FIRE ANT injection, solution SHAGBARK HICKORY injection, solution MIXED ASPERGILLUS injection, solution MIXED FEATHERS inject

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (SOLENOPSIS INVICTA - UNII:5O7CR4P444)

Prieinama:

ALK-Abello, Inc.

INN (Tarptautinis Pavadinimas):

SOLENOPSIS INVICTA

Sudėtis:

SOLENOPSIS INVICTA 0.05 g in 1 mL

Vartojimo būdas:

SUBCUTANEOUS

Terapinės indikacijos:

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. A patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms, IgE antibodies, positive skin tests, or properly controlled challenge testing. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control. Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction (also see WARNINGS AND ADVERSE

Produkto santrauka:

3 and 4 vial sets in serial dilutions prepared for therapy. 10 mL and 50 mL, single antigens or specified mixtures, potency expressed in PNU/mL (up to and including 100,000 PNU/mL) or W/V (up to and including 1:10 W/V), aqueous or in 50% glycerin, to be diluted prior to use. 1:10 w/v short ragweed extracts contain ≥ 300 units/mL of AgE. To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2° to 8° C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.

Autorizacija statusas:

Biologic Licensing Application

Prekės savybės

FIRE ANT- FIRE ANT INJECTION, SOLUTION
SHAGBARK HICKORY- SHAGBARK HICKORY INJECTION, SOLUTION
MIXED ASPERGILLUS- MIXED ASPERGILLUS INJECTION, SOLUTION
MIXED FEATHERS- MIXED FEATHERS INJECTION, SOLUTION
MIXED RAGWEED- MIXED RAGWEED INJECTION, SOLUTION
ALK-ABELLO, INC.
----------
THERAPEUTIC ALLERGENIC EXTRACT
DIRECTIONS FOR USE OF
THERAPEUTIC ALLERGENIC EXTRACTS
WARNING
This product is intended for use by physicians who are experienced in
the
administration of allergenic extracts and the emergency care of
anaphylaxis or for
use under the guidance of an allergy specialist.
Patients should be instructed to recognize adverse reaction symptoms
and
cautioned to contact the physician’s office if reaction symptoms
occur. As with all
allergenic extracts, severe systemic reactions may occur. In certain
individuals,
these reactions may rarely result in death. Patients should be
observed for 20 to
30 minutes following treatment, and emergency measures, as well as
personnel
trained in their use, should be immediately available in the event of
a life-threatening
reaction. Patients with unstable asthma or steroid dependent
asthmatics and
patients with underlying cardiovascular disease are at greater risk.
Adverse events
are to be reported to Med Watch (1-800-FDA-1088), Adverse Event
Reporting ,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20852-9787.
This product should not be injected intravenously. Deep subcutaneous
routes have
proven to be safe. 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 support systems. Parenteral fluid and/or plasma
expanders may
be utilized for the treatment of shock. Adrenocorticosteroids may be
administered
parenterally or intravenously.
Refer to WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections below.
DESCRIPTION
Sterile therapeutic extracts are supplied in either Phenol Saline
Dilu