Pneumococcal Polysaccharide Vaccine Pneumo 23

PNEUMOCOCCAL POLYSACCHARIDE VACCINE PNEUMO 23™

Connaught

Active Immunizing Agent

Action And Clinical Pharmacology: Pneumococcal polysaccharide vaccine, Pneumo 23 is a capsular polysaccharide vaccine against disease caused by 23 of the most common types of S. pneumoniae (pneumococcus). Approximately 90% of cases of pneumococcal bacteremia and meningitis are caused by these 23 types. Although the overall incidence of pneumococcal infections in Canada is not known, invasive disease is most common in the very young, the elderly, and in certain specific groups at high risk.

In clinical studies involving more than 1 000 volunteers, serum capsular polysaccharide antibodies start to increase 10 to 15 days following immunization with the pneumococcal polysaccharide vaccine. Although the duration of protection has not yet been determined it may last approximately 5 to 10 years. Encouraging and concordant studies from a randomized controlled trial in France, from 3 of 4 case-control studies, and from the epidemiological analysis by the CDC, all support the consensus that pneumococcal polyvalent vaccines are effective in immunocompetent older persons with high-risk conditions. Almost 90% of elderly people achieve antibody levels 300 ng antibody nitrogen/mL. Clinical trials with the pneumococcal polysaccharide vaccine have also shown that healthy adults develop excellent antibody responses following pneumococcal vaccination: 80% or more of subjects develop at least a 2-fold rise in antibody levels. In humans, the capsular polysaccharide vaccine, after i.m. injection, induce IgG and IgM antibody type.

Indications And Clinical Uses: For the prevention of invasive infection, such as pneumonia or meningitis, caused by those types of pneumococci contained in the vaccine.

A single dose of pneumococcal vaccine should be given to persons in the following groups at increased risk of pneumococcal disease or its complications:

Adults: All persons ³65 years of age. Adults with asplenia, splenic dysfunction or sickle-cell disease. Adults with the following conditions: chronic cardiorespiratory disease, cirrhosis, alcoholism, chronic renal disease, nephrotic syndrome, diabetes mellitus, chronic cerebrospinal fluid leak, HIV infection and other conditions associated with immunosuppression (Hodgkin’s disease, lymphoma, multiple myeloma, immunosuppression for organ transplantation).

Children: Children ³2 years of age with asplenia, splenic dysfunction or sickle-cell disease. All children ³2 years of age with nephrotic syndrome, chronic cerebrospinal fluid leak, HIV infection and other conditions associated with immunosuppression.

The pneumococcal polysaccharide vaccine may be given simultaneously with influenza, meningococcal and Hib conjugate vaccines at separate sites with separate syringes.

Where possible, the vaccine should be given at least 10 to 14 days before splenectomy or initiation of immunosuppressive therapy.

Children: The pneumococcal polysaccharide vaccine is not recommended for children
History of a confirmed or suspected pneumococcal infection is not a contraindication and should be considered according to underlying risk status. The pneumococcal polysaccharide vaccine is not recommended for prevention of recurrent upper respiratory tract infections, particularly otitis media and sinusitis.

Revaccination: Adults should not be routinely given more than 1 dose of pneumococcal vaccine. Revaccination after 3 to 5 years should be considered for children with sickle-cell anemia, asplenia or nephrotic syndrome, who will be £10 years old at revaccination. Revaccination of older children and adults at highest risk of fatal infection (asplenic patients) should be considered for those who received pneumococcal vaccine 6 or more years previously, as well as for those shown to have rapid decline in pneumococcal antibody levels (patients with nephrotic syndrome, renal failure or transplant recipients).

Contra-Indications: General: Immunization with the pneumococcal polysaccharide vaccine, should be deferred in the presence of any acute illness, including febrile illness. A minor afebrile illness such as mild upper respiratory infection is not usually reason to defer immunization.

Absolute Contraindications: Allergy to any component of the pneumococcal polysaccharide vaccine (see Supplied) or an allergic or anaphylactic reaction to a previous dose of pneumococcal vaccine are contraindications to vaccination.

Immunization is contraindicated in persons who were given a pneumococcal vaccine within the previous 3 years.

Manufacturers’ Warnings In Clinical States: Pneumococcal polysaccharide vaccine will not immunize against types of pneumococci other than those contained in the vaccine.

If the pneumococcal polysaccharide vaccine is used in persons with malignancies receiving immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, or who are otherwise immunocompromised (including HIV infected individuals), the expected immune response may not be obtained.

