FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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 individwali.
English: M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA M-M-RVAXPRO - Trab f'kunjett u solvent f'kunjett - Pakkett ta' 1, 10
English: 2 Wistar RA 27/3 strain (live, attenuated) ……………….….not less than 1x10 3 CCID50*
Maltese: Razza tal-virus2 ħosba Ġermaniża Wistar RA 27/3 (tat-tip ħaj, attenwat) ............... mhux inqas minn 1x103 CCID50*
English: 1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x10 3 CCID50*
Maltese: Razza tal-virus1 tal-gattone Jeryl Lynn™ [Livell B] (tat-tip ħaj, attenwat) ............. mhux inqas minn 12.5x103 CCID50*
English: The conclusion of the MAH is not endorsed by the PRAC.
Maltese: Il-konklużjoni tal-MAH mhijiex approvata mill-PRAC.
English: The most common adverse reactions reported with the use of M-M-RVAXPRO were: fever (38.5°C or higher); injection site reactions including pain, swelling and erythema.
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati bl-użu ta' M-M-RVAXPRO kienu: deni (38.5°C jew ogħla); reazzjonijiet fis-sit tal-injezzjoni li jinkludu wġigħ, nefħa u eritema.
English: In a clinical trial, 752 children received M-M-RVAXPRO, either intramuscularly or subcutaneously.
Maltese: Fi prova klinika, 752 tifel u tifla rċevew M-M-RVAXPRO, jew ġol-muskoli jew taħt il-ġilda.
English: 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.
Maltese: 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.
English: 3 CCID50* Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) not less than 12,5 x10
Maltese: Razza tal-virus tal-gattone Jeryl Lynn™ [Livell B] (tat-tip ħaj, attenwat) mhux inqas minn 12.5x103 CCID50*
English: EU/1/06/337/011 - pack of 1 EU/1/06/337/012 - pack of 10 EU/1/06/337/013 - pack of 20
Maltese: EU/1/06/337/011 EU/1/06/337/012 EU/1/06/337/013
English: Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions.
Maltese: Adulti u adoloxxenti bi storja ta' allerġiji jistgħu potenzjalment ikunu f'riskju akbar ta' anafilassi jew ta' reazzjonijiet anafilaktojde.
English: • Swollen lymph nodes.
Maltese: • Tħossok imdardar (nawsja).
English: Solvent for M-M-RVAXPRO
Maltese: Mediċini oħra u M-M-RVAXPRO
English: • Rash (including measles-like rash).
Maltese: • Raxx (li jinkludi raxx bħal tal-ħosba).
English: In addition and as previously underlined from the first of June 2010 until the fifth of February 2016, the Dutch Pharmacovigilance Center (Lareb) received 327 reports of MedDRA® Preferred Term (PT) ‘Crying' (preferred term) following immunization with the MMR vaccine.
Maltese: Barra minn hekk u kif kien enfasizzat qabel mill-ewwel ta' Ġunju 2010 sal-ħamsa ta' Frar 2016, iċĊentru Olandiż tal-Farmakoviġilanza (Lareb) irċieva 327 rapport tat-Terminu Ppreferut (PTPreferred Term) ta' MedDRA® ‘Biki' (terminu ppreferut) wara tilqim bil-vaċċin tal-MMR. Lesponiment kien stmat bħala 171,000 tarbija fis-sena.
English: Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose A clinical study was conducted with the quadrivalent measles, mumps, rubella and varicella vaccine manufactured by Merck & Co., Inc., administered with a 2-dose schedule, the doses being given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose.
Maltese: Stima tal-immunoġeniċità fi tfal li kellhom minn 9 xhur sa 12-il xahar meta ngħatat l-ewwel doża Sar studju kliniku bit-tilqima kwadrivalenti tal-ħosba, il-gattone, il-ħosba Ġermaniża u l-ġidri r-riħ mmanifatturata minn Merck & Co., Inc., mogħtija bi skeda ta' żewġ dożi, bid-dożi mogħtija tlett xhur bogħod minn xulxin f'1,620 individwu b'saħħtu li kellhom minn 9 xhur sa 12-il xahar meta ngħatat lewwel doża.
