MIFISO KIT

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

MISOPROSTOL; MIFEPRISTONE

Disponibbli minn:

LINEPHARMA INTERNATIONAL LIMITED

Kodiċi ATC:

G03XB51

INN (Isem Internazzjonali):

MIFEPRISTONE, COMBINATIONS

Dożaġġ:

200MCG; 200MG

Għamla farmaċewtika:

KIT

Kompożizzjoni:

MISOPROSTOL 200MCG; MIFEPRISTONE 200MG

Rotta amministrattiva:

BUCCAL

Unitajiet fil-pakkett:

1 MIFEPRISTONE AND 4 MISOPROSTOL PER PACK

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0257170002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-12-16

Karatteristiċi tal-prodott

_Mifiso (mifepristone tablets and misoprostol tablets kit) _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MIFISO
Mifepristone tablet
Tablet, mifepristone 200 mg, oral administration
Progesterone receptor modulator
and
Misoprostol tablets
Tablets (4), misoprostol 200 mcg (each),
buccal administration
Prostaglandin
Medical Termination of Pregnancy
Sponsor:
LINEPHARMA INTERNATIONAL LIMITED
16, Upper Woburn Place,
London, WC1H 0BS
United Kingdom
Date of Initial Authorization:
DEC. 15, 2022
Date of Revision:
DEC. 15, 2022
Importer and distributor in Canada:
LINEPHARMA INTERNATIONAL INC.
402-21 St Clair Ave E
Toronto, Ontario
M4T 1L9
Submission Control No: 265940
_Mifiso (mifepristone tablets and misoprostol tablets kit) _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjus