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DIFLUCAN 2 MG/ML SOLUTION FOR INFUSION

Active substance: FLUCONAZOLE

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Service Développement Fareva Amboise
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DIFLUCAN IV UK IRL
8817124
8817123
A Plat (plat)
157x470 mm

NOIR
Couleur:
Minimum font size: 9 pts
Version: 2

Préparé par : Fanny BOUVIER

Date: 12/12/2014

Text only is subject to market approval.



Diflucan® 2 mg/ml
solution for infusion
fluconazole

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.
- If you have any further questions, ask your doctor,
pharmacist or nurse.
- 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 of the side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Diflucan is and what it is used for
2. What you need to know before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. Contents of the pack and other information
1. What Diflucan is and what it is used for
Diflucan is one of a group of medicines called
“antifungals”. The active substance is fluconazole.
Diflucan is used to treat infections caused by fungi and
may also be used to stop you from getting candidal
infection. The most common cause of fungal infections
is a yeast called Candida.
Adults
You might be given this medicine by your doctor to treat
the following types of fungal infections:
- Cryptococcal meningitis – a fungal infection in the
brain
- Coccidioidomycosis – a disease of the
bronchopulmonary system
- Infections caused by Candida and found in the blood
stream, body organs (e.g. heart, lungs) or urinary
tract
- Mucosal thrush - infection affecting the lining of the
mouth, throat and denture sore mouth
You might also be given Diflucan to:
- stop cryptococcal meningitis from coming back
- stop mucosal thrush from coming back
- stop you from getting an infection caused by Candida
(if your immune system is weak and not working
properly)
Children and adolescents (0 to 17 years old)
You might be given this medicine by your doctor to treat
the following types of fungal infections:
- Mucosal thrush - infection affecting the lining of the
mouth, throat
- Infections caused by Candida and found in the blood
stream, body organs (e.g. heart, lungs) or urinary
tract
- Cryptococcal meningitis – a fungal infection in the
brain
You might also be given Diflucan to:
- stop you from getting an infection caused by Candida
(if your immune system is weak and not working
properly)
- stop cryptococcal meningitis from coming back
2. What you need to know before you take Diflucan
Do not take Diflucan
- if you are allergic to fluconazole, to other medicines
you have taken to treat fungal infections or to any of
the other ingredients of this medicine (listed in section
6). The symptoms may include itching, reddening of
the skin or difficulty in breathing
- if you are taking astemizole, terfenadine
(antihistamine medicines for allergies)
- if you are taking cisapride (used for stomach upsets)
- if you are taking pimozide (used for treating mental
illness)
- if you are taking quinidine (used for treating heart
arrhythmia)
- if you are taking erythromycin (an antibiotic for
treating infections)
Warnings and precautions
Talk to your doctor or nurse before taking Diflucan
- if you have liver or kidney problems
- if you suffer from heart disease, including heart
rhythm problems
- if you have abnormal levels of potassium, calcium or
magnesium in your blood
- if you develop severe skin reactions (itching,
reddening of the skin or difficulty in breathing)
Other medicines and Diflucan
Tell your doctor immediately if you are taking
astemizole, terfenadine (an antihistamine for treating
allergies) or cisapride (used for stomach upsets) or
pimozide (used for treating mental illness) or quinidine
(used for treating heart arrhythmia) or erythromycin (an
antibiotic for treating infections) as these should not be
taken with Diflucan (see section: “Do not take Diflucan
if you”).
There are some medicines that may interact with
Diflucan. Make sure your doctor knows if you are taking
any of the following medicines:
- rifampicin or rifabutin (antibiotics for infections)
- alfentanil, fentanyl (used as anaesthetic)
- amitriptyline, nortriptyline (used as anti-depressant)
- amphotericin B, voriconazole (anti-fungal)
- medicines that thin the blood to prevent blood clots
(warfarin or similar medicines)
- benzodiazepines (midazolam, triazolam or similar
medicines) used to help you sleep or for anxiety
- carbamazepine, phenytoin (used for treating fits)
- nifedipine, isradipine, amlodipine, felodipine and
losartan (for hypertension- high blood pressure)
- ciclosporin, everolimus, sirolimus or tacrolimus (to
prevent transplant rejection)
- cyclosphosphamide, vinca alkaloids (vincristine,
vinblastine or similar medicines) used for treating
cancer

