A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Candin Warnings, Precautions, Pregnancy, Nursing, Abuse - Candida Albicans
Candin Warnings, Precautions, Pregnancy, Nursing, Abuse - Candida Albicans
WARNINGS
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.
PRECAUTIONS
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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