Complete SPL Sections#
RECENT MAJOR CHANGES
RECENT MAJOR CHANGES SECTION
Warning and Precautions, Anaphylaxis Following False Negative Food Allergen Skin Test Results (5.3) 01/2023
HIGHLIGHTS OF PRESCRIBING INFORMATION
SPL UNCLASSIFIED SECTION
These highlights do not include all the information needed to use Non-Standardized Allergenic Extracts (Pollens, Molds, Epidermals, Insects, Foods and Miscellaneous Inhalants) safely and effectively. See full prescribing information for Non-Standardized Allergenic Extracts. Non-Standardized Allergenic Extracts (Pollens, Molds, Epidermals, Insects, Foods, and Miscellaneous Inhalants) Solutions for percutaneous, intradermal or subcutaneous administration. Initial U.S. Approval: 1968 WARNING: SEVERE ALLERGIC REACTIONS See full prescribing information for complete boxed warning. Non-Standardized Allergenic Extracts can cause severe life-threatening systemic reactions, including anaphylaxis. (5.1) Do not administer these products to patients with severe, unstable or uncontrolled asthma. (4) Observe patients in the office for at least 30 minutes following treatment.Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction. (5.1) Patients with extreme sensitivity to these products, on an accelerated immunotherapy build-up, switching to another lot, receiving high doses of these products, and patients exposed to similar allergens may be at increased risk of a severe allergic reaction. (5.1) These products may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a systemic allergic reaction, and for patients receiving medications such as beta-blockers that may make them unresponsive to epinephrine or inhaled bronchodilators. (5.1, 5.2) RECENT MAJOR CHANGES Warning and Precautions, Anaphylaxis Following False Negative Food Allergen Skin Test Results (5.3) 01/2023 INDICATIONS AND USAGE Non-Standardized Allergenic Extracts are indicated for: Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific allergens. (1) Immunotherapy for reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or in vitro testing for allergen-specific IgE antibodies. (1) Food extracts have not been proven safe or effective in allergen immunotherapy. DOSAGE AND ADMINISTRATION For percutaneous, intradermal or subcutaneous use only. The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response. See full prescribing information for instructions on preparation, administration, and adjustments of dose. (2.1) DOSAGE FORMS AND STRENGTHS Non-Standardized Allergenic Extracts are labeled in weight/volume and/or protein nitrogen units (PNU)/milliliter (a measure of total protein), and are supplied as sterile aqueous stock concentrates at up to 1:10 weight/volume or 40,000 PNU/milliliter, or 50% glycerin stock concentrates at up to 1:20 weight/volume. (3) CONTRAINDICATIONS Severe, unstable or uncontrolled asthma. (4) History of any severe systemic or local allergic reaction to an allergen extract. (4) WARNINGS AND PRECAUTIONS Severe allergic reactions have occurred following the administration of other allergenic extracts and may occur in individuals following the administration of Non-Standardized Allergenic Extracts in the following situations: Extreme sensitivity to Non-Standardized Allergenic Extracts, receipt of high doses of Non-Standardized Allergenic Extracts, or concomitant exposure to similar environmental allergens. (5.1) Receiving an accelerated immunotherapy build-up schedule (e.g., “rush” immunotherapy), or changing from one allergenic lot to another. (5.1) ADVERSE REACTIONS The most common adverse reactions, occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy, are local adverse reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain). (6) Systemic adverse reactions, occurring in ≤ 7% of patients who receive subcutaneous immunotherapy, include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. These can be fatal. (6) To report SUSPECTED ADVERSE REACTIONS, contact GREER Laboratories, Inc. at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . DRUG INTERACTIONS Antihistamines and other medications that suppress histamine, including topical corticosteroids, topical anesthetics and tricyclic antidepressants can interfere with skin test results. (7) See 17 for PATIENT COUNSELING INFORMATION
FULL PRESCRIBING INFORMATION: CONTENTS*
SPL INDEXING DATA ELEMENTS SECTION
WARNING: SEVERE ALLERGIC REACTIONS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Preparation for Administration 2.2 Diagnostic Testing 2.3 Immunotherapy 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Serious Systemic Adverse Reactions 5.2 Epinephrine 5.3 Anaphylaxis Following False Negative Food Allergen Skin Test Results 5.4 Cross-Reactions and Dose Sensitivity 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 7.1 Antihistamines 7.2 Topical Corticosteroids and Topical Anesthetics 7.3 Tricyclic Antidepressants 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 14 CLINICAL STUDIES 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the Full Prescribing Information are not listed.
