PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION

PRODUCT MONOGRAPH

INCLUDING PATIENT MEDICATION INFORMATION

NEXPLANON?

Etonogestrel extended release subdermal implant

Extended release implant, 68 mg per implant (to deliver up to 70 mcg etonogestrel per day),

Subdermal

Hormonal Contraceptive

Merck Canada Inc.

16750 route Transcanadienne

Kirkland QC Canada H9H 4M7

merck.ca

Date of Preparation:

May 25, 2020

Submission Control No: 226314

NEXPLANON? (etonogestrel extended release subdermal implant)

Page 1 of 52

RECENT MAJOR LABEL CHANGES

Not applicable

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

1.3

Overweight women................................................................................................................ 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 Adjustment ..................................................................... 6

4.3

Administration........................................................................................................................ 6

4.4

Reconstitution...................................................................................................................... 18

4.5

Missed Dose ........................................................................................................................ 18

5

OVERDOSAGE ............................................................................................................................. 18

6

DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................... 18

7

WARNINGS AND PRECAUTIONS ............................................................................................... 20

7.1

Special Populations ............................................................................................................. 24

7.1.1 Pregnant Women ................................................................................................................ 24

7.1.2 Breast-feeding .................................................................................................................... 25

7.1.3 Pediatrics ............................................................................................................................ 25

7.1.4 Geriatrics ............................................................................................................................ 25

7.1.5 Overweight Women ............................................................................................................ 25

8

ADVERSE REACTIONS................................................................................................................ 25

8.1

Adverse Reaction Overview ................................................................................................ 25

8.2

Clinical Trial Adverse Reactions ......................................................................................... 26

8.3

Less Common Clinical Trial Adverse Reactions ( ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download