FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a normal observation.
Maltese: Din hija osservazzjoni normali.
English: (≥1/10,000 to <1/1,000)
Maltese: (≥1/10,000 sa <1/1,000)
English: (≥1/100 to <1/10)
Maltese: (≥1/100 sa <1/10)
English: 8 micrograms
Maltese: 8 mikrogrammi
English: Bordetella pertussis antigens (Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1)
Maltese: Antigeni tal-Bordatella pertussis (Toxoid tal-Pertussis1, Filamentous haemagglutinin1 , Pertactin1)
English: Interference with laboratory testing
Maltese: Interferenza ma' testijiet fil-laboratorju
English: 1adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
Maltese: 1adsorbit fuq aluminium oxide hydrated (Al(OH)3)
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code: J07CA09
Maltese: Vaċċini batteriċi u virali kombinati, Kodiċi ATC: J07CA09 Immunoġeniċità
English: Hib powder: lactose anhydrous
Maltese: Trab tal-Hib: lactose anhydrous
English: At least 25.4% (anti-PT), 97.5% (anti-FHA) and 87.0% (anti-PRN) of children were seropositive against the pertussis components.
Maltese: 4% (antiPT), 97.5% (anti-FHA) u 87.0% (anti-PRN) tat-tfal kienu seropożittivi kontra l-komponenti ta' pertussis.
English: 1adsorbed on Al(OH)3
Maltese: 1adsorbit fuq (Al (OH)3
English: • Store in a refrigerator (2°C - 8°C).
Maltese: • Aħżen fi friġġ (2°C - 8°C).
English: HIV infection is not considered as a contraindication.
Maltese: Infezzjoni tal-HIV mhix meqjusa bħala kontraindikazzjoni.
English: Singapore
Maltese: Singapor
English: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89, 1330 Rixensart
Maltese: Rue de l'Institut 89, 1330 Rixensart
English: GlaxoSmithKline Biologicals s.a. Parc de la Noire Epine 20, rue Fleming, 1300 Wavre
Maltese: Parc de la Noire Epine 20, rue Fleming, 1300
English: Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Maltese: Tel: + 420 2 22 00 11 11 Ccz.info@gsk.com
English: Uncommon Cough Rare
Maltese: Mhux komuni Sogħla Rari
English: 25 micrograms
Maltese: 25 mikrogrammi
English: B-1330 Rixensart, Belgium
Maltese: B-1330 Rixensart, Belġju
English: EU/1/00/152/001 - 1 vial and 1 pre-filled syringe without needle EU/1/00/152/002 - 10 vials and 10 pre-filled syringes without needles EU/1/00/152/005 - 1 vial and 1 pre-filled syringe with 2 needles EU/1/00/152/006 - 10 vials and 10 pre-filled syringes with 20 needles
Maltese: EU/1/00/152/001 - kunjett 1 u siringa mimlija għal-lest mingħajr labra EU/1/00/152/002 - 10 kunjetti u 10 siringi mimlija għal-lest mingħajr labar EU/1/00/152/005 - kunjett 1 u siringa 1 mimlija għal-lest b'2 labriet EU/1/00/152/006 - 10 kunjetti u 10 siringi mimlija lesti b'20 labra
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Hib powder:
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: Infanrix hexa will confer an anti-PRP immune response (cut-off ≥ 0.15µg/ml) in at least 84% of the infants.
Maltese: Infanrix hexa ser jagħti rispons immuni anti-PRP (cut-off ≥ 0.15 μg/ml) f'mill-inqas 84% tat-trabi.
English: Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Maltese: Medium 199 li prinċipalment fih amino acids, mineral salts, vitamini
English: Hepatitis B surface antigen (HBs)2,3
Maltese: Antiġen tas-superfiċje ta' l-epatite B (HBs)2,3
English: 3-5-11 months of age N=530 (4 studies)
Maltese: 3-5-11-il xahar ta' eta N=530 (4 studj)
English: Date of latest renewal: 31 August 2010
Maltese: Data tal-aħħar tiġdid: 31 t'Awwissu 2010
English: 2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4)
Maltese: 2manifatturat fuq ċelloli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rekombinanti tad-DNA 3adsorbit fuq aluminium phosphate (AlPO4 )
English: DTPa-HBV-IPV suspension: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections
Maltese: Suspensjoni ta' DTPa-HBV-IPV: sodium chloride (NaCl), medium 199 li fih prinċipalment amino acids, mineral salts, vitamini u ilma għall-injezzjonijiet
English: Infanrix hexa, Powder and suspension for suspension for injection.
