FrancophonIA/ELRC3.0 huggingface dataset:
English: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, saccharose, essential amino acids including L-phenylalanine, sodium hydroxide and/or acetic acid and/or hydrochloric acid (for pH adjustment), and water for injections.
Maltese: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, sakkarosju, aċidi amminiċi essenzjali li jinkludu L-phenylalanine, sodium hydroxide u/jew acetic acid u/jew hydrochloric acid (għall aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: Sanofi Pasteur Parc Industriel d'Incarville 27100 Val de Reuil France
Maltese: Sanofi Pasteur SA Parc Industriel d'Incarville 27100
English: 8 D antigen units5
Maltese: 8 D unitajiet t'antiġen5
English: 32 D antigen units5
Maltese: 32 D unità t'antiġen5
English: Hepatitis B surface antigen6
Maltese: Antiġen superfiċjali ta' Epatite B6
English: Primary 2-4-6 months and booster at 12-24 months
Maltese: Primarja 2-4-6 xahar u buster fit-12-24 xahar
English: • Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;
Maltese: • Biki persistenti, li ma jistax jiġi kkonslat li jdum għal ≥ 3 hours, li jseħħ fi żmien 48 siegħa mill-vaċċinazzjoni;
English: 40 D antigen units5
Maltese: 40 D unità t'antiġen5
English: Manufacturer: Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, France
Maltese: Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, Franza
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Maltese: (≥1/1,000 sa <1/100)
English: 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles
Maltese: 1 siringa mimlija lesta b'labra 1 (0.5 ml) 10 siringi mimlija lesti b'10 labriet (0.5 ml) 1 siringa mimlija lesta b'2 labriet (0.5 ml) 10 siringi mimlija lesti b'20 labriet (0.5 ml)
English: Adverse Events
Maltese: Reazzjonijiet Avversi
English: 1541 avenue Marcel Mérieux 69280 Marcy L'Etoile France
Maltese: Sanofi Pasteur SA 1541 avenue Marcel Mérieux 69280 Marcy L'Etoile Franza
English: 3 Or equivalent activity determined by an immunogenicity evaluation 4 Produced on Vero cells
Maltese: 3 Jew attività ekwivalenti determinata minn evalwazzjoni tal-immunoġeniċità
English: STATEMENT OF ACTIVE SUBSTANCE(S) One dose1 (0.5 ml) contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Doża waħda1 (0.5 ml) fiha:
English: Hypotonic reactions or hypotonic-hyporesponsive episodes (HHE)
Maltese: Reazzjonijiet ipotoniċi jew episodji ipotoniċi iporisponsivi (HHE - hypotonic hyporesponsive episodes)
English: Sanofi Pasteur, Parc Industriel d'Incarville, 27100 Val de Reuil, France
Maltese: Sanofi Pasteur, Parc Industriel d'Incarville, 27100
English: Table 1: Adverse Reactions from clinical trials and reported during commercial use System Organ Class
Maltese: Tabella 1:Reazzjonijiet avversi minn provi kliniċi u rappurtati bl-użu kummerċjali
English: 12 micrograms
Maltese: 12 il mikrogramma
English: Data on concomitant administration of Hexacima with a meningococcal C conjugate vaccine or a meningococcal group A, C, W-135 and Y conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Maltese: Data dwar l-amministrazzjoni konkomitanti ta ' Hexacima ma' vaċċin konjugat ta' meningokokkus C jew grupp meningokokkali A, C, W-135 u Y vaċċin konjugat ma uriet l-ebda interferenza klinikament rilevanti fir-rispons ta' antikorpi għall kull wieħed mill- antiġeni.
English: The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexacima (N=148) at 2, 4, 6 months of age.
Maltese: Ir-rispons immuni għal Hib (PRP) u l-antiġeni tal-pertussis (PT u FHA) kienu evalwati wara 2 dożi fi subsett ta ' individwi li ngħataw Hexacima (N = 148) fi 2, 4 , 6 xhur ta' età.
