ANAPEN JUNIOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

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Download Ciri produk (SPC)
14-01-2022

Bahan aktif:

EPINEPHRINE

Boleh didapati daripada:

ENDO VENTURES LTD.

Kod ATC:

C01CA24

INN (Nama Antarabangsa):

EPINEPHRINE

Dos:

0.15MG

Borang farmaseutikal:

SOLUTION

Komposisi:

EPINEPHRINE 0.15MG

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

0.3ML

Jenis preskripsi:

Ethical

Kawasan terapeutik:

ALPHA-AND BETA-ADRENERGIC AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0104871011; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2022-01-14

Ciri produk

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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.
_ _
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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