MIXED ASPERGILLUS: Package Insert and Label Information (Page 2 of 2)

OVERDOSAGE

Signs and symptoms of overdose are typically local and systemic reactions. For a description and management of overdose reactions, refer to “Adverse Reaction” section above.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

When diluting bulk extracts, use of Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA (albumin saline) is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly, 10 fold dilutions are used to achieve a desired concentration for initiation and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 PNU/mL extract into 4.5 mL of diluent will yield 5 mL of extract at 1,000 PNU/mL. For weight volume products, a 1:100 w/v dilution may be prepared from a 1:10 w/v by transferring 0.5 mL of the 1:10 w/v to 4.5 mL of diluent. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.

Starting dose for immunotherapy is related directly to a patient’s sensitivity as determined by carefully executed skin testing. Degree of sensitivity can be established by determination of D₅₀ .¹¹ A general rule is to begin at 1/10 of the dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction).

For example, if a patient exhibits a 2+ intradermal reaction to 1 AU/mL, the first dose should be no higher than 0.05 mL of 0.1 AU/mL. Dosage may be increased by 0.05 mL each time until 0.5 mL is reached, at which time the next 10-fold more concentrated dilution can be used, beginning with 0.05 mL, if no untoward reaction is observed.

Interval between doses in the early stages of immunotherapy is no more than once to twice a week, and may gradually be increased to once every two weeks. Generally, maintenance injections may be given as infrequently as once every two weeks to once a month.

Injections are given subcutaneously, preferably in the arm. It is advantageous to give injections in alternate arms and routinely in the same area. In some patients, a local tolerance to the allergen may develop thus preventing a possible severe local reaction.

Formal stability studies for diluted and undiluted forms of unstandardized extracts have not been performed; therefore, it is recommended that minimal amounts of the concentrate be diluted so that the diluted product is used up within a relatively short period of time; i.e., preferably not more than four weeks.

PRE-SEASONAL METHOD OF TREATMENT

Treatment of hay fever by the pre-seasonal method should be started 6-10 weeks prior to the usual onset of symptoms. Therapy should be started early enough to permit a graduated series of doses at 2-7 day intervals. It is recommended that the larger doses be spaced 5-7 days apart.

Some physicians continue therapy into or through the season by repeating a reduced or MAINTENANCE dose at weekly or biweekly intervals. If during the season, hay fever symptoms develop, relief may be provided by giving supplemental treatment. If the last dose was well-tolerated and not more than 2 weeks has elapsed since it was given, this dose may be given again and repeated every 4 to 7 days.

PERENNIAL TREATMENT

The patient’s tolerance to the offending pollen or pollens is first established by the injection of a series of graduated doses as outlined in the PRE-SEASONAL METHOD, not necessarily given pre-seasonally, since perennial therapy may be begun at any time. After completion of the ascending series of injections, from 1/4 to 1/2 of the highest well-tolerated dose is continued at 2 to 3 week intervals throughout the year. Shortly before the usual onset of symptoms (4 to 5 weeks prior to the season) the interval between injections is shortened and the dosage is gradually increased, according to the Pre-Seasonal schedule, until maximum well-tolerated dose is again attained. This top dose should be reached just before the usual onset of symptoms at which time the treatment is discontinued. If patient’s symptoms persist, therapy may be continued at a reduced dosage level, usually 1/4 to 1/2 of the top dose.

DOSAGE ADJUSTMENTS

For Products Containing Short Ragweed.

In transferring patients from unstandardized to standardized product, the physician should establish the potency relationships, perhaps by comparative skin testing, prior to injecting the first standardized dose.

AgE is important in adjusting dosage of Short Ragweed extracts to accurately transfer a patient from older extracts to fresher material. In such cases, the dosage of AgE should be considered in addition to the W/V dilution or protein nitrogen units. Antigen E concentration continuously declines in Short Ragweed Pollen extracts at a rate that varies with the formulation of the product. Aqueous extracts retain Antigen E potency less effectively than glycerin 50% (v/v) extracts. These differences are reflected in the expiration date declared on the vial. The continuous decline should be considered. Also, where ragweed is a component of an allergen mixture, clinical response to the other components must be considered in adjustment of dosage based on AgE content alone. The usual course of immunotherapy is three to five years.

Caution: A small percent of individuals allergic to Short Ragweed are more sensitive to minor antigens such as Ra3 Ra5 than AgE. There is no correlation between the amount of these antigens and either AgE or PNU content.

NOTE: For extracts of Short Ragweed or equal part mixture of Short and Tall Ragweed refer to AgE dosage schedule. The AgE content for those products is indicated on the vial label. The physician may use the formula below to determine the AgE dosage for each injection.

