ALLERGENIC EXTRACT - POLLENS SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

POLLEN

Dostopno od:

JUBILANT HOLLISTERSTIER LLC

Koda artikla:

V01AA20

INN (mednarodno ime):

VARIOUS

Odmerek:

40000UNIT

Farmacevtska oblika:

SOLUTION

Sestava:

POLLEN 40000UNIT

Pot uporabe:

INTRADERMAL

Enote v paketu:

5/10/30/50ML

Tip zastaranja:

Schedule D

Terapevtsko območje:

ALLERGENIC EXTRACTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0107826007; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2000-02-09

Lastnosti izdelka

S u b cu ta neo us
Inje ction
Im m unotherapy
M anufactured by:
Distributed in Canada by:
Jubilant HollisterStier LLC
Om ega
Laboratories
S pokane, Washington 99207 US A
M o n tré al ,
Québec
H3M
3E4
Canada
Decem ber 05, 2022
360420-C04
extract are those
to
which the
patient is allergic, and to
which s/he will
be
exposed, typical
allergic sym ptom s may follow shortly after
the injection, particularly
when the antigen load
from exposure plus the injected antigen exceeds the patient’s antige
n tolerance.
THE CON CE NTRA TE S H OULD N OT B E IN JE CTE D A T A NY TIM E UNLE S
S
TOLERA NCE HAS BEE N ES TA BLIS HE D.
DILUTE CONCENTRA TE D EX TRACTS
WITH S TE RILE A LB UM IN SA LINE WITH P HE NOL (0.4%) FOR INTRADE RM
A L
TE S TING.
INJECTIONS S HOULD NEV ER B E GIV EN INTRA VENOUS LY . Subcutaneous
injection
is recomm ended. Intracutaneous or intramuscular injections m ay
produce large local
reactions or
be excessively painful. AFTER INSERTING NEEDLE SUBCUTA NEOUSLY ,
B UT B E FORE INJE CTING, A LWAY S WITHDRA W THE P LUNGE R SLIGHTLY .
IF
B LOOD AP PE A RS IN THE SY RINGE , CHA NGE THE NE E DLE A ND GIVE THE
INJE CTION IN A NOTHE R S ITE .
Rarely, a patient is encountered who
develops systemic reactions to
mi n ute
doses of
a lle rgen
and
d oe s
no t
dem on stra te
in crea si ng
tol e ran ce
to
i nje cti on s
a fte r
se ve ral
mo nth s
of treatm ent. If systemic reactions or excessive local responses
occur persistently at very
sm all doses, efforts at imm unotherapy should be stopped.
P A TIENTS
S HOULD
BE
OB SERVED
IN
THE
OFFICE
FOR
30
M INUTES
A FTER
EACH
TREA TME NT INJE CTION. M ost severe reactions will occur within this
time period, and
rapid treatm ent m easures should be instituted. S ee ADV ERSE
REACTIONS S ection for
such treatm ent m easures.
In order to avoid darkening and possible precipitation, do not dilute
P rivet pollen with
solutions containing phenol. Injections of this extract discolored by
reaction with phenol
m ay produce a lasting tattoo-like discoloration of the skin.
Long-term studies in