DUAVIVE 0.45/20 conjugated estrogens/bazedoxifene (as acetate) 0.45 mg/20 mg modified release tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

conjugated estrogens, Quantity: 0.45 mg; bazedoxifene acetate, Quantity: 22.56 mg (Equivalent: bazedoxifene, Qty 20 mg)

Tilgjengelig fra:

Pfizer Australia Pty Ltd

INN (International Name):

Bazedoxifene acetate,conjugated estrogens

Legemiddelform:

Tablet, modified release

Sammensetning:

Excipient Ingredients: lactose monohydrate; hypromellose; microcrystalline cellulose; hyprolose; macrogol 400; magnesium stearate; sucrose palmitate; ascorbic acid; powdered cellulose; calcium phosphate; sucrose; propylene glycol; purified water; isopropyl alcohol; iron oxide black; titanium dioxide; iron oxide red; polydextrose; povidone; hyetellose; maltitol solution; poloxamer

Administreringsrute:

Oral

Enheter i pakken:

7 Tablets Sample Pack, 28 Tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

DUAVIVE is indicated for treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.,- DUAVIVE should be used for the shortest duration consistent with treatment goals and risks for the individual woman.,- Experience in women older than 65 years is limited.

Produkt oppsummering:

Visual Identification: A pink, oval shaped, tablet marked on one side with 0.45/20; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-12-15

Informasjon til brukeren

DUAVIVE
® 0.45/20
_Conjugated estrogens/bazedoxifene_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Duavive. 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 taking DUAVIVE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DUAVIVE IS
USED FOR
This medicine is used for the
treatment of symptoms, such as "hot
flushes" and sweating, which are
associated with menopause in women
who still have their uterus (womb).
_HOW DUAVIVE WORKS_
This medicine contains two active
substances called conjugated
estrogens and bazedoxifene.
Conjugated estrogens belong to a
group of medicines called
menopausal hormone therapy
(MHT). Bazedoxifene belongs to a
group of non-hormonal medicines
called selective estrogen receptor
modulators (SERMs).
Menopause occurs naturally in
women, typically between the ages of
45 and 55. During menopause, your
body produces less estrogen than it
did beforehand. This can cause
symptoms such as "hot flushes".
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
DUAVIVE
_WHEN YOU MUST NOT TAKE IT_
DUAVIVE SHOULD ONLY BE TAKEN IF
YOU HAVE BEEN FULLY INFORMED OF THE
RISKS.
The decision to take DUAVIVE
should be based on your particular
needs and health and made after a
careful medical evaluation.
TALK REGULARLY WITH YOUR DOCTOR
ABOUT WHETHER YOU STILL NEED
TREATMENT WITH DUAVIVE.
DO NOT TAKE DUAVIVE IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
conjugated estrogens or
bazedoxifene
•
any of the ingredients listed at the
end of this l

Preparatomtale

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Supersedes: pfpduavt11216
Page 1 of 25
AUSTRALIAN
PRODUCT
INFORMATION
–
DUAVIVE
 0.45/20 (CONJUGATED ESTROGENS/BAZEDOXI-
FENE)
WARNING
THE RISK ASSOCIATED WITH DUAVIVE IS UNKNOWN DUE TO THE LACK OF LONG
TERM SAFETY DATA
(SEE SECTIONS 4.3 CONTRAINDICATIONS, 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE AND 4.8
ADVERSE EFFECTS (UNDESIRABLE EFFECTS), DESCRIPTION OF SELECTED ADVERSE
REACTIONS).
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED RISKS
OF STROKE AND DEEP VEIN THROMBOSIS (DVT) IN POSTMENOPAUSAL WOMEN AGED
50 TO 79 YEARS
(MEAN
AGE
63.6
YEARS)
DURING
7.1
YEARS
OF
TREATMENT
WITH
CONJUGATED
ESTROGENS
(0.625 MG/DAY)
ALONE
THERAPY
RELATIVE
TO
PLACEBO.
ESTROGEN-ALONE
THERAPY
IS
ALSO
ASSOCIATED WITH AN INCREASE RISK OF OVARIAN CANCER.
1.
NAME OF THE MEDICINE
Conjugated estrogens/bazedoxifene.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DUAVIVE 0.45/20 modified release tablet contains 0.45 mg of
conjugated estrogens
(CE) and bazedoxifene acetate equivalent to 20 mg of bazedoxifene.
EXCIPIENT(S) WITH KNOWN EFFECT
Each tablet contains 96.9 mg sucrose (includes 0.7 mg sucrose as
sucrose palmitate), 59.8 mg
lactose monohydrate and 0.2 mg maltitol solution (a component of
Opaglos 2 Clear) (see
Section 4.4 Special warnings and precautions for use, Other
conditions).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Modified release tablet.
DUAVIVE 0.45 mg/20 mg is a pink, oval shaped, tablet marked on one
side with “0.45/20”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
DUAVIVE is indicated for treatment of moderate to severe vasomotor
symptoms associated
with menopause in women with a uterus.
•
DUAVIVE should be used for the shortest duration consistent with
treatment goals and
risks for the individual woman.
Version: pfpduavt10619
Supersedes: pfpduavt11216
Page 2 of 25
•
Experience in women older than 65 years is limited.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dose is as a singl