FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively, and there is potential for voriconazole to increase the plasma concentrations of substances metabolised by these CYP450 isoenzymes.
Maltese: L-inibituri u l-indutturi ta' dawn l-isoenzimi jistgħu jżidu jew inaqqsu il-konċentrazzjoni ta' voriconazole fil-plażma, rispettivament, u hemm potenzjal għal voriconazole li jżid l-konċentrazzjonijiet tas-sustanzi mmetabolizzati minn dawn l-isoenzimi tal-CYP450.
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Hikma 200 mg powder for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Voriconazole Hikma 200 mg trab għal soluzzjoni għall-infużjoni
English: The ERG changes did not progress over 29 days of treatment and were fully reversible on withdrawal of voriconazole.
Maltese: 9 Tinkludi dispnea u dispnea wara eżerċzjoni.
English: • Enlarged lymph glands (sometimes painful), , failure of blood marrow, (increased eosinophil)
Maltese: • Tkabbir tal-glandola limfatika (xi kultant bl-uġigħ), insuffiċjenza tal-mudullun, (żieda fl eosinofili)
English: It is recommended that voriconazole is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Maltese: Huwa rrikmandat li voriconazole jingħata b'rata massima ta' 3 mg/kg fis-siegħa fuq siegħa jew 3 sigħat.
English: Based on the population pharmacokinetic analysis, 12- to 14year-old adolescents weighing less than 50 kg should receive children's doses (see section 4.2).
Maltese: Fuq bażi tal-analiżi farmakokinetika, adolexxenti ta' bejn 12 u 14-il sena li jiżnu anqas minn 50 kg għandhom jingħataw dożi bħal dawk tat-tfal (ara sezzjoni 4.2).
English: Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”).
Maltese: Interazzjonijiet bejn voriconazole u prodotti mediċinali oħra huma mniżżla fit -tabella t'hawn taħt (darba kuljum bħala “QD”, darbtejn kuljum bħala “BID”, tlett darbiet kuljum bħala “TID” u mhux determinat bħala “ND”).
English: Not for administration as a bolus injection.
Maltese: M'għandux jingħata bħala injezzjoni bolus.
English: Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk (see section 4.5).
Maltese: L-użu f'daqqa ta' voriconazole u rifabutin għandu jiġi evitat jekk il-benefiċċju ma jkunx akbar mir-riskju (ara sezzjoni 4.5).
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Maltese: Meta t-trattament b'voriconazole jitwaqqaf, id-dożaġġ inizjali ta' efavirenz għandu jkun mibdul għal li kien (ara sezzjonijiet 4.4 u 4.5).
English: • Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness
Maltese: • Aċċessjonijiet, rogħda jew movimenti tal-muskoli mhux ikkontrollati, tnemnim jew sensazzjonijiet mhux normali tal-ġilda, żieda fit-ton tal-muskoli, ngħas, sturdament
English: Dosage adjustment
Maltese: Skema tad-doża
English: Compatible Infusion Solutions: The reconstituted solution can be diluted with:
Maltese: Soluzzjonijiet Kompatibbli għal Infużjoni:
English: The severity of the adverse reactions was generally mild to moderate.
Maltese: Is-severità tar-reazzjonijiet avversi kienet ġeneralment ħafifa għal moderata.
English: Co-administration of voriconazole and low dose ritonavir (100 mg BID) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Maltese: Amministrazzjoni ta' voriconazole u doża baxxa ta' ritonavir (100 mg BID) għandu jiġi evitat, għajr meta l-istima tal-benefiċċju u r-riskju talpazjent jiġġustifika l-użu ta' voriconazole.
English: The recommended dose for adults (including elderly patients) is as follows:
Maltese: Id-doża rakkomandata għall-adulti (inkluż pazjenti anzjani) hija kif ġej:
English: Successful response was seen in 24 patients (15 complete, 9 partial responses).
Maltese: Rispons ta' suċċess kien muri f'24 pazjent (15-il rispons sħiħ, 9 risponsi parzjali).
English: Co-administration of standard doses of voriconazole with efavirenz doses of 400 mg once daily or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at thesedoses.
