Standardized Mite Dermatophagoides Farinae
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Questions & Answers
Side Effects & Adverse Reactions
Standardized Mites extract labeled in AU/mL are not interchangeable with non-standardized mite extracts.
Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.
DO NOT INJECT INTRAVENOUSLY. All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death. Allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma, (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Standardized mite allergenic extracts are intended for use in the diagnosis and therapy of D.farinae and D.pteronyssinus mite allergy, as established by allergy history and skin test reactivity (6,10). Standardized Mite extracts are not interchangeable with non standardized mite extracts. To select patients for a confirmation of allergic disease diagnosis and/or treatment with allergen extracts, screening tests should be done using in vivo identification testing methods (i.e. scratch or intradermal testing).(13)
Standardized mite extract containing equal parts of D.farinae and D.pteronyssinus is intended for therapy only. The use of standardized mites extract is indicated for hypersensitization treatment and may be used as part of the over-all management of the allergic patient. This treatment is particularly to be recommended when a patient's sensitivity to mite has been determined initially by scratch or intradermal skin tests.
History
There is currently no drug history available for this drug.
Other Information
Standardized mite extract is a sterile injectable solution containing the extractable of Dermatophagoides farinae or Dermatophagoides pteronyssinus, 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, distilled water for injection, 0.4%, phenol as preservative and 50% glycerin by volume in sterile containers. All extracts are aseptically filled. Standardized mite extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections.
It has been recognized that mites are one of the most common allergens in House Dust (1,2). Recent research and extensive clinical trials have shown that the mite component is important enough to separate it from the other antigenic components of House Dust. The two species of Dermatophagoides are found in the United States.(4)
Persons thought to be allergic to House Dust should be tested for sensitivity to mites. Standardized extracts have been prepared to diagnose and treat with D. farinae and D. pteronyssinus.
The Allergy Units are assigned to these extracts based on the relative potency by ELISA Inhibition to the Center for Biologics Evaluation and Research (CBER) reference. The CBER mite reference preparation has been assigned 10,000 AU/mL, based on quantitative skin assays.(11)
Extracts are prepared from supplied raw material containing greater than 99% pure adult mites and mite stages by actual count. The mites have been grown on a medium containing yeast and pork products. Cleaning of the raw material removes at least 99% of the medium. This medium contains no material of human origin. The extracting fluid contains 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, distilled water for injection, 0.4% phenol as preservative and 50% glycerin by volume as stabilizer.
The raw material is extracted with diluent, glycerinated, and the potency on the label is expressed in Allergy Units (AU/mL). Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (Σ E ≥ 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (Σ E ≥ 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites and 4 positives in 40 individuals at an estimated 10% contamination.(5) Two of the individuals who were skin test positive to mite extract and who were also skin test positive to mite medium extract were also skin tested by the puncture method with an extract of yeast (Sacchoromyces spp) and were positive.
Sources
Standardized Mite Dermatophagoides Farinae Manufacturers
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Nelco Laboratories, Inc.
![Standardized Mite Dermatophagoides Farinae Injection, Solution Standardized Mite Dermatophagoides Pteronyssinus Injection, Solution [Nelco Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Standardized Mite Dermatophagoides Farinae | Nelco Laboratories, Inc.
It is imperative that the physician determine the initial dose of the product by skin testing. Patients being switched from a Standardized Mite extract to a new Standardized Mite extract (both labeled in AU/mL) should be skin tested with both extracts to determine the relative potency of the extracts and the dosage adjusted accordingly.
For safe and effective use of allergen extracts, sterile solutions, vials, syringes, etc. should be used and aseptic precautions observed in making dilution's. The usual precautions to be observed in administering extracts are necessary. A sterile tuberculin syringe graduated in 0.1 mL units to measure each dose for the prescribed dilution should be used.
Recommended dosage and range:(Diagnostic) The concentration of Standardized Mite extract for Scratch or Prick-puncture testing is 10,000 AU/mL, glycerinated, supplied in 5 mL dropper vials. Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes. Wheal and erythema size may be recorded by actual measurement or the extent of both responses.
Prick-puncture tests on Mite allergic subjects: 10 puncture tests (bifurcated needle) on mite allergic subjects yielded the following:
# Person Mean sum of wheal Range Mean sum of Erythema Range (mm) D. farinae 10 17.4 mm 12-21 mm 78.8 mm 63-97 mm D. pteronyssinus 10 18.0 mm 10-37 mm 68.7 mm 46-114 mmIntradermal tests (using 0.05 mL) on 10 puncture positive patients AU/mL to elicit 50 mm sum of dia. of erythema reaction (10)
# Persons Mean Range (AU/mL) D. farinae 10 0.029 AU/mL 0.077-0.005 AU/mL D. pteronyssinus 10 0.024 AU/mL 0.78-0.0004 AU/mLPatients with a negative scratch or prick-puncture test: Patients who do not react to a valid scratch or prick- puncture test should be tested intradermally with a 0.02 to 0.05 mL of a 50 AU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 100 AU/mL extract dilution. The negative puncture test control must be diluted appropriately for ID use. It is supplied in 5 mL and 10 mL vials of 50% glycerin (v/v).
To prepare a 50 AU/mL dilution from 10,000 AU/mL vial:
Take 5.0mL of 10,000AU/mL + 5.0 mL of diluent = Vial A @5,000 AU/mL.
Take 1.0 of Vial A + 9.0 mL diluent = Vial B @ 500 AU/mL.
Take 1.0 of Vial B + 9.0 mL diluent = Vial C @ 50 AU/mL.
Patients tested only by the intradermal method: Patients being suspected of being highly allergic should be tested with 0.02 to 0.05 mL of a 0.1 AU/mL dilution.(3) A negative test should be followed by repeat tests using progressively stronger concentrations until the maximal recommended strength of 100 AU/mL is reached. The negative puncture test control must be diluted appropriately for intradermal use. It is supplied in 5 mL and 10 mL vials of 50% glycerin (v/v).
Recommended dosage and range: (Therapeutic) Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be 0.1 mL of 0.01 to 0.1 AU/mL. Patients with lesser sensitivity may be started at 1.0 to 10.0 AU/mL. The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) for the subsequent dose. Maximum dosage has not been established however, the upper limits of l mL of 10,000 AU/mL may be painful due to glycerin content. The dosage of allergenic extract does not vary significantly with the allergic disease under treatment.
After therapeutic injections patients should always be observed for at least 30 minutes. If adverse reactions appear, the next therapeutic injection of extract should be reduced to the dose which does not elicit a reaction and subsequent doses increased slowly. If local reactions occur, reduce subsequent injections to a dose which did not elicit this reaction.
Preparation Instructions: To prepare dilution for intradermal and therapeutic use, one starts with 10,000 AU/mL concentrate and makes a 1:10 dilution by adding 1.0 mL of the concentrate to 9.0 mL of sterile diluent. Subsequent dilution's are made in similar manner.
TEN-FOLD DILUTION SERIES Dilution Extract Diluent mL AU/mL 0 Concentrate 0 10,000 1 1 mL concentrate 9 1,000 2 1 mL dilution #1 9 100 3 1 mL dilution #2 9 10 4 1 mL dilution #3 9 1 5 1 mL dilution #4 9 0.1 6 1 mL dilution #5 9 0.01Intervals between doses: The optimal interval between doses of allergenic extract has not been definitely established. However, as it is customary practiced, injections are given 1,2, or 3 times per week until the maintenance dose of extract is reached. At this time, the injection interval may be increased to 2 weeks, then 3 weeks and finally to 4 weeks. If the patient does not return for 6-8 weeks after the last injection, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of 1,2, or 3 dilution's may be made depending on a consideration of the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to a fresh extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.(14)
Duration of Treatment: The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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