BRAVELLE POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

UROFOLLITROPIN

Disponibbli minn:

FERRING INC

Kodiċi ATC:

G03GA04

INN (Isem Internazzjonali):

UROFOLLITROPIN

Dożaġġ:

75UNIT

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

UROFOLLITROPIN 75UNIT

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

2ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

GONADOTROPINS AND ANTIGONADOTROPINS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0115014001; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2019-07-18

Karatteristiċi tal-prodott

1
PRODUCT MONOGRAPH
BRAVELLE™
(UROFOLLITROPIN FOR INJECTION, PURIFIED)
SUBCUTANEOUS OR INTRAMUSCULAR INJECTION
GONADOTROPIN
75 IU FSH ACTIVITY PER VIAL
Ferring Inc.
200 Yorkland Boulevard
Suite 800
North York, Ontario
M2J 5C1
Date of Approval : January 11, 2008
Submission Control No:
115067
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................................
3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINICAL
USE..........................................................................................
3
CONTRAINDICATIONS
...............................................................................................................
4
WARNINGS AND
PRECAUTIONS..............................................................................................
4
ADVERSE
REACTIONS................................................................................................................
8
DRUG INTERACTIONS
..............................................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................................
12
OVERDOSAGE
............................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
14
STORAGE AND
STABILITY......................................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
...................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 16
PART II: SCIENTIFIC INFORMATION
............................................................................................
17
PHARMACEUTICAL
INFORMATION..