English: Anti-Polio type 3 (≥ 8 (1/dilution))
Maltese: Anti-Poljo tip 3 (≥ 8 (1/dilution))
English: In addition:
Maltese: JIS:
English: EU/1/13/828/002 EU/1/13/828/003 EU/1/13/828/004 EU/1/13/828/005 EU/1/13/828/006 EU/1/13/828/007
Maltese: EU/1/13/828/002 EU/1/13/828/003 EU/1/13/828/004
English: For instructions on handling see section 6.6.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 IU International Unit
Maltese: 1 Assorbit fuq aluminium hydroxide, idrat (0.6 mg Al3+) 2 Uniti Internazzjonali
English: Anti-diphtheria (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-PTe (≥ 8 EU/ml) Anti-FHAe (≥ 8 EU/ml) Anti-HBs (≥ 10 mIU/ml) Anti-Polio type 1 (≥ 8 (1/dilution))
Maltese: IU/ml) Anti-PTe (≥ 8 EU/ml) Anti-FHAe (≥ 8 EU/ml) Anti-HBs (≥ 10 mIU/ml) Anti-Poljo tip 1 (≥ 8 (1/dilution))
English: Hexacima in vials EU/1/13/828/001
Maltese: Hexacima f'kunjetti EU /1/13/ 828/ 001
English: Effectiveness in protecting against Hib invasive disease
Maltese: Effettività fil-protezzjoni kontra l-marda invażiva tal-Hib
English: Pyrexia (body temperature ≥39.6°C)
Maltese: Għoqda fis-sit tal-injezzjoni Deni (temperatura tal-ġisem ≥ 39.6°C)
English: • Swelling or inflammation of the brain (encephalopathy/encephalitis).
Maltese: • Nefħa jew infjammazzjoni tal-moħħ (enċefalopatija/enċefalite).
English: Anti-Polio type 2 (≥ 8 (1/dilution))
Maltese: Anti-Poljo tip 2 (≥ 8 (1/dilution))
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Maltese: Il-vaċċin jista 'jkun fiha traċċi ta' glutaraldehyde formaldehyde, neomycin, streptomycin u polymyxin B
English: • Hepatitis B surface antigen
Maltese: • Antiġen superfiċjali ta' Epatite B
English: It causes severe coughing that may lead to problems with breathing.
Maltese: rata tal-qalb mgħaġġla assoċjat ma 'disturbi respiratorji.
English: Table 3: Seroprotection ratesa at the age of 4.5 years old after vaccination with Hexacima Antibody Thresholds
Maltese: Tabella 3: Rati ta' protezzjoni fis-serum a fl-età ta' 4.5 snin wara vaċċinazzjoni b'Hexacima Limiti meħtieġa ta'
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan iħalli monitoraġ kontiwu tal-proporzjoni tal-benefiċju/riskju tal-prodott mediċinali.
English: (Polyribosylribitol Phosphate) conjugated to Tetanus protein
Maltese: (Polyribosylribitol Phosphate)
English: Pack of 1 or 10.
Maltese: Daqs ta' pakkett ta' 1 jew 10.
English: No data are available in older children (see sections 4.8 and 5.1).
Maltese: M'hemmx informazzjoni disponibbli fi tfal akbar (ara sezzjonijiet 4.8 u 5.1).
English: An updated RMP should be submitted:
Maltese: L-RMP aġġornat għandu jiġi ppreżentat:
English: No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy (see section 4.4).
Maltese: L-ebda interazzjoni klinikament sinifikanti ma' trattamenti jew prodotti bijoloġiċi oħra ma ġiet irrappurtata ħlief fil- każ ta' terapija immunosoppressiva (ara sezzjoni 4.4).
English: Immune memory against Hepatitis B had been demonstrated by the presence of an anamnestic response to a challenge Hepatitis B vaccination at the age of 9 years in 93% of vaccinees with development of geometric mean concentrations at 3692 (95% CI: 1886 - 7225) mIU/ml after vaccination.
