Allergenic Extract, Egg and Meat

Name: Allergenic Extract, Egg and Meat

Allergenic Extract, Egg and Meat - Clinical Pharmacology

The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells. When allergenic extracts are used for immunotherapy, the effect is an increase in immunoglobulin G (IgG) and an increased T suppresser lymphocyte which interferes with the allergic response.(2) With repeated administration of allergenic extracts changes develop in regards to IgG and IgE production and mediator-releasing cells. The histamine release response is reduced in some patients.

Indications and Usage for Allergenic Extract, Egg and Meat

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity.

Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.

How is Allergenic Extract, Egg and Meat Supplied

Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml).

Sizes:

Diagnostic Scratch: 5 ml dropper application vials

Diagnostic Intradermal: 5 ml or 10 ml vials.

Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.

Storage

The expiration date of allergen extracts 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 Jacobs, Robert L., Geoffrey W.Rake,Jr., et.al. Potentiated Anaphylaxis in Patients with Drug-induced Beta-adrenergic Blockade. J.Allergy & Clin. Immunol., 68(2): 125-127. August 1981.

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

3. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

4. Reid,M.J., Lockey,R.F., Turkeltaub,P.C., Platts-Mills,T.A.E., Survey of fatalities from skin testing and immunotherapy 1985-1989. Journal of Allergy Clin. Immunol. 92 (1): 6-15, July 1993.

5. Murray, A.B., Ferguson, A., Morrison, B., The frequency and severity of cat allergy vs dog allergy in atopic children. J. Allergy Clin. Immunolo: 72, 145-9, 1983.

6. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

Container labeling

EGG WHITE 
egg white injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1130
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EGG WHITE (EGG WHITE) EGG WHITE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1130-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1130-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1130-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1130-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
EGG YOLK 
egg yolk injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1134
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EGG YOLK (EGG YOLK) EGG YOLK 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1134-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1134-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1134-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1134-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
WHOLE EGG 
whole egg injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1138
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EGG (EGG) EGG 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1138-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1138-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1138-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1138-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
BEEF 
beef injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1142
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BEEF (BEEF) BEEF 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1142-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1142-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1142-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1142-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
CHICKEN MEAT 
chicken meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1146
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHICKEN (CHICKEN) CHICKEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1146-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1146-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1146-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1146-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
DUCK MEAT 
duck meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1150
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUCK (DUCK) DUCK 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1150-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1150-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1150-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1150-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
LAMB 
lamb injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1154
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMB (LAMB) LAMB 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1154-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1154-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1154-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1154-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
BEEF LIVER 
beef liver injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1158
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLERGENIC EXTRACT- BEEF LIVER (ALLERGENIC EXTRACT- BEEF LIVER) ALLERGENIC EXTRACT- BEEF LIVER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1158-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1158-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1158-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1158-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
PORK 
pork injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1162
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PORK (PORK) PORK 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1162-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1162-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1162-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1162-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
TURKEY 
turkey injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1166
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TURKEY (TURKEY) TURKEY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1166-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1166-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1166-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1166-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
VEAL 
veal injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:36987-1170
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VEAL (VEAL) VEAL 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM BICARBONATE  
PHENOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:36987-1170-1 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:36987-1170-2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:36987-1170-3 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:36987-1170-4 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
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.
(web3)