POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE- johnson grass sorghum halepense injection, solution POLLENS - GRASSES, OATS

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
16-06-2017

Aktiv ingrediens:

SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP)

Tilgjengelig fra:

Jubilant HollisterStier LLC

INN (International Name):

SORGHUM HALEPENSE POLLEN

Sammensetning:

SORGHUM HALEPENSE POLLEN 0.1 g in 1 mL

Administreringsrute:

PERCUTANEOUS

Indikasjoner:

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,

Produkt oppsummering:

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.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

                                POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE- JOHNSON GRASS
SORGHUM
HALEPENSE INJECTION, SOLUTION
POLLENS - GRASSES, OATS, COMMON, CULTIVATED AVENA SATIVA- OATS,
COMMON,
CULTIVATED AVENA SATIVA INJECTION, SOLUTION
POLLENS - GRASSES, GRASS MIX 8- GRASS MIX 8 INJECTION, SOLUTION
POLLENS - GRASSES, SOUTHERN GRASS MIX- POLLENS - GRASSES, SOUTHERN
GRASS
MIX INJECTION, SOLUTION
POLLENS - TREES, ACACIA ACACIA LONGIFOLIA- ACACIA LONGIFOLIA
INJECTION, SOLUTION
POLLENS - TREES, ALDER, RED ALNUS RUBRA- ALDER, RED ALNUS RUBRA
INJECTION, SOLUTION
POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA- ASH, WHITE FRAXINUS
AMERICANA INJECTION, SOLUTION
POLLENS - TREES, BEECH, AMERICAN FAGUS GRANDIFOLIA- BEECH, AMERICAN
FAGUS
GRANDIFOLIA INJECTION, SOLUTION
POLLENS - TREES, BIRCH MIX- BIRCH MIX INJECTION, SOLUTION
POLLENS - TREES, BOTTLE BRUSH CALLISTEMON SPP.- BOTTLE BRUSH
CALLISTEMON
SPP. INJECTION, SOLUTION
POLLENS - TREES, BOXELDER/MAPLE MIX- BOXELDER/MAPLE MIX INJECTION,
SOLUTION
JUBILANT HOLLISTERSTIER LLC
----------
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 cardiovascu
                                
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