Maltese: Infanrix hexa, Trab u suspensjoni għal suspensjoni għall-injezzjoni.
English: Lymphadenopathy2, thrombocytopenia2
Maltese: Limfandenopatija 2, tromboċitopenja2
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or formaldehyde, neomycin and polymyxin.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1, jew formalina, neomycin u polymyxin.
English: 1 dose (0.5 ml)
Maltese: 1 doża (0.5 ml)
English: 2-dose
Maltese: 2 dożi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/152/021 - pack of 50 (5 X 10) without needles
Maltese: FIS-SUQ EU/1/00/152/021 - pakkett ta' 50 (5 X 10) mingħajr labar
English: 8 D-antigen unit type 3 (Saukett strain)4
Maltese: 8 Unità ta' D-antiġen tip 3 (tar-razza Saukett) 4
English: weeks N= 265 (1 study)
Maltese: N= 265 (studju)
English: - neomycin or polymyxin (antibiotics).
Maltese: Dan il-vaċċin fih neomycin u polymyxin (antibijotiċi).
English: Poliovirus (inactivated) (IPV) type 1 (Mahoney strain)4
Maltese: Poliovirus (inattivat) (IPV) tip 1 (tar-razza Mahoney)4
English: Persistence of the immune response
Maltese: Persistenza tar-rispons immuni
English: (polyribosylribitol phosphate, PRP) 3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Maltese: (polyribosylribitol phosphate, PRP) 3 konjugat ma toxoid tat-tetnu bħala proteina ġarriera madwar 25 mikrogramma
English: With regards to hepatitis B, seroprotective antibody concentrations (≥10 mIU/ml) following a 3-dose primary and booster schedule with Infanrix hexa have been shown to persist in ≥ 85% of subjects 4-5 years of age, in ≥72% of subjects 7-8 years of age, in ≥60% of subjects 12-13 years of age and in 53.7% of subjects 14-15 years of age.
Maltese: Fir-rigward tal-epatite B, il-konċentrazzjonijiet ta' antikorpi seroprotettivi (≥10 mIU/ml) wara skeda primarja u booster ta' 3 dożi b'Infanrix hexa ntwerew li jippersistu f'≥ 85% tal-individwi li għandhom bejn 4 u 5 snin, f'≥ 72% tal-individwi li għandhom bejn 7-8 snin, f'≥60% ta' individwi minn 12 sa 13il sena u f'53.7% tal-individwi ta' bejn l-14-15-il sena.
English: 40 D-antigen unit type 2 (MEF-1 strain)4
Maltese: Unità ta' D-antiġen tip 2 (tar-razza MEF-1) 4
English: Considerations
Maltese: Konsiderazzjonijiet
English: months N= 1693 (6 studies)
Maltese: 2-4-6 xhur N= 1693 (6 studji)
English: DTPa-HBV-IPV suspension:
Maltese: TAD- DTPA HBV IPV
English: Poliovirus (inactivated) type 1 (Mahoney strain)4
Maltese: Poliovirus (inattivat) tip 1 (tar-razza Mahoney) 4
English: In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, GuillainBarré syndrome, encephalopathy, encephalitis and meningitis have been reported.
Maltese: F`każijiet rari ħafna ġew irrappurtati, reazzjonijiet allerġiċi li jixbħu l-mard tas-serum, paralażi, newropatija, nevrite, pressjoni baxxa, vaskulite, lichen planus, eritema multiforme, artrite, dgħjufija muskolari, is-sindromu ta' Guillain-Barré, enkefalopatija, enkefalite u meninġite.
