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FLUCONAZOLE REDIBAG 2MG/ML SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tell your doctor if you

• Cryptococcal meningitis – a fungal infection in the brain

• Carbamazepine, phenytoin (used for treating fits)

• Coccidioidomycosis – a disease of the bronchopulmonary system

• nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension –
high blood pressure)

• Infections caused by Candida and found in the blood stream, body organs
(e.g. heart, lungs) or urinary tract

• Ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant
rejection)

• Mucosal thrush – infection affecting the lining of the mouth, throat.

• Cyclosphophamide, vinca alkaloids (vincristine, vinblastine or similar
medicines) used for treating cancer

You might also be given Fluconazol Redibag to:
• Stop cryptococcal meningitis from coming back

• Halofantrine (used for treating malaria)

• Stop mucosal thrush from coming back

• Statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for
reducing high cholesterol levels

• Stop you from getting an infection caused by Candida (if your immune system
is weak and not working properly).

• Methadone (used for pain)

Children and adolescents (0 to 17 years old)

• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam,
diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))

You might be given this medicine by your doctor to treat following types of fungal
infections:

• Oral contraceptives

• Mucosal thrush – infection affecting the lining of the mouth, throat

• Prednisone (steroid)

• Infections caused by Candida and found in the blood stream, body organs
(e.g. heart, lungs) or urinary tract

• Zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• Medicines for diabetes such as chlorpropamide, glibenclamide, glipizide, or
tolbutamide

• Cryptococcal meningitis – a fungal infection in the brain.
You might also be given Fluconazol Redibag to:

• Theophylline (used to control asthma)

• Stop you from getting an infection caused by Candida (if your immune system
is weak and not working properly)

• Vitamin A (nutritional supplement).
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.

• Stop cryptococcal meningitis from coming back.
2. BEFORE YOU are given FLUCONAZOLE REDIBAG

Pregnancy and breast-feeding

You should not be treated with Fluconazole Redibag if you

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding
and your doctor will decide whether you should be given Fluconazole Redibag.

• are allergic (hypersensitive) to fluconazole, to other medicines you have taken
to treat fungal infections or to any of the other ingredients of Fluconazole
Redibag. The symptoms may include itching, reddening of the skin or difficulty
in breathing

Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that
occasionally dizziness or fits may occur.

• are taking astemizole, terfenadine (antihistamine medicines for allergies)
• are taking cisapride (used for stomach upsets)
• are taking pimozide (used for treating mental illness)

Important information about some of the ingredients of Fluconazole Redibag

• are taking quinidine (used for treating heart arrhythmias)

Fluconazole Redibag contains 0.154 mmol sodium per ml. To be taken into
consideration by patients on a controlled sodium diet.
BE-30-01-993

1

DATE

Date

Signature

Shelf-Life

• Benzodiazepines (midazolam, triazolam or similar medicines) used to help you
sleep or for anxiety
Storage Conditions and

You might be given this medicine by your doctor to treat the following types of
fungal infections:

Information

• Medicines that thin the blood to prevent blood clots (warfarin or similar
medicines)

and Re‑imbursement

Adults

Name

• Amphotericin B, voriconazole (anti-fungal)

Barcodes, Symbols

• Amitriptyline, nortriptyline (used as anti-depressant)

Fluconazole is used to treat infections caused by fungi and may also be used to
stop from getting candidal infection. The most common cause of fungal infection is
yeast called Candida.

Country

• Alfentanil, fentanyl (used as anaesthetic)

product information

• Rifampicin or rifabutin (antibiotics for infections)

Fluconazole Redibag is one of a group of medicines called “anti-fungals”. The
active substance is fluconazole.

excipients)

1. WHAT FLUCONAZOLE REDIBAG IS AND WHAT IT IS USED FOR

SOP CE-RAPV-009

There are some medicines that may interact with Fluconazole Redibag. Make sure
your doctor knows if you are taking any of following medicines:

ARTWORK APPROVAL

6. Further information

composition (API &

5. How to store Fluconazole Redibag

Product name, strength,

4. Possible side effects

proofread as per RA

3. How Fluconazole Redibag is given

Product Information

Tell your doctor immediately if your 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 Fluconazole Redibag (see section : “You should not be treated
with Fluconazole Redibag if you”).

