Procomvax

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
29-07-2009
Summary of Product characteristics Summary of Product characteristics (SPC)
29-07-2009
Public Assessment Report Public Assessment Report (PAR)
29-07-2009

Active ingredient:

polyribosylribitol phosphate mill-Haemophilus influenzae tat-tip b bħala PRP-OMPC, il-membrana ta 'barra kumpless tal-proteina tal Neisseria meningitidis (il-membrana ta' barra kumpless tal-proteina tar-razza B11 ta 'Neisseria meningitidis sottogrupp B), adsorbit ta' l-epatite B-antiġen tal-wiċċ prodott f'ċelloli tal-ħmira rikombinanti (Saccharomyces cerevisiae)

Available from:

Sanofi Pasteur MSD, SNC

ATC code:

J07CA

INN (International Name):

haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine

Therapeutic group:

Vaċċini

Therapeutic area:

Hepatitis B; Meningitis, Haemophilus; Immunization

Therapeutic indications:

PROCOMVAX huwa indikat għall-vaċċinazzjoni kontra l-marda invażivi ikkawżat minn influwenza ĦEMOFILLIKA tip b u kontra l-infezzjoni kkawżat mill-sottotipi magħrufa kollha tal-virus tal-hepatitis B fit-trabi 6 ġimgħat sa 15-il xahar.

Product summary:

Revision: 9

Authorization status:

Irtirat

Authorization date:

1999-05-07

Patient Information leaflet

                                PRODOTT MEDIĊINALI LI M’GĦADUX AWTORIZZAT
16
B. FULJETT TA’ TAGĦRIF
PRODOTT MEDIĊINALI LI M’GĦADUX AWTORIZZAT
17
FULJETT TA’ TAGĦRIF
AQRA SEWWA DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIM IL-MEDIĊINA.
-
Żomm dan il-fuljett. Jista' jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit-tabib jew
lill-ispiżjar tiegħek.
-
Din il-mediċina ġiet mogħtija lit-tifel/tifla tiegħek. Tagħtihx
lil persuni oħra.
F’DAN IL-FULJETT
:
1.
X’inhu PROCOMVAX u għalxiex jintuża
2.
Qabel ma tuża PROCOMVAX
3.
Kif għandek tuża PROCOMVAX
4.
Effetti sekondarji li jista’ jkollu
5.
Kif taħżen PROCOMVAX
6.
Aktar tagħrif
PROCOMVAX suspensjoni għal injezzjoni f’kunjett.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) u Hepatitis
B (Recombinant) Vaccine.
Is-sustanzi attivi huma:
Polyribosylribitol phosphate (PRP) minn _Haemophilus influenzae
_tat-tip b bħala PRP-OMPC
7.5 µg
_ _
_Neisseria meningitidis OMPC _(kumpless tal-proteina tal-membrana
ta’ barra
125 µg
tar-razza B11 ta’ _Neisseria meningitidis sottogrupp B)_
Antiġen tal-wiċċ assorbit ta’ l-epatite B prodott f’ċelloli
rikombinanti tal-ħmira
5.0 µg
(_Saccharomyces cerevisiae)_
f’0.5 ml.
Is-sustanzi l-oħra huma: amorphous aluminium hydroxyphosphate
sulphate u sodium borate f’0.9% ta’
sodium chloride
Detentur ta’ l-Awtorizzazzjoni għat-Tqegħid fis-Suq: Sanofi
Pasteur MSD SNC, 8 rue Jonas Salk, F-
69007 Lyon
Manifatturat minn: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN.
Haarlem, L-Olanda
1.
X’INHU PROCOMVAX U GĦALXIEX JINTUŻA
PROCOMVAX huwa vaċċin injettabbli f’kunjett ta’ doża waħda
ta’ 0.5ml.
PROCOMVAX huwa indikat biex jipproteġi aħjar lit-tifel/tifla
tiegħek kontra mard invażiv ikkawżat
minn _Haemophilus influenzae _tat-tip b (infezzjoni tat-tessuti
tal-moħħ u tan-nerv li jgħaddi minn ġos-
sinsla, infezzjoni tad-demm, eċċ.) u kontra infezzjoni tad-demm
ikkawżata mis-sottotipi magħrufa
kollha tal-virus ta’ l-epatite B. Il-vaċċin jista’
                                
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Summary of Product characteristics

