Parental drug products should be inspected visually for particulate matter and discoloration prior to adminitration, whenever solution and container permit. The product should be discarded if discoloration or particles are observed.

DIAGNOSTIC USE: Standardized grass pollen extract may be used to diagnose sensitivity to grass pollen by performing skin tests on persons with a history of grass pollen allergy. Due to the risk of adverse reactions occuting in highly sensitive persons, it is mandatory to initially test all patients percutaneously using the scratch, prick or puncture method. If a properly performed percutaneous test is negative, an intradermal test may be used with caution. 

PUNCTURE TEST: The punture test should be performed first with 10,000 BAU/mL extract. Data for the puncture test using 10,000 BAU/mL extract are summarized in Table 1 under CLINICAL PHARMOCOLOGY. If the puncture test to 10,000 BAU/mL extract is negative, the test may be repeated using 100,000 BAU/mL extract. Appropriate positive and negative controls for skin test interpretation are necessary. Reactions are quarntified based on size of erythema and wheal in reaction to controls. 

INTRADERMAL TEST: An intradermal test should only be performed after a puncture test has been properly administered with a negative result. It is usually safe to initiate intradermal testing with a 1:1,000 v/v diluton of the extract to which a negative puncture test was observed. For example, if a puncture test is done with 10,000 BAU/mL extract and is negative, the intradermal test may be performed with 0.05 mL of 10 BAU/mL extract. The dose may be increased to 0.05 mL of 100 BAU/mL extract if the intradermal test with 10 BAU/mL extract is negative. 

THERAPEUTIC USE: The dosage of grass pollen extract administered by subcutaneous injection during immunotherapy is highly individualized and varies according to the patient. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be low, such as 0.1 mL of a 0.01 BAU/mL dilution. The amount of extract is increased at each injection, but not more than 50%-100% of the previous amount, and the next increment is governed by the response to the last injection. Local reactions that persist longer than 24 hours are undesirable and any systemic reaction is an indication that the dose should be reduced (at least 50%). The upper limits of dosage have not been established, but doses larger than 0.2 mL of concentrate containing 50% glycerol may be painful due to the glycerol in the extract. The potency of each standardized grass pollen in a final mixture should not exceed that obtained from using a 10,000 BAU/mL stock concentrate of each grass included in the mix. Concentrate containing 100,000 BAU/mL should be diluted to 10,000 BAU/mL extract before being used to prepare final mixtures, or alternatively, the volume of 100,000 BAU/mL extract added to the mixture should be reduced 10-fold. 

The optimum interval between dosed of grass pollen extract has not been definitely established. However, as is customarily practiced, injections are given one or two times per week until the maintenance dose is reached. At this time, the injection interval may be increased to 2 weeks, then to 3 weeks and finally 4 weeks. If the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 50% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made, depending on the amount of time that has elapsed since the last injection. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced 75% [one-quarter (25%) of the previous dose administered from the old lot of extract]. A period of three to five years of injection therapy constitutes an average course of treatment. Children and geriatric patients appear to tolerate injections of allergenic extract well, and no special recommendations need to be made for these groups (see PRECAUTIONS - PEDIATRIC USE).

PREPARING DILUTIONS: To prepare dilutions for intradermal skin tests and therapeutic use, the stock concentrate may be diluted as shown in Table 4. Vial #1 is made by adding 1.0 mL of the concentrate to 9.0 mL of sterile diluent. This process is repeated until the desired concentration is achieved. Each number of allergy units per mL in each dilution is shown in Table 4. 

*If 100,000 BAU/mL extract is used to prepare dilutions, the 100,000 BAU/mL extract should be diluted 1:10 v/v before the directions shown in the table are followed.