FULL PRESCRIBING INFORMATION
BOXED WARNING SECTION
WARNING: SEVERE ALLERGIC REACTIONS Non-Standardized Allergenic Extracts can cause severe life-threatening systemic reactions, including anaphylaxis. (5.1) Do not administer these products to patients with severe, unstable or uncontrolled asthma. (4) Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction. (5.1) Patients with extreme sensitivity to these products, those on an accelerated immunotherapy build-up schedule, those switching to another allergenic lot, those receiving high doses of Non-Standardized Allergenic Extracts, or those also exposed to similar allergens may be at increased risk of a severe allergic reaction. (5.1) These products may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. (5.1) These products may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Non-Standardized Allergenic Extracts are indicated for: Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens. Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. Food extracts have not been proven safe or effective in allergen immunotherapy.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
For percutaneous, intradermal or subcutaneous use only. The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response. 2.1 Preparation for Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if either of these conditions exist. The extracts are diluted with sterile diluents when used for percutaneous and intradermal testing, or for subcutaneous immunotherapy. Extracts labeled “For Diagnostic Use Only” are intended for percutaneous and intradermal testing only. These extracts have not been shown by adequate data to be safe and effective for therapeutic use. The extracts labeled For Diagnostic Use Only are the foods Barley, Coffee, Oat, Pineapple, Rye, Spinach, Wheat, the insects Flea, House Fly, Mosquito, and the plant and plant parts Cottonseed and Flax. Undiluted 50% glycerin stock concentrate is used for percutaneous testing. To prepare 10-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with the stock concentrate. Proceed as shown in Table 1. The 10-fold dilution series uses 0.5 milliliters of concentrate added to 4.5 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner. To prepare 10-fold dilutions for intradermal testing and immunotherapy, start with a 1:10 weight/volume, 1:20 weight/volume, or up to a 40,000 PNU/milliliter stock concentrate. Proceed as shown in Table 1. The 10-fold dilution series uses 0.5 milliliter of concentrate added to 4.5 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin-saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner. Table 1: 10-fold Dilution Series* Dilution Extract Milliliters of Diluent Dilution Strength (w/v) Dilution Strength (w/v) Dilution Strength (PNU/milliliter) 0 Concentrate 1:10 1:20 20,000 1 0.5 mL Concentrate 4.5 1:100 1:200 2,000 2 0.5 mL Dilution 1 4.5 1:1,000 1:2,000 200 3 0.5 mL Dilution 2 4.5 1:10,000 1:20,000 20 4 0.5 mL Dilution 3 4.5 1:100,000 1:200,000 2 5 0.5 mL Dilution 4 4.5 1:1,000,000 1:2,000,000 0.2 6 0.5 mL Dilution 5 4.5 1:10,000,000 1:20,000,000 0.02 *There is no direct potency correlation across the table between PNU/milliliter and w/v. Undiluted 50% glycerin stock concentrate is used for percutaneous testing. To prepare 5-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with the stock concentrate. Proceed as shown in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner. To prepare 5-fold dilutions for intradermal testing or immunotherapy, start with a 1:10 weight/volume, 1:20 weight/volume, or up to a 40,000 PNU/milliliter stock concentrate. Proceed as shown in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin-saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner. Table 2: 5-fold Dilution Series* Dilution Extract Milliliters of Diluent Dilution of Strength (w/v) Dilution of Strength (w/v) Dilution of Strength (PNU/milliliter) 0 Concentrate 1:10 1:20 20,000 1 1 mL Concentrate 4 1:50 1:100 4,000 2 1 mL Dilution 1 4 1:250 1:500 800 3 1 mL Dilution 2 4 