English: After reconstitution,1 dose (0.5 ml) contains: Measles virus Enders' Edmonston strain (live attenuated)
Maltese: Razza tal-virus tal-ħosba Enders' Edmonston (ħaj, attenwat)
English: • An illness consisting of muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body (Guillain-Barré syndrome).
Maltese: • Marda li tikkonsisti fi dgħufija fil-muskoli, sensazzjonijiet mhux normali, tingiż fid-dirgħajn, fir-riġlejn, u fil-parti ta' fuq tal-ġisem (Sindrome ta' Guillain-Barré).
English: Excipients with known effect:
Maltese: Twissijiet u prekawzjonijiet:
English: 1 Enders' Edmonston strain (live, attenuated) ………...…….not less than 1x10 3 CCID50*
Maltese: Razza tal-virus1 tal-ħosba Enders' Edmonston (tat-tip ħaj, attenwat) ...................... mhux inqas minn 1x103 CCID50*
English: 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 (see section 4.3); disseminated mumps and rubella vaccine virus infection has also been reported.
Maltese: F'individwi immunokompromessi b'mod sever li bi żball ġew imlaqqma b'tilqima li kien fiha l-ħosba, ġew irrappurtati, enċefalite b'inclusion body mill-ħosba, pnewmonite, u riżultat fatali bħala konsegwenza diretta ta' infezzjoni mifruxa bil-virus tal-ħosba tal-vaċċin (ara sezzjoni 4.3); ġiet irrappurtata ukoll infezzjoni mifruxa bil-virus tal-gattone u tal-ħosba Ġermaniża tal-vaċċin.
English: After 2 doses, the seroprotection rates against measles were 98.1% when the first dose was given at 11 months compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective met).
Maltese: Wara 2 dożi, irrati ta' seroprotezzjoni kontra l-ħosba kienu ta' 98.1% meta l-ewwel doża ngħatat fl-età ta' 11-il xahar meta mqabbel ma' 98.9% meta l-ewwel doża ngħatat fl-età ta' 12-il xahar (l-iskop ta' non-inferjorità tal-istudju ntlaħaq).
English: Infants from 9 to 12 months of age vaccinated with a measles-containing vaccine during measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin and/or immaturity of the immune system (see sections 4.2 and 5.1).
Maltese: Trabi li għandhom minn 9 xhur sa 12-il xahar imlaqqma b'tilqima li fiha l-ħosba waqt tifqigħat talħosba jew għal raġunijiet oħra jistgħu ma jirrispondux għall-vaċċin minħabba l-preżenza ta' antikorpi ta' oriġini materna li jkunu qed jiċċirkolaw f'dan iż-żmien u/jew immaturità tas-sistema immuni (ara sezzjonijiet 4.2 u 5.1).
English: Gently agitate to mix thoroughly.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: Warnings and precautions Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have experienced any of the following: - If you or your child have an allergic reaction to eggs or anything that contained egg - If you or your child have a history or family history of allergies or of convulsions (fits) - If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising or bleeding for longer than usual - If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease.
Maltese: - Jekk inti jew it-tifel/tifla tiegħek għandkom reazzjoni għall-bajd jew għal xi ħaġa li fiha l-bajd - Jekk inti jew it-tifel/tifla tiegħek għandkom storja jew storja familjari ta' allerġiji jew ta' konvulżjoni/aċċessjoni (fits) - Jekk inti jew it-tifel/tifla tiegħek għandkom xi effett sekondarju wara t-tilqima bil-ħosba, gattone, jew ħosba Ġermaniża (f'tilqima singola jew f'tilqima kombinata, bħat-tilqima kontra lħosba, il-gattone u l-ħosba Ġermaniża immanifatturata minn Merck & Co., Inc., jew M-MRVAXPRO) li jinvolvi tbenġil malajr jew fsad itwal min-normal - Jekk inti jew it-tifel/tifla tiegħek intom infettati bl-HIV iżda ma turux sintomi tal-marda talHIV.
English: • Injection-site bruising.
Maltese: • Tbenġil fis-sit tal-injezzjoni.
English: Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 2 needles.
Maltese: Trab u solvent għal suspensjoni għal injezzjoni f'siringa mimlija għal-lest Kunjett 1 b'doża waħda (trab) + siringa 1 mimlija għal-lest (solvent) + 2 labriet.
