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CANDIN- candida albicans skin test antigen injection, solution


  1. Patient Information
  2. Revised: 1/2018document Id:

Patient Information 

Local reactions to CANDIN can include redness, swelling, pruritus, excoriation and discoloration of the skin. These reactions usually subside within hours or days after administration of the skin test. In some patients, skin discoloration may persist for several weeks. Progression of the DTH reaction to vesiculation, necrosis and ulceration are possible. Patients should be informed that all foreign antigens have the remote possibility of causing Type I anaphylactic reactions that may require the administration of epinephrine and other drugs or emergency procedures and may be life threatening in some cases. Patients should report any serious adverse reactions to their health care provider.


Sections or subsections omitted from the full prescribing information are not listed.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL

Candida albicansSkin Test Antigen For Cellular Hypersensitivity

CANDIN

NDC 59584-138-01 1D barcode: 59584-138-01

Volume: 1 mL (10 Tests)

Dose: 0.1 mL Intradermally

See Package Insert

Store: 2-8 C Rx Only

Preservative: 0.4% PHENOL

Mfd. for Nielsen BioSciences, Inc.

San Diego CA 92121

2D barcode

Lot:

Exp:

Candin Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - CARTON

DOSE: 0.1 mL intradermally. See circular. (panel 1)

CONTENTS: 1 mL multidose vial (ten tests).

INGREDIENTS:Candidaantigen in buffered saline with 0.03% albumin USP, 8ppm polysorbate 80 and phenol 0.4% as a preservative.

Rev 9/15

Lot: CAxxx(on end flap)

Expiration Date: (on end flap)

Candida albicansSkin Test Antigen to Assess Cellular Hypersensitivity(panel 2)

CANDIN

Skin Test Strength

For use in assessing cell-mediated or delayed-type

hypersensitivity toCandida albicans.

Mfd. for Nielsen BioSciences, Inc., U.S. License 1903

San Diego, CA 92121

Potency: Measured by delayed-type intradermal

skin tests in humans. (panel 3)

Storage: Store at 2-8 C (35-46 F). Do not freeze.

No U.S. Standard of Potency.

Rx only.

1D barcode: 59584-138-01 (4th panel)

2D GS1 serialized barcode (on end flap)

Candin Box

CANDIN
candida albicans skin test antigen injection, solution
Product Information
Product TypeSTANDARDIZED ALLERGENICItem Code (Source)NDC:59584-138
Route of AdministrationINTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDIDA ALBICANS(UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)CANDIDA ALBICANS1 U in 0.1 mL
Inactive Ingredients
Ingredient NameStrength
ALBUMIN HUMAN(UNII: ZIF514RVZR)0.03 mg in 0.1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.5 mg in 0.1 mL
SODIUM BICARBONATE(UNII: 8MDF5V39QO)0.25 mg in 0.1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.8 ug in 0.1 mL
PHENOL(UNII: 339NCG44TV)0.4 mg in 0.1 mL
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59584-138-011 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10325712/01/1995
Labeler -Nielsen BioSciences, Inc. (078835288)
Registrant -Nielsen BioSciences, Inc. (078835288)
Establishment
NameAddressID/FEIBusiness Operations
Allermed Laboratories, Inc.073364531manufacture
Establishment
NameAddressID/FEIBusiness Operations
Nielsen BioSciences, Inc.078835288manufacture

Revised: 1/2018document Id: 

d44377f4-9394-4e36-a5d0-a980ab30ccefSet id: 4254e4c8-4a44-4766-8caf-61c65dc3267cVersion: 15Effective Time: 20180103Nielsen BioSciences, Inc.



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