Standardized Mite Mix, Dermatophagoides Pteronyssinus and Dermatophagoides Farinae, 10000 AU Per ML

STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 10000 AU PER ML- dermatophagoides farinae and dermatophagoides pteronyssinus injection, solution
STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 30000 AU PER ML- dermatophagoides farinae and dermatophagoides pteronyssinus injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 30 AU PER ML- dermatophagoides pteronyssinus injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 300 AU PER ML- dermatophagoides pteronyssinus injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, BULK, 10000 AU PER ML- dermatophagoides pteronyssinus injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, SCRATCH OR BULK, 30000 AU PER ML- dermatophagoides pteronyssinus injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 30 AU PER ML- dermatophagoides farinae injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 300 AU PER ML- dermatophagoides farinae injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, BULK, 10000 AU PER ML- dermatophagoides farinae injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, SCRATCH OR BULK, 30000 AU PER ML- dermatophagoides farinae injection, solution
Jubilant HollisterStier LLC

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. 1 Therefore, emergency measures and personnel trained in their use should 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.
Standardized glycerinated extracts may be more potent than regular extracts and therefore, are not directly interchangeable with non-standardized extracts, or other manufacturers’ products.
This product should never be injected intravenously.

Refer also to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE sections for further discussion.

DESCRIPTION:

Mite extract is a sterile solution containing the extractables of Dermatophagoides farinae or Dermatophagoides pteronyssinus , 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin by volume as a preservative. Source material for the extract is the whole bodies of the mites. The mites are grown on a medium of brine shrimp eggs and wheat germ, and are handled and cleaned in a manner that the maximum carryover of the medium components is less than 1%. The medium contains no material of human origin.
Sterile, diluted mite extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% albumin (human), not more than 0.003% sodium bicarbonate, and 0.4% phenol as a preservative.
Skin test trials were conducted to evaluate the skin reactivity of medium components mixed in the approximate proportion used for mite growth. Twenty-three individuals who were puncture test reactive (∑E≥40mm) to either D. farinae or D. pteronyssinus were tested with an extract of medium components at an estimated 1% carryover level. None of these patients had a ∑E response more than 3mm larger than the negative control by puncture test with the concentrate of the medium components extract. One of the 23 patients had a reaction with ∑E≥20mm when tested intradermally with a 1:100 (v/v) dilution of the concentrate of the medium components extracts.
Standardized D. farinae and D. pteronyssinus extract concentrates (stock concentrates) containing 30,000 Allergy Units/mL (AU/mL) are supplied in dropper vials for scratch, prick or puncture tests. Stock concentrates are also available in multiple-dose vials containing 10,000 AU/mL and 30,000 AU/mL to be diluted for intradermal testing and immunotherapy.
Standardized D. farinae and D. pteronyssinus extract dilutions (at 30 AU/mL and 300 AU/mL) are supplied for intradermal diagnostic tests described in Section DOSAGE AND ADMINISTRATION, Diagnosis, Part 2.a.

Product Concentration:

1. Allergy Units (AU/mL). The potency of extracts labeled in Allergy Units (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.

2. Bioequivalent Allergy Units (BAU/mL). Other standardized allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by in vitro assay or major allergen content) to CBER, FDA Reference Preparations. The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50 EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50, Bioequivalent Allergy Units are assigned as follows:

BAU/mLD50
100,00013-15
10,00010.9-12.9
1,0008.8-10.8
1006.7-8.7
3. Concentrate Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength.
e.g.Concentrate
50%Short Ragweed 1:20 w/v
25%Std Cat Hair 10,000 BAU/mL
25%Std Mite D. farinae 10,000 AU/mL
Actual Allergen Strength In concentrate Mixture=Allergen Manufacturing StrengthX% allergen in Formulation (by volume or parts)

CLINICAL PHARMACOLOGY:

26 The mechanisms by which hyposensitization is achieved are not completely understood. It has been shown that repeated injections of appropriate allergenic extracts will ameliorate the intensity of allergic symptoms upon contact with the allergen. 6, 7, 8, 9 Clinical studies which address the efficacy of immunotherapy are available. The allergens which have been studied are cat, mite, and some pollen extracts.10, 11, 12, 13, 14, 15

IgE antibodies bound to receptors on mast cell membranes are required for the allergic reaction, and their level is probably related to serum IgE concentrations. Immunotherapy has been associated with decreased levels of IgE, and also with increases in allergen specific IgG “blocking” antibody.

The histamine release response of circulating basophils to a specific allergen is reduced in some patients by immunotherapy, but the mechanism of this change is not yet clear.

The relationships among changes in blocking antibody, reaginic antibody, and mediator-releasing cells, and successful immunotherapy need study and clarification.

Dermatophagoides are found in approximately 80% of house dust samples throughout the world. 22, 23 D. farinae is common in much of the United States,24 although D. pteronyssinus is predominant in certain coastal regions, and both species are commonly found in homes.25 Persons suspected of having allergy to house dust should be tested for sensitivity to each mite.

INDICATIONS AND USAGE:

16, 17, 18, 26 Standardized glycerinated allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.20, 21

CONTRAINDICATIONS:

There are no known absolute contraindications to immunotherapy. See PRECAUTIONS for pregnancy risks.

Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or those 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 allergy treatment regimen. Patients should be treated only if the benefit of treatment outweighs the risks.1

Any injections, including immunotherapy, should be avoided in patients with a bleeding tendency.
Since there are differences of opinion concerning the possibility of routine immunizations exacerbating autoimmune diseases, immunotherapy should be given cautiously to patients with autoimmune diseases, and only if the risk from exposure to the allergen is greater than the risk of exacerbating the autoimmune process.

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