In patients receiving antibiotic prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after immunization with the pneumococcal polysaccharide vaccine.

Corticosteroid therapy can result in immunosuppression although the exact dose and duration of therapy required to suppress the immune system is not well defined. Persons treated with high doses of systemic steroids, e.g., ³2 mg/kg/day of prednisone orally for more than 2 weeks, should be considered to have a compromised immune system.

If the pneumococcal polysaccharide vaccine is given less than 14 days prior to splenectomy or initiation of chemotherapy, it may not elicit the expected immune response.

As with any vaccine, immunization with the pneumococcal polysaccharide vaccine may not protect 100% of susceptible individuals.

Very rare Arthus-like phenomenae have been reported. They are reversible without after-effects and mainly occur in persons with high initial pneumococcal antibody levels.

Precautions: General: The possibility of allergic reactions in individuals sensitive to components of the vaccine should be evaluated. Epinephrine HCl Solution (1:1 000) should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Health care providers should be familiar with current recommendations for the initial management of anaphylaxis in nonhospital settings.

Before an injection of any vaccine, all appropriate precautions should be taken to prevent adverse reactions. This includes a review of the patient’s history with respect to possible hypersensitivity to the vaccine or similar vaccine, determination of previous immunization history, and the presence of any contraindications to immunization, current health status, and a current knowledge of the literature concerning the use of the vaccine under consideration.

Special care should be taken to ensure that the injection does not enter a blood vessel.

Caution: A separate, sterile syringe and needle, or a sterile disposable unit, must be used for each individual patient to prevent the transmission of infectious agents. There have been case reports of transmission of HIV and hepatitis by failure to scrupulously observe sterile technique.

Needles should not be recapped and should be disposed of properly.

Administer the vaccine s.c. or i.m., do not administer i.v.

It is recommended that the pneumococcal polysaccharide vaccine be given at least 2 weeks before splenectomy, the initiation of a chemotherapy or an immunosuppressive treatment.

Pregnancy: The safety of the pneumococcal polysaccharide vaccine in pregnant women has not been specifically evaluated.

Reproduction studies have not been conducted with the pneumococcal polysaccharide vaccine. The vaccine should be given to a pregnant woman only if clearly needed.

Lactation : The pneumococcal polysaccharide vaccine may be given to lactating women.

Adverse Reactions: Local reactions at the injection site including pain, erythema, and induration occur in approximately 60% of vaccinees. These reactions are generally mild and transient.

Rarely, Arthus-like reactions have been reported. These occur mainly in persons with high pneumococcal antibody levels.

Systemic Reactions: Fever ³38.5°C occurs in approximately 2% of vaccinees. Febrile episodes occur early after vaccination and generally resolve within 24 hours. Headache and/or general malaise occur in
Allergic-type reactions including urticaria, angioedema and anaphylaxis have been reported.

Rarely, more severe systemic reactions have been reported in the literature following administration of pneumococcal polysaccharide vaccines. These include thrombocytopenia, vasculitis, generalized rash, and relapse of known underlying immune conditions. The relationship, if any, between these reactions and pneumococcal vaccine is unknown.

Physicians, nurses, and pharmacists should report any adverse occurrences temporally related to the administration of the product in accordance with local requirements and to the Medical Director, Connaught Laboratories Limited, 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4.

Dosage And Administration: The immunizing dose is a single injection of 0.5 mL given i.m. or s.c.

Revaccination: One injection of 0.5 mL (see Indications).

Administration: Parenteral biological products should be inspected visually for extraneous particulate matter and/or discoloration before administration. If these conditions exist, the product should not be administered.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.

Shake the prefilled syringe well before administering dose.

Administer the vaccine i.m. or s.c. The preferred site is the deltoid area.

After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

Do not inject i.v.

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.

Availability And Storage: Pneumococcal polysaccharide vaccine, is a clear, colorless liquid prepared from purified pneumococcal capsular antigens. Each dose of 0.5 mL contains: purified S. pneumoniae polysaccharides, 25 µg of each of the following serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F; phenol as a preservative; isotonic buffered solution (composition: sodium chloride, disodium phosphate, monosodium phosphate, water for injection).

Prefilled syringes of 0.5 mL (single dose), packages of 10. Store between 2 and 8°C. Do not freeze. Product that has been exposed to freezing should not be used. Do not use vaccine after expiration date.

PNEUMOCOCCAL POLYSACCHARIDE VACCINE PNEUMO 23™ Connaught Active Immunizing Agent

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