AgE dosage can be monitored by using the following formula:

W/V compounded products:

Labeled AgE X Dose (mL) = dose in AgE

PNU compounded products:

Labeled AgE/mL X dose in PNU = dose in AgE

Labeled PNU/mL

HOW SUPPLIED

1. Concentrate in multiple dose vials:
   
2. Sterile Diluent for Allergenic Extracts (Phenol Saline) is supplied in vials of 4.5 mL, 9.0 mL, 30 mL and 100 mL.

10 mL and 50 mL, single antigens or specified mixtures, potency expressed in PNU/mL (up to and including 100,000 PNU/mL) or W/V (up to and including 1:10 W/V), aqueous or in 50% glycerin, to be diluted prior to use. 1:10 w/v short ragweed extracts contain ≥ 300 units/mL of AgE.

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. 65:288, 1980.
   
3. Umetsu, D.T. et al: Serum sickness triggered by anaphylaxis: a complication of immunotherapy. J. Allergy Clin. Immunol. 76:713, 1985.
   
4. Phannphak, P. and Kohler, P.F.: Onset of polyarteritis nodosa during allergic hyposenitization treatment. Am. J. Med. 68:479, 1980.
   
5. Kohler, P.F.: Immune complexes and allergic disease. In: Middleton et al: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
   
6. Bousquet, J.: In vivo methods for the study of allergy: skin test, techniques, and interpretation. In: Middleton et al: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
   
7. Committee on the Safety of Medicines. CSM update: desensitising vaccines. Brit Med. J. 293:948,1986.
   
8. Lockey, R.F. et al: Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79:660, 1987.
   
9. Reid, M.J. et al: Survey of fatalities from skin testing and immunotherapy. 1985-1989. J. Allergy Clin. Immunol. ;92:6, 1993.
   
10. Van Metre, T.E. et al: A controlled study of the effectiveness of the Rinkel method and the current standard method of immunotherapy for ragweed pollen hayfever. J. Allergy Clin. Immunol. 66:500, 1980.
    
11. Turkeltaub, P.C., Rastogi, S.C., Baer, H., et al: A standardized quantitative skin-test assay of allergen potency and stability: studies on the allergen dose-response curve and effect of wheal, erythema, and patient selection on assay results, J. Allergy Clin. Immunol. 70:343, 1982.

Revised April 2017 158M

© ALK-Abelló, Inc.

Distributed in Canada by:

ALK-Abelló Pharmaceuticals, Inc.

#35-151 Brunel Road

Mississauga, Ontario

Canada L4Z 2H6

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACTmL sterile multiple dose vial

MIXED ASPERGILLUS aspergillus flavus var. oryzae, aspergillus niger var. niger, aspergillus repens, aspergillus terreus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8035 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 40000 [PNU] in 1 mL ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 40000 [PNU] in 1 mL ASPERGILLUS FLAVUS VAR. ORYZAE (ASPERGILLUS FLAVUS VAR. ORYZAE) ASPERGILLUS FLAVUS VAR. ORYZAE 40000 [PNU] in 1 mL ASPERGILLUS TERREUS (ASPERGILLUS TERREUS) ASPERGILLUS TERREUS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.009 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8035-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED FEATHERS anas platyrhynchos feather, anser anser feather, gallus gallus feather injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8041 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER (GALLUS GALLUS FEATHER) GALLUS GALLUS FEATHER 20000 [PNU] in 1 mL ANAS PLATYRHYNCHOS FEATHER (ANAS PLATYRHYNCHOS FEATHER) ANAS PLATYRHYNCHOS FEATHER 20000 [PNU] in 1 mL ANSER ANSER FEATHER (ANSER ANSER FEATHER) ANSER ANSER FEATHER 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.009 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8041-10 10.5 mL in 1 VIAL None 2 NDC:0268-8041-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

4 WEED MIX amaranthus retroflexus pollen, chenopodium album pollen, plantago lanceolata pollen and xanthium strumarium pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8003 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (XANTHIUM STRUMARIUM POLLEN) XANTHIUM STRUMARIUM POLLEN 40000 [PNU] in 1 mL PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA POLLEN 40000 [PNU] in 1 mL CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) CHENOPODIUM ALBUM POLLEN 40000 [PNU] in 1 mL AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID SODIUM HYDROXIDE SODIUM CHLORIDE 0.009 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8003-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

9 TREE MIX acer saccharinum pollen, alnus rhombifolia pollen, betula lenta whole, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus alba pollen, quercus alba pollen, ulmus americana pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8020 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 40000 [PNU] in 1 mL FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 40000 [PNU] in 1 mL ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 40000 [PNU] in 1 mL BETULA LENTA WHOLE (BETULA LENTA WHOLE) BETULA LENTA WHOLE 40000 [PNU] in 1 mL ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 40000 [PNU] in 1 mL CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 40000 [PNU] in 1 mL QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 40000 [PNU] in 1 mL POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 40000 [PNU] in 1 mL PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8020-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

