PMS-PROGESTERONE CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
15-08-2018

Viambatanisho vya kazi:

PROGESTERONE

Inapatikana kutoka:

PHARMASCIENCE INC

ATC kanuni:

G03DA04

INN (Jina la Kimataifa):

PROGESTERONE

Kipimo:

200MG

Dawa fomu:

CAPSULE

Tungo:

PROGESTERONE 200MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/100

Dawa ya aina:

Prescription

Eneo la matibabu:

PROGESTINS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0106327003; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2018-08-22

Tabia za bidhaa

                                PRODUCT MONOGRAPH
Pr
PMS-PROGESTERONE
Progesterone Capsules
200 mg
PROGESTIN
PHARMASCIENCE INC.
DATE OF PREPARATION:
6111 Ave. Royalmount
August 20, 2018
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No: 211548
_pms-PROGESTERONE Product Monograph Page 2 of 33_
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
.................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
15
OVERDOSAGE
................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 16
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIALS
..........................................................................................................
20
TOXICOLOGY
...........................................................................
                                
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