Ovestin

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Estriol 0.1%{relative};  

Доступно од:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Међународно име):

Estriol 0.1% w/w

Дозирање:

0.1 %

Фармацеутски облик:

Vaginal cream

Састав:

Active: Estriol 0.1%{relative}   Excipient: Cetyl alcohol Chlorhexidine hydrochloride Glycerol Lactic acid Octyldodecanol Polysorbate 60 Purified water Sodium hydroxide Sorbitan stearate Spermaceti Stearyl alcohol

Јединице у пакету:

Tube, Physician's sample, 15g, 15 g

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Aspen Oss B.V

Терапеутске индикације:

Atrophy of the lower urogenital tract related to oestrogen deficiency, notably: · for the treatment of vaginal complaints such as dyspareunia, dryness and itching. · for the prevention of recurrent infections of the vagina and lower urinary tract. · in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence. Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery. A diagnostic aid in case of a doubtful atrophic cervical smear.

Резиме производа:

Package - Contents - Shelf Life: Tube, Physician's sample, 15g - 15 g - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Tube, 15g - 15 g - 36 months from date of manufacture stored at or below 25°C. Do not freeze

Датум одобрења:

1986-12-18

Информативни летак

NEW ZEALAND CONSUMER MEDICINE INFORMATION
OVESTIN CREAM
1
OVESTIN CREAM
_estriol 0.1% (1 mg per g) _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
WHAT OVESTIN CREAM IS USED FOR
BEFORE USING OVESTIN CREAM
HOW TO USE OVESTIN CREAM
SIDE EFFECTS OF OVESTIN
CREAM AFTER USING OVESTIN
CREAM PRODUCT DESCRIPTION
This leaflet answers some common
questions about Ovestin Cream.
It does not contain all of the available
information and 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 Ovestin Cream
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT OVESTIN CREAM
IS USED FOR
Ovestin
Cream
is
a
Hormone
Replacement
Therapy
(HRT).
It
contains the female hormone estriol
(an
estrogen).
Ovestin
is
used
in
postmenopausal women with at least
12
months since
their
last natural
period. Ovestin is used for relief of
symptoms
occurring
after
menopause. During menopause, the
amount of estrogens produced
by a
woman’s body gradually drops. If the
ovaries
are
removed
surgically
(ovariectomy) before menopause, the
decrease
in
estrogen
production
occurs very abruptly. The shortage of
estrogens
during
menopause
may
cause the vaginal wall to become thin
and
dry.
As
a
result,
sexual
intercourse
may become painful and
vaginal itching and infections may
occur. Estrogen deficiency may also
lead
to
sy

Карактеристике производа

NEW ZEALAND DATA SHEET
Ovestin Vaginal Cream – Data Sheet 1
1.
PRODUCT NAME
Ovestin Vaginal Cream 0.1%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Estriol 1 mg/g
3.
PHARMACEUTICAL FORM
White to almost white homogenous cream.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atrophy of the lower urogenital tract related to estrogen deficiency,
notably:
•
for the treatment of vaginal complaints such as dyspareunia, dryness
and itching.
•
for the prevention of recurrent infections of the vagina and lower
urinary tract.
•
in the management of micturition complaints (such as frequency and
dysuria) and mild urinary
incontinence.
Pre-
and
post-operative
therapy
in
postmenopausal
women
undergoing
vaginal
surgery.
A
diagnostic aid in case of a doubtful atrophic cervical smear.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
OVESTIN is an estrogen-only product that may be given to women with or
without a uterus.
ATROPHY OF THE LOWER UROGENITAL TRACT:
1 application per day for the first weeks, followed by a gradual
reduction, based on relief of
symptoms, until a maintenance dosage (e.g. 1 application twice a week)
is reached.
PRE- AND POST-OPERATIVE THERAPY IN POSTMENOPAUSAL WOMEN UNDERGOING
VAGINAL SURGERY:
1 application per day in the 2 weeks before surgery; 1 application
twice a week in the 2 weeks after
surgery.
A DIAGNOSTIC AID IN CASE OF A DOUBTFUL ATROPHIC CERVICAL SMEAR:
1 application on alternate days in the week before taking the next
smear.
METHOD OF ADMINISTRATION
OVESTIN cream should be administered intravaginally by means of a
calibrated applicator before
retiring at night.
One application (applicator filled to the red ring mark) contains 0.5
g OVESTIN cream which
corresponds to 0.5 mg estriol.
INSTRUCTIONS FOR USE FOR THE PATIENT
1.
Remove cap from the tube, invert it, and use the sharp point to open
the tube.
2.
Screw the end of the applicator onto the tube. Make sure the plunger
is fully inserted into the
barrel.
3.
Squeeze tube slowly to fill the applicator with the cream until the
plunger stops (at