BAYBERRY POLLEN injection, solution REDWOOD POLLEN injection, solution JACK PINE POLLEN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89)

Available from:

Antigen Laboratories, Inc.

INN (International Name):

MORELLA CERIFERA POLLEN

Composition:

MORELLA CERIFERA POLLEN 0.05 g in 1 mL

Administration route:

INTRADERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. Do not administer in the presence of diseases characterized by bleeding diathesis. Individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. Patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease.

Product summary:

Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Fresh egg white extract is available at 1:9 v/v extraction ratio. Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Refer to container label for actual Antigen E content. Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

BAYBERRY POLLEN - BAYBERRY POLLEN INJECTION, SOLUTION
REDWOOD POLLEN - REDWOOD POLLEN INJECTION, SOLUTION
JACK PINE POLLEN - JACK PINE POLLEN INJECTION, SOLUTION
ANTIGEN LABORATORIES, INC.
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ALLERGENIC EXTRACT
WARNINGS
ALLERGENIC EXTRACT IS INTENDED FOR USE BY, OR UNDER THE GUIDANCE OF,
PHYSICIANS WHO ARE
EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS FOR DIAGNOSIS
AND/OR
IMMUNOTHERAPY AND THE EMERGENCY CARE OF ANAPHYLAXIS. THIS EXTRACT IS
NOT DIRECTLY
INTERCHANGEABLE WITH OTHER ALLERGENIC EXTRACTS. THE INITIAL DOSE MUST
BE BASED ON SKIN
TESTING AS DESCRIBED IN THE “DOSAGE AND ADMINISTRATION” SECTION OF
THIS INSERT.
PATIENTS SWITCHING FROM OTHER TYPES OF EXTRACTS TO ANTIGEN
LABORATORIES’ ALLERGENIC EXTRACTS
SHOULD BE STARTED AS IF THEY WERE UNDERGOING TREATMENT FOR THE FIRST
TIME. PATIENTS BEING
SWITCHED FROM ONE LOT OF EXTRACT TO ANOTHER FROM THE SAME MANUFACTURER
SHOULD HAVE THE
DOSE REDUCED BY 75%.
SEVERE SYSTEMIC REACTIONS MAY OCCUR WITH ALL ALLERGENIC EXTRACTS. IN
CERTAIN INDIVIDUALS,
ESPECIALLY IN STEROID-DEPENDENT/UNSTABLE ASTHMATICS, THESE
LIFE-THREATENING REACTIONS MAY
RESULT IN DEATH. PATIENTS SHOULD BE OBSERVED FOR AT LEAST 20 MINUTES
FOLLOWING ALLERGENIC
EXTRACT INJECTIONS. TREATMENT AND EMERGENCY MEASURES, AS WELL AS
PERSONNEL TRAINED IN
THEIR USE, MUST BE AVAILABLE IN THE EVENT OF A LIFE-THREATENING
REACTION. SENSITIVE PATIENTS MAY
EXPERIENCE SEVERE ANAPHYLACTIC REACTIONS RESULTING IN RESPIRATORY
OBSTRUCTION, SHOCK, COMA
AND/OR DEATH. REPORT SERIOUS ADVERSE EVENTS TO MEDWATCH, 5600 FISHERS
LANE, ROCKVILLE,
MD 20852-9787, PHONE 1-800-FDA-1088.
THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY. DEEP SUBCUTANEOUS
ROUTES HAVE PROVEN
TO BE SAFE. SEE THE “WARNINGS”, “PRECAUTIONS”, “ADVERSE
REACTIONS” AND
“OVERDOSAGE” SECTIONS.
PATIENTS RECEIVING BETA-BLOCKERS MAY NOT BE RESPONSIVE TO EPINEPHRINE
OR INHALED
BRONCHODILATORS. RESPIRATORY OBSTRUCTION NOT RESPONDING TO PARENTERAL
OR INHALED
BRONCHODILATORS MAY REQUIRE THEOPHYLLINE, OXYGEN, INTUBATION AND THE
USE OF LIFE