FDA label c8129b8e-5759-459a-bbc3-02830cadb059

WARNINGS Standardized Allergenic Extract is intended for use by physicians who are experienced in the administration of standardized (AU/mL) allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Standardized allergenic extracts are 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 being switched from other types of extract to standardized allergenic extracts should be started as though they were coming under treatment for the first time. Standardized Mite extract is NOT directly interchangeable with non-standardized Mite extract. This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. (14) Patients should be observed for at least 30 minutes following treatment and emergency measures and personnel trained in their use should be immediately available in the event of a life threatening reaction. (See Precautions) Allergenic extracts may be used with caution for patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease. (Contraindications) Extreme caution should be taken when using allergenic extracts for patients who are taking beta-blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodialators. Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, Md. 20852-9787, call 1-800-FDA-1088.

WARNINGS Standardized Mites extract labeled in AU/mL are not interchangeable with non-standardized mite extracts. Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. DO NOT INJECT INTRAVENOUSLY. All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death. Allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma, (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.

ADVERSE REACTIONS Anaphylaxis and other systemic reactions may occur such as induced asthma, itching of nose and throat, breathlessness, urticaria and local reactions. Local reactions can be defined as an area of large erythema, swelling or pruritus at the injection site. Further indications of adverse reactions are edema, wheezing, dyspnea, locomotive impairment, marked perspiration, coughing, hypertension, shock and upper airway obstruction. Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema and hypotension. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause shock and loss of consciousness. Fatalities have occurred rarely. These systemic reactions occur with varying frequency in different clinics. To some extent, the reaction rate is related to the type and dose of administered extract and to the degree of sensitivity of the patient. Despite all precautions, occasional reactions are unavoidable. Reports from regulatory authorities in Sweden to the Center for Biologics Evaluation and Research (CBER) indicated that several deaths have been associated with the use of mite extracts. The CBER was subsequently informed that these deaths may have been related to use by physicians or other health professionals untrained in the administration of potent allergens rather than a product defect. It should be noted that anaphylaxis and deaths following the injection of mite extracts have also been reported by the British Committee on Safety in Medicine in the British Medical Journal, V293,pp948,1986. Local reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site. These reactions may appear within a few minutes to hours and persist for several days. Local cold applications and oral antihistamines may be effective treatment. For marked and prolonged local reactions steroids may be helpful.