Premarin

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Conjugated estrogens 1.25mg;  

Tilgængelig fra:

Wyeth (NZ) Ltd

INN (International Name):

Conjugated estrogens 1.25 mg

Dosering:

1.25 mg

Lægemiddelform:

Tablet

Sammensætning:

Active: Conjugated estrogens 1.25mg   Excipient: Calcium sulfate Carnauba wax Glyceryl mono-oleate Ink Lactose monohydrate Macrogol 20000 Magnesium stearate Methylcellulose Microcrystalline cellulose Quinoline yellow Shellac Stearic acid Sucrose Sunset yellow FCF Titanium dioxide

Enheder i pakken:

Blister pack, 28 tablets, 28 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Wyeth Pharmaceuticals Inc

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, 28 tablets - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, 3 x 28 tablets - 84 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisation dato:

1969-12-31

Produktets egenskaber

Version: pfdpremt10119
Supersedes: pfdpremt10716
Page 1 of 18
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).
Version: pfdpremt10119
Supersedes: pfdpremt10716
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