Maltese: L-amministrazzjoni ta' dożi standard ta' voriconazole flimkien ma' efavirenz doża ta' 400mg jew aktar darba kuljum huwa kontraindikat, billi efavirenz inaqqas b'mod sinifikanti l-konċentrazzjonijiet ta' voriconazole fil-plażma f'suġġetti b'saħħithom b'dawn id-dożi.
English: For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed below) to obtain a final voriconazole solution containing 0.5-5 mg/ml.
Maltese: Biex jingħata, il-volum meħtieġ tal-konċentrat rikostitwit jiġi miżjud ma' soluzzjoni kompatibbli rakkomandata għall-infużjoni (dettaljata fit-tabella hawn isfel) biex tinkiseb soluzzjoni finali ta' voriconazole li fiha 0.5-5 mg/ml.
English: • Treatment of invasive aspergillosis.
Maltese: • Kura ta' asperġillosi invażiva.
English: Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Maltese: Minn dawn is-7 pazjenti, 3 kellhom infezzjoni f'għajnejhom, 1 kellu infezzjoni tassinus, u 3 kellhom infezzjoni mifruxa.
English: Individuals 11 to 65 years of age
Maltese: Individwi minn 11 sa 65 sena
English: 53100 Siena, Italy
Maltese: 53100 Siena, L-Italja
English: EU/1/10/614/003
Maltese: EU/1/10/614/002 EU/1/10/614/003
English: 7.1 to 12.5 micrograms
Maltese: 7.1 sa 12.5 mikrogrammi
English: 16.7 to 33.3 micrograms
Maltese: 16.7 sa 33.3 mikrogrammi
English: 3.3 to 8.3 micrograms
Maltese: 3.3 sa 8.3 mikrogrammi
English: 5 micrograms
Maltese: 5 mikrogrammi
English: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italy
Maltese: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), L-Italja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/614/003 - 1 dose pack EU/1/10/614/002 - 5 doses pack
Maltese: EU/1/10/614/003 - pakkett ta' doża 1 EU/1/10/614/002 - pakkett ta' 5 dożi
English: Menveo ACWYPS Menveo ACWY-P S Menveo ACWYPS Menveo ACWY-PS A N=280 N=281 N=280 N=281 N=253 N=238 N=253 N=238
Maltese: Menveo ACWY -PS Menveo ACWY -PS Menveo ACWY -PS Menveo ACWY-PS A N=280 N=281 N=280 N=281 N=253 N=238 N=253 N=238
English: N=50 N=50
Maltese: N=50
English: 2-5 years
Maltese: 2-5 snin
English: Among Menveo recipients, 58.9%, 16.4%, 21.3% and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively.
Maltese: Menveo, 58.9%, 16.4%, 21.3% u 3.4% kienu fil-grupp ta' età ta' 11-18-il sena, 19-34 sena, 35-55 sena u 56-65 sena, rispettivament.
English: 21 months 3 years 5 years
Maltese: 21 xahar 3 snin 5 snin
English: Serogroup
Maltese: Serogrupp
English: (≥1/10,000 to <1/1,000)
Maltese: (≥1/10,000 sa < 1/1,000)
English: Date of latest renewal: 04 December 2014
Maltese: Data tal-aħħar tiġdid: 4 ta' Diċembru 2014
English: 6-10 years
Maltese: 6-10 snin
English: (≥1/100 to <1/10)
Maltese: (≥1/100 sa < 1/10)
English: Potassium dihydrogen phosphate
Maltese: Sucrose Potassium dihydrogen phosphate
English: (≥1/1,000 to <1/100)
Maltese: (≥1/1,000 sa < 1/100)
English: Immunogenicity in adults
Maltese: Immunoġeniċità fl-adulti
English: Sero grou p
Maltese: Sero gru pp
English: V59P6E1 (5 years post vaccination)
Maltese: V59P6E1 (5 snin wara t-tilqima)
English: MenCWY Conjugate
Maltese: Konjugat ta' MenCWY
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar l-istudju pedjatriku.
English: Excipients: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, water for injection.
Maltese: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, ilma għall-injezzjoni.
