Kliovance

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Estradiol hemihydrate 1.03mg equivalent to 1 mg oestradiol;  ;  ;  ; Norethisterone acetate 0.5mg;  ;  ;  

Beschikbaar vanaf:

Novo Nordisk Pharmaceuticals Ltd

INN (Algemene Internationale Benaming):

Estradiol hemihydrate 1.03 mg (=1 mg oestradiol)

farmaceutische vorm:

Film coated tablet

Samenstelling:

Active: Estradiol hemihydrate 1.03mg equivalent to 1 mg oestradiol       Norethisterone acetate 0.5mg       Excipient: Copovidone Hypromellose Lactose monohydrate Magnesium stearate Maize starch Purified talc Triacetin

Eenheden in pakket:

Calendar pack, 3 x 28 tablets, 84 tablets

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Bayer AG

Product samenvatting:

Package - Contents - Shelf Life: Calendar pack, 3 x 28 tablets - 84 tablets - 24 months from date of manufacture stored at or below 25°C

Autorisatie datum:

1997-12-04

Bijsluiter

Kliovance®
®
Tablets 23.02.2022 1 of 10
PACKAGE LEAFLET
KLIOVANCE® 1 MG/0.5 MG FILM-COATED TABLETS
Estradiol/norethisterone acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kliovance
®
is and what it is used for
2.
What you need to know before you take Kliovance
®
3.
How to take Kliovance
®
4.
Possible side effects
5.
How to store Kliovance
®
6.
Contents of the pack and other information
1.
What Kliovance
®
is and what it is used for
Kliovance
®
is a continuous combined Hormone Replacement Therapy (HRT). It
contains two types of
female hormones, an oestrogen and a progestagen. Kliovance
®
is used in postmenopausal women
with at least 1 year since their last natural period.
Kliovance
®
is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This can cause
symptoms such as hot face, neck and chest (‘hot flushes’).
Kliovance
®
alleviates these symptoms
after menopause. You will only be prescribed Kliovance
®
if your symptoms seriously hinder your daily
life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all
available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable
for you, you can use Kliovance
®
to prevent osteoporosis after menopause.
Kliovance
®
is prescribed for women who have not had their womb removed, and whose
periods
stoppe

Productkenmerken

_ _
1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
KLIOVANCE
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
17ß-oestradiol 1mg and Norethisterone acetate 0.5mg tablets.
3 PHARMACEUTICAL FORM
Kliovance calendar dial pack contains 28 tablets as described below:
White, round, film coated, biconvex tablets with a diameter of 6mm.
The tablets are engraved
“NOVO 288” on one side and the Apis bull on the other side. Each
tablet contains 1mg of 17ß-
oestradiol and 0.5mg of norethisterone acetate.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Kliovance is indicated for the treatment of menopausal symptoms
related to oestrogen
deficiency, including urogenital atrophy. Kliovance is also indicated
for the prevention of
osteoporosis in postmenopausal women.
The experience of treating women older than 65 years is limited.
4.2 Dose and method of administration
Kliovance is a continuous combined HRT product intended for use in
women with an intact
uterus. One tablet should be taken orally once a day without
interruption, preferably at the
same time of the day.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective
dose for the shortest duration (see also section 4.4) should be used.
Kliovance
avoids
monthly
withdrawal
bleeding
associated
with
sequential
hormone
replacement therapy (HRT) regimens. During the initial months of
therapy sporadic bleeding
or spotting episodes may occur; however, these tend to decrease with
time and after 9 to 12
months of treatment less than 3% of women report bleeding.
Relief of menopausal symptoms is achieved during the first few weeks
of treatment in the
majority of women. A switch to a higher dose combination product could
be indicated if the
response after 3 months is insufficient for symptom relief.
In women with amenorrhoea and not taking HRT or women in transition
from another
continuous
combined HRT
product,
treatment
with
Kliovance
may be
started
on
any
convenient day. In women in transition from a sequential HRT regimens,
treatment should
start righ