INFORMATION FOR HEALTH PROFESSIONALS
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Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV is a suspension of three types of poliovirus, Type 1 (Mahoney), Type 2 (M.E.F.1) and Type 3 (Saukett), grown in human diploid strain MRC-5 cell cultures, concentrated, purified and inactivated with formaldehyde. Formaldehyde (27 ppm) and 2-phenoxyethanol (0.5% v/v) are added as preservatives. Albumin (Human) is added as a stabilizer to a concentration of 0.5% v/v. By calculation, the vaccine contains 20 ppm Tween 80 and less than 1 ppm of bovine serum. Trace amounts of streptomycin and/or polymyxin B and neomycin may be present from the cell culture growth medium. The vaccine is clear and colourless.
Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV is indicated as an active immunizing agent to be administered, as described below, for the prevention of poliomyelitis.
Primary immunization of infants at or above the age of two months, and children up to their seventh birthday: Three doses of 0.5 mL each should be administered subcutaneously at intervals of 8 weeks, followed by a fourth dose of 0.5 mL approximately 12 months after the third dose.
In infancy, the primary schedule is usually integrated with DPT Adsorbed immunization, beginning at 8 to 12 weeks of age.
Primary immunization of older children (after their seventh birthday) and adults: Two doses of 0.5 mL each administered subcutaneously 8 weeks apart, followed by a third dose of 0.5 mL, approximately 12 months after the second dose.
Booster Doses: All children who have received the initial four doses in infancy and in early childhood should be given a booster dose of 0.5 mL of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV before entering school. However, if the fourth primary dose is administered on or after the fourth birthday, a fifth (supplementary) dose is not required at school entry. Further recall doses of 0.5 mL should be given every 10 years thereafter.
Adults: Most adults are already immune and have a very small risk of exposure to poliomyelitis. Immunization is recommended for certain adults who are at greater risk of exposure to poliovirus than the general population, including:
Adults at increased risk of exposure who are unvaccinated should receive a primary series of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV as outlined above. Those with incomplete primary immunization should receive the remaining dose(s) of the primary series regardless of the interval since the last dose. Those who have previously completed a primary series of inactivated poliomyelitis vaccine, should receive a single booster dose of 0.5 mL.
Adults who have not been adequately immunized against poliomyelitis are at a very small risk of developing vaccine-associated paralysis when children in the household are given live, oral poliovirus vaccine. Therefore, prior to use of the live, oral poliovirus vaccine for immunization of a family member, some health care personnel recommend that adults who have never received any polio vaccine should be given at least two doses of inactivated poliomyelitis vaccine a month apart, or preferably, the full primary series.
The vaccine should be administered by subcutaneous injection. The injection may conveniently be made into the subcutaneous tissue near the insertion of the deltoid muscle. The site of injection should be prepared with a suitable antiseptic.
A separate sterile syringe and needle should be used for each individual patient to prevent transmission of hepatitis viruses and other infectious agents.
In order to avoid intravenous injection, pull back the plunger of the syringe to make certain that no blood is withdrawn before injecting the desired dose.
Tap the ampoule to ensure that the solution is in the lower portion rather than in the neck of the ampoule.
Wipe the neck of the ampoule with a suitable antiseptic. Using a sterile piece of cotton or a sterile towel, break off the top of the ampoule at the coloured line (no file is required). Then, with the sterile syringe and needle, withdraw the contents of the ampoule into the syringe, holding the ampoule in such a way that the point of the needle is kept immersed throughout the withdrawal.
Once the ampoule has been opened, any of its contents not used immediately should be discarded.
Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the health care provider also maintain a permanent record of the immunization history of each individual. This official record should contain the name of the vaccine, date given, manufacturer and lot number.
Immunization with Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV should be deferred in the presence of acute febrile illness, including respiratory infections.
The vaccine should be clear and colourless. Any vaccine showing particulate matter or turbidity should be discarded.
Inactivated poliomyelitis vaccine is the vaccine of choice for immunizing immunodeficient patients and their household contacts. Although patients with immune deficiency diseases such as combined immunodeficiency, hypogammaglobulinaemia and agammaglobulinaemia, those with altered immune states due to diseases such as leukaemia, lymphoma or generalized malignancy, and those with immune systems compromised by therapy with corticosteroids, alkylating drugs, antimetabolites or radiation may not develop a protective immune response, Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV should be administered. Because of the possibility of immunodeficiency in other members of a household in which there has been one such case, Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV should be used to immunize subsequent children until the immune status of the recipient and of other children in the family is documented.
Since the vaccine contains trace amounts of animal protein and may contain trace amounts of streptomycin and/or polymyxin B and neomycin, the possibility of allergic reactions in individuals sensitive to these substances should be borne in mind when considering the use of this vaccine.
As with any biological product, Epinephrine Hydrochloride Solution (1: 1000) should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs.
Although there is no convincing evidence documenting adverse effects of inactivated poliomyelitis vaccine on the pregnant woman or the developing foetus, it is prudent on theoretical grounds to avoid vaccinating pregnant women.
Local reactivity at the injection site as observed during the Canadian Clinical Trials consisted of redness, hardness and pain or discomfort occurring in 14%, 4% and 12% of vaccinees, respectively, usually on the evening following injection and declining thereafter to minimal levels.
As both of the first and second Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV injections were administered at the same time, but at a different site from the first and second injections of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DPT Adsorbed), interpretation of systemic reactivity cannot be attributed solely to either vaccine. However, the systemic reactivity associated with administration of DPT Adsorbed in previous clinical trials would tend to indicate that the DPT Adsorbed was the major contributory factor.
Store Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV between 2° and 8°C. DO NOT FREEZE.
Prescription Medicine
IPV is supplied in packages containing 5 x 0.5 mL ampoules. Each single dose of 0.5 mL is formulated to contain 40 D units of poliovirus antigen Type 1, 8 D units of poliovirus antigen Type 2 and 32 D units of poliovirus antigen Type 3.
Nil
CSL (NZ) Limited
PO Box 62590
Penrose
AUCKLAND
New Zealand
Telephone: (09) 579 8105
May 2000