (gomma tal- chlorobutyl), mingħajr labra, f' pakkett ta '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 pack size 1, 10 and 20.
Trab f' kunjett (Ħġieġ ta 'Tip 1) b' tapp (gomma tal- butyl) u solvent f' siringa mimlija għal- lest (Ħġieġ ta' Tip 1) bi plunger stopper u b' għata għall- ponta (gomma tal- chlorobutyl), b' labra waħda jew b' żewġ labriet imwaħħlin, f' pakkett ta '1, 10 u 20.
22 Reconstitution instructions
Struzzjonijiet għar- rikostituzzjoni
Inject the entire content of the syringe into the vial containing the powder.
Injetta l- kontenut kollu tas- siringa ġol- kunjett li fih it- trab.
Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume.
Neħħi l- kontenut kollhu tal- kunjett tal- vaċċin rikostitwit għal ġos- siringa u injetta l- volum kollu.
IThe reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
20 Il- vaċċin rikostitwit ma jistax jintuża jekk jidher xi frak jew jekk l- apparenza tas- solvent jew tat- trab jew tal- vaċċin rikostitwit tkun differenti minn kif ġie deskritt hawn fuq.
23 ANNEX II
21 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Waarderweg 39 2031 BN Haarlem The Netherlands
Waarderweg 39 2031 BN Haarlem L- Olanda
Not aplicable.
Ma jgħoddx f' dan il- każ.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ KE kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
25 ANNEX III
23 ANNESS III
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
M- M- RVAXPRO - Trab f' kunjett u solvent f' kunjett - Pakkett ta '1, 10
M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps, and rubella vaccine (live)
M- M- RVAXPRO Trab u solvent għal suspensjoni għall- injezzjoni Vaċċin tal- ħosba, gattone, u ħosba Ġermaniża (ħaj).
Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/ 3 strain (live attenuated)
Wara rikostituzzjoni, doża waħda (0. 5 ml) fiha: mhux inqas minn 1x103 CCID50 * Razza tal- virus tal- ħosba Enders ’ Edmonston (ħaj, attenwat) Razza tal- virus tal- gattone Jeryl Lynn™ [Livell B] (tat- tip ħaj, attenwat) mhux inqas minn 12. 5x103 CCID50 * mhux inqas minn 1 x103 CCID50 * Virus tar- rubella razza Wistar RA 27/ 3 (ħaj, attenwat)
* 50% cell culture infectious dose
* 50% doża infettuża ta 'kultura taċ- ċelloli
Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid, sodium hydroxide and water for injections.
Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 b' Hanks ’ salts, MEM, monosodium L- glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid, sodium hydroxide u ilma għall- injezzjonijiet.
Powder and solvent for suspension for injection One single dose vial (powder) and one single dose vial (solvent).
Trab u solvent għal suspensjoni għall- injezzjoni Kunjett ta 'doża waħda (trab) u kunjett ta' doża waħda (solvent).
10 single dose vials (powder) and 10 single dose vials (solvent).
10 kunjetti ta 'dożi waħda (trab) u 10 kunjetti ta' doża waħda (solvent).
Intramuscular (IM) or subcutaneous (SC) use.
Użu ġol- muskoli (IM) jew taħt il- ġilda (SC).
Store and transport refrigerated (2°C-8°C) Do not freeze Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator
Żomm kiesaħ waqt il- ħażna u l- ġarr (2 °C– 8 °C) Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta 'barra biex tilqa' mid- dawl Wara rikostituzzjoni, uża minnufih jew fi żmien 8 sigħat jekk maħżun fi friġġ
Please read the package leaflet for disposal of medicines no longer required
Jekk jogħġbok aqra l- fuljett tal- pakkett dwar kif għandek tarmi l- mediċini li mhumiex aktar meħtieġa
EU/ 1/ 06/ 337/ 001 – pack of 1 EU/ 1/ 06/ 337/ 002 – pack of 10
EU/ 1/ 06/ 337/ 001 – pakkett ta '1 EU/ 1/ 06/ 337/ 002 – pakkett ta' 10
INSTRUCTIONS IN USE
STRUZZJONIJIET DWAR L- UŻU
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL OF POWDER
KUNJETT TA 'TRAB
M-M-RVAXPRO Powder for suspension for injection.
