Standardized Cat Hair

Standardized Cat Hair Manufacturers

• Antigen Laboratories, Inc.
  

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  Standardized Cat Hair | Antigen Laboratories, Inc.

  

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  DOSAGE AND ADMINISTRATION
      The current standard method of immunotherapy dates back to Noon.  Therapy is begun with a low dose which has been shown to be tolerated by both experience and skin testing.  The initial dilution of allergenic extract, starting dose, and progression of dosage must be carefully determined on the basis of the patient’s history and results of skin tests.
      The physician who undertakes immunotherapy should be concerned with the degree of sensitivity of the patient.  (See “INDICATIONS AND USAGE”.)  Strongly positive skin tests may be risk factors for systemic reactions.  Less aggressive immunotherapy schedules may be indicated for such patients.
      Serial five-fold or ten-fold dilutions of the extract are used to make more dilute extract concentrations.  Other concentrations can be prepared by appropriate dilution.  In brief, the allergist can prepare any dilution of extract that is considered appropriate for the patient.
      Prick-Puncture Testing: To identify cat sensitive individuals and as a safety precaution, it is recommended that a prick or puncture test using a drop of the 10,000 BAU/ml extract concentrate be performed prior to initiating very dilute intradermal testing.  Prick (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 bifurcated vaccinating needle.  The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins.  The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space.  Glycerinated extracts are recommended for prick testing using the most concentrated dilution.  A positive reaction is approximately 10-15 mm erythema with 2.5 mm wheal.
      A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other reasons.  A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.
      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen.  The more sensitive the patient the higher the probability that he/she will have symptoms related upon natural exposure to the offending Cat allergen.  Hence, the importance of good patient history.  Less sensitive individuals can be tested intradermally with an appropriately diluted extract. (See Intradermal Testing.)
  
  

  SERIAL DILUTIONS
  APPROXIMATE BAU/ml RESULTING FROM 1:10 DILUTION
  OF ALLERGENIC EXTRACT CONCENTRATE
  Allergenic Extract Concentrate
  DILUTUION #
  DILUTION EXPONENT
  10,000 BAU/ML
  5,000 BAU/ML
  1,000 BAU/ML
  1
  10-1
  1,000
  500
  100
  2
  10-2
  100
  50
  10
  3
  10-3
  10
  5.0
  1.0
  4
  10-4
  1
  0.5
  0.1
  5
  10-5
  0.1
  0.05
  0.01
  6
  10-6
  0.01
  0.005
  0.001
  7
  10-7
  0.001
  0.0005
  0.0001
  8
  10-8
  0.0001
  0.00005
  0.00001
  9
  10-9
  0.00001
  0.000005
  0.000001
  10
  10-10
  0.000001
  0.0000005
  0.0000001
  SERIAL DILUTIONS
  APPROXIMATE BAU/ml RESULTING FROM 1:5 DILUTION
  OF ALLERGENIC EXTRACT CONCENTRATE
  Allergenic Extract Concentrate
  DILUTION #
  DILUTION EXPONENT
  10,000 BAU/ML
  5,000 BAU/ML
  1,000 BAU/ML
  1
  5-1
  2,000
  1,000
  200
  2
  5-2
  400
  200
  40
  3
  5-3
  80
  40
  8.0
  4
  5-4
  16
  8.0
  1.6
  5
  5-5
  3.2
  1.6
  0.32
  6
  5-6
  0.64
  0.32
  0.064
  7
  5-7
  0.128
  0.064
  0.0128
  8
  5-8
  0.0256
  0.0128
  0.00256
  9
  5-9
  0.00512
  0.00256
  0.000512
  10
  5-10
  0.001024
  0.000512
  0.0001024

