DBL Fluorouracil Injection BP 50mgmL

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

FLUOROURACIL

थमां उपलब्ध:

PFIZER PRIVATE LIMITED

ए.टी.सी कोड:

L01BC02

डोज़:

50 MG/ML

फार्मास्यूटिकल फॉर्म:

INJECTION

रचना:

FLUOROURACIL 50 MG/ML

प्रशासन का मार्ग:

INTRAVENOUS, INTRA-ARTERIAL

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

Hospira Australia Pty Ltd

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

1990-09-06

उत्पाद विशेषताएं

DBL
™ FLUOROURACIL INJECTION BP
1.
NAME OF THE MEDICINE
Fluorouracil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of DBL Fluorouracil Injection BP contains fluorouracil 25 mg
or 50 mg.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Fluorouracil Injection BP is a sterile, colourless,
preservative-free solution containing 5-
Fluorouracil in Water for Injections, prepared with the aid of sodium
hydroxide. The pH of the
solution is approximately 8.9. DBL Fluorouracil Injection BP is a
clear, colourless to slightly
yellow solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluorouracil is indicated alone or in combination for the palliative
treatment of malignant
tumours, particularly of the breast, colon or rectum; and in the
treatment of gastric, primary
hepatic, pancreatic, uterine (cervical particularly), ovarian and
bladder carcinomas.
Fluorouracil should only be used when other proven measures have
failed or are considered
impractical.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage being based on the patient’s actual weight. Ideal weight
is used only if the patient
is obese or if there has been a spurious weight gain due to oedema,
ascites or other forms of
abnormal fluid retention. Prior to treatment each patient is to be
carefully evaluated in order to
estimate the optimum initial dosage of fluorouracil.
THE TOTAL DAILY DOSE OF FLUOROURACIL SHOULD NOT EXCEED 1 GRAM.
The following regimens have been recommended for use of fluorouracil
as a single agent in
adults:
_INTRAVENOUS INFUSION _
15 mg/kg bodyweight (to a maximum of 1 g) daily diluted in 300 to 500
mL of 5% glucose
given over a period of 4 hours. Infusion may be continued daily until
the first gastrointestinal
side effects occur, i.e., stomatitis, diarrhoea, leucopenia and
thrombocytopenia, treatment must
be discontinued until the side effects have receded (until the white
blood cell (WBC) count has
risen to 3,000 to 4,000 per mm
3
or platelet count to