DIFLUCAN 2 Mg/Ml Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
26-05-2018
Summary of Product characteristics
(SPC)
26-05-2018
Active ingredient:
FLUCONAZOLE
Available from:
Pfizer Limited
ATC code:
J02AC01
INN (International Name):
FLUCONAZOLE
Dosage:
2 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Triazole derivatives
Authorization status:
Authorised
Authorization date:
1989-08-22
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE U
S
E
R
D
I
F
L
U
C
A
N
®
2
M
G
/
M
L
SOLUTION FOR INFU
S
I
ON
fl
ucon
a
z
o
l
e
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START U
S
I
NG
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFO
R
M
A
T
I
ON
FOR
Y
OU
.
-
Keep this leaflet. You may need to read
it
a
g
a
i
n.
- If
you have any further questions, ask your
doc
t
o
r
,
pharmacist or nu
r
s
e
.
-
This medicine has been prescribed for you only.
Do
not pass
it
on to others.
It
may harm them, even
if t
h
e
ir
signs of illness are the same as
yours.
- If
you get any of the side effects, talk to your
doctor,
pharmacist or nurse. This includes any possible
s
i
d
e
effects not listed in this leaflet. See section
4.
WHAT IS IN THIS L
EAFLE
T:
1. What Diflucan is and what
it
is used
for
2. What you need to know before you take D
ifl
uc
a
n
3. How to take
D
ifl
uc
a
n
4. Possible side
e
ff
e
c
t
s
5. How to store
D
ifl
uc
a
n
6. Contents of the pack and other i
n
f
o
r
m
a
ti
on
1
.
WHAT DIFLUCAN IS AND WHAT IT IS USED FOR
Diflucan
is
one of a group of medicines called
“
a
n
tif
ung
a
l
s
”
.
T
h
e
active substance is fluconazole. Diflucan is used
to
treat infections caused by fungi and may also be
us
e
d
to stop you from getting c
a
nd
i
d
a
l
infection. The most common cause of fungal infections is a
yeast called
_C_
_a_
_nd_
_i_
_d_
_a_
.
A
DU
L
T
S
You might be given this medicine by your doctor to tr
ea
t
the following types of fungal in
f
e
c
ti
ons:
-
Cryptococcal meningitis –
a fungal infection in the
b
r
a
i
n
-
Coccidioidomycosis –
a disease of t
h
e
bronchopulmonary sys
t
e
m
-
Infections caused by _Candida _and found in the
blood
stream, body organs (e.g. heart, lungs) or urinary tr
a
c
t
-
Mucosal thrush
-
infection affecting the lining of
th
e
mouth, throat and denture sore
mouth
You might also be given Diflucan
to:
-
stop cryptococcal meningitis from coming b
a
ck
-
stop mucosal thrush from coming b
a
ck
-
stop you from getting an infection caused by _Candida _
(if
your immune system is weak and not
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflucan 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
1 vial with 100 ml solution for infusion contains 200 mg fluconazole.
Excipient(s) with known effect:
Each ml contains 9 mg sodium chloride (equivalent to 0.154 mmol
sodium) (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless solution with no visible particles
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diflucan is indicated in the following fungal infections (see section
5.1).
Diflucan is indicated in adults for the treatment of:
• Cryptococcal meningitis (see section 4.4).
• Coccidioidomycosis (see section 4.4).Invasive candidiasis.
• Mucosal candidiasis including oropharyngeal, oesophageal
candidiasis, candiduria and chronic
mucocutaneous candidiasis.
• Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or topical treatment are insufficient.
Diflucan is indicated in adults for the prophylaxis of:
• Relapse of crytopcoccal meningitis in patients with high risk of
recurrence.
• Relapse of oropharyngeal or oesophageal candidiasis in patients
infected with HIV who are at high risk of
experiencing relapse.
• Prophylaxis of candidal infections in patients with prolonged
neutropenia (such as patients with
haematological malignancies receiving chemotherapy or patients
receiving Hematopoietic Stem Cell
Transplantation (see section 5.1)).
Diflucan is indicated in term newborn infants, infants, toddlers,
children and adolescents aged from 0 to 17 years old:
Diflucan is used for the treatment of mucosal candidiasis
(oropharyngeal, oesophageal), invasive candidiasis,
cryptococcal meningitis and the prophylaxis of candidal infections in
immunocompromised patients. Diflucan can be
used as maintenance therapy to prevent relapse of cryptococcal
meningitis in children with high risk of reoccurrence
(see section 4.4).
Therapy
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