Short Ragweed (Page 3 of 3)

OVERDOSAGE

A local reaction characterized by erythema and edema that persists for several hours or longer, or a recurrence of allergic symptoms following an injection requires that the dosage be reduced. Additional extract should not be given until all evidence of a previous reaction has disappeared.
Severe generalized symptoms or anaphylaxis following an injection must be treated immediately with epinephrine HCL 1:1000 as follows: Usual Dosage — Children under 12 years 0.1 to 0.2 cc; persons over 12 years 0.3 to 0.5 cc, repeated as necessary every 10 to 15 minutes. Intravenous antihistamines and hydro-cortisone also may be used, but only after sufficient epinephrine has been give. (see Adverse Reaction Systemic). Immunotherapy after anaphylaxis should only be considered if the probable cause of anaphylaxis can be identified, such as accidental intravenous injection or failure to reduce the dosage after a previous local reaction or during periods of high external exposure to ragweed pollen.

SUPPLIED

Short ragweed pollen extract and mixed short-giant ragweed pollen extract in concentrated form (w/v 1:20) are supplied in 1 ml dropper vials for scratch or prick testing and in 10 ml, and 50 ml vials for bulk use. Dilutions other than 1:20 w/v may be custom ordered.

REFERENCES

  1. Norman, P.S. and L.M. Lichtenstein. Capacity of purified antigens and whole pollen extracts to release histamine from leukocytes of hay fever patients. J. Allergy and Clinical Immunology. 52:94, 1973.
  2. Gleich, G.J., J.B. Larson, R.T. Jones and H. Baer. Measurement of the potency of allergenic extracts by their inhibitory capacities in the radioallergosorbent test. J. Allergy and Clinical Immunology. 53:158, 1974.
  3. Norma, P.S., W.L. Winkenwerder and L. Lichtenstein. Immunotherapy of hay fever with ragweed antigen E: comparisons with whole pollen extract and placebos. J. Allergy. 42:93, 1968.
  4. Baer, H., H. Godfrey, C.J. Maloney, P.S. Norman, and L.M. Lichtenstein. The potency and antigen E content of commercially prepared ragweed extracts. J. Allergy. 45:347, 1970.
  5. Center, J.G., N. Shuller and L.D. Zeleznick. Stability of antigen E in commercially prepared ragweed pollen extracts. J. Allergy and Clinical Immunology. 54:305, 1974.
  6. Hiatt, C.W., H. Baer, and M.L. Hooton. Kinetics of thermal decay of antigen E from short ragweed pollen. J. Biological Standardization. 5:39, 1977.
  7. Norman, P.S., L.M. Lichtenstein and K. Ishizaka. Diagnostic tests in ragweed hay fever. J. Allergy and Clinical Immunology. 52:210, 1973.
  8. Bruce, C.A., R.R. Rosenthal, L.M. Lichtenstein and P.S. Norman. Diagnostic tests in ragweed-allergic asthma. J. Allergy and Clinical Immunology. 53:230, 1974.
  9. Lowell, F.C. and W. Franklin. A double-blind study of the effectiveness and specificity of injection therapy in ragweed hay fever. New England Journal of Medicine. 273:675, 1965.
  10. Franklin, W. and F.C. Lowell. Comparison of two dosages of ragweed extract in the treatment of pollinosis. J.American Medical Association. 201:915, 1967.
  11. Johnstone, D.E. Study of the role of antigen dosage in the treatment of pollinosis and pollen asthma. American Medical Association, Journal of Diseases of Children. 94:1, 1957.
  12. Levy, D.A., L.M. Lichtenstein, E.O. Goldstein and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigations. 50:360, 1971.
  13. Melam, H.L., J.J. Purzansky, R. Patterson and S. Singer. Clinical and immunologic studies of ragweed immunotherapy. J. Allergy. 47:262, 1971.
  14. Levy, D.A. and A.G. Osher. Studies on the mechanism of hypersensitivity phenomena. XVI. In vitro assays of reaginic activity in human sera: effect of therapeutic immunization on seasonal titer changes. J. of Immunology. 99:1068, 1967.
  15. Connell, J.T. and W.B. Serman. Changes in skin — sensitizing antibody titer after injections of aqueous pollen extract. J. of Allergy. 43:22, 1969.
  16. Sprecace, G.A., S.G. Pomper, W.B. Sherman, A. Lemlich and H. Ziffer. The effects of antigen injections on skin reactivity to antigens. J. Allergy. 38:9, 1966.
  17. Pruzansky, J.J. and R. Patterson. Histamine release from leukocytes of hypersensitive individuals. II Reduced sensitivity of leukocytes after injection therapy. J. Allergy. 39:44, 1967.
  18. Kin, T.P., P.S. Norman, and L.M. Lichtenstein. Isolation and characterization of allergens from ragweed pollen. IV, Biochemistry 6:1992, 1967.
  19. Lichtenstein, L.M., P.S. Norman and W.L. Winkenwerder. A single year of immunotherapy for ragweed hay fever. Annals of Internal Medicine. 75:663, 1971.
  20. Cooke, R.A. and A. Vander Veer, Jr., Human Sensitization. J. Immunology 1:201, 1916.
  21. Vander Veer, A., R.A. Cooke and W.C. Spain. Diagnosis and treatment of seasonal hay fever. American J. Medical Science. 174:101, 1927.
  22. Wodehouse, R.P. Patterns of allergic sensitization. Annals of Allergy. 6:358, 1948.
  23. Wodehouse, R.P. Antigenic analysis of gel diffusion. I. Ragweed pollen. International Archives of Allergy. 5:425, 1954.
  24. Prince, H.E. and P.G. Secrest. Immunologic relationship of giant, wester, common ragweed and marsh elder (Iva ciliate). J. Allergy 10:537, 1939.
  25. Bernstein, I.L., M. Perera, J. Gallagher, J.G. Michael and S.G.O. Johansson. Invitro cross allergenicity of major aeroallergenic pollens by the radioallergosorbent technique. J. Allergy and Clinical Immunology. 57:141, 1976.
  26. Leiferman, K., G.J. Gleich and R.T. Jones. The cross-reactivity of IgE antibodies with pollen allergens. II. Analysis of various species of ragweed and other fall weed pollens. J. Allergy and Clinical Immunolgoy. 58:140, 1976.
  27. Simon, F.A. Allergenic relationship of the pollens of dwarf and giant ragweed to several of their botanic relatives. J. Experimental Medicine. 77:185, 1943.

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SHORT RAGWEED ambrosia artemisiifolia injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49643-315
Route of Administration CUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA POLLEN 1 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.25 g in 10 mL
SODIUM BICARBONATE 0.125 g in 10 mL
GLYCERIN 5.3 mL in 10 mL
PHENOL 0.4 g in 10 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49643-315-05 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49643-315-10 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49643-315-30 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49643-315-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103113 03/22/1982
Labeler — Allermed Laboratories, Inc. (073364531)
Establishment
Name Address ID/FEI Operations
Allermed Laboratories, Inc. 073364531 manufacture (49643-315)

Revised: 09/2019 Allermed Laboratories, Inc.

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