INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FLUVIRIN®

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

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