ALLERGENIC EXTRACTS, K-O-R-T GRASS MIXTURE SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

STANDARDIZED KENTUCKY BLUE/JUNE GRASS POLLEN; STANDARDIZED ORCHARD GRASS POLLEN; STANDARDIZED REDTOP GRASS POLLEN; STANDARDIZED TIMOTHY GRASS POLLEN

Доступно од:

GREER LABORATORIES INC

АТЦ код:

V01AA02

INN (Међународно име):

GRASS POLLEN

Дозирање:

100000UNIT; 100000UNIT; 100000UNIT; 100000UNIT

Фармацеутски облик:

SOLUTION

Састав:

STANDARDIZED KENTUCKY BLUE/JUNE GRASS POLLEN 100000UNIT; STANDARDIZED ORCHARD GRASS POLLEN 100000UNIT; STANDARDIZED REDTOP GRASS POLLEN 100000UNIT; STANDARDIZED TIMOTHY GRASS POLLEN 100000UNIT

Пут администрације:

INTRACUTANEOUS

Јединице у пакету:

15G/50G

Тип рецептора:

Schedule D

Терапеутска област:

ALLERGENIC EXTRACTS

Резиме производа:

Active ingredient group (AIG) number: 0457493003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2015-10-09

Карактеристике производа

PO Box 800
Lenoir, NC 28645
USA
U.S. Government License No. 308
ALLERGENIC EXTRACTS
POLLENS, MOLDS,
EPIDERMALS, INSECTS,
DUSTS, FOODS,
AND
MISCELLANEOUS INHALANTS
Suggested Dosage Schedule
and Instructions
CONTROL #:179425 DATE OF AUTHORIZATION: OCTOBER 9, 2015
1
_`_
WARNING
THIS
ALLERGENIC
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.
ALLERGENIC
EXTRACTS
MAY
CAUSE
SEVERE
OR
FATAL
ANAPHYLAXIS IN EXTREMELY SENSITIVE PATIENTS. THE INITIAL DOSE
MUST BE BASED ON SKIN TESTING AS DESCRIBED IN THE DOSAGE
AND ADMINISTRATION SECTION OF THIS INSERT. PATIENTS SHOULD
BE INSTRUCTED TO RECOGNIZE ADVERSE REACTION SYMPTOMS AND
CAUTIONED
TO
CONTACT
THE
PHYSICIAN’S
OFFICE
IF
REACTION
SYMPTOMS OCCUR. IN CERTAIN INDIVIDUALS, THESE REACTIONS
COULD BE FATAL. PATIENTS SHOULD BE OBSERVED FOR AT LEAST 20
MINUTES FOLLOWING TREATMENT.
EMERGENCY MEASURES, AS WELL AS PERSONNEL TRAINED IN
THEIR USE, SHOULD BE IMMEDIATELY AVAILABLE IN THE EVENT OF A
LIFE-THREATENING REACTION. PATIENTS BEING SWITCHED FROM
ONE
LOT
OF
EXTRACT
TO
ANOTHER
FROM
THE
SAME
MANUFACTURER SHOULD HAVE THEIR DOSE REDUCED BY 75%.
THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY.
REFER
ALSO
TO
THE
WARNINGS,
PRECAUTIONS,
ADVERSE
REACTIONS AND OVERDOSAGE SECTIONS BELOW.
2
DESCRIPTION
Allergenic
Extracts
are
supplied as
a
sterile
solution for
intracutaneous
or
subcutaneous administration. Concentrates contain the soluble
extractants of the
source material with 0.5% sodium chloride and 0.54% Sodium bicarbonate
at a pH of
6.8 to 8.4 as aqueous extracts in water for injection or in 50%
glycerin. Aqueous
extracts contain 0.4% phenol as a preservative and 50% glycerinated
extracts contain
0.2% phenol. Diluted aqueous extracts contain Buffered Saline with
0.5% sodium
chloride, 0.04% potassium phosphate, 0.11% sodium phosphate
heptahydrate, and
0.4% phenol in water for injection.
Source materials for these extracts are as follows