RECOMBIVAX HB (ADULT DIALYSIS WITH PRESERVATIVE) SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)

Disponible desde:

MERCK CANADA INC

Código ATC:

J07BC01

Designación común internacional (DCI):

HEPATITIS B, PURIFIED ANTIGEN

Dosis:

40MCG

formulario farmacéutico:

SOLUTION

Composición:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 40MCG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

1ML

tipo de receta:

Schedule D

Área terapéutica:

VACCINES

Resumen del producto:

Active ingredient group (AIG) number: 0119570003; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2005-09-17

Ficha técnica

PRODUCT MONOGRAPH
RECOMBIVAX HB
®
(hepatitis B vaccine [recombinant])
Injectable Solution
Vaccine for immunization against infection
caused by hepatitis B virus including
all known subtypes
MERCK FROSST CANADA LTD.
Date of Revision:
16711 Trans Canada Highway
Kirkland QC H9H 3L1
Canada
www.merckfrosst.com
CONTROL # 115825
DATE OF APPROVAL:
FEBRUARY 14, 2008
RECOMBIVAX HB
®
is a Registered Trademark of Merck & Co., Inc.
Used under license.
1
PRODUCT MONOGRAPH
NAME OF DRUG
RECOMBIVAX HB
®
(hepatitis B vaccine [recombinant])
Injectable Solution
THERAPEUTIC CLASSIFICATION
Vaccine for immunization against infection caused by
hepatitis B virus including all known subtypes
ACTION AND CLINICAL PHARMACOLOGY
Hepatitis B virus is one of at least five hepatitis viruses that cause
a systemic
infection, with major pathology in the liver. The others are hepatitis
A, hepatitis C,
hepatitis D, and hepatitis E viruses.
Hepatitis B virus is an important cause of viral hepatitis. There is
no specific
treatment for this disease. The incubation period for type B hepatitis
is relatively
long; six weeks to six months may elapse between exposure and the
onset of
clinical symptoms. The prognosis following infection with hepatitis B
virus is variable
and dependent on at least three factors: (1) Age - Infants and younger
children
usually experience milder initial disease than older persons;
1
(2) Dose of Virus -
The higher the dose, the more likely acute icteric hepatitis B will
result;
1
and, (3)
Severity of associated underlying disease - Underlying malignancy or
pre-existing
hepatic disease predisposes to increased morbidity and mortality.
1
2
Persistence of viral infection (the chronic hepatitis B virus carrier
state) occurs in
5-10% of persons following acute hepatitis B, and occurs more
frequently after initial
anicteric hepatitis B than after initial icteric disease.
Consequently, carriers of
hepatitis B surface antigen (HBsAg) frequently give no history of
recognized acute
hepatitis. The World Health Organization estimated that m