DBL™ Fluorouracil

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Fluorouracil 50 mg/mL;  ;  

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Fluorouracil 50 mg/mL

Dosering:

50 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Fluorouracil 50 mg/mL    

Enheder i pakken:

Vial, 5 x 5mL pack, 5 dose units

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Chemische Fabrik Berg GmbH

Terapeutiske indikationer:

DBL® Fluorouracil Injection B.P. 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.

Produkt oversigt:

Package - Contents - Shelf Life: Vial, 5mL - 5 dose units - 18 months from date of manufacture stored Store at 8-25°C, do not refrigerate. Protect from light - Vial, 10mL - 5 dose units - 24 months from date of manufacture stored Store at 8-25°C, do not refrigerate. Protect from light - Vial, glass, 50ml - 1 dose units - 24 months from date of manufacture stored Store at 8-25°C, do not refrigerate. Protect from light - Vial, glass, 20ml - 5 dose units - 24 months from date of manufacture stored Store at 8-25°C, do not refrigerate. Protect from light

Autorisation dato:

1986-08-27

Produktets egenskaber

Version: pfdfluoi10221
Supersedes: hhdfluoi10720
Page 1 of 14
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DBL
™
Fluorouracil 25 mg/ml Solution for Injection.
DBL
™
Fluorouracil 50 mg/ml Solution for Injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of DBL Fluorouracil containing 25 mg or 50 mg of fluorouracil.
DBL Fluorouracil
is a sterile preservative free solution of 5-Fluorouracil in Water for
Injection, prepared with
the aid of Sodium Hydroxide.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
DBL Fluorouracil Injection is a clear, colourless to slightly yellow
solution.
The pH of the solution is approximately 8.9.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Fluorouracil Injection 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
DOSE
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.
The total daily dose of fluorouracil should not exceed 1 gram. The
initial recommended
doses should be reduced by one third to a half if any of the following
conditions are present:
1.
poor nutritional state.
Version: pfdfluoi10221
Supersedes: hhdfluoi10720
Page 2 of 14
2.
after major surgery (within previous 30 days).
3.
inadequate bone marrow function (W.B.C. count less than 5,000 per
mm³; platelet
count less than 100,000 per mm
3
).
4.
impaired hepatic and/or renal function.
The following regimes 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