Hexyon

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Active ingredient:

filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid

Available from:

Sanofi Pasteur Europe

ATC code:

J07CA09

INN (International Name):

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

Therapeutic group:

Vaċċini

Therapeutic area:

Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria

Therapeutic indications:

Hexyon (DTaP-IPV-HB-Hib) huwa indikat għat-tilqim primarja u booster tat-trabi u toddlers minn sitt ġimgħat ta ' età kontra diphtheria, tetanus, pertussis, epatite B, poliomyelitis u invażivi mard ikkawżat minn influwenza ĦEMOFILLIKA tip b (Hib). L-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Product summary:

Revision: 30

Authorization status:

Awtorizzat

Authorization date:

2013-04-17

Patient Information leaflet

                                37
B. FULJETT TA’ TAGĦRIF
38
FULJETT TA’ TAGĦRIF: TAGĦRIF GĦALL-UTENT
HEXYON, SUSPENSJONI GĦALL-INJEZZJONI F’SIRINGA MIMLIJA GĦAL-LEST
Vaċċin ikkonjugat (adsorbit) għal difterite, tetnu, pertussi
(komponent aċellulari), epatite B (rDNA),
poljomelite (inattivat) u
_Haemophilus influenzae_
tip b
AQRA SEW DAN IL-FULJETT KOLLU QABEL IT-TIFEL/TIFLA TIEGĦEK TIĠI
MLAQQMA, PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
•
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
•
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar jew
l-infermier tiegħek.
•
Jekk it-tifel/tifla ikollhom xi effetti sekondarji, kellem lit-tabib,
lill-ispiżjar jew lill-infermier
tiegħek. Dan jinkludi xi effett sekondarju possibbli li m’huwiex
elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Hexyon u għalxiex jintuża
2.
X’għandek tkun taf qabel mat-tifel/tifla tiegħek jingħata Hexyon
3.
Kif jingħata Hexyon
4.
Effetti sekondarji possibbli
5.
Kif taħżen Hexyon
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU HEXYON U GĦALXIEX JINTUŻA
Hexyon (DTaP-IPV-HB-Hib) huwa vaċċin li jintuża biex jipproteġi
kontra mard infettiv.
Hexyon jgħin biex jipproteġi kontra d-difterite, it-tetnu,
il-pertussi, l-epatite B, il-poljomelite u mard serju
kkawżat minn
_Haemophilus influenzae tip b. _
Hexyon jingħata lit-tfal minn 6 ġimgħat..
Il-vaċċin jaġixxi billi jġiegħel lill-ġisem jipproduċi
protezzjoni għalih innifsu (antikorpi) kontra l-batterja
u l-virusis li jikkaġunaw dawn l-infezzjonijiet differenti:
•
Id-difterite hija marda infettiva li ġeneralment taffettwa
l-griżmejn. Fil-griżmejn, l-infezzjoni
tikkaġuna uġigħ u nefħa li tista’ twassal għal soffokazzjoni.
Il-batterju li jikkaġuna l-marda jagħmel
ukoll tossina (velenu) li tista’ tagħmel ħsara l-qalb, il-kliewi u
n-nervituri.
•
Tetnu (xi kultant jissejjaħ xedaq maqful) huwa normalment ikkawżat
mill-batterju tat-tetnu li jidħol
f’ferita fonda. Il-batterju jagħmel tossina
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Hexyon suspensjoni għall-injezzjoni f’siringa mimlija għal-lest
Hexyon suspensjoni għall-injezzjoni.
Vaċċin ikkonjugat (adsorbit) għal difterite, tetnu, pertussi
(komponent aċellulari), epatite B (rDNA),
poljomelite (inattivat) u
_Haemophilus influenzae_
tip b.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Doża waħda
1
(0.5 mL) fiha:
Tossojdi tad-Difterite
mhux inqas minn 20 IU
2,4
(30 Lf)
Tossojdi tat-Tetnu
mhux inqas minn 40 IU
3,4
(10 Lf)
Antiġeni ta’
_Bordetella_
_pertussis_
Tossojdi ta’ Pertussi
25 mikrogramma
Emaglutinin Filamentuż
25 mikrogramma
Poljovirus (Inattivat)
5
Tip 1 (Mahoney)
29 D unità t’antiġen
6
Tip 2 (MEF-1)
7 D unitajiet t’antiġen
6
Tip 3 (Saukett)
26 D unità t’antiġen
6
Antiġen superfiċjali ta’ Epatite B
7
10 mikrogrammi
_Haemophilus influenzae_
polysaccharide tip b
12-il mikrogramma
(Polyribosylribitol Phosphate)
konjugat għal proteina tat-Tetnu
22-36 mikrogramma
1
Assorbit fuq aluminium hydroxide, idrat (0.6 mg Al
3+
)
2
Bħala l-limitu ta’ kunfidenza ’l baxx (p= 0.95) u mhux inqas minn
30 IU bħala valur medju
3
Bħala l-limitu ta’ kunfidenza ’l baxx (p= 0.95)
4
Jew attività ekwivalenti determinata minn evalwazzjoni
tal-immunoġeniċità
5
Ikkoltivat fuq ċelluli ta’ Vero
6
Dawn il-kwantitajiet ta’ antiġen huma eżatt l-istess bħal dawk
espressi preċedentement bħala unitajiet ta’
antiġen
40-8-32 D
, għat-tip ta’ virus 1, 2 u 3 rispettivament, meta ddeterminati