English: Table 1: Seroprotection Rates to Measles, Mumps, and Rubella 6 Weeks Post-Dose 1 and 6 Weeks Post-Dose 2 of the quadrivalent measles, mumps, rubella and varicella vaccine manufactured by Merck & Co., Inc. - Full Analysis Set
Maltese: Tabella 1: Rati ta' Seroprotezzjon għall-Ħosba, il-Gattone u l-Ħosba Ġermaniża 6 Ġimgħat wara lEwwel Doża u 6 Ġimgħat wara t-Tieni Doża tat-tilqima kwadrivalenti tal-Ħosba, il-Gattone, il-Ħosba Ġermaniża u l-Ġidri r-riħ mmanifatturata minn Merck & Co., Inc.
English: M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).
Maltese: M-M-RVAXPRO m'huwiex kontra indikat f'individwi li qed jieħdu corticosteroids topikali jew inkella f'doża baxxa parenterali (e.ż. għal profilassi ta' l-ażma jew terapija ta' sostituzzjoni).
English: • Itching; inflammation of the fatty tissue under the skin; red or purple, flat, pinhead spots under the skin; hardened, raised area of the skin; serious illness with ulcers or blistering of the skin, mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Maltese: • Ħakk; infjammazzjoni tat-tessut xaħmi ta' taħt il-ġilda; ponot ħomor jew vjola, ċatti, daqs ras ta' labra taħt il-ġilda; roqgħa ta' ġilda iebsa u mqabbża; marda serja bl-ulċeri jew nfafet fil-ġilda, fil-ħalq, flgħajnejn, u/jew fil-ġenitali (sindrome ta' Stevens-Johnson).
English: The powder is a light yellow compact crystalline cake.
Maltese: It-trab huwa kejk kristallin kumpatt isfar ċar.
English: 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.
Maltese: M'hemmx evidenza kkonfermata li tindika li virus bħal dan huwa trasmess lil persuni suxxettibbli li jiġu f'kuntatt ma' individwi mlaqqma.
English: Powder and solvent for suspension for injection 1 single dose vial (powder) + 1 vial (solvent).
Maltese: U KONTENUT Trab u solvent għal suspensjoni għall-injezzjoni Kunjett 1 b'doża waħda (trab) + kunjett 1 (solvent).
English: General disorders and administration site conditions Fever (38.5°C or higher), Injection site erythema,
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Deni (38.5°C jew ogħla), Eritema fis-sit tal-injezzjoni, Uġigħ fis-sit talinjezzjoni, u Nefħa fis-sit tal-injezzjoni
English: What M-M-RVAXPRO looks like and contents of the pack
Maltese: Kif jidher M-M-RVAXPRO u l-kontenut tal-pakkett
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in pack size 1, 10, and 20.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (gomma tal-butyl) u solvent f'siringa mimlija għal-lest (ħġieġ) bi plunger stopper (gomma tal-chlorobutyl) u b'għata għall-ponta (gomma tal-styrene-butadiene) mingħajr labra, f'pakkett ta' 1, 10 u 20.
English: All adverse reactions were evaluated in 1940 children.
Maltese: Ir-reazzjonijiet mhux mixtieqa ġew evalwati fl-1940 tifel u tifla.
English: *These side effects were reported with the use of M-M-RVAXPRO or with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or with its monovalent (single) components, during post-marketing use and/or during clinical studies.
Maltese: *Dawn l-effetti sekondarji kienu rrappurtati bl-użu ta' M-M-RVAXPRO jew bit-tilqima tal-ħosba, talgattone, u tal-ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc., jew bil-komponenti monovalenti (waħedhom) tagħha, waqt l-użu ta' wara t-tqegħid fis-suq u/jew waqt l-istudji kliniċi.
English: • Injection-site rash.
Maltese: • Raxx fis-sit tal-injezzjoni.
English: 20 single dose vials (powder) + 20 prefilled syringes (solvent) + 20 needles.
Maltese: 10 kunjetti b'doża waħda (trab) + 10 siringi mimlija għal-lest (solvent) + 20 labra . 20 kunjett b'doża waħda (trab) + 20 siringa mimlija għal-lest (solvent) + 40 labra.
