REDDY-PROGESTERONE CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PROGESTERONE

Pieejams no:

DR. REDDY'S LABORATORIES INC

ATĶ kods:

G03DA04

SNN (starptautisko nepatentēto nosaukumu):

PROGESTERONE

Deva:

100MG

Zāļu forma:

CAPSULE

Kompozīcija:

PROGESTERONE 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

2X15

Receptes veids:

Prescription

Ārstniecības joma:

PROGESTINS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2017-04-20

Produkta apraksts

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.........................................................................................................