  
      Intradermal testing: The surface of the upper and lower arm is the usual location for skin testing.  It is important that a new sterile, disposable syringe and needle be used for each extract tested.  Intracutaneous test dilutions should be made with aqueous diluent.  Three-fold, five-fold or ten-fold dilutions may be prepared from stock concentrate extract.  (1) Start testing with the most dilute allergenic extract concentration.  (2) A volume of 0.01-0.02 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal).  (3) For patients with a suspected cat sensitivity an allergenic extract dilution of 5-10 (0.005 BAU/ml) or 10-7 (0.001 BAU/ml) dilution should be used for initial skin testing.  Sensitivity of the patient can be expressed only if the minimum concentration required for a 1+ or 2+ reaction (see chart below) is determined by performing a skin test titration.  The reaction should be read after fifteen minutes.
  
  EVALUATION OF SKIN REACTIONS
  

  GRADE
  mm ERYTHEMA mm WHEAL 0
  less than 5
  less than 5
  +/-
  5-10
  5-10
  1+
  11-20
  5-10
  2+
  21-30
  5-10
  3+
  31-40
  10-15
  or with pseudopods
  4+
  greater than 40
  greater than 15
  or with many pseudopods
  

      If after 20 minutes no skin reaction is obtained, continue the testing using increments in the concentration until a reaction of 5-10 mm wheal and 10-30 mm erythema is obtained, or until the concentration of 5-2 or 10-1 has been tested.  As a negative control the diluent, a concentration of less than 0.5% glycerine (5-3 or 10-3), does not produce positive skin wheal and erythema.  The diluent should be tested and included in the interpretation of the skin reactions.17
  
  INTRADERMAL TESTING--SKIN ENDPOINT TITRATION
      The allergenic extract to which the patient is sensitive, the patient’s degree of sensitivity and the initial dose of allergen to be used in immunotherapy can be quantitated using five-fold dilutions of allergenic extract for intracutaneous testing.  The critical variable is the size of the wheal and erythema produced by the intracutaneous injection of 0.01-0.02 ml of the test allergen producing a 4 mm diameter superficial wheal.  For initial screening 5-10 (0.005 BAU/ml) is a safe dilution.  When a sequence of five-fold or ten-fold dilutions of an allergen are injected, the endpoint is detected by noting the dilution that first produces a wheal and erythema (15 minutes after injection) that is 2 mm larger than wheals with erythema produced by weaker, non-reacting dilutions (5 mm negative wheal).  The endpoint dilution is used as a starting dose concentration for immunotherapy.
      Normally, immunotherapy with allergenic extracts can be started with 0.15 ml of the endpoint of reaction.  In any allergic patient, a safe starting dose can be determined by finding the first dose by intradermal skin testing producing a 1+ reaction or the dilution producing the skin endpoint. 
      If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered.  The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts.  This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient.  Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.
       Some patients may tolerate larger doses of the allergenic extract depending on patient response.7  Because dilute extracts tend to lose activity on storage, the first dose from a more concentrated vial should be the same or less than the previous dose.8, 12
      Dosages progressively increase thereafter according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief of symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose, the largest dose tolerated by the patient short of aggravating existing symptoms, systemic symptoms, or anaphylaxis, or patient demonstrates untoward reactions that indicate the dose to be excessive.  This maintenance dose may be continued at regular intervals perennially.  It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions.
  
  

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• Nelco Laboratories, Inc.
  

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  Standardized Cat Hair | Nelco Laboratories, Inc.

  

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  It is imperative that the physician determine the initial dose of the product by skin testing. Patients being switched from extracts not labeled in Bioequivalency Allergy Units should be started as if they were coming under treatment for the first time. Patients being switched from one lot of Standardized Cat Hair to another lot of Standardized Cat Hair (from the same or different manufacturers) should have the initial dose from the new lot reduced by 75%. Patients being switched from a Standardized Cat Pelt extract to a Standardized Cat Hair extract (both labeled in BAU/mL) should be skin tested with both extracts to determine the relative potency of the extracts and the dosage adjusted accordingly.