English: Administration of immune globulins concomitantly with M-M-RVAXPRO may interfere with the expected immune response.
Maltese: L-għoti ta' immune globulins flimkien ma' M-M-RVAXPRO jista' jinterferixxi mar-rispons t'immunità mistenni.
English: Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema
Maltese: Reazzjoni anafilaktojd, Anafilassi u fenomeni marbuta miegħu bħal Edima anġjonewrotika, Edima fil-wiċċ, u Edima periferali
English: • Injection-site redness; injection-site pain; injection-site swelling.
Maltese: • Infjammazzjoni tar-retina (ġol-għajn) b'tibdiliet fil-vista.
English: M-M-RVAXPRO may be given with Prevenar and/or hepatitis A vaccine at the same visit at a separate injection site (e.g. the other arm or leg).
Maltese: M-M-RVAXPRO jista' jingħata ma' Prevenar u/jew mal-vaċċin tal-epatite A fl-istess vista f'sit talinjezzjoni differenti (eż. fid-driegħ jew fir-riġel l-ieħor).
English: Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin.
Maltese: It-tilqima trid tiġi posposta għal ta' l-inqas 3 xhur wara trasfużjoni tad-demm jew plasma, jew għoti ta' serum immune globulin uman.
English: 10 single dose vials (powder) + 10 pre-filled syringes (solvent) + 20 needles.
Maltese: 10 kunjetti b'doża waħda (trab) + 10 siringi mimlija għal-lest (solvent) + 10 labriet. 20 kunjett b'doża waħda (trab) + 20 siringa mimlija għal-lest (solvent) + 20 labra.
English: Time point
Maltese: TIKKETTAR
English: Store and transport refrigerated (2°C - 8°C).
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2 °C - 8 °C).
English: How to use M-M-RVAXPRO
Maltese: M-M-RVAXPRO
English: Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 1 needle.
Maltese: Trab u solvent għal suspensjoni għal injezzjoni f'siringa mimlija għal-lest Kunjett 1 b'doża waħda (trab) + siringa 1 mimlija għal-lest (solvent) + labra 1.
English: 1 Enders' Edmonston strain (live, attenuated) ……….not less than 1x10 3 CCID50*
Maltese: Razza tal-virus tal-ħosba Enders' Edmonston (ħaj, attenwat) mhux inqas minn 1x103 CCID50*
English: 10 single dose vials (powder) + 10 prefilled syringes (solvent) + 10 needles.
Maltese: 10 kunjetti b'doża waħda (trab) + 10 siringi mimlija għal-lest (solvent) bil-labra.
English: 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.
Maltese: 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.
English: Powder and solvent for suspension for injection.
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni
English: EU/1/06/337/001 - pack of 1 EU/1/06/337/002 - pack of 10
Maltese: EU/1/06/337/002 - pakkett ta' 10
English: Additionally, other adverse reactions 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 in section b. The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Maltese: Barra minn hekk, reazzjonijiet 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 filqosor f'sezzjoni b.
English: Infants between 9 and 12 months of age:
Maltese: Trabi li għandhom bejn 9 xhur u 12-il xahar:
English: Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Maltese: L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (biex jaġġusta l-pH), u sodium hydroxide (biex jaġġusta l-pH)
English: 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).
Maltese: B'konsegwenza ta' dan, trasmissjoni minħabba kuntatt 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).
English: Among these children, the vaccine-related adverse reactions, summarised in section b, were observed in individuals following vaccination with M-M-RVAXPRO (excluding isolated reports with frequency <0.2%).
Maltese: Fost dawn it-tfal, ir-reazzjonijiet avversi marbuta mat-tilqima, miġbura fil-qosor f'sezzjoni b, ġew osservati f'individwi wara tilqima b'M-M-RVAXPRO (rapporti iżolati bi frekwenza < 0.2 % ma ġewx ikkunsidrati).
English: EU/1/06/337/003 - pack of 1 EU/1/06/337/004 - pack of 10
Maltese: EU/1/06/337/004 - pakkett ta' 10
English: How to store M-M-RVAXPRO
Maltese: X'fih M-M-RVAXPRO
English: • Whenever the risk management system is modified , especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata, speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: • Nasal congestion and sore throat; upper respiratory tract infection or viral infection; runny nose.
