PREMARIN TABLET 0.625 mg

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Conjugated Estrogens Desiccation with Lactose 14.57mg @4.29% CE

Verfügbar ab:

PFIZER PRIVATE LIMITED

ATC-Code:

G03CA57

Dosierung:

0.625 mg

Darreichungsform:

TABLET, SUGAR COATED

Zusammensetzung:

Conjugated Estrogens Desiccation with Lactose 14.57mg @4.29% CE 0.625 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

PFIZER IRELAND PHARMACEUTICALS

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

1990-05-22

Gebrauchsinformation

PREMARIN
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of
1.
NAME OF THE MEDICINAL PRODUCT
Premarin
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Conjugated Estrogens
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Moderate to severe vasomotor symptoms associated with estrogen
deficiency.
2.
Prevention and management of osteoporosis associated with estrogen
deficiency. When
prescribing solely for the prevention of postmenopausal osteoporosis,
therapy should only be
considered
for
women
at
significant
risk
of
osteoporosis
and
for
whom
non-estrogen
medications are not considered to be appropriate. When prescribing
solely for the management
of postmenopausal osteoporosis, non-estrogen medications should be
first considered.
3.
Atrophic vaginitis and atrophic urethritis. When prescribing solely
for the treatment of
symptoms of vulvar and vaginal atrophy, topical vaginal products
should be considered.
4.
Female hypoestrogenism.
ET (estrogen therapy) and HT (hormone therapy) should not be initiated
or continued to prevent
coronary heart disease (see section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, CARDIOVASCULAR
RISK
).
The benefits and risks of ET and HT must always be carefully weighed,
including consideration of the
emergence of risks as therapy continues (see section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
Estrogens with or without progestins should be prescribed at the
lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the
individual woman. In the absence of
comparable data, the risks of HT should be assumed to be similar to
all estrogens and estrogen/progestin
combinations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of Premarin may be continuous (e.g., without a break in
therapy) or cyclic (e.g., three
weeks on and one week off).
The lowest effective dose should be administered. Patients

Fachinformation

PREMARIN
® TABLET
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
Premarin
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Conjugated Estrogens (CE)
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Moderate to severe vasomotor symptoms associated with estrogen
deficiency.
2.
Prevention and management of osteoporosis associated with estrogen
deficiency. When
prescribing solely for the prevention of postmenopausal osteoporosis,
therapy should only be
considered
for
women
at
significant
risk
of
osteoporosis
and
for
whom
non-estrogen
medications are not considered to be appropriate. When prescribing
solely for the management
of postmenopausal osteoporosis, non-estrogen medications should be
first considered.
3.
Atrophic vaginitis and atrophic urethritis. When prescribing solely
for the treatment of
symptoms of vulvar and vaginal atrophy, topical vaginal products
should be considered.
4.
Female hypoestrogenism.
ET (estrogen therapy) and HT (hormone therapy) should not be initiated
or continued to prevent
coronary heart disease (see section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE, CARDIOVASCULAR
RISK).
The benefits and risks of ET and HT must always be carefully weighed,
including consideration of the
emergence of risks as therapy continues (see section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
Estrogens with or without progestins should be prescribed at the
lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the
individual woman. In the absence of
comparable data, the risks of HT should be assumed to be similar to
all estrogens and estrogen/progestin
combinations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of Premarin may be continuous (e.g., without a break in
therapy) or cyclic (e.g., three
weeks on and one week off).
The lowest effective dose should be administered. Patien