  Recommended usual dosage and range: (Scratch or Prick Testing)

  The general method of making a scratch test is to first scarify the skin and then apply a drop of extract to the scratch. Make scarifications at least 2.5 cm apart. Hold the scarifier between thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt the outer layers of epidermis but should not produce immediate oozing of blood. One drop (0.05 mL) of extract is rubbed or applied into each scratch. Always apply a control scratch with each test set. Sterile Diluting fluid (for a negative control) is used in exactly the same way as an active test extract. Histamine may be used as a positive control. Scratch or prick test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction.

  Recommended usual dosage and range: (Intradermal Testing)

  Patients 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 0.05 mL of a 50 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 100 BAU/mL extract dilution. The negative puncture control must be diluted appropriately for intradermal use. .

  To prepare a 50 BAU/mL dilution from 10,000 BAU/mL vial:

  Take 5.0 mL of the 10,000 BAU/mL + 5.0 mL of diluent =Vial A @5,000 BAU/mL.

  Take 1.0 of vial A + 9.0 mL diluent = vial B @500 BAU/mL.

  Take 1.0 of vial B + 9.0 mL diluent = vial C @50 BAU/mL.

  Patients being suspected of being highly allergic should be tested with 0.05 mL of a 0.1 BAU/mL dilution. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximal recommended strength of 100 BAU/mL is reached. The negative puncture test control must be diluted appropriately for intradermal use. To prepare this dilution follow the tenfold dilution series chart for therapeutic allergens.

  Allergic response is based on measurement of wheal and erythema with respect to positive and negative control skin tests. 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.

  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, and the clinical response and tolerance to the extract administered during the injection regimen. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment.

  In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be 0.05mL of 0.01 to 0.1 BAU/mL. Patients with lesser sensitivity may be started using 1.0 BAU/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.

  Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. Any evidence of a local or generalized reaction requires a reduction in dosage. 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 more slowly. The upper limits of dosage have not been established. Doses larger than 0.2 mL of 10,000 BAU/mL may be painful due to glycerin content. (9)

  Preparation Instructions To prepare a dilution for intradermal and therapeutic use, one starts with 10,000 BAU/mL stock concentrate and makes a 1:10 dilution by adding 1.0 mL of the concentrate to 9.0 mL of sterile diluent. Subsequent dilutions are made in similar manner.

  TEN-FOLD DILUTION SERIES Dilution Extract Diluent mL BAU/mL 0 Concentrate 0 10,000 1 1mL concentrate 9 1,000 2 1mL dilution #1 9 100 3 1mL dilution #2 9 10 4 1mL dilution #3 9 1 5 1mL dilution #4 9 0.1 6 1mL dilution #5 9 0.01

  Intervals between doses: The optimal interval between doses of allergenic extract has not been definitely established. However, as it is customary practiced, injections are given once or twice 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.

  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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• Allergy Laboratories, Inc.
  

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  Standardized Cat Hair | Allergy Laboratories, Inc.

  

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  DIAGNOSTIC SKIN TESTING:

  Puncture tests performed on 10 highly sensitive patients with 10,000 BAU/ml Cat Hair Extract showed a mean sum of diameter wheal of 17.00mm ± 4.59 and a mean sum of diameter Erythema of 71.60 +14.01.

  Intradermal skin test results in highly sensitive patients is shown below using the same extract as used in the puncture test above.

  BAU/ml to elicit 50mm sum of Diameter of Erythema reaction Number of Patients Mean       Range            10 0.0128       0.0021-0.1957

  These products are used to determine a patient's sensitivity to specific antigens and aid in the diagnosis and treatment of atopic diseases. After a thorough history a decision can be made as to which allergens will be appropriate to use for testing. The recommended procedure is to initially perform puncture tests, then follow with intradermal tests. See recommended dosage below.

