Miller Moth (Page 3 of 3)

HOW SUPPLIED

The stock concentrate of allergenic extract is expressed in weight/volume, at 1:50 w/v (2%) or 1:20 w/v (5%). It is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml sterile dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.

STORAGE

Store all stock concentrates and dilutions at 2-8 degrees C and keep at this temperature during office use. The expiration date of the allergenic extract is listed on the container label. Dilutions of the allergenic extract concentration containing less then 50% glycerine are less stable. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen.

REFERENCES

1. Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp 135-163, 1988.

2. Bousquet, Jean: “In vivo methods for study of allergy: Skin tests” Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp. 419-436, 1988.

3. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 9-48.

4. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: “A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever,” The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, pg. 511, December 1980.

5. Wasserman, S.: The Mast Cell and the Inflammatory Response. The Mast CeIl–its role in health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.

6. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, Vol. I, Chapter 58, p. 1365, edited by Middleton et al.

7. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. J. Dis. Child.,pp. 123-222,1972.

8. Willoughby, J.W.: Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery:

Instructional Courses, Vol. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988.

9. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas: “Survey of Fatalities From Skin Testing and Immunotherapy 1985-1989,” Journal of Allergy and Clinical Immunology, Vol. 92, No.1, pp. 6-15, 1993.

CONTAINER LABELING

5 mL Blue Diagnostic Label
(click image for full-size original)
5 mL Red Diagnostic Label
(click image for full-size original)
10 mL Diagnostic Label
(click image for full-size original)
30/50 mL Diagnostic Label
(click image for full-size original)
MILLER MOTH
miller moth injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0461
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITOTROGA CEREALELLA (SITOTROGA CEREALELLA) SITOTROGA CEREALELLA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0461-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0461-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0461-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0461-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0461-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
Labeler — Antigen Laboratories, Inc. (030705628)
Registrant — Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Operations
Antigen Laboratories, Inc. 030705628 manufacture

Revised: 11/2009 Antigen Laboratories, Inc.

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