Maltese: Il-memorja immuni kontra l-epatite B ġiet murija permezz tal-presenza ta' rispons anamnestiku meta ngħatat il-vaċċinazzjoni tal-Epatite B fl-età ta' 9 snin f'93% ta' dawk li ħadu l-vaċċin bi żvilupp ta' konċentrazzjonijiet medji ġeometriċi ta' 3692 (95% CI:
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-Immaniġġar tar-Riskju (RMP)
English: Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexacima against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal).
Maltese: L-effikaċja tal-vaċċin tal-antiġeni tal-pertussi aċellulari (aP) li hemm f' Hexacima kontra l-aktar pertussi tipika severa mfissra mill-WHO (≥ 21 jum ta' sogħla parossimali) hi dokumentata fi studju każwali u double-blind fost trabi b'doża primarja ta' 3 permezz tal-vaċċin DTaP f'pajjiż endemiku (Senegal).
English: Primary 6-10-14 weeks and booster at 15-18 months
Maltese: Primarja 6-10-14-il ġimgħa u buster fil
English: • Tetanus Toxoid
Maltese: • Tossojdi tat-Tetnu
English: Pack of 10.
Maltese: Daqs tal-pakkett ta ' 10 .
English: 5 Or equivalent antigenic quantity determined by a suitable immunochemical method 6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Maltese: Jew kwantità antiġenika ekwivalenti stabbilita b'metodu immunokimiku 6 Prodott fiċ-ċelluli tal-ħmira Hansenula polymorpha bit-teknoloġija rikombinanti ta' DNA
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 mwielda b'mod prematur ħafna (fi jew qabel 28 ġimgħa ta' tqala) jista' jkun li n-nifsijiet ikunu ta' perjodu itwal minn normal u dan iseħħ għal 2 - 3 ijiem wara t-tilqima.
English: • Poliomyelitis (often just called polio) is caused by viruses that affect the nerves.
Maltese: • Poljomelite (spiss imsejħa poljo) hija kkawżata minn virusis li jaffettwaw in-nervituri.
English: Table 2: Seroprotection/Seroconversion rates* one month after booster vaccination with Hexacima
Maltese: Tabella 2: Rati ta' Seroprotezzjoni/Serokonverżjoni* xahar wara tilqim buster b' Hexacima
English: divízia vakcín Sanofi Pasteur Tel.: +421 2 33 100 100
Maltese: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. divízia vakcín Sanofi Pasteur Tel.: +421 2 33 100 100
English: The vaccine effectiveness was of 96.7% for the full primary series, and 98.5% for booster dose (irrespective of priming).
Maltese: L-effettività tal-vaċċin kienet ta' 96.7% għas-serje primarja sħiħa, u 98.5% għal doża buster
English: Anti-diphtheria (≥ 0.01 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) Anti-PT (Seroconversion ‡‡) (Vaccine response§) Anti-FHA (Seroconversion ‡‡) (Vaccine response§)
Maltese: Antidifterite (≥ 0.01 IU/ml) Antitetnu (≥ 0.01 IU/ml) Anti-PT
English: A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexacima.
Maltese: Storja ta' aċċessjonijiet bid-deni, storja familjari ta' konvulżjonijiet jew is-Sindromu ta' Mewt f'Daqqa fi Trabi (SIDS - Sudden Infant Death Syndrome) ma jikkostitwixxux kontraindikazzjoni għall-użu ta' Hexacima.
English: EXP
Maltese: antikorpi
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Maltese: Hexacima huwa disponibbli f'pakkett li fih 1 jew 10 siringi mimlija lesti b'labra 1 separata.
English: • Diphtheria Toxoid
Maltese: • Tossojdi tad-Difterite
English: Hexacima is provided as a suspension for injection in vial (0.5 ml).
