INSECTS EXTRACTS

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

INSECTS EXTRACTS

제공처:

TRUPHARM MARKETING 1985 LTD.

ATC 코드:

V01AA07

약제 형태:

SOLUTION FOR INJECTION

구성:

INSECTS EXTRACTS

관리 경로:

INTRADERMAL

처방전 유형:

Required

Manufactured by:

ABELLO ALK S.A., USA

치료 그룹:

INSECTS

치료 영역:

INSECTS

치료 징후:

Skin testing and immunotherapy.

승인 날짜:

2022-11-30

제품 특성 요약

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