English: In the powder: potassium dihydrogen phosphate and sucrose.
Maltese: Fit-trab: potassium dihydrogen phosphate u sucrose.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 March 2010
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Marzu 2010
English: While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people.
Maltese: Filwaqt li infezzjoni bil-Virus tal-Immunodefiċjenza Umana (HIV) mhijiex kontraindikazzjoni, Menveo ma ġiex evalwat speċifikament f'nies li huma immunokompromessi.
English: Marketing Authorisation Holder: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Maltese: GSK Vaccines S.r.l., Via Fiorentina 1, 53100
English: Pre-boo ster 7 days 28 days 100% 2 years
Maltese: Qabel il-booster 7 ijiem28 jum 100% Sentejn 100%
English: The hSBA was the original correlate of protection against meningococcal disease.
Maltese: L-hSBA kien il-korrelat oriġinali ta' protezzjoni kontra l-marda meningokokkali.
English: Serogrou p
Maltese: Serogru pp
English: In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate and water for injection (See also end of Section 2).
Maltese: Fis-soluzzjoni: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate u ilma għall-injezzjoni (Ara wkoll it-tmiem ta' Sezzjoni 2).
English: Bellaria-Rosia 53018 Sovicille (SI) Italy
Maltese: GSK Vaccines S.r.l. Bellaria-Rosia 53018 Sovicille (SI) L-Italja
English: V59P13E1 (3 years post vaccination)
Maltese: V59P13E1 (3 snin wara t-tilqima)
English: Long-term antibody persistence data following vaccination with Menveo are available up to 5 years after vaccination (see section 4.4 and 5.1).
Maltese: Dejta fit-tul dwar il-persistenza tal-antikorpi wara t-tilqima b'Menveo hi disponibbli sa 5 snin wara t-tilqima (ara sezzjoni 4.4 u 5.1).
English: Five doses (10 vials) per package.
Maltese: Ħames dożi (10 kunjetti) kull pakkett.
English: Timepo int
Maltese: Doża waħda
English: Menveo does not protect against diphtheria.
Maltese: Menveo ma jipproteġix kontra d-difterija.
English: In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among adults aged 19 to 55 years.
Maltese: Fil-prova importanti ħafna tal-immunoġeniċità, V59P13, ir-risponsi immuni għal Menveo ġew evalwati fost adulti ta' bejn id-19 u l-55 sena.
English: In adolescents (11 to 18 years of age), Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine, Adsorbed (Tdap) alone or Tdap and Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-administration of the vaccines.
Maltese: Fl-adolexxenti (11 sa 18-il sena), Menveo ġie evalwat f'żewġ studji ta' għoti flimkien b'Vaċċin ta' kontra t-Tetnu, id-Difterija Mnaqqsa u l-Pertussi Aċellulari, Adsorbita (Tdap) waħdu jew Tdap flimkien ma' Vaċċin Kwadrivalenti tal-Papillomavirus Uman (Tipi 6, 11, 16 u 18), Rikombinanti
English: Menveo is given as an intramuscular injection, preferably into the deltoid muscle.
Maltese: Menveo jingħata bħala injezzjoni ġol-muskoli, preferibbilment fil-muskolu deltojde.
English: In two supportive studies V59P8 and V59P10 immunogenicity of Menveo was compared to ACWY-PS.
Maltese: F'żewġ studji ta' appoġġ V59P8 u V59P10 l-immunoġeniċità ta' Menveo kienet imqabbla ma' ACWY-PS.
English: Not known: tonic convulsion, febrile convulsion, syncope Ear and labyrinth disorders
Maltese: Mhux magħruf: konvulżjoni tonika, konvulżjoni bid-deni, sinkope
English: Immunogenicity in adolescents
Maltese: Immunoġeniċità fl-adolexxenti
English: N=42 N=49 N=49
Maltese: N=42 N=49 N=49 N=42
English: Conjugated to Corynebacterium diphtheriae CRM197 protein
Maltese: Konjugat għal proteina Corynebacterium diphtheriae CRM197
English: Immunogenicity was assessed in a subset of 150 subjects in each vaccine group.
Maltese: L-immunoġeniċità kienet evalwata f'subsett ta' 150 individwu f'kull grupp tal-vaċċin.
English: These include the following vaccines: tetanus, reduced diphtheria and acellular pertussis (Tdap), human papillomavirus (HPV), yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies, hepatitis A and B and meningococcal group B (Bexsero).
Maltese: (Tdap), vaċċin tal-papillomavirus uman (HPV), deni isfar, deni tat-tifojde (Vi polysaccharide), enċefalite Ġappuniża u rabies, epatite A u B u grupp meningokokkali B (Bexsero).
English: In the pivotal study V59P20 immunogenicity of Menveo was compared to ACWY-D; 1170 children were vaccinated with Menveo and 1161 received the comparator vaccine in the per protocol populations.
Maltese: Fl-istudju importanti ħafna V59P20 l-immunoġeniċità ta' Menveo kienet imqabbla ma' ACWY-D; 1170 tifel u tifla ġew ivvaċċinati b'Menveo u 1161 irċivew il-vaċċin komparatur fil-popolazzjonijiet skont il-protokoll.
English: Common: nausea, vomiting, diarrhea
Maltese: Komuni: dardir, rimettar, dijarea
English: The characterization of the safety profile of Menveo in adolescents and adults is based on data from five randomised controlled clinical trials including 6401 participants (from 11-65 years of age) who received Menveo.
Maltese: Il-karatterizzazzjoni tal-profil tas-sigurtà ta' Menveo fl-adolexxenti u fl-adulti hu bbażat fuq dejta minn ħames provi kliniċi kkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali li inkludew 6,401 parteċipant (ta' bejn 11-65 sena) li rċivew Menveo.
English: Time point
Maltese: Punt ta'
English: hSBA GMTs
Maltese: L-hSBA GMTs għal serogruppi
English: N=41 N=49 N=49
Maltese: N=41 N=49 N=49 N=41
English: Table 3: Persistence of immune responses 5 years after primary vaccination with Menveo, and immune responses 1 month after a booster dose among subjects aged 2 - 5 years and 6 -10 years at the time of primary vaccination
Maltese: Tabella 3: Persistenza ta' risponsi immuni 5 snin wara t-tilqima primarja b'Menveo, u risponsi immuni xahar wara d-doża booster fost individwi li kellhom 2 - 5 snin u 6 -10 snin fil-ħin tat-tilqima primarja
English: Common: arthralgia
Maltese: Komuni: mijalġja, artralġja
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1, jew għat-tossojde tad-difterija (CRM197), jew reazzjoni ta' theddida għall-ħajja wara għoti preċedenti ta' vaċċin li fih komponenti simili (ara sezzjoni 4.4).
English: The incidence and severity of any, local, systemic, and other reactions were generally similar in the Menveo groups across all studies and within the adolescent and adult age groups.
Maltese: L-inċidenza u s-severità ta' kwalunkwe reazzjoni lokali, sistemika u ta' xorta oħra kienet ġeneralment simili fil-gruppi ta' Menveo tul l-istudji kollha u fi ħdan il-gruppi ta' adolexxenti u tal-adulti.
English: The efficacy of Menveo has been inferred by measuring the production of serogroup-specific anti-capsular antibodies with bactericidal activity.
Maltese: L-effikaċja ta' Menveo ġiet dedotta bil-kejl tal-produzzjoni ta' antikorpi antikapsulari speċifiċi għas-serogrupp b'attività batteriċida.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Maltese: 1 doża (0.5 ml)
English: In the subset of subjects aged 11-18 years who were seronegative at baseline (hSBA < 1:4), the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 75% (780/1039); serogroup C 80% (735/923); serogroup W-135 94% (570/609); serogroup Y 81% (510/630).
