Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
COTTON FIBER (UNII: 70LDW53ROO) (COTTON FIBER - UNII:70LDW53ROO)
Antigen Laboratories, Inc.
COTTON FIBER
COTTON FIBER 0.05 g in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
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.
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.
Biologic Licensing Application
COTTON LINTERS - COTTON LINTERS INJECTION, SOLUTION JUTE - JUTE INJECTION, SOLUTION KAPOK - KAPOK INJECTION, SOLUTION ORRIS ROOT - ORRIS ROOT INJECTION, SOLUTION PYRETHRUM - PYRETHRUM INJECTION, SOLUTION LEAF TOBACCO - LEAF TOBACCO INJECTION, SOLUTION ANTIGEN LABORATORIES, INC. ---------- 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 O Izlasiet visu dokumentu