9 TREE MIX acer saccharinum pollen, alnus rhombifolia pollen, betula lenta whole, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus alba pollen, quercus alba pollen, ulmus crassifolia pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8021 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 0.1 g in 1 mL FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.1 g in 1 mL ULMUS CRASSIFOLIA POLLEN (ULMUS CRASSIFOLIA POLLEN) ULMUS CRASSIFOLIA POLLEN 0.1 g in 1 mL BETULA LENTA WHOLE (BETULA LENTA WHOLE) BETULA LENTA WHOLE 0.1 g in 1 mL ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 0.1 g in 1 mL CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 0.1 g in 1 mL QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.1 g in 1 mL POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 0.1 g in 1 mL PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE SODIUM BICARBONATE 0.0027 g in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8021-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

HICKORY PECAN MIX carya illinoinensis pollen, carya ovata pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8029 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 0.1 g in 1 mL CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8029-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MIDWEST MOLDS chaetomium globosum, cochliobolus sativus, gibberella zeae, mucor plumbeus, phoma exigua var. exigua, rhizopus arrhizus var. arrhizus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8039 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL CHAETOMIUM GLOBOSUM (CHAETOMIUM GLOBOSUM) CHAETOMIUM GLOBOSUM 20000 [PNU] in 1 mL GIBBERELLA ZEAE (GIBBERELLA ZEAE) GIBBERELLA ZEAE 20000 [PNU] in 1 mL MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 20000 [PNU] in 1 mL PHOMA EXIGUA VAR. EXIGUA (PHOMA EXIGUA VAR. EXIGUA) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL RHIZOPUS ARRHIZUS (RHIZOPUS ARRHIZUS) RHIZOPUS ARRHIZUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8039-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED MOLDS alternaria alternata, aspergillus flavus var. oryzae, aspergillus niger var. niger, aspergillus repens, aspergillus terreus, cladosporium sphaerospermum, penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8046 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 10000 [PNU] in 1 mL CLADOSPORIUM SPHAEROSPERMUM (CLADOSPORIUM SPHAEROSPERMUM) CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU] in 1 mL ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 10000 [PNU] in 1 mL ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 10000 [PNU] in 1 mL ASPERGILLUS FLAVUS VAR. ORYZAE (ASPERGILLUS FLAVUS VAR. ORYZAE) ASPERGILLUS FLAVUS VAR. ORYZAE 10000 [PNU] in 1 mL ASPERGILLUS TERREUS (ASPERGILLUS TERREUS) ASPERGILLUS TERREUS 10000 [PNU] in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8046-10 10.5 mL in 1 VIAL None 2 NDC:0268-8046-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED MOLDS alternaria alternata, aspergillus flavus var. oryzae, aspergillus niger var. niger, aspergillus repens, aspergillus terreus, cladosporium sphaerospermum, penicillium chrysogenum var. chrysogenum, penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8047 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL CLADOSPORIUM SPHAEROSPERMUM (CLADOSPORIUM SPHAEROSPERMUM) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 20000 [PNU] in 1 mL ASPERGILLUS FLAVUS VAR. ORYZAE (ASPERGILLUS FLAVUS VAR. ORYZAE) ASPERGILLUS FLAVUS VAR. ORYZAE 20000 [PNU] in 1 mL ASPERGILLUS TERREUS (ASPERGILLUS TERREUS) ASPERGILLUS TERREUS 20000 [PNU] in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8047-10 10.5 mL in 1 VIAL None 2 NDC:0268-8047-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED MOLDS alternaria alternata, aspergillus flavus var. oryzae, aspergillus niger var. niger, aspergillus repens, aspergillus terreus, cladosporium sphaerospermum, penicillium chrysogenum var. chrysogenum, penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8048 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 40000 [PNU] in 1 mL CLADOSPORIUM SPHAEROSPERMUM (CLADOSPORIUM SPHAEROSPERMUM) CLADOSPORIUM SPHAEROSPERMUM 40000 [PNU] in 1 mL ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 40000 [PNU] in 1 mL ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 40000 [PNU] in 1 mL ASPERGILLUS FLAVUS VAR. ORYZAE (ASPERGILLUS FLAVUS VAR. ORYZAE) ASPERGILLUS FLAVUS VAR. ORYZAE 40000 [PNU] in 1 mL ASPERGILLUS TERREUS (ASPERGILLUS TERREUS) ASPERGILLUS TERREUS 40000 [PNU] in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8048-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED PENICILLIUM penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8052 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8052-10 10.5 mL in 1 VIAL None 2 NDC:0268-8052-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED PENICILLIUM penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8053 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8053-10 10.5 mL in 1 VIAL None 2 NDC:0268-8053-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED RAGWEED ambrosia artemisiifolia, ambrosia trifida pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8059 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA (AMBROSIA ARTEMISIIFOLIA) AMBROSIA ARTEMISIIFOLIA 40000 [PNU] in 1 mL AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8059-10 10.5 mL in 1 VIAL None 2 NDC:0268-8059-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MIXED RAGWEED ambrosia artemisiifolia, ambrosia trifida pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8060 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA (AMBROSIA ARTEMISIIFOLIA) AMBROSIA ARTEMISIIFOLIA 0.1 g in 1 mL AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8060-10 10.5 mL in 1 VIAL None 2 NDC:0268-8060-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MOLD MIX 1 alternaria alternata, aspergillus niger var. niger, cladosporium sphaerospermum, cochliobolus sativus and penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8064 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL CLADOSPORIUM SPHAEROSPERMUM (CLADOSPORIUM SPHAEROSPERMUM) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8064-10 10.5 mL in 1 VIAL None 2 NDC:0268-8064-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MOLD MIX 1 alternaria alternata, aspergillus niger var. niger, cladosporium sphaerospermum, cochliobolus sativus and penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8065 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU] in 1 mL COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 40000 [PNU] in 1 mL ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 40000 [PNU] in 1 mL ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 40000 [PNU] in 1 mL CLADOSPORIUM SPHAEROSPERMUM (CLADOSPORIUM SPHAEROSPERMUM) CLADOSPORIUM SPHAEROSPERMUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8065-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MOLD MIX 2 aureobasidium pullulans, curvularia inaequalis, fusarium roseum, mucor plumbeus, phizopus oryzae injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8068 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU] in 1 mL CURVULARIA INAEQUALIS (CURVULARIA INAEQUALIS) CURVULARIA INAEQUALIS 20000 [PNU] in 1 mL GIBBERELLA ZEAE (GIBBERELLA ZEAE) GIBBERELLA ZEAE 20000 [PNU] in 1 mL MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 20000 [PNU] in 1 mL RHIZOPUS ARRHIZUS (RHIZOPUS ARRHIZUS) RHIZOPUS ARRHIZUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8068-10 10.5 mL in 1 VIAL None 2 NDC:0268-8068-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MOLD MIX 2 aureobasidium pullulans, curvularia inaequalis, fusarium roseum, mucor plumbeus, phizopus oryzae injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8069 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU] in 1 mL CURVULARIA INAEQUALIS (CURVULARIA INAEQUALIS) CURVULARIA INAEQUALIS 40000 [PNU] in 1 mL GIBBERELLA ZEAE (GIBBERELLA ZEAE) GIBBERELLA ZEAE 40000 [PNU] in 1 mL MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 40000 [PNU] in 1 mL RHIZOPUS ARRHIZUS (RHIZOPUS ARRHIZUS) RHIZOPUS ARRHIZUS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID PHENOL 0.004 mL in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL SODIUM CHLORIDE 0.009 g in 1 mL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8069-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

