FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety in infants with human immunodeficiency (HIV) infection
Maltese: Sigurtà fit-trabi bl-infezzjoni ta' l-immunodefiċjenza umana (HIV)
English: Protective efficacy in Africa
Maltese: Effikaċja protettiva fl-Afrika
English: • If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4.
Maltese: • Jekk il-membrana ma tkunx ġiet imtaqqla, ritornat għassezzjoni B u rrepeti l-istadji 2, 3 u 4.
English: Protective efficacy in Latin America
Maltese: Effikaċja protettiva fl-Amerika Latina
English: Rotarix is available in a pack of 1, 5, 10 or 25.
Maltese: Rotarix jista' jiġi f'pakketti ta' 1, 5, 10 jew 25.
English: PHARMACEUTICAL FORM Oral suspension.
Maltese: Suspensjoni orali.
English: Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy
Maltese: Kategorija farmakoterapewtika: vaċċini kontra d-dijarea minn rotavirus, Kodiċi ATC: JO7BH01 Effikaċja protettiva
English: Vaccine efficacy was 100% (95% CI: 67.5; 100).
Maltese: L-effikaċja tat tilqima kienet 100% (95% CI: 67.5; 100).
English: Intussusception
Maltese: intussusezzjoni)
English: Malawi
Maltese: Il-Malawi
English: Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder
Maltese: Qawwija (SCID - Severe Combined Immunodeficiency disorder)
English: Effectiveness
Maltese: Effettivita'
English: Rotarix contains sucrose and sorbitol
Maltese: Rotarix fih sucrose u sorbitol
English: < 5 yrs
Maltese: < 5 snin
English: Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy of the lyophilised formulation
Maltese: Kategorija farmakoterapewtika: vaċċini kontra d-dijarea minn rotavirus, Kodiċi ATC: JO7BH01 Effikaċja protettiva tal-forma lajofiliżżata
English: 2, 3 to 4 months
Maltese: 2, 3 sa 4 xhur
English: In a retrospective database study in Belgium conducted in children 5 years of age and younger, the direct and indirect impact of Rotarix vaccination on rotavirus-related hospitalisation ranged from 64% (95% CI: 49;76) to 80% (95% CI: 77;83) two years after vaccine introduction.
Maltese: Fi studju retrospettiv li sar fil-Belġju fuq tfal ta' 5 snin u anqas, l-impatt dirett u indirett tat-tilqima Rotarix fuq rikoveru l-isptar relatat mar-rotavirus varja minn 64% (95% CI: 49;76) sa 80% (95% CI: 77;83) sentejn wara l-introduzzjoni tal-vaċċin.
English: This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4).
Maltese: Dan il-prodott fih 9 mg sucrose u 13.5 mg sorbitol (ara sezzjoni 4.4) Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Rotarix contains sucrose
Maltese: Rotarix fih sucrose
English: • irritability
Maltese: • dijarrea • irritabilità
English: Powder and solvent for oral suspension.
Maltese: Trab u solvent għal suspensjoni orali.
English: During the third year of life, there were no cases of severe RV gastro-enteritis in the Rotarix group (N=4,222) versus 13 (0.3%) in the placebo group (N=4,185).
Maltese: fil-grupp ta' Rotarix (N=4,222) kontra 13 (0.3%) fil-grupp tal-plaċebo (N=4,185).
English: A clinical study performed in Africa (Rotarix: N = 2,974; placebo: N = 1,443) evaluated Rotarix given at approximately 10 and 14 weeks of age (2 doses) or 6, 10 and 14 weeks of age (3 doses).
Maltese: Studju kliniku li sar fl-Afrika (Rotarix: N = 2,974; plaċebo: N = 1,443) evalwa Rotarix mogħtija madwar l-età ta' 10 u 14-il ġimgħa (2 dożi) jew fl-età ta' 6, 10 u 14-il ġimgħa (3 dożi).
English: EXP {MM/YYYY}
Maltese: JIS {MM/YYYY}
English: In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51,000 infants.
Maltese: F'total ta' tlieta w għoxrin prova klinika, madwar 106,000 doża ta' Rotarix (fil-forma lajofiliżżata jew likwida) ngħataw lil madwar 51,000 tarbija.
English: Powder: dextran, sucrose, sorbitol (see also section 2, Rotarix contains sucrose and sorbitol), amino acids, Dulbecco's Modified Eagle Medium (DMEM) Solvent: calcium carbonate, xanthan gum, sterile water
Maltese: Trab: dextran, sucrose, sorbitol (ara wkoll sezzjoni 2, Rotarix fih sucrose u sorbitol), amino aċidi, Dulbecco's Modified Eagle Medium (DMEM)
English: < 4 yrs
Maltese: < 4 snin
English: Efficacy (%) [95% CI ]
Maltese: Effettivita' % [95% CI]
English: Multi-monodose (5-single dose) squeezable tube presentation connected by a bar 1.5 ml of oral suspension in a squeezable tube (polyethylene) presented in a multi-monodose (5-single dose) squeezable tube presentation connected by a bar, in pack size of 50 tubes.
Maltese: 1.5 ml ta 'sospensjoni orali f'tubu li jingħafas (polietilene) ippreżentat f'formazzjoni ta' tubu li jista 'jiġi ppressat multi-monodose (5 doża waħda) konnessa minn bar, f'pakkett daqs ta' 50 tubu.
English: A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section 4.8).
Maltese: Studju kliniku f'numru limitat ta' trabi pożittivi għal HIV, mingħajr sintomi jew bi ftit sintomi ħfief, ma wera l-ebda problema evidenti ta' sigurtà (ara sezzjoni 4.8).
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Maltese: • fi trabi li jkunu twieldu b'mod prematur (qabel jew qabel 28 ġimgħa ta 'tqala), lakuni itwal min-normal bejn in-nifs jistgħu jseħħu għal 2-3 ijiem wara t-tilqima.
English: g) Pull it from the connecting bar.
Maltese: g) Iġbdu mill-bar tal-konnessjoni.
English: Rotarix is available in a pack of 1, 10 or 50.
Maltese: Rotarix jista' jiġi f'pakketti ta' 1, 10 jew 50.
English: G1P[8] G2P[4] G3P[8] G4P[8] G9P[8]
Maltese: G1P[8] G2P[4] G3P[8] G9P[8]
English: Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
Maltese: Rotarix hu indikat għall-immunizzazzjoni attiva tat-trabi mill-età ta' 6 ġimgħat sa 24 ġimgħa għallprevenzjoni ta' gastro-enterite li tkun ġejja minn infezzjoni ta' rotavirus (ara sezzjonijiet 4.2, 4.4 u
English: For subjects with a predisposition for intussusception, see section 4.3.
Maltese: Għall-individwi bi predispożizzjoni għall-intussuxezzjoni, ara sezzjoni 4.3.
English: In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were administered to approximately 1,900 infants.
Maltese: F'total ta' erbgħa provi kliniċi, madwar 3,800 doża ta' Rotarix ingħataw lil madwar 1,900 tarbija.
English: Other medicines and Rotarix
Maltese: Mediċini oħra u Rotarix
English: A clinical study performed in Latin America evaluated Rotarix in more than 20,000 subjects.
Maltese: Fi studju kliniku ta' Rotarix li twettaq fl-Amerika Latina ġie evalwat f'iktar minn 20,000 suġġett.
English: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00
Maltese: Tel: + 46 (0)8 638 93 00
English: Calcium carbonate Xanthan gum Sterile water
Maltese: Karbonat tal-kalċju Gomma tax-xanthan Ilma sterili
English: Squeezable tube
Maltese: Membrana Tubu
English: Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine.
Maltese: Rotarix jista' jingħata flimkien ma' kull wieħed minn dawn il-vaċċini monovalenti jew kombinati li ġejjin [inklużi vaċċini eżavalenti (DTPa-HBV-IPV/Hib)]: vaċċin għad-difterja-tetanu-sogħla konvulsiva b'ċellula sħiħa (DTPw), vaċċin għad-difterja-tetnu-sogħla konvulsiva bla ċelluli (DTPa), vaċċin tip b Haemophilus influenzae (Hib), vaċċin tal-poljo inattivat (IPV), vaċċin ta' l-epatite B (HBV), vaċċin ta' pneumococcal conjugate u vaċċin ta' meningococcal serogroup C conjugate.
