Fluconazole 2 Mg/Ml Solution For Infusion
Package leaflet: Information for the user Fluconazole 2 mg/ml solution for infusion
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 side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Fluconazole 2 mg/ml solution for infusion is and what it is used for
2. What you need to know before you are given Fluconazole 2 mg/ml solution for infusion
3. How Fluconazole 2 mg/ml solution for infusion is given
4. Possible side effects
5. How to store Fluconazole 2 mg/ml solution for infusion
6. Contents of the pack and other information
1. What Fluconazole 2 mg/ml Solution for infusion is and what it is used for
Fluconazole is one of a group of medicines called ”antifungals”. 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 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 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 - 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 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.
2. What you need to know before you are given Fluconazole Do not take 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 2 mg/ml solution for infusion. 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).
Warning and precautions
Talk to your doctor or nurse before taking Fluconazole
- 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)
- if you develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue , muscle weakness, loss of appetite, weight loss, abdominal pain).
Other medicines and Fluconazole
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 Fluconazole (see section “Do not take Fluconazole”).
There are some medicines that may interact with Fluconazole. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, 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 (indanedione, 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)
- hydrochlorothiazide(a ‘water pill’)
- amiodarone (used for treating heart problems)
Pregnancy, breast-feeding and fertility
If you are pregnant, trying to become 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 medicines.
You should not take Fluconazole while you are pregnant unless your doctor has told you to.
You can continue breast-feeding after taking a single dose of Fluconazole up to 200 mg.
You should not breast-feed if you are taking a repeated dose of Fluconazole.
Driving and using machines
When driving vehicles or using machines it should be taken into account that occasionally dizziness or fits may occur.
Fluconazole contains sodium
Fluconazole contains 0.154 mmol sodium per ml. To be taken into consideration by patients on a controlled sodium diet.
3. How Fluconazole 2 mg/ml Solution for Infusion is given
This medicine will be given by your doctor or nurse as a slow 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 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 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 |
800mg on the first day then 400 mg once daily until you are told to stop |
|
To treat mucosal infections affecting the lining of the 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 the 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 |
Adolescents (from 12 to 17 years old)
Follow the dose prescribed by your doctor (either adults or children posology).
Infants, toddlers and children (from 28 days 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 |
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 newborn infants (0 to 27 days of age)
Use in newborn infants (from 15 to 27 days old):
- The same dose as above but given once every 2 days. A maximum dose of 12 mg per kg of body weight every 48 hours should not be exceeded.
Use in newborn infants (0 to 14 days old):
- The same dose as above but given once every 3 days. A maximum dose of 12 mg per kg of body weight every 72 hours should not be exceeded.
Doctors sometimes prescribe different doses to these. Always take this medicine exactly as your doctor has told you. 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 receive 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 (hallucination 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 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 (may affect 1 in 1,000 people). 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).
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)
Fluconazole may affect your adrenal glands and the levels of steroid hormones produced. The signs of adrenal problems include:
- tiredness
- muscle weakness
- loss of appetite
- weight loss
- abdominal pain
If any of these 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 (may affect up to 1 in 10 people) are listed below:
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash
Uncommon (may affect up to 1 in 100 people)
- reduction in red blood cells which can make skin pale and cause weakness or breathlessness
- decreased appetite
- inability to sleep, feeling drowsy
- fits, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste
- constipation, difficult digestion, wind, dry mouth
- muscle pain
- wheals, blistering (hives), itching, increased sweating
- tiredness, general feeling of being unwell, fever
Rare (may affect up 1 in 1, 000 people)
- 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
- 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.
5. How to store Fluconazole
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 bag after EXP. The expiry date refers to the last day of that month.
Storage conditions:
Do not store above 30° C. Do not freeze.
From the microbiological point of view once opened the product should be used immediately, and any unused infusion should be discarded.
For single use only.
Do not use Fluconazole if you notice visible particles, if the solution is unclear or if the bag is damaged.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Fluconazole contains
- The active substance is fluconazole.
- 1 ml of solution for infusion contains 2 mg of fluconazole.
- 100 ml of solution for infusion contains 200 mg of fluconazole.
- 200 ml of solution for infusion contains 400 mg of fluconazole.
- The other ingredients are: sodium chloride and water for injections.
What Fluconazole looks like and contents of the pack
Fluconazole is a clear, colourless solution with pH 6. The medicine is supplied to the hospital in plastic (polycine) infusion bags fitted with a polypropylene infusion port. The port is sealed with a rubber stopper and a polypropylene snap-cap. The infusion bags are contained in a transparent polypropylene overpouch.
Pack sizes: 100 ml bags (200 mg fluconazole) in packs of 1, 5 or 10 bags
200 ml bags (400 mg fluconazole) in packs of 1 , 5 or 10 bags Not all package sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG
Teva Pharmaceutical Works Private Limited Company, H-2100 Godollo, Tancsics Mihaly u. 82., Hungary
January 2016
PL 00289/0974
The following information is intended for medical or healthcare professionals only
This medicinal product is for single use only. After use, discard any remaining solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The solution should be inspected visually for particulate matter and discolouration prior to administration. Only clear solutions, without particles, should be used. Check for the presence of small leaks by firmly squeezing the inner-bag. In case of leaks the solution must be destroyed as sterility may be affected.
Fluconazole intravenous infusion is compatible with the following administration fluids:
- Glucose 50 mg/ml (5%) solution
- Ringer’s solution
- Hartmann’s solution
- Potassium chloride 3 mg/ml (0.3%) in 50 mg/ml (5%) glucose solution
- Sodium bicarbonate 4.2% solution
- Sodium chloride 9 mg/ml (0.9%) solution
The diluted solutions should be inspected visually for particulate matter and discolouration prior to administration. Only clear and colourless solutions should be used.
Fluconazole may be infused through an existing line with one of the above listed fluids. No specific incompatibilities have been noted, although mixing with any other drug prior to infusion is not recommended.
Handling:
Do not remove the bag from overpouch until ready for use.
To open, carefully cut overpouch at one end and remove solution bag. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
Preparing the administration:
Use sterile materials for preparation and administration. Hang the bag on the infusion stand through the hole. The solution must be administered with sterile equipment and an aseptic technique. The equipment must be primed with the solution in order to prevent the system from air penetration. Connect an administration set. Consult the instructions of the set in order to connect the set and to prime, and administer the solution.
Infusion rates and instructions _for use
The infusion rate should not exceed 10 ml/min (20 mg/min).
Fluconazole 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 C1-. 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 may be administered either orally or by intravenous infusion the route being dependent on the clinical state of the patient.
For instruction on handling of the product, see section 6.6 of the SmPC.
CAUTION: Do not use plastic bags in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
From the microbiological point of view, once opened this product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
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