Package Inserts / Directions for Use
Our various Package Inserts and Directions for Use are available for download in this section.
GREER® Allergenic Extracts Package Inserts:
Devices Directions for Use:
AllerMed Laboratories, Inc. Package Inserts:
Standardized Grass Pollen
To report suspected adverse reactions, contact Stallergenes Greer at 1.855.274.1322.
You can also report suspected adverse reactions to the FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.
Allergenic extracts are indicated for skin test diagnosis and treatment (immunotherapy) of patients with seasonal and perennial allergies.
See the package inserts for the full Prescribing Information for the specific extracts.
IMPORTANT SAFETY INFORMATION
- Do not inject intravenously.
- Do not administer these products to patients with severe, unstable, or uncontrolled asthma.
- Allergenic extracts may cause severe life-threatening systemic reactions, including the rare occurrence of anaphylaxis or death. Systemic reactions include: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Other adverse reactions include: nausea, emesis, abdominal cramps, and diarrhea.
- Intended for use only by physicians who are experienced in the administration of allergenic extracts.
- 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.
- Patients with extreme sensitivity to these products, those on an accelerated immunotherapy build-up schedule, those switching to another allergenic lot, those receiving high doses of these products, or those also exposed to similar allergens may be at increased risk of a severe allergic reaction.
- Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a severe allergic reaction.
- These products may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
Please click here for Package Inserts with full Prescribing Information, including Boxed Warnings.
To report suspected adverse reactions, contact Stallergenes Greer at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.