FLUVIRIN®
1994
REGISTRATION NUMBER:
28/30.1/0711
PROPRIETARY NAME
(and dosage form):
FLUVIRIN®
DESCRIPTIVE NAME:
Inactivated Influenza Vaccine
(Surface Antigen)
PHARMACOLOGICAL CLASSIFICATION:
A 30.1 Biological antigen
SCHEDULING STATUS:
S2
COMPOSITION:
Each 0,5 mL dose contains inactivated influenza virus subunits:
| A/Texas/36/91 (H1N1) | > 15 µg | ||
| A/Johannesburg/33/91(H3N2) | > 15 µg | ||
| B/Harbin/07/94 | > 15 µg | ||
| Preservative: | Thiomersal 0,01% m/v | ||
These are the strains currently recommended for South Africa
in 1996. These strains may change for subsequent years.
IDENTIFICATION:
Slightly opalescent liquid free from extraneous particles.
PHARMACOLOGICAL ACTION OF THE MEDICINE:
After injection, increasing levels of the surface antigens in the
circulation stimulate the production of immunoglobulins of the M and G type
which first become detectable in the serum at about 5 - 7 days, rising to a
maximum between 10 - 21 days. A rise of fourfold in the circulating levels of a
specific antibody is taken as indicative of a successful (and thus protective)
response.
INDICATIONS:
Prophylaxis against influenza in high risk groups, especially the elderly.
Also recommended for patients with chronic cardiac disease, chronic pulmonary
disease, chronic renal disease or diabetes and patients receiving
immunosuppressive therapy.
CONTRA-INDICATIONS:
FLUVIRIN is contra-indicated in persons sensitive to egg, chicken or
influenzal viral protein.
Immunisation should be delayed if there is active or suspected infection.
The vaccine should not be given to patients with a history of anaphylaxis to
polymyxin and neomycin.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children aged four and over: 0,5 mL by deep subcutaneous or
intramuscular injection. Young children who may not have been previously
infected, or who have not received trivalent influenza vaccine in the past four
years, may require two doses of vaccine given at an interval of 4 - 6 weeks, to
ensure a protective antibody response.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reaction, possibly with inflammation and lymphangitis. At the site of
injection an induration or sterile abscess may develop. Fever and malaise
sometimes occur and severe febrile reactions have been reported.
Hypersensitivity reactions may occur and anaphylaxis has been reported.
Various neurological syndromes have been temporally associated with
administration of influenza vaccine, the most notable report being
Guillain-Barré syndrome occurring after vaccination with inactived swine
influenza vaccine in 1976.
Influenza vaccination has been associated with development and exacerbation of
Henoch-schoniem purpura.
Precautions:
Enquiry regarding previous hypersensitivity should precede the
administartion of FLUVIRIN®.
Vaccination should be postponed in patients suffering from any accute illness
although minor infections without fever or systemic upset are not regarded as
contra-indications.
Caution should be observed in patients with less severe manifestations of
antibiotic hypersensitivity.
Measures to treat anaphylaxis, including adrenaline should be immediately
available.
Before injection of a vaccine any alcohol or disinfectant used for cleansing the
skin should be allowed to evaporate.
FLUVIRIN® should not be administered during pregnancy unless it is
considered there is a significant risk of exposure to infection.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and
supportive.
PRESENTATION:
Carton containing one 0,5 mL disposable syringe.
Carton containing ten 0,5 mL disposable syringes.
STORAGE INSTRUCTIONS:
Store between 2° - 8°C, protected from light.
Do not freeze.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
Medpro Pharmaceutica (Pty) Ltd
Unit 9 Rosen Heights
Rosenpark
Pasita Street
BELLVILLE
7350
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1994
® Registered trademark of Evans Medical Limited