ANCOTIL 2.5g/250mL injection

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

flucytosine, Quantity: 10 mg/mL

Saatavilla:

iNova Pharmaceuticals (Australia) Pty Ltd

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: sodium chloride; hydrochloric acid; trometamol; water for injections

Antoreitti:

Intravenous

Kpl paketissa:

250mL x 5

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

INDICATIONS AS AT 15 MARCH 1996: Antocil is indicated in the treatment of generalised candidiasis, cryptococcosis and chromoblastomycosis.

Tuoteyhteenveto:

Visual Identification: Clear, colourless liquid; Container Type: Bottle; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-08-23

Pakkausseloste

ANCOTIL
® INJECTION
_Flucytosine 1%_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ancotil. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Ancotil against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ANCOTIL IS USED
FOR
This medicine is used to treat:
•
fungal or yeast infections in your
body, which are also known as
candidiasis, cryptococcosis or
chromoblastomycosis.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ANCOTIL HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Ancotil for another purpose.
Ancotil is not addictive.
Ancotil is available only with a
doctor's prescription.
BEFORE YOU HAVE
ANCOTIL
_WHEN YOU MUST NOT HAVE IT_
DO NOT HAVE ANCOTIL IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
flucytosine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives.
DO NOT HAVE ANCOTIL IF YOU KNOW
THAT YOU DO NOT HAVE ANY ACTIVITY OF
THE ENZYME DIHYDROPYRIMIDINE
DEHYDROGENASE (DPD) (COMPLETE
DPD DEFICIENCY).
DO NOT HAVE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
HAVING THIS MEDICINE.
It is not known if the active
ingredient in Ancotil passes into
breast milk and there is a possibility
that your baby may be affected.
DO NOT HAVE ANCOTIL AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, your
pharmacist will dispose of it for you.
_BEFORE YOU START TO HAVE IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION – ANCOTIL (FLUCYTOSINE)
INJECTION
1
NAME OF THE MEDICINE
Flucytosine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of Ancotil is 5-flucytosine (5-FC), a
fluorinated pyrimidine. Ancotil is
available as an isotonic infusion solution (1%) containing 0.805%
sodium chloride. Ancotil also
contains the excipients hydrochloric acid, trometamol and water for
injections.
3
PHARMACEUTICAL FORM
Ancotil is a clear, colourless liquid. It is a 2.5 g/250 mL (1% w/v)
injection administered
intravenously.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ancotil
is
indicated
in
the
treatment
of
generalised
candidiasis,
cryptococcosis
and
chromoblastomycosis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Intravenous administration of Ancotil using the infusion solution
(37.5 – 50 mg per kg) is given
as infusions of short duration (20 to 40 minutes). In patients whose
renal function is normal, this
dose is repeated at six hourly intervals.
Special Dosage Instructions: In patients with impaired renal function
the interval between
individual doses should be increased as follows:
Creatinine Clearance
Interval
between
single
doses
of
50
mg
per
kg
bodyweight
(maximum dose)
>40 mL per minute
6 hours
40 – 20 mL per minute
12 hours
20 – 10 mL per minute
24 hours
<10 mL per minute
Determination of serum concentration of 5-FC 12 hours after the
initial dose. Further doses are given as required in order to
maintain
serum
concentration
of
between
25
and
50
micrograms/mL.
(A method of determining 5-FC in biological fluids is described by
Schoenebeck
3
.)
2
Ancotil can be efficiently eliminated by both haemodialysis and
peritoneal dialysis. With both
methods,
clearance
is
approximately
as
good
as
that
of
creatinine
(see
section
5.2
Pharmacokinetic Properties – Excretion).
4.3
C
ONTRAINDICATIONS
Ancotil should not be administered to patients with:
•
known hypersensitivity to the medicine or any of the excipients
•
known complete dihydropyrimidine dehydrogenase (DPD) deficiency (see
secti