                                PRODOTT MEDIĊINALI LI M’GĦADUX AWTORIZZAT
1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
PRODOTT MEDIĊINALI LI M’GĦADUX AWTORIZZAT
2
1.
ISEM TAL-PRODOTT MEDIĊINALI
PROCOMVAX sospensjoni għall-injezzjoni
Haemophilus b Conjugate (Meningococcal Protein Conjugate) u Hepatitis
B (Recombinant) Vaccine
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Polyribosylribitol phosphate (PRP) minn _Haemophilus influenzae
_tat-tip b_ _bħala PRP-OMPC
7.5 µg
_ _
_Neisseria meningitidis OMPC _(complex tal-proteina tal-membrana ta'
barra
125 µg
tar-razza B11 ta’ _Neisseria meningitidis sottogrupp B)_
Antiġen tal-wiċċ assorbit ta’ l-epatite B prodott f’ċelloli
rikombinanti tal-ħmira
5.0 µg
(_Saccharomyces cerevisiae)_
f’0.5 ml.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Sospensjoni għal injezzjoni f’kunjett.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
PROCOMVAX huwa indikat għal tilqim kontra mard invażiv ikkawżat
minn _Haemophilus influenzae_
tat-tip b u kontra infezzjoni kkawżata mis-sottotipi magħrufa kollha
tal-virus ta’ l-epitite B fi trabi
minn 6 ġimgħat sa 15-il xahar.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
METODU TA’ KIF GĦANDU JINGĦATA
GĦAL GĦOTI GĦAL ĠOL-MUSKOLI
_Tinjettax fil-vini, minn ġol-ġilda jew taħt il-ġilda. _
POŻOLOĠIJA_ _
Trabi m
wielda minn ommijiet HBsAg negattivi għandhom jiġu mlaqqma bi tliet
dożi ta’ 0.5 ml ta’
PROCOMVAX, idealment ta’ 2, 4, u 12 -15–il xahar. Jekk l-iskeda
rakkomandata ma tkunx tista’ tiġi
segwita eżatt, l-intervall bejn l-ewwel żewġ dożi għandu jkun
ta’ madwar xahrejn u l-intervall bejn it-
tieni u t-tielet doża għandu jkun kemm jista’ jkun qrib
għat-tmienja sa ħdax-il xahar. Iridu jingħataw
it-tliet dożi biex tkun kompletata l-iskeda tat-tilqim.
Tfal li jirċievu doża waħda ta’ vaċċin kontra l-epatite B malli
jitwieldu jew ftit wara t-twelid jistgħu
jingħataw PROCOMVAX fuq l-iskeda ta’ 2, 4, u 12-15–il xahar.
_Tfal mhux imlaqqma
                                
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Similar products

Active ingredient polyribosylribitol phosphate mill-Haemophilus influenzae tat-tip b bħala PRP-OMPC, il-membrana ta 'barra kumpless tal-proteina tal Neisseria meningitidis (il-membrana ta' barra kumpless tal-proteina tar-razza B11 ta 'Neisseria meningitidis sottogrupp B), adsorbit ta' l-epatite B-antiġen tal-wiċċ prodott f'ċelloli tal-ħmira rikombinanti (Saccharomyces cerevisiae)

polyribosylribitol phosphate mill-Haemophilus influenzae tat-tip b bħala PRP-OMPC, il-membrana ta 'barra kumpless tal-proteina tal Neisseria meningitidis (il-membrana ta' barra kumpless tal-proteina tar-razza B11 ta 'Neisseria meningitidis sottogrupp B), adsorbit ta' l-epatite B-antiġen tal-wiċċ prodott f'ċelloli tal-ħmira rikombinanti (Saccharomyces cerevisiae)

ATC code J07CA

J07CA

Marketed by Sanofi Pasteur MSD, SNC

Sanofi Pasteur MSD, SNC

INN (International Name) haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine

haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine

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Patient Information leaflet Patient Information leaflet Bulgarian 29-07-2009
Summary of Product characteristics Summary of Product characteristics Bulgarian 29-07-2009
Public Assessment Report Public Assessment Report Bulgarian 29-07-2009
Patient Information leaflet Patient Information leaflet Spanish 29-07-2009
Summary of Product characteristics Summary of Product characteristics Spanish 29-07-2009
Public Assessment Report Public Assessment Report Spanish 29-07-2009
Patient Information leaflet Patient Information leaflet Czech 29-07-2009
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Public Assessment Report Public Assessment Report Czech 29-07-2009
Patient Information leaflet Patient Information leaflet Danish 29-07-2009
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Procomvax