Pollens – Weeds and Garden Plants, Short Ragweed, Ambrosia Artemisiifolia: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED

Scratch, Prick or Puncture Test extracts are supplied in 5 mL dropper bottles at 1:20 w/v and are preserved with glycerin. Intradermal extracts are supplied in multiple dose 5 mL vials at a concentration of 500 PNU/mL, and are preserved with phenol. Treatment sets are supplied as ordered by the physician. “Bulk” extracts are preserved with glycerin and are supplied in 10, 30 and 50 mL multidose vials at the w/v or PNU/mL ordered by the physician. Please see the current catalog or professional price

STORAGE

The expiration date is listed on the container label. To insure the maximum potency of Short Ragweed extract and its dilutions, it is recommended that the product be maintained at a temperature of 2° — 8°C at all times, even during use. Dilutions are less stable than the Concentrate. If loss of potency is suspected, the product should be checked by skin testing with equal units of a freshly prepared dilution on known ragweed pollen allergic individuals.

LIMITED WARRANTY SECTION

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCES

1. Lockey, R.F., L.M. Benedict, P.C. Turkeltaub, S.C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79 (4): 660-677, April 1987.

2. Jacobs, R.L., G.W. Rake, Jr. et al. Potentiated anaphylaxis in patients with drug induced beta-adrenergic blockade. J. Allergy and Clin. Immunol. 68 (2): 125-127, August 1981.

3. Griffith, I.J., J. Pollock, D.G. Klapper, B.L. Rogers and A.K. Nault,. Sequence Polymorphism of Amb a I and Amb a II, the Major Allergens in Ambrosia artemisiifolia (Short Ragweed). Int. Arch. Allergy Apply. Immunol., 96: 296-304, 1991.

4. Underdown, B.J. and L. Goodfriend. Isolation and characterization of an allergen from short ragweed pollen. Biochem. 8 (3): 980-989, 1969.

5. Griffiths, B.W. and R. Brunet. Isolation of a basic protein antigen of low ragweed pollen. Can. J. Biochem. 49 (3): 396-400, 1971.

6. Lapkoff, C.B. and L. Goodfriend. Isolation of a low molecular weight ragweed allergen: Ra-5. Int. Arch. Allergy Appl. Immunol. 46 (2): 215-229, 1974.

7. Hussain, R. and D.G. Marsh. Characterization and allergenic activity of ragweed allergens Ra-6, Ra-7, Ra-8. J. Allergy Clin. Immunol. 65 (3): 230, abstr. 218, 1980.

8. Goodfriend, L., A.M. Choudhury, J. Del Carpio and T.P. King. Cytochrome C: New ragweed pollen allergen. Fed. Proc. 38 (3, part II): 1415, abstr. 6261, 1979.

9. Norman, P.S. Postgraduate Course Presentation. An overview of immunotherapy, implications for the future. J. Allergy Clin. Immunol. 65 (2): 87-96, 1980.

10. Lowell, F.C., W. Franklin. A “double-blind” study of treatment with aqueous allergenic extracts in cases of allergic rhinitis. J. Allergy 34 (2): 165-182, 1983.

11. Lowell, F.C., W. Franklin. A double-blind study of the effectiveness and specificity of injection therapy in ragweed hay fever. N. Eng. J. Med. 273 (13): 675-679, 1965.

12. Zavazal, V., A. Stajner. Immunologic changes during specific treatment of the atopic state. II. Acta. Allergol. 25 (1): 11-17, 1970.

13. Reisman, R.E., J.I. Wypych, E.E. Arbesman. Relationships of immunotherapy, seasonal pollen exposure and clinical response to serum concentrations of total IgE and ragweed-specific IgE. Int. Arch. Allergy Appl. Immunol. 48 (6): 721-730, 1975.

14. Chapman, M.D., T.A.E. Platts-Mills, M. Gabriel, H.K. Ng, W.G.L. Allen, L.E. Hill, A.J. Nunn. Antibody response following prolonged hyposensitization with Dermatophagoides pteronyssinus extract. Int. Arch. Allergy Appl. Immunol. 61: 431-440, 1980.

15. Norman, P.S., W.L. Winkenwerder. Maintenance immunotherapy in ragweed hay fever. J. Allergy 74: 273-282, 1971.

16. Norman, P.S., W.L. Winkenwerder, L.M. Lichtenstein. Immunotherapy of hay fever with ragweed Antigen E; comparisons with whole pollen extract and placebos. J.Allergy 42: 93-108, 1968.

