Rx Item-Candin Fda Stndrd Tst 1ml By Nielsen Biosciences

CANDIN- candida albicans injection, solution
Nielsen BioSciences, Inc.

WARNING

The expected response to CANDIN� is a local area of inflammation at the site of the skin test. The size of reaction depends upon the sensitivity of the person receiving the test, but is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur which may require treatment with local cold compresses and anti-inflammatory medication. (2.3, 6.1)
Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life-threatening reaction. Patients should be observed for at least 20 minutes following the administration of a skin test. (6.2)
CANDIN� should never be given intravenously. See also Warnings and Precautions. (5.1)
Serious adverse reactions to CANDIN� should be reported to Nielsen BioSciences, Inc. at (855) 855-1212 or MEDWATCH, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9782. Telephone: (800) 332-1088 or www.vaers.hhs.gov. (6.3)
1 INDICATIONS AND USAGE



CANDIN� is indicated for use as a recall antigen for detecting cell-mediated hypersensitivity by intracutaneous (intradermal) testing. The product may be useful in evaluating the cellular immune response in patients suspected of having reduced cellular hypersensitivity. Because some persons with normal cellular immunity are not hypersensitive to Candida, a response rate less than 100% to the antigen is to be expected in normal individuals. Therefore, the concurrent use of other licensed cell-mediated hypersensitivity skin test antigens is recommended. The product should not be used to diagnose or treat Type 1 allergy to Candida albicans.

The potency of CANDIN� is measured by DTH skin tests in humans. The procedure involves concurrent (side-by-side) testing of production lots with an Internal Reference (IR), using sensitive adults who have been previously screened and qualified to serve as test subjects. The induration response at 48 hours elicited by 0.1 mL of a production lot is measured and compared to the response elicited by 0.1 mL of the IR. The test is satisfactory if the potency of the production lot does not differ more than � 20% from the potency of the IR, when analyzed by the paired t-test (two-tailed) at a p value of 0.05.

The potency of the IR is monitored by DTH skin testing. Persons included in the potency assay are qualified as test subjects by receiving four skin tests with the IR from which a mean induration response (mm) is calculated. Current skin tests with the IR must show that the potency of the IR has not changed more than � 20% from the mean qualifying response in the same test subjects, when analyzed by the paired t-test (two-tailed) at a p value of 0.05. The required induration response at 48 hours to the IR is 15 mm � 20%.

2 DOSAGE AND ADMINISTRATION

2.1 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particles or discoloration are observed, the product should not be used and it should be discarded.

2.2 CANDIN� should be administered intradermally on the volar surface of the forearm or on the outer aspect of the upper arm. The test dose is 0.1 mL. The skin should be cleansed with 70% alcohol before applying the skin test. The intradermal injection must be given as superficially as possible causing a distinct, sharply defined bleb. An unreliable reaction may result if the product is injected subcutaneously. A positive DTH reaction to CANDIN� consists of induration = 5 mm.

2.3 Interpretation of Skin Test: The time required for the induration response to reach maximum intensity varies with the individual. The reaction usually begins within 24 hours and peaks between 24 and 48 hours. The skin test should be read at 48 hours by visually inspecting the test site and palpating the indurated area. Measurements should be made across two diameters as shown in the figure below. The mean of the longest and midpoint orthogonal diameters of the indurated area should be reported as the DTH response. For example, a reaction that is 10 mm (longest diameter) by 8 mm (midpoint orthogonal diameter) has a sum of 18 mm and a mean of 9 mm. The DTH response is therefore 9 mm.
Area of induration (shaded area)

Candin Area of Induration
(click image for full-size original)
3 DOSAGE FORMS AND STRENGTHS

3.1 CANDIN� is a solution for intradermal injection supplied in a 1 mL multi-dose vial.

3.2 The skin-test strength of CANDIN� has been determined from dose-response studies in healthy adults [see CLINICAL STUDIES (14)]. The product is intended to elicit an induration response = 5 mm in immunologically competent persons with cellular hypersensitivity to the antigen [see DOSAGE AND ADMINISTRATION (2.2)].

Rx Item-Candin Fda Stndrd Tst 1ml By Nie
Item No.: RX324071 NDC No.59584013801 UPC No.:359584138013 NDC No. 59584-0138-01 UPC/GTIN No. 3-59584-13801-3 MPN No. 13801 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.

Candin Fda Stndrd Tst 1Ml By Nielsen Bio
BRAND: CANDIN NDC: 59584-0138-01,59584013801 UPC: 3-59584-13801-3,359584138013 Nielsen Biosciences Inc

CANDIDA ALBICANS SKIN TES
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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