- halofantrine (used for treating malaria)
- statins (atorvastatin, simvastatin and fluvastatin or
similar medicines) used for reducing high cholesterol
levels
- methadone (used for pain)
- celecoxib, flurbiprofen, naproxen, ibuprofen,
lornoxicam, meloxicam, diclofenac (Non-Steroidal
Anti-Inflammatory Drugs (NSAID))
- oral contraceptives
- prednisone (steroid)
- zidovudine, also known as AZT; saquinavir (used in
HIV-infected patients)
- medicines for diabetes such as chlorpropamide,
glibenclamide, glipizide or tolbutamide
- theophylline (used to control asthma)
- vitamin A (nutritional supplement)
- ivacaftor (used for treating cystic fibrosis)
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Driving and using machines
When driving vehicles or using machines it should be
taken into account that occasionally dizziness or fits may
occur.
Diflucan contains sodium
Diflucan contains 0.154 mmol sodium per ml. To be taken
into consideration by patients on a controlled sodium diet.
3. How to take Diflucan
This medicine will be given by your doctor or nurse as
a slow injection (infusion) into your vein. Diflucan is
supplied as a solution. It will not be diluted further. There
is more information for healthcare professionals in a
section at the end of the leaflet.
The recommended doses of this medicine for different
infections are below. Check with your doctor or nurse if
you are not sure why you are being given Diflucan.
Adults
Condition
To treat cryptococcal
meningitis

To stop cryptococcal
meningitis from coming
back
To treat
coccidioidomycosis

Dose
400 mg on the first day
then 200 mg to 400 mg
once daily for 6 to 8 weeks
or longer if needed.
Sometimes doses are
increased up to 800 mg
200 mg once daily until
you are told to stop

200 mg to 400 mg once
daily from 11 months for
up to 24 months or longer
if needed. Sometimes
doses are increased up to
800 mg
To treat internal fungal
800 mg on the first day
infections caused by
then 400 mg once daily
Candida
until you are told to stop
To treat mucosal
200 mg to 400 mg on the
infections affecting the
first day then 100 mg to
lining of mouth, throat
200 mg until you are told
and denture sore mouth
to stop
To treat mucosal thrush
50 mg to 400 mg once
– dose depends on where daily for 7 to 30 days until
the infection is located
you are told to stop
To stop mucosal
100 mg to 200 mg once
infections affecting the
daily, or 200 mg 3 times a
lining of mouth, throat
week, while you are at risk
of getting an infection
To stop you from getting 200 mg to 400 mg once
an infection caused by
daily while you are at risk
Candida (if your immune of getting an infection
system is weak and not
working properly)
Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults
or children posology).
Children to 11 years old
The maximum dose for children is 400 mg daily.
The dose will be based on the child’s weight in
kilograms.
Condition
Mucosal thrush and
throat infections caused
by Candida – dose and
duration depends on the
severity of the infection
and on where the infection
is located
Cryptococcal meningitis
or internal fungal
infections caused by
Candida
To stop children from
getting an infection
caused by Candida (if their
immune system is not
working properly)

Daily dose
3 mg per kg of body
weight (6 mg per kg of
body weight might be
given on the first day)

6 mg to 12 mg per kg of
body weight

3 mg to 12 mg per kg of
body weight

Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
• The same dose as above but given once every 2 days.
The maximum dose is 12 mg per kg of body weight
every 48 hours.
Use in children less than 2 weeks old:
• The same dose as above but given once every 3 days.
The maximum dose is 12 mg per kg of body weight
every 72 hours.
Elderly
The usual adult dose should be given unless you have
kidney problems.
Patients with kidney problems
Your doctor may change your dose, depending on your
kidney function.



Package leaflet: Information for the user

If you take more Diflucan than you should
If you are concerned that you may have been given too
much Diflucan, tell your doctor or nurse immediately. The
symptoms of a possible overdose may include hearing,
seeing, feeling and thinking things that are not real
(hallucination and paranoid behaviour).
If you forget to take Diflucan
As you will be given this medicine under close medical
supervision, it is unlikely that a dose would be missed.
However tell your doctor or pharmacist if you think that a
dose has been forgotten.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
A few people develop allergic reactions although serious
allergic reactions are rare. If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. If you get any of the following
symptoms, tell your doctor immediately.
- sudden wheezing, difficulty in breathing or tightness in the
chest
- swelling of eyelids, face or lips
- itching all over the body reddening of the skin or itchy red
spots
- skin rash
- severe skin reactions such as a rash that causes blistering
(this can affect the mouth and tongue).
Diflucan may affect your liver. The signs of liver problems
include:
- tiredness
- loss of appetite
- vomiting
- yellowing of your skin or the whites of your eyes (jaundice)
If any of these happen, stop taking Diflucan and tell your
doctor immediately.
Other side effects:
Additionally, if any of the following side effects gets serious,
or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash
Uncommon side effects (may affect up to 1 in 100 people) are:
- reduction in red blood cells which can make skin pale and
cause weakness or breathlessness
- decreased appetite
- inability to sleep, feeling drowsy
- fit, dizziness, sensation of spinning, tingling, pricking or
numbness, changes in sense of taste
- constipation, difficult digestion, wind, dry mouth
- muscle pain
- liver damage and yellowing of the skin and eyes (jaundice)
- wheals, blistering (hives), itching, increased sweating
- tiredness, general feeling of being unwell, fever
Rare side effects (may affect up to 1 in 1,000 people) are:
- lower than normal white blood cells that help defend
against infections and blood cells that help to stop bleeding
- red or purple discoloration of the skin which may be
caused by low platelet count, other blood cell changes
- blood chemistry changes (high blood levels of cholesterol,
fats)
- shaking
- low blood potassium
- abnormal electrocardiogram (ECG), change in heart rate or
rhythm
- liver failure
- allergic reactions (sometimes severe), including
widespread blistering rash and skin peeling, severe skin
reactions, swelling of the lips or face
- hair loss
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly (see details
below). By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
5. How to store Diflucan
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is
stated on the pack after EXP. The expiry date refers to the
last day of that month.
Storage conditions:
- Glass vials: Do not freeze.
- Plasticised PVC bags: Store below 30°C. Do not freeze.
- Once opened the product should be used immediately.
Any unused infusion should be discarded. This medicinal
product is for single use only.
- Do not use this medicine if you notice visible particles or if
the solution is unclear or discoloured.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how throw away
medicines you no longer use. These measures will help
protect the environment.