English: Bronchitis, apnoea2 [see section 4.4 for apnoea in very preterm infants (≤ 28 weeks of gestation)]
Maltese: Bronkite, apnea2 [ara sezzjoni 4.4 għal apnea fit-trabi mwieldin ħafna qabel iż-żmien (≤ 28 ġimgħa ta' tqala)]
English: Very common Fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain,
Maltese: Komuni ħafna Deni ≥ 38°C, nefħa lokali fil-post talinjezzjoni (≤ 50 mm), għeja , uġigħ, ħmura
English: • Haemophilus influenzae type b (Hib): can cause brain swelling (inflammation).
Maltese: • Haemophilus influenzae ta' tip b (Hib): tista' tikkawża nefħa (infjammazzjoni) fil-moħħ.
English: Other medicines and Infanrix hexa
Maltese: Mediċini oħra u Infanrix hexa
English: • Risk Management Plan (RMP) Not applicable.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli.
English: 2-4-12 months of age N=223 (1 study)
Maltese: 2-4-12-il xahar ta' età N=223 (studju wieħed)
English: One month after primary vaccination at least 98.7% of subjects were seroprotected against diphtheria, tetanus and poliovirus types 1 and 2; at least 90.9% had seroprotective antibody levels against the hepatitis B, PRP and poliovirus type 3 antigens; and all subjects were seropositive for antibodies against FHA and PRN while 94.9% were seropositive for anti-PT antibodies.
Maltese: Xahar wara t-tilqima primarja tal-inqas 98.7% tal-individwi kienu seroprotetti kontra d-difterite, ittetnu u l-poljovirus tat-tipi 1 u 2; tal-inqas 90.9% kellhom livelli ta' antikorpi seroprotettivi kontra l antiġeni tat-tip 3 tal-epatite B, tal-PRP u tal-poljovirus; u l-individwi kollha kienu seropożittivi għal antikorpi kontra l-FHA u l-PRN filwaqt 94.9% kienu seropożittivi għal antikorpi kontra l-PT.
English: Protective immunity against the three poliovirus types and PRP was observed in at least 91.0% of children and against diphtheria and tetanus in at least 64.7% of children.
Maltese: L-immunità protettiva kontra t-tliet tipi ta' poljovirus u PRP kienet osservata f'talinqas 91.0% tat-tfal u kontra d-difterite u t-tetnu f'mill-inqas 64.7% tat-tfal.
English: Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), meningococcal serogroup B vaccine (MenB), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine.
Maltese: PCV13), il-vaċċin tal-konjugat tas-serogrupp C meningokokkali (il-konjugati CRM197 u TT), il-vaċċin tal-konjugat tas-serogruppi A, C, W-135 u Y meningokokkali (konjugat TT), il-vaċċin tas-serogrupp B meningokokkali (MenB), il-vaċċin tar-rotavirus orali u l-ħosba, il-gattone, il-ħosba Ġermaniża u l ġidri r-riħ.
English: The immunogenicity of Infanrix hexa has been evaluated in clinical studies from 6 weeks of age.
Maltese: L-immunoġeniċità ta' Infanrix hexa ġiet evalwata fi studji kliniċi minn 6 ġimgħat ta' età.
English: • Hepatitis B: is caused by the hepatitis B virus.
Maltese: • Epatite B: hija kkawżata mill-virus tal-epatite B.
English: This rises to 88% in case of concomitant use of pneumococcal vaccine containing tetanus toxoid as carrier and to 98% when Infanrix hexa is co-administered with a TT conjugated meningococcal vaccine (see section 4.5).
Maltese: Dan jiżdied sa 88% f'każ ta' użu konkomitanti ta' vaċċin pnewmokokkali li fih toxoid tat-tetnu bħala trasportatur u sa 98% meta Infanrix hexa jingħata flimkien ma' vaċċin meningokokkali konjugat TT (ara sezzjoni 4.5).
English: • The booster dose should be given at least 6 months after the last priming dose and preferably before 18 months of age.
Maltese: • Id-doża booster għandha tingħata mill-inqas 6 xhur wara l-aħħar doża primarja u preferibbilment qabel it-18-il xahar ta' età.
English: 2-4-12 months of age N=196 (1 study)
Maltese: 2-4-12-il xahar ta' età N=196 (studju wieħed)
English: Tetanus toxoid1
Maltese: Toxoid tat-tetnu1
English: N = number of subjects † cut-off accepted as indicative of protection * Post booster, 94.4% of subjects in the 2-4-12 months schedule and 97.0% of subjects in the 3-5-11 months schedule had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection.
