Standardized Mite Dermatophagoides Farinae (Page 4 of 4)

HOW SUPPLIED

Diagnostic Allergens- Scratch or Prick test: 10,000 AU/mL, 50% glycerin in 5 mL dropper vials.

Intradermal test- 100 AU/mL in 5 mL or 10 mL sterile multiple dose vials.

Therapeutic allergens – In 5 mL, 10 mL, 50 mL multiple dose vials as individual allergens, stock mixture containing 5000 AU/mL of D. farinae plus 5000 AU/mL of D. pteronyssinus, or mixture prescribed by physician.

Dilution’s of concentrate can be made with either buffered diluent with 0.4% phenol or 50% glycerin (v/v) with salts.

STORAGE

The expiration date of Standardized Mite extract containing 10,000 AU/mL in 50% glycerin (v/v) is listed on the container label. Store extracts upon arrival at 2° to 8°C and keep them in this range during office use.

WARRANTY: We warrant that this product was prepared and tested according to the standards of the FDA and is true to label. Because of biological differences in individuals and because allergenic extracts are manufactured to be potent and because we have no control over the conditions of use, we cannot and do not warrant either a good effect or against an ill effect following use.

REFERENCES

1. Wharton, G.W.: House Dust Mites, J.Med. Entomol.12:577,1976.

2. Vorhorst.R., M.Spieksnma and Varekamp: House Dust atopy and the house mite. Linden, Stafleu’s Scientific Publishing Co.,1969.

3. Bear,H. :Allergy to House Dust Mites. Immuno Allergy Practice. 5:356, 1983.

4. Lang, J.D. and S.Mulla: Distribution and abundance of House Dust Mites.Dermatophagoides (Spp) in different zones of Southern California. Environmental Entomology 6:123, 1977.

5. Seltzer,J.M. Standardization and Relative Potency of D.farinae extract. Jour.Allergy and Clin.Immuno. Vol. 77 p204, 1986.

6. Murray,A.B. A.C. Ferguson, B.J. Morrison: Diagnosis of House Dust Mite Allergy in asthmatic children. J. Allergy Clin. Immuno. 71:21, 1983.

7. Warner,J.O., J.F.Price, J.F. Soothill, Controlled trials of hyposensitization to D.pteronyssinus in children with asthma. Lancet 2:912, 1978.

8. Smith, A.P. Hyposentization with D.pteronyssinus antigen. Trials in asthma induced by house dust. Br.Med.4.204,1971.

9. Glasser,J., Allergy in Childhood. C. Thomas, 29, 1956.

10. Pauli,G, J.C.Bessot, R.Thierry, A.Lamensons:Correlation between skin tests, inhalation tests and specific IgE in a study of 120 subjects allergic to house dust and D.pteronyssinus. Clin.Allergy 7:337,1977.

11. Quantitative Intradermal Procedure for Evaluation of Subject Sensitivity to Standardized Allergenic Extracts and for Assignment of Bioequivalent Allergy Units to Reference Preparations using the ID50EAL method. Methods & Procedures Manual, CBER, 1993.

12. Lockey,R., L.M.Benedict, P.C.Turkeltaub, S.O.Bukantz. Fatalities from immunotherapy and skin testing. J.Allergy Clin Immuno.,79(4), 1987.

13. Evans,R., H. Pence, H.Kaplan, R.Rockllin: The Effect of Immunotherapy on Humoral and Cellular Response in Ragweed Hayfever. J.Clin.Inv. 57, 1976.

14. Gleich, G., J.W. Younginger: The RAST test: A Method to Measure IgE Antiboides and the Potency of Allergy Extracts, N.Y. Acad. Sci.57 (7), 1981.

15. Ishizaka,K.: Cellular Events in the IgE Antibody Response. Adv. in Immuno. 23:50-75, 1976.

16. Bousquet.J.,Djoukadar, F.Hewitt, B.Guerin, B.Michel, Comparison of the stability of a mite and a pollen extract stored in normal conditions of use.Clin.Allergy, 15,1985.

CONTAINER LABELING

5 mL Std Mite Scratch
(click image for full-size original)
Std Mite Intradermal
(click image for full-size original)
Std Mite Therapeutic
(click image for full-size original)
STANDARDIZED MITE DERMATOPHAGOIDES FARINAE
standardized mite dermatophagoides farinae injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1844
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES FARINAE (DERMATOPHAGOIDES FARINAE) DERMATOPHAGOIDES FARINAE 10000 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
WATER
PHENOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1844-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1844-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1844-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1844-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102193 06/12/1987
STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS
standardized mite dermatophagoides pteronyssinus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1845
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
WATER
PHENOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1845-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1845-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1845-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1845-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102194 02/22/1990
Labeler — Nelco Laboratories, Inc. (054980867)
Registrant — Nelco Laboratories, Inc. (054980867)
Establishment
Name Address ID/FEI Operations
Nelco Laboratories, Inc. 054980867 manufacture

Revised: 12/2009 Nelco Laboratories, Inc.

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