English: In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric vaccines (see section 4.5), the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination.
Maltese: F'analiżi miġbura minn sbatax-il prova klinika kontrollata bi plaċebo (Ewropa, Amerika ta' Fuq, Amerika Latina, Asja, Afrika) inkluż dawk il-provi fejn Rotarix ingħata flimkien ma' vaċċini pedjatriċi ta' rutina (ara sezzjoni 4.5), r-reazzjonijiet avversi li ġejjin (miġbura 31 jum wara t-tilqim) ġew ikkunsidrati bħala possibilment relatati mat-tilqim.
English: Adverse reactions
Maltese: Reazzzjonijiet avversi
English: Powder and solvent for oral suspension
Maltese: Trab u solvent għal suspensjoni orali
English: Date of latest renewal: 14 January 2016
Maltese: AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Frar 2006 Data tal-aħħar tiġdid:14 ta' Jannar 2016
English: In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered Rotarix lyophilised formulation and 339 received placebo.
Maltese: F'studju kliniku, Rotarix ingħata lil 670 tarbija mwielda qabel iż-żmien, minn 27 sa 36 ġimgħa ta' tqala waqt li 339 trabi rċievew il-plaċebo.
English: All m: months yrs: years
Maltese: Kollha m: xhur yrs: snin
English: Human rotavirus RIX4414 strain (live, attenuated)*
Maltese: Razza ta' Rotavirus uman RIX4414(b'ħajja attenwata)*
English: Bond et al. (2018) suggested some noncompliance to such recommendation in a recent conference abstract.
Maltese: (2018) issuġġerixxa xi nuqqas ta' konformità ma' rakkomandazzjoni bħal din f'astratt ta' konferenza riċenti.
English: In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving Rotarix when compared to the group receiving placebo.
Maltese: F'tlett provi kliniċi kontrollati bi plaċebo (Finlandja, Indja u Bangladexx), fejn Rotarix ingħata waħdu (l-għoti ta' vaċċini pedjatriċi ta' rutina kien jitqassam fuq perijodi), ma kienx hemm differenza sinifikanti fl-inċidenza u severità ta' l-effetti soliċitati (miġbura 8 t'ijiem wara t-tilqim), dijarea, rimettar, nuqqas t'aptit, deni, irritabilità u sogħla/mnieħer iqattar fil-grupp li ħadu Rotarix meta mqabbla mall-grupp li ħadu plaċebo.
English: Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus.
Maltese: Rotarix ma jagħti ebda protezzjoni kontra gastro-enterite kawżata minn patoġeni għajr rotavirus.
English: The efficacy against severe RV gastro-enteritis requiring hospitalisation was 100% (95% CI: 72.4; 100).
Maltese: L-effikaċja kontra gastro-enterite severa kkawżata minn RV bi bżonn ta' dħul l-isptar kienet ta' 100% (95% CI: 72.4; 100).
English: All m: months yrs: years * Not statistically significant (P ≥ 0.05).
Maltese: Kollha m: xhur yrs: snin * Mhux statistikament sinifikanti (P >0.05).
English: Similar studies in Armenia, Australia, Brazil, Canada, El Salvador and Zambia showed a reduction of 45 to 93% between 2 and 4 years after vaccine introduction.
Maltese: Studji simili fl-Armenja, fl-Awstralja, fil-Brażil, filKanada, f'El Salvador u fiż-Żambja wrew tnaqqis ta' 45% sa 93% bejn sentejn u 4 snin wara lintroduzzjoni tal-vaċċin.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% CI: 44.0;73.2).
Maltese: L-effikaċja tat tilqima kontra gastroenterite qawwija waqt l-ewwel sena tal-ħajja kienet 61.2% (95% CI: 44.0;73.2).
English: Squeezable tube EU/1/05/330/009 EU/1/05/330/010
Maltese: UE / 1/05/330/009 UE / 1/05/330/010
English: The presence of a minor infection is not a contra-indication for immunisation.
Maltese: Il-presenza ta' infezzjoni minuri mhijiex kontra-indikazzjoni għall-immunizazzjoni.
English: EU/1/05/330/011
Maltese: UE / 1/05/330/011
English: Rotarix oral suspension in multi-monodose (5 single dose) squeezable tube presentation connected by a bar
Maltese: Sospensjoni orali ta 'Rotarix f'formazzjoni ta' tubu squeezable multi-monodose (5 doża waħda) konnessa minn bar
English: 25 glass containers: powder 25 oral applicators: solvent 25 transfer adapters 25 x 1 dose (1 ml)
Maltese: 25 kontenituri tal-ħġieġ: trab 25 applikaturi tal-ħalq: solvent 25 transfer adapters
English: Despite a low reporting rate of urticaria events (i.e. 0.013 cases per 100,000 doses distributed), some spontaneous cases suggested a possible association between Rotarix vaccination and urticaria.
Maltese: Minkejja rata ta' rappurtar baxxa ta' avvenimenti ta' urtikarja (jiġifieri 0.013-il każ għal kull 100,000 doża mqassma), xi każijiet spontanji ssuġġerew assoċjazzjoni possibbli bejn it-tilqima ta' Rotarix u urtikarja.
English: How Rotarix works:
Maltese: Kif jaħdem Rotarix:
English: In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].
Maltese: Fi provi kliniċi, intweriet effikaċja kontra gastro-enterite ikkawżata mill-ġenotipi ta' rotavirus l-aktar komuni G1P[8], G2P[4], G3P[8], G4P[8] u G9P[8].
English: 1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl) 1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap (rubber butyl).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Doża waħda ta' trab f'kontenitur tal-ħġieġ (ħġieġ tat-tip I) b'tapp (rubber butyl) 1 ml ta' solvent f'applikatur tal-ħalq (ħġieġ tat-tip I) b'tapp planġer u għatu protettiv (rubber butyl).
English: Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose.
Maltese: Frak antiġen virali skopert b'ELISA instab f'50% ta' ħmieġ solidu wara l-ewwel doża ta' Rotarix fil-forma lajofiliżżata u f'4% ta' ħmieġ solidu wara t-tieni doża.
English: • Hold the tube upright.
Maltese: • Żomm it-tubu wieqaf.
English: • Very rare: hives (urticaria)
Maltese: • Rari ħafna: ħorriqija (urtikarja
English: (2) GSK sponsored studies (3) Data from a post-hoc analysis (4) Vaccine effectiveness was calculated using rotavirus-negative hospital control participants (estimates from
Maltese: (2) Studji sponsorjati minn GSK (3) Dejta minn analiżi post-hoc
English: A clinical study conducted in Asia (Hong Kong, Singapore and Taiwan) (Total vaccinated cohort : Rotarix: N = 5,359; placebo: N = 5,349) evaluated Rotarix given according to different schedules (2, 4 months of age; 3, 4 months of age).
Maltese: Rotarix: N = 5,359; plaċebo: N = 5,349) evalwa Rotarix mogħti skont skedi differenti (età ta' 2, 4
English: • Keep the tube held upright.
Maltese: • Żomm it-tubu f'pożizzjoni wieqfa.
English: Rotarix is not intended for use in adults.
Maltese: Rotarix mhuwiex maħsub għal użu minn adulti.
English: 2nd year of life Rotarix N=2,554 Placebo N=1,294 Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
Maltese: Plaċebo N=1,294 Effikaċja tal-vaċċin (%) kontra kull gastro-enterite bir-rotavirus u kontra gastro enterite severi bir-rotavirus [95% CI]
English: < 3 yrs
Maltese: < 3 snin
English: It is important that you follow the instructions of your doctor or nurse regarding return visits.
