PROMETRIUM CAPSULE
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
29-03-2021
Daži šī produkta dokumenti pašlaik nav pieejami. Varat nosūtīt pieprasījumu mūsu klientu apkalpošanas dienestam, un mēs jums paziņosim, tiklīdz mēs tos varēsim iegūt.
Nosūtīt pieprasījumu.
Nosūtīt pieprasījumu.
Aktīvā sastāvdaļa:
PROGESTERONE
Pieejams no:
ORGANON CANADA INC.
ATĶ kods:
G03DA04
SNN (starptautisko nepatentēto nosaukumu):
PROGESTERONE
Deva:
100MG
Zāļu forma:
CAPSULE
Kompozīcija:
PROGESTERONE 100MG
Ievadīšanas:
ORAL
Vienības iepakojumā:
28/100
Receptes veids:
Prescription
Ārstniecības joma:
PROGESTINS
Produktu pārskats:
Active ingredient group (AIG) number: 0106327002; AHFS:
Autorizācija statuss:
APPROVED
Autorizācija datums:
2011-02-17
Produkta apraksts
Page 1 of 34
PRODUCT MONOGRAPH
PROMETRIUM
®
Progesterone capsules
100 mg
Progestin
Organon Canada Inc.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.organon.ca
Date of Revision:
March 29, 2021
Submission Control No: 249484
_ _
_ _
Page 2 of 34
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
..............................................................................................................
Izlasiet visu dokumentu
