PREMARIN VAGINAL CREAM 0.625MGG

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

OESTROGENS,CONJUGATED

Saadav alates:

PFIZER (MALAYSIA) SDN. BHD.

INN (Rahvusvaheline Nimetus):

OESTROGENS,CONJUGATED

Ühikuid pakis:

14 gm 0 1 Units Units

Valmistatud:

PF Consumer Healthcare Canada ULC

Infovoldik

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PREMARIN
®
VAGINAL CREAM
Conjugated estrogens (0.625 mg/g)
2
WHAT IS IN THIS LEAFLET
1.
What PREMARIN VAGINAL
CREAM is used for
2.
How PREMARIN VAGINAL
CREAM works
3.
Before you use PREMARIN
VAGINAL CREAM
4.
How to use PREMARIN VAGINAL
CREAM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PREMARIN
VAGINAL CREAM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PREMARIN VAGINAL
CREAM IS USED FOR
PREMARIN VAGINAL CREAM is used
to treat
-
atrophic vaginitis (thinning, drying
and inflammation of the vaginal
walls)
-
dyspareunia (painful intercourse)
-
kraurosis vulvae (a condition
affecting the female external genitalia,
resulting in drying, shriveling and
itching of the parts
HOW PREMARIN VAGINAL CREAM
WORKS
PREMARIN VAGINAL CREAM
contains a mixture of natural hormones
called conjugated estrogens, which are
similar to the hormones produced by the
ovaries before menopause. When given
during or after menopause, they can help
control some of the symptoms, such as
vaginal itching, dryness, and burning or
pain during intercourse.
BEFORE YOU USE PREMARIN
VAGINAL CREAM
-
_When you must not use it_
Do not use PREMARIN VAGINAL
CREAM:
- if you have abnormal uterine bleeding
which is not diagnosed
- if you have or have had breast cancer,
or if you are suspected of having it
- if you have or suspected to have
abnormal growth which is sensitive to
estrogens, such as cancer of the lining
of the womb (endometrium) or
excessive thickening of the womb
lining (endometrial hyperplasia)
- if you have or have had a disease
caused by blood clots in the arteries,
such as a heart attack or stroke or
vein, such as in the legs or the lungs;
- if you have or have previously had
liver disease
- if you have a disorder affecting your
blood clotting
- if you are allergic to estrogen or any
of the ingredients found in
PREMARIN VAGINAL CREAM
_Pregnancy and lactation_
You should stop using PREMARIN
VAGINAL CREAM

Toote omadused

Pfizer Confidential
1
CLD Title
: Premarin Vaginal Cream (Conjugated Estrogen)
CLD Date
:
06 July 2021
Country
:
Malaysia
Reference Document
:
CDS version 29.0 (dated 15 Apr 2015), USPI (Revised:
09/18)
Reason for change
: PfLEET number 2021-0070961 (S2): To remove pediatric information
related to tablets.
Pfizer Confidential
2
1. NAME OF THE MEDICINAL
PRODUCT
PREMARIN
®
VAGINAL
CREAM
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Premarin
®
(conjugated estrogens) Vaginal Cream – Each gram contains 0.625 mg
conjugated estrogens,
USP.
Premarin Vaginal Cream contains a mixture of conjugated estrogens
obtained exclusively from natural
sources, occurring as the sodium salts of water-soluble estrogen
sulfates blended to represent the average
composition of material derived from pregnant mares’ urine. It is a
mixture of sodium estrone sulfate and
sodium equilin sulfate. It contains as concomitant components, as
sodium sulfate conjugates, 17 α-
dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin.
3. PHARMACEUTICAL
FORM
Cream formulation
4. CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATION
Premarin (conjugated estrogens, CE) Vaginal Cream is indicated in the
treatment of atrophic vaginitis,
dyspareunia and kraurosis vulvae.
Estrogens with or without progestins should not be used for the
prevention of cardiovascular disease or
dementia (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS and SECTION
4.8 UNDESIRABLE EFFECTS).
4.2 POSOLOGY AND METHOD OF
ADMINISTRATION
Use of Premarin Vaginal Cream, alone or in combination with a
progestin, should be with the lowest
effective dose and for the shortest duration consistent with treatment
goals and risks for the individual
woman. Post-menopausal women should be re-evaluated periodically as
clinically appropriate to determine
if treatment is still necessary.
When estrogen is prescribed for a post-menopausal woman with a uterus,
a progestin should also be
considered to reduce the risk of endometrial cancer.
A woman without a uterus does not need a progestin. In some cases,
h