DUAVIVE 20 mg/0.45 mg modified - release tablets

国: マレーシア

言語: 英語

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

有効成分:

Bazedoxifene Acetate; Conjugated Estrogens

から入手可能:

PFIZER (MALAYSIA) SDN. BHD.

INN（国際名）:

Bazedoxifene Acetate; Conjugated Estrogens

パッケージ内のユニット:

28tablet Tablets; 7tablet Tablets; 28 Tablets; 7 Tablets

製:

Pfizer Ireland Pharmaceuticals.,

情報リーフレット

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DUAVIVE
Conjugated estrogens/Bazedoxifene (0.45 mg/20 mg)
1
PLD TITLE
: Conjugated Estrogens/Bazedoxifene
PLD DATE
: 29 May 2019
COUNTRY
: Malaysia
REFERENCE DOCUMENT
:
Conjugated estrogens 0.45 mg/bazedoxifene 20 mg (Duavive) Malaysia LPD
dated 13 March
2018
REASON FOR CHANGE
: To update PRH address and reporting section
: To add Serial Number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DUAVIVE
Conjugated estrogens/Bazedoxifene (0.45 mg/20 mg)
2
WHAT IS IN THIS LEAFLET
1.
What Duavive is used for
2.
How Duavive works
3.
Before you use Duavive
4.
How to use Duavive
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Duavive
8.
Product Description
9.
Manufacturer & Product Registration
Holder
10.
Date of Revision
1. WHAT DUAVIVE IS USED FOR
DUAVIVE is indicated for:
-The treatment of moderate to severe
vasomotor symptoms (i.e. hot flashes,
sweating) associated with menopause.
-The prevention of post-menopausal
osteoporosis
2. HOW DUAVIVE WORKS
Estrogens are hormones made by a
woman's ovaries. The ovaries normally
stop making estrogens when a woman is
between 45 and 55 years old. This drop in
body estrogen levels causes the “change
of life” or menopause (the end of
monthly menstrual periods).
Duavive contains Conjugated estrogens
with bazedoxifene. Conjugated estrogens
and bazedoxifene function by binding to
and activating the two estrogen receptors
(α and β).
Conjugated estrogens are composed of
multiple estrogens that demonstrate tissue
selective estrogen receptor agonist
activity. Bazedoxifene demonstrates both
tissue selective estrogen receptor agonist
and antagonist activity.
3. BEFORE YOU USE DUAVIVE
•
_When you must not use it _
_Pregnancy and lactation _
Do not take Duavive if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take Duavive if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
Do not take Duavive if yo

製品の特徴

Pfizer Confidential
CLD Title
: Bazedoxifene/Conjugated Estrogens (Duavive)
CLD Date
: 25 November 2020
Country
: Malaysia
Reference Documents
: CDS v7.0 Dated 16 November 2018; USPI Dated 03 February 2020
(Sections
4.1 & 4.2)
Reason for change
: PfLEET 2020-0066102 (S2): To remove clinical information that is
specific
to CE 0.625 mg that does not include information for CE 0.45 mg.
: To remove the unapproved indications mentioned in section 5.1.
Pfizer Confidential
1
PFIZER
DUAVIVE
Bazedoxifene/Conjugated Estrogens
1.
NAME OF THE MEDICINAL PRODUCT
DUAVIVE 20 mg/0.45 mg MODIFIED - RELEASE TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Conjugated estrogens (CE) and bazedoxifene
COMPOSITION
Active ingredient: Each tablet contains 0.45 mg of CE and bazedoxifene
acetate equivalent to
20 mg bazedoxifene.
CHEMICAL NAME
Conjugated estrogens are a mixture of sodium estrone sulfate and
sodium equilin sulfate, and
also contain as concomitant components, sodium sulfate conjugates,
17α-dihydroequilin, 17α-
estradiol, and 17β-dihydroequilin.
Bazedoxifene is supplied as the acetate salt (bazedoxifene acetate)
whose chemical name is
1H-Indol-5-ol, 1-[[4-[2-(hexahydro-1H-azepin-1-yl)
ethoxy]phenyl]methyl]-2-(4-
hydroxyphenyl)-3-methyl-, monoacetate.
_Structure _
N
CH
3
OH
O
H
O
N
CH
3
COOH
.
BAZEDOXIFENE ACETATE
MOLECULAR FORMULA
C
30
H
34
N
2
O
3
•
C
2
H
4
O
2
Bazedoxifene acetate
Pfizer Confidential
2
MOLECULAR WEIGHT
530.65
Bazedoxifene acetate
PHYSICAL CHARACTERISTICS
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.
Bazedoxifene acetate is a white to tan powder. The aqueous solubility
of bazedoxifene is pH-
dependent. Solubility is higher at lower pH. The solubility of
bazedoxifene acetate in
unbuffered sterile water was measured to be 923 μgA/mL at pH 5.4.
3.
PHARMACEUTICAL FORM
Oval, biconvex, pink tablets, branded with “0.45/20” in bl