1:1,250 1:2,500 160 4 1 mL Dilution 3 4 1:6,250 1:12,500 32 5 1 mL Dilution 4 4 1:31,250 1:62,500 6.4 6 1 mL Dilution 5 4 1:156,250 1:312,500 1.28 *There is no direct potency correlation across the table between PNU/milliliter and w/v. 2.2 Diagnostic Testing Diagnostic testing can be performed via percutaneous or intradermal administration of the Non-Standardized Allergenic Extracts. A positive skin test reaction should be interpreted in relation to the patient’s history and known exposure to the specific allergen(s). Percutaneous Skin Testing Preparation and Dose For percutaneous testing (prick or puncture), use glycerinated extract; use the extracts at the highest available stock concentration. In patients suspected to be at greater risk for systemic allergic reaction, use 10-fold or 5-fold dilutions of the concentrate. Prick test: Place one drop of extract with appropriate controls on the skin and with a skin test device, pierce through the drop into the skin with a slight lifting motion. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner or in accordance with the device manufacturer’s recommendations. Puncture test: Place one drop of extract or control on the skin and pierce the skin through the drop with a skin test device perpendicular to the skin. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner or in accordance with the device manufacturer’s recommendations. Interpreting Results When using percutaneous skin test devices, follow the directions provided with the test devices. A glycerinated histamine control solution (6 milligrams/milliliter or 1 milligram/milliliter histamine base) may be used as the positive control. A 50% glycerin-saline solution may be used as the negative control. Read and record skin test responses 15 to 20 minutes after exposure. Individual patient reactivity can vary with time, allergen potency, and/or immunotherapy, as well as testing technique. The most reliable method of recording a skin test reaction is to measure the largest diameter of both wheal and erythema. While some correlation exists between the size of the skin test reaction and the degree of sensitivity, other factors should be considered in the diagnosis of allergy to specific allergens (see Figure 1 below). Figure 1: Measurement of Wheal and Flare Use a paper or plastic millimeter skin reaction guide as shown below. Fifteen minutes after application of the skin test, measure the length and midpoint orthogonal width of each flare and wheal from the inner edge of the reaction. The length of the skin test is defined as the largest diameter and the width of the skin test is defined as the diameter perpendicular to the length at its midpoint. Consider the wheal and flare as separate entities. First, measure the flare and then independently measure the wheal. Measuring the Flare Measuring the Wheal The average diameter measurement in the example above of the flare is (26 mm + 36 mm)/2 = 31 mm and the average diameter of the wheal is (10 mm + 16 mm)/2 = 13 mm. Responses to positive controls should be at least 3 millimeters larger than responses to the negative controls. Negative controls should elicit no reaction or only reactions of small diameter (less than 2 millimeters wheal, less than 5 millimeters erythema). If either the positive or negative control response does not meet the above criteria, results for the allergenic extracts tested at the same time should be considered invalid and be repeated. Intradermal Skin Testing Preparation and Dose For intradermal testing, dilute stock concentrate to 1:100 to 1:1000 volume to volume of Non-Standardized Allergenic Extracts stock concentrate solution. Dilute the stock concentrate solution with sterile diluent [see Dosage and Administration (2.1)]. Use normal or buffered saline or normal saline with human serum albumin (HSA) diluent. If the result from the initial test dose is negative, subsequent intradermal tests using increasingly stronger doses may be performed up to the maximum recommended strength of 1:25 volume to volume dilu...
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Non-Standardized Allergenic Extracts are labeled in weight/volume and/or protein nitrogen units (PNU)/milliliter (a measure of total protein), and are supplied as sterile aqueous stock concentrates at up to 1:10 weight/volume or 40,000 PNU/milliliter, or 50% glycerin stock concentrates at up to 1:20 weight/volume.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Non-Standardized Allergenic Extracts are contraindicated in patients with: Severe, unstable or uncontrolled asthma History of any severe systemic or local allergic reaction to an allergen extract
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
5.1 Serious Systemic Adverse Reactions Serious systemic adverse reactions have occurred following the administration of other allergenic extracts and may occur in individuals following the administration of Non-Standardized Allergenic Extracts in the following situations: Extreme sensitivity to the specific allergen(s) Receipt of an accelerated immunotherapy build-up schedule (e.g., “rush” immunotherapy) Receipt of high doses of allergenic extracts or concomitant exposure to similar environmental allergens Change from one allergenic extract lot to another allergenic extract lot High-risk patients have had fatal reactions. Consider using more dilute preparations in patients suspected to be at greater risk of systemic allergic reaction [see Dosage and Administration (2.1)]. Administer Non-Standardized Allergenic Extracts in a healthcare setting under the supervision of a physician prepared to manage a severe systemic or a severe local allergic reaction.Observe patients in the office for at least 30 minutes following administration. 1 5.2 Epinephrine Non-Standardized Allergenic Extracts may not be suitable for patients with certain medical conditions that may reduce the ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. Examples of these medical conditions include but are not limited to: markedly compromised lung function (either chronic or acute), unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension. These products may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include: Βeta-adrenergic blockers : Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating effects of epinephrine. Alpha-adrenergic blockers, ergot alkaloids : Patients taking alpha-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, alpha-adrenergic blockers antagonize the vasoconstricting and hypertensive effects of epinephrine. Similarly, ergot alkaloids may reverse the pressor effects of epinephrine. Tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and certain antihistamines : The adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine, and diphenhydramine. Cardiac glycosides, diuretics : Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias. 5.3 Anaphylaxis Following False Negative Food Allergen Skin Test Results False negative skin test results associated with anaphylaxis from subsequent exposure to the allergen have been reported during postmarketing diagnostic use of some food allergenic extracts. Based on the patient’s clinical history and index of suspicion, healthcare providers should consider confirming negative skin testing with serologic testing by measuring specific serum IgE or with a medically-supervised oral food challenge. 5.4 Cross-Reactions and Dose Sensitivity When determining the final dose of an allergen mixture for immunotherapy, consider cross-reactivity among component extracts. Determine the initial dilution of allergenic extract, starting dose, and progression of dosage based on the patient’s history and results of skin tests 2 [see Dosage and Administration (2.1)]. Strongly positive skin tests can be indicators for potential adverse reactions.
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The most common adverse reactions, occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy are local adverse reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain). 1 Systemic adverse reactions, occurring in < 7% of patients who receive subcutaneous immunotherapy, 3 include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. These adverse reactions can be fatal. 1 The allergenic extracts labeled “For Diagnostic Use Only” that contain sodium formaldehyde sulfoxylate (SFS) can cause slight discoloration of the skin at the site of administration. This discoloration can remain for extended amounts of time.
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
7.1 Antihistamines Do not perform skin testing with allergenic extracts within 3 to 10 days of use of first-generation H 1 -histamine receptor blockers (e.g., clemastine, diphenhydramine) and second-generation antihistamines (e.g., loratadine, cetirizine). These products suppress histamine skin test reactions and could mask a positive response. 2 7.2 Topical Corticosteroids and Topical Anesthetics Topical corticosteroids can suppress skin reactivity; therefore, discontinue use at the skin test site for 2 to 3 weeks before skin testing. Avoid use of topical local anesthetics at skin test sites as they can suppress flare responses. 2 7.3 Tricyclic Antidepressants Tricyclic antidepressants can have potent antihistamine effects that can affect skin testing. If tricyclic medication has been recently discontinued, allow 7 to 14 days before initiating skin testing. 2
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
8.1 Pregnancy Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no human or animal data to establish the presence or absence of Non-Standardized Allergenic Extracts-associated risks during pregnancy. 8.2 Lactation Risk Summary It is not known whether Non-Standardized Allergenic Extracts are present in human milk. Data are not available to assess the effects of these extracts on the breastfed child or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Non-Standardized Allergenic Extracts and any potential adverse effects on the breastfed child from the extracts or from the underlying maternal condition. 8.4 Pediatric Use For use of these products in children younger than 5 years of age, consideration should be given to the patient’s ability to comply and cooperate with allergen immunotherapy and the potential for difficulty in communicating with the child regarding systemic reactions. 1 8.5 Geriatric Use Data are not available to determine if subjects 65 years of age and older respond differently to allergen immunotherapy than younger subjects.
11 DESCRIPTION
DESCRIPTION SECTION
Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
12.1 Mechanism of Action The skin test reaction results from interaction of the introduced allergen and allergen-specific IgE antibodies bound to mast cells, leading to mast cell degranulation and release of histamine, tryptase and other mediators, which results in the formation of the wheal and flare. The precise mechanisms of action of allergen immunotherapy are not known. Immunologic responses to immunotherapy include changes in allergen-specific IgE levels, allergen-specific IgG levels, and regulatory T cell responses. 1
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
Specific immunotherapy with allergenic extracts is helpful in reducing symptoms associated with exposure to the offending allergens. A summary of effectiveness by the Panel on Review of Allergenic Extracts, an advisory committee to the U.S. Food and Drug Administration, has been published. 4
15 REFERENCES
REFERENCES SECTION
Cox LJ, Nelson H, Lockey R.Allergen immunotherapy: A practice parameter third update. J Allergy Clin Immunol . 2011;127:(1)S1-55. Bernstein IL, Li JT, Bernstein DI, et al.Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol . 2008;100:S1-148. Greenberg MA, Kaufman CR, Gonzalez GE, et al. Late and immediate systemic-allergic reactions to inhalant allergen immunotherapy. J Allergy Clin Immunol . 1986;77:865-870. Federal Register Proposed Rule: Biological Products: Implementation of Efficacy Review, Allergenic Extracts, Federal Register 1985;50: 3082-3288.
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Non-Standardized Allergenic Extracts and mixes may be supplied as aqueous stock concentrates of up to 1:10 weight/volume or 40,000 PNU/milliliter for intradermal and subcutaneous testing. The extracts may also be supplied as 50% glycerin stock concentrates of up to 1:20 weight/volume for use in percutaneous skin testing and subcutaneous immunotherapy. Non-Standardized Allergenic Extracts are labeled in weight/volume and/or PNU/milliliter and may be provided in 5, 10, and 50 milliliter vials. Glycerinated extracts are also supplied in 5 milliliter dropper vials for prick or puncture testing. Non-Standardized Allergenic Extracts available are as follows: Pollens ‑ Grasses Bahia Grass, Paspalum notatum Brome, Smooth, Bromus inermis Canarygrass, Reed, Phalaris arundinacea Johnson Grass, Sorghum halepense Quack (Couch) Grass, Elymus repens Ryegrass, Giant Wild, Leymus condensatus Ryegrass, Italian, Lolium multiflorum Velvetgrass, Holcus lanatus Wheatgrass, Western, Pascopyrum smithii Pollens - Trees Acacia, Acacia dealbata Alder, Hazel, Alnus serrulata Alder, Red, Alnus rubra Alder, White, Alnus rhombifolia Ash, Arizona (Velvet), Fraxinus velutina Ash, Green, Fraxinus pennsylvanica Ash Mix (Equal parts Fraxinus pennsylvanica , Fraxinus americana ) Ash, Oregon, Fraxinus latifolia Ash, White, Fraxinus americana Aspen, Populus tremuloides Beech, American, Fagus grandifolia Birch, Black-Sweet, Betula lenta Birch, Mix (Equal parts Betula lenta , Betula nigra , Betula populifolia ) Birch, River, Betula nigra Birch, Spring, Betula occidentalis Birch, White, Betula populifolia Box Elder, Acer negundo Cedar, Mountain, Juniperus ashei Cedar, Red, Juniperus virginiana Cedar, Salt (Tamarisk), Tamarix gallica Central/Eastern 4 Tree Mix (Equal parts Ulmus americana , Acer negundo , Carya illinoinensis , Quercus virginiana ) Cottonwood, Arizona (Fremont), Populus fremontii Cottonwood, Black, Populus trichocarpa Cottonwood, Eastern, Populus deltoides Cottonwood, Western, Populus deltoides ssp. monilifera Cypress, Arizona, Callitropsis arizonica Cypress, Bald, Taxodium distichum Eastern Oak Mix (Equal parts Quercus velutina , Quercus rubra , Quercus alba ) Eastern 6 Tree Mix (Equal parts Fagus grandifolia , Populus deltoides , Quercus rubra , Betula nigra , Carya ovata , Fraxinus americana ) Eastern 7 Tree Mix (Equal parts Ulmus americana , Fagus grandifolia , Populus deltoides , Quercus rubra , Betula nigra , Carya ovata , Fraxinus americana ) Eastern 8 Tree Mix (Equal parts Ulmus americana , Fagus grandifolia , Populus deltoides , Quercus rubra , Betula nigra , Carya ovata , Fraxinus americana , Acer saccharum ) Eastern 10 Tree Mix (Equal parts Platanus occidentalis , Ulmus americana , Fagus grandifolia , Populus deltoides , Quercus rubra , Betula nigra , Carya ovata , Fraxinus americana , Acer saccharum , Liquidambar styraciflua ) Elm, American, Ulmus americana Elm, Cedar, Ulmus crassifolia Elm Mix (Equal parts Ulmus americana , Ulmus pumila ) Elm, Siberian, Ulmus pumila Eucalyptus, Bluegum, Eucalyptus globulus Hackberry, Celtis occidentalis Hazelnut, American, Corylus americana Hickory Mix (Equal parts Carya glabra , Carya ovata , Carya laciniosa , Carya tomentosa ) Hickory-Pecan Mix (Equal parts Carya illinoinensis , Carya ovata ) Hickory, Shagbark, Carya ovata Hickory, Shellbark, Carya laciniosa Hickory, White, Carya tomentosa Juniper Mix (Equal parts Juniperus monosperma , Juniperus scopulorum ) Juniper, Oneseed, Juniperus monosperma Juniper, Pinchot, Juniperus pinchotii Juniper, Rocky Mountain, Juniperus scopulorum Juniper, Utah, Juniperus osteosperma Juniper, Western, Juniperus occidentalis Locust Blossom, Black, Robinia pseudoacacia Mango Blossom, Mangifera indica Maple-Box Elder Mix (Equal parts Acer saccharum , Acer negundo ) 2 Maple Mix (Equal parts Acer rubrum , Acer saccharum ) 3 Maple Mix (Equal parts Acer rubrum , Acer saccharinum , Acer saccharum ) Maple, Red, Acer rubrum Maple, Silver/Soft, Acer saccharinum Maple, Sugar/Hard, Acer saccharum Melaleuca, Melaleuca quinquenervia Mesquite, Velvet, Prosopis velutina Mulberry, Paper, Broussonetia papyrifera Mulberry, Red, Morus rubra Mulberry, White, Morus alba Oak, Arizona (Gambel), Quercus gambelii Oak, Black, Quercus velutina Oak, Bur, Quercus macrocarpa Oak, California Black, Quercus kelloggii Oak, California Live, Quercus agrifolia Oak, California White, Quercus lobata Oak, Post, Quercus stellata Oak, Red, Quercus rubra Oak, Virginia Live, Quercus virginiana Oak, Water, Quercus nigra Oak, Western White, Quercus garryana Oak, White, Quercus alba Olive, Olea europaea Olive, Russian, Elaeagnus angustifolia Orange Pollen, Citrus X sinensis Palm, Queen, Syagrus romanzoffiana Pecan, Carya illinoinensis Peppertree Mix (Equal parts Schinus molle , Schinus terebinthifolius ) Pine, Australian (Beefwood), Casuarina equisetifolia Pine, Loblolly, Pinus taeda Pine, Longleaf, Pinus palustris Pine Mix (Equal parts Pinus taeda , Pinus strobus , Pinus echinata ) Pine, Ponderosa, Pinus ponderosa Pine, Virginia Scrub, Pinus virginiana Pine, White (Eastern), Pinus strobus Pine, White (Western), Pinus monticola Pine, Yellow, Pinus echinata Poplar, Lombardy’s, Populus nigra Poplar, White, Populus alba Privet, Ligustrum vulgare Sweetgum, Liquidambar styraciflua Sycamore, American, Platanus occidentalis Sycamore, California (Western), Platanus racemosa 11 Tree Mix (Equal parts Fagus grandifolia , Platanus occidentalis , Ulmus americana , Juglans nigra , Salix nigra , Populus deltoides , Quercus rubra , Betula nigra , Carya ovata , Acer saccharum , Fraxinus americana ) Walnut, Black, Juglans nigra Walnut, California Black, Juglans californica Walnut, English, Juglans regia Wax Myrtle, Morella cerifera Western Oak Mix (Equal parts Quercus kelloggii , Quercus agrifolia , Quercus garryana ) Western 3 Tree Mix (Equal parts Olea europaea , Ulmus pumila , Platanus racemosa ) Western 10 Tree Mix (Equal parts Acacia dealbata , Acer negundo , Populus fremontii , Olea europaea , Ulmus pumila , Betula occidentalis , Juniperus occidentalis , Platanus racemosa , Quercus garryana , Morus alba ) Western Walnut Mix (Equal parts Juglans californica , Juglans regia ) Willow, Arroyo, Salix lasiolepis Willow, Black, Salix nigra Pollens - Weeds and Garden Plants Allscale, Atriplex polycarpa Amaranth, Green, Amaranthus hybridus Baccharis Mix (Equal parts Baccharis sarothroides , Baccharis halimifolia ) Burningbush (Kochia), Kochia scoparia spp. scoparia Burrobrush, Ambrosia salsola Central/Western Weed Mix (Equal parts Kochia scoparia ssp. scoparia , Chenopodium album , Salsola kali ) Cocklebur, Xanthium strumarium Common Weed Mix (Equal parts Xanthium strumarium , Plantago lanceolata , Chenopodium album , Amaranthus retroflexus , Salsola kali ) Dock-Sorrel Mix (Equal parts Rumex acetosella , Rumex crispus ) Dock, Yellow (Curly), Rumex crispus Dogfennel, Eupatorium capillifolium Goldenrod, Solidago canadensis Iodinebush, Allenrolfea occidentalis Lamb's Quarters, Chenopodium album Lenscale (Quailbrush), Atriplex lentiformis Marsh Elder, True (Rough), Iva annua Marshelder, Burweed (Giant Poverty), Cyclachaena xanthiifolia Mixed Amaranths (Equal parts Amaranthus hybridus , Amaranthus palmeri , Amaranthus retroflexus ) Mugwort, Common, Artemisia vulgaris National Weed Mix (Equal parts Xanthium strumarium , Ambrosia trifida , Chenopodium album , Amaranthus retroflexus , Ambrosia artemisiifolia ) Nettle, Urtica dioica Palmer's Amaranth, Amaranthus palmeri Pigweed, Rough Redroot, Amaranthus retroflexus Pigweed, Spiny, Amaranthus spinosus Plantain, English, Plantago lanceolata Plantain-Sorrel Mix (Equal parts Plantago lanceolata , Rumex acetosella ) Rabbit Bush, Ambrosia deltoidea Ragweed, Desert, Ambrosia dumosa Ragweed, False, Ambrosia acanthicarpa Ragweed, Giant (Tall), Ambrosia trifida Ragweed, Lanceleaf, Ambrosia bidentata Ragweed, Slender, Ambrosia confertiflora Ragweed, Western, Ambrosia psilostachya Russian Thistle, Salsola kali Sagebrush, Common,...
17 PATIENT COUNSELING INFORMATION
PATIENT COUNSELING INFORMATION
Instruct patient to remain under observation in the office for 30 minutes or longer after an injection. Caution patient that reactions can occur more than 30 minutes after skin testing or an injection. Instruct patient to recognize the following symptoms as adverse reactions and to immediately return to the office or immediately seek other medical attention if any of these symptoms occur following skin testing or an injection: Unusual swelling and/or tenderness at the injection site Hives or itching of the skin Swelling of the face and/or mouth Sneezing, coughing or wheezing Shortness of breath Nausea Dizziness or faintness Manufacturer: U.S. License No. 308 Greer Laboratories, Inc. Lenoir, NC 28645 U.S.A
