Animal Allergens

Animal Allergens Manufacturers

• Jubilant Hollisterstier Llc
  

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  Animal Allergens | Jubilant Hollisterstier Llc

  

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  1. General
  Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  2. Scratch, Prick or Puncture Testing Methods
  There are two general methods of skin testing. (1) The skin is scarified first, and the extract is then applied. (2) A drop of extract is put onto the skin, and a prick or puncture is made through the drop. Avoid touching tip of dropper to skin. Either method is satisfactory, but the second requires that the instrument be cleansed between tests or that separate needles be used.

  The extracts for scratch, prick or puncture testing are supplied in dropper vials and should be kept in a rack or box in rows of 10 vials corresponding to the rows of tests to be applied to the skin.

  All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests (e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol). The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract.

  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. Delayed reactions may rarely occur from tests, so it may be helpful to examine the test sites in 24 hours.

  Use of Scarifiers and Spacing. Make scarifications at least 2.5 cm apart. Use more space between pollen tests to prevent smearing into adjacent sites. Hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt only the outer layers of epidermis but should not produce immediate oozing of blood. The amount of pressure needed to produce a satisfactory scratch will vary between patients according to the thickness or fragility of their skin. Experience will indicate the proper amount of pressure to exert in making the scratch. If the scarifier is kept sharp and the scratch made quickly, discomfort to the patient is minimized.

  Use of Prick Test Needles. The skin is cleaned and single drops of each extract applied to the properly identified test sites. A small, sterile disposable needle, such as a 1/2-inch 26 gauge needle (with the bevel up), a bifurcated vaccinating needle, or a Prick Lancetter™ is inserted through the drop superficially into the skin, the skin lifted slightly and the needle withdrawn. No bleeding should be produced. After about 1 minute the extract may be wiped away.

  3. Most Satisfactory Sites for Testing
  Prior to testing, clean the skin area to be tested with ether or alcohol and allow to dry. Use a sterile instrument for each patient. The back or the volar surface of the arms are the most satisfactory sites for testing. Skin of the posterior thighs or abdomen may be used if necessary. Avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret. The most satisfactory areas of the back 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 of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space.

  4. Use of Antigen Mixes
  The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction, it does not indicate which pollen(s) are responsible, and, in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.

  5. Reading Skin Test Reactions
  A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient’s sensitivity to that allergen.

  Standardized Products
  (a) Mites:
  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 highly sensitive subjects showed the following:

  Species
  Mean Sum of Wheal
  ± Std. Dev. (mm)
  Mean Sum of Erythema
  ± Std. Dev. (mm)
  D. farinae
  22.4 ± 10.7
  82.2 ± 21.7
  D. pteronyssinus
  24.0 ± 9.9
  89.3 ± 24.5

  The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.
  

  (b) Cat Hair and Cat Pelt: 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
  ± Std. Dev (mm)
  Standardized
  Cat Hair
  15.1 ± 3.8
  73.3 ± 14.3
  Standardized
  Cat Pelt
  13.9 ± 4.3
  67.3 ± 13.3

  The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.

  (c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: Short Ragweed extract at 1:20 w/v in 50% glycerin containing approximately 100 to 300 units of Antigen E/mL or Giant and Short Ragweed Mix at 1:20 w/v in 50% glycerin containing approximately 50 to 150 units of Antigen E/mL are usually used for scratch, prick or puncture testing.
  Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

  Grade
  Erythema
  mm
  Papule or Wheal
  mm
  Corresponding
  mm ∑E
  0
  <5
  <5
  <10
  ± 5-10
  5-10
  10-20
  1+
  11-20
  5-10
  20-40
  2+
  21-30
  5-10
  40-60
  3+
  31-40
  10-15 (a)
  60-80
  4+
  >40
  >15 (b)
  >80
  (a) or with pseudopods (b) or with many pseudopods

  A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of the year, known exposures, and eating habits.
  THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGIC HISTORY. THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.

  6. Geriatric Use

  
  The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1

  7. Pediatric Use

  
  The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1

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• Jubilant Hollisterstier Llc
  

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  Animal Allergens | Jubilant Hollisterstier Llc

  

  ---

  1. General
  Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  2. Intradermal Testing Methods
  Cleanse the rubber stopper of the vial with liquid antiseptic before withdrawing extract. A sterile tuberculin syringe with 26-gauge, short-bevel needle should be used for the injection. The anterior surface of the upper and lower arm is preferable for testing. Cleanse the skin with soap and water or wash with alcohol or other antiseptic. Introduce the needle between the superficial layers of the skin and inject 0.02 mL of the extract. Test sites should be at least 2.5 cm apart, and no more than 10 to 20 antigens should be introduced at one time. This group can be followed with additional groups of 10, providing the reactions are not numerous or strong. The same amount of extract should be injected in each site for proper comparison. It is advisable to avoid testing with more than one allergen in the same group in each series, i.e., nuts, fish, epidermals, etc. A site should be injected with 0.02 mL of the control solution. All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests [e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol (0.4%)]. The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract. False positive reactions are sometimes encountered in intradermal testing, and the possibility of irritation reactions should always be taken into consideration. In cases where the patient is known to be quite sensitive, screen testing by scratch, prick or puncture method is recommended, and intradermal testing should be done with caution. The intradermal strength supplied is usually safe for testing patients presenting negative scratch, prick or puncture test reactions. It is recommended that a 1:10 dilution of the stock intradermal strength be used in preliminary testing of patients not previously screened by scratch, prick or puncture tests.
  
