As has been observed with other, unstandardized, antigens used for DTH skin testing (14), it is possible that some patients may have exquisite immediate hypersensitivity to CANDIN^®. In persons with bleeding tendency, bruising and non specific induration may occur due to the trauma of the skin test.

General

Physicians using this product must have available the facilities and medications necessary to treat all potential local and systemic side effects that can occur from the injection of an antigenic substance. Epinephrine (1:1,000) must be immediately available. The patient, or parent or guardian, should be questioned about previous reactions to this product or a similar product.

The antigen must be injected intradermally as superficially as possible, causing a distinct, sharply defined bleb at the skin test site. An unreliable reaction may result if the product is injected subcutaneously. It must not be given intravenously; care should be taken to avoid injection into a blood vessel.

A separate sterile syringe and needle should be used for each patient to prevent transmission of infectious agents. Needles should be disposed of properly and should not be recapped.

Delayed or cellular hypersensitivity reactions can be diminished or completely suppressed if the person has received corticosteroids (see DRUG INTERACTIONS).

Patient INFORMATION

See PATIENT INFORMATION section.

Drug Interactions

See DRUG INTERACTIONS section.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been conducted with CANDIN^® to determine its potential for carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy

Category C: Animal reproduction studies have not been conducted with CANDIN^®. It is also not known whether CANDIN^® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CANDIN^® should be given to pregnant women only if clearly needed.

Nursing Mothers

It is not known whether CANDIN^® is excreted in human milk. Because drugs may be excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of intradermally administered CANDIN^® have not been established in children.

Geriatric Use

CANDIN^® has not been adequately studied in geriatric patients. However, the DTH response to CANDIN^® may be diminished in geriatric patients, since the aging process is known to alter cell mediated immunity (1).

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