Pollens – Trees, Oak, Red Quercus Rubra: Package Insert and Label Information

POLLENS — TREES, OAK, RED QUERCUS RUBRA- quercus rubra pollen injection, solution
POLLENS — TREES, OLIVE OLEA EUROPAEA- olea europaea pollen injection, solution
POLLENS — TREES, OLIVE, RUSSIAN ELAEAGNUS ANGUSTIFOLIA- elaeagnus angustifolia pollen injection, solution
POLLENS — TREES, PALM, QUEEN COCOS PLUMOSA- syagrus romanzoffiana pollen injection, solution
POLLENS — TREES, PALO VERDE CERCIDIUM FLORIDUM- parkinsonia florida pollen injection, solution
POLLENS — TREES, PECAN CARYA CARYA ILLINOENSIS- carya illinoinensis pollen injection, solution
POLLENS — TREES, PEPPER TREE, CALIFORNIA SCHINUS MOLLE- schinus molle pollen injection, solution
POLLENS — TREES, PINE MIX- pinus contorta pollen and pinus ponderosa pollen injection, solution
POLLENS — TREES, PRIVET LIGUSTRUM VULGARE- ligustrum vulgare pollen injection, solution
POLLENS — TREES, SYCAMORE, AMERICAN EASTERN PLATANUS OCCIDENTALLIS- platanus occidentalis pollen injection, solution
POLLENS — TREES, TREE MIX 11- fraxinus americana pollen, betula nigra pollen, juglans nigra pollen, populus deltoides pollen, ulmus americana pollen, carya ovata pollen, acer saccharum pollen, quercus rubra pollen, platanus occidentalis pollen and salix nigra pollen injection, solution
POLLENS — TREES, TREE MIX 5- carya illinoinensis pollen, acer saccharum pollen, acer negundo pollen, acer rubrum pollen, quercus rubra pollen, quercus virginiana pollen, quercus alba pollen, platanus occidentalis pollen and salix nigra pollen injection, solution
POLLENS — TREES, TREE MIX 6- fraxinus americana pollen, betula papyrifera pollen, betula nigra pollen, betula pendula pollen, juglans nigra pollen, populus deltoides pollen and ulmus americana pollen injection, solution
POLLENS — TREES, TREE OF HEAVEN AILANTHUS ALTISSIMA- ailanthus altissima pollen injection, solution
POLLENS — TREES, WALNUT, BLACK JUGLANS NIGRA- juglans nigra pollen injection, solution
Jubilant HollisterStier LLC

WARNINGS

This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction. Allergenic extracts may potentially elicit a severe life threatening systemic reaction, rarely resulting in death.7 Therefore, emergency measures and personnel trained in their use must be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician’s office if symptoms occur. Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. This product should never be injected intravenously. Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections for further discussion.

DESCRIPTION

Sterile extracts for scratch, prick or puncture testing are supplied in dropper vials containing, in addition to the extract allergens and antigens, 50% (v/v) glycerin as preservative, 0.5% sodium chloride and 0.275% sodium bicarbonate. The strength of these extracts may be expressed in terms of

  • Weight to Volume (w/v)
  • Protein Nitrogen Units/mL (PNU/mL)
  • Amb a 1 Units/mL (Amb a 1/mL)
  • Allergy Units/mL (AU/mL)
  • Bioequivalent Allergy Units/mL (BAU/mL)
  • Concentrate

1. Weight to volume (w/v).
For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted materials will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. AP™ (acetone precipitated) extracts, if present, are prepared by reconstituting dry, allergenically active concentrates produced by precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.

2. Protein Nitrogen Units per mL (PNU/mL).
One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, the PNU content of extracts from different manufacturers is not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.

3. Amb a 1. Of the many allergens which have been purified and characterized from Short Ragweed (Amb a 112 , Amb a 213 , Ra314 , Ra4(BPA-R)15 , Ra516 , Ra6, Ra7, and Ra817 , and cytochrome C18), Amb a 1 (also known as Antigen E) is considered the most important and has been selected as the basis for standardization. Extracts of Short Ragweed containing Amb a 1 are diffused in agar against standard anti-serum to Amb a 1, and compared to the diffusion of standard Amb a 1 solutions. The amount of Amb a 1 is expressed as units of Amb a 1 per mL of extract.

If an extract is diluted with a diluent or other allergenic extracts, the Amb a 1 concentration must be determined by calculation.

4. Allergy Units per mL (AU/mL).
The potency of extracts labeled in Allergy Units per mL (AU/mL) is determined by in vitro comparison to a reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA).

5. Bioequivalent Allergy Units per mL (BAU/mL).
When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50 EAL method 13 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and such products are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.

6. Concentrate.
Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.

CLINICAL PHARMACOLOGY

Allergenic extracts for scratch, prick or puncture testing, used according to the DOSAGE AND ADMINISTRATION section, produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with reaction of antigen with IgE on the surface of basophils or mast cells, which initiates a series of biochemical events resulting in the production of histamine and other mediators. These, in turn, produce the immediate-type “wheal and flare” skin reaction.

INDICATIONS & USAGE

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established. 14
In addition to a carefully taken history, the use of glycerin-containing extracts in scratch, prick or puncture testing is an accepted method in the diagnosis of allergic conditions. 1, 2, 3 Extracts of all allergens do not produce equivalent results in scratch, prick or puncture tests. The intensity of the skin reactions produced will be determined by two factors: the degree of sensitivity of the patient, and the nature of the allergenic extract applied.
Scratch, prick or puncture tests are not as sensitive as the intradermal test, but are safer and cause less discomfort. They may, therefore, be the method of choice when a large number of tests are needed, or when testing the pediatric patient. In some cases, where the relatively insensitive scratch, prick or puncture tests are negative or do not confirm the allergic history, follow-up intradermal tests may be positive. However, ANTIGENS PRODUCING LARGE 3 to 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

CONTRAINDICATIONS

There are no known absolute contraindications to allergy skin testing. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal anaphylaxis treatment regimen.

WARNINGS

Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which s/he is sensitive. Use caution when skin testing patients during a season when pollen is present. Refer to boxed WARNINGS Section.

PRECAUTIONS

1. General

Always have injectable epinephrine and a tourniquet available when tests are being made. (See ADVERSE REACTIONS section.) Generally 50 to 60 scratch, prick or puncture tests can be applied safely at one sitting. Patients whose history suggests severe sensitivity should have only 5 to 10 tests applied at a time and these tests applied to the volar surface of one arm. These tests should not all be of the same type of antigen; that is, all grass pollens, all weed pollens, all danders, etc. One or two tests from several classes of antigens should be applied at a time. As soon as a large wheal begins to develop, wipe the antigen from it with a damp cotton sponge. After 10 minutes wipe off all the antigens with a damp cotton sponge, followed by a dry cotton sponge. Be careful not to wipe antigen from a positive reaction onto an adjacent test site.

2 Information for Patients

Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 minute observation period, and be warned to return to the office promptly if symptoms occur after leaving.

3. Drug Interactions

Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.9 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.9, 10 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.11 Topical local anesthetics may suppress the flare responses and should be
avoided in skin test sites.12

4. Carcinogenesis, mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

5. Pregnancy

4,5
Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.

6. Nursing Mothers

There are no current studies on secretion of the allergenic extract components in human milk or effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

7. Pediatric Use

Wheal sizes in response to allergen skin testing can be smaller in infants than in adults. The skin response to histamine parallels that for allergens; therefore, appropriate positive control skin tests should always be performed.1

8. Geriatric Use

Skin test wheal size decreases with age. The decrease in allergen-induced skin test reaction parallels that to histamine; therefore, appropriate positive skin test controls should always be performed.1

ADVERSE REACTIONS

1. Local Reactions
If a severe local reaction occurs during scratch, prick or puncture testing, WIPE OFF test antigen. Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.

2. Systemic Reactions
With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.
Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.7, 8
It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, WIPE OFF test antigen, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1,000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.
EPINEPHRINE:
ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and other appropriate drugs. Oxygen should be given by mask. Intravenous antihistamine, theophylline or corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures (Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986). Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.
3. Adverse Event Reporting
Report all adverse events to Jubilant HollisterStier LLC Customer Technical Services Department at 1 (800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH program. Preprinted forms (FDA Form 3500) are available from the FDA by calling 1 (800) FDA-1088. Completed forms should be mailed to MEDWATCH, 5600 Fisher Lane, Rockville, MD 20852-9787 or Fax to: 1 (800) FDA-0178.

Page 1 of 3 1 2 3

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.