  * The negative intradermal control used for the 100 BAU/ml concentration should contain 0.5% (v/v) glycerin. SCRATCH OR PUNCTURE TEST:       Concentration   Dosage       10,000 BAU/ml     0.05 ml (1 drop) INTRADERMAL TEST: A. Patients with a negative scratch or puncture test.       Concentration Dosage       1) 50 BAU/ml 0.02 ml       2) 100 BAU/ml* if 50 BAU/ml is negative B. Patients tested by intradermal only.       Concentration Dosage        0.5 BAU/ml 0.02 ml If negative, repeat tests with stronger concentrations
  until a maximum of 100 BAU/ml* is reached.

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• Jubilant Hollisterstier Llc
  

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  Standardized Cat Hair | Jubilant Hollisterstier Llc

  

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  3, 16, 17, 18
  (1) General
  Sterile aqueous diluent containing human serum albumin is recommended when preparing dilutions of the concentrate for intradermal testing or immunotherapy. 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 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 tests are performed by placing a drop of extract on the skin and piercing through the drop perpendicular to the skin with a device such as a Prick Lancetter. After about 1 minute the extract may be wiped away with a dry sponge. The diameter of wheal and erythema reactions are measured 15 minutes after the prick or puncture is made, and the sensitivity class of the patient determined by the table presented at the end of the diagnosis section. Less sensitive individuals (Class 0 to 1+) can be tested intradermally with the recommended dilutions of the extract concentrate (see intradermal testing information below). The skin test concentration of 10,000 BAU/mL (10-19.9 Fel d 1 units/mL) in dropper vials is used for prick or puncture testing. Puncture tests performed on 15 highly sensitive subjects showed the following:
  Product
  Mean Sum of Wheal ± Std. Dev. (mm)
  Mean Sum of Erythema ± 1 Std. Dev. (mm)
  Standardized Cat Hair
  15.1 ± 3.8
  73.3 ± 14.3
  The sum of a skin response is the sum of the longest diameter and the midpoint orthogonal diameter.
  
  Intradermal endpoint titration (IET) tests were completed using the same 15 subjects to determine the mean concentration required to produce a ∑E of 50mm (D 50). That concentration contained 0.049 BAU/mL (range 0.006 to 0.661 BAU/mL). Intradermal extract should be used as follows: Intradermal Tests should be done only on patients with a negative prick or puncture test. Patients who do not react to a valid prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 100 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 1,000 BAU/mL extract solution. If the intradermal dilutions were prepared from glycerinated concentrate, the negative control used with this latter dilution should contain 5% glycerol. Skin tests are graded in terms of the wheal and erythema response noted at 15 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
  < 5 mm
  <5 mm
  <10 mm
  ±
  5-10 mm
  5-10 mm
  10-20 mm
  1+
  5-10 mm
  11-20 mm
  20-40 mm
  2+
  5-10 mm
  21-30 mm
  40-60 mm
  3+
  10-15 mm a
  31-40 mm
  60-80 mm
  4+
  >15 mm b
  >40 mm
  >80 mm
  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 aqueous diluent. 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 10-20 mm erythema (∑E 20-40 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 which 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 20 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 glycerinated concentrate may be painful due to the glycerin content. The dosage of 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 10,000 BAU/mL
  Dilution
  Extract
  + Diluent
  =
  BAU/mL
  Concentration
  0
  Concentrate
  +0 mL
  =
  10,000
  1
  1 mL concentrate
  +9 mL
  =
  1,000
  2
  1 mL dilution #1
  +9 mL
  =
  100
  3
  1 mL dilution #2
  +9 mL
  =
  10
  4
  1 mL dilution #3
  +9 mL
  =
  1
  5
  1 mL dilution #4
  +9 mL
  =
  0.1
  6
  1 mL dilution #5
  +9 mL
  =
  0.01
  7
  1 mL dilution #6
  +9 mL
  =
  0.001
  
  (4) Pediatric Use

  (See PRECAUTIONS)
  

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