Miller Moth

Miller Moth

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Questions & Answers

Side Effects & Adverse Reactions

Extreme caution is necessary when using diagnostic skin tests in highly sensitive patients who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment. IN THESE CASES THE POTENCY FOR SKIN TESTS MUST BE ADJUSTED TO THE PATIENT'S SENSITIVITY AND TOLERANCE. Refer to boxed “WARNINGS" and “OVERDOSAGE" sections.

Epinephrine 1:1000 should be available when a new lot of allergenic extract is utilized. Patient re-evaluation may be necessary. Injections should never be given intravenously. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following skin testing. Patients should be observed for 20-30 minutes after skin testing.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.

History

There is currently no drug history available for this drug.

Other Information

Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I).

The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:

The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic).

The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.).

The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum).

Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae).

Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera).

Cricket source material is pulverized whole bodies of crickets (Gryllidae).

Moth source material is pulverized whole bodies of moths of the order Frenatae.

The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.

FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:

INACTIVE INGREDIENTS:

Sodium chloride……………………………………………………………………...0.95%

Sodium bicarbonate………………………………………………………………….0.24%

USP Glycerine…………………………………………………………………50% (v/v)

Water for Injection…………………………………………………………q.s. to volume

Active allergens are described by common and scientific name on the stock concentrate container label.

Miller Moth Manufacturers


  • Antigen Laboratories, Inc.
    Miller Moth Injection, Solution [Antigen Laboratories, Inc.]

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