POLLENS - WEEDS, CARELESS WEED AMARANTHUS PALMERI- careless weed amaranthus palmeri injection, solution POLLENS - WEEDS, CARELE

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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Ficha técnica Ficha técnica (SPC)
18-11-2019

Ingredientes activos:

AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH)

Disponible desde:

Jubilant HollisterStier LLC

Designación común internacional (DCI):

AMARANTHUS PALMERI POLLEN

Composición:

AMARANTHUS PALMERI POLLEN 0.05 g in 1 mL

Vía de administración:

PERCUTANEOUS

indicaciones terapéuticas:

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only . Data to support the therapeutic use of products labeled with this statement have not been established. 14 In addition to a carefully taken history, the use of glycerin-containing extracts in scratch, prick or puncture testing is an accepted method in the diagnosis of allergic conditions. 1, 2, 3 Extracts of all allergens do not produce equivalent results in scratch, prick or puncture tests. The intensity of the skin reactions produced will be determined by two factors: the degree of sensitivity of the patient, and the nature of the allergenic extract applied. Scratch, prick or puncture tests are not as sensitive as the intradermal test, but are safer and cause less discomfort. They may, therefore, be the method of choice when a large number of tests are needed, or when testing the pediatric patient. In some cases, where the relatively insensitive scratch, prick or puncture tests are negative or do not confirm the

Resumen del producto:

In 5 mL dropper bottles of extract at 1:10 w/v except pollen at 1:20, AP™ extracts at 1:50 w/v, except AP™ Dog Hair-Dander at 1:100 w/v, AP™ House Dust at 20,000 PNU/mL, some mixes as Concentrate, and Standardized products at AU/mL (Mite extracts at 30,000 AU/mL) or BAU/mL (Cat Hair and Pelt extracts at 10,000 BAU/mL) value. Strengths are listed on product labels. 

Estado de Autorización:

Biologic Licensing Application

Ficha técnica

                                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
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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INSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE
TESTING
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.7 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 and cautioned to contact the
physician's office if symptoms
occur. Patients on non-selective 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. This product should never be injected intravenously. Refer
also to the WARNINGS,
PRECAUTIONS, and ADVERSE REACTIONS Sections for further discussion.
DESCRIPTION
Sterile extracts for scratch, prick or puncture testing are supplied
in dropper vials containing, in
addition to the extract allergens and antigens, 50% (v/v) glycerin as
preservative, 0.5% sodium chloride
and 0.275% sodium bicarbonate. The strength of these extracts may be
expressed in terms of
Weight to Volume (w/v)
Protein Nitrogen Units/mL (PNU/mL)
Amb a
                                
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