17. Ohman, J.L., S.R. Findlay, K. Leiterman. Immunotherapy in cat-induced asthma: double-blind trial with evaluation of in vivo and vitro responses. J. Allergy Clin. Immunol. 74: 230, 1984.

18. Sundin, B., G. Lilja, V. Graff-Lonnevig, G. Hedlin, H. Heilborn, K. Norrlind, K-O Pegelow, and H. Lowenstein. Immunotherapy with partially purified and standardized animal dander extracts. I Clinical results from a double-blind study on patients with animal dander asthma. J. Allergy Clin. Immunol. 77: 478, 1986.

19. Hunt, K.J., Valentine, M.D., Sobotka, A.K., Benton, A.W., Amodio, F.J., and Lichtenstein, L.M. A controlled trial of immunotherapy in insect hypersensitivity. New Eng. J. Med. 299: 157-161, July 27, 1978.

20. Middleton, E., C.E. Reed and E.F. Ellis (Eds.). Allergy Principles and Practice. C.V. Mosby Co., St. Louis, 1978, pp. 877-898.

21. Sheldon, J.M., R.G. Lovell and K.P. Mathews. A Manual of Clinical Allergy, Second Edition, W.B. Saunders, Philadelphia, 1967, pp. 107-112.

22. Sherman, W.B. Hypersensitivity Mechanism and Management. W.B. Saunders, Philadelphia, 1968, pp. 169-172.

23. Swineford, O. Asthma and Hay Fever. Charles C. Thomas, Springfield, IL, 1971, pp. 148-155.

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

25. Murray, A.B., A.C. Ferguson and B.J. Morrison. Diagnosis of house dust mite allergy in asthmatic children: What constitutes positive history. J. Allergy Clin. Immunol. 71:21, 1983.

26. Lichtenstein, L.M., P.S. Norman and W.L. Winkenwerder. Clinical and in vitro studies on the role of immunotherapy in ragweed hay fever. Amer. J. Med. 44 (4): 514-524, 1968.

27. Reisman, R.E., K. Wicher and C.E. Arbesman. Immunotherapy with Antigen E. J. Allergy 44 (2): 82-95, 1969.

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

29. Reid, M.J., G. Gurka. Deaths associated with skin testing and immunotherapy. J.Allergy Clin. Immunol. 97(1) Part 3:231, Abstract 195, January 1996.

30. Thompson, R.A., et al, report of a WHO/IUIS working group. The current status of allergen immunotherapy (hyposensitization). Allergy. 44: 369-379, 1989.

31. Malling, H.J., B. Weeke, et al, The European Academy of Allergology and Clinical Immunology. Position Papers. Allergy. 48 (Supplement 14): 9-82, 1993.

32. Pipkorn, U. Pharmacological influence of anti-allergic medication on in Vivo allergen testing. Allergy 43: 81-86, 1988.

33. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clinical Immunology 79 (2): 345-349, February 1987.

34. Rao, K.S., et al. Duration of suppressive effect of tricyclic antidepressants on histamine induced wheal and flare reactions on human skin. Allergy Clinical Immunology 82: 752-757, November 1988.

35. Pipkorn, U., and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy 17: 307-311, 1987.

36. Metzger, W.J., E. Turner and R. Patterson. The safety of immunotherapy during pregnancy. J. Allergy Clin. Immunol. 61 (4): 268-272, 1978.

37. Li, J.T., R.F. Lockey, I.L. Bernstein, J.M. Portnoy, R.A. Nicklas. Allergen Immunotherapy: A Practice Parameter. Ann. Allergy, Asthma and Immunotherapy 90 (1): 26, 2003.

38. Patterson, R., et al. Allergy Principles and Practice, 2nd ed. E. Middleton, Jr., C.E. Reed, E.F. Ellis, Ed., C.V. Mosby Co., St. Louis, MO, 1983, Chapter 52.

39. Levy, D.A., L.M. Lichtenstein, E.O. Goldstein, and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigation 50: 360, 1971.

40. Peebles, R.S., Jr., B. Bochner, H.J. Zeitz, ed. Anaphylaxis in the elderly. Immunology and Allergy Clinics of North America. 13 (3): 627-646, August 1993.

