POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS- sagebrush, mugwort artemisia vulgaris injection, solut

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D)

Available from:

Jubilant HollisterStier LLC

INN (International Name):

ARTEMISIA VULGARIS POLLEN

Composition:

ARTEMISIA VULGARIS POLLEN 0.05 g in 1 mL

Administration route:

PERCUTANEOUS

Therapeutic indications:

Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed antigen. Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to dog dander in kennel owners and employees,

Product summary:

In 10 mL, 30 mL and 50 mL vials at the w/v, Concentrate, v/v dilution of Concentrate, AU/mL (Standardized Mite Extracts: D. farinae, D. pteronyssinus 10,000 and 30,000 AU/mL; Mite Mixtures: 5,000 AU/mL each species, or 15,000 AU/mL each species), BAU/mL (Standardized Cat Hair and Cat Pelt extracts: 10,000 BAU/mL; Standardized Grass extracts: 10,000 and 100,000 BAU/mL); Amb a 1 units/mL; or PNU/mL ordered by the physician. Please see the current Allergy Product Catalog.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA
VULGARIS- SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS INJECTION, SOLUTION
POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING SHAD ATRIPLEX
CANESCENS- SCALE, WING SHAD ATRIPLEX CANESCENS INJECTION, SOLUTION
POLLENS - WEEDS AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS-
SCOTCH BROOM CYTISUS SCOPARIUS INJECTION, SOLUTION
POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA-
SORREL, SHEEP RUMEX ACETOSELLA INJECTION, SOLUTION
POLLENS - WEEDS, CARELESS WEED AMARANTHUS PALMERI- CARELESS WEED
AMARANTHUS PALMERI INJECTION, SOLUTION
POLLENS - WEEDS, CARELESS/PIGWEED MIX- CARELESS/PIGWEED MIX INJECTION,
SOLUTION
POLLENS - WEEDS, DOCK/SORREL MIX- POLLENS - WEEDS, DOCK/SORREL MIX
INJECTION,
SOLUTION
POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX- GIANT, SHORT,
WESTERN
RAGWEED MIX INJECTION, SOLUTION
JUBILANT HOLLISTERSTIER LLC
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ALLERGENIC EXTRACTS IN BULK VIALS
WARNINGS
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 must
be available immediately
in the event of such a reaction.
Patients should be instructed to recognize adverse reaction symptoms,
be observed in the office
for at least 30 minutes after skin testing or treatment, and be
cautioned to contact the physician's
office if symptoms occur. See ADVERSE REACTION section of this package
insert regarding
adverse event reporting.
Standardized glycerinated extracts may be more potent than regular
extracts and therefore are not
directly interchangeable with non-standardized extracts, or other
manufacturers' products.
Patients with cardiovascular diseases and/or pulmonary diseases such
as symptomatic unstable,
steroid dependent asthma, and/or those w