VELVETGRASS- holcus lanatus solution REED CANARYGRASS- phalaris arundinacea solution BAHIA GRASS- paspalum notatum solution S

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01)

متاح من:

Greer Laboratories, Inc.

طريقة التعاطي:

INTRADERMAL

الخصائص العلاجية:

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-Standardize

ملخص المنتج:

16.1 How Supplied 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: *SFS – Sodium Formadehyde Sulfoxylate 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.

الوضع إذن:

Biologic Licensing Application

خصائص المنتج

VELVETGRASS- HOLCUS LANATUS SOLUTION
REED CANARYGRASS- PHALARIS ARUNDINACEA SOLUTION
BAHIA GRASS- PASPALUM NOTATUM SOLUTION
SMOOTH BROME- BROMUS INERMIS SOLUTION
JOHNSON GRASS- SORGHUM HALEPENSE SOLUTION
GIANT WILD RYEGRASS- LEYMUS CONDENSATUS SOLUTION
ITALIAN RYEGRASS- LOLIUM MULTIFLORUM SOLUTION
WESTERN WHEATGRASS- PASCOPYRUM SMITHII SOLUTION
COUCH QUACK GRASS- ELYMUS REPENS SOLUTION
GREER LABORATORIES, INC.
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NON STANDARDIZED ALLERGENIC EXTRACTS
POLLENS, MOLDS, EPIDERMALS, INSECTS, DUSTS, FOODS, AND MISCELLANEOUS
INHALANTS
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NON-
STANDARDIZED ALLERGENIC EXTRACTS (POLLENS, MOLDS, EPIDERMALS, INSECTS,
FOODS
AND MISCELLANEOUS INHALANTS) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR NON-STANDARDIZED ALLERGENIC EXTRACTS.
NON-STANDARDIZED ALLERGENIC EXTRACTS (POLLENS, MOLDS, EPIDERMALS,
INSECTS,
FOODS, AND MISCELLANEOUS INHALANTS)
SOLUTIONS FOR PERCUTANEOUS, INTRADERMAL OR SUBCUTANEOUS
ADMINISTRATION.
INITIAL U.S. APPROVAL: 1968
WARNING: SEVERE ALLERGIC REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NON-STANDARDIZED ALLERGENIC EXTRACTS CAN CAUSE SEVERE LIFE-THREATENING
SYSTEMIC REACTIONS, INCLUDING ANAPHYLAXIS. (5.1)
DO NOT ADMINISTER THESE PRODUCTS TO PATIENTS WITH SEVERE, UNSTABLE OR
UNCONTROLLED ASTHMA. (4)
OBSERVE PATIENTS IN THE OFFICE FOR AT LEAST 30 MINUTES FOLLOWING
TREATMENT.EMERGENCY MEASURES AND PERSONNEL TRAINED IN THEIR USE MUST
BE AVAILABLE IMMEDIATELY IN THE EVENT OF A LIFE-THREATENING REACTION.
(5.1)
PATIENTS WITH EXTREME SENSITIVITY TO THESE PRODUCTS, ON AN ACCELERATED
IMMUNOTHERAPY BUILD-UP, SWITCHING TO ANOTHER LOT, RECEIVING HIGH DOSES
OF
THESE PRODUCTS, AND PATIENTS EXPOSED TO SIMILAR ALLERGENS MAY BE AT
INCREASED RISK OF A SEVERE ALLERGIC REACTION. (5.1)
THESE PRODUCTS MAY NOT BE SUITABLE FOR PATIENTS WITH CERTAIN
UNDERLYING
MEDICAL CONDITIONS THAT MAY REDUCE THEIR ABILITY TO SURVIVE A SYSTEMIC
ALLERGIC REACTION, AND FOR PATIENTS RECEIVING MEDIC