Maltese: * Wara d-doża booster, 94.4% tal-individwi fl-iskeda ta' 2-4-12-il xahar u 97.0% tal-individwi fliskeda ta' 3-5-11-il xahar kellhom konċentrazzjoni anti-PRP ≥ 1 µg/ml li tindika protezzjoni fit-tul.
English: One month after the booster dose at least 98.4% of subjects had seroprotective or seropositive antibody levels against each of the antigens except against PT (at least 96.8%) and hepatitis B (at least 88.7%).
Maltese: Xahar wara d-doża booster tal-inqas 98.4% tal-individwi kellhom livelli ta' antikorpi seroprotettivi jew seropożittivi kontra kull wieħed mill-antiġeni ħlief kontra PT (tal-inqas 96.8%) u epatite B (talinqas 88.7%).
English: Data have shown no clinically relevant interference in the antibody response to each of the individual antigens, although inconsistent antibody response to poliovirus type 2 in co-administration with Synflorix was observed (seroprotection ranging from 78% to 100%) and the immune response rates to the PRP (Hib) antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age were higher if coadministered with a tetanus toxoid conjugate pneumococcal or meningococcal vaccine (see section 5.1).
Maltese: Dejta ma wriet ebda interferenza klinikament rilevanti fir-rispons tal-antikorpi għal kull antiġenu individwali, għalkemm kien osservat rispons tal-antikorpi inkonsistenti għall-poljovirus tat-tip 2 fl għoti flimkien ma' Synflorix (seroprotezzjoni li tvarja minn 78% sa 100%) u r-rati ta' rispons immuni għall-antiġenu PRP (Hib) ta' Infanrix hexa wara 2 dożi mogħtija f'2 u 4 xhur ta' età kienu ogħla jekk ingħata ma' vaċċin pnewmokokku jew meningokokkali tal-konjugat tat-toxoid tat-tetnu (ara sezzjoni 5.1).
English: 3-5-11 months of age N=532 (3 studies)
Maltese: 3-5-11-il xahar ta' età N=532 (studju wieħed)
English: 2 adsorbed on AlPO4
Maltese: 2adsorbit fuq (AlPO4)
English: The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Infanrix hexa fit-tfal minn età 'l fuq minn 36 xahar ma ġewx determinati.
English: For adjuvants, see section 2.
Maltese: Għal sustanzi awżiljari ara taqsima 2
English: The persistence of the immune response to a 3-dose primary (at 2-3-4, 3-4-5 or 2-4-6 months of age) and booster (in the second year of life) schedule with Infanrix hexa was evaluated in children 4-8 years of age.
Maltese: Il-persistenza tar-rispons immunitarju għal skeda primarja u booster ta' 3 dożi (f'2-3-4, 3-4-5 jew 2-46 xhur ta' età) u booster (fit-tieni sena tal-ħajja) b'Infanrix hexa kienet evelwata fi tfal li għandhom bejn 4 u 8 snin.
English: • The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV
Maltese: Is-suspensjoni tad-difterite, tetnu, pertussis aċellulari, epatite B, poljomelite inattivat (DTPa-HBV
English: Data from clinical studies show similar incidences of fever when Infanrix hexa is co-administered with other pneumococcal saccharide conjugated vaccine.
Maltese: Dejta minn studji kliniċi turi inċidenzi simili ta' deni meta Infanrix hexa jingħata flimkien ma' vaċċin konjugat saccharide pnewmokokkali ieħor.
English: The following drug-related adverse reactions were reported in clinical studies (data from more than 16,000 subjects) and during post-marketing surveillance.
Maltese: Ir-reazzjonijiet avversi li ġejjin li huma marbuta mal-mediċina kienu rrappurtati fi studji kliniċi (dejta minn aktar minn 16,000 individwu) u waqt sorveljanza wara t-tqegħid fis-suq.
