Sterile Diluent For Allergenic Extract (Page 4 of 4)

HOW SUPPLIED

Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Fresh egg white extract is available at 1:9 v/v extraction ratio.

Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Refer to container label for actual Antigen E content.

Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml 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° C. Keep at this temperature during office use. The expiration date of the allergenic extracts is listed on the container label. Dilutions of the allergenic extracts containing less than 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. Bousquet, Jean: “In vivo methods for study of allergy: Skin tests” Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I, Chap. 19, pp 419-436, 1988.

2. Long, W.F., Taylor, R.J., Wagner, C.J., et al.: Skin test suppression by antihistamines and the development of subsensitivity, J. Allergy Clin. Immunol., pp. 76-113, 1985.

3. 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.

4. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. 1, Chap. 58, pp. 1365-1376, 1988.

5. 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.

6. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. NIAID Task Force Report, U.S. Dept. HEW, NIH Publication No. 79-387, Chapter 4, pp. 213-217, May 1979.

7. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. I, Chap. 4, p. 52, edited by Middleton et al.

8. Nelson, H.S.: “The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract.” The Journal of Allergy and Clinical Immunology, Vol. 63, No. 6, pp. 417-425, June 1979.

9. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 84-86.

10. Rocklin, R.E., Sheffer, A.L., Grainader, D.K. and Melmon, K.: “Generation of antigen-specific suppressor cells during allergy desensitization”, New England Journal of Medicine, 302, May 29, 1980, pp. 1213-1219.

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

12. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 133-138.

13. 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, p. 511, December 1980.

14. Wasserman, S.: The Mast Cell and the Inflammatory Response. The Mast Cell-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.

15. Perelmutter, L.: IgE Regulation During Immunotherapy of Allergic Diseases. Annals of Allergy, Vol. 57, August 1986.

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

17. 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.

CONTAINER LABELING

10 Percent Glycero-Saline
(click image for full-size original)
50 Percent Glycerine
(click image for full-size original)
Evans Solution
(click image for full-size original)
HSA
(click image for full-size original)
NSP
(click image for full-size original)
STERILE DILUENT FOR ALLERGENIC EXTRACT
glycerine and phenol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-9932
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 0.1 mL in 1 mL
PHENOL (PHENOL) PHENOL 0.004 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE 0.0009 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-9932-1 4 mL in 1 VIAL None
2 NDC:49288-9932-2 8 mL in 1 VIAL None
3 NDC:49288-9932-3 100 mL in 1 VIAL None
4 NDC:49288-9932-4 4.5 mL in 1 VIAL None
5 NDC:49288-9932-5 9 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STERILE DILUENT FOR ALLERGENIC EXTRACT
phenol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-9933
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOL (PHENOL) PHENOL 0.004 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE 0.009 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-9933-1 2 mL in 1 VIAL None
2 NDC:49288-9933-2 4 mL in 1 VIAL None
3 NDC:49288-9933-3 4.5 mL in 1 VIAL None
4 NDC:49288-9933-4 8 mL in 1 VIAL None
5 NDC:49288-9933-5 9 mL in 1 VIAL None
6 NDC:49288-9933-6 24 mL in 1 VIAL None
7 NDC:49288-9933-7 30 mL in 1 VIAL None
8 NDC:49288-9933-8 100 mL in 1 VIAL None
9 NDC:49288-9933-9 40 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STERILE DILUENT FOR ALLERGENIC EXTRACT
human albumin and phenol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-9934
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUMIN (HUMAN) (ALBUMIN (HUMAN)) ALBUMIN (HUMAN) 0.0003 mL in 1 mL
PHENOL (PHENOL) PHENOL 0.004 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE 0.009 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-9934-1 4 mL in 1 VIAL None
2 NDC:49288-9934-2 4.5 mL in 1 VIAL None
3 NDC:49288-9934-3 8 mL in 1 VIAL None
4 NDC:49288-9934-4 9 mL in 1 VIAL None
5 NDC:49288-9934-5 100 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STERILE DILUENT FOR ALLERGENIC EXTRACT
glycerine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-9935
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 0.5 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.00166 g in 1 mL
SODIUM BICARBONATE 0.00091 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-9935-1 4 mL in 1 VIAL None
2 NDC:49288-9935-2 4.5 mL in 1 VIAL None
3 NDC:49288-9935-3 8 mL in 1 VIAL None
4 NDC:49288-9935-4 9 mL in 1 VIAL None
5 NDC:49288-9935-5 24 mL in 1 VIAL None
6 NDC:49288-9935-6 100 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STERILE DILUENT FOR ALLERGENIC EXTRACT
glycerine and phenol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-9936
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 0.25 mL in 1 mL
PHENOL (PHENOL) PHENOL 0.004 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.005 g in 1 mL
SODIUM CITRATE 0.00075 g in 1 mL
POTASSIUM PHOSPHATE 0.000567 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-9936-1 8 mL in 1 VIAL None
2 NDC:49288-9936-2 24 mL in 1 VIAL None
3 NDC:49288-9936-3 100 mL in 1 VIAL None
4 NDC:49288-9936-4 4 mL in 1 VIAL None
5 NDC:49288-9936-5 4.5 mL in 1 VIAL None
6 NDC:49288-9936-6 9 mL in 1 VIAL 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: 12/2009 Antigen Laboratories, Inc.

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