PROVERA 5MG TABLETS

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
21-10-2014

Viambatanisho vya kazi:

MEDROXYPROGESTERONE ACETATE

Inapatikana kutoka:

PFIZER CANADA ULC

ATC kanuni:

G03DA02

INN (Jina la Kimataifa):

MEDROXYPROGESTERONE

Kipimo:

5MG

Dawa fomu:

TABLET

Tungo:

MEDROXYPROGESTERONE ACETATE 5MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

PROGESTINS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0106339005; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

1998-03-05

Tabia za bidhaa

                                _ _
_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
...........................................................................................
                                
                                Soma hati kamili
                                
                            

Nyaraka katika lugha zingine

Tabia za bidhaa Tabia za bidhaa Kifaransa 14-11-2014

Tafuta arifu zinazohusiana na bidhaa hii