Maltese: Fis-subsett tal-individwi ta' bejn il-11-18-il sena li kienu seronegattivi fil-linja bażi (hSBA < 1:4), il-proporzjon tal-individwi li kisbu hSBA ≥ 1:8 wara doża ta' Menveo kien kif ġej: serogrupp A 75% (780/1039); serogrupp C 80% (735/923); serogrupp W-135 94% (570/609); serogrupp Y 81%
English: At baseline, the percentage of subjects with hSBA ≥1:8 across the two age strata was 1%-5% for serogroup A, 13%-28% for serogroup C, 42%-64% for serogroup W-135, and 6%-19% for serogroup
Maltese: Fil-linja bażi, il-perċentwali ta' individwi b'hSBA ta' ≥ 1:8 fiż-żewġ saffi ta' età kienet ta' 1%-5% għal serogrupp A, 13%-28% għal serogrupp C, 42%-64% għal serogrupp W-135, u 6%-19% għal serogrupp Y.
English: Paediatric population (under 2 years of age)
Maltese: Popolazzjoni pedjatrika (taħt l-età ta' sentejn)
English: There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years.
Maltese: Hemm dejta limitata f'individwi ta' età ta' bejn il-56-65 sena u m'hemm ebda dejtaf'individwi>65 sena.
English: Menveo can be given concomitantly with any of the following vaccines: monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies and meningococcal group B (Bexsero).
Maltese: Menveo jista' jingħata flimkien ma' kwalunkwe mill-vaċċini li ġejjin: epatite A u B monovalenti u kombinati deni isfar, deni tat-tifojde (Vi polysaccharide), enċefalite Ġappuniża, rabies u grupp meningokokkali B (Bexsero).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri hija essenzjalment ‘ħielsa mis-sodium'.
English: Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Maltese: Tabella 4: Risponsi ta' antikorpi batteriċida tas-serum wara Menveo xahar wara l-vaċċinazzjoni fost individwi ta' bejn 11-18-il sena
English: Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1).
Maltese: Studji b'Menveo urew tnaqqis fit-titers tal-antikorpi batteriċida tas-serum kontra serogrupp A meta ntuża l-kompliment uman fl-assaġġ (hSBA) (ara sezzjoni 5.1).
English: Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash and swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure; fits (convulsions) including fits associated with fever; balance disorder; faint; infection of the skin at the injection site; injection site swelling, including extensive swelling of the injected limb.
Maltese: Reazzjonijiet allerġiċi li jistgħu jinkludu nefħa severa tax-xufftejn, ħalq, gerżuma (li tista' tikkawża diffikultà biex tibla'), diffikultà biex tieħu n-nifs bi tħarħir jew sogħla, raxx u nefħa tal-idejn, saqajn u għekiesi, tintilef minn sensik, pressjoni tad-demm baxxa ħafna; aċċessjonijiet (konvulżjonijiet) li jinkludu aċċessjonijiet assoċjati ma' deni; disturb fil-bilanċ; ħass ħażin; infezzjoni tal-ġilda fis-sit tal-injezzjoni; nefħa fis-sit tal-injezzjoni, li tinkludi nefħa estensiva tad-driegħ/riġel injettat.
English: In the pivotal, randomised, observer-blind study V59P20, in which participants were stratified by age (2 through 5 years and 6 through 10 years), the immunogenicity of a single dose of Menveo one month post vaccination was compared with the single dose of ACWY-D. Immunogenicity results one month after Menveo vaccination among subjects aged 2-5 years and 6-10 years are summarized below in Table 1
Maltese: Fl-istudju importanti ħafna, randomizzat u blindat V59P20, li fih il-parteċipanti ġew stratifikati skont l-età (sentejn sa 5 snin u 6 sa 10 snin), l-immunoġeniċità ta' doża waħda ta' Menveo xahar wara l-vaċċinazzjoni tqabblet mad-doża waħda ta' ACWY-D.
English: Sodium dihydrogen phosphate monohydrate
Maltese: Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Sodium chloride
English: 5 year persistence 1 month after booster
Maltese: Persistenza ta' 5 snin
English: One dose (2 vials) per package.
Maltese: (2 kunjetti) kull pakkett.
English: For children (from 2 years of age), adolescents and adults: a single (0.5 ml) injection will be given.
Maltese: Għal tfal (minn sentejn), adolexxenti u adulti: injezzjoni waħda (0.5 ml) se tingħata.
