Ancotil 2.5g/250ml Solution for Infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Flucytosine

Commercializzato da:

Mylan IRE Healthcare Limited

Codice ATC:

J02AX; J02AX01

INN (Nome Internazionale):

Flucytosine

Dosaggio:

2.5/250

Forma farmaceutica:

Solution for infusion

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Other antimycotics for systemic use; flucytosine

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

1976-06-08

Foglio illustrativo

Patient Information Leaflet
ANCOTIL 2.5 G/250 ML (1G IN 100 ML) SOLUTION FOR INFUSION
flucytosine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

This leaflet tells you about Ancotil
.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ancotil is and what it is used for
2.
What you need to know before you are given Ancotil
3.
How Ancotil is given
4.
Possible side effects
5.
How to store Ancotil
6.
Contents of the pack and other information
1.
WHAT ANCOTIL IS AND WHAT IT IS USED FOR
Ancotil Solution for Infusion contains an anti-fungal agent. It is
used to treat certain yeast and
fungal infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ANCOTIL
SOLUTION FOR INFUSION
DO NOT TAKE ANCOTIL

if you are allergic (hypersensitive) to flucytosine or any of the
other ingredients of
Ancotil (these are listed in section 6, ‘’Other Information’’)

if you are breast-feeding

if you are using any medicine which are irreversible inhibitors of
dihydropyrimidine
dehydrogenase enzyme (DPD) e.g. brivudine, sorivudine and their
analogues

if you know that you do not have any activity of the enzyme
dihydropyrimidine
dehydrogenase (DPD) (complete DPD deficiency).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ancotil

if you have a liver, kidney or blood problem. Your doctor may need to
carry
out blood tests during your treatment.
ANCOTIL CONTAINS SODIUM
This medicine contains 792 mg sodium (main component of cooking/table
salt) in each bottle
(250 ml). This is equivalent to 40 % of the recommended max

Scheda tecnica

Health Products Regulatory Authority
24 March 2022
CRN00CQH3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ancotil 2.5g/250ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each infusion bottle contains 2.5 g in 250 ml (1 g in 100 ml) of
flucytosine.
Excipients with known effect: Each bottle contains 792 mg (34 mmol)
sodium equivalent to 316 mg (14 mmol) in 100 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless to slightly yellow sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ancotil is indicated for the treatment of systemic yeast and fungal
infections due to sensitive organisms: such infections include
cryptococcosis, candidiasis, chromomycosis and infections due to
_Torulopsis glabrata _and_ Hansenula._
In order to prevent the development of secondary antibiotic
resistance, especially in the treatment of cryptococcal meningitis
and severe systemic candidiasis, it is recommended that Ancotil should
be given in combination with
amphotericin-B. Amphotericin-B may also be given in combination with
Ancotil in severe or chronic infections due to other
organisms. In cases of cryptococcal meningitis, where toxicity of
amphotericin B, or a combination of flucytosine with
amphotericin B is dose limiting, a combination of flucytosine with
fluconazole is recommended.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults _
Ancotil for Infusion should be administered using a giving set. It may
be administered directly into a vein, through a central
venous catheter, or by intra-peritoneal infusion. The recommended
daily dosage in adults is 200mg/kg bodyweight divided
into four doses over the 24 hours. In patients harbouring extremely
sensitive organisms a total daily dose of 100 to 150mg/kg
bodyweight may be sufficient.
Adequate effects can, however, often be obtained with a lower dose.
It is suggested that the duration of the infusion should be of the
order of 20 to 40 minutes prov