A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Yf-Vax Indications, Dosage, Storage, Stability - Yellow Fever Vaccine
Yf-Vax Indications, Dosage, Storage, Stability - Yellow Fever Vaccine
INDICATIONS AND USAGE
YF-VAX® [Yellow Fever Vaccine] is recommended for active immunization of persons ³9 months of age travelling to or living in areas where yellow fever infection is reported or yellow fever vaccination is required.8
Pregnant women should be considered for immunization only if they are travelling to high-risk areas, travel cannot be postponed and a high level of prevention against mosquito exposure is unfeasible.2 (See PRECAUTIONS – Pregnancy.)
The vaccine is recommended for travellers passing through or living in countries in Africa and South America where yellow fever infection is officially reported. It is also recommended for travel outside the urban area of countries that do not officially report yellow fever but lie in the yellow fever "endemic zones".8
Yellow fever vaccination is required by law upon entry to certain countries irrespective of the traveller’s country of origin and in other countries when travellers are coming from endemic areas. In some cases, vaccination against yellow fever is recommended, although not required by law, e.g., if yellow fever has been reported in the country of destination. In some Asian and other tropical countries where yellow fever does not exist but the transmitting mosquito is found, vaccination is required for arrivals from an endemic country to prevent importation of the disease. Current information on the countries for which an International Certificate of Vaccination is required can be obtained from local health departments or from Health Canada’s Travel Medicine Program Web site.8
The period of validity of the International Certificate of Vaccination for yellow fever is 10 years, beginning 10 days after primary immunization and immediately after reimmunization.8
Laboratory personnel who might be exposed to virulent yellow fever virus or to concentrated preparations of the 17D vaccine strain by direct or indirect contact or by aerosols also should be vaccinated.6
DOSAGE AND ADMINISTRATION
DOSAGE
Primary vaccination. For persons of all ages, a single subcutaneous injection of 0.5 mL of reconstituted vaccine is administered.8 Immunity develops by the 10th day after primary vaccination in most individuals.1,2
Booster doses. The International Health Regulations require revaccination at intervals of 10 years. Revaccination boosts antibody titre; however, evidence from several studies suggests that yellow fever vaccine immunity persists for at least 30 to 35 years and probably for life.8
Give the patient a permanent personal immunization record. In addition, it is essential that the physician or nurse record the immunization history in the permanent medical record of each patient. This permanent office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.
ADMINISTRATION
Inspect for extraneous particulate matter and/or discolouration before use. If these conditions exist, the product should not be administered.
For information on vaccine administration see the current edition of the Canadian Immunization Guide or visit the Health Canada website.
Reconstitution of Freeze-Dried Product and Withdrawal from Stoppered Vial
DO NOT REMOVE THE STOPPER FROM THE VIAL.
Reconstitute the vaccine using only the diluent supplied (Sodium Chloride Injection). Draw the volume of the diluent, shown on the diluent label, into a suitable size syringe. Slowly inject the diluent into the vial containing the vaccine, let stand for one or two minutes and then carefully swirl mixture until a uniform suspension is achieved. Avoid vigorous shaking as this tends to cause foaming of the suspension.
SWIRL THE PRODUCT VIAL WELL before withdrawing each dose.
Withdraw the required dose (0.5 mL) of the reconstituted vaccine into a syringe. Aseptic technique must be used for withdrawal of each dose. (See PRECAUTIONS.)
Use vaccine within 60 minutes following reconstitution. All reconstituted vaccine and containers which remain unused after one hour must be disposed of properly (e.g., sterilized or disposed in hazardous waste containers).8
If a germicide is used to cleanse the skin before immunization, it should be allowed to dry before the vaccine is administered.
Administer the vaccine subcutaneously.
Do not inject intravenously or intramuscularly.
If immunization of a person with a history of severe egg sensitivity and a positive skin test to the vaccine is imperative, see the information about Hypersensitivity Reactions and Desensitization outlined in PRECAUTIONS.
STORAGE
YF-VAX® [Yellow Fever Vaccine] must be maintained continuously at 5° to -30°C (41° to -22°F) until reconstituted for use.
YF-VAX® is shipped in a container with solid carbon dioxide; do not use vaccine unless shipping case contains some dry ice on arrival.
The vial of diluent should not be allowed to freeze.
The reconstituted vaccine must be kept refrigerated and used within one hour following reconstitution.
All reconstituted vaccine and containers which remain unused after one hour must be disposed of properly (e.g., sterilized or disposed in hazardous waste containers).8
Do not use vaccine after expiration date.
HOW SUPPLIED
Package of 1 x 5 dose vial of vaccine and package of 1 x 3 mL vial of diluent.
Package of 5 x 1 dose vials of vaccine and package of 5 x 0.6 mL vials of diluent.
Vaccine Information Service: 1-888-621-1146 or 416-667-2779.
Visit us at www.aventispasteur.com/canada
Full product monograph available on request.
REFERENCES
1. Monath TP. Yellow Fever. In: Plotkin SA and Orenstein WA, editors. Vaccines,
2. Monath TP, et al. Prevention of yellow fever in persons traveling to the tropics. Clin Infect Dis 2002;34:1369-78.
6. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Yellow Fever Vaccine. MMWR 2002;51(RR-17):1-10.
8. National Advisory Committee on Immunization. General Considerations. Yellow Fever Vaccine. In: Canadian Immunization Guide, 6th ed. Her Majesty the Queen in Right of Canada, represented by the Minister of Public Works and Government Services Canada, 2002:14-8,233-41.
Product Information as of May 2004.
Manufactured by: Aventis Pasteur Inc. Swiftwater, PA 18370 USA, Distributed by: Aventis Pasteur Limited, Toronto, Ontario, Canada, R10-0504
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