Adacel/Adacel Polio

Adacel/Adacel Polio

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Per Adacel 0.5 mL Diphtheria toxoid (reduced), tetanus toxoid, adsorbed acellular pertussis vaccine. Per Adacel Polio 0.5 mL Tetanus toxoid, diphtheria toxoid (reduced), adsorbed acellular pertussis vaccine w/ inactivated poliomyelitis virus type 1, 2, 3 vaccine
Indications/Uses
Adacel Active booster immunization for the prevention of tetanus, diphtheria & pertussis in persons ≥4 yr. Passive protection against pertussis in early infancy following maternal immunization during pregnancy. Alternative for the 5th dose of tetanus, diphtheria & acellular pertussis vaccine (DTaP) in childn 4-6 yr, concomitantly w/ inactivated poliomyelitis vaccine. Tetanus prophylaxis in wound management. Adacel Polio Active booster immunization for the prevention of tetanus, diphtheria, pertussis & poliomyelitis in persons ≥4 yr. May be an alternative for the 5th dose of diphtheria, tetanus, acellular pertussis & inactivated poliomyelitis vaccine (DTaP-IPV) in childn 4-6 yr. Tetanus prophylaxis in wound management.
Dosage/Direction for Use
Adacel/Adacel Polio Adult & childn ≥4 yr 1 single dose inj (0.5 mL) IM, preferably on deltoid muscle. Management of tetanus-prone wounds Persons 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. Adacel Redosing at 5-10 yr intervals to boost immunity. Pregnant women Administer during the 2nd or 3rd trimester to provide passive protection of infants against pertussis.
Contraindications
Hypersensitivity. Acute neurological disorders eg, encephalopathy of unknown origin w/in 7 days of previous pertussis vaccination.
Special Precautions
Do not administer intravascularly, intradermally, SC or into the buttocks. Postpone vaccination in case of acute or febrile illness. Risk of hematoma in patients w/ any bleeding disorders eg, haemophilia or thrombocytopenia, or those on anticoagulant therapy. Hypersensitivity reactions may occur. Do not administer in patients w/ progressive or unstable neurological disorder, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established, the condition has stabilized & the benefit clearly outweighs the risk. If Guillain-Barré syndrome occurred w/in 6 wk of receipt of prior vaccine containing tetanus toxoid, carefully consider potential benefits & possible risks before vaccination. Pregnancy & lactation. Immunocompromised patients. Adacel Not for childn <4 yr.
Adverse Reactions
Adacel Inj site pain, tiredness; inj site swelling, erythema; fever (≥38°C), headache, myalgia. In childn 4-6 yr, adolescents 11-17 yr, adult 18-64 yr: Nausea, diarrhea, vomiting, rash, sore or swollen joints, chills, axillary lymph node swelling. In childn 4-6 yr: Anorexia. Adacel Polio Inj site pain, tiredness; inj site swelling & redness; fever, diarrhea, vomiting, sore or swollen joints. In adolescents 12-18 yr & adults 19-60 yr: Headache; nausea, body ache, chills. In childn 3-5 yr: Rash.
Drug Interactions
Immunosuppressive treatments may interfere w/ the development of the expected immune response. Do not mix in the same syringe w/ other parenterals.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
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
Presentation/Packing
Form
Adacel vaccine (inj)
Packing/Price
(pre-filled syringe) 0.5 mL x 1's
Form
Adacel Polio vaccine (inj)
Packing/Price
(pre-filled syringe) 0.5 mL x 1's
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