PROVERA 5MG TABLETS
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
21-10-2014
Niektoré dokumenty týkajúce sa tohto produktu nie sú momentálne k dispozícii, môžete poslať požiadavku na náš zákaznícky servis a my vás upozorníme hneď, ako ich dokážeme získať.
Poslať žiadosť.
Poslať žiadosť.
Aktívna zložka:
MEDROXYPROGESTERONE ACETATE
Dostupné z:
PFIZER CANADA ULC
ATC kód:
G03DA02
INN (Medzinárodný Name):
MEDROXYPROGESTERONE
Dávkovanie:
5MG
Forma lieku:
TABLET
Zloženie:
MEDROXYPROGESTERONE ACETATE 5MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
PROGESTINS
Prehľad produktov:
Active ingredient group (AIG) number: 0106339005; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
1998-03-05
Súhrn charakteristických
_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate tablets USP)
2.5 mg, 5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
29 September 2014
SUBMISSION CONTROL NO: 176877
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2014
_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
...........................................................................................
Prečítajte si celý dokument
