Država: Kanada
Jezik: engleski
Izvor: Health Canada
WHITE FACED HORNET VENOM PROTEIN
JUBILANT HOLLISTERSTIER LLC
V01AA07
INSECTS
1300MCG
POWDER FOR SOLUTION
WHITE FACED HORNET VENOM PROTEIN 1300MCG
SUBCUTANEOUS
10ML
Schedule D
ALLERGENIC EXTRACTS
Active ingredient group (AIG) number: 0114084004; AHFS:
APPROVED
2018-02-16
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 Pročitajte cijeli dokument