Yellow Fever Vaccine: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use YF-VAX safely and effectively. See full prescribing information for YF-VAX.

See full insert sheet at this link at the Natural News Reference website.

YF-VAX (Yellow Fever Vaccine)

Subcutaneous injection

Initial U.S. Approval:

INGREDIENTS AND EXCIPIENTS

YF-VAX® [Yellow Fever Vaccine] is a live attenuated freeze-dried vaccine prepared by culturing the 17D-204 strain of yellow fever virus in living avian leukosis virus-free (ALV) chicken embryos. The vaccine, which contains sorbitol and gelatin as stabilizers, is lyophilized and hermetically sealed under nitrogen. No preservative is added. The vaccine must be reconstituted immediately before use with the sterile diluent provided (Sodium Chloride Injection USP – contains no preservative). After reconstitution, YF-VAX® is a slight pink-brown suspension. YF-VAX® complies with the yellow fever vaccine standards of the World Health Organization (WHO).

INDICATIONS AND USAGE

YF-VAX is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories:

Persons Living in or Traveling to Endemic Areas – While the actual risk for contracting yellow fever during travel is probably low, variability of itineraries, behaviors and seasonal incidence of disease make it difficult to predict the actual risk for a given individual living in or traveling to a known endemic or epidemic area. Greater risk is associated with living in or traveling to areas of South America and Africa where yellow fever infection is officially reported at the time of travel and with traveling outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone.

Persons Traveling Internationally Through Countries with Yellow Fever – Some countries require an individual to have a valid International Certificate of Vaccination or Prophylaxis (ICVP) if the individual has been in countries either known or thought to harbor yellow fever virus. The certificate becomes valid 10 days after vaccination with YF-VAX. (13) (14)

Laboratory Personnel – Laboratory personnel who handle virulent yellow fever virus or concentrated preparations of the yellow fever vaccine virus strains may be at risk of exposure by direct or indirect contact or by aerosols. (14)

DOSAGE AND ADMINISTRATION

Administer a single subcutaneous injection of 0.5 mL of reconstituted vaccine

DOSAGE FORMS AND STRENGTHS

YF-VAX® is supplied as a sterile lyophilized powder in either 1 dose or 5 dose vial. The diluent (Sodium Chloride Injection USP – contains no preservative) is supplied in 3 mL or 0.6 mL Vials. After reconstitution, YF-VAX® is a slight pink-brown suspension.

CONTRAINDICATIONS

Hypersensitivity , Altered Immune Status, thymic dysfunction

WARNINGS AND PRECAUTIONS

Severe Allergic Reactions , Yellow fever vaccine-associated viscerotropic disease, Yellow fever vaccine-associated neurotropic disease

ADVERSE REACTIONS

Adverse reactions to YF-VAX include mild headaches, myalgia, low-grade fevers, or other minor symptoms for 5 to 10 days. Local reactions including edema, hypersensitivity, pain or mass at the injection site have also been reported following yellow fever vaccine administration. Immediate hypersensitivity reactions, characterized by rash, urticaria, and/or asthma, occur principally among persons with histories of allergy to eggs or other substances contained in the vaccine.

DRUG INTERACTIONS

Immunosuppressive treatments may be a contraindication to the administration of YF-VAX® due to the increased risk of severe adverse reactions linked to immunodepression

USE IN SPECIFIC POPULATIONS

Pregnancy

Animal reproduction studies have not been conducted with YF-VAX. It is also not known whether YF-VAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. YF-VAX should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this vaccine is excreted in human milk. However, breast-feeding infant Yellow Fever encephalitis has been very rarely reported following maternal vaccination with live attenuated yellow-fever vaccine. The vaccination of nursing women should be avoided when possible, particularly when infants are under 9 months of age, (8) because of the probable risk of the transmission of 17D virus to the breast-fed infant. When travel of nursing women to high-risk yellow fever endemic areas cannot be avoided or postponed, such individuals may be immunized. (3)

Pediatrics

YF-VAX® is contraindicated in infants <9 months of age because of the risk of encephalitis and travel of such persons to rural areas in yellow fever endemic zones or to countries experiencing an epidemic should be postponed or avoided, whenever possible.

Revision:

https://www.vaccineshoppe.com/image.cfm?doc_id=13708&image_type=product_pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Yellow-Fever-Vaccine.pdf