Climara 50

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Estradiol hemihydrate 3.92mg equivalent to estradiol 3.79 mg (50 µg/24h)

Verfügbar ab:

Bayer New Zealand Limited

INN (Internationale Bezeichnung):

Estradiol hemihydrate 3.92 mg (equivalent to estradiol 3.79 mg (50 µg/24h))

Dosierung:

50 mcg/24h

Darreichungsform:

Transdermal patch

Zusammensetzung:

Active: Estradiol hemihydrate 3.92mg equivalent to estradiol 3.79 mg (50 µg/24h) Excipient: Acrylates copolymer Ethyl oleate Glyceryl monolaurate Isopropyl myristate

Einheiten im Paket:

Sachet, aluminium foil, laminated, 4 patches

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Bayer AG

Anwendungsgebiete:

For short-term treatment of complaints associated with the menopause and post-menopause, including signs and symptoms of oestrogen deficiency, whether naturally or surgically induced. Oestrogen replacement therapy in women with an intact uterus should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals. Prevention of postmenopausal osteoporosis.

Produktbesonderheiten:

Package - Contents - Shelf Life: Sachet, aluminium foil, laminated - 4 patches - 36 months from date of manufacture stored at or below 30°C

Berechtigungsdatum:

1994-05-19

Gebrauchsinformation

CLIMARA
®
CMI
1
CONSUMER MEDICINE INFORMATION
CLIMARA
®
_oestradiol _
WARNING
The Women’s Health Initiative (WHI) trial examined the health
benefits and risks of combined
_oestrogen plus progestogen_ therapy (n=16,608) and _oestrogen-alone_
therapy (n=10,739) in
postmenopausal women aged 50 to 79 years.
The _oestrogen plus progestogen_ arm of the WHI trial indicated an
increased risk of
_myocardial infarction (MI), stroke, invasive breast cancer, pulmonary
embolism and deep _
_vein thrombosis _in postmenopausal women receiving treatment with
combined conjugated
equine estrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate
(MPA, 2.5
mg/day) for 5.2 years compared to those receiving placebo.
The _oestrogen-alone_ arm of the WHI trial indicated an increased risk
of_ stroke and deep vein _
_thrombosis _in hysterectomised women treated with CEE-alone (0.625
mg/day) for 6.8 years
compared to those receiving placebo.
Other doses of oral conjugated oestrogens with medroxyprogesterone
acetate, and other
combinations and dosage forms of oestrogens and progestogens were not
studied in the
WHI clinical trials and, in the absence of comparable data, these
risks should be assumed to
be similar.
Therefore, the following should be given serious consideration at the
time of prescribing:
•
Oestrogens with or without progestogens should not be prescribed for
primary or
secondary prevention of cardiovascular diseases.
•
Oestrogens with or without progestogens should be prescribed at the
lowest effective
dose for the approved indication.
•
Oestrogens with or without progestogens should be prescribed for the
shortest period
possible for the approved indication.
•
For the prevention of osteoporosis, oestrogen treatment should be
considered in light
of other available therapies.
CLIMARA
®
CMI
1_ _
CLIMARA
®
(CLIM·AR·RAH)
_oestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Climara. It does
not contain all the available
information. It does not take th

Fachinformation

CLIMARA DS XV1.0, CCDS 16
Page 1 of 21
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
CLIMARA®
_estradiol _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CLIMARA 25 patch contains 2.0 mg of estradiol (equivalent to 2.0 mg
estradiol hemihydrate)
releasing a nominal 25 micrograms per 24 hours.
CLIMARA 50 patch contains 3.8 mg of estradiol (equivalent to 3.9 mg
estradiol hemihydrate)
releasing a nominal 50 micrograms per 24 hours.
CLIMARA 75 patch contains 5.7 mg of estradiol (equivalent to 5.9 mg
estradiol hemihydrate)
releasing a nominal 75 micrograms per 24 hours.
CLIMARA 100 patch contains 7.6 mg of estradiol (equivalent to 7.8 mg
estradiol hemihydrate)
releasing a nominal 100 micrograms per 24 hours.
For a list of excipients see 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The CLIMARA transdermal delivery system is a transparent oval patch
containing estradiol in an
acrylate adhesive matrix.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
For short-term treatment of complaints associated with the menopause
and post-menopause,
including signs and symptoms of estrogen deficiency, whether naturally
or surgically induced.
Estrogen replacement therapy in women with an intact uterus should
always be opposed by a
progestogen in an adequate dosage regimen to ensure secretory
transformation of the
endometrium at regular intervals.
Prevention of postmenopausal osteoporosis.
For further information please refer to 5.1 Pharmacodynamic
properties.
4.2
Dose and method of administration
Hormonal contraception should be stopped when hormone replacement
therapy (HRT) is started
and the patient should be advised to take non-hormonal contraceptive
precautions, if required.
CLIMARA DS XV1.0, CCDS 16
Page 2 of 21
_Dosage Regimen _
Hormone replacement therapy should only be continued for as long as
the benefit in alleviation of
severe symptoms outweighs the risk for the individual woman. The need
for continuing treatment
should be reviewed periodically (e.g. at 6-monthly intervals).
Treatment should be based on
individual considerations (s