Estalis Continuous

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Estradiol hemihydrate 0.62mg equivalent to oestradiol 50 µg/24 hours;  ; Norethisterone acetate 2.7mg equivalent to norethisterone acetate 140 µg/24 hours;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Estradiol hemihydrate 0.62 mg (equivalent to oestradiol 50 µg/24 hours)

Dosage:

50/140

Pharmaceutical form:

Transdermal patch

Composition:

Active: Estradiol hemihydrate 0.62mg equivalent to oestradiol 50 µg/24 hours   Norethisterone acetate 2.7mg equivalent to norethisterone acetate 140 µg/24 hours   Excipient: Acrylic adhesive Dipropylene glycol Oleic acid Povidone Silicone adhesive

Units in package:

Sachet, aluminium foil, laminate paper/PE/Al/PE, 8 patches

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

Treatment of symptoms of oestrogen deficiency in postmenopausal women with an intact uterus. Prevention of osteoporosis in postmenopausal women with an intact uterus.

Product summary:

Package - Contents - Shelf Life: Sachet, aluminium foil, laminate paper/PE/Al/PE - 8 patches - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months unopened stored at or below 25°C

Authorization date:

2002-07-12

Summary of Product characteristics

 
1
NEW ZEALAND DATA SHEET 

ESTALIS
®
 CONTINUOUS 
(OESTRADIOL/NORETHISTERONE ACETATE) 

TRANSDERMAL PATCH RELEASING 

50 micrograms/24 hours of oestradiol and 140 micrograms/24 hours of
norethisterone acetate 
50 micrograms/24 hours of oestradiol and 250 micrograms/24 hours of
norethisterone acetate 

TRADE NAME(S) 
ESTALIS
®
 Continuous 50/140 
ESTALIS
®
 Continuous 50/250 
DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORM 
Transdermal patch. 
ACTIVE SUBSTANCE(S) 
The active components of the Estalis
®
 Continuous matrix transdermal patch are oestradiol 
hemihydrate and norethisterone acetate. The remaining components
are pharmacologically 
inactive. 
Two Estalis Continuous matrix transdermal patches are available. They
release oestradiol 
and norethisterone acetate (NETA) in the following quantities and
at the following rates over a 
period of 3.5 to 4 days: 
NAME 
NOMINAL RELEASE RATE 
(MICROGRAM/DAY) 
OESTRADIOL/NETA 
OESTRADI
OL 
CONTENT 
(MG)* 
NETA 
CONTENT (MG)
SURFACE 
AREA (CM
2
) 
SHAPE 
Estalis 
Continuous 
50/140 0.620 
2.70 9 
Round 
Estalis 
Continuous 
50/250 0.512 
4.80 16 
Round 
*

1 mg oestradiol  hemihydrate is equivalent to 0.968 mg oestradiol 

_LIST OF EXCIPIENTS _
Adhesive matrix: silicone adhesive, acrylic adhesive, povidone, oleic
acid, dipropylene glycol, 
Backing layer: polyester film laminate, 

2
Protective (release liner): fluoropolymer coated polyester film. 
INDICATIONS 
The Estalis Continuous regimen is indicated for the following: 
•  Treatment of symptoms of oestrogen deficiency in
postmenopausal women with an intact 
uterus. 
•  Prevention of osteoporosis in postmenopausal women with an
intact uterus. (see sections 
Dosage and Administration and Warnings and Precautions). 
DOSAGE AND ADMINISTRATION 
DOSAGE 
ADULTS AND ELDERLY 
For all therapeutic indications, the lowest effective dose should be
used. 
Hormone replacement therapy (HRT) involving combined
oes