Fluviral S/F

FLUVIRAL S/F®

BioChem Vaccines

Whole-Virion and Split-Virion Influenza Virus Vaccine, Inactivated

Active Immunizing Agent

Action And Clinical Pharmacology: Fluviral S/F, split-virion influenza vaccine, promotes an active immunization against influenza. Within 7 days after injection of the vaccine there is an increase in circulating antibody to the viral hemagglutination, and peripheral blood lymphocytes are primed to respond to in vitro stimulation by vaccine antigens. I.M. injection of inactivated vaccine leads to the presence of local IgG antibody in the upper and lower respiratory tract.

Cytotoxic T lymphocyte response occurs after administration of either killed or live virus vaccines and is detectable in the absence of demonstrable antibody response.

Indications And Clinical Uses: For the active immunization of people in the following groups: Adults and children with: a) chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma) severe enough to require regular medical follow-up or hospital care; b) other chronic conditions such as diabetes and other metabolic diseases, cancer, immunodeficiency (including HIV infection) or immunosuppression, renal disease, or hemoglobinopathy and anemia.

Chronic cardiac and pulmonary disorders in persons over the age of 45 are by far the most important risk factors for influenza-related mortality.

Residents of nursing homes and other chronic care facilities: Such residents generally have one or more medical conditions outlined in above group. In addition, their institutional environment may promote spread of the disease. Recent studies have shown that the use of vaccine in this setting will decrease occurrence of illness, and has an even greater impact on reducing the rates of hospitalization, pneumonia and death.

Geriatrics: Persons ³65 years of age: The risk of severe morbidity and mortality related to influenza is moderately increased in healthy persons over 65 years of age but is not nearly as great as in persons with chronic underlying disease.

Children and adolescents (aged 6 months to 18 years) treated for long periods with ASA: Treatment with ASA for long periods might increase the risk of Reye’s syndrome after influenza infection.

Persons infected with human immunodeficiency virus (HIV): Limited information exists regarding the frequency and severity of influenza illness among HIV-infected persons, but reports suggest that symptoms may be prolonged and the risk for complications increased for some HIV-infected persons. Because influenza can result in serious illness and complications, vaccination is a prudent precaution and will result in protective antibody levels in many recipients. However, the antibody response to vaccine may be low in persons with advanced HIV-related illnesses; giving a second dose of vaccine 4 or more weeks after the first does not improve the immune response for these persons. Further studies are also required to determine whether influenza immunization can adversely affect patients infected with HIV. To date, some studies indicate that influenza immunization can be associated with transient increases in plasma HIV concentration, but no study has demonstrated an adverse effect of this temporary change on HIV disease progression.

People capable of transmitting influenza to those at high risk should receive annual vaccination.

Health-care personnel who have extensive contact with individuals in the high-risk groups previously described: The potential for introducing influenza to persons in the high-risk groups outlined above, particularly those in institutions, should be reduced through vaccination programs targeted to health-care personnel.

Household contacts (including children) of individuals at risk: Because low antibody responses to influenza vaccine may occur in some individuals at high risk (e.g., the elderly, people with immunodeficiency), annual vaccination of their household contacts may reduce the risk of influenza exposures.

Other people: People who provide essential community services may be considered for vaccination programs to minimize the disruption of routine activities in epidemics. Influenza vaccine may also be administered to those persons who wish to reduce their chances of acquiring infection.

Pregnancy: Vaccination is recommended for pregnant women in high risk groups (see above section). Vaccine is considered safe for pregnant women – regardless of their stage of pregnancy. Although excess morbidity and mortality were observed among pregnant women during the pandemic outbreaks in 1918-1919 and 1957-1958, further studies are needed to determine whether pregnancy per se is a risk factor that warrants routine influenza immunization.

People at high risk of influenza complications embarking on foreign travel to destinations where influenza is likely to be circulating should be vaccinated with the most current available vaccine. In the tropics, influenza can occur throughout the year. In the southern hemisphere, peak activity occurs from April through September. In the northern hemisphere, peak activity occurs from November through March.

Contra-Indications: Fluviral S/F should not be given to subjects with an acute respiratory infection or with any other active infection or serious febrile illness. On the other hand, a minor indisposition such as a mild infection of the upper respiratory tract is not necessarily a contraindication to vaccination.

Allergic reactions are extremely rare and usually attributable to extreme sensitivity to certain components of the vaccine, probably to trace amounts of residual egg protein. Vaccination is not recommended for subjects who develop anaphylactic type reactions when they eat eggs [urticaria (hives), edema of the mouth and throat, difficulty in breathing, hypotension and shock]. Subjects whose allergy to eggs is not of the anaphylactic type, as well as those who are allergic to chicken and to feathers may be vaccinated.

Do not administer this vaccine to individuals known to be sensitive to thimerosal.

Manufacturers’ Warnings In Clinical States: It is possible that the normal immune response following influenza vaccination may not develop in subjects undergoing immunosuppressive therapy.

Precautions: Sterile epinephrine HCl solution 1:1 000 should always be readily available in case an acute anaphylactic reaction should occur.

Increase of serum theophylline to toxic levels following the administration of influenza vaccine has been recorded in individuals who take oral theophylline as a maintenance therapy. Some doctors recommended a cessation of theophylline or a reduction in dose for 24 hours following vaccination.

The administration of influenza vaccine may also delay the hepatic metabolism of other medications such as oral anticoagulants.

False-positive HIV antibody tests were reported after immunization with the 1991-1992 influenza vaccines. The incidence of false-positive tests declined with the development of different tests so that such false-positive HIV antibody tests are not likely to be a problem now.