2. Before you are given Fluconazole Redibag

EUROPEAN LABELLING CENTRE

Taking other medicines

1. What Fluconazole Redibag is and what it is used for

RA Proofreading Checklist

In this leaflet:

all figures cited in the

• develop severe skin reactions (itching, reddening of the skin or difficulty in
breathing).

• have abnormal levels of potassium, calcium or magnesium in your blood

National Regulations

• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

RA
PROOFREAD + APPROVED

• suffer from heart disease, including heart rhythm problems

Consistency check with

• have liver or kidney problems

• This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.

Compliance with

• If you have any further questions, ask your doctor or pharmacist.

• are taking erythromycin (an antibiotic for treating infections).

13 June 2012

Take special care with Fluconazole Redibag:

• Keep this leaflet. You may need to read it again.

2nd DRAFT

Read all of this leaflet carefully before you start using this medicine.

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APPROVED

Fluconazole Redibag 2 mg/ml Solution for Infusion

If you receive more Fluconazole Redibag than you should

3. HOW FLUCONAZOLE REDIBAG IS GIVEN

If you are concerned that you may have been given too much Fluconazole Redibag,
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).

This medicine will be given by your doctor or nurse as a slow injection (infusion)
into your vein. Fluconazole Redibag is provided as a “ready-to-use” solution,
and does not require further dilution. There is more information for healthcare
professionals in section at the end of the leaflet.

If a dose of Fluconazole has been forgotten

How much and how often?

4. POSSIBLE SIDE EFFECTS

Date

Signature

Name

Other side effects:

Country

• Yellowing of the skin or the whites of your eyes (jaundice).
If any of these happen, stop taking Fluconazole Redibag and tell your doctor
immediately.

RA
PROOFREAD + APPROVED

• Vomiting

excipients)

• Loss of appetite

SOP CE-RAPV-009

• Tiredness

ARTWORK APPROVAL

Fluconazole Redibag may affect your liver. The signs of liver problems include:

composition (API &

• Severe skin reactions such as a rash that causes blistering (this can affect the
mouth and tongue).

Product name, strength,

• Skin rash

proofread as per RA

• Itching all over the body reddening of the skin or itchy red spots

Product Information

• Swelling of the eyelids, face or lips

EUROPEAN LABELLING CENTRE

• Sudden wheezing, difficulty in breathing or tightness of the chest

RA Proofreading Checklist

Dose
400 mg on the first day then 200 to
400 mg once daily for 6 to 8 weeks or
longer if needed. Sometimes doses are
increased up to 800 mg
To stop cryptococcal meningitis from
200 mg once daily until you are told
coming back
to stop
To treat coccidioidomycosis
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 infections
800 mg on the first day then 400 mg
caused by Candida
once daily until you are told to stop.
To treat mucosal infections affecting the 200 mg to 400 mg on the first day then
lining of mouth, throat
100 mg to 200 mg until you are told
to stop.
To treat mucosal thrush – dose depends 100 mg to 400 mg once daily for 7 to
on where the infection is located
30 days until you are told to stop.
To stop mucosal infections affecting the 100 mg to 200 mg once daily, or
lining of mouth, throat
200 mg 3 times a week, while you are
at risk of getting an infection
To stop you from getting an infection
200 mg to 400 mg once dailywhile you
caused by Candida (if your immune
are at risk of getting an infection
system is weak and not working
properly)

DATE

Like all medicines, Fluconazole Redibag can cause side effects, although not
everybody gets them.
A few people develop allergic reactions although serious allergic reaction are
rare. If you get any of the following symptoms, tell your doctor immediately:

Condition
To treat cryptococcal meningitis

2nd DRAFT

Adults

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.

