POLLINEX R LIQUID
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-10-2017
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Active ingredient:
MODIFIED RAGWEED TYROSINE ADSORBATE; MODIFIED RAGWEED TYROSINE ADSORBATE; MODIFIED RAGWEED TYROSINE ADSORBATE; MODIFIED RAGWEED TYROSINE ADSORBATE
Available from:
ALLERGY THERAPEUTICS (UK) LTD
ATC code:
V01AA02
INN (International Name):
GRASS POLLEN
Dosage:
210UNIT; 500UNIT; 1400UNIT; 4300UNIT
Pharmaceutical form:
LIQUID
Composition:
MODIFIED RAGWEED TYROSINE ADSORBATE 210UNIT; MODIFIED RAGWEED TYROSINE ADSORBATE 500UNIT; MODIFIED RAGWEED TYROSINE ADSORBATE 1400UNIT; MODIFIED RAGWEED TYROSINE ADSORBATE 4300UNIT
Administration route:
SUBCUTANEOUS
Units in package:
0.5 ML SYRINGE; 1 ML VIAL
Prescription type:
Schedule D
Therapeutic area:
ALLERGENIC EXTRACTS
Product summary:
Active ingredient group (AIG) number: 0447001001; AHFS:
Authorization status:
APPROVED
Authorization date:
2002-03-12
Summary of Product characteristics
Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICAL INFORMATION
PR
POLLINEX
®
-R
Modified Ragweed Pollen Allergen Tyrosine Adsorbate
Pre-filled Syringes
105 PNU/0.5 ml, 250 PNU/0.5 ml, 700 PNU/0.5 ml, 2150 PNU/0.5 ml
Vials
210 PNU/ml, 500 PNU/ml, 1400 PNU/ml, 4300 PNU/ml
Suspension for Injection
Professed
Allergen Extracts
Allergy Therapeutics (UK) Limited
Dominion Way
Worthing, West Sussex, BN14 8SA
United Kingdom
Date of Preparation:
OCT 31, 2012
Date of Authorization:
September 29, 2017
Distributor:
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
St-Laurent, Québec, H4M 2P2
Submission Control No: 206879
®
Registered Trademark of Allergy Therapeutics (UK) Limited
Allergy Therapeutics (UK) Limited
POLLINEX-R
Dossier ID: e116428
CONFIDENTIAL
Pg 1
Sequence0014
Page 2 of 25
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
DESCRIPTION
....................................................................................................................
3
INDICATIONS AND CLINICAL
USE...............................................................................4
CONTRAINDICATIONS
....................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................7
DRUG
INTERACTIONS.....................................................................................................8
DOSAGE AND
ADMINISTRATION...............................................................................10
OVERDOSAGE
.................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
.........................................................
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