WHITE-FACED HORNET VENOM PROTEIN MULTIUSE 13.0 ML (1300MCG) POWDER FOR SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

WHITE FACED HORNET VENOM PROTEIN

Saatavilla:

JUBILANT HOLLISTERSTIER LLC

ATC-koodi:

V01AA07

INN (Kansainvälinen yleisnimi):

INSECTS

Annos:

1300MCG

Lääkemuoto:

POWDER FOR SOLUTION

Koostumus:

WHITE FACED HORNET VENOM PROTEIN 1300MCG

Antoreitti:

SUBCUTANEOUS

Kpl paketissa:

10ML

Prescription tyyppi:

Schedule D

Terapeuttinen alue:

ALLERGENIC EXTRACTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0114084004; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-02-16

Valmisteyhteenveto

Manufactured by:
Distributed in Canada by:
Jubilant HollisterStier LLC
Omega Laboratories
Spokane, Washington 99207 USA
Montréal, Québec
H3M 3E4 Canada
Control#: 210133 Date of Approval: February 16, 2018
WARNINGS
This product is intended for use only by physicians who are
experienced in the administration of
high dose allergy injection therapy, or for use under the guidance of
an allergist.
Hymenoptera Venom extracts may potentially elicit a severe
life-threatening systemic reaction
rarely resulting in death.
(1)
Therefore, emergency measures and personnel trained in their use
must be available immediately in the event of such a reaction.
Patients should be instructed
to recognize adverse reaction symptoms, observed in the office for at
least 30 minutes after
skin testing or treatment, and cautioned to contact the physician’s
office if symptoms occur.
All patients should have available an Emergency Anaphylaxis Kit
containing epinephrine and be
instructed in its use for emergency treatment of possible systemic
reactions occurring at times
after the patient has departed the testing or treatment premises.
Patients with cardiovascular diseases and/or pulmonary diseases such
as symptomatic, unstable,
steroid-dependent asthma, and/or those who are receiving
cardiovascular drugs such as beta
blockers, may be at higher risk for severe adverse reactions. These
patients may also be more
refactory to the normal allergy treatment regimen. Patients should be
treated only if the benefit
of treatment outweighs the risk.
(1)
PATIENTS ON BETA BLOCKERS MAY BE MORE REACTIVE TO ALLERGENS GIVEN FOR
TEST-
ING OR TREATMENT AND MAY BE UNRESPONSIVE TO THE USUAL DOSES OF
EPINEPHRINE
USED TO TREAT ALLERGIC REACTIONS.
(2)
Immunotherapy for insect sting allergy should be given to those
patients who have experienced
significant systemic reactions (for detailed description of symptoms
see INDICATIONS AND
CLINICAL USE and ADVERSE REACTIONS) from insect stings and who
demonstrate hypersen-
sitivity by skin testing with these products. The o