English: Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Maltese: Oligosaccharides tal-grupp meningokokkali A 10 mikrogrammi konjugati mal-proteina Corynebacterium diphtheriae CRM197 16.7-33.3 mikrogrammi
English: A significant increase in the hSBA GMTs against all four serogroups was also observed at 7 and 28 days after the booster dose (Table 8).
Maltese: GMTs konta l-erba' serogruppi kollha ġiet osservata wkoll 7 u 28 jum wara d-doża booster (Tabella 8).
English: P Value Menveo vs ACWYPS
Maltese: Valur p Menveo vs ACWY-P S
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2°C - 8°C).
English: Serum bactericidal activity (SBA) was measured using human serum as the source of exogenous complement (hSBA).
Maltese: L-attività batteriċida tas-serum (SBA) tkejlet permezz tas-serum uman bħala s-sors ta' kompliment esoġenuż (hSBA).
English: GSK Vaccines S.r.l.
Maltese: GSK Vaccines S.r.l. Via Fiorentina 1
English: Serog roup
Maltese: Serogr upp
English: Other medicines and Menveo
Maltese: Mediċini oħra u Menveo
English: A randomised, observer-blind study was conducted in children 12 to 59 months of age in Finland and Poland (V59P7).
Maltese: Studju randomizzat u osservat u bl-agħma sar fuq tfal ta' bejn it-12 sa 59 xahar fil-Finlandja u l-Portugall (V59P7).
English: At 1 year post last vaccination, the percentages of subjects with hSBA ≥1:8 after the 2-dose series and the single dose were both lower than at 1 month post-vaccination (30% after the 2-dose series, 11%20% after the single dose for serogroup A; 61%-81% and 41%-55% for serogroup C; 92%-94% and 90%-91% for serogroup W-135; 67%-75% and 57%-65% for serogroup Y).
Maltese: Sena wara l-aħħar tilqima , il-perċentwali ta' individwi b'hSBA ta' ≥ 1:8 wara s-serje ta' 2 dożi u d-doża waħda kienu t-tnejn iktar baxxi milli xahar wara t-tilqima (30% wara s-serje ta' 2 dożi, 11%-20% wara d-doża waħda għal serogrupp A; 61%-81% u 41%-55% għal serogrupp C; 92%-94% u 90%-91% għal serogrupp W-135; 67%-75% u 57%-65% għal serogrupp Y).
English: The onset of immune response after the primary vaccination with Menveo in healthy subjects 18 through 22 years of age was evaluated in study V59P6E1.
Maltese: Il-bidu tar-rispons immuni wara t-tilqima primarja b'Menveo f'individwi b'saħħithom li kellhom minn 18 sa 22 sena ġie evalwat fi studju V59P6E1.
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Maltese: Oligosaccharides tal-grupp meningokokkali C 5 mikrogrammi konjugati mal-proteina Corynebacterium diphtheriae CRM197 7.1-12.5 mikrogrammi
English: In another randomised, observer-blind study (V59P8) US children were immunized with a single dose of either Menveo (N=284) or ACWY-PS (N=285).
Maltese: Fi studju ieħor randomizzat u bl-agħma (V59P8) tfal mill-Istati Uniti rċivew immunizzazzjoni b'doża waħda jew ta' Menveo (N=284) jew ta' ACWY-PS (N=285).
English: At 1 month post-first vaccination, the percentages of subjects with hSBA ≥ 1:8 were consistently higher in the Menveo group for all four serogroups (63% vs 39%, 46% vs 39%, 78% vs 59%, and 65% vs 57% for Menveo as compared to ACWY-PS for serogroups A, C, W-135, and Y, respectively).
Maltese: Xahar wara l-ewwel vaċċinazzjoni, il-perċentwali ta' individwi b'hSBA ≥ 1:8 kienu konsistentement ogħla fil-grupp ta' Menveo għall-erba' serogruppi kollha (63% kontra 39%, 46% kontra 39%, 78% kontra 59%, u 65% kontra 57% għal Menveo meta mqabbla ma' ACWY-PS għas-serogruppi A, C, W135, u Y, rispettivament).