Ipol (Injection) Rx
Poliomyelitis virus (types 1, 2 and 3), inactivated; formaldehyde < 0.02%; single dose syringes; Gluten free.
Pack(s): 0.5 mL .Fields:
Pack(s): 0.5 mL .Fields:
Dose: Primary course: 3 x 0.5 mL doses SCI at 8 week intervals, then 4th dose 12 months after 3rd; 0.5 mL booster dose before school entry. Unvaccinated adults: primary course; incomplete primary course: remainder of scheduled doses; increased exposure: 0.5 mL booster dose
Inactivated poliomyelitis vaccine is a sterile suspension of three strains of poliovirus: type l (Mahoney), type 2 (MEFI) and type 3 (Saukett). The viruses are grown in cultures of VERO cells, a continuous line of monkey kidney cells, by the microcarrier technique. The viruses are concentrated, purified and made noninfectious by inactivation with formaldehyde. Each sterile immunising dose (0.5 mL) of trivalent vaccine is formulated to contain antigen type 1 40 D units, antigen type 2 8 D units, and antigen type 3 32 D units.
Formaldehyde 0.02% (maximum) as preservative; traces of neomycin, streptomycin and polymyxin B used in vaccine production may be present.
Ipol is a highly purified inactivated poliovirus vaccine produced by microcarrier culture. In four studies of primary infant vaccination with a two dose schedule of inactivated poliomyelitis vaccine, 409 of a total of 419 infants had protective levels of serum antibody to all three of the poliovirus types after completion of the schedule. Mucosal response, measured by IgA in stool and saliva, was significantly lower with inactivated polio vaccine than with oral polio vaccine.
Data on antibody persistence are limited and so the optimal time for boosters, upon completion of the primary course, has not been established.
Active immunisation of infants, children and adults for the prevention of poliomyelitis. Recommendations for the use of live and inactivated poliovirus vaccines are described in the NHMRC Immunisation Procedures book.It is recommended that all infants, unimmunised children and adolescents not previously immunised be vaccinated routinely against paralytic poliomyelitis. Ipol should be offered to patients who have refused oral polio vaccine, or in whom oral polio vaccine is contraindicated.
Ipol is also indicated for the following individuals.The primary vaccination of immunocompromised individuals of all ages (see Precautions), and household contacts of such individuals (when vaccination is indicated).
Unvaccinated or inadequately vaccinated adults (e.g. those who had not completed a primary series of vaccination or not received a booster dose since infancy), particularly if at increased risk of exposure to live polio virus, including travellers to areas or countries where poliomyelitis is epidemic or endemic; laboratory workers handling specimens which may contain polio viruses; and healthcare workers in close contact with patients who may be excreting polioviruses.
History of hypersensitivity to any component of the vaccine, including neomycin, streptomycin and polymyxin B. If anaphylaxis or anaphylactic shock occurs within 24 hours of administration of a dose of vaccine, no further doses should be given.
Any significant acute febrile illness, including respiratory infections.
Adrenaline (1:1,000) and other appropriate agents should be available to control immediate allergic reactions.
Inactivated poliomyelitis vaccine should be used in all patients with immunodeficiency diseases and members of such patients' households when vaccination of such persons is indicated.
Patients with immune deficiency diseases, e.g. human immunodeficiency virus (HIV) infection, combined immunodeficiency, hypogammaglobulinaemia and agammaglobulinaemia, and those with altered immune states due to diseases such as leukaemia, lymphoma or generalised malignancy or with immune systems compromised by therapy with corticosteroids, alkylating drugs, antimetabolites or radiation, may or may not develop a protective immune response after administration of inactivated poliomyelitis vaccine.
Use in pregnancy.
Animal reproduction studies have not been conducted with Ipol. Ipol should be given to pregnant women only if clearly needed. There is no convincing evidence of risk to the fetus from immunisation of pregnant women using inactivated virus vaccines.
Transient local reactions at the site of injection have been observed during clinical trials. Erythema, induration and pain occurred in 33%, 1% and 13% of vaccinees, respectively. Other symptoms noted in more than 5% of vaccinated infants included sleepiness, fussiness, crying, decreased appetite and spitting up of feeds.
In a study using Ipol in the US, 7%, 12% and 4% of children reported with temperatures over 38.1 deg. C, following the first, second and third doses, respectively.
As most of the children in the clinical trials received diphtheria-tetanus-pertussis (DTP) at the same time as inactivated polio vaccine (but at a separate site), it was not possible to attribute reactions to a particular vaccine; however, the reactions observed were not significantly different to those seen when DTP is given alone.
Although no causal relationship between Ipol and Guillain-Barre syndrome (GBS) has been established, GBS has been temporally related to administration of another inactivated poliovirus vaccine.
There are no known interactions of Ipol with drugs or foods. Simultaneous administration of other parenteral vaccines is not contraindicated.
Dosage and Administration
Ipol is for subcutaneous injection only. Do not administer intravenously. Do not administer orally and do not mix with any other preparation in the same syringe.
After preparation of the injection site, immediately administer the vaccine subcutaneously. In infants and small children, the midlateral aspect of the thigh is the preferred site. In adults, the vaccine should be administered in the deltoid or triceps region.
(See Indications.) Three doses of 0.5 mL each should be administered subcutaneously at intervals of eight 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 (diphtheria and tetanus toxoids and pertussis vaccine) immunisation, beginning at 8 to 12 weeks of age.
(See Indications.) 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 before entering school.
Adults at risk of exposure (see Indications) and who are unvaccinated, should receive a primary series of Ipol as outlined above; those with incomplete primary immunisation should receive the remaining doses of the primary series, regardless of the interval since the last dose; those who have previously completed a primary series of poliomyelitis vaccine should receive a single booster dose of 0.5 mL.
A primary series of injections of Ipol may be preferred to oral vaccination because of the very slight possibility of vaccine associated polio in adult vaccinees.
Injection (clear, colourless solution), 0.5 mL (single dose syringes): 1's, 10's.
Store at 2 to 8 deg. C. (Refrigerate. Do not freeze.)