Standardized Mite Dermatophagoides Pteronyssinus
Dosage form: injection
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This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction.
Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. 1 Therefore, emergency measures and personnel trained in their use should be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur.
Standardized glycerinated extracts may be more potent than regular extracts and therefore, are not directly interchangeable with non-standardized extracts, or other manufacturers' products.
This product should never be injected intravenously.
Refer also to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE sections for further discussion.
DESCRIPTION:
Mite extract is a sterile solution containing the extractables of Dermatophagoides farinae or Dermatophagoides pteronyssinus, 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin by volume as a preservative. Source material for the extract is the whole bodies of the mites. The mites are grown on a medium of brine shrimp eggs and wheat germ, and are handled and cleaned in a manner that the maximum carryover of the medium components is less than 1%. The medium contains no material of human origin.
Sterile, diluted mite extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% albumin (human), not more than 0.003% sodium bicarbonate, and 0.4% phenol as a preservative.
Skin test trials were conducted to evaluate the skin reactivity of medium components mixed in the approximate proportion used for mite growth. Twenty-three individuals who were puncture test reactive (∑E≥40mm) to either D. farinae or