1 PVC bag with 200 ml solution for infusion contains
400 mg fluconazole.
- The other ingredients are: sodium chloride, water for
injections and sodium hydroxide (for pH adjustment).
What Diflucan solution for infusion looks like and contents
of the pack
- Diflucan is a clear, colourless solution with no visible
particles.
- It comes in either glass vials or plasticised PVC bags
- Pack sizes:
- 1 vial containing 25 ml solution for infusion
- 1, 48 vial(s) containing 50 ml solution for infusion
- 1, 40 vial(s) containing 100 ml solution for infusion
- 1 vial containing 200 ml solution for infusion
- 1, 5, 10, 20 plasticised PVC bag(s) containing 100 ml
solution for infusion
- 1, 5, 10, 20 plasticised PVC bag(s) containing 200 ml
solution for infusion
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United kingdom
Manufacturer
Fareva Amboise
Zone Industrielle
29 route des Industries
37530 Pocé-sur-Cisse
France
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria

Diflucan 2 mg/ml
Infusionslösung
Belgium, Bulgaria, Denmark, Diflucan
Finland, Iceland, Ireland,
Italy, Luxembourg, Norway,
Portugal, Poland, Sweden,
United Kingdom
Cyprus, Greece
Fungustatin
Czech Republic
Diflucan IV
Estonia
Diflucan 2mg/ml
France
Triflucan 2 mg/ml, solution
injectable pour perfusion
Germany
Diflucan i.v. 2 mg/ml,
Infusionslösung
Hungary
Diflucan 2 mg/ml oldatos
infúzió
Latvia
Diflucan 2 mg/ml solution
for infusion
Romania
Diflucan 2 mg/ml soluţie
perfuzabilă
Netherlands
Diflucan I.V. 2 mg/ml,
oplossing voor infusie
Slovakia
Diflucan IV 2mg/ml
Slovenia
Diflucan 2 mg/ml raztopina
za infundiranje
Spain
Diflucan 2mg/ml solucion
para Perfusion
This leaflet was last revised in: 11/2014
Ref: DF 7_0 UK/IE
----------------------------------------------------------------------The following information is intended for medical or
healthcare professionals only:
Intravenous infusion should be administrated at a rate
not exceeding 10 ml/minute. Diflucan is formulated in
sodium chloride 9 mg/ml (0.9%) solution for infusion, each
200 mg (100 ml bottle) containing 15 mmol each of Na+
and C1-. Because Diflucan is available as a dilute sodium
chloride solution, in patients requiring sodium or fluid
restriction, consideration should be given to the rate of fluid
administration.
Fluconazole intravenous infusion is compatible with the
following administration fluids:
a) Dextrose 5% and 20%
b) Ringer’s solution
c) Hartmann’s solution
d) Potassium chloride in dextrose
e) Sodium bicarbonate 4.2% and 5%
f) Aminosyn 3.5%
g) Sodium chloride 9 mg/ml (0.9%)
h) Dialaflex (interperitoneal dialysis Soln 6.36%)
Fluconazole may be infused through an existing line
with one of the above listed fluids. Although no specific
incompatibilities have been noted, mixing with any other
medicinal products prior to infusion is not recommended.
The solution for infusion is for single use only.
From a microbiological point of view, the dilutions should be
used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of
the user and would normally not be longer than 24 hours at
2 to 8 ° C, unless dilution has taken place in controlled and
validated aseptic conditions.
The dilution is to be made under aseptic conditions. The
solution is to be inspected visually for particulate matter and
discoloration prior to administration. The solution should
only be used if the solution is clear and free from particles.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.

6. Contents of the pack and other information
What Diflucan solution for infusion contains
- The active substance is fluconazole.
- Each ml contains 2 mg of fluconazole.
1 vial with 25 ml solution for infusion contains 50 mg
fluconazole.
1 vial with 50 ml solution for infusion contains 100 mg
fluconazole.
1 vial with 100 ml solution for infusion contains 200 mg
fluconazole.
1 vial with 200 ml solution for infusion contains 400 mg
fluconazole.
1 PVC bag with 100 ml solution for infusion contains
200 mg fluconazole.

8817124

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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