Dermatophagoides Farinae And Dermatophagoides Pteronyssinus
Generic Name: dermatophagoides farinae and dermatophagoides pteronyssinus
Brand Names:
Standardized Mite Dermatophagoides Farinae, Standardized Mite Dermatophagoides Pteronyssinus, Standardized Mite Mix Dermatophagoides Farinae And Dermatophagoides Pteronyssinus
11 DESCRIPTION Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus ), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.
Overview
11 DESCRIPTION Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus ), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.
Uses
1 INDICATIONS AND USAGE Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity.
Dosage
2 DOSAGE AND ADMINISTRATION Do not inject intravenously. Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded. 2.1 Diagnostic Testing For diagnosis of a patient with a suspected allergy to either species of dust mite ( D. farinae or D.
Side Effects
6 ADVERSE REACTIONS Systemic reactions consist primarily of allergic symptoms, such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death. Based on published studies, 7,8 systemic reactions occur in less than 1% of patients receiving conventional immunotherapy to greater than 36% in some studies of patients receiving rush immunotherapy. Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain).
Interactions
7 DRUG INTERACTIONS 7.1 Beta Adrenergic Drugs Patients receiving beta blocker drugs may not be responsive to beta adrenergic drugs used to treat anaphylaxis 10 , and may wish to temporarily postpone treatment day of skin testing. All such decisions should be made in consultation with the physician [see Warnings and Precautions (5.2)]. 7.2 Antihistamines 1 Skin testing with allergenic extracts should not be performed within 2-3 days of first-generation H 1 -histamine receptor blockers (e.g., clemastine, diphenhydramine) and within 3 to 10 days of second-generation antihistamines (e.g., loratadine, terfenadine), except for astemizole, which requires an interval of 30-60 days between allergenic extract exposure and use.
Warnings
WARNING: ANAPHYLAXIS Do not inject intravenously. (2.2) Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. (5.1) This allergenic product is intended for use only by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. (5.1) The initial dose must be based on skin test. 5 WARNINGS AND PRECAUTIONS 5.1 Serious Systemic Reactions All concentrates of Greer Standardized Mite Extracts have the ability during skin testing and immunotherapy to elicit serious systemic reactions including anaphylactic shock and death [see Adverse Reactions (6)]. A review of the literature indicates that the incidence of near-fatal reactions to immunotherapy, defined as severe respiratory compromise, hypotension, or both, and requiring emergency treatment with epinephrine, has been estimated as 5.4 events per million injections in a 10-year retrospective survey of allergists. 3 Fatalities from immunotherapy injections have been estimated to occur at a rate of approximately one death per 2.0 to 2.8 million injections in 4-, 10- and 12-year retrospective surveys of allergists. 4 CONTRAINDICATIONS None. None (4)
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Mite extracts in 50% Glycero-Coca solution are supplied as follows: D. farinae : NDC 22840-0033 5,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 5 mL percutaneous test vial D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 10, 30, and 50 mL vials D.
Frequently Asked Questions
What is Dermatophagoides Farinae And Dermatophagoides Pteronyssinus used for?▼
1 INDICATIONS AND USAGE Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity.
What are the side effects of Dermatophagoides Farinae And Dermatophagoides Pteronyssinus?▼
6 ADVERSE REACTIONS Systemic reactions consist primarily of allergic symptoms, such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death. Based on published studies, 7,8 systemic reactions occur in less than 1% of patients receiving conventional immunotherapy to greater than 36% in some studies of patients receiving rush immunotherapy. Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain).
What are the important warnings for Dermatophagoides Farinae And Dermatophagoides Pteronyssinus?▼
WARNING: ANAPHYLAXIS Do not inject intravenously. (2.2) Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. (5.1) This allergenic product is intended for use only by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. (5.1) The initial dose must be based on skin test. 5 WARNINGS AND PRECAUTIONS 5.1 Serious Systemic Reactions All concentrates of Greer Standardized Mite Extracts have the ability during skin testing and immunotherapy to elicit serious systemic reactions including anaphylactic shock and death [see Adverse Reactions (6)]. A review of the literature indicates that the incidence of near-fatal reactions to immunotherapy, defined as severe respiratory compromise, hypotension, or both, and requiring emergency treatment with epinephrine, has been estimated as 5.4 events per million injections in a 10-year retrospective survey of allergists. 3 Fatalities from immunotherapy injections have been estimated to occur at a rate of approximately one death per 2.0 to 2.8 million injections in 4-, 10- and 12-year retrospective surveys of allergists. 4 CONTRAINDICATIONS None. None (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.