Treatment Set TS334946 (Page 3 of 3)

OVERDOSAGE

If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 epinephrine-hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes.

The epinephrine HCL 1: 1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.

Patients unresponsive to epinephrine may be treated with theophylline. Studies on asthmatic subjects reveal that plasma concentrations of theophylline of 5 to 20 ug/ml are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 ug/ml. A loading dose of aminophylline of 5.6 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 ug/ml. (Mitenko and Ogilive 1973b; Nicholoson and Chick 1973).

Other beta-adrenergic drugs such as isoproterenol, isoetharine, or albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5 ml or the 0.5% solution for isoproterenol HCL; albuterol is longer acting than isoproterenol by any route of administration. The albuterol inhaler delivers approximately 90 mcg of albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4 to 6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340 mcg isoetharine. The average adult dose is one to two inhalations.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require Theophylline, low-flow oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock and low flow (two liters per minute) oxygen may be utilized if indicated. Adenocorticosteroids may be administered parenterally or intravenously. 8

HOW SUPPLIED

Individual treatment sets as prescribed by the physician. The allergenic extract contains a variable number of individual doses depending on the patient’s sensitivity and maximum tolerated maintenance treatment dose.

REFERENCES

1. Baer, Harold E.: The Regulation of Allergenic Extracts by theā€¢ U.S. Food and Drug Administration, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 10-11.

2. Baer, Harold E.: Evaluation of RAST Inhibition, International Joint Steering Committee for Allergen Standardization, Course on Allergen Standardization, The Protein Laboratory, University of Copenhagen, August 4-9, 1980.

3. Baer, Harold E., L. Bolin, D. Levy, H. Lowenstein, & A. DeWeck: Standard reference extracts, (round table discussion), International Joint Steering Committee for Allergen Standardization, Course on Allergen Standardization. The Protein Laboratory, University of Copenhagen, August 4-9, 1980.

4. Baer, Harold E.: Second International Paul-Ehrlich Seminar on Regulatory Control and Standardization of Allergenic Extract, Frankfurt, Germany, September 13-15, 1981.

5. Evans, Richard, III and Summers, Richard: In vivo and in vitro tests to confirm clinical findings — Diagnostic tests for allergic patients. Journal of Respiratory Diseases, Vol. 65, No. 7, July 1981.

6. Fadal, Richard G. & Nalebuff, Donald J.: Tools of the Allergists: Old and New. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 37-61.

7. Allergenic Products: Antigen E. Potency Test: Additional Standards for Miscellaneous Products, 21 CFR Part 680, Federal Register, Vol. 46, No. 147, Friday, July 31, 1981, Rules and Regulations, pp. 39128-39136.

8. Goodman, Louis S., Gillman, Alfred: Editors, The Pharmacological Basis of Therapeutics. MacMillan Publishing Co., Inc., Chapter 19, p. 375.

9. Kniker, William T.: Clinical Science and Common Sense in the Diagnosis and Immunotherapy of Respiratory Allergy. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 16-33.

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

11. Nalebuff, Donald J. and Fadal, Richard G.: The Modified RAST Assay: An Aid in the Diagnosis and Management of Allergic Disorders. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 64-76.

12. Nelson, Harold 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.

13. Norman, Philip S., Lichtenstein, L.M., Ishizaka, K.: Diagnostic tools in ragweed hay fever. A comparison of direct skin tests IgE antibody measurements and basophil histamine release. The Journal of Allergy and Clinical Immunology. Vol. 52, 1973, pp. 210.

14. Rocklin, Ross E., Sheffer, Albert L., Grainader, Dirk K., and Melmon, Kenneth: Generation of antigen-specific suppressor cells during allergy desensitization. New England Journal of Medicine, 302: May 29, 1980, pp. 1213-1219.

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

16. 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.

17. Van Metre, Thomas E., Jr., Adkinson, N. Franklin, Jr., Amodio, Frank J., Lichtenstein, Lawrence L., Mardinay, Michael R., Jr., Norman, Philip S., Rosenberg, Gary L., Sobotka, Anne K., & Valentine, Martin D.: 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.

18. 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.

CONTAINER LABELING

5 mL Rx Set Label
(click image for full-size original)
10 mL Rx Set Label
(click image for full-size original)
TREATMENT SET TS334946
treatment set ts334946 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0774
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 160 [BAU] in 1 mL
AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 0.00002666 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00002666 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (AMBROSIA PSILOSTACHYA POLLEN) AMBROSIA PSILOSTACHYA POLLEN 0.00002666 g in 1 mL
CYNODON DACTYLON POLLEN (CYNODON DACTYLON POLLEN) CYNODON DACTYLON POLLEN 16 [BAU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA POLLEN 0.00008 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (JUNIPERUS VIRGINIANA POLLEN) JUNIPERUS VIRGINIANA POLLEN 0.002 g in 1 mL
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.00008 g in 1 mL
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.00004 g in 1 mL
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.00004 g in 1 mL
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.00008 g in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.0004 g in 1 mL
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.0004 g in 1 mL
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 0.00008 g in 1 mL
KOCHIA SCOPARIA POLLEN (KOCHIA SCOPARIA POLLEN) KOCHIA SCOPARIA POLLEN 0.002 g in 1 mL
CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) CHENOPODIUM ALBUM POLLEN 0.0004 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (IVA ANNUA VAR. ANNUA POLLEN) IVA ANNUA VAR. ANNUA POLLEN 0.0004 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS POLLEN 0.0004 g in 1 mL
SALSOLA KALI POLLEN (SALSOLA KALI POLLEN) SALSOLA KALI POLLEN 0.002 g in 1 mL
RUMEX ACETOSELLA POLLEN (RUMEX ACETOSELLA POLLEN) RUMEX ACETOSELLA POLLEN 0.00008 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
GLYCERIN
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0774-3 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS334947
treatment set ts334947 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0775
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS HAIR (CANIS LUPUS FAMILIARIS HAIR) CANIS LUPUS FAMILIARIS HAIR 0.00008 g in 1 mL
PERIPLANETA AMERICANA (PERIPLANETA AMERICANA) PERIPLANETA AMERICANA 0.00008 g in 1 mL
GALLUS GALLUS FEATHER (GALLUS GALLUS FEATHER) GALLUS GALLUS FEATHER 0.00002666 g in 1 mL
ANAS PLATYRHYNCHOS FEATHER (ANAS PLATYRHYNCHOS FEATHER) ANAS PLATYRHYNCHOS FEATHER 0.00002666 g in 1 mL
ANSER ANSER FEATHER (ANSER ANSER FEATHER) ANSER ANSER FEATHER 0.00002666 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) DERMATOPHAGOIDES PTERONYSSINUS 16 [AU] in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.00008 g in 1 mL
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.0004 g in 1 mL
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.0004 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.0004 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0004 g in 1 mL
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.0004 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.00008 g in 1 mL
PLEOSPORA HERBARUM (PLEOSPORA HERBARUM) PLEOSPORA HERBARUM 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
PHENOL
SODIUM BICARBONATE
WATER
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0775-3 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
Labeler — Antigen Laboratories, Inc. (030705628)
Registrant — Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Operations
Antigen Laboratories, Inc. 030705628 manufacture

Revised: 03/2010 Antigen Laboratories, Inc.

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