ALLERJECT SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

EPINEPHRINE

Mevcut itibaren:

VALEO PHARMA INC

ATC kodu:

C01CA24

INN (International Adı):

EPINEPHRINE

Doz:

0.15MG

Farmasötik formu:

SOLUTION

Kompozisyon:

EPINEPHRINE 0.15MG

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

0.76ML DELIVERING 0.15ML

Reçete türü:

Ethical

Terapötik alanı:

ALPHA-AND BETA-ADRENERGIC AGONISTS

Ürün özeti:

Active ingredient group (AIG) number: 0104871002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2016-08-09

Ürün özellikleri

PRESCRIBING INFORMATION
ALLERJECT
®
Epinephrine Injection, USP
Unidose 0.3 mg / 0.3 mL epinephrine
Unidose 0.15 mg / 0.15 mL epinephrine
Voice-assisted Auto-Injector
Pharmaceutical standard: USP
Catecholamine/Sympatomimetic
ATC Code: C01CA24
Valeo Pharma Inc.
16667 Hymus Blvd.
Kirkland, Quebec
H9H 4R9
Date of Preparation:
December 20, 2022
Submission Control No: 269583
_Page 2 of 23 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
6
WARNINGS AND
PRECAUTIONS
....................................................................................
6
ADVERSE REACTIONS
....................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
10
DOSAGE AND ADMINISTRATION
...............................................................................
11
OVERDOSAGE
.................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 13
STORAGE AND STABILITY
..........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 14
PART II: SCIENTIFIC INFORMATION
................................................................................
16
PHARMACEUTICAL
INFORMATION
............................................................................
16
TOXICOLOGY
..............................................................................