Maltese: Huwa importanti li ssegwi l-istruzzjonijiet tat-tabib jew infermier tiegħek dwar iż-żjarat ta 'ritorn.
English: < 4 yrs 3-11 m
Maltese: < 4 snin 3-11 m
English: Impact on mortality§
Maltese: Impatt fuq il-mortalità§
English: † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale * Not statistically significant (p ≥ 0.05).
Maltese: Gastro-enterite severa kienet definita bħala qari ta' ≥11 fuq l-iskala Vesikari * Mhux sinifikanti b'mod statistiku (p ≥ 0.05).
English: • Very rare: intussusception (part of the intestine gets blocked or twisted).
Maltese: • Rari ħafna: intussusezzjoni (parti mill-musrana tiġi mblukkata jew mibruma).
English: Oral suspension in pre-filled oral applicator 1 pre-filled oral applicator 1 dose (1.5 ml)
Maltese: Suspensjoni orali f'applikatur tal-ħalq mimli lest applikatur tal-ħalq 1 mimli lest doża waħda (1.5 ml)
English: 5 glass containers: powder 5 oral applicators: solvent 5 transfer adapters 5 x 1 dose (1 ml)
Maltese: 5 kontenituri tal-ħġieġ: trab 5 applikaturi tal-ħalq: solvent 5 transfer adapters
English: 10 glass containers: powder 10 oral applicators: solvent 10 transfer adapters 10 x 1 dose (1 ml)
Maltese: 10 kontenituri tal-ħġieġ: trab 10 applikaturi tal-ħalq: solvent 10 transfer adapters
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (1.5 ml) contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Doża waħda (1.5 ml) jkun fiha:
English: Efficacy up to 2 years of age Rotarix N= 5,263 Placebo N= 5,256 Vaccine efficacy (%) against severe rotavirus gastro-enteritis [95% CI] Genotype
Maltese: Plaċebo N= 5,256 Effikaċja tat-tilqima (%) kontra gastro-enterite severa kkawżata minn rotavirus
English: Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.
Maltese: Rotarix jista 'jingħata fl-istess ħin li ibnek / bintek jirċievu vaċċini oħra normalment rakkomandati, bħal difterite, tetnu, pertussis (sogħla konvulsiva), Haemophilus influenzae tip b, poljo orali jew inattivat, vaċċini ta' l-epatite B kif ukoll konjugat serogruppu pnewokokku u meningokokkali vaċċini.
English: C Check the tube has opened correctly 1.
Maltese: Iċċekkja li t-tubu infetaħ b'mod korrett 1.
English: Up to 6 additional cases per 100,000 infants have been observed in these countries against a background incidence of 25 to 101 per 100,000 infants (less than one year of age) per year, respectively.
Maltese: Sa 6 każijiet addizzjonali għal kull 100,000 tarbija kienu osservati f'dawn il-pajjiżi fl-isfond ta' inċidenza ta' 25 sa 101 għal kull 100,000 tarbija (ta' età inqas minn sena) kull sena, rispettivament.
English: Severe rotavirus gastro-enteritis† Rotarix N=2,974 Placebo N=1,443
Maltese: Kwalunkwe gastro-enterite b'rotavirus Rotarix N=2,974
English: Discard the used oral tubes in approved biological waste containers according to local regulations.
Maltese: Armi t-tubi orali użati fi skart bijoloġiku approvat kontenituri skond ir-regolamenti lokali.
English: < 3 yrs 6-11 m
Maltese: < 3 snin 6-11 m
English: System Organ Class
Maltese: Klassi tas-Sistemi u tal-Organi Frekwenza
English: • he/she has any disorder of the gastrointestinal system.
Maltese: • hu/hi għandu/ha xi disturb fis-sistema gastro-intestinali.
English: In addition, efficacy against uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated.
Maltese: Barra minn hekk, intweriet ukoll effikaċja kontra ġenotipi ta' rotavirus mhux komuni G8P[4] (gastro-enterite qawwija) u G12P[6] (kwalunkwe gastro enterite).
