Nielsen Biosciences, Inc.
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Nielsen Biosciences, Inc. Drugs
2.1 Preparation for Administration
Spherusol ® is a clear, colorless sterile solution for intradermal administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exists, the skin test antigen should not be administered.
Spherusol ® is administered as a 0.1 mL dose by intradermal injection to the volar surface of the forearm using a tuberculin syringe (0.5 or 1.0 mL) and a ½ inch 26-27 gauge needle. The needle should be inserted bevel side up in the skin at a 15-20 degree angle. Intradermal injection of 0.1 mL Spherusol ® will result in a bleb 5-10 mm in diameter at the injection site.
2.3 Skin Test Assessment
The injection site should be assessed for induration at 48 hours (±4 hours) following administration. The response to the skin test should be measured by taking the mean of the orthogonal diameters of the area of induration. A mean induration of ≥ 5 mm is considered a positive delayed-type hypersensitivity response to Spherusol ®.
Repeat administration of Spherusol ® has not been evaluated.
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