Duavive

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Bazedoxifene acetate 22.56mg equivalent to 20mg bazedoxifene - in tablet subcoat;  ; Conjugated estrogens 0.45mg (10.4895 mg conjugated estrogens (CE) dessication with lactose (containing 4.29% CE) - in tablet core);  

Disponível em:

Pfizer New Zealand Limited

DCI (Denominação Comum Internacional):

Bazedoxifene acetate 22.56 mg (equivalent to 20mg bazedoxifene - in tablet subcoat)

Dosagem:

0.45mg/20mg

Forma farmacêutica:

Modified release tablet

Composição:

Active: Bazedoxifene acetate 22.56mg equivalent to 20mg bazedoxifene - in tablet subcoat   Conjugated estrogens 0.45mg (10.4895 mg conjugated estrogens (CE) dessication with lactose (containing 4.29% CE) - in tablet core)   Excipient: Ascorbic acid Hyprolose Hypromellose     Isopropyl alcohol Lactose monohydrate Macrogol 400 Magnesium stearate Microcrystalline cellulose   Opacode black NS-78-17821 Opadry pink 03B14899 Opaglos clear 98Z19173 Purified water     Sucrose   Sucrose palmitate

Tipo de prescrição:

Prescription

Fabricado por:

F.I.S. Fabbrica Italiana Sintetici SpA

Indicações terapêuticas:

Duavive is indicated for treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. The experience treating women older than 65 years is limited.

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, PVC/Aclar/PVC blister, sealed in an aluminium foil laminate pouch - 7 dose units - 60 days opened stored at or below 25°C protect from moisture 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/Aclar/PVC blister, sealed in an aluminium foil laminate pouch - 28 dose units - 60 days opened stored at or below 25°C protect from moisture 36 months from date of manufacture stored at or below 25°C protect from moisture

Data de autorização:

2015-07-03

Folheto informativo - Bula

DUAVIVE
®
0.45/20
1
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 th

Características técnicas

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Duavive

0.45mg/20mg modified-release tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duavive (conjugated estrogens/bazedoxifene), pairs conjugated
estrogens with bazedoxifene,
a selective estrogen receptor modulator (SERM).
Each
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 modified-release tablet contains 96.9 mg sucrose (includes 0.7 mg
sucrose as sucrose
monopalmitate), 59.8 mg lactose monohydrate and 0.2 mg maltitol liquid
(present in Opaglos
clear coating).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
The Duavive 0.45 mg/20 mg modified-release tablet is a pink,
oval-shaped, tablet marked on
one side with “0.45/20”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duavive is indicated
_ _
for the treatment of estrogen deficiency symptoms in postmenopausal
women with a uterus (with at least 12 months since the last menses)
for whom treatment with
progestin-containing therapy is not appropriate.
The experience treating women older than 65 years is limited.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSE _
For
initiation
and
continuation
of
treatment
of
postmenopausal
symptoms,
the
lowest
effective dose for the shortest duration (see section 4.4) should be
used.
If a tablet is forgotten, it should be taken as soon as the patient
remembers. Therapy should
then be continued as before. If more than one tablet has been
forgotten, only the most recent
tablet should be taken, the patient should not take double the usual
dose to make up for
missed tablets.
Duavive may be given at any time of day, without regard to meals.
Tablets should be
swallowed whole. Tablets should not be chewed, crushed or broken.
Version:
pfdduavt10418
Supersedes:
pfdduavt10316
Page 1 of 21
Dose dispensing is not appropriate for this product.
_SPECIAL POPULATIONS _
_Elderly _
Duavive has not been studied in women over 75 years of age. In 224
women in