GONAL-F PEN SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FOLLITROPIN ALFA

Disponibil de la:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Codul ATC:

G03GA05

INN (nume internaţional):

FOLLITROPIN ALFA

Dozare:

300UNIT

Forma farmaceutică:

SOLUTION

Compoziție:

FOLLITROPIN ALFA 300UNIT

Calea de administrare:

SUBCUTANEOUS

Unități în pachet:

0.5ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

GONADOTROPINS AND ANTIGONADOTROPINS

Rezumat produs:

Active ingredient group (AIG) number: 0145621009; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2005-08-19

Caracteristicilor produsului

_ _
GONAL-f Pen
®
Product Monograph_ _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
GONAL-F
 PEN
Follitropin alfa Injection
300 IU/0.5 mL (22 µg/0.5 mL), 450 IU/0.75 mL (33 µg/0.75 mL)
and 900 IU/1.5 mL (66 µg/1.5 mL) in prefilled pens filled by mass
Pharmaceutical Standard: Professed
Therapeutic Classification: Gonadotropin
EMD Serono, A Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga ON L5K 2N6
A Business of Merck KGaA, Darmstadt, Germany
Date of Initial Approval:
August 19, 2005
Date of Revision:
May 3, 2019



Merck KGaA, Darmstadt, Germany
Submission Control No.: 224799
_ _
GONAL-f Pen
®
Product Monograph_ _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
DESCRIPTION
.................................................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
.................................................................................................
9
DRUG INTERACTIONS
...............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
12
OVERDOSAGE
..............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 14
STORAGE AND
STABILITY.......................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
.....