Maltese: • Ħmura fis-sit tal-injezzjoni; uġigħ fis-sit tal-injezzjoni; nefħa fis-sit tal-injezzjoni.
English: After two doses, the seroprotection rates against measles were 94.6% when the first dose was given at 9 months compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective not met).
Maltese: 6% meta lewwel doża ngħatat fl-età ta' 9 xhur meta mqabbla ma' 98.9% meta l-ewwel doza ingħatat fl-età ta' 12-il xahar (l-iskop ta' non-inferjorità tal-istudju ma ntlaħaqx).
English: Encephalitis and Encephalopathy
Maltese: Enċefalite u Enċefalopatija
English: Blood and the lymphatic system disorders Regional lymphadenopathy, Thrombocytopenia
Maltese: Limfadenopatija lokali, Tromboċitopenija
English: The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases (see section 4.8).
Maltese: Il-proporzjoni bejn ir-riskju u l-benefiċċju għandu jiġi evalwat sew qabel ma tiġi kkunsidrata tilqima f'dawn il-każijiet (ara sezzjoni 4.8).
English: M-M-RVAXPRO powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)
Maltese: M-M-RVAXPRO trab u solvent għal suspensjoni għall-injezzjoni Vaċċin tal-ħosba, gattone, u ħosba Ġermaniża (ħaj)
English: Dose 1 at 11 months / Dose 2 at 14 months N = 480
Maltese: L-ewwel doża fl-età ta'11-il xahar/ Ittieni doża fl-età ta' 14-il xahar
English: • Discharge and itching of the eyes with crusting of eyelids (conjunctivitis).
Maltese: • Tnixxija u ħakk fl-għajnejn bi qxur f'tebqet l-għajn (konġuntivite).
English: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Maltese: It-tilqim jista' jiġi kkunsidrat f'pazjenti b'defiċjenzi immuni magħżula fejn il-benefiċċji jkunu aktar mir-riskji (pazjenti bl-HIV mingħajr sintomi, defiċjenzi tas-sottoklassi
English: M-M-RVAXPRO powder and solvent for suspension for injection Measles, mumps, and rubella vaccine (live)
Maltese: M-M-RVAXPRO Trab u solvent għal suspensjoni għal injezzjoni Vaċċin tal-ħosba, gattone u ħosba Ġermaniża (ħaj)
English: VIAL OF POWDER
Maltese: Tilqim wara espożizzjoni
English: In addition, individuals who experienced thrombocytopenia with the first dose of M-M-RVAXPRO (or its component vaccines) may develop thrombocytopenia with repeat doses.
Maltese: It-tilqima jista' jkun fiha traċċi ta' albumina rikombinanti umana (rHA) Din it-tilqima fiha traċċi ta' neomycin.
English: One dose is given at an elected date usually from 12 months of age.
Maltese: Tingħata doża waħda f'data magħżula, normalment mill-età ta' 12-il xahar.
English: Vascular disorders Vasculitis
Maltese: TWISSIJA(IET) SPEĊJALI
English: The general safety profile of either administration routes were comparable, although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Maltese: 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.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for measles / mumps / rubella vaccines (live, attenuated), the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għat-tilqim tal-ħosba / gattone / rubella (ħaj, attenwat), il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: M-M-RVAXPRO powder for suspension for injection in pre-filled syringe
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Musculoskeletal, connective tissue and bone disorders Arthritis † and/or Arthralgia † (usually transient and rarely chronic), Myalgia
Maltese: Disturbi muskolu-skeletriċi, tat-tessuti konnettivi u tal-għadam
English: Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com
Maltese: Tel: + 4021 529 29 00 msdromania@merck.com
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle-shield (natural rubber) in a pack size of 1 and 10.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Trab f'kunjett (ħġieġ) b'tapp (gomma tal-butyl) u solvent f'siringa mimlija għal-lest (ħġieġ) b'labra mwaħħla u bi plunger stopper (gomma tal-chlorobutyl) u għata għal-labra (gomma naturali) f'pakkett ta' 1 u ta' 10.