  3. Use of Antigen Mixes
  The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction it does not indicate which pollen(s) are responsible, and in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.
  
  4. Reading Skin Test Reactions
  A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient's sensitivity to that allergen.
  Standardized Products
  (a) Mites: The skin test concentrations of 30 AU/mL and 300 AU/mL in multiple dose vials are used for intradermal testing.
  Intradermal skin test results in selected highly sensitive subjects are presented for reference purposes:
  AU/mL that Elicited ∑E = 50 mm Allergen
  Number of
  Persons
  Mean
  2 Std. Dev. Range
  D. farinae
  12
  0.0609
  0.0015-2.6016
  D. pteronyssinus
  12
  0.333
  0.0003-4.0077
  Intradermal extracts should be used as follows:
  (1) 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.
  (2) 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.
  (b) Cat Hair and Cat Pelt: Intradermal endpoint titration (IET) tests were completed with Cat Pelt extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 (D 50) mm.That concentration contained 0.042 BAU/mL (range 0.002 to 0.890 BAU/mL).
  IET tests were completed with Cat Hair extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 mm (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% glycerin.
  Standardized Cat Hair and Cat Pelt products are not interchangeable with each other or any other cat products including those labeled AU/mL.
  (c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: The intradermal strength for Short Ragweed extract is usually 500 PNU, which by calculation contains approximately 0.7 to 3 units of Antigen E/mL. For Giant and Short Ragweed mix the suggested intradermal strength is 500 PNU, which by calculation contains 0.4 to 1.5 units of Antigen E/mL. These strengths are usually safe for testing patients previously having negative scratch, prick or puncture test reactions. A 1:10 dilution of the stock intradermal strength should be used in preliminary testing of patients not previously screened by scratch, prick, or puncture tests. A study of ragweed sensitive patients9 indicates that intradermal tests, using 0.05 mL of extract, produce positive reactions (1+ to 2+) at Antigen E concentrations of from 2.7x10 -1 to 2.7x10 -6 units per mL. The equivalent PNU range was 100 to 0.001 PNU per mL. 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. 5. Geriatric Use

  The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1

  6. Pediatric Use

  The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1
  

  Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

  Grade
  Erythema
  mm
  Papule or Wheal
  mm
  Coresponding
  mm ∑E
  0
  <5
  <5
  <10
  ±
  5-10
  5-10
  10-20
  1+
  11-20
  5-10
  20-40
  2+
  21-30
  5-10
  40-60
  3+
  31-40
  10-15 (a)
  60-80
  4+
  >40
  >15 (b)
  > 80
  

  a or with pseudopods

  b or with many pseudopods
  

  A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of year, known exposures, and eating habits.
  THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGENIC HISTORY; RATHER, THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.

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• Jubilant Hollisterstier Llc
  

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  Animal Allergens | Jubilant Hollisterstier Llc

  

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  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  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.
  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 and may be very painful.
  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. Dilutions should be made accurately and aseptically, using sterile diluent, vials, syringes, etc. Mix thoroughly and gently by rocking or swirling. Maintain stock solutions and dilutions constantly at 2° - 8°C. 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.
  Following is 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 according to the patient's tolerance and reaction. Decrease the size of the dose if the previous injection resulted in marked local or the slightest general reaction. Another dose should never be given until all reactions resulting from the previous dose have disappeared.
  The starting dose should be based on skin tests of the extract to be used for immunotherapy. 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 0-40 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. Subsequent doses can 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 for a pollen extract is 0.2 mL of the Concentrate, while for a non-pollen extract the maximum suggested dose is 0.5 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 is normally 3 to 7 days during dose building regimen.
  Normally immunotherapy can be started with a 1:100,000 dilution of extracts labeled in weight/volume. Certain therapeutic mixtures are labeled as Concentrate, (v/v) dilutions of Concentrate, Amb a 1, Allergy units/mL or Bioequivalent Allergy Units/mL. (See DESCRIPTION.) Strength of each antigen in the mixture is indicated in the product labeling. For beginning treatment, use at least a 1,000-fold dilution of the Concentrate extract for non-pollens, and at least a 10,000-fold dilution of the Concentrate extract for pollens.
  In some patients, the dosage may be increased more rapidly than recommended above. 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.
  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.
  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 extract may be painful if glycerin is present. 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.
  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.)
  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. 2. Pediatric Use

  The dose for the pediatric population is the same as for adults.
  
  

  
  

  3. Geriatric Use

  The dose for elderly patients is the same as for adult patients under 65.36

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