Premarin

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Conjugated estrogens 0.625mg;  ; Conjugated estrogens 0.625mg (Includes 3% overage); Conjugated estrogens 0.625mg

Saadav alates:

Pfizer New Zealand Limited

INN (Rahvusvaheline Nimetus):

Conjugated estrogens 0.625 mg

Annus:

0.625 mg

Ravimvorm:

Tablet

Koostis:

Active: Conjugated estrogens 0.625mg   Excipient: Calcium sulfate Carnauba wax Glyceryl mono-oleate Lactose monohydrate Macrogol 20000 Magnesium stearate Methylcellulose Microcrystalline cellulose Opaglos clear 98Z19173 Shellac Stearic acid Sucrose Titanium dioxide Urethane dimethacrylate luting resin Active: Conjugated estrogens 0.625mg (Includes 3% overage) Excipient: Calcium sulfate Carnauba wax Glyceryl mono-oleate Lactose monohydrate Macrogol 20000 Magnesium stearate Methylcellulose Microcrystalline cellulose Opacode Opalux maroon AS-3910 Shellac Stearic acid Sucrose Titanium dioxide Active: Conjugated estrogens 0.625mg Excipient: Carnauba wax Hyprolose Hypromellose     Lactose monohydrate Macrogol 400 Magnesium stearate Microcrystalline cellulose   Opacode white NS-78-18011 Opadry Maroon 03B16083 Sucrose

Ühikuid pakis:

Blister pack, 1 x 14, 14 tablets

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Pfizer Global Manufacturing

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, - 14 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, 2 x 28 - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, 3 x 28 - 84 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, 4 x 28 - 112 tablets - 24 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

1969-12-31

Infovoldik

PREMARIN
1
PREMARIN
®
_Conjugated estrogens Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
PREMARIN Tablets. It does not
contain all of 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
PREMARIN against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PREMARIN IS
USED FOR
PREMARIN is a type of treatment
called hormone replacement therapy
(HRT) and contains the hormone
estrogen in the form known as
conjugated estrogens.
PREMARIN helps to relieve the
discomfort many women feel during
and after menopause, including
symptoms such as "hot flushes",
sweating and vaginal dryness. It
helps to prevent thinning of the bones
(osteoporosis), which can cause
fractures.
PREMARIN is also used to treat
women where either the ovary does
not function properly or has been
removed.
If your doctor thinks you will need to
take estrogens for a long time,
including for the prevention of
osteoporosis, he or she will have
considered the benefits and risks of
other treatments before prescribing
PREMARIN for you.
_HOW IT WORKS_
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".
Some women also have problems
with dryness of the vagina causing
discomfort during or after sexual
intercourse. Some women develop
osteoporosis during or after
menopause. This is a thinning of the
bones making them weaker and more
likely to break, especially the bones
of the spine, hip and wrist.
Conjugated estrogens are like the
hormones produced by the ovaries
before menopause. When given
during or after menopause, they can
help control the symptoms.
estrogen is u

Toote omadused

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Premarin
®
0.3 mg, 0.625 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Premarin tablet contains 0.3 mg or 0.625 mg conjugated estrogens.
Conjugated estrogens (CE) is a mixture of natural estrogens (of equine
origin) composed
principally of the sodium salts of water soluble sulfate esters of
estrone, equilin, and 17
alpha-dihydroequilin, together with smaller amounts of 17
alpha-estradiol, equilenin, and 17
alpha-dihydroequilenin, 17 beta-dihydroequilin, 17
beta-dihydroequilenin, 17 beta-estradiol
and delta 8, 9-dihydroestrone.
EXCIPIENT(S) WITH KNOWN EFFECT
Each Premarin 0.3 mg tablet contains 61.7 mg lactose monohydrate and
45 mgsucrose.
Each Premarin 0.625 tablet contains 54.1 mg lactose monohydrate and 45
mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Premarin 0.3 mg tablet is dark green, oval biconvex sugar-coated and
marked with “0.3
”
in
white ink.
Premarin 0.625 tablet is maroon, oval biconvex sugar-coated and marked
with
“
0.625
”
in
white ink.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Estrogens with or without progestogens should be prescribed at the
lowest effective doses
and for the shortest duration consistent with treatment goals and
risks for the individual
woman.
Premarin is indicated:
AS
REPLACEMENT
THERAPY
FOR
ESTROGEN
DEFICIENCY
STATES
ASSOCIATED
WITH
CLIMACTERIC
MANIFESTED BY:
•
moderate to severe vasomotor symptoms associated with the estrogen
deficiency in
natural and surgical menopause (sweating, hot flushes).
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Page 2 of 18
•
atrophic vaginitis due to menopause.
When prescribing solely for the treatment of symptoms of vaginal
atrophy, topical vaginal
products should be considered.
There is no evidence that estrogens are effective for anxiety or
depression without associated
vasomotor symptoms, and they should not be used to treat such
conditions.
FOR THE PREVENTI