English: All G1P[8] G2P[4]
Maltese: Kollha G1P[8] G2P[4]
English: † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale
Maltese: Gastro-enterite severa ddefinita bħala punteġġ >11 fuq l-iskala Vesikari
English: As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) since data from observational safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8).
Maltese: Bħala prekawzjoni, professjonisti fil-qasam tas-saħħa għandhom isegwu kwalunkwe sintomu li jagħti indikazzjoni ta' intussuxezzjoni (uġigħ addominali sever, rimettar persistenti, demm fl-ippurgar, nefħa addominali u/jew deni għoli) minħabba li dejta minn studji għal osservazzjoni ta' sigurtà jindikaw żieda fir-riskju ta' intussuxxezzjoni, l-aktar fl-ewwel 7 ijiem wara tilqim b'rotavirus (ara sezzjoni 4.8).
English: EU/1/05/330/005 - pack of 1 pre-filled oral applicator EU/1/05/330/006 - pack of 5 pre-filled oral applicators EU/1/05/330/007 - pack of 10 pre-filled oral applicators EU/1/05/330/008 - pack of 25 pre-filled oral applicators
Maltese: EU/1/05/330/007 - pakkett ta' 10 applikaturi tal-ħalq mimlijin lesti EU/1/05/330/008 - pakkett ta' 25 applikaturi tal-ħalq mimlijin lesti
English: In a clinical study, 100 infants with HIV infection were administered Rotarix lyophilised formulation or placebo.
Maltese: Fi studju kliniku, Rotarix jew plaċebo ngħata lil 100 tarbija bl-infezzjoni ta' l-HIV.
English: A clinical study performed in Europe evaluated Rotarix given according to different European schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4,000 subjects.
Maltese: Ewropej differenti (2,3 xhur; 2,4 xhur; 3,4 xhur; 3,5 xhur) f'4,000 suġġett.
English: In observational studies, vaccine effectiveness was demonstrated against severe gastro-enteritis leading to hospitalisation due to rotavirus of common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] as well as the less common rotavirus genotypes G9P[4] and G9P[6].
Maltese: Fi studji ta' osservazzjoni, l-effettivita' tal-vaċċin intweriet kontra gastro-enterite severa li wasslet għal rikoveru l-isptar minħabba rotavirus ta' ġenotipi komuni G1P[8], G2P[4], G3P[8], G4P[8] u G9P[8] kif ukoll il-ġenotipi ta' rotavirus l-inqas komuni G9P[4] u G9P[6].
English: After your child has received Rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 “Possible side effects”).
Maltese: Wara li t-tarbija tiegħek tkun ħadet Rotarix, kellem tabib/professjonist fil-qasam mediku tiegħek immedjatament jekk it-tarbija tiegħek ikollha uġigħ sever fl-istonku, rimettar persistenti, demm fl ippurgar, stonku minfuħ u/jew deni għoli (ara wkoll sezzjoni 4 “Effetti sekondarji possibbli”).
English: Rotarix powder and solvent for oral suspension Rotavirus vaccine, live
Maltese: Rotarix trab u solvent għal suspensjoni orali Vaċċin ta' rotavirus, ħaj
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (1.5 ml) ikun fiha:
English: Hypersensitivity after previous administration of rotavirus vaccines.
Maltese: Sensittività eċċessiva wara li jkunu ngħataw vaċċini ta' rotavirus.
English: A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] genotype during the first year of life.
Maltese: Analiżi miġbura flimkien ta' ħames studji dwar l-effikaċja*, irriżultat f'effikaċja ta' 71.4% (95% CI:20.1;91.1) kontra gastro-enterite severi bir-rotavirus (qari Vesikari ≥11) kawżata mill-ġenotip
English: Strains with P[8] genotype † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale * Not statistically significant (p ≥ 0.05).
Maltese: Gastro-enterite severa ddefinita bħala punteġġ ta'>11 fuq l-iskala Vesikari * Mhux statistikament sinifikanti (p ≥ 0.05).
English: * Not statistically significant (P ≥ 0.05).
Maltese: * Mhux statistikament sinifikanti (P ≥ 0.05).