INACTIVATED POLIOMYELITIS VACCINE (DIPLOID CELL ORIGIN) - IPV SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY

Boleh didapati daripada:

SANOFI PASTEUR LIMITED

Kod ATC:

J07BF03

INN (Nama Antarabangsa):

POLIOMYELITIS, TRIVALENT, INACTIVATED, WHOLE VIRUS

Dos:

8UNIT; 32UNIT; 40UNIT

Borang farmaseutikal:

SOLUTION

Komposisi:

INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 8UNIT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT 32UNIT; INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY 40UNIT

Laluan pentadbiran:

SUBCUTANEOUS

Unit dalam pakej:

5X0.5ML

Jenis preskripsi:

Schedule D

Kawasan terapeutik:

VACCINES

Ringkasan produk:

Active ingredient group (AIG) number: 0332952002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2014-09-19

Ciri produk

sanofi pasteur
1.3.1 Product Monograph
238 – IPV MRC-5
Administrative Change – Clean Product Monograph
Confidential/Proprietary Information
Page 1 of 13
PRODUCT MONOGRAPH
INACTIVATED POLIOMYELITIS VACCINE
(DIPLOID CELL ORIGIN) - IPV
Dosage Form:
Solution for Injection
Single Dose Ampoule
Active Immunizing Agent
(For the Prevention of Poliomyelitis)
Sanofi Pasteur Limited
DATE OF PREPARATION:
1755 Steeles Ave. West
October 24, 2005
Toronto, ON
M2R 3T4
Control#: 101754
sanofi pasteur
1.3.1 Product Monograph
238 – IPV MRC-5
Administrative Change – Clean Product Monograph
Confidential/Proprietary Information
Page 2 of 13
PRODUCT MONOGRAPH
INACTIVATED POLIOMYELITIS VACCINE
(DIPLOID CELL ORIGIN) - IPV
Dosage Form:
Solution for Injection
Single Dose Ampoule
Active Immunizing Agent
(For the Prevention of Poliomyelitis)
ACTION AND CLINICAL PHARMACOLOGY
Poliomyelitis is a disease that may cause irreversible paralysis in a
certain proportion of infected
individuals. It is a highly infectious disease caused by three types
of the enterovirus poliovirus. (1)
It is primarily spread by the fecal-oral route of transmission but may
also be spread by the
pharyngeal route. Following introduction of poliovirus vaccine in
Canada in 1955, indigenous
disease has been virtually eliminated.
The last significant outbreak of poliomyelitis occurred in 1978-79,
when there were 11 cases of
paralytic disease among unimmunized contacts of imported cases. The
last case of poliomyelitis
attributed to imported, wild virus occurred in 1988. (1) However,
circulation of wild viruses does
occur in rare circumstances (2), and it remains crucial that the
highest possible level of vaccine-
induced immunity be maintained in the population. Inactivated
Poliomyelitis Vaccine (Diploid
Cell Origin) - IPV, (sometimes referred to as e-IPV), is an enhanced
formalin-inactivated product
which has a higher potency than the original IPV. The three poliovirus
types are propagated in
human diploid cells. A primary series induces protective antibody
levels in mo