REDDY-PROGESTERONE CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
04-11-2022

Viambatanisho vya kazi:

PROGESTERONE

Inapatikana kutoka:

DR. REDDY'S LABORATORIES INC

ATC kanuni:

G03DA04

INN (Jina la Kimataifa):

PROGESTERONE

Kipimo:

100MG

Dawa fomu:

CAPSULE

Tungo:

PROGESTERONE 100MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

2X15

Dawa ya aina:

Prescription

Eneo la matibabu:

PROGESTINS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0106327002; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2017-04-20

Tabia za bidhaa

                                1
PRODUCT MONOGRAPH
PR
REDDY-PROGESTERONE
Progesterone capsules 100 mg
Progestin
MANUFACTURED BY:
DR. REDDY’S LABORATORIES, INC.
Princeton, NJ – 08540 USA
IMPORTED AND DISTRIBUTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1
CANADA
Date of Revision:
Nov 4, 2022
Submission
Control No: 264364
2
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
............................................................................................
15
DOSAGE AND
ADMINISTRATION..........................................................................
16
OVERDOSAGE
..........................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 17
STORAGE AND
STABILITY.....................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 19
PART II: SCIENTIFIC
INFORMATION..........................................................................
20
PHARMACEUTICAL
INFORMATION
.......................................................................
20
CLINICAL
TRIALS....................................................................................................
21
TOXICOLOGY.........................................................................................................
                                
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