Persons who experience Arthus-type hypersensitivity reactions or a temperature of 39.4°C ( > 103° F) following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given even emergency doses of Td more frequently than every 10 years even if they have a wound that is neither clean not minor.
DTP should not be given to children with any coagulation disorder, including thrombocytopenia that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.
Recent studies suggest that infants and children with a history of convulsions in first-degree family members (i.e. siblings and parents) have a 3:2 fold increased risk for neurologic events compared DTP vaccine and permanent neurologic damage. Infants and children with recognized possible or potential underlying neurologic conditions seem to be at enhanced risk for the appearance of manifestation of the underlying neurologic disorder within two or three days following vaccination.
The administration of DTP to children with proven or suspected underlying neurologic disorders that are not actively evolving must be decided on an individual basis.

PRECAUTIONS
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the parent's history with respect to possible sensitivity and any previous adverse reactions to the vaccine or similar vaccines. Previous immunization history, current health status and a current knowledge of the literature concerning the use of the vaccine under consideration. Immunosuppressed patients may not respond.
Prior to administration of DTP, health care personnel should inform the patient or guardian of the patient the benefits and risks of immunization, and also inquire about the recent health status of the patient to be injected. Parents of a child with a family history of seizures should be informed that their child has an increased risk of seizures following DTP administration and should be instructed regarding appropriate medical care in the unlikely event of a seizure. Special care should be taken to ensure that the injection does not enter a blood vessel. WHO does not recommend mixing different vaccines in one syringe before injection.
ADRENALINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE. For treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5ml of 1:1000 injection) given s/c or i/m. Single dose should not exceed 1 mg (1ml). For infants and children the recommended dose of adrenaline is 0.01mg/kg (0.01ml/kg of 1:1000 injection). Single pediatric dose should not exceed 0.5mg (0.5ml). The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving.
As with the use of all vaccines the vaccine should remain under observation for not less than 30 minutes for possibility of occurrence of immediate or early allergic reactions. Efcorlin hydrochloride and antihistaminics should also be available in addition to supportive measures such as oxygen inhalation.

DRUG INTERACTIONS
As with other intramuscular injections, use with caution in patients on anticoagulant therapy. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses) may reduce the immune response to vaccines. Short-term (< 2 weeks) corticosteroid therapy or intraarticular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.

ADVERSE REACTIONS
Adverse reactions associated with the use of this vaccine include local redness, warmth, edema, and induration with or without tenderness, as well as urticaria and rash. Systemic reactions such as fever, headache, nausea and weakness may appear in a few subjects. Some data suggests that febrile reactions are more likely to occur in those who have experienced such responses after prior doses.
The frequency of local reactions and fever following DTP vaccination is significantly higher with increasing number of doses of DTP, while other mild to moderate systemic reactions. (e.g. fretfulness, vomiting) are significantly less frequent. If local redness 2.5 cm occurs the likelihood of recurrence after another DTP dose increases significantly. Evidence does not indicate a causal reaction between DTP vaccine and SIDS. Studies showing a temporal relation between these events are consistent with the expected occurrence of SIDS over the age range in which DTP immunization typically occurs. Deaths due to causes other than SIDS including deaths due to serious injections have occurred in infants following the administration of DTP. No association has been shown for hospitalizations due to infectious diseases and receipt of DTP.

Mild systemic reactions such as fever, drowsiness, fretfulness and anorexia occur quite frequently. Rarely, an anaphylactic reaction (i.e. hives, swelling of the mouth, difficulty in breathing, hypertension or shock and death) have been reported after receiving preparations containing diphtheria, tetanus and / or pertussis antigens.
Arthus-type hypersensitivity reactions characterized by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid.
Moderate to severe systemic events, including high fever (i.e. temperature of 40.5°C (105°F) and persistent, inconsolable crying lasting 3 hours or more. These events occur infrequently and appear to be without sequalae.
Occasionally, a nodule may be palpable at the injection site of adsorbed products for several weeks. Sterile abscesses at the site of injection have been reported (6 to 10 per million doses).

NERVOUS SYSTEM
The following neurologic illnesses have been reported as temporally associated with vaccine containing tetanus toxoid; neurological complications including cochlear lesion, brachial plexus neuropathies, paralysis of the radial nerve, paralysis of the recurrent nerve, accommodation paresis, and EEG disturbances with encephalopathy. It has been suggested that there is a causal relation between Guillain-Barre syndrome (GBS) and vaccines containing tetanus toxoid. In the differential diagnosis of polyradiculoneuropathies following administration of a vaccine containing tetanus toxoid should be considered as a possible etiology. Short-lived convulsions (usually febrile), or collapse (hypotonic hyporesponsive episode) occur infrequently and appear to be without sequelae.
More severe neurologic events, such as a prolonged convulsion, or encephalopathy, although rare, have been reported in temporal association with DTP administration. An analysis of these data failed to show any cause and effect association.

CARDIOVASCULAR SYSTEM
An infant who developed myocarditis several hours after immunization has been reported.

RESPIRATORY SYSTEM
Respiratory difficulties including apnea have been observed.

LOCAL
Rash and allergic reactions have been observed.

STORAGE
Diphtheria, Tetanus, Pertussis and Hepatitis B Vaccine Adsorbed should be stored at a temperature between 2°C and 8°C (35° to 46°F).

NOT TO BE FROZEN
Product, which has been exposed to freezing, should not be used.

PRESENTATION
0.5 ml - 1 dose ampoule carton
5 ml-10 doses vial carton.