CENTER-AL – CHENOPODIUM ALBUM POLLEN: Package Insert and Label Information (Page 2 of 2)

HOW SUPPLIED

Therapeutic Center-Al Allergenic Extracts, Alum Precipitated, are supplied in 10 mL and 30 mL vials, in concentrations of 10,000 PNU/mL and 20,000 PNU/mL. Prescription treatment sets for individual patients are also available. Center-Al must be stored continuously at 2° to 8°C. DO NOT FREEZE. Diluent: Sterile Diluent for allergenic extracts (Phenol-Saline) is provided in vials of 4.5 mL, 9.0 mL, and 30 mL.

STORAGE: To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2° to 8°C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.

REFERENCES

  1. Norman, P.S.et.al.: Immunotherapy of hayfever with ragweed antigen E. Comparisons with whole pollen extract and placebo. J. Allergy 42: 93, 1968.
  2. Van Metre, T.E. et. al.: A controlled study of the effectiveness of the Rinkel method of immunotherapy for ragweed pollen hayfever. J. Allergy Clin. Immunol. 61:384, 1978.
  3. Norman, P.S. and Lichtenstein, L.M.: Comparisons of alum precipitated and unprecipitated aqueous ragweed pollen extracts in the treatment of hayfever. J. Allergy Clin. Immunol. 61: 384, 1978.
  4. Ransom, J.H.: Clinical and laboratory evaluation of alum precipitated ragweed extract. Ann. Allergy 28: 22, 1970.
  5. Ransom, J.H.: Frequency of reactions to alum precipitated ragweed extract. Ann. Allergy 29: 635, 1971.
  6. Lazar, H. and Leoffler, J.A.: Evaluation of an alum precipitated mixed ragweed antigen: a three-year study. Ann. Allergy 28: 214, 1970.
  7. Norman, P.S., Winkenwerder, W.L., and Lichtenstein, L.M.: Trials of alum precipitated pollen extracts in the treatment of hayfever. J. Allergy Clin. Immunol. 50: 31, 1972.
  8. Nelson, H.S.: Long-term immunotherapy with aqueous and alum precipitated grass extracts. Ann. Allergy 45: 333, 1980.
  9. Norman,. P.S.: The role of In-Vitro assays in the evaluation of immunotherapy. Recent Advances in Immunotherapy. Port Washington, NY 1973.
  10. Lazar, H.: Clinical presentation covering 6 years of observation. Recent Advances in Immunotherapy. Port Washington, NY 1973.
  11. Haynes, J.T.: A clinical study of 23 ragweed sensitive patients. Recent Advances in Immunotherapy. Port Washington, NY 1973.
  12. Ransom, J.H.: Ragweed patient study. Recent Advances in Immunotherapy. Port Washington, NY 1973.
  13. Committee on the Safety of Medicines. CSM update: desensitizing vaccines. Brit. Med. J. 1986; 293:948.
  14. Lockey, R.F. et al.: Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 1987; 79:660.
  15. Reid, M.J. et al.: Survey of fatalities from skin testing and immunotherapy. 1985-1989. J. Allergy Clin. Immunol. 1993; 92:6.

Revision: June 2013

© ALK-Abello, Inc. 2013

168H

Distributed in Canada by:
ALK-Abello Pharmaceuticals, Inc.
#35-151 Brunel Road Mississauga, Ontario
Canada L4Z 2H6

PRINCIPAL DISPLAY PANEL

Allergenic Extract, Alum Precipitated
Center-AL
DIN 0064892230 mL Sterile Multiple Dose Vial

Allergenic Extract, Alum Precipitated
Center-AL
DIN 00648922
30 mL Sterile Multiple Dose Vial
(click image for full-size original)
CENTER-AL — CHENOPODIUM ALBUM POLLEN chenopodium album pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0097
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) CHENOPODIUM ALBUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0097-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0097-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — ACER SACCHARUM POLLEN acer saccharum pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0100
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0100-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0100-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — FESTUCA PRATENSIS POLLEN festuca pratensis pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0103
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESTUCA PRATENSIS POLLEN (FESTUCA PRATENSIS POLLEN) FESTUCA PRATENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0103-10 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — FESTUCA PRATENSIS POLLEN festuca pratensis pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0104
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESTUCA PRATENSIS POLLEN (FESTUCA PRATENSIS POLLEN) FESTUCA PRATENSIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0104-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — PROSOPIS JULIFLORA POLLEN prosopis juliflora pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0107
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (PROSOPIS JULIFLORA POLLEN) PROSOPIS JULIFLORA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0107-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0107-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — ARTEMISIA VULGARIS POLLEN artemisia vulgaris pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0110
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (ARTEMISIA VULGARIS POLLEN) ARTEMISIA VULGARIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0110-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0110-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — MORUS RUBRA POLLEN morus rubra pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0113
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (MORUS RUBRA POLLEN) MORUS RUBRA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0113-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0113-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — QUERCUS AGRIFOLIA POLLEN quercus agrifolia pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0116
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (QUERCUS AGRIFOLIA POLLEN) QUERCUS AGRIFOLIA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0116-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0116-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — QUERCUS VIRGINIANA POLLEN quercus virginiana pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0119
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) QUERCUS VIRGINIANA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0119-10 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — QUERCUS ALBA POLLEN quercus alba pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0122
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0122-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0122-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — AVENA SATIVA POLLEN avena sativa pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0125
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVENA SATIVA POLLEN (AVENA SATIVA POLLEN) AVENA SATIVA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0125-10 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — OLEA EUROPAEA POLLEN olea europaea pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0128
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (OLEA EUROPAEA POLLEN) OLEA EUROPAEA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0128-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-0128-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — OLEA EUROPAEA POLLEN olea europaea pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0129
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (OLEA EUROPAEA POLLEN) OLEA EUROPAEA POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0129-10 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — OLEA EUROPAEA POLLEN olea europaea pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0130
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (OLEA EUROPAEA POLLEN) OLEA EUROPAEA POLLEN 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0130-10 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
CENTER-AL — OLEA EUROPAEA POLLEN olea europaea pollen injection, suspension
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0131
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (OLEA EUROPAEA POLLEN) OLEA EUROPAEA POLLEN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUM 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0131-10 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
Labeler — ALK-Abello, Inc. (809998847)

Revised: 02/2020 ALK-Abello, Inc.

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