ANAPEN SOLUTION
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
14-01-2022
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Werkstoffen:
EPINEPHRINE
Beschikbaar vanaf:
ENDO VENTURES LTD.
ATC-code:
C01CA24
INN (Algemene Internationale Benaming):
EPINEPHRINE
Dosering:
0.3MG
farmaceutische vorm:
SOLUTION
Samenstelling:
EPINEPHRINE 0.3MG
Toedieningsweg:
INTRAMUSCULAR
Eenheden in pakket:
0.3ML
Prescription-type:
Ethical
Therapeutisch gebied:
ALPHA-AND BETA-ADRENERGIC AGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0104871002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2022-01-14
Productkenmerken
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Page 1 of 21
ANAPEN and ANAPEN JUNIOR
Prescribing Information
ANAPEN
®
Sterile epinephrine injection Mfr. Std.
Unidose 0.3 mg epinephrine auto-injector
ANAPEN
® JUNIOR
Sterile epinephrine injection Mfr. Std.
Unidose 0.15 mg epinephrine auto-injector
Catecholamine / Sympatomimetic
Endo Ventures Ltd.
Date of Revision:
First Floor, Minerva House,
January 14, 2022
Simmonscourt Road, Ballsbridge
Dublin 4, Ireland
Importer/Distributor:
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
St-Laurent, H4M 2P2
Quebec, Canada
Submission Control No: 255336
®
Registered trademark of Bioprojet UK Ltd.
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Page 2 of 21
ANAPEN and ANAPEN JUNIOR
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
...............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
.......................................
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