INSECTS EXTRACTS

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

INSECTS EXTRACTS

Verfügbar ab:

TRUPHARM MARKETING 1985 LTD.

ATC-Code:

V01AA07

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

INSECTS EXTRACTS

Verabreichungsweg:

INTRADERMAL

Verschreibungstyp:

Required

Hergestellt von:

ABELLO ALK S.A., USA

Therapiegruppe:

INSECTS

Therapiebereich:

INSECTS

Anwendungsgebiete:

Skin testing and immunotherapy.

Berechtigungsdatum:

2022-11-30

Fachinformation

ALLERGENIC EXTRACTS,
FOR DIAGNOSTIC USE ONLY
DIRECTIONS FOR USE
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.
As with all allergenic extracts, severe systemic reactions may occur.
In certain individuals these life-threatening reactions may result
in death. Fatalities associated with skin testing have been reported.
Patients should be observed for at least 20 - 30 minutes following
testing. Emergency measures and adequately trained personnel 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
to a fatal outcome from a systemic allergic reaction.
Sensitive patients may experience severe anaphlactic reactions
resulting in respiratory obstruction, shock, coma and/or death.
Adverse
events are to be reported to MedWatch (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. 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.
Port Washington, NY 11050
U.S. Government License No. 1256
DESCRIPTION
Sterile diagnostic extracts are supplied in either phenol-saline
diluent for Intradermal Testing or in diluent containing glycerin 50%
(v/v)
for Percutaneous Testing and phenol 0.4% (preservative). Inactive
ingredients may include: sodium chloride for isotonicity, gly