permezz ta’ metodu
immunokemikali xieraq ieħor
7
Prodott fiċ-ċelluli tal-ħmira
_ Hansenula polymorpha _
bit-teknoloġija rikombinanti ta’ DNA
Il-vaċċin jista’ jkun fih traċċi ta’, glutaraldehyde,
formaldehyde, neomycin, streptomycin u polymyxin B li
jintużaw waqt il-proċess ta’ produzzjoni (ara sezzjoni 4.3).
Eċċipjent b’effett magħruf
Phenylalanine……………85 mikrogramma
(Ara sezzjoni 4.4)
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEW
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 23-06-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 23-06-2023
Public Assessment Report Public Assessment Report Bulgarian 06-07-2016
Patient Information leaflet Patient Information leaflet Spanish 23-06-2023
Public Assessment Report Public Assessment Report Spanish 06-07-2016
Patient Information leaflet Patient Information leaflet Czech 23-06-2023
Public Assessment Report Public Assessment Report Czech 06-07-2016
Patient Information leaflet Patient Information leaflet Danish 23-06-2023
Public Assessment Report Public Assessment Report Danish 06-07-2016
Patient Information leaflet Patient Information leaflet German 23-06-2023
Public Assessment Report Public Assessment Report German 06-07-2016
Patient Information leaflet Patient Information leaflet Estonian 23-06-2023
Public Assessment Report Public Assessment Report Estonian 06-07-2016
Patient Information leaflet Patient Information leaflet Greek 23-06-2023
Public Assessment Report Public Assessment Report Greek 06-07-2016
Patient Information leaflet Patient Information leaflet English 23-06-2023
Public Assessment Report Public Assessment Report English 06-07-2016
Patient Information leaflet Patient Information leaflet French 23-06-2023
Public Assessment Report Public Assessment Report French 06-07-2016
Patient Information leaflet Patient Information leaflet Italian 23-06-2023
Public Assessment Report Public Assessment Report Italian 06-07-2016
Patient Information leaflet Patient Information leaflet Latvian 23-06-2023
Public Assessment Report Public Assessment Report Latvian 06-07-2016
Patient Information leaflet Patient Information leaflet Lithuanian 23-06-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 23-06-2023
Public Assessment Report Public Assessment Report Lithuanian 06-07-2016
Patient Information leaflet Patient Information leaflet Hungarian 23-06-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 23-06-2023
Public Assessment Report Public Assessment Report Hungarian 06-07-2016
Patient Information leaflet Patient Information leaflet Dutch 23-06-2023
Public Assessment Report Public Assessment Report Dutch 06-07-2016
Patient Information leaflet Patient Information leaflet Polish 23-06-2023
Public Assessment Report Public Assessment Report Polish 06-07-2016
Patient Information leaflet Patient Information leaflet Portuguese 23-06-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 23-06-2023
Public Assessment Report Public Assessment Report Portuguese 06-07-2016
Patient Information leaflet Patient Information leaflet Romanian 23-06-2023
Public Assessment Report Public Assessment Report Romanian 06-07-2016
Patient Information leaflet Patient Information leaflet Slovak 23-06-2023
Public Assessment Report Public Assessment Report Slovak 06-07-2016
Patient Information leaflet Patient Information leaflet Slovenian 23-06-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 23-06-2023
Public Assessment Report Public Assessment Report Slovenian 06-07-2016
Patient Information leaflet Patient Information leaflet Finnish 23-06-2023
Public Assessment Report Public Assessment Report Finnish 06-07-2016
Patient Information leaflet Patient Information leaflet Swedish 23-06-2023
Public Assessment Report Public Assessment Report Swedish 06-07-2016
Patient Information leaflet Patient Information leaflet Norwegian 23-06-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 23-06-2023
Patient Information leaflet Patient Information leaflet Icelandic 23-06-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 23-06-2023
Patient Information leaflet Patient Information leaflet Croatian 23-06-2023
Public Assessment Report Public Assessment Report Croatian 06-07-2016

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