CYCLOSPORINE CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CYCLOSPORINE

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

L04AD01

INN（国際名）:

CICLOSPORIN

投薬量:

25MG

医薬品形態:

CAPSULE

構図:

CYCLOSPORINE 25MG

投与経路:

ORAL

パッケージ内のユニット:

30

処方タイプ:

Prescription

治療領域:

IMMUNOSUPPRESSIVE AGENTS

製品概要:

Active ingredient group (AIG) number: 0115996002; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2018-08-01

製品の特徴

PRODUCT MONOGRAPH CYCLOSPORINE
Cyclosporine Capsules
Soft Gelatin Capsule 25, 50 and 100 mg
USP (Modified)
Immunosuppressive agent
Sandoz Canada Inc.
Date of Preparation:
145 Jules-Léger
October 7, 2009
Boucherville, QC
J4B 7K8
Submission Control No: 133027
_Cyclosporine _
_ _
_Page 2 of_
48
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL
USE.........................................................................
4
CONTRAINDICATIONS
..............................................................................................
4
WARNINGS AND
PRECAUTIONS.............................................................................
4
ADVERSE
REACTIONS.............................................................................................
13
DRUG INTERACTIONS
.............................................................................................
17
DOSAGE AND
ADMINISTRATION.........................................................................
21
OVERDOSAGE
...........................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 26
STORAGE AND
STABILITY.....................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 30
PART II: SCIENTIFIC INFORMATION
................................................................... 32
PHARMACEUTICAL
INFORMATION.....................................................................
32
DETAILED
PHARMACOLOGY................................................................................
33
TOXICOLOGY
............................................................................................................
37
REFERENCES
................................................