APO-DIVALPROEX TABLET (DELAYED-RELEASE)
देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
उत्पाद विशेषताएं
(SPC)
17-11-2023
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
VALPROIC ACID (DIVALPROEX SODIUM)
थमां उपलब्ध:
APOTEX INC
ए.टी.सी कोड:
N03AG01
INN (इंटरनेशनल नाम):
VALPROIC ACID
डोज़:
125MG
फार्मास्यूटिकल फॉर्म:
TABLET (DELAYED-RELEASE)
रचना:
VALPROIC ACID (DIVALPROEX SODIUM) 125MG
प्रशासन का मार्ग:
ORAL
पैकेज में यूनिट:
100
प्रिस्क्रिप्शन प्रकार:
Prescription
चिकित्सीय क्षेत्र:
MISCELLANEOUS ANTICONVULSANTS
उत्पाद समीक्षा:
Active ingredient group (AIG) number: 0112996004; AHFS:
प्राधिकरण का दर्जा:
APPROVED
प्राधिकरण की तारीख:
2021-12-21
उत्पाद विशेषताएं
_APO-DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_ Page 1 of 79 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DIVALPROEX
Divalproex Sodium Delayed-Release Tablets
Delayed-Release Tablets, 125 mg, 250 mg and 500 mg valproic acid (as
divalproex sodium), Oral
Apotex Standard
Antiepileptic
Submission
Control Number:
280469
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAR 23, 1999
Date of Revision:
NOV
17, 2023
_APO-DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_ Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
11/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity
11/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
02/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Hyperammonemia
11/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Patients
at Risk of Hypocarnitinemia
11/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious
or Fatal Hepatotoxicity
11/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
02/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
02/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Pregnancy
Exposure Risk related to Valproate
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 4
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
..................................
पूरा दस्तावेज़ पढ़ें