41. Turkeltaub, P.C., MD, and P.J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84 (6): 886-890, Dec. 1989.

42. Norman, P.S., L.M. Lichtenstein, and K. Ishizaka. Diagnostic tests in ragweed hay fever. J. Allergy Clin. Immunol. 52 (4): 212-224, 1973.

Ragweed Mix 5 mL, 1:20 w/v Carton Label

Ragweed Mix 5 mL, 1:20 w/v Carton Label
(click image for full-size original)

Ragweed Mix 5 mL, 1:20 w/v Vial Label

Ragweed Mix 5 mL, 1:20 w/v Vial Label
(click image for full-size original)

Ragweed Mix 10 mL, 1:20 w/v Carton Label

Ragweed Mix 10 mL, 1:20 w/v Carton Label
(click image for full-size original)

Ragweed Mix 10 mL, 1:20 w/v Vial Label

Ragweed Mix 10 mL, 1:20 w/v Vial Label
(click image for full-size original)

Ragweed Mix 50 mL, 1:20 w/v Carton Label

Ragweed Mix 50 mL, 1:20 w/v Carton Label
(click image for full-size original)

Ragweed Mix 50 mL, 1:20 w/v Vial Label

Ragweed Mix 50 mL, 1:20 w/v Vial Label
(click image for full-size original)

Standardized Short Ragweed 5 mL, 1:20 w/v Carton Label

Standardized Short Ragweed 5 mL, 1:20 w/v Carton Label
(click image for full-size original)

Standardized Short Ragweed 5 mL, 1:20 w/v Vial Label

Standardized Short Ragweed 5 mL, 1:20 w/v Vial Label
(click image for full-size original)

Standardized Short Ragweed 10 mL, 1:20 w/v Carton Label

Standardized Short Ragweed 10 mL, 1:20 w/v Carton Label
(click image for full-size original)

Standardized Short Ragweed 10 mL, 1:20 w/v Vial Label

Standardized Short Ragweed 10 mL, 1:20 w/v Vial Label
(click image for full-size original)

Standardized Short Ragweed 50 mL, 1:20 w/v Carton Label

Standardized Short Ragweed 50 mL, 1:20 w/v Carton Label
(click image for full-size original)

Standardized Short Ragweed 50 mL, 1:20 w/v Vial Label

Standardized Short Ragweed 50 mL, 1:20 w/v Vial Label
(click image for full-size original)
POLLENS — WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA short ragweed, ambrosia artemisiifolia injection, solution
Product Information
Product Type Item Code (Source) NDC:65044-2297
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65044-2297-1 5 mL in 1 VIAL None
2 NDC:65044-2297-2 10 mL in 1 VIAL None
3 NDC:65044-2297-3 30 mL in 1 VIAL None
4 NDC:65044-2297-4 50 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103880 10/18/1977
POLLENS — WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA short ragweed, ambrosia artemisiifolia injection, solution
Product Information
Product Type Item Code (Source) NDC:65044-2298
Route of Administration INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65044-2298-5 5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103880 10/18/1977
POLLENS — WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA ragweed, mixed ambrosia injection, solution
Product Information
Product Type Item Code (Source) NDC:65044-2315
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 0.05 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65044-2315-1 5 mL in 1 VIAL None
2 NDC:65044-2315-2 10 mL in 1 VIAL None
3 NDC:65044-2315-3 30 mL in 1 VIAL None
4 NDC:65044-2315-4 50 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103880 10/18/1977
POLLENS — WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA ragweed, mixed ambrosia injection, solution
Product Information
Product Type Item Code (Source) NDC:65044-2316
Route of Administration INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 500 [PNU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65044-2316-5 5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103880 10/18/1977
POLLENS — WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA ragweed, mixed ambrosia injection, solution
Product Information
Product Type Item Code (Source) NDC:65044-2317
Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 20000 [PNU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65044-2317-2 10 mL in 1 VIAL None
2 NDC:65044-2317-3 30 mL in 1 VIAL None
3 NDC:65044-2317-4 50 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103880 10/18/1977
Labeler — Jubilant HollisterStier LLC (069263643)
Registrant — Jubilant HollisterStier LLC (069263643)

Revised: 11/2021 Jubilant HollisterStier LLC

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