Maltese: Hexacima jiġi bħala suspensjoni għall-injezzjoni fi kunjett (0.5 ml).
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;
Maltese: • Kollass jew stat bħal f'xokk (episodju ipotoniku-iporisponsiv) fi żmien 48 siegħa mit-tilqima;
English: • This vaccine does not protect against infections caused by other types of Haemophilus influenzae nor against meningitis due to other micro-organisms.
Maltese: • Dan il-vaċċin ma jipproteġix kontra infezzjonijiet ikkawżati minn tipi oħra ta' Haemophilus influenzae u lanqas kontra l-meninġite kkawżati minn mikro-organiżmi oħra.
English: Marketing Authorisation Holder: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon , France
Maltese: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Franza
English: A dose of 0.5 ml is withdrawn using a syringe for injection.
Maltese: Doża ta ' 0.5 ml tinġibed permezz ta' siringa għall-injezzjoni.
English: • Hepatitis B is caused by the hepatitis B virus.
Maltese: • Epatite B hija kkawżata mill-virus tal-epatite B.
English: - collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination.
Maltese: - kollass jew stat bħal f'xokk b'episodju ipotoniku-iporisponsiv (tnaqqis fl-enerġija) fi żmien 48 siegħa mit-tilqima.
English: Essential amino acids including L-phenylalanine Sodium hydroxide, acetic acid or hydrochloric acid (for pH adjustment) Water for injections.
Maltese: Aċidi amminiċi essenzjali li jinkludu L-phenylalanine Sodium hydroxide, acetic acid jew hydrochloric acid (għall-aġġustament tal-pH)
English: Serious allergic reactions are a rare possibility (may affect up to 1 in 1,000 people) after receiving this vaccine.
Maltese: Reazzjonijiet allerġiċi serji huma possibiltà rari (jistgħu jaffettwaw minn perusna 1 minn kull 1,000) wara it-teħid ta' din it-tilqima.
English: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o.
Maltese: Hrvatska sanofi-aventis Croatia d.o.o Tel.:
English: After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.
Maltese: Wara li tħawwad, l-apparenza normali tal-vaċċin hu suspensjoni bajdanija imdardra.
English: • A dose of 0.5 ml is withdrawn using a syringe for injection
Maltese: • Doża ta '0.5 ml tinġibed permezz ta' siringa għall-injezzjoni
English: Abnormal crying (prolonged crying)
Maltese: Komuni ħafna Anoressja (nuqqas ta aptit)
English: Hexacima in vials
Maltese: Hexacima.
English: Hexacima is a whitish, cloudy suspension.
Maltese: Hexacima, suspensjoni għall-injezzjoni.
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Maltese: Hexacima huwa disponibbli f'pakkett li fih 1 jew 10 siringi mimlija lesti b'2 labriet separati.
English: IM
Maltese: IU2
English: Tetanus Toxoid not less than 40 IU2,3
Maltese: Tossojdi tat-Tetnu mhux inqas minn 40 IU2,3
English: The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Ir-riskju potenzjali t'apnea u l-ħtieġa għal monitoraġġ respiratorju għal 48 sa72 siegħa għandhom jiġu kkunsidrati meta tingħata l-ewwel serje ta' tilqim lil trabi prematuri ħafna (li jitwieldu wara ≤ 28 ġimgħa ta' tqala) u speċjalment f'dawk bi storja preċedenti ta' immaturità respiratorja.
English: • previously had Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis and sensitivity disorders) or brachial neuritis (severe pain and decreased mobility of arm and shoulder) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
Maltese: • kellhom qabel is-sindromu ta' Guillain-Barré (infjamazzjoni temporanju tan-nervituri, paraliżi u diżordni fis-sensitivita) jew newrite brakjali (uġigħ kbir u tnaqqis fil-mobilita tad-driegħ u l-ispalla)
English: Hexacima suspension for injection in pre-filled syringe Hexacima suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni
English: Other medicines or vaccines and Hexacima
Maltese: Mediċini jew vaċċini oħra u Hexacima
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexacima or a vaccine containing the same components or constituents.
