CENTER-AL – DACTYLIS GLOMERATA 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

CENTER-AL — DACTYLIS GLOMERATA POLLEN dactylis glomerata pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0134 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA 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:0268-0134-10 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 — CARYA ILLINOINENSIS POLLEN carya illinoinensis pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0137 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS 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:0268-0137-10 10 mL in 1 VIAL, MULTI-DOSE None 2 NDC:0268-0137-30 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 — AMARANTHUS RETROFLEXUS POLLEN amaranthus retroflexus pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0140 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS 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:0268-0140-10 10 mL in 1 VIAL, MULTI-DOSE None 2 NDC:0268-0140-30 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 — AMARANTHUS RETROFLEXUS POLLEN amaranthus retroflexus pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0141 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS POLLEN 5000 [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:0268-0141-30 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 — PLANTAGO LANCEOLATA POLLEN plantago lanceolata pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0144 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA 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:0268-0144-10 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 — PLANTAGO LANCEOLATA POLLEN plantago lanceolata pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0146 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA 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:0268-0146-10 10 mL in 1 VIAL, MULTI-DOSE None 2 NDC:0268-0146-30 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 — PLANTAGO LANCEOLATA POLLEN plantago lanceolata pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0145 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA 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:0268-0145-10 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 — PLANTAGO LANCEOLATA POLLEN plantago lanceolata pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0147 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA 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:0268-0147-10 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 — POPULUS ALBA POLLEN populus alba pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0150 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS 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:0268-0150-10 10 mL in 1 VIAL, MULTI-DOSE None 2 NDC:0268-0150-30 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 — AMBROSIA ACANTHICARPA POLLEN ambrosia acanthicarpa pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0153 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ACANTHICARPA POLLEN (AMBROSIA ACANTHICARPA POLLEN) AMBROSIA ACANTHICARPA 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:0268-0153-30 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 — AMBROSIA ARTEMISIIFOLIA POLLEN ambrosia artemisiifolia pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0156 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA 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:0268-0156-30 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 — AMBROSIA ARTEMISIIFOLIA POLLEN ambrosia artemisiifolia pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0157 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) AMBROSIA ARTEMISIIFOLIA 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:0268-0157-30 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 — AMBROSIA TRIFIDA POLLEN ambrosia trifida pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0160 Route of Administration 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

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:0268-0160-30 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 — AMBROSIA TRIFIDA POLLEN ambrosia trifida pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0161 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA 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:0268-0161-30 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 — AMBROSIA PSILOSTACHYA POLLEN ambrosia psilostachya pollen injection, suspension

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0164 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (AMBROSIA PSILOSTACHYA POLLEN) AMBROSIA PSILOSTACHYA 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:0268-0164-10 10 mL in 1 VIAL, MULTI-DOSE None 2 NDC:0268-0164-30 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

Labeler — ALK-Abello, Inc. (809998847)

Revised: 02/2020 ALK-Abello, Inc.