Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
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)
Sanofi Pasteur MSD, SNC
J07CA
haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine
Vaccines
Hepatitis B; Meningitis, Haemophilus; Immunization
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.,
Revision: 9
Withdrawn
1999-05-07
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 Прочетете целия документ
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 Прочетете целия документ