Fluorouracil Accord

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Fluorouracil 50 mg/mL;  

Disponible des:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosis:

5000 mg/100mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Fluorouracil 50 mg/mL   Excipient: Hydrochloric acid Sodium hydroxide Water for injection

tipo de receta:

Prescription

indicaciones terapéuticas:

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.

Resumen del producto:

Package - Contents - Shelf Life: Vial, glass, 100 mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. do not refrigerate or freeze

Data d'autorització:

2019-02-05

Informació per a l'usuari

Fluorouracil Accord – version 4.0
1
FLUOROURACIL ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN FLUOROURACIL ACCORD?
Fluorouracil Accord contains the active ingredient Fluorouracil.
Fluorouracil Accord belongs to a group of medicines known as
antineoplastic or cytotoxic agents. It is used to treat some types of
cancer. Fluorouracil Accord is classified as an
'antimetabolite' type of cytotoxic agent. It works by interfering with
the growth of cancer cells which are eventually destroyed.
For more information, see Section 1. Why am I using Fluorouracil
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN FLUOROURACIL ACCORD?
Do not use if you have ever had an allergic reaction to any medicine
containing Fluorouracil or any of the ingredients listed at
the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Fluorouracil Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fluorouracil Accord and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW WILL I BE GIVEN FLUOROURACIL ACCORD?
Fluorouracil Accord will be given to you by a doctor or a nurse.
More instructions can be found in Section 4. How will I be given
Fluorouracil Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN FLUOROURACIL ACCORD?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if you have a fever or infection before,
during or after being given
Fluorouracil Accord.
•
If you become pregnant during or soon after being given Fluorouracil
Accord, tell your doctor.
•
Tell the surgeon or anaesthetist that you are being given Fluorouracil
Accord if you are going t

Fitxa tècnica

Page 1 of 13
NEW ZEALAND DATA SHEET
FLUOROURACIL ACCORD (FLUOROURACIL) INJECTION
1
PRODUCT NAME
Fluorouracil Accord 50 mg/mL injection solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorouracil Accord injection solution contains fluorouracil as the
active ingredient. Five strengths are
available as follows: 250 mg/5 mL, 500 mg/10 mL, 1 g/20 mL, 2.5 g/50
mL and 5 g/100 mL. The
2.5 g/50 mL and 5 g/100 mL vials are Pharmacy Bulk Packs.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Fluorouracil Accord Solution for Injection is a clear, colourless to
slightly pale yellow solution
containing fluorouracil for use as an intravenous infusion or
injection. The pH of the fluorouracil
injection solution is approximately 8.9.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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
D
OSE AND METHOD OF ADMINISTRATION
GENERAL DIRECTIONS
Fluorouracil Accord contains no antimicrobial agent. The product is
for single use in one patient only.
Discard any residue.
The use of the Pharmacy Bulk Pack should be restricted to suitably
qualified pharmacists operating in
suitably equipped hospital pharmacies or compounding centres. The
Pharmacy Bulk Pack is intended
for multiple dispensing but should be spiked only once.
To reduce microbiological hazard, use as soon as practicable after
preparation. If storage is necessary,
hold at 2°C to 8°C for not more than 24 hours after preparation.
Administration should be completed
within 24 hours of preparation of the infusion and any residue
discarded according to the guidelines for
the disposal of cytotoxic drugs (see
HANDLING PRECAUTIONS
and
SPILLS AND DISPOSAL
).
Fluorouracil Injection may be admin