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Evra (norelgestromin / ethinyl estradiol) – Labelling - G03AA13

Updated on site: 06-Oct-2017

Medication nameEvra
ATC CodeG03AA13
Substancenorelgestromin / ethinyl estradiol
ManufacturerJanssen-Cilag International NV

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch norelgestromin/ethinyl estradiol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 patch of 20 cm2 contains: 6 mg norelgestromin and 600 micrograms ethinyl estradiol

1 patch releases: 203 micrograms norelgestromin and 33.9 micrograms ethinyl estradiol per 24 hours

3.LIST OF EXCIPIENTS

Backing layer: low-density pigmented polyethylene outer layer, polyester inner layer.

Middle layer: polyisobutylene/polybutene adhesive, crospovidone, lauryl lactate, non-woven-polyester fabric.

Third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.

4.PHARMACEUTICAL FORM AND CONTENTS

3 transdermal patches

9 transdermal patches

18 transdermal patches

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light and moisture.

Do not refrigerate or freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Do not flush used or unused patches down the toilet. See enclosed leaflet for disposal instructions.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse, Belgium

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/02/223/001: 3 transdermal patches

EU/1/02/223/002: 9 transdermal patches

EU/1/02/223/003: 18 transdermal patches

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

evra

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch

norelgestromin/ethinyl estradiol

2.METHOD OF ADMINISTRATION

Transdermal use

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Contains 1 transdermal patch

6.OTHER

Reminder stickers

Use these stickers on your calendar to help you remember when to change your patch

 

 

 

Current Cycle

Next Cycle

First Patch

Second Patch

Third Patch

Remove Patch

First patch

(Week 1)

(Week 2)

(Week 3)

Get New Patch

 

Patch disposal label

PATCH DISPOSAL LABEL

To dispose of used patch:

1.place used patch so that the sticky side covers the shaded area

2.remove backing paper

3.close adhesive label and seal

4.discard with solid waste

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