Adacel

/ Medici

Recommended Dose: The immunization schedule with ADACEL® should follow local recommendations.
ADACEL® (0.5mL) should be administered as a booster dose by the intramuscular route.
Re-dosing with ADACEL® can be used to boost immunity to diphtheria, tetanus and pertussis at 5- to 10-year intervals.
The preferred site is into the deltoid muscle.
Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on the safety and efficacy has not been determined.
See prescribing information for full details.

ADACEL® is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis in children, adolescents and adults aged 4 to 64 years.
Adacel can be concomitantly administered with Inactivated Poliomyelitis Vaccine (IPV) at separate sites to complete the vaccination series, when indicated.

Hypersensitivity: Known systemic hypersensitivity reaction to any component of ADACEL® or a lifethreatening reaction after previous administration of the vaccine or a vaccine containing one or more of the same components are contraindications to vaccination. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such persons may be referred to an allergist for evaluation if further immunizations are considered.
Acute Neurological Disorders: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with any pertussis-containing vaccine, including ADACEL®.

Should not be administered into the buttocks, nor by the intradermal or subcutaneous route. Do not administer by intravascular injection. Ensure the needle does not penetrate a blood vessel. The use of fractional doses (doses Pregnancy and lactation: Vaccination in pregnancy is not recommended unless there is a define risk of acquiring pertussis. As the vaccine is inactivated, risk to the embryo or the fetus is highly improbable. The benefits versus the risks of administration in 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. The effect of administration during lactation has not been assessed. As the vaccine is inactivated, any risk to the mother or the infant is highly improbable. The benefits versus the risks of administration during lactation should carefully be evaluated by the health-care provider, particularly when there is a high probable risk of disease transmission through exposure to a household contact or during an outbreak in the community. The risk of disease transmission from the infected mother to the infant who may not have been fully immunized should also be evaluated.
See prescribing information for full details.

Children (4 to 6 Years)
Very common: Anorexia (decreased appetite), Diarrhoea, Fatigue/Asthenia, Injection site pain, Injection site erythema, Injection site swelling.
Common: Nausea, Vomiting, Rash, Generalized aching or Muscular weakness, Arthralgia or Joint swelling, Pyrexia, Chills, Axillary adenopathy.
Adolescents (11 to 17 Years)
Very common: Headache, Diarrhoea, Nausea, Generalized aching or Muscular weakness, Arthralgia or Joint swelling, Fatigue/Asthenia, Malaise, Chills, Injection site pain, Injection site erythema, Injection site swelling.
Common: Vomiting, Rash, Pyrexia, Axillary adenopathy
Adults (18 to 64 Years)
Very common: Headache, Diarrhoea, Generalized aching or Muscular weakness, Fatigue/Asthenia, Malaise, Injection site pain, Injection site erythema, Injection site swelling.
Common: Nausea, Vomiting, Rash, Arthralgia or Joint swelling, Pyrexia, Chills, Axillary adenopathy.
See prescription for full details.

If any other vaccines are administered during the same visit, they must be given at separate sites with separate syringes. Should not be mixed in the same syringe with other parenterals.
See prescribing information for full details.

Pregnancy: Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 2 prospective observational studies (2670 pregnancy outcomes), 4 retrospective observational studies (81,701 pregnancy outcomes), and from passive surveillance of women who received during the 2nd or 3rd trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child. As with other inactivated vaccines, it is not expected that vaccination during any trimester would harm the fetus. The benefits versus the risks of administering during pregnancy should be evaluated.
Lactation: It is not known whether the active substances are excreted in human milk However, the effect on breast-fed infants of the administration to their mothers has not been studied. As inactivated vaccine, any risk to the infant is unlikely. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.