Adacel/Adacel Polio

Adacel Active immunization against tetanus, diphtheria & pertussis in patients ≥4 yr as booster following primary immunization. Passive protection against pertussis in early infancy following maternal immunization during pregnancy. Adacel Polio Active booster immunization for the prevention of tetanus, diphtheria, pertussis & poliomyelitis in patients ≥4 yr. Alternative for the 5th dose of diphtheria, tetanus, acellular pertussis & inactivated poliomyelitis vaccine in childn 4-6 yr. Tetanus prophylaxis in wound management.

Single IM inj of 0.5 mL, preferably into the deltoid muscle. Adacel Can be used for repeat vaccination to boost immunity to diphtheria, tetanus & pertussis at 5-10 yr intervals. Can be used in the management of tetanus prone injuries w/ or w/o concomitant administration of tetanus Ig according to official recommendations. May be administered to pregnant women during the 2nd or 3rd trimester to provide passive protection of infants against pertussis. Adacel Polio Patients who have completed primary immunization against tetanus & who sustain wounds that are minor & uncontaminated should receive a booster dose of a tetanus toxoid-containing prep if they have not received tetanus toxoid w/in the preceding 10 yr. For tetanus-prone wounds, a booster is appropriate if the patient has not received a tetanus toxoid-containing prep w/in the preceding 5 yr. For adults who have not previously received a dose of acellular pertussis vaccine, a single tetanus-diphtheria booster dose should be replaced by a combined tetanus-diphtheria-acellular pertussis vaccine.

Patients who experienced encephalopathy of unknown origin w/in 7 days of previous immunization w/ pertussis-containing vaccine. Adacel Hypersensitivity to diphtheria, tetanus or pertussis vaccines, to any other component of the vaccine, or to any residual substances carried over from the manufacturing process (formaldehyde & glutaraldehyde). Postpone vaccination in patients w/ acute severe febrile illness. Adacel Polio Hypersensitivity to any component of the vaccine or life-threatening reaction after previous administration of the vaccine or vaccine containing ≥1 of the same components.

Do not administer by intravascular inj. Do not use intradermal or SC routes of administration. Do not administer into the gluteal area. Do not administer to patients w/ progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy until treatment regimen has been established & condition has stabilized. Carefully consider potential benefits & possible risks when deciding to give any vaccine containing tetanus toxoid if Guillain-Barré syndrome has occurred w/in 6 wk of receipt of prior vaccine containing tetanus toxoid. Risk of reduced immunogenicity w/ immunosuppressive treatment or immunodeficiency. Vaccination of HIV-infected patients or patients w/ chronic immunodeficiency (eg, AIDS) is recommended even if Ab response might be limited. Assess risks & benefits of vaccination before deciding to immunize a nursing woman. Adacel Do not use for primary immunization. Carefully consider vaccination in patients w/ history of serious or severe reaction w/in 48 hr of previous inj w/ vaccine containing similar components. IM inj should be given w/ care in patients on anticoagulant therapy or suffering from coagulation disorders because of haemorrhage risk, & administration by deep SC inj may be considered in these situations, although there is risk of increased local reactions. Persistent nodule at inj site may occur, particularly if administered into superficial layers of SC tissue. Caution in latex-sensitive individuals. Adacel Polio Do not use for the treatment of disease caused by Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani or poliomyelitis infections. Postpone vaccination in case of acute or febrile disease. IM inj can cause inj site hematoma in patients w/ any bleeding disorders (eg, haemophilia or thrombocytopenia) or in patients on anticoagulant therapy, & should not be administered to such patients unless potential benefits outweigh risk of administration. Hypersensitivity reactions may occur following administration even in patients w/ no prior history of hypersensitivity to the vaccine components. Carefully evaluate benefits versus risks of administration during pregnancy when there is a high probable risk of exposure.

Adacel Headache; diarrhoea; fatigue/asthenia, inj site pain/erythema/swelling. Vomiting; rash; pyrexia, axillary adenopathy. Adults (18-64 yr): Generalized aching or muscular weakness; malaise. Nausea; arthralgia or joint swelling; chills. Adolescents (11-17 yr): Nausea; generalized aching or muscular weakness, arthralgia or joint swelling; malaise, chills. Childn (4-6 yr): Decreased appetite. Nausea; generalized aching or muscular weakness, arthralgia or joint swelling; chills. Adacel Polio Inj site pain/swelling/redness; fever, diarrhea, vomiting, sore/swollen joints, tiredness. Adults (19-60 yr) & adolescents (12-18 yr): Headache, nausea, body ache, chills. Childn (3-5 yr): Rash.

Adacel Can be administered concomitantly w/ inactivated influenza vaccine, hepatitis B vaccine, inactivated or oral poliomyelitis vaccine & recombinant HPV vaccine. Use separate limbs for inj site of concomitant parenteral vaccines. May be administered concomitantly w/ other vaccines or Ig at separate inj site. Adacel Polio Immunosuppressive treatments may interfere w/ development of expected immune response. May be administered concurrently w/ hepatitis B vaccine. May be used concomitantly w/ trivalent influenza vaccine. Has been safely administered concomitantly w/ MMR vaccine in non-controlled clinical studies in childn 3-5 yr. No available data on concomitant use w/ varicella vaccine. Administer vaccines concomitantly using separate syringes at separate sites. Do not mix in the same syringe w/ other parenterals.

Vaccines, Antisera & Immunologicals

J07CA02 - diphtheria-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
J07AJ52 - pertussis, purified antigen, combinations with toxoids ; Belongs to the class of pertussis bacterial vaccines.

Adacel: P₁S₁S₃, Adacel Polio: P₁S₁S₃, A