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

• Decreased appetite
• Inability to sleep, feeling drowsy
• Fit, Dizziness, sensation of spinning, tingling, pricking or numbness, changes
in sense of taste
• Constipation, difficult ingestion, wind, dry mouth

6 mg to 12 mg per kg of body weight

• Muscle pain

3 mg to 12 mg per kg of body weight

• Liver damage and yellowing of the skin and eyes (jaundice)
• Wheals, blistering (hives), itching, increased sweating
• Tiredness, general feeling of being unwell, fever.

Use in children 0 to 4 weeks of age

Rare side effects which affect 1 to 10 users in 10,000 are listed below

Use in children of 3 to 4 weeks of age:

• Lower than normal white blood cells that help defend against infections and
blood cells that help to stop bleeding

• 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.

• Red or purple discoloration of the skin which may be caused by low platelet
count, other blood cell changes

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 the body weight every 72 hours.

• Blood chemistry changes (high blood levels of cholesterol, fats)
• Shaking

Doctors sometimes prescribe different doses to these. Always take your medicine
exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

• Low blood potassium
• Abnormal electrocardiogram (ECG), change in heart rate or rhythm
• Liver failure

Elderly
The usual adult dose should be given unless you have kidney problems.

• Allergic reactions (sometimes severe), including widespread blistering rash
and skin peeling, severe skin reactions, swelling of the lips and the face

Patients with kidney problems

• Hair loss.

Your doctor may change your dose, depending on your kidney function.
2

If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor, pharmacist or nurse.
BE-30-01-993

Storage Conditions and

Shelf-Life
Information

• Reduction in red blood cells which can make skin pale and cause weakness
or breathlessness

and Re‑imbursement

The maximum dose for children is 400 mg daily.
The dose will be based on the child’s weight in kilograms.

Barcodes, Symbols

Uncommon side effects which affect 1 to 10 users in 1,000 are listed below:

product information

• Rash.

Children to 11 years old

all figures cited in the

Follow the dose prescribed by your doctor (either adults or children posology).

National Regulations

• Stomach discomfort, diarrhoea, feeling sick, vomiting
• Increases in blood tests of liver function

Compliance with

• Headache

Consistency check with

Common side effects which affect 1 to 10 users in 100 are listed below:

Adolescents from 12 to 17 years old

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)

13 June 2012

If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

The usual 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 Fluconazole Redibag.

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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.

Your doctor will decide how much you need and when it will be given to you.
This will depend upon your age, weight, medical history, other medicines being
taken and the infection being treated.

Therefore, although no specific incompatibilities have been noted, mixing with any
other medicinal products prior to infusion is not recommended.

5. HOW TO STORE FLUCONAZOLE REDIBAG
Keep out of the reach and sight of children.
Do not use after expiry date which is stated on the pack after EXP. The expiry date
refers to the last day of that month.
Store in the original package in order to protect from light or moisture. Do not
freeze.

Special precautions for disposal and other handling:
Each bag is intended for single use only.

Discard after single use.
Discard any unused portion.

• Attach an administration set. Refer to complete directions accompanying set
for connection, priming of the set and administration of the solution.

Marketing Authorisation Holder and Manufacturer

excipients)

• Suspend container from eyelet support.

SOP CE-RAPV-009

• Use sterile material for preparation and administration.

– Pack sizes: 10 x 50 ml, 20 x 50 ml, 10 x 100 ml, 20 x 100 ml, 10 x 200 ml or
20 x 200 ml. Not all pack sizes may be marketed.

ARTWORK APPROVAL

2. Preparation for administration

Fluconazole Redibag is supplied in a flexible plastic bag. Bags contain 50 ml,
100 ml and 200 ml of fluconazole 2 mg/ml solution.

composition (API &

Check the solution for clarity and absence of foreign matters. If solution is not clear
or contains foreign matters, discard the solution.