English: N = number of subjects * Samples tested by ELISA to have anti-diphtheria antibody concentrations < 0.1 IU/ml were re-tested using Vero-cell neutralisation assay (seroprotection cut-off ≥ 0.016 IU/ml): 96.5% of the subjects were seroprotected § Number of subjects from 2 clinical studies
Maltese: * Kampjuni ttestjati minn ELISA bħala li għandhom konċentrazzjonijet ta' antikorpi kontra d-difterite < 0.1 IU/ml kienu ttestjat mill-ġdid permezz ta' assaġġ ta' newtralizzazzjoni taċ-ċelloli Vero (cut-off tas-seroprotezzjoni ≥ 0.016 IU/ml): 96.5% tal-individwi kienu seroprotetti
English: 10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
Maltese: 10 x 1 doża (0.5 ml)
English: Fever of greater than 39.5°C was reported in 18% of children receiving Infanrix hexa with MMRV vaccine, as compared to 3.3% of children receiving Infanrix hexa alone and 19.3% of children receiving MMRV alone (see sections 4.4 and 4.5).
Maltese: Deni ta' aktar minn 39.5°C kien irrapportat fi 18% tat-tfal li rċevew Infanrix hexa ma' vaċċin MMRV, meta mqabbel ma' 3.3% tat-tfal li rċevew Infanrix hexa waħdu u 19.3% tat-tfal li rċevew MMRV waħdu (ara sezzjonijiet 4.4 u
English: I.M.
Maltese: A.
English: Serological correlates of protection have been established for diphtheria, tetanus, polio, Hepatitis B and Hib.
Maltese: Korrelazzjonijiet seroloġiċi ta' protezzjoni ġew stabbiliti għal difterite, tetnu, poljo, epatite B u Hib.
English: Infanrix hexa will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Maltese: Infanrix hexa mhux ser jipprevjeni mard ikkawżat minn patoġeni għajr Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus tal-epatite B, poljovirus jew Haemophilus influenzae tat-tip b. Madankollu, jista' jkun mistenni li l-epatite D ser tiġi evitata bl-immunizzazzjoni peress li l epatite D (ikkawżata mill-aġent delta) ma sseħħx fin-nuqqas ta' infezzjoni tal-epatite B.
English: redness
Maltese: Labra
English: Hepatitis B surface antigen2,3
Maltese: Antiġen tas-superfiċje ta' l-epatite B 2,3
English: Component of a multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles
Maltese: Komponent ta' pakkett multiplu li fih 5 pakketti, kull wieħed fih 10 kunjetti u 10 siringi mimlija għallest mingħajr labar
English: Post marketing experience
Maltese: KONDIZZJONIJIET U REKWIŻITI
English: Bordetella pertussis antigens Pertussis toxoid (PT)1
Maltese: Toxoid tal-Pertussis (PT)1
English: Lactose anhydrous
Maltese: Lactose anhydrous Sodium chloride
English: months N= 1055 (6 studies)
Maltese: 3-4-5 xhur N= 1055 (6 studji)
English: Fever ≥39.5°C was observed in 2.6% and 1.5% of infants receiving Infanrix hexa with or without Prevenar, respectively (see sections 4.4 and 4.5).
Maltese: Deni ta' ≥39.5°C kien osservat f'2.6% u 1.5% fi trabi li rċivew
English: not less than 40 International Units (IU)
Maltese: mhux anqas minn 40 Unità Internazzjonali (IU)
English: Powder and suspension for suspension for injection.
Maltese: Trab u suspensjoni għal suspensjoni għall-injezzjoni.
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: GlaxoSmithKline Biologicals s.a.
English: Pre-filled syringe: suspension
Maltese: Siringa mimlija għal-lest: suspensjoni
English: Very common: (≥1/10) Common:
Maltese: Mhux komuni: (≥1/1,000 sa <1/100) Rari:
English: • Store in the original package in order to protect from light.
Maltese: • Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: 1 vial and 1 pre-filled syringe + 2 needles
Maltese: Kunjett u siringa 1 mimlija għal-lest + 2 labriet
English: However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 month's schedule.
Maltese: Madankollu, d-dejta tindika li l-protezzjoni kontra l-pertussis tista' tkun qed tbatti fl-età ta' 7-8 snin b'din l-iskeda ta' 3-5-12-il xahar.
