STANDARDIZED BERMUDA GRASS POLLEN (Page 4 of 4)

HOW SUPPLIED :

Bulk extract (stock concentrate) in 50% (v/v) glycerin containing 10,000 BAU/ml or 100,000 BAU/ml is supplied in 10ml, 30ml, and 50ml vials. Bermuda Grass bulk extract is available in 10,000 BAU/ml only. Scratch testing for Bermuda Grass in 50% (v/v) glycerin containing 10,000 BAU/ml is supplied in 2ml dropper vials. Scratch testing for the other grasses in 50% (v/v) glycerin containing 10,000 BAU/ml or 100,000 BAU/ml is supplied in 2ml dropper vials. Intradermal testing (aqueous) for all standardized grasses containing 100 BAU/ml is supplied in 5ml vials.

STORAGE:

These extracts should be stored at 2 to 8 degrees Celsius. Excessive heating (above room temperature) and repeated freeze-thawing should be avoided. The dating period (expiration date) is shown on the vial label. Once extracts are diluted the shelf life decreases. Extracts should be reordered when out of date. Please allow a minimum of three (3) weeks for delivery due to the holding period for sterility testing.

REFERENCES:

  1. ELISA Competition Assay, October 1993. In Methods of the Allergenics Products Testing Laboratory, Food and Drug Administration.
  2. Turkeltaub, P. Rastogi, S.C.: Quantitative Intradermal Procedure for Evaluation of Subject Sensitivity to Standardized Allergenic Extracts and for Assignment of Bioequivalent Allergy Units to Reference Preparations Using the ID5 o EAL Method, November 1994. In Methods of the Allergenic Products Testing Laboratory Center for Biologics Evaluation and Research, Food and Drug Administration.
  3. Wasserman, S.I.: Biochemical Mediators of Allergic Reactions. In Patterson, R (ed): Allergic Diseases: Diagnosis and Management, p. 86, Philadelphia, J.B. Lippincott Co., 1985.
  4. Grammer, L.C.: Principle of Immunologic Management of Allergic Diseases Due to Extrinsic Antigens. In Patterson, R. (ed) Allergic Diseases: Diagnosis and Management, p. 358, Philadelphia, J.B. Lippincoit Co., 1985.
  5. Booth, B.H., Diagnosis of Immediate Hypersensitivity, In Patterson, R. (ed): Allergic Diseases: Diagnosis and Management, p. 102, Philadelphia, J.B. Lippincott Co., 1985.
  6. Bousquet, J., Michel F.: In vivo Methods for Study of Allergy: Skin Tests, Techniques, and Interpretation. In Middleton, E. Jr., Reed, C.E. and Ellis, E.F. (ed): Allergy Principles and Practice, (Vol. 1) p. 583, St Louis. The C.V. Mosby Co., 1993.
  7. Metzger, W.J. et. al.: The Safety of Immunotherapy During Pregnancy. J. Allergy Clin. Immunol., 64 (4): 268-272, 1978.
  8. Patterson, R. et. al.: Immunotherapy. In Middleton, E. Jr., Reed, C.E. and Ellis, E.F. (ed): Allergy; Principles and Practice, (Vol. 2) p. 1119, St Louis, The C.V. Mosby Co., 1983.
  9. Norman, P.S., In vivo Methods of Study of Allergy: Skin and Mucosal Tests, Techniques and Interpretation. In Middleton, E. Jr. Reed, C.E. and Ellis, E.F. (ed): Allergy Principles and Practice, (Vol. 1) p. 258, St Louis, The C.V. Mosby Co., 1978.
  10. Van Metre, T.E. Jr, Adkinson, N.F. Jr.: Immunotherapy for Aeroallergen Disease. In Middleton, E. Jr., Reed, C.E. and Ellis, E.F. (ed): Allergy Principles and Practice, (Vol. 2) p. 1499, St Louis, The C.V. Mosby Co. 1993.

Revised 5/20/97

ALLERGY LABORATORIES, INC.
U.S. License #103 Oklahoma City, OK 73109 • (405) 235-1451 • ( 800 ) 654-3971

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACT

STANDARDIZED POLLEN

Preservative 50% Glycerin (v/v)

Dose/Route: See Enclosure

Store at 2-8°C, NON RETURNABLE

ALLERGY

LABORATORIES, INC

Oklahoma City, OK 73109

U.S Govt. License No. 103

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL
STANDARDIZED BERMUDA GRASS POLLEN cynodon dactylon pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-084
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON POLLEN (CYNODON DACTYLON POLLEN) CYNODON DACTYLON POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-084-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-084-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-084-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-084-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101379 05/29/1997
STANDARDIZED KENTUCKY BLUEGRASS POLLEN poa pratensis pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-087
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-087-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-087-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-087-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-087-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101380 05/29/1997
STANDARDIZED MEADOW FESCUE GRASS POLLEN festuca elatior pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-092
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESTUCA PRATENSIS POLLEN (FESTUCA PRATENSIS POLLEN) FESTUCA PRATENSIS POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-092-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-092-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-092-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-092-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101381 05/29/1997
STANDARDIZED ORCHARD GRASS POLLEN dactylis glomerata pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-097
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-097-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-097-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-097-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-097-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101382 05/29/1997
STANDARDIZED REDTOP GRASS POLLEN agrostis alba pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-099
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-099-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-099-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-099-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-099-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101383 05/29/1997
STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN lolium perenne pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-102
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOLIUM PERENNE POLLEN (LOLIUM PERENNE POLLEN) LOLIUM PERENNE POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-102-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-102-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-102-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-102-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101384 06/25/1997
STANDARDIZED SWEET VERNAL GRASS POLLEN anthoxanthum odoratum pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-106
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTHOXANTHUM ODORATUM POLLEN (ANTHOXANTHUM ODORATUM POLLEN) ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-106-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-106-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-106-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-106-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101385 05/29/1997
STANDARDIZED TIMOTHY GRASS POLLEN phleum pratense pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-107
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) PHLEUM PRATENSE POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 50 mL in 100 mL
SODIUM CHLORIDE 0.166 g in 100 mL
SODIUM BICARBONATE 0.091 g in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54575-107-02 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54575-107-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54575-107-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:54575-107-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101386 05/29/1997
Labeler — Allergy Laboratories, Inc. (007191810)
Establishment
Name Address ID/FEI Operations
Allergy Laboratories, Inc. 007191810 MANUFACTURE

Revised: 03/2010 Allergy Laboratories, Inc.

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