SLENDER RAGWEED- ambrosia confertiflora solution SOUTHERN RAGWEED- ambrosia bidentata solution SHEEP RED SORREL- rumex acetose

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMBROSIA CONFERTIFLORA POLLEN (UNII: 63TBJ590BL) (AMBROSIA CONFERTIFLORA POLLEN - UNII:63TBJ590BL)

Available from:

Greer Laboratories, Inc.

Administration route:

INTRADERMAL

Therapeutic indications:

Non-Standardized Allergenic Extracts are indicated for: - Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens. - Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. Food extracts have not been proven safe or effective in allergen immunotherapy. Non-Standardized Allergenic Extracts are contraindicated in patients with: - Severe, unstable or uncontrolled asthma - History of any severe systemic or local allergic reaction to an allergen extract 8.1 Pregnancy Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no human or animal data to establish the presence or absence of Non-Standardized

Product summary:

Non-Standardized Allergenic Extracts and mixes may be supplied as aqueous stock concentrates of up to 1:10 weight/volume or 40,000 PNU/milliliter for intradermal and subcutaneous testing. The extracts may also be supplied as 50% glycerin stock concentrates of up to 1:20 weight/volume for use in percutaneous skin testing and subcutaneous immunotherapy. Non-Standardized Allergenic Extracts are labeled in weight/volume and/or PNU/milliliter and may be provided in 5, 10, and 50 milliliter vials. Glycerinated extracts are also supplied in 5 milliliter dropper vials for prick or puncture testing. Non-Standardized Allergenic Extracts available are as follows: 16.2 Storage and Handling Maintain at 2 to 8°C (36 to 46°F) during storage and use. Dilutions of concentrated extracts that result in a glycerin content of less than 50% can reduce extract stability. Extract dilutions at 1:100 volume to volume 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 allergic patient.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

SLENDER RAGWEED- AMBROSIA CONFERTIFLORA SOLUTION
SOUTHERN RAGWEED- AMBROSIA BIDENTATA SOLUTION
SHEEP RED SORREL- RUMEX ACETOSELLA SOLUTION
ALLSCALE- ATRIPLEX POLYCARPA SOLUTION
YELLOW CURLY DOCK- RUMEX CRISPUS SOLUTION
DESERT RAGWEED- AMBROSIA DUMOSA SOLUTION
FALSE RAGWEED- AMBROSIA ACANTHICARPA SOLUTION
SCALE ATRIPLEX MIX- ATRIPLEX POLYCARPA, ATRIPLEX LENTIFORMIS AND
ATRIPLEX
CANESCENS SOLUTION
WESTERN RAGWEED MIX- AMBROSIA ACANTHICARPA, AMBROSIA
PSILOSTACHYA SOLUTION
IODINE BUSH- ALLENROLFEA OCCIDENTALIS SOLUTION
BURROBRUSH- HYMENOCLEA SALSOLA SOLUTION
3 WEED MIX- XANTHIUM STRUMARIUM, CHENOPODIUM ALBUM, AMARANTHUS
RETROFLEXUS SOLUTION
LENSCALE QUAILBRUSH- ATRIPLEX LENTIFORMIS SOLUTION
TRUE ROUGH MARSH ELDER- IVA ANNUA SOLUTION
RABBIT BUSH- AMBROSIA DELTOIDEA SOLUTION
DOG FENNEL- EUPATORIUM CAPILLIFOLIUM SOLUTION
GIANT RAGWEED- AMBROSIA TRIFIDA SOLUTION
NATIONAL WEED MIX- XANTHIUM STRUMARIUM, AMBROSIA TRIFIDA, CHENOPODIUM
ALBUM, AMARANTHUS RETROFLEXUS AND AMBROSIA ARTEMISIIFOLIA SOLUTION
BURWEED GIANT POVERTY MARSH ELDER- IVA XANTHIFOLIA SOLUTION
COMMON MUGWORT- ARTEMISIA VULGARIS SOLUTION
ENGLISH PLANTAIN- PLANTAGO LANCEOLATA SOLUTION
SPINY PIGWEED- AMARANTHUS SPINOSUS SOLUTION
COMMON WEED MIX- XANTHIUM STRUMARIUM, PLANTAGO LANCEOLATA,
CHENOPODIUM ALBUM, AMARANTHUS RETROFLEXUS AND SALSOLA KALI SOLUTION
COMMON SAGEBRUSH- ARTEMISIA TRIDENTATA SOLUTION
WINGSCALE- ATRIPLEX CANESCENS SOLUTION
SAGE MIX- ARTEMISIA TRIDENTATA AND ARTEMISIA LUDOVICIANA SOLUTION
RUSSIAN THISTLE- SALSOLA KALI SOLUTION
PALMERS AMARANTH- AMARANTHUS PALMERI SOLUTION
DOCK-SORREL MIX- RUMEX ACETOSELLA AND RUMEX CRISPUS SOLUTION
WESTERN RAGWEED- AMBROSIA PSILOSTACHYA SOLUTION
ROUGH REDROOT ROUGH REDROOT- AMARANTHUS RETROFLEXUS SOLUTION
CARELESS WEED, AMARANTH GREEN- AMARANTHUS HYBRIDUS SOLUTION
PIGWEED MIX- AMARANTHUS HYBRIDUS, AMARANTHUS PALMERI AND AMARANTHUS
RETROFLEXUS SOLUTION
CENTRAL WESTERN WEED MIX- KOCHIA SCOPARIA, CHENOPODIUM ALBUM AND
SALSOLA KALI SOLUTION
BACCHARIS- BACCHARIS SPP. SOLUTION
FIREBUSH KOCHIA- KOCHIA SCOPARIA SOLUTION
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