English: Hepatitis B surface antigen2
Maltese: Antiġen tas-superfiċje ta' l-epatite B2
English: N = number of subjects * in a subgroup of infants not administered hepatitis B vaccine at birth, 77.7% of subjects had anti-HBs titres ≥ 10 mIU/ml ** Post booster, 98.4% of subjects had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection † cut-off accepted as indicative of protection
Maltese: N = numru ta' individwi * f'subgrupp ta' trabi li ma ngħatawx il-vaċċin tal-epatite B fit-twelid, 77.7% tal-individwi kellhom livelli anti-HB ≥ 10 mIU/ml
English: not less than 30 International Units (IU)
Maltese: mhux anqas minn 30 Unità Internazzjonali (IU)
English: Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate.
Maltese: Dejta klinika ġġenerata b'paracetamol u b'ibuprofen tissuġġerixxi li l-użu profilattiku ta' paracetamol jista' jnaqqas ir-rata taddeni, waqt li l-użu profilattiku ta' ibuprofen wera effett limitat fit-tnaqqis tar-rata tad-deni.
English: Syringe cap
Maltese: MINGĦAJR LABAR
English: Hepatitis B immunological memory was confirmed in children 4 to 15 years of age.
Maltese: Il-memorja immunoloġika tal-epatite B kienet ikkonfermata fi tfal li għandhom bejn 4 u 15-il sena.
English: • if your baby was 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: • jekk it-tarbija tiegħek titwieled prematura ħafna (fit-28 ġimgħa ta' tqala jew qabel) jista' jkun hemm perjodi itwal min-normal bejn nifs u ieħor għal 2-3 ijiem wara t-tilqima.
English: How to store Infanrix hexa
Maltese: Kif jaħdem Infanrix hexa
English: Anti-Polio type 3 (1/8 dilution) †
Maltese: Anti-Polio tip 3 (dilwizzjoni 1/8) †
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Maltese: Vaċċin (adsorbit) konjugat tad-difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV), u Haemophilus influenzae ta'tip b (Hib).
English: In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
Maltese: Prevenar (PCV7) bħala doża ta' rinforz (ir-raba') għaż-żewġ tilqimiet, deni ≥ 38.0°C kien irrappurtat f'43.4% fi trabi li rċivew Prevenar u Infanrix hexa fl-istess ħin meta mqabbla ma' 30.5% fi trabi li rċivew it-tilqima eżavalenti waħedha.
English: The signs may include:
Maltese: Wara li jiġi rikostitwit:
English: Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Maltese: Vaċċin (adsorbit) konjugat tad-difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV), u Haemophilus influenzae ta' tip B (Hib).
English: Anti-Polio type 2 (1/8 dilution) †
Maltese: Anti-Polio tip 2 (dilwizzjoni 1/8) †
English: However the stability has been demonstrated for 8 hours at 21°C after reconstitution.
Maltese: Madanakollu, ntwera li jibqa tajjeb għal 8 sigħat wara li jiġi rikostitwit, f'temperatura ta' 21°C.
English: Anti-Polio type 1 (1/8 dilution) †
Maltese: Anti-Polio tip 1 (dilwizzjoni 1/8) †
English: Children at 7-8 years of age
Maltese: 11 u 13-il xahar ta' età.
English: Upon storage, a clear liquid and white deposit may be observed in the pre-filled syringe containing the DTPa-HBV-IPV suspension.
Maltese: Meta jinħażen, jista' jiġi osservat likwidu ċar u depożitu abjad fis-siringa mimlija għal-lest li fiha s suspensjoni DTPa-HBV-IPV.
English: The lyophilised Haemophilus influenzae type b (Hib) component is a white powder.
Maltese: Il-komponent tal-Haemophilus influenzae tip b (Hib) lajofiliżżat huwa trab abjad.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Tabulated summary of adverse reactions
Maltese: Reazzjonijiet avversi miġbura f'tabella
English: Stability data indicate that the vaccine components are stable at temperatures up to 25°C for 72 hours.
Maltese: Tagħrif dwar l-istabbilità jindika li l-komponenti tal-vaċċin huma stabbli f'temperaturi sa 25°C għal 72 siegħa.