Procomvax

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC, outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B), adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)

Fáanlegur frá:

Sanofi Pasteur MSD, SNC

ATC númer:

J07CA

INN (Alþjóðlegt nafn):

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

Meðferðarhópur:

Vaccines

Lækningarsvæði:

Hepatitis B; Meningitis, Haemophilus; Immunization

Ábendingar:

PROCOMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age.,

Vörulýsing:

Revision: 9

Leyfisstaða:

Withdrawn

Leyfisdagur:

1999-05-07

Upplýsingar fylgiseðill

MEDICINAL PRODUCT NO LONGER AUTHORISED
15
B. PACKAGE LEAFLET
MEDICINAL PRODUCT NO LONGER AUTHORISED
16
PACKAGE LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This vaccine has been prescribed for your child and you should not
pass it on to others.
IN THIS LEAFLET
:
1.
What PROCOMVAX is and what it is used for
2.
Before you use PROCOMVAX
3.
How to use PROCOMVAX
4.
Possible side effects
5.
Storing PROCOMVAX
6.
Further information
PROCOMVAX suspension for injection in vial.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and
Hepatitis B (Recombinant)
Vaccine.
The active substances are:
Polyribosylribitol phosphate (PRP) from _Haemophilus influenzae _type
b_ _as PRP-OMPC
7.5 µg
_ _
_Neisseria meningitidis OMPC _(outer membrane protein complex
125 µg
of the B11 strain of _Neisseria meningitidis subgroup B)_
Adsorbed hepatitis B surface antigen produced in recombinant yeast
cells
5.0 µg
(_Saccharomyces cerevisiae)_
in 0.5 ml.
The other ingredients are: amorphous aluminium hydroxyphosphate
sulphate and sodium borate in
0.9% sodium chloride
Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas
Salk, F-69007 Lyon
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN
Haarlem, The Netherlands
1
WHAT PROCOMVAX IS AND WHAT IT IS USED FOR
PROCOMVAX is an injectable vaccine in a 0.5ml single dose vial.
PROCOMVAX is indicated
to help protect your child against invasive disease caused by
_Haemophilus _
_influenzae _type b (infection of brain and spinal cord tissues,
infection of the blood, etc.) and against
infection of the liver caused by all known subtypes of hepatitis B
virus. The vaccine can be
administered in most infants 6 weeks to 15 months of age.
2.
BEFORE YOU USE PROCOMVAX
DO NOT USE PROCOMVAX:
-
if your child is allergic to any component of the vaccine.
-
in infants younger than 6 weeks of age
-
if your child has fever (vacci

Vara einkenni

MEDICINAL PRODUCT NO LONGER AUTHORISED
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
MEDICINAL PRODUCT NO LONGER AUTHORISED
2
1.
NAME OF THE MEDICINAL PRODUCT
PROCOMVAX suspension for injection
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and
Hepatitis B (Recombinant)
Vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Polyribosylribitol phosphate (PRP) from _Haemophilus influenzae _type
b_ _as PRP-OMPC
7.5 µg
_ _
_Neisseria meningitidis OMPC _(outer membrane protein complex
125 µg
of the B11 strain of _Neisseria meningitidis subgroup B)_
Adsorbed hepatitis B surface antigen produced in recombinant yeast
cells
5.0 µg
(_Saccharomyces cerevisiae)_
in 0.5 ml.
For excipent, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in vial.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROCOMVAX is indicated for vaccination against invasive disease caused
by _Haemophilus _
_influenzae_ type b and against infection caused by all known subtypes
of hepatitis B virus in infants 6
weeks to 15 months of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY_ _
Infants born of HBsAg negative mothers should be vaccinated with three
0.5ml doses of
PROCOMVAX, ideally at 2, 4, and 12-15 months of age. If the
recommended schedule cannot be
followed exactly, the interval between the first two doses should be
approximately two months and the
interval between the second and third dose should be as close as
possible to eight to eleven months.
All three doses must be administered to complete the vaccination
regimen.
Children who receive one dose of hepatitis B vaccine at or shortly
after birth may be administered
PROCOMVAX on the schedule of 2, 4, and 12 -15 months of age.
_Children not vaccinated according to recommended schedule _
Vaccination schedules for children not vaccinated according to the
recommended schedule should be
considered on an individual basis.
METHOD OF ADMINISTRATION
FOR INTRAMUSCULAR ADMINISTRATION
_Do not inject intravenously, intradermally, or subcutaneously_
MEDICINAL PRODUCT NO LO