Fluconazole 2mg/Ml Solution For Infusion
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 meningitisfrom 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 oncedaily 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 |
Patient Information Leaflet Fluconazole 2 mg/ml Solution for Infusion Fluconazole
Please read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you are the parent of a child who is to be given this medicine, read the leaflet replacing “you” with “your child” throughout.
• The medicine is prescribed only for you, and you should 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 get serious, or you notice any side effects not listed in the leaflet, please tell your doctor, nurse or pharmacist.
• If you have further questions, please ask your nurse, doctor or pharmacist.
The name of your medicine is Fluconazole 2mg/ml Solution for Infusion
In the rest of this leaflet Fluconazole 2mg/ml solution for infusion is called Fluconazole.
What is in this leaflet:
1. What Fluconazole is and what it is used for
2. What you need to know before you take Fluconazole
3. How to take Fluconazole
4. Possible side-effects
5. How to store Fluconazole
6. Contents of the pack and other information
What Fluconazole 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 candidalinfection. 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 trush 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 take Fluconazole
The doctor or nurse giving you this medicine will ask some questions about you. They need the following information before you have this medicine for the first time.
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. The symptoms may include itching, reddening of the skin or difficulty in breathing
• are taking astemizole, 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 arrhythmia)
• are taking erythromycin (an antibiotic for treating infections)
Do not take Fluconazole if any of the above statements are true.
Take special care with Fluconazole
Before your treatment starts, tell your doctor or nurse if:
• 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).
• have liver or kidney problems
—
The following information is intended for medical or healthcare professionals only :
For single use only. Discard any unused solution.
The solution should 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.
Fluconazole 2 mg/ml solution for infusion can be infused by means of an infusion system with one of the following solutions and should not be mixed with other medicinal products in a solution infusion.
Taking other medicines
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 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 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 (NonSteroidal 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)
Your doctor may want to carry out some extra blood tests if you are taking any of these medicines to check that your medicines are working together correctly.
Pregnancy and breastfeeding
• If you are pregnant, or think you may be pregnant you must tell your doctor
• If you are breastfeeding, you must tell your doctor as the Fluconazole will be in the breastmilk and may affect your baby.
Your doctor will not usually give you this medicine during pregnancy and breastfeeding. 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
Fluconazole contains salt (sodium chloride). The solution for infusion contains 3.54mg of sodium per ml.
One bag of 100ml contains 354mg of sodium.
One bag of 200ml contains 709mg of sodium.
This should be taken into consideration by patients on a controlled sodium diet.
If you are on a low sodium (salt) diet tell your doctor or other medical staff before they give you Fluconazole 2mg/ml solution for infusion.
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
3. How to take Fluconazole
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.
|
Diluent |
Resulting concentration of fluconazole |
|
Sodium chloride injection 0.9% |
1.0 mg/ml |
|
Dextrose injection 20% |
1.0 mg/ml |
|
Lactated Ringer’s injection |
1.0 mg/ml |
|
Ringer’s injection |
1.0 mg/ml |
|
Potassium chloride 0,3%-Dextrose 5% injection |
1.0 mg/ml |
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.
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
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
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 kgof 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
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 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.
Possible side-effects
Like all medicines, Fluconazole 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 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)
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, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash
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
5. How to store Fluconazole
Your doctor, nurse or pharmacist will usually store your medicine for you.
Keep out of the reach and sight of children.
Do not use FLUCONAZOLE NORIDEM 2 mg/ml after the expiry date which is stated on the carton and the label on the plastic container (bag) after EXP.
The expiry date refers to the last day of that month.
Do not use if the solution is cloudy, discoloured or contains particles.
Store below 25°C. Do not freeze or refrigerate.
Keep the bag in the outer carton to protect from light
For single use only. Use immediately after first opening the bottle.
Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product 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 36 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Your medicine may be mixed with certain other medicines that may also be given by infusion. Please ask your doctor, nurse or pharmacist if you want any more information about this.
Medicines should not be disposed of via wastewater or Household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will hep to protect the environment
6. Contents of the package and further information
What Fluconazole contains
The active substance is Fluconazole.
1 ml of solution contains 2 mg of fluconazole
Each 50 ml (millilitre) bag will contain 100 mg (milligram) of Fluconazole. Each 100 ml (millilitre) bag will contain 200 mg (milligram) of Fluconazole.
The other ingredients are Sodium Chloride (see Section 2) and Water for Injections.
What Fluconazole looks like and contents of the pack
Fluconazole 2 mg/ml solution for infusion is a clear and colourless aqueous solution for infusion.
It is a ready to use plastic bag with rubber closures, and aluminium caps.
Pack sizes: 50ml bags (100mg Fluconazole) in packs of 10 bags
100ml bags (200mg Fluconazole) in packs of 10 bags Not all package sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: To be completed nationally Manufacturer: To be completed nationally
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Fluconazole 2mg/ml Solution for infusion
DE: Fluconazol Noridem2 mg/ml Infusionslosung im Beutel
IE: Fluconazole 2mg/ml Solution for infusion
FR: Fluconazole Noridem 2mg/ml
ES: Fluconazole Kern Pharma 2mg/ml Solution for infusion
AT: Fluconazole Noridem 2mg/ml Solution for infusion
GR: Fluconazole Noridem 2mg.ml Solution for infusion