|
|
|
9 of 9 H1N1 Flu Shots / Flu Mist |
|
|
|
 |
| Novartis Influenza A H1N1 2009 Monovalent Vaccine Single Dose
|
|
|
Mercury Levels: | Trace amount (≤ 1 mcg mercury per 0.5-mL dose)
| |
Recipient's Age: | 4 years and older
| |
H1N1 Flu Shot or Mist: | shot
| |
Manufacturer: | Novartis
| |
|
|
|
|
|
|
|
|
 |
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
Dosage and Administration
Based on currently available information the vaccination regimen is as follows:
- Children 4 through 9 years of age: Two 0.5-mL intramuscular injections
approximately 1 month apart
- Children 10 through 17 years of age: A single 0.5-mL intramuscular injection
- Adults 18 years of age and older: A single 0.5-mL intramuscular injection
Dosage Forms and Strengths
Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular
injection, is supplied in two presentations:
- Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury derivative used during
manufacture, is removed by subsequent purification steps to a trace amount (≤ 1 mcg
mercury per 0.5-mL dose)
-
Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose).
Thimerosal is added as preservative.
Contraindications
History of systemic hypersensitivity reactions to egg proteins, or any other
component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening
reactions to previous influenza vaccinations.
Warnings and Precautions
- If Guillain-Barre syndrome has occurred within 6 weeks of receipt of prior influenza
vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should
be based on careful consideration of the potential benefits and risks.
- Immunocompromised persons may have a reduced immune response to Influenza A
(H1N1) 2009 Monovalent Vaccine.
Adverse Reactions
Adverse Reaction information is based on studies conducted with seasonal trivalent
Influenza Virus Vaccine manufactured by Novartis (FLUVIRIN).
The most frequently reported adverse reactions are mild hypersensitivity reactions (such
as rash), local reactions at the injection site, and influenza-like symptoms.
To report SUSPECTED ADVERSE REACTIONS contact Novartis Vaccines at 1-
800-244-7668, or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
Drug Interactions
- Do not mix with any other vaccine in the same syringe or vial.
- Immunosuppressive therapies may reduce immune response to Influenza A (H1N1)
2009 Monovalent Vaccine.
Use In Specific Populations
- Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not
been established in pregnant women, nursing mothers or children less than 4 years of
age.
- Antibody responses to the trivalent seasonal Influenza Virus Vaccine manufactured
by Novartis (FLUVIRIN) were lower in the geriatric population than in younger
subjects.
|
|
Dosage Information:
Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury derivative used during manufacture, is removed by subsequent purification steps to a trace amount (≤1 mcg mercury per 0.5-mL dose).
|
Pregnanct Safe:
Consult your physician
|
|
|
|
|