FAPP MIXTURE aspergillus flavus var. oryzae, aspergillus niger var. niger, aspergillus repens, aspergillus terreus, gibberella zeae, penicillium chrysogenum var. chrysogenum, phoma exigua var. exigua injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8025 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GIBBERELLA ZEAE (GIBBERELLA ZEAE) GIBBERELLA ZEAE 20000 [PNU] in 1 mL ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 20000 [PNU] in 1 mL ASPERGILLUS FLAVUS VAR. ORYZAE (ASPERGILLUS FLAVUS VAR. ORYZAE) ASPERGILLUS FLAVUS VAR. ORYZAE 20000 [PNU] in 1 mL ASPERGILLUS TERREUS (ASPERGILLUS TERREUS) ASPERGILLUS TERREUS 20000 [PNU] in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL PHOMA EXIGUA VAR. EXIGUA (PHOMA EXIGUA VAR. EXIGUA) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.009 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8025-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

MIXED ASPERGILLUS aspergillus flavus var. oryzae, aspergillus niger var. niger, aspergillus repens, aspergillus terreus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8034 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 20000 [PNU] in 1 mL ASPERGILLUS FLAVUS VAR. ORYZAE (ASPERGILLUS FLAVUS VAR. ORYZAE) ASPERGILLUS FLAVUS VAR. ORYZAE 20000 [PNU] in 1 mL ASPERGILLUS TERREUS (ASPERGILLUS TERREUS) ASPERGILLUS TERREUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.009 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8034-10 10.5 mL in 1 VIAL None 2 NDC:0268-8034-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 05/24/2023

Labeler — ALK-Abello, Inc. (809998847)

Revised: 05/2023 ALK-Abello, Inc.