Maltese: Sensittività eċċessiva għas-sustanzi attivi, għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1, għal traċċi ta` residwi (glutaraldehyde, formaldehyde, neomycin, streptomycin u polymyxin B), għal kull vaċċin ta' pertussi, jew wara l-għoti preċedenti ta Hexacima jew vaċċin li jkun fih l-istess komponenti jew kostitwenti.
English: • Common side effects (may affect up to 1 in 10 people) are: - abnormal crying (prolonged crying) - diarrhoea - injection site hardness (induration)
Maltese: • Reazzjonijiet komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 persuni) huma: - nuqqas t'aptit (anoressja) - biki
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), without needle.
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija minn qabel (ħġieġ tip I) b'tapp planġer (halobutyl) u għatu tat-tarf (halobutyl), mingħajr labra.
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Maltese: 1 Assorbit fuq aluminium hydroxide, idrat (0.6 mg Al3+) 2 Bħala l-limitu ta' kunfidenza 'l baxx (p= 0.95) 3 Jew attività ekwivalenti determinata minn evalwazzjoni tal-immunoġeniċità
English: There may be a clinically relevant interference in the antibody response of Hexacima and a varicella vaccine and these vaccines should not be administered at the same time.
Maltese: Jista' jkun hemm interferenza klinikament rilevanti fir-rispons antikorporali ta' Hexacima u tilqim ta variċella u dawn il-vaċċini m'għandhomx jingħataw fl-istess żmien.
English: N = Number of individuals analysed (per protocol set) a: Generally accepted surrogates (PT, FHA) or correlates of protection (other components) b: 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) c: 2, 4, 6 months with hepatitis B vaccination at birth (Colombia) d: Due to an OPV National Immunisation Days in the country, Polio results have not have been analysed e: 8 EU/ml corresponds to 4 LLOQ (Lower Limit Of Quantification in enzyme-linked immunosorbent assay
Maltese: d: Minħabba Ġranet Nazzjonali ta' Tilqim b'OPV fil-pajjiż, ir-riżultati tal-Poljo ma ġewx analizzati e: 8 EU/ml jikkorrispondu għal 4 LLOQ (Il-limitu l-baxx ta' Kwantifikazzjoni f'analiżi immunosorbenti mqabbad ma' enzima ELISA-enzyme-linked immunosorbent assay ).
English: The other ingredients are:
Maltese: Barra minn hekk:
English: There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh possible risks.
Maltese: Jista jkun hemm ċirkostanzzi, bħal inċidenza għolja ta pertussis, fejn il- benefiċċji potenzjali huma akbar mir-riskji possibli.
English: d- Potential adverse events (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexacima and not directly with Hexacima)
Maltese: d- Każijiet avversi potenzjali (i.e. każijiet avversi li ġew rrappurtati b'vaċċini oħra li fihom wieħed jew aktar mill-komponenti jew kostitwenti ta' Hexacima u mhux direttament b'Hexacima)
English: The recommended injection site is preferably the antero-lateral area of the upper thigh and the deltoid muscle in older children (possibly from 15 months of age).
Maltese: Is-sit ta' injezzjoni rakkomandat huwa prefibbilment in-naħa antero-laterali tal-koxxa u il-muskoli tad-deltojde fi tfal akbar (possibilment minn 15-il xahar)
English: Hexacima helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexacima is given to children from six weeks of age.
Maltese: Hexacima jgħin biex jipproteġi kontra d-difterite, it-tetnu, il-pertussi, l-epatite B, il-poljomelite u mard serju kkawżat minn Haemophilus influenzae tip b. Hexacima jingħata lit-tfal minn 6 ġimgħat..
