SANDOZ PAROXETINE TABLETS

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Предлага се от:

SANDOZ CANADA INCORPORATED

АТС код:

N06AB05

INN (Международно Name):

PAROXETINE

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 10MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0123131003; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2019-08-01

Данни за продукта

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PRODUCT MONOGRAPH
Pr
SANDOZ PAROXETINE
TABLETS
Paroxetine Tablets, USP
10 mg, 20 mg and 30 mg
Paroxetine (as paroxetine hydrochloride)
Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent
–
Social Phobia (Social Anxiety Disorder) – Post-traumatic Stress
Disorder Therapy
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Quebec
J4B 7K8
Date of Revision:
March 15, 2017
Submission Control No.: 202484
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_Sandoz Paroxetine Tablets _
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_Page 2 of 58 _
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
6
ADVERSE REACTIONS
13
DRUG INTERACTIONS
23
DOSAGE AND ADMINISTRATION
28
OVERDOSAGE
31
ACTION AND CLINICAL PHARMACOLOGY
32
STORAGE AND STABILITY
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
35
PART II: SCIENTIFIC INFORMATION
37
PHARMACEUTICAL INFORMATION
37
CLINICAL TRIALS
39
DETAILED PHARMACOLOGY
45
TOXICOLOGY
46
REFERENCES
49
PART III: CONSUMER INFORMATION
54
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SANDOZ PAROXETINE TABLETS
Paroxetine Tablets
10 mg, 20 mg and 30 mg
Paroxetine (as paroxetine hydrochloride)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS
Oral
Tablet
10 mg, 20 mg and
30 mg
Colloidal silicon dioxide, croscarmellose sodium,
magnesium stearate, microcrystalline cellulose,
polyethylene glycol, titanium dioxide_._ In addition,
10 MG tablets also contain: D&C yellow #10 aluminum
lake, FD&C yellow #6/Sunset yellow FCF aluminum
lake, hypromellose, polydextrose, triacetin.
20 MG tablets also contain: D&C red #30 aluminum
lake, hypromellose, polydextrose, triacetin.
30 MG tablets also contain: FD&C blue #2/Indigo
carmine aluminum lake, hypromellose, polydextrose,
triacetin.
INDICATIONS AND CLINICAL USE
ADULTS
DEPRESSION
Sandoz Paroxetine Tablets (paroxetine hydrochloride) is indicated for
symptomatic relief of
Major Depre