PHARMORUBICIN CS INJECTION 10 mg5 ml

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

EPIRUBICIN HCl

제공처:

PFIZER PRIVATE LIMITED

ATC 코드:

L01DB03

복용량:

10 mg/5 ml

약제 형태:

INJECTION

구성:

EPIRUBICIN HCl 10 mg/5 ml

관리 경로:

INTRAVENOUS

처방전 유형:

Prescription Only

Manufactured by:

PFIZER (PERTH) PTY LTD

승인 상태:

ACTIVE

승인 날짜:

1998-09-25

환자 정보 전단

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FRONT
PRODUCT INFORMATION
Pharmorubicin
®
 Injection 10 mg/5 mL, 
20 mg/10 mL, 50 mg/25 mL and 200 mg/100 mL
NAME OF THE DRUG
epirubicin hydrochloride
DESCRIPTION
Pharmorubicin (epirubicin hydrochloride) is supplied 
as a ready-to-use solution (Pharmorubicin Injection). 
Pharmorubicin Injection is a clear and clean red 
solution. Structurally, Pharmorubicin differs from 
Adriamycin
®
 (doxorubicin hydrochloride) only in the 
orientation of the hydroxyl group at the 4 position 
on the aminoglycoside ring. The chemical name of 
epirubicin hydrochloride is (8S, 10S)-10-(3-Amino-
2,3,6-trideoxy-α-L-_arabino_-hexopyranosyloxy)-8-
glycolloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-
methoxynaphthacene-5,12-dione hydrochloride.
The structural formula is:
CAS 56390-09-1
Pharmorubicin is a red-orange, almost odourless, 
hygroscopic powder, sparingly soluble in water and 
dilute alcohol.
PHARMACOLOGY
The mechanism of action of Pharmorubicin has not 
been fully elucidated but is probably related to its 
ability to bind DNA. Cell culture studies have shown 
cell penetration, localisation in the nucleus and 
inhibition of nucleic acid synthesis and mitosis. 
Pharmorubicin has proved to be active on the 
following experimental tumours: L 1210 ascites and 
P388 leukaemias, sarcoma SA 180 (solid and ascitic 
forms), melanoma B 16, mammary carcinoma, Lewis 
lung carcinoma and colon carcinoma 38.
The specificity of Pharmorubicin toxicity appears to 
be related primarily to proliferative activity of normal 
tissue. Thus, bone marrow, gastrointestinal tract, 
lymphoid organs and the gonads are the main normal 
tissues damaged. Degenerative or functional 
alterations in liver and kidneys were also seen in 
animals dosed with Pharmorubicin.
Like most other antitumour and immunosuppressant 
agents, Pharmorubicin, under experimental 
conditions, has mutagenic properties and is 
carcinogenic in laboratory animals (see Precautions, 
Use in Pre

제품 특성 요약

PHARMORUBICIN
® CS
(epirubicin hydrochloride)
1.
NAME OF THE MEDICINE
Epirubicin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
vial
of
Pharmorubicin
contains
10
mg/5
mL
and
50 mg/25
mL
of
epirubicin
hydrochloride (strength 2 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SOLUTION FOR INJECTION
Pharmorubicin is a clear, red ready for use solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pharmorubicin has produced responses in a wide spectrum of neoplastic
diseases, and is
indicated for the treatment of:
•
breast cancer;
•
gastric cancer;
•
ovarian cancer;
•
small cell lung cancer;
•
lymphoma (non-Hodgkin’s lymphoma);
•
advanced/metastatic soft tissue sarcoma;
•
superficial bladder cancer (Tis; Ta).
In bladder cancer, Pharmorubicin is also indicated in the prophylaxis
of recurrence after
transurethral resection of stage T1 papillary cancers and stage Ta
multifocal papillary cancers
(Grade 2 and 3).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
NOTE:
The recommended lifetime cumulative dose limit of Pharmorubicin is 900
mg/m
2
body surface area.
_INTRAVENOUS ADMINISTRATION _
Under conditions of normal recovery from drug-induced toxicity
(particularly bone marrow
depression and stomatitis), the recommended dosage schedule in adults,
as described below,
is as a single intravenous injection administered at 21 day intervals.
Standard doses are 75 to 90 mg/m
2
. Pharmorubicin produces predominantly haematological
dose limiting toxicities which are predicted from the known
dose–response profile of the drug.
Based on the patient’s haematological status the physician should
determine the choice of
dose.
Higher doses, up to 135 mg/m
2
as a single agent and 120 mg/m
2
in combination, every
3-4 weeks have been effective in the treatment of breast cancer. In
the adjuvant treatment of
early breast cancer patients with positive lymph nodes, doses ranging
from 100 mg/m
2
to
120 mg/m
2
every 3-4 weeks are recommended. Careful monit