NTP-DICLOFENAC SODIUM TABLET (ENTERIC-COATED)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DICLOFENAC SODIUM

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

M01AB05

INN (mednarodno ime):

DICLOFENAC

Odmerek:

50MG

Farmacevtska oblika:

TABLET (ENTERIC-COATED)

Sestava:

DICLOFENAC SODIUM 50MG

Pot uporabe:

ORAL

Enote v paketu:

100/500/1000

Tip zastaranja:

Prescription

Terapevtsko območje:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0114417002; AHFS:

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2015-08-06

Lastnosti izdelka

1
PRODUCT MONOGRAPH
Pr
NTP-DICLOFENAC SODIUM
Pr
NTP-DICLOFENAC SODIUM SR
(Diclofenac Sodium)
50 mg Enteric Coated Tablets
75 mg Slow Release Tablets
Non steroidal Anti-Inflammatory Drug (NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165996
Date of Preparation:
July 22, 2013
2 TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
5
ADVERSE REACTIONS
.....................................................................................
15
DRUG INTERACTIONS
.....................................................................................
17
DOSAGE AND ADMINISTRATION
................................................................. 20
OVERDOSAGE
...................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
............................................... 22
STORAGE AND STABILITY
.............................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 24
PART II: SCIENTIFIC INFORMATION
................................................................... 26
PHARMACEUTICAL INFORMATION
............................................................. 26
CLINICAL TRIALS
.............................................................................................
27
DETAILED PHARMACOLOGY
........................................................................
30
TOXICOLOGY
....................................................................................................
31
REFERENCES