Fluconazole Redibag is a clear, colourless solution with no visible particles.

Product name, strength,

What Fluconazole Redibag looks like and contents of the pack

proofread as per RA

Some opacity of the plastic bag due to moisture absorption during the sterilisation
process may be observed. This is normal and does not affect the solution quality or
safety. The opacity will diminish gradually.

The other ingredients are sodium chloride and water for injections.
Fluconazole Redibags are solutions for intravenous infusion.

Product Information

Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard
solution, as sterility may be impaired.

EUROPEAN LABELLING CENTRE

Remove the bag from the overpouch just before use.

RA Proofreading Checklist

1. Opening

The active substance is fluconazole. Each ml of solution for infusion contains 2 mg
fluconazole.
50 ml Solution for Infusion contains 100 mg fluconazole
100 ml Solution for Infusion contains 200 mg fluconazole
200 ml Solution for Infusion contains 400 mg fluconazole

DATE

Do not reconnect partially used bags. Any unused medicinal product or waste
material should be disposed of in accordance with local requirements.

What Fluconazole Redibag contains

Date

This leaflet does not contain all the information about this medicine. If you have any
questions or are not sure about anything, ask your doctor.

Signature

6. FURTHER INFORMATION

13 June 2012

The solution should be administered with sterile equipment using an aseptic
technique. The equipment should be primed with the solution in order to prevent air
entering the system.

Name

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to throw away medicine you no longer use. These measures will
help protect the environment.

Country

Do not connect bags to each other. Such use could result in air embolism due to
residual air being drawn from the primary container before the administration of the
fluid from the secondary container is completed.

RA
PROOFREAD + APPROVED

Do not remove the bag from the overwrap until ready for use.

Only use a bag if the solution is clear, without visible particles and if the container
is undamaged.

2nd DRAFT

Once opened, any unused infusion must be discarded.

MARKETING
APPROVED

Only use a bag if the solution is clear, without visible particles and if the container
is undamaged.

Marketing Authorisation Holder:
Baxter Healthcare Limited
Caxton Way
Thetford
Norfolk
IP24 3SE
UK

This section contains practical information regarding administration. Read the SPC
for full information on posology and methods of administration (including dose
modification for patients with impaired renal or liver function), contraindications,
warnings, etc.
Intravenous infusion should be administrated at a rate not exceeding 10 ml/minute.
Fluconazole Redibag is formulated in sodium chloride 9 mg/ml (0.9%) solution
for infusion, each 200 mg (100 ml bag) containing 15 mmol each of Na+ and Cl-.
Because Fluconazole Redibag consists of a 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 9mg/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. Fluconazole Redibag 2 mg/ml is a ready-to-use Solution for Infusion.
3

BE-30-01-993

Storage Conditions and

product information

all figures cited in the

Shelf-Life
Information

The following information is intended for medical or healthcare professionals
only:

and Re‑imbursement

Date of Last Revision: February 2012

Barcodes, Symbols

The leaflet was last approved in June 2012

National Regulations

Baxter S.A., Boulevard Rene Branquart 80, B-7860 Lessines, Belgium

Compliance with

Manufacturer:

Consistency check with

Baxter and Redibag are trademarks of Baxter International Inc.

4

BE-30-01-993
Information

and Re‑imbursement

Barcodes, Symbols

National Regulations

Shelf-Life

Storage Conditions and

product information

all figures cited in the

Consistency check with

Date

Signature

Name

Country

RA
PROOFREAD + APPROVED

excipients)

SOP CE-RAPV-009
Compliance with

composition (API &

proofread as per RA

DATE

ARTWORK APPROVAL
Product name, strength,

Product Information

2nd DRAFT

EUROPEAN LABELLING CENTRE
RA Proofreading Checklist

MARKETING
APPROVED

13 June 2012

Expand Transcript

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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