ESTRO-PESS estradiol (as hemihydrate) 10 microgram modified release pessary blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

estradiol hemihydrate, Quantity: 10.3 microgram (Equivalent: estradiol, Qty 10 microgram)

Հասանելի է:

Aspen Pharmacare Australia Pty Ltd

Դեղագործական ձեւ:

Pessary, modified release

Կազմը:

Excipient Ingredients: hypromellose; lactose monohydrate; magnesium stearate; maize starch; macrogol 6000

Կառավարման երթուղին:

Vaginal

Միավորները փաթեթում:

18 pessaries + 1 applicator, 24 pessaries + 1 applicator, 24 pessaries + 6 applicators, 18 pessaries + 6 applicators

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

ESTRO-PESS is indicated for the treatment of atrophic vaginitis due to estrogen deficiency in postmenopausal women.,ESTRO-PESS is not intended for children or males.

Ապրանքի ամփոփագիր:

Visual Identification: Each pessary is white, round, film coated tablet embossed with "E" one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2022-03-30

Տեղեկատվական թերթիկ

Page 1 of
ESTRO-PESS
_Estradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT ESTRO-PESS IS USED FOR 1
BEFORE YOU USE ESTRO-PESS ........... 1
HOW TO USE ESTRO-PESS ................. 3
WHILE YOU ARE USING ESTRO-PESS
....................................................... 3
Estro-Pess
when
placed
in
the
vagina
allows estradiol to be released. This may
relieve discomfort in the vagina.
Your doctor may have prescribed Estro-
Pess for another reason.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
ESTRO-PESS
HAS
BEEN PRESCRIBED FOR YOU.
•
you are allergic to estradiol or any
of
the
other
ingredients
in
Estro-
Pess (listed under
_‘Ingredients’_
)
•
it is after the expiry date (‘Expiry’)
printed on the pack
•
the packaging is torn or shows signs
of tampering.
Estro-Pess should not be used in children
or by males.
SIDE EFFECTS.................................... 3
STOP USING YOUR MEDICINE AT ONCE AND
STORAGE .......................................... 4
PRODUCT DESCRIPTION .................... 4
DIRECTIONS FOR USE ........................ 5
This
leaflet
answers
some
common
questions about Estro-Pess. It does not
contain all the available information. It
does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using Estro-Pess against the benefits
they expect it will have for you.
ASK YOUR DOCTOR OR PHARMACIST IF YOU
HAVE
ANY
CONCERNS
ABOUT
USING
THIS
MEDICINE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
Estro-Pess
is
available
only
by
prescription at pharmacies.
WHAT ESTRO-PESS IS
USED FOR
Estro-Pess
is
a
local
hormone
replacement therapy (HRT). Estro-Pess
is a modified release pessary containing
the female sex hormone, estradiol. The
estradiol in Estro-Pess is identical to the
estradiol
produced
in
the
ovaries
of
women, and
is
classified as a
natural
estrogen.
Estro-Pess
is
prescribed
to
treat
a
condition called atrophic vaginitis. The
symptoms include dryness and irritation
in

Ապրանքի հատկությունները

Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
ESTRO-PESS (ESTRADIOL) MODIFIED RELEASE PESSARY
1.
NAME OF THE MEDICINE
Estradiol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ESTRO-PESS pessary contains 10.3 microgram estradiol hemihydrate,
equivalent to
10 microgram of estradiol.
ESTRO-PESS is an estrogen preparation for intravaginal application
based on the active
human estrogen estradiol. The ESTRO-PESS modified release pessary
formulation is based
on a hydrophilic cellulose-derived matrix which on contact with
moisture hydrates and
provides a controlled release of estradiol.
For the full list of excipients, see Section 6.1 list of excipients
3.
PHARMACEUTICAL FORM
Modified release pessary. Each pessary is white, round, film coated
tablet embossed with "E"
one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ESTRO-PESS is indicated for the treatment of atrophic vaginitis due to
estrogen deficiency in
postmenopausal women.
ESTRO-PESS is not intended for children or males.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
ESTRO-PESS may be used in women with or without an intact uterus.
Initial dose: 1 modified release pessary daily for 2 weeks.
Maintenance dose: 1 modified release pessary twice a week.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest
Special Warnings and Precautions for Use
be used. Patient review should occur 3-6 months after treatment
initiation.
Reassessment of risks and benefits should occur no less frequently
than annually.
Method of Administration
ESTRO-PESS is administered deep intravaginally using the applicator(s)
in the enclosed pack.
1. Open the blister pack and remove the applicator.
2.Pull the plunger out of the applicator until it comes to a stop.
Press a vaginal tablet from the
separate blister and place it firmly in the holder of the applicator
end (wide end)
3.Insert the applicator carefully into the vagina. Stop when you can
feel some resistance (8-10
cm).
4.To release the vaginal tablet, press the push-button