Treatment Set TS338618

TREATMENT SET TS338618 — felis catus hair, cynodon dactylon pollen, phleum pratense pollen, ambrosia artemisiifolia pollen, iva annua var. annua pollen and fraxinus americana pollen injection, solution
TREATMENT SET TS338909 — dermatophagoides farinae, fraxinus americana pollen, poa pratensis pollen, alternaria alternata, juniperus virginiana pollen, acer negundo pollen, betula nigra pollen, quercus alba pollen, pleospora herbarum, sorghum halepense pollen, kochia scoparia pollen, ustilago cynodontis, sporisorium cruentum, ambrosia trifida pollen, ambrosia artemisiifolia pollen, ambrosia psilostachya pollen, carya illinoinensis pollen and carya alba pollen injection, solution
TREATMENT SET TS338910 — gallus gallus feather, anas platyrhynchos feather, anser anser feather, cynodon dactylon pollen, ustilago nuda hordei, ustilago maydis, ustilago avenae, ustilago tritici, periplaneta americana, iva annua var. annua pollen, amaranthus retroflexus pollen and salsola kali pollen injection, solution
TREATMENT SET TS339118 — canis lupus familiaris hair, dermatophagoides farinae, aspergillus fumigatus, dermatophagoides pteronyssinus, fusarium oxysporum, phoma destructiva, periplaneta americana, cochliobolus sativus, cladosporium cladosporioides, penicillium chrysogenum var. chrysogenum, aureobasidium pullulans var. pullutans, ustilago nuda hordei, ustilago maydis, ustilago avenae, ustilago tritici, gallus gallus feather, anas platyrhynchos feather and anser anser feather injection, solution
TREATMENT SET TS339119 — carya alba pollen, carya illinoinensis pollen, ambrosia trifida pollen, ambrosia artemisiifolia pollen, ambrosia psilostachya pollen, ulmus americana pollen, cynodon dactylon pollen, juniperus virginiana pollen, populus deltoides pollen, betula nigra pollen, fraxinus americana pollen, quercus alba pollen, sorghum halepense pollen, chenopodium album pollen, iva annua var. annua pollen, amaranthus retroflexus pollen, salsola kali pollen and rumex acetosella pollen injection, solution
Antigen Laboratories, Inc.

WARNINGS

Individual allergenic extract treatment vial is intended for use by physicians who are experienced in the administration of allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Individual allergenic extract treatment vials are not directly interchangeable with other allergenic extracts. The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from other types of extract to individual treatment vials should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician’s office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals, these reactions may be life-threatening. Patient should be observed for at least 20 minutes following treatment and emergency measures as well as personnel trained in their use should be immediately available in the event of a life-threatening reaction.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the warnings, precautions, adverse reactions and overdosage sections below.

DESCRIPTION

Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician’s prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified.

Ingredients — Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial.

Dating Period — A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery.

CLINICAL PHARMACOLOGY

The mechanisms by which immunotherapy (hyposensitization) is achieved are not completely understood. Anaphylaxis or “anaphylactic shock,” and hay fever are caused by the same basic process: the production of IgE antibody, its attachment to mast cells and, on renewed contact with the same antigen explosive degranulation of the mast cells and release of mediators, which act on smooth muscle, mucous glands, and blood vessels. With massive release there is bronchospasm, vomiting, skin rashes, edema of the nose and throat, and vascular collapse, sometimes fatal, while with more localized release one or more of these symptoms predominates, depending on the site (tissue shock organ) of exposure to the antigen.

Antigens that can trigger these reactions are known as “allergens”; they have very diverse origins but a curious similarity of molecular weight. People who suffer unduly from allergy are called “atopic”; this trait is usually inherited and has been attributed to a variety of constitutional abnormalities.

The IgE dependent degranulation of mast cells is initiated by the bridging of pairs of cell-bound IgE by antigen and terminates rapidly. Bridging results in alteration of the cell membrane, which is associated with increased energy dependent entry of calcium, alterations in phospholipid metabolism and increase of cyclic adenosine monophosphate (cyclic AMP).

The mast cell membrane is ruffled and possesses receptors both for the Fc portion of IgE and C3b. Receptors for anaphylatoxin (C3a and C5a), have been defined functionally. In addition to IgE antigen interaction and stimulation by anaphylatoxin, mast cells may be degranulated by non-immunological stimuli such as enzymes, ionophores, polycations, radio-contrast dyes and opiates. Atopic individuals develop their symptoms principally as a result of IgE-dependent processes; however, non- IgE mediated mechanisms for the release of mast cell mediators provide additional potential for recruitment of mediators.

Subsequent to activation, the secretion of granules is under cyclic nucleotide regulation. Of direct relevance is the possibility that the mast cell itself, by histamine (H2) and prostaglandins (E2 , D2 , I2) may increase cyclic AMP and inhibit secretion. Conversely histamine (H1) could elevate cyclic GMP and PGF, 2 alpha lower cyclic AMP, augmenting the release of mediators. 18

INDICATIONS AND USAGE

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person’s allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests — in vitro or in vivo — serve only to confirm the physician’s suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient’s symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11

THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.

CONTRAINDICATIONS

There are no absolute contraindications; however, extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients, who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment. IN THESE CASES BOTH THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT’S SENSlTIVITY AND TOLERANCE.

This product is not intended for the treatment of patients who do not experience allergic symptoms upon natural exposure to the allergen. At the present time there has been no demonstrated adverse effects on the fetus when allergenic extract immunotherapy is administered during gestation to pregnant women.

100,000 AU/ml standardized allergenic extract should be used by physicians with experience in maximal dose immunotherapy and treatment of anaphylaxis.

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