INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE- influenza a virus a/california/7/2009(h1n1)-like antigen (formaldehyde inactivated)

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 5I5HVC73I8) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:EUJ84UN96Z)

제공처:

Sanofi Pasteur Inc.

INN (International Name):

INFLUENZA A VIRUS A/CALIFORNIA/7/2009-LIKE ANTIGEN -LIKE HEMAGGLUTININ ANTIGEN - UNII:EUJ84UN96Z)

구성:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL

관리 경로:

INTRAMUSCULAR

치료 징후:

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions (5) and Description (11) ] Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Available information for Fluzone vaccine is provided in this section. Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction

제품 요약:

Single-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-25. Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-70. Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-50. Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-90. Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 49281-640-15. Vial stoppers and syringe plungers do not contain latex. Store all Influenza A (H1N1) 2009 Monovalent Vaccine presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. Between uses, return the multi-dose vial to the recommended storage conditions at 2º to 8ºC (35º to 46ºF). Do not use after the expiration date shown on the label.

승인 상태:

Biologic Licensing Application

제품 특성 요약

INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE- INFLUENZA A VIRUS
A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)
INJECTION, SUSPENSION
SANOFI PASTEUR INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFLUENZA A (H1N1) 2009 MONOVALENT
VACCINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
INFLUENZA A (H1N1) 2009 MONOVALENT
VACCINE.
INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE
MANUFACTURED BY SANOFI PASTEUR INC.
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 1980
RECENT MAJOR CHANGES
INDICATIONS AND USAGE ( 1 )
[9 /20 0 9 ]
DOSAGE AND ADMINISTRATION ( 2.2 )
[9 /20 0 9 ]
INDICATIONS AND USAGE
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza
virus vaccine indicated for active immunization of
persons 6 months of age and older against influenza disease caused by
pandemic (H1N1) 2009 virus. (1)
DOSAGE AND ADMINISTRATION
BASED ON CURRENTLY AVAILABLE INFORMATION THE VACCINATION REGIMEN IS AS
FOLLOWS:
CHILDRE N
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■
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ADULTS
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DOSAGE FORMS AND STRENGTHS
Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for
intramuscular injection, is supplied in four
pre se ntations:
Prefilled syringe, 0.25 mL, no preservative; distinguished by a pink
syringe plunger rod (3)
Prefilled syringe, 0.5 mL, no preservative (3)
Single-dose vial, 0.5 mL, no preservative (3)
Multi-dose vial, 5 mL, contains thimerosal, a mercury derivative,
added as a preservative. Each 0.5 mL dose contains 25
mcg mercury. (3, 11 )
CONTRAINDICATIONS
Severe hypersensitivity to egg proteins or any component of the
vaccine or life-threatening reactions after previous
administration of any influenza vaccine. (4, 11)
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of
previous influenza vaccination, the decision to give
Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful
consideration of the potential benefits and
risks. (5.1)
Immunocompromised persons may h