M- M- RVAXPRO Trab għal suspensjoni għall- injezzjoni.
IM or SC use
Użu IM jew SC
1 dose
doża 1
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL OF SOLVENT
KUNJETT TA 'SOLVENT
Solvent for M-M-RVAXPRO Water for injections
Solvent għal M- M- RVAXPRO Ilma għall- injezzjonijiet
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe with attached needle - Pack of 1, 10
M- M- RVAXPRO - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' labra mwaħħla - Pakkett ta '1, 10
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)
M- M- RVAXPRO Trab u solvent għal suspensjoni għal injezzjoni f' siringa mimlija għal- lest Vaċċin tal- ħosba, gattone, u ħosba Ġermaniża (ħaj)
*50% cell culture infectious dose
* 50% doża infettuża ta 'kultura taċ- ċelloli
Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid, sodium hydroxide and water for injections.
Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 b' Hanks ’ salts, MEM, monosodium L- glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid, sodium hydroxide u ilma għall- injezzjonijiet.
Powder and solvent for suspension for injection in pre-filled syringe One single dose vial (powder) and one single dose prefilled syringe with attached needle (solvent).
Trab u solvent għal suspensjoni għal injezzjoni f' siringa mimlija għal- lest Kunjett wieħed ta 'doża waħda (trab) u siringa ta' doża waħda mimlija għal- lest bil- labra mwaħħla (solvent).
10 single dose vials (powder) and 10 single dose prefilled syringes with attached needle (solvent).
10 kunjetti ta 'doża waħda (trab) u 10 siringi ta' doża waħda mimlija għal- lest bil- labra mwaħħla (solvent).
Intramuscular (IM) or subcutaneous (SC) use.
Jingħata ġol- muskoli (IM) jew taħt il- ġilda (SC).
Store and transport refrigerated (2°C-8°C) Do not freeze Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator
Żomm kiesaħ waqt il- ħażna u l- ġarr (2 °C – 8 °C) Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta 'barra biex tilqa' mid- dawl Wara rikostituzzjoni, uża minnufih jew fi żmien 8 sigħat jekk maħżun fi friġġ
EU/ 1/ 06/ 337/ 003 – pack of 1 EU/ 1/ 06/ 337/ 004 – pack of 10
EU/ 1/ 06/ 337/ 003 – pakkett ta '1 EU/ 1/ 06/ 337/ 004 – pakkett ta' 10
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe without needle - Pack of 1, 10, 20
M- M- RVAXPRO - Trab f' kunjett u solvent f' siringa mimlija għal- lest mingħajr labra - Pakkett ta '1, 10, 20
Powder and solvent for suspension for injection in pre-filled syringe One single dose vial (powder) and one single dose prefilled syringe without needle (solvent).
Trab u solvent għal suspensjoni għal injezzjoni f' siringa mimlija għal- lest Kunjett wieħed ta 'doża waħda (trab) u siringa ta' doża waħda mimlija għal- lest mingħajr labra (solvent).
10 single dose vials (powder) and 10 single dose prefilled syringes without needle (solvent).
10 kunjetti ta 'doża waħda (trab) u 10 siringi ta' doża waħda mimlija għal- lest mingħajr labra (solvent).
20 single dose vials (powder) and 20 single dose prefilled syringes without needle (solvent).
20 kunjett ta 'doża waħda (trab) u 20 siringa ta' doża waħda mimlija għal- lest mingħajr labra (solvent).
Please 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/ 06/ 337/ 005 – pack of 1 EU/ 1/ 06/ 337/ 006 – pack of 10 EU/ 1/ 06/ 337/ 007 – pack of 20
EU/ 1/ 06/ 337/ 005 – pakkett ta '1 EU/ 1/ 06/ 337/ 006 – pakkett ta' 10 EU/ 1/ 06/ 337/ 007 – pakkett ta '20
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needle – Pack of 1, 10, 20
M- M- RVAXPRO - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' labra waħda mhux imwaħħla - Pakkett ta '1, 10, 20
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)
M- M- RVAXPRO Trab u solvent għal suspensjoni għall- injezzjoni f' siringa mimlija għal- lest Vaċċin tal- ħosba, gattone, u ħosba Ġermaniża (ħaj).
Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/ 3 strain (live attenuated)
Wara rikostituzzjoni, doża waħda (0. 5 ml) fiha: mhux inqas minn 1x103 CCID50 * Razza tal- virus tal- ħosba Enders ’ Edmonston (ħaj, attenwat) Razza tal- virus tal- gattone Jeryl Lynn™ [Livell B] (tat- tip ħaj, attenwat) mhux inqas minn 12. 5x103 CCID50 * mhux inqas minn 1 x103 CCID50 * Virus tar- rubella razza Wistar RA 27/ 3, (ħaj, attenwat)
Powder and solvent for suspension for injection in pre-filled syringe One single dose vial (powder) and one single dose prefilled syringe with one unattached needle (solvent).
Trab u solvent għal suspensjoni għal injezzjoni f' siringa mimlija għal- lest Kunjett wieħed ta 'doża waħda (trab) u siringa ta' doża waħda mimlija għal- lest b' labra waħda mhux imwaħħla (solvent).
10 single dose vials (powder) and 10 single dose prefilled syringes with one unattached needle (solvent).
10 kunjetti ta 'doża waħda (trab) u 10 siringi ta' doża waħda mimlija għal- lest b' labra waħda mhux imwaħħla (solvent).
20 single dose vials (powder) and 20 single dose prefilled syringes with one unattached needle (solvent).
20 kunjett ta 'doża waħda (trab) u 20 siringa ta' doża waħda mimlija għal- lest b' labra waħda mhux imwaħħla (solvent).
EU/ 1/ 06/ 337/ 008 – pack of 1 EU/ 1/ 06/ 337/ 009 – pack of 10 EU/ 1/ 06/ 337/ 010 – pack of 20
EU/ 1/ 06/ 337/ 008 – pakkett ta '1 EU/ 1/ 06/ 337/ 009 – pakkett ta' 10 EU/ 1/ 06/ 337/ 010 – pakkett ta '20
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needles - Pack of 1, 10, 20
M- M- RVAXPRO - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' żewġ labriet mhux imwaħħlin - Pakkett ta '1, 10, 20
Powder and solvent for suspension for injection in pre-filled syringe One single dose vial (powder) and one single dose prefilled syringe with two unattached needles (solvent).
Trab u solvent għal suspensjoni għal injezzjoni f' siringa mimlija għal- lest Kunjett wieħed ta 'doża waħda (trab) u siringa ta' doża waħda mimlija għal- lest b' żewġ labriet mhux imwaħħla (solvent).
10 single dose vials (powder) and 10 single dose pre-filled syringes with two unattached needles (solvent).
10 kunjetti ta 'doża waħda (trab) u 10 siringi ta' doża waħda mimlija għal- lest b' żewġ labriet mhux imwaħħla (solvent).
20 single dose vials (powder) and 20 single dose pre-filled syringes with two unattached needles (solvent).
20 kunjett ta 'doża waħda (trab) u 20 siringa ta' doża waħda mimlija għal- lest b' żewġ labriet mhux imwaħħla (solvent).
EU/ 1/ 06/ 337/ 011 – pack of 1 EU/ 1/ 06/ 337/ 012 – pack of 10 EU/ 1/ 06/ 337/ 013 – pack of 20
EU/ 1/ 06/ 337/ 011 – pakkett ta '1 EU/ 1/ 06/ 337/ 012 – pakkett ta' 10 EU/ 1/ 06/ 337/ 013 – pakkett ta '20
44 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
M-M-RVAXPRO Powder for suspension for injection in pre-filled syringe
M- M- RVAXPRO Trab għal suspensjoni għall- injezzjoni f' siringa mimlija għal- lest
45 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN