Standardized Mite Mix

Standardized Mite Mix Manufacturers

• Jubilant Hollisterstier Llc
  

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  Standardized Mite Mix | Jubilant Hollisterstier Llc

  

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  1. General
  Sterile aqueous diluent containing human serum albumin [Albumin Saline with Phenol (0.4%)] or diluent of 50% glycerin may be used when preparing dilutions of the concentrate for immunotherapy. For intradermal testing dilutions, Albumin Saline with Phenol is recommended.
  Dilutions should be made accurately and aseptically, using sterile diluent, vials, syringes, etc. Mix thoroughly and gently by rocking or swirling.
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
  
  2. Diagnosis
  To identify highly sensitive individuals and as a safety precaution, it is recommended that a scratch, prick or puncture test using a drop of the extract concentrate be performed prior to initiating intradermal testing. Prick tests are performed by placing a drop of extract on the skin and piercing through the drop into the skin with a slight lifting motion. Puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a Prick Lancetter. Fifteen minutes after puncture is made the diameter of wheal and erythema reactions are measured, and the sensitivity class of the patient determined by the table presented at end of Diagnosis Section. Less sensitive individuals (Class 0 to 1+) can be tested intradermally with the recommended dilutions of the extract concentrate (See intradermal testing instructions). The skin test concentration of 30,000 AU/mL in dropper vials is used for scratch, prick or puncture testing.
  Puncture tests performed on 12 selected highly sensitive subjects showed the following:
  Species
  Mean ∑ Wheal
  ± Std/ Dev (mm)
  Mean ∑ Erythema
  ± Std. Dev (mm)
  D. farinae
  22.4 ± 10.7
  82.3 ± 21.7
  D. pteronyssinus
  24.0 ± 9.9
  89.3 ± 24.5
  
  ∑ equals the sum of the longest diameter and the mid-point orthogonal diameter. Extract for intradermal testing should be prepared by diluting the 30,000 AU/mL stock concentrate, provided in multiple-dose vials, with sterile aqueous diluent (refer to the dilution table displayed in the immunotherapy section below). To administer the intradermal strength dilutions, a 1 mL tuberculin syringe with a short 27-gauge needle should be used. The needle is inserted intradermally at a 30° angle, bevel down, and 0.02 to 0.05 mL of the extract is injected. Fifteen minutes following injection, the diameter of wheal and erythema reactions are measured, and the patient's sensitivity class is determined by the table on the following page. Intradermal skin test results in selected highly sensitive subjects are presented for reference purposes:
  
  
  Allergen
  
  Number of
  Persons
  
  
  Mean
  AU/mL that Elicited
  ∑E = 50mm
  2 Std. Dev Range
  D. farinae
  12
  0.0609
  0.0015 - 2.6016
  D. pteronyssinus
  12
  0.0333
  0.0003 - 4.0077
  Intradermal extract should be used as follows:
  a. Patients with a negative scratch, prick or puncture test:
  Patients who do not react to a valid scratch, prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 30 AU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 300 AU/mL extract solution. The negative control used with this latter dilution should contain 0.5% glycerin.
  b. Patients tested only by the intradermal method:
  Patients suspected of being highly allergic should be tested with 0.02 to 0.05 mL of a solution containing 0.03 AU/mL. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 300 AU/mL is reached. The negative control used with this latter dilution should contain 0.5% glycerin. 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 of the extent of both responses. Refer to the following table to determine the skin test sensitivity class. The corresponding ∑E(sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.
  Class Wheal Diameter Erythema Diameter Corresponding ∑E 0 <5mm <5mm <10mm ± 5-10mm 5-10mm 10-20mm 1+ 5-10mm 11-20mm 20-40mm 2+ 5-10mm 21-30mm 40-60mm 3+ 10-15mma 31-40mm 60-80mm 4+ >15mmb >40mm >80mm a. or with pseudopods
  b. or with many pseudopods
  3. Immunotherapy
  Allergen extracts should be administered using a sterile syringe with 0.01 mL gradations and a 25-27 gauge x 1/2"to 5/8" needle. The injections are given subcutaneously. The most common sites of injection are the lateral aspect of the upper arm or thigh. Intracutaneous or intramuscular injections may produce large local reactions which may be very painful.
  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. The starting dose should be based on skin tests of the extract to be used for immunotherapy. To prepare dilutions for intradermal and therapeutic use, make a 1:10 dilution by adding 1.0 mL of the concentrate to 9.0 mL of Sterile Albumin Saline with Phenol (0.4%). Subsequent serial dilutions are made in a similar manner. (See Table I.) To determine the starting dose, begin intradermal testing with the most dilute extract preparation. Inject 0.02 mL and read the reaction after 15 minutes. Intradermal testing is continued with increasing concentrations of the extract until a reaction of 11-20 mm erythema (∑E20-40 mm) and/or a 5 mm wheal occurs. This concentration at a dose of 0.03 mL then can serve as a starting dose for immunotherapy and be increased by 0.03 mL to as high as 0.12 mL increments each time, until 0.3 mL is reached. At this time, a dilution 10 times as strong can be used, starting with 0.03 mL. Proceed in this way until a tolerance dose is reached or symptoms are controlled. Suggested maintenance dose is 0.2 mL of the concentrate. Occasionally, higher doses are necessary to relieve symptoms. Special caution is required in administering doses greater than 0.2 mL. The interval between doses normally is 3 to 7 days.
  This is offered as a suggested schedule for average patients and will be satisfactory in most cases. However, the degree of sensitivity varies in many patients. The size of the dose should be adjusted and should be regulated by the patient's tolerance and reaction. The size of the dose should be decreased if the previous injection resulted in marked local or the slightest general reaction. Another dose should never be given until all local reactions resulting from the previous dose have disappeared.
  In some patients, the dosage may be increased more rapidly than called for in the schedule. In seasonal allergies, treatment should be started and the interval between doses regulated, so that at least the first twenty doses will have been administered by the time symptoms are expected. Thus, the shorter the interval between the start of immunotherapy and the expected onset of symptoms, the shorter the interval between each dose. Some patients may even tolerate daily doses. A maintenance dose, the largest dose tolerated by the patient that relieves symptoms without producing undesirable local or general reactions, is recommended for most patients. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of the glycerin concentrate may be painful due to the glycerin content. The dosage of the allergenic extract does not vary significantly with the respiratory allergic disease under treatment. The size of this dose and the interval between doses will vary and can be adjusted as necessary. Should symptoms develop before the next injection is scheduled, the interval between doses should be decreased. Should allergic symptoms or local reactions develop shortly after the dose is administered, the size of the dose should be decreased. In seasonal allergies, it is often advisable to decrease the dose to one-half or one-quarter of the maximum dose previously attained if the patient has any seasonal symptoms.
  The interval between maintenance doses can be increased gradually from one week to 10 days, to two weeks, to three weeks, or even to four weeks if tolerated. Repeat the doses at a given interval three or four times to check for untoward reactions before further increasing the interval. Protection is lost rapidly if the interval between doses is more than four weeks. (See WARNINGS Section.) 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.
  
  TABLE 1
  TEN-FOLD DILUTION SERIES
  Standardized Extracts Labeled 30,000 AU/mL
  Dilution
  Extract
  +Diluent
  =
  AU/mL
  Concentration
  0
  Concentrate
  +0 mL
  =
  30,000
  1
  1 mL Concentrate
  +9 mL
  =
  3,000
  2
  1 mL dilution #1
  +9 mL
  =
  300
  3
  1mL dilution #2
  +9 mL =
  30
  4
  1 mL dilution #3
  +9 mL =
  3
  5
  1 mL dilution #4
  +9 mL =
  0.3
  6
  1 mL dilution #5
  +9 mL =
  0.03
  7
  1 mL dilution #6
  +9 mL =
  0.003
  4. Pediatric Use

  The dose for the pediatric population is the same as for adults. (See PRECAUTIONS.)

  5. Geriatric Use

  The dose for elderly patients is the same as for adult patients under 65.29

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