Presentation and Status in Health Basket
Pre-filled Syringe (solution for injection)
Should be administered as a single injection of 1 dose (0.5 mL) by the intramuscular route. The preferred site is the deltoid muscle. Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on safety and efficacy has not been determined. Health-care professionals should refer to the National Advisory Committee on Immunization.
A thorough attempt must be made to determine whether a patient has completed primary immunization. Persons who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation if they have not received tetanus toxoid within the preceding 10 years. For tetanus-prone wounds (e.g., wounds contaminated with dirt, feces, soil and saliva, puncture wounds, avulsions and wounds resulting from missiles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years.
For adults who have not previously received a dose of acellular pertussis vaccine, a single tetanus-diphtheria (Td) booster dose should be replaced by a combined tetanus-diphtheria-acellular pertussis vaccine (Tdap).
Method of administration: Inspect for extraneous particulate matter and/or discolouration before use. If these conditions exist, the product should be discarded.
Shake the vial or syringe well until a uniform, cloudy, suspension results. When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual patient to prevent disease transmission. Needles should not be recapped but should be disposed of according to biohazard waste guidelines.
Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.
A single injection of one dose (0.5 mL) of ADACEL®-POLIO should be administered by intramuscular route. Administration should preferably be performed in the deltoid muscle.
Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from the age of four years and over as a booster following primary immunization.
ADACEL®-POLIO is not intended for primary immunization.
ADACEL®-POLIO is not to be used for the treatment of disease caused by B. pertussis, C. diphtheriae or C. tetani or Poliomyelitis infections.
Persons who have had tetanus, diphtheria or pertussis should still be immunized since these clinical infections do not always confer immunity. Human Immunodeficiency Virus (HIV)-infected persons, both asymptomatic and symptomatic, should be immunized against tetanus, diphtheria and pertussis according to standard schedules
The use of ADACEL®-POLIO should be determined on the basis of official recommendations.
Hypersensitivity to the active substances, to any of the excipients or any residual component carried over from manufacture (formaldehyde, gluteraldehyde, streptomycin, neomycin and polymyxin B). Anaphylactic or other allergic reactions to a previous dose of a vaccine containing diphtheria or tetanus toxoids, poliomyelitis viruses or pertussis (acellular or whole cell). Evolving encephalopathy: Should not be administered to subjects who experienced an encephalopathy of unknown origin within 7 days of previous immunization with a pertussis-containing vaccine, or to subjects who have experienced other neurological complications following previous immunization with any of the antigens in the vaccine. Vaccination should be deferred in the presence of any acute illness, particularly febrile illness. A minor afebrile illness such as mild upper respiratory infection does not usually entail vaccination postponement.
Should not be administered as primary immunization or as boosters in children less than 3 years of age. In subjects who presented with Guillain-Barre syndrome or brachial neuritis following prior administration of a vaccine containing tetanus toxoid, careful consideration must be taken regarding potential benefits and possible risks.
Adolescents and adults: Very common: Headache, nausea, arthralgia/joint swelling, myalgia, asthenia, chills, injection site pain, swelling, erythema. Common: Vomiting, diarrhea, fever>38°C.
Children 5 to 6 years old: Very common: Fatigue, injection site pain, swelling. Common: Fever>38°C, injection site erythema and pruritus.
Children 3 to 5 years old: Very common: fatigue, fever>37.5°C, irritability, injection site pain, swelling, erythema.
Common: Nausea, vomiting, diarrhea, rash, injection site bruising and dermatitis.
See prescribing information for full details.
No interaction studies have been carried out with other vaccines, biological products or medicdbinal products. However, in accordance with commonly accepted vaccination recommendations, as with any inactivated vaccine, there is no theoretical reason not to administer concomitantly with other vaccines or immunoglobulins at separate injection sites.
Pregnancy and Lactation
The effect on embryo-foetal development has not been assessed. Limited post-marketing data is available following administration in pregnant women. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis. As the vaccine is inactivated, risk to the embryo or the fetus is improbable. The benefits versus the risks of administering during pregnancy should be carefully evaluated when there is a high probable risk of exposure to a household contact or during an outbreak in the community.
Use in lactation: The effect of administration during lactation has not been assessed. However, as it contains toxoids or inactivated antigens, there should be no expected risk for breastfed children. The benefits compared the risk of administering to lactating women should be assessed by the health-care professionals.