English: Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Maltese: Hexacima (DTaP-IPV-HB-Hib) hu indikat għal trabi u tfal żgħar minn sitt ġimgħat għal tilqim primarju u bħala buster kontra d-difterite, it-tetnu, il-pertussi, epatite B, poljomelite u mard invażiv ikkawżat minn
English: • Very rare side effects (may affect up to 1 in 10,000 people) are: - episodes when your child goes into a shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE).
Maltese: • Reazzjonijiet rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000 ruħ) huma: - episodji meta t-tifel jew tifla tiegħek tmur fi stat bħal f'xokk jew isir/issir pallida, tintelaq u ma tirrispondix għal perjodu ta' żmien (reazzjonijiet ipotoniċi jew episodji ipotoniċi iporesponsivi - HHE hypotonic-hyporesponsive episodes).
English: Trometamol
Maltese: - rimettar
English: Immune responses to Hib and pertussis antigens after 2 doses at 2 and 4 months of age
Maltese: Ir-rispons immuni għall-antiġeni tal-Hib u l-pertussis wara 2 dożi fit-2 u r-4 xahar ta' età
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Maltese: Doża 1 (0.5 ml)
English: Hexacima in vials 0.5 ml suspension in vial (type I glass) with a stopper (halobutyl).
Maltese: 0.5 ml suspensjoni (ħġieġ tip I) b'tapp (halobutyl) .
English: The long term capability of the acellular pertussis (aP) antigens contained in Hexacima to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule.
Maltese: Hexacima biex titnaqqas l-inċidenza ta' pertussi u jiġi kkontrollat il-mard ta' pertussi fit-tfulija ntweriet f'sorveljanza nazzjonali ta' 10 snin fuq il-marda ta' pertussi fl-Iżvezja bil-vaċċin pentavalenti DTaP
English: The following information is intended for healthcare professionals only:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni:
English: Hexacima 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: Clostridium tetani, Bordetella pertussis, il-virus ta' epatite B, poljovirus jew Haemophilus influenzae tip b. Madankollu, jista' jkun mistenni li l-epatite D ser tiġi mxekkla mill-immunizzazzjoni peress li epatite D (ikkawżata mill-aġent delta) ma sseħħx fl-assenza ta' infezzjoni b'epatite B. Hexacima mhux ser jipproteġi kontra l-infezzjoni ta' epatite kkawżata minn aġenti oħrajn bħal epatite A, epatite Ċ u l-epatite E jew minn patoġeni oħra tal-fwied.
English: The immune responses to PRP, PT and FHA antigens one month after 2 doses given at 2 and 4 months of age were similar to those observed one month after a 2-dose priming given at 3 and 5 months of age: anti-PRP
Maltese: Ir-rispons immuni għal PRP, PT u FHA Antiġeni xahar wara 2 dożi mogħtija f'2 u 4 xhur ta 'età kienu simili għal dawk osservati xahar wara induzzjoni 2- doża li ngħatat 3 u 5 xhur ta' età : titers anti-PRP ≥ 0.15 mg / ml kienu osservati 73.0 %
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Rapportaġ ta' reazzjonijiet avversi issuspetati wara awtorizazjoni tal-prodott mediċinali huwa importanti.
English: Associated symptoms may include cyanosis, redness, transient purpura and severe crying.
Maltese: Sintomi assoċjati jistgħu jinkludu ċjanożi, ħmura, purpura għaddiena u biki sever.
English: These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness or pain at the injection site, and get better within 3-5 days without the need for treatment.
Maltese: Dawn ir-reazzjonijiet jibdew fi żmien 24-72 siegħa wara t-tilqima, jistgħu jkunu assoċjati ma', eritema, sħana, tenerezza jew uġigħ fis-sit ta' injezzjoni u jgħaddu waħedhom fi żmien 3-5 ijiem.
English: The safety and efficacy of Hexacima in infants less than 6 weeks of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Hexacima fit- trabi inqas minn 6 ġimgħat ma ġewx stabbiliti.