Fluconazole 2mg/Ml Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER Fluconazole 2mg/ml Solution for Infusion
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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.
• 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 nurse.
In this leaflet:
1. What Fluconazole is and what it is used for
2. Before you are given Fluconazole Infusion
3. How Fluconazole Infusion is given
4. Possible side effects
5. How to store Fluconazole Infusion
6. Further information
Your medicine is called Fluconazole 2mg/ml Solution for Infusion (referred to as Fluconazole Infusion in this leaflet.
1. what fluconazole is and what it IS USED FOR
2. BEFORE YOU ARE GIVEN FLUCONAZOLE INFUSION
3. HOW FLUCONAZOLE INFUSION IS GIVEN
Fluconazole infusion is one of a group of medicines called antifungal agents. The active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi and may also be used to stop you from getting candidal infections. 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 - infections affecting the lining of the mouth, throat and denture sore mouth
You might also be given fluconazole 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 - infections 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 fluconazole 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
You should not be treated with Fluconazole if you:
• are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Fluconazole Infusion. The symptoms may include itching, reddening of the skin or difficulty in breathing.
• are taking astemizole or terfenadine (antihistamine medicines for allergies)
• are taking cisapride (used for stomach upsets).
• are taking pimozide (used for treating mental illness)
• are taking quinidine (used for treating heart rhythm disorders)
• are taking erythromycin (an antibiotic for treating infections).
Take special care with Fluconazole
Tell your doctor if you:
• have liver or kidney problems.
• suffer from heart disease including heart rhythm problems
• have abnormal levels of potassium, calcium or magnesium in your blood.
• develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).
Taking other medicines:
Tell your doctor immediately if you are taking astemizole, terfenadine (antihistamines 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 (see section: “Do not take Fluconazole if you”).
There are some medicines that may interact with Fluconazole. Make sure your doctor knows if you are taking any of the following medicines:
• rifampicin or rifabutin (antibiotics for infections)
• alfentanil, fentanyl (used as anaesthetics)
• amitriptyline, nortriptyline (used as anti-depressants)
• 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 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 (NSAIDs))
• 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)
Please tell your doctor or pharmacist if you are taking or have recently taken, any other medicines including medicines obtained without a prescription.
Pregnancy and breast-feeding:
Tell the doctor or nurse if you are pregnant, trying to become pregnant or breast feeding and your doctor will decide whether you should be given Fluconazole.
Ask your doctor or other medical staff for advice before taking any medicine. Driving and using machines
When driving vehicles or using machines it should be taken into account that occasionally dizziness or fits may occur.
Important information about some of the ingredients of Fluconazole Infusion
Fluconazole infusion is diluted in 0.9% sodium chloride solution.
Fluconazole infusion 100mg/50ml contains 7.5mmol of sodium.
Fluconazole infusion 200mg/100ml contains 15mmol of sodium.
Fluconazole infusion 400mg/200ml contains 30mmol of sodium.
This should be taken into consideration by patients on a controlled sodium diet.
This medicine will be given by your doctor or nurse as a slow injection (infusion) into your vein.
Fluconazole 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 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.
Adults
|
Condition |
Dose |
|
To treat cryptococcal meningitis |
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 |
|
To stop cryptococcal meningitis from coming back |
200 mg once daily until you are told 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 caused by Candida |
800 mg on the first day then 400 mg once daily until you are told to stop |
|
To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth |
200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop |
|
To treat mucosal thrush - dose depends on where the infection is located |
50 mg to 400 mg once daily for 7 to 30 days until you are told to stop |
|
To stop mucosal infections affecting the lining of mouth, throat |
100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection |
|
To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly) |
200 mg to 400 mg once daily while you are at risk of getting an infection |
K-
INFORMATION FOR THE HEALTHCARE PROFESSIONAL The following information is intended for medical or healthcare professionals only.
Intravenous infusion should be administered at a rate not exceeding 10 ml/minute. Fluconazole infusion is formulated in sodium chloride 9 mg/ml (0.9%) solution for infusion, each 200 mg containing 15 mmol each of Na+ and CI-. Because Fluconazole 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 20%
b) Ringer’s solution
c) Hartmann’s solution
d) Potassium chloride in dextrose
e) Sodium bicarbonate 4.2%
f) Sodium chloride 9 mg/ml (0.9%)
FRONT
|
Condition |
daily dose |
|
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 |
3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day) |
|
Cryptococcal meningitis or internal fungal infections caused by Candida |
6 mg to 12 mg per kg of body weight |
|
To stop children from getting an infection caused by Candida (if their immune system is not working properly) |
3 mg to 12 mg per kg of body weight |
Use in children 0 to 4 weeks of age
5. HOW TO STORE Fluconazole INFUSION
6. further information
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.
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.
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.
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
If you have been given more Fluconazole than you should
If you are concerned that you may have been given too much Fluconazole, tell your doctor or nurse immediately. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucinations and paranoid behaviour).
If a dose of Fluconazole has been forgotten
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 product, ask your doctor or other medical staff.
Rare side effects which affect 1 to 10 users in 10,000 are listed below:
• 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 via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children.
Store in the original container. Do not refrigerate or freeze.
Do not use unless the solution is clear and the container undamaged. The doctor or nurse will check that the expiry date on the label has not passed. Do not use Fluconazole infusion after the expiry date which is stated on the carton and label. Once open, the infusion will be used immediately and any unused solution will be thrown away.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
What Fluconazole Solution for Infusion contains
The active ingredient is fluconazole 2mg/ml
The other ingredients are sodium chloride, sodium hydroxide and water for injections.
What Fluconazole Solution for Infusion looks like and the contents of each pack
Your medicine is a clear solution in a plastic infusion bag, inside a polyester/ aluminium/ polypropylene overbag.
Each 50ml, 100ml and 200ml infusion bag contains 100mg, 200mg and 400mg fluconazole respectively.
Marketing Authorisation Holder: Manufacturer:
Villerton Invest S.A., Facta Farmaceutici SpA,
40 Avenue Monterey, Nucleo Industriale S. Atto,
L-2163 Luxembourg. S. Nicolo a Tordino,
64100 Teramo, Italy.
4. POSSIBLE SIDE EFFECTS
This leaflet was last revised in December 2014
Like all medicines, Fluconazole Infusion 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 of the following symptoms, tell your doctor immediately:
• sudden wheeziness, difficulty in breathing or tightness in 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).
Fluconazole 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 theses happen, stop taking Fluconazole 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 which affect 1 to 10 users in 100 are listed below:
• headache • stomach discomfort,
• increases in blood tests of liver function diarrhoea, feeling sick,
• rash vomiting
Uncommon side effects which affect 1 to 10 users in 1,000 are listed below:
• 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
L08GBFLC03
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
L08GBFLC03
ACSI061F01