EVRA TRANSDERMAL PATCH (6 mg600 mcg)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ETHINYLESTRADIOL; NORELGESTROMIN

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC code:

G03AA13

Dosage:

600 mcg/patch

Pharmaceutical form:

PATCH

Composition:

ETHINYLESTRADIOL 600 mcg/patch; NORELGESTROMIN 6 mg/patch

Administration route:

TRANSDERMAL

Prescription type:

Prescription Only

Manufactured by:

LTS LOHMANN THERAPIE-SYSTEME AG

Authorization status:

ACTIVE

Authorization date:

2003-09-17

Patient Information leaflet

 
PRODUCT NAME 
EVRA
 (norelgestromin/ethinyl estradiol)  

DOSAGE FORMS AND STRENGTHS  
EVRA is a transdermal patch containing 6 mg
norelgestromin (NGMN) and 600 
micrograms ethinyl estradiol (EE).

Each EVRA transdermal patch has a contact surface area
of 20 cm
2
  and is designed to 
provide continuous delivery of NGMN and
EE into the bloodstream over a seven-day 
duration of wear (see _Pharmacokinetic Properties_). 

EVRA is a thin, matrix-type
transdermal patch consisting of three layers: 
_-  The backing
layer _is composed of a beige flexible film. It provides structural 
support and
protects the middle adhesive layer from the environment. 
_-  The middle layer _contains inactive components and the
active components 
norelgestromin and EE. 
_-  The third layer is the release liner_, which protects the
adhesive layer during 
storage and is removed just prior to application 

For Excipients, see _List of Excipients_. 

CLINICAL  INFORMATION  
INDICATIONS  
Female Contraception  

DOSAGE AND ADMINISTRATION  
EVRA should be applied to clean, dry, hairless, intact healthy
skin on the buttock, 
abdomen, upper outer arm or upper torso, in a place where it will not be rubbed by tight 
clothing. EVRA should not be placed on
the breasts or on skin that is red, irritated or cut.  
To help avoid potential irritation, do not place a
new patch on the same area of skin as the 
patch you have just removed, however, the patch may be
applied within the same 
anatomic site. The patch should be pressed down
firmly until the edges stick well.   To 
prevent interference with the adhesive
properties of EVRA, no make-up, creams, lotions, 
powders or other topical products should be applied to the
skin area where the EVRA 
patch is currently placed or will be applied shortly.

Summary of Product characteristics

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INVOLVED PLANT:
PRODUCT NAME:
CUTTING GUIDES / SIZE:
AFFILIATE ORIGINATOR:
COMMODITY CODE:
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NOTES:
PHARMACODE:
ORIGINATING FROM LCR / MKPR Number:
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PACKAGING & LABEL
MANAGEMENT
COMMODITY TYPE:
Abbott - Established Pharmaceuticals Division
Version Number: 1.0
Effective date: 05-SEP-2021
Approved date: 22-JUL-2021
QMForm051768/1
PLM.14.01.F01
Gedeon Richter Plc
Evra Transdermal Patch
71,5x88_500x700 mm
N.A.
Black - Cutting Die
Helvetica Neue / 9 pt
N.A.
LCR-19282-2023-DEV
Leaflet
29435330_Leaflet
Singapore
17/05/2023
Karthik.V
PRODUCT NAME
(norelgestromin/ethinyl estradiol)
DOSAGE FORMS AND STRENGTHS
EVRA
®
is a thin, matrix-type transdermal patch consisting of three layers:
The backing layer is composed of a beige flexible film consisting of a
low-density
pigmented polyethylene outer layer and a polyester inner layer. It
provides structural
support and protects the middle adhesive layer from the environment.
The middle layer contains polyisobutylene/polybutene adhesive,
crospovidone,
non-woven polyester fabric and lauryl lactate as inactive components.
The active
components in this layer are the hormones, norelgestromin (NGMN) and
ethinyl
estradiol (EE).
The third layer is the release liner, which protects the adhesive
layer during storage
and is removed just prior to application. It is a transparent
polyethylene terephthalate
(PET) film with a polydimethylsiloxane coating on the side that is in
contact with the
middle adhesive layer.
EVRA
®
is a transdermal patch containing 6 mg NGMN and 600 micrograms EE.
Each EVRA
®
transdermal patch has a contact surface area of 20 cm
2
and is designed
to provide continuous delivery of NGMN and EE into the bloodstream
over a seven-
day duration of wear. (see Pharmacokinetic Properties.)
For excipien