ALMOND: Package Insert and Label Information

ALMOND- almond injection, solution
APPLE- apple injection, solution
APRICOT- apricot injection, solution
ASPARAGUS- asparagus injection, solution
AVOCADO- avocado injection, solution
BANANA- banana injection, solution
BARLEY- barley injection, solution
BEEF- beef injection, solution
BELL PEPPER- green bell pepper injection, solution
BLACK PEPPER- black pepper injection, solution
BRAZIL NUT- brazil nut injection, solution
BROCCOLI- broccoli injection, solution
BUCKWHEAT- buckwheat injection, solution
CABBAGE- cabbage injection, solution
CANTALOUPE- cantaloupe injection, solution
CARROT- carrot injection, solution
CASEIN- casein injection, solution
CELERY- celery injection, solution
CHERRY- sweet cherry injection, solution
CHICKEN MEAT- chicken injection, solution
CINNAMON- cinnamon injection, solution
CLAM- northern quahog injection, solution
COCOA BEAN- cocoa injection, solution
COCONUT- coconut injection, solution
CODFISH- atlantic cod injection, solution
COFFEE- arabica coffee bean injection, solution
COWS MILK- skim milk injection, solution
CRAB- red king crab injection, solution
CUCUMBER- cucumber injection, solution
EGG WHITE- egg white injection, solution
EGG YOLK- egg yolk injection, solution
EGG, WHOLE- egg injection, solution
ENGLISH WALNUT- english walnut injection, solution
FLOUNDER- summer flounder injection, solution
GARLIC- garlic injection, solution
GOATS MILK- goat milk injection, solution
GRAPEFRUIT- grapefruit injection, solution
GREEN PEA- pea injection, solution
HALIBUT- atlantic halibut injection, solution
HONEYDEW- honeydew melon injection, solution
KIDNEY BEAN- kidney bean injection, solution
LAMB- lamb injection, solution
LEMON- lemon injection, solution
LETTUCE- lettuce injection, solution
LIMA BEAN- lima bean injection, solution
LOBSTER- american lobster injection, solution
MIXED FISH- atlantic halibut, atlantic cod and summer flounder injection, solution
MIXED SHELLFISH- red king crab, common shrimp, american lobster and eastern oyster injection, solution
MUSHROOM- cultivated mushroom injection, solution
MUSTARD- white mustard seed injection, solution
OAT GRAIN- avena sativa whole injection, solution
OLIVE- black olive injection, solution
ONION- onion injection, solution
ORANGE- orange injection, solution
OYSTER- eastern oyster injection, solution
PEACH- peach injection, solution
PEANUT- peanut injection, solution
PEAR- pear injection, solution
PECAN NUT- pecan injection, solution
PINEAPPLE- pineapple injection, solution
PISTACHIO NUT- pistachio injection, solution
PLUM- plum injection, solution
PORK- pork injection, solution
RICE- white rice injection, solution
RYE GRAIN- rye injection, solution
SALMON- atlantic salmon injection, solution
SESAME SEED- sesame seed injection, solution
SHRIMP- common shrimp injection, solution
SOYBEAN- soybean injection, solution
SPINACH- spinach injection, solution
SQUASH- zucchini injection, solution
STRAWBERRY- strawberry injection, solution
STRINGBEAN- string bean injection, solution
SWEET CORN- corn injection, solution
SWEET POTATO- sweet potato injection, solution
THEA SINENSIS- tea leaf injection, solution
TOMATO- tomato injection, solution
TUNA- northern bluefin tuna injection, solution
TURKEY- turkey injection, solution
VANILLA- vanilla bean injection, solution
VITIS SPP- grape injection, solution
WATERMELON- watermelon injection, solution
WHEAT GRAIN- wheat injection, solution
WHITE POTATO- potato injection, solution
ALK-Abello, Inc.

ALLERGENIC EXTRACTS,

FOR DIAGNOSTIC USE ONLY

DIRECTIONS FOR USE

Port Washington, NY 11050

U.S. Government License No. 1256

DESCRIPTION

Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer.

Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety.

Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously.

Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety.

CLINICAL PHARMACOLOGY

Diagnostically (for skin testing) the allergen combines with IgE antibodies fixed to mast cells in the skin. This complexing causes an increase in cellular permeability and degranulation of the mast cells releasing chemical mediators. These mediators (such as histamine) are responsible for a local inflammatory response of wheal and erythema typical of a positive skin test reaction and also, the symptoms commonly associated with allergic disease.¹ The more mediator release, the larger the reaction (wheal and erythema).

ALMOND Indications and Usage

These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.

CONTRAINDICATIONS

Patients on beta blockers can be non-responsive to beta agonists that may be required to reverse a systemic reaction (also, see boxed WARNING statement and ADVERSE REACTIONS). The physician should carefully weigh the benefit derived from skin testing vs. the risk to the patient should a systemic reaction arise.

Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction^2,3. See also PRECAUTIONS and ADVERSE REACTIONS.

WARNING S

Severe Allergic Reactions :

Patients should always be observed for at least 20 — 30 minutes after skin testing. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstruction, hypotension, coma and death (see ADVERSE REACTIONS), applications of a tourniquet above the injection site and administration of 0.2 mL to 1 mL (0.01 mg/kg) of epinephrine injection (1:1,000) are recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15-minute intervals. Patients under treatment with beta blockers may be refractory to the usual dose of epinephrine.

Volume expanders and vasopressor agents may be required to reverse hypotension, inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In case of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.

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 the 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.

PRECAUTIONS

INFORMATION FOR PATIENTS:

Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to testing. Also, see ADVERSE REACTIONS and WARNINGS Sections.

Patients should always be observed 20 to 30 minutes after testing.

General:

1. In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications for skin testing must be weighed carefully against the risk of temporarily aggravating the symptoms by the testing itself. Objective assessment of pulmonary function such as Peak Expiratory Flow Rate (PEFR) before allergen administration and prior to discharge may be useful in unstable asthmatics to reduce the chances of exacerbation of the patient’s asthma. Patients should be instructed to describe any active allergic symptoms as described above prior to skin testing and encouraged to report any late reactions from this testing. Also, see ADVERSE REACTIONS and WARNING sections.
   
2. Store allergenic extracts between 2°-8°C at all times, even during use.
   
3. Care must be taken to avoid drawing blood.
   1. For percutaneous testing, if blood is observed, immediately wipe the allergen from the site.
      
   2. For intradermal skin testing, pull gently on the syringe plunger and note if any blood enters the syringe. If blood is obtained, reposition the needle and repeat before injecting (see DOSAGE AND ADMINISTRATION).
   
   
4. Allergenic extracts become less potent with age. Allergenic extracts containing glycerin 50% v/v are relatively stable. Non-glycerinated aqueous extracts, particularly dilute forms as used for intradermal skin testing, have been shown to be extremely unstable. Until such time as stability studies are complete with dilute allergens, new intradermal strength materials should be prepared every few weeks.
   
5. Use standard aseptic precautions if making dilutions from stock concentrates to intradermal strength.
   
6. For intradermal testing: Extracts in glycerin 50% v/v must be diluted with a non-glycerinated diluent and must be diluted at least 25-fold to less than 2% glycerin by volume, as glycerin above this level can cause false positive intradermal skin test results.

Pregnancy — Category C:

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.

Controlled studies of hyposensitization with moderate to high doses of allergenic extracts during conception and all trimesters of pregnancy have failed to demonstrate any risk to the fetus or to the mother⁴. However, on the basis of histamine’s known ability to contract the uterine muscle, the release of significant amounts of histamine from allergen exposure to skin test overdose should be avoided on theoretical grounds. Therefore, allergenic extracts should be used cautiously in a pregnant woman and only if clearly needed.

Pediatric Use:

Allergenic extracts for diagnostic use have been given safely in infants and young children. Infants have lower skin test reactivity to histamine, as well as common allergens. Skin test reactivity gradually increases to age 6 and plateaus to age 60. Therefore, small skin test reactions should be anticipated in children under age 6.

Geriatric Use:

Skin test reactivity gradually decreases after age 60. Therefore, smaller skin test reactions should be anticipated in adults over age 60.

Nursing Mothers:

It is not known if allergens administered subcutaneously appear in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

Carcinogenesis, mutagenesis, impairment of fertility:

Studies in animals have not been performed.

Drug Interactions:

Drugs can interfere with the performance of skin tests⁵.

Antihistamines: Response to mediator (histamine) released by allergens is suppressed by antihistamines. The length of suppression varies and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines. The duration of this suppression may be as little as 24 hours (chlorpheniramine) and can be as long as 40 days (astemizole).

Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine which may last for a few weeks.

Beta₂ Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.

Dopamine: Intravenous infusion of dopamine may inhibit skin test responses.

Beta Blocking Agents: Propranolol can significantly increase skin test reactivity.

Other Drugs: Short acting steroids, inhaled beta₂ agonists, theophylline and cromolyn do not seem to affect skin test response.

ADVERSE REACTIONS

Fatalities from skin testing in the United States have been extensively reviewed by Lockey.² Six fatalities were associated with intradermal testing without previous percutaneous testing, and one was associated with a combination of percutaneous (scratch) and intradermal skin testing. With careful attention to dosage and administration, fatal reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and overdosage could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts for skin testing understand, and be prepared for the treatment of severe reactions.

Local:

Immediate wheal and erythema reactions are to be expected; but if very large, may be the first manifestation of a systemic reaction. In such cases, immediately wipe the test site(s) with sterile gauze or cotton to remove excess allergen.