PROMETRIUM CAPSULE
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
29-03-2021
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
PROGESTERONE
Inapatikana kutoka:
ORGANON CANADA INC.
ATC kanuni:
G03DA04
INN (Jina la Kimataifa):
PROGESTERONE
Kipimo:
100MG
Dawa fomu:
CAPSULE
Tungo:
PROGESTERONE 100MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
28/100
Dawa ya aina:
Prescription
Eneo la matibabu:
PROGESTINS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0106327002; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2011-02-17
Tabia za bidhaa
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
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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
..............................................................................................................
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