POLLENS - WEEDS, KOCHIA SCOPARIA- kochia scoparia injection, solution POLLENS - WEEDS, MARSHELDER/POVERTY MIX injection, soluti

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5)

Tilgjengelig fra:

Jubilant HollisterStier LLC

INN (International Name):

BASSIA SCOPARIA POLLEN

Sammensetning:

BASSIA SCOPARIA POLLEN 0.05 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 - WEEDS, KOCHIA SCOPARIA- KOCHIA SCOPARIA INJECTION, SOLUTION
POLLENS - WEEDS, MARSHELDER/POVERTY MIX- POLLENS - WEEDS,
MARSHELDER/POVERTY
MIX INJECTION, SOLUTION
POLLENS - WEEDS, WEED MIX 2630- WEED MIX 2630 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 who are receiving
cardiovascular drugs such as beta
blockers, may be at higher risk for severe adverse reactions. These
patients may also be more
refractory to the normal allergy treatment regimen. Patients should be
treated only if the benefit of
treatment outweighs the risks.1
Patients on beta blockers may be more reactive to allergens given for
testing or treatment and may
be unresponsive to the usual doses of epinephrine used to treat
allergic reactions. 2
This product should never be injected intravenously.
Refer to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE
Sections for further discussion.
DESCRIPTION
The all