TARO-CALCITRIOL CAPSULE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CALCITRIOL

Доступна з:

TARO PHARMACEUTICALS INC

Код атс:

A11CC04

ІПН (Міжнародна Ім'я):

CALCITRIOL

Дозування:

0.25MCG

Фармацевтична форма:

CAPSULE

Склад:

CALCITRIOL 0.25MCG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

VITAMIN D

Огляд продуктів:

Active ingredient group (AIG) number: 0113628001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2019-02-12

Характеристики продукта

PRODUCT MONOGRAPH
PR
TARO-CALCITRIOL
Calcitriol Capsules
Soft-gelatin capsules; 0.25 mcg and 0.5 mcg
Taro Standard
Vitamin D3 Metabolite
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
Date of Preparation:
February 11, 2019
Submission Control No: 208690
_Page 1 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
5
DRUG INTERACTIONS
...................................................................................................
7
DOSAGE AND ADMINISTRATION
...............................................................................
8
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
.........................................................................................................
15
DETAILED PHARMACOLOGY
..........................................................