ESTRACYT CAPSULE 140 mg

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

ESTRAMUSTINE PHOSPHATE SODIUM EQV ESTRAMUSTINE

Beszerezhető a:

PFIZER PRIVATE LIMITED

ATC-kód:

L01XX11

Adagolás:

140 mg

Gyógyszerészeti forma:

CAPSULE

Összetétel:

ESTRAMUSTINE PHOSPHATE SODIUM EQV ESTRAMUSTINE 140 mg

Az alkalmazás módja:

ORAL

Recept típusa:

Prescription Only

Gyártó:

Pfizer Italia S.r.l.

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

1997-08-13

Betegtájékoztató

LPD Ref.: EST
–SIN–MS–1209/1 
Date of Last Revision: 20 Sep 2011 
Country: Singapore, Malaysia 
Based on CDS #730 (March 19, 2008) 

PFIZER CONFIDENTIAL 
Page 1 
1. 
NAME OF THE MEDICINAL PRODUCT 
Estracyt Capsules 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each capsule contains estramustine phosphate disodium salt equivalent to
estramustine         
  phosphate 140 mg. 
3. 
PHARMACEUTICAL FORM

    Size 1, opaque white, self-locking hard
gelatin capsules with the radial imprint   
    “ESTRACYT” on the cap and “K Ph
750” on the body in black ink, containing an off- 
    white powder. 
4. 
CLINICAL PARTICULARS 
4.1. 
THERAPEUTIC INDICATIONS 
Prostatic carcinoma in advanced stage,
especially in patients with hormone refractory tumors 
and as primary therapy in those patients who present with
prognostic factors indicative of a poor 
response to purely hormonal therapy. 
4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 
Estramustine should be administered by personnel experienced
in the use of antineoplastic 
therapy. 
The dose range is 7-14 mg/kg (4 - 8 capsules) daily in 2 (or
3) divided doses. Recommended 
starting dose is 4-6 capsules to
achieve a dose of at least 10 mg/kg. The capsules should be 
taken not less than 1 hour before, or 2 hours
after, meals. They should be swallowed with a 
glass of water. Milk, milk products or
drugs containing calcium, magnesium or aluminium (e.g. 
antacids) must not be taken
simultaneously with estramustine capsules. 
If no response is observed after 4 - 6 weeks, treatment should
be discontinued. 
4.3. 
CONTRAINDICATIONS 
Estramustine should not be used in patients with: 
  -Known hypersensitivity to either estradiol or to nitrogen
mustards 
  -Severe hepatic disease 
  -Severe cardiovascular disease: ischemic,
thromboembolic or complications related t

Termékjellemzők

1.
NAME OF THE MEDICINAL PRODUCT
Estracyt Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains estramustine phosphate disodium salt equivalent
to estramustine
phosphate 140 mg.
3.
PHARMACEUTICAL
FORM
Size 1, opaque white, self-locking hard gelatin capsules with the
radial imprint “ESTRACYT”
on the cap and “K Ph 750” on the body in black ink, containing an
off-white powder.
4.
CLINICAL
PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Prostatic carcinoma in advanced stage, especially in patients with
hormone refractory
tumors and as primary therapy in those patients who present with
prognostic factors
indicative of a poor response to purely hormonal therapy.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Estramustine should be administered by personnel experienced in the
use of antineoplastic
therapy.
The dose range is 7-14 mg/kg (4-8 capsules) daily in 2 (or 3) divided
doses. Recommended
starting dose is 4-6 capsules to achieve a dose of at least 10 mg/kg.
The capsules should be
taken not less than 1 hour before, or 2 hours after, meals. They
should be swallowed with a
glass of water. Milk, milk products or drugs containing calcium,
magnesium or aluminium
(e.g. antacids) must not be taken simultaneously with estramustine
capsules.
If no response is observed after 4-6 weeks, treatment should be
discontinued.
4.3.
CONTRAINDICATIONS
Estramustine should not be used in patients with:
−
Known hypersensitivity to either estradiol or to nitrogen mustards
−
Severe hepatic disease
−
Severe cardiovascular disease: ischemic, thromboembolic or
complications related to
fluid retention
Page 1
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Estramustine should be used with caution in patients with a history of
thrombophlebitis,
thrombosis or thromboembolic disorders, especially if associated with
estrogen therapy.
Caution should also be used in patients with cerebral vascular or
coronary artery disease.
Glucose Tolerance - Because glucose tolerance may be decreased,
diabetic patients should
be carefully foll