Fluzone Quadrivalent: 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 Fluzone® Quadrivalent safely and effectively. See full prescribing information for Fluzone Quadrivalent.

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

Fluzone Quadrivalent (Influenza Vaccine)

Suspension for Intramuscular Injection

2016-2017 Formula

Initial US Approval (Fluzone Quadrivalent): 2013

INGREDIENTS AND EXCIPIENTS

Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The viruscontaining allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation.

Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color.

Antibiotics are not used in the manufacture of Fluzone Quadrivalent

The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex.

Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2016-2017 influenza season: A/California/07/2009 X-179A (H1N1), A/ Hong Kong/4801/2014 X-263B (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/ Brisbane/60/2008 (B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 6. The single-dose, pre-filled syringe (0.25 mL and 0.5 mL) and the single-dose vial (0.5 mL) are manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.

Table 6: Fluzone Quadrivalent Ingredients

Ingredient	Quantity (per dose)/Fluzone Quadrivalent 0.25 mL Dose	Quantity (per dose)/Fluzone Quadrivalent 0.5 mL Dose
Active Substance: Split influenza virus, inactivated strainsa:	30 mcg HA total	60 mcg HA total
A (H1N1)	7.5 mcg HA	15 mcg HA
A (H3N2)	7.5 mcg HA	15 mcg HA
B/(Victoria lineage)	7.5 mcg HA	15 mcg HA
B/(Yamagata lineage)	7.5 mcg HA	15 mcg HA
Other:
Sodium phosphate-buffered isotonic sodium chloride solution	QSb to appropriate volume	QSb to appropriate volume
Formaldehyde	≤50 mcg	≤100 mcg
Octylphenol ethoxylate	≤125 mcg	≤250 mcg
Preservative
Single-dose presentations	–	–
Multi-dose presentation (thimerosal)	12.5 mcg mercury	25 mcg mercury

^aper United States Public Health Service (USPHS) requirement

^bQuantity Sufficient

“-” Indicates information is not applicable

INDICATIONS AND USAGE

Fluzone Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. (1)

Fluzone Quadrivalent is approved for use in persons 6 months of age and older. (1)

DOSAGE AND ADMINISTRATION

For intramuscular use only (2)

Age	Dose	Schedule
6 months through 35 months	One or two doses a, 0.25 mL each	If 2 doses, administer at least 4 weeks apart
36 months through 8 years	One or two doses a, 0.5 mL each	If 2 doses, administer at least 4 weeks apart
9 years and older	One dose, 0.5 mL	–

^a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines

“-” Indicates information is not applicable

DOSAGE FORMS AND STRENGTHS

Suspension for injection supplied in 4 presentations: prefilled single-dose syringe (pink plunger rod), 0.25 mL; prefilled single-dose syringe (clear plunger rod), 0.5 mL; singledose vial, 0.5 mL; multi-dose vial, 5 mL. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine. (4)

WARNINGS AND PRECAUTIONS

If Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks. (5.1)

ADVERSE REACTIONS

In children 6 months through 35 months of age, the most common (≥10%) injection-site reactions were pain (57%) or tenderness (54%), erythema (37%), and swelling (22%); the most common solicited systemic adverse reactions were irritability (54%), abnormal crying (41%), malaise (38%), drowsiness (38%), appetite loss (32%), myalgia (27%), vomiting (15%), and fever (14%). (6.1)

In children 3 years through 8 years of age, the most common (≥10%) injectionsite reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). (6.1)

In adults 18 years and older, the most common (≥10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). (6.1)

In adults 65 years of age and older, the most common (≥10%) injection-site reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%). (6.1)

USE IN SPECIFIC POPULATIONS

Pregnancy Category B

A developmental and reproductive toxicity study has been performed in female rabbits at a dose approximately 20 times the human dose (on a mg/kg basis) and has revealed no evidence of impaired female fertility or harm to the fetus due to Fluzone Quadrivalent. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Fluzone Quadrivalent should be given to a pregnant woman only if clearly needed.

In the developmental and reproductive toxicity study, female rabbits were administered Fluzone Quadrivalent or control saline (each 0.5 mL/dose) by intramuscular injection 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation. The administration of Fluzone Quadrivalent did not result in systemic maternal toxicity (no adverse clinical signs and no change in body weight or food consumption). In addition, no adverse effects on pregnancy, parturition, lactation, or embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.

Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with Fluzone Quadrivalent during pregnancy. Healthcare providers are encouraged to enroll women who receive Fluzone Quadrivalent during pregnancy in Sanofi Pasteur Inc.’s vaccination pregnancy registry by calling 1-800-822-2463.

Nursing Mothers

It is not known whether Fluzone Quadrivalent is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone Quadrivalent is administered to a nursing woman

Pediatric Use

Safety and effectiveness of Fluzone Quadrivalent in children below the age of 6 months have not been established.

Geriatric Use

Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. [See Clinical Studies (14.5).] Antibody responses to Fluzone Quadrivalent are lower in persons ≥65 years of age than in younger adults.

Safety and effectiveness of Fluzone Quadrivalent have not been established in pregnant women or children less than 6 months of age. (8.4)

Pregnancy: Pregnancy registry available. Call Sanofi Pasteur Inc. at 1-800-822-2463.

Antibody responses to Fluzone Quadrivalent are lower in persons ≥65 years of age than in younger adults. (8.5)

Revised: June 2016

https://www.vaccineshoppe.com/image.cfm?doc_id=13725&image_type=product_pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Fluzone-Quadrivalent.pdf