Standardized Grass Pollen

Standardized Grass Pollen Manufacturers

• Jubilant Hollisterstier Llc
  

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  Standardized Grass Pollen | Jubilant Hollisterstier Llc

  

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  1. General
  Sterile aqueous diluent containing albumin (human) [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 (0.4%) 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
  Prick or Puncture Test: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick or puncture test using a drop of 10,000 BAU/mL extract be performed prior to initiating intradermal testing. If this test is negative, a second prick/puncture test may be performed using a 100,000 BAU/mL extract. 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 concentrate on the skin and piercing 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 Table 3. Less sensitive individuals (Class 0 to 1+) can be tested intradermally with the recommended dilutions of the extract concentrate (See intradermal testing instructions).
  Intradermal Test: Patients with a negative prick or puncture test should be tested intradermally with 100 BAU/mL. If this test is negative, a second intradermal test may be performed using a 1,000 BAU/mL extract. The negative control should have glycerin concentration equivalent to the glycerin concentration of the intradermal test solution, not to exceed 5% glycerin.
  It is recommended that patients be tested using the intradermal technique only after screening by prick or puncture test.
  Extract for intradermal testing should be prepared by diluting the stock concentrate, provided in multiple-dose vials, with Sterile Albumin Saline with Phenol (0.4%) (refer to Table 4 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 below. 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 Table 3 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.

  TABLE 3 Classification of Skin Test Sensitivity for Intradermal and Pick or Puncture 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
  Allergenic 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 4.) 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 ∑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.
  Potencies of 10,000 BAU/mL and 100,000 BAU/mL are available for treatment. The two selections are available to facilitate safe switching by providing flexibility in dosing. For previously untreated patients, initiate treatment using dilutions made from the 10,000 BAU/mL concentrate. If tolerated and symptoms justify a higher dosage, then use of dilutions made from the 100,000 BAU/mL concentrate is warranted. Proceed with caution when using 100,000 BAU/mL in higher doses.
  When converting a patient who is currently receiving non-standardized grass pollen extracts, it is recommended that skin testing be performed to compare the potency of the new and old extracts. If you choose not to skin test as recommended, but to continue therapy, the maximum first dose of the new allergenic product should not exceed 10% (1/10) of the previous dose.
  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 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 4
  TEN-FOLD DILUTION SERIES
  Standardized Extracts Labeled 100,000 BAU/mL
  Dilution
  Extract
  + Diluent
  =
  BAU/mL Concentration
  0 Concentrate
  +0 mL
  =
  100,000 1 1 mL Concentrate +9 mL
  =
  10,000 2 1 mL dilution #1 +9 mL = 1,000 3 1 mL dilution #2 +9 mL = 100 4 1 mL dilution #3 +9 mL = 10 5 1 mL dilution #4 +9 mL = 1.0 6 1 mL dilution #5 +9 mL = 0.10 7 1 mL dilution #6 +9 mL = 0.010 (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 65.4

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