Pregnancy: The National Advisory Council on Immunization considers influenza vaccine safe in pregnancy.

Simultaneous Administration of Other Vaccines: The target groups for influenza and pneumococcal vaccination overlap considerably. Health care providers should take the opportunity to vaccinate eligible persons against pneumococcal disease during the same visit at which influenza vaccine is given. The concurrent administration of the 2 vaccines at different sites does not increase the risk of side effects. Pneumococcal vaccine, however, is given only once, whereas influenza vaccine is given annually. Children at high risk may receive influenza vaccine at the same time but at a different site from that used for routine pediatric vaccines.

Information for the Patient: Patients should be informed of the most common side effects:

Local Reactions: Soreness and redness at the injection site that may last for up to 2 days.

Systemic Reactions: fever, headache, myalgia. These reactions begin 6 to 12 hours after vaccination and can persist for 1 or 2 days.

Note: Should these symptoms persist or worsen, patients should be instructed to see a physician.

Adverse Reactions: Subvirion, or split-virion vaccines contain purified portions of the virus rather than the entire virus. Generally, these have been shown to be associated with fewer adverse effects in children and young adults, while maintaining an immunogenicity similar to that of whole virus preparations. Because of their lower rates of side effects, only split virus preparations are recommended for children under 13 years of age.

Local and systemic reactions are reported after vaccination with a split-virion influenza vaccine.

There were very few reports of fever as defined by temperature over 38°C.

Soreness at the injection site was the most frequently reported symptom, and was generally rated as mild and resolved the day after vaccination.

For systemic symptoms, headache and muscle aches were the most common. As with local symptoms, these were generally reported as mild and of limited duration.

Immediate, allergic-type responses, such as hives, angioedema, allergic asthma, or systemic anaphylaxis occur extremely rarely. These reactions probably result from sensitivity to some vaccine component – most likely residual egg proteins (see Contraindications).

There have been reports of other neurological illnesses, including facial paralysis, encephalitis, encephalopathy, demyelinating disease and labyrinthitis, associated with other influenza vaccines. Any relationship, other than temporal, to the vaccine has not been established.

Unlike the 1976-1977 swine influenza vaccine, subsequent vaccines prepared from other virus strains have not been clearly associated with an increased frequency of Guillain-Barre syndrome. Influenza vaccine is not known to predispose to Reye’s syndrome.

Notification of Reactions: It is desirable that all unusual reactions, arising from any vaccination whatsoever, or following shortly thereafter, be reported to the manufacturer of the product and to the provincial epidemiologist.

Since the likelihood of febrile convulsions is greater in children aged 6 to 35 months, special care should be taken in weighing relative risks and benefits in this group.

Administration: Caution: A separate sterile syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of hepatitis B virus, HIV virus, or other infectious agents from one person to another.

Check carefully the expiry date of the vaccine. Any vaccine beyond its expiry date should not be used.

Shake the container vigorously each time before withdrawing vaccine.

Never remove the rubber stopper from the container. Moisten the surface of the rubber stopper with a tampon of sterile cotton wool soaked in a suitable antiseptic and allow the antiseptic to act for a few moments, then wipe dry with a sterile dry swab. Draw into the syringe a volume of air equal to the amount of vaccine to be withdrawn from the container. Shake the container vigorously then pierce the center of the rubber stopper with the sterile needle attached to the syringe. Turn the vial upside down and inject into it the air from the syringe. Keeping the point of the needle immersed in the vaccine, withdraw immediately (into the syringe) the desired volume.

Disinfect the skin at the site of injection with a suitable antiseptic and wipe dry with a tampon of sterile cotton wool. The injection of 0.5 mL of Fluviral S/F, should be given i.m., usually in the deltoid muscle.

Do not inject split-virion influenza vaccine i.v.

To avoid injection into a vein, it is necessary, before injecting the dose of vaccine, to withdraw the piston of the syringe sufficiently to ensure that the needle has not entered a blood vessel.

All vaccinees should be observed for about 15 minutes after vaccination. If an anaphylactic reaction develops, sterile epinephrine HCl (1:1 000) should be administered.

It is desirable that the entire contents of a multidose vial be used at the same vaccination session.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the physician or nurse record the immunization history in the permanent medical record of each patient. This permanent office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.

Disposal: Fluviral S/F vaccine and materials used during vaccination may be disposed of in the same way as other drugs. Since Fluviral S/F is an inactivated vaccine, it presents no risk of contaminating the work area during manipulation.

Availability And Storage: Fluviral S/F for i.m. injection is a trivalent, split-virion influenza vaccine prepared from virus grown in the allantoic cavity of embryonated hens’ eggs. The virus is inactivated with formaldehyde purified by centrifugation and disrupted with sodium deoxycholate in Triton X-100. Each dose of 0.5 mL of a whitish, slightly opalescent liquid, contains: hemaglutinin 15 µg of each of the following strains: A/Beijing/262/95 (H1N1), A/Sydney/5/97 H3N2, B/Harbin/7/94. The composition of Fluviral S/F is established in agreement with the recommendations of the Canadian National Advisory Committee on Immunization (N.A.C.I.). Thimerosal 0.01% is present in both whole and split-virion preparations as a preservative. Split-virion vaccine also contains trace residual amounts of egg proteins and deoxycholate. Vials of 5 mL (10 doses). Store in the refrigerator between 2 and 8°C. Do not freeze. Freezing destroys activity. Do not use vaccine which has been frozen.

FLUVIRAL S/F® BioChem Vaccines Whole-Virion and Split-Virion Influenza Virus Vaccine, Inactivated Active Immunizing Agent

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