STANDARDIZED MITE DERMATOPHAGOIDES FARINAE- dermatophagoides farinae concentrate STANDARDIZED MITE MIX DERMATOPHAGOIDES FARINAE

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q)

Beschikbaar vanaf:

Greer Laboratories, Inc.

INN (Algemene Internationale Benaming):

Dermatophagoides farinae

Samenstelling:

Dermatophagoides farinae 5000 [AU] in 1 mL

Toedieningsweg:

INTRADERMAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. None. 8.1 Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with Greer Standardized Mite Extracts. It is also not known whether Greer Standardized Mite Extracts can cause fetal harm when administered to a pregnant woman or whether they can affect reproduction capacity. Standardized Mite Extracts should be given to a pregnant woman only if clearly needed. Studies have not been performed in animals to determine whether extracts affect fertility in males or females,

Product samenvatting:

16.1 How Supplied Mite extracts in 50% Glycero-Coca solution are supplied as follows: 16.2 Storage and Handling Store dust mite extract at 2 to 8°C (36 to 46°F). Keep dust mite extract at 2 to 8°C (36 to 46°F) during office use. Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

STANDARDIZED MITE DERMATOPHAGOIDES FARINAE- DERMATOPHAGOIDES
FARINAE CONCENTRATE
STANDARDIZED MITE MIX DERMATOPHAGOIDES FARINAE AND
DERMATOPHAGOIDES PTERONYSSINUS- DERMATOPHAGOIDES FARINAE AND
DERMATOPHAGOIDES
PTERONYSSINUS CONCENTRATE
STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS- DERMATOPHAGOIDES
PTERONYSSINUS CONCENTRATE
GREER LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GREER STANDARDIZED MITE EXTRACTS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GREER STANDARDIZED
MITE EXTRACTS.
STANDARDIZED MITE EXTRACT ( _DERMATOPHAGOIDES FARINAE_)
STANDARDIZED MITE EXTRACT ( _DERMATOPHAGOIDES PTERONYSSINUS_)
STANDARDIZED MITE EXTRACT MIXTURE ( _DERMATOPHAGOIDES FARINAE_ AND
_DERMATOPHAGOIDES PTERONYSSINUS_)
SOLUTION FOR PERCUTANEOUS, INTRADERMAL, OR SUBCUTANEOUS ADMINISTRATION
INITIAL U.S. APPROVAL: 1987
WARNING: ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DO NOT INJECT INTRAVENOUSLY (2.2)
ALLERGENIC EXTRACTS MAY CAUSE SEVERE LIFE-THREATENING SYSTEMIC
REACTIONS, INCLUDING THE RARE
OCCURRENCE OF ANAPHYLAXIS OR DEATH (5.1)
INTENDED FOR USE ONLY BY EXPERTS EXPERIENCED IN ADMINISTERING ALLERGIC
EXTRACTS AND TRAINED TO PROVIDE
EMERGENCY TREATMENT (5.1)
INITIAL DOSE MUST BE BASED ON SKIN TEST (2.1)
OBSERVE PATIENTS IN THE OFFICE FOR AT LEAST 30 MINUTES FOLLOWING
TREATMENT. EMERGENCY MEASURES
ANDPERSONNEL TRAINED IN THEIR USE MUST BE AVAILABLE IMMEDIATELY IN THE
EVENT OF LIFE THREATENING
RE AC TIO N(5.1)
IMMUNOTHERAPY MAY NOT BE SUITABLE FOR PATIENTS WITH MEDICAL CONDITIONS
THAT REDUCE THEIR ABILITY
TOSURVIVE A SYSTEMIC REACTION (5)
INDICATIONS AND USAGE
Greer Standardized Mite Extracts are allergenic extracts indicated
for: (1)
Diagnosis of skin test reactivity to dust mite allergen (1)
Treatment of mite-induced allergic asthma, rhinitis and conjunctivitis
in patients that show hypersensitivity to dust
mites based on clinical history, allergen exposure history, and skin
test reactivity (1)
(