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Tetavax

Tetavax

Manufacturer:

sanofi pasteur

Distributor:

DKSH
Concise Prescribing Info
Contents
Tetanus toxoid
Indications/Uses
Tetanus prevention & post-exposure tetanus prophylaxis for recent wounds that may have been contaminated w/ tetanus spores in subjects who have not had any primary vaccination or for whom primary vaccination is incomplete or uncertain; neonatal tetanus prophylaxis in non-immunised women either of childbearing age or pregnant in countries where neonatal tetanus is frequent; primary vaccination; booster inj.
Dosage/Direction for Use
IM/SC Post-tetanus exposure prophylactic vaccination Patient not immunised or partially immunised Minor-clean wound: Tetanus toxoid 0.5 mL single dose. Major-clean or tetanus prone wound: Human tetanus Ig 250 IU in 1 arm & tetanus toxoid 0.5 mL single dose in the other arm. Tetanus prone, delayed or incomplete debridement: Human tetanus Ig 500 IU in 1 arm, tetanus toxoid 0.5 mL single dose in the other arm & antibiotic therapy. Patient completely immunized 5-10 yr since last booster dose Major-clean or tetanus prone wound: Tetanus toxoid 0.5 mL single dose. Tetanus prone, delayed or incomplete debridement: Tetanus toxoid 0.5 mL single dose & antibiotic therapy, >10 yr since last booster dose Minor-clean wound: Tetanus toxoid 0.5 mL single dose. Major-clean or tetanus prone wound: Human tetanus Ig 250 IU in 1 arm & tetanus toxoid 0.5 mL single dose in the other arm. Tetanus prone, delayed or incomplete debridement: Human tetanus Ig 500 IU in 1 arm, tetanus toxoid 0.5 mL single dose in the other arm & antibiotic therapy. Neonatal tetanus prophylaxis Woman of childbearing age & non-immunized pregnant 2 successive inj at least 4 wk apart, preferably ≥90 days before birth. Primary immunization Adult 2 successive inj 1-2 mth apart followed by a booster dose 6-12 mth after the 2nd inj. Booster inj 0.5 mL single dose, 10 yr after primary immunization & every 10 yr thereafter.
Contraindications
Hypersensitivity. Neurological disorder after a previous vaccination. Postpone vaccination in case of fever, acute disease or chronic progressive illness.
Special Precautions
Appropriate medical treatment should be available & supervise patient in case of anaphylactic reaction following vaccination. Avoid in persons who received a complete primary vaccination or a booster dose in the previous 5 yr to prevent hypersensitivity reactions. Do not inj intravascularly & intradermally. Carefully consider potential benefits & risks if Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior tetanus toxoid-containing vaccine. Syncope can occur following, or even before, any vaccination as a psychogenic response to needle inj; place procedures to prevent any injury due to fainting & manage syncopal reactions. Immune response may be decreased w/ immunosuppressive treatment or immunodeficiency. Consider potential risk of apnoea & need for resp monitoring for 48-72 hr when administering the primary immunization series to very premature infants (born ≤28 wk of gestation). Pregnancy & lactation.
Adverse Reactions
Lymphadenopathy; type I hypersensitivity reactions; cephalalgia, dizziness; hypotension; allergic-like symptoms (eg, urticaria, generalized pruritus or erythema); myalgia, arthralgia; inj site reactions (eg, pain, rash, induration or oedema), transient pyrexia, malaise.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AM01 - tetanus toxoid ; Belongs to the class of tetanus bacterial vaccines.
Presentation/Packing
Form
Tetavax susp for inj ≥40 IU/0.5 mL
Packing/Price
(multidose vial) 10 dose x 1's; (pre-filled syringe) 0.5 mL x 1's
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