Fosfomycin 40 Mg/Ml Powder For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSFOMYCIN 40 mg/ml
Powder for solution for infusion Fosfomycin
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 have any further questions, ask your doctor, or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What FOSFOMYCIN 40 mg/ml is and what it is used for
2. What you need to know before you are given FOSFOMYCIN 40 mg/ml
3. How FOSFOMYCIN 40 mg/ml is given
4. Possible side effects
5. How to store FOSFOMYCIN 40 mg/ml
6. Contents of the pack and other information
1. What FOSFOMYCIN 40 mg/ml is and what it is used for
FOSFOMYCIN 40 mg/ml (called “FOSFOMYCIN” in this leaflet) belongs to a group of medicines called antibiotics. It works by killing certain types of germs (bacteria) that cause serious infectious diseases. If left untreated, an infectious disease can spread through your body and may be fatal. It is important that you receive effective treatment for this condition.
FOSFOMYCIN is given as an infusion into a vein (a drip) by a doctor or a nurse.
FOSFOMYCIN is used in adults and children to treat the following infections caused by bacteria.
• Infections of the lung
• Infections of the bones
• Infections of the kidney and bladder
• Infections of the brain (meningitis)
FOSFOMYCIN is used when other antibiotics cannot be used or have not worked.
2. What you need to know before you are given FOSFOMYCIN 40 mg/ml
In certain circumstances your doctor may decide not to give you FOSFOMYCIN.
Do not have FOSFOMYCIN and tell your doctor if:
• You are allergic (hypersensitive) to fosfomycin or any of the other ingredients of FOSFOMYCIN (see section 6: Content of the pack and other information).
If you are not sure, talk to your doctor, pharmacist or nurse before having FOSFOMYCIN.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before taking this medicine if you suffer from one of the following disorders:
- heart problems (cardiac insufficiency)
- high blood pressure (hypertension)
- a certain disorder of the hormone system (hyperaldosteronism)
- high levels of blood sodium (hypernatraemia)
- fluid accumulation in the lungs (pulmonary oedema)
- kidney problems. Your doctor may need to change the dose of FOSFOMYCIN (see section 3 of this leaflet).
Conditions you need to look out for
FOSFOMYCIN can cause serious side effects. These include allergic reactions and inflammation of the large intestine. You must look out for certain symptoms while you are taking FOSFOMYCIN, to reduce the risk of any problems. See “Conditions to look out for” in Section 4.
Other medicines and FOSFOMYCIN
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
So far, no harmful interference has been noted when FOSFOMYCIN is given together with other medicines.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before you are given FOSFOMYCIN if you are pregnant, planning to become pregnant, or if you are breast-feeding. FOSFOMYCIN may pass to the baby in the womb or through breast milk. If you are pregnant or breast-feeding your doctor will only give you FOSFOMYCIN when it is clearly needed.
Driving and using machines
When FOSFOMYCIN is given, there may be side effects such as dizziness, confusion or problems with the vision (see also section 4 “Possible Side Effects”). If these occur, you should not drive or operate machinery.
Important information about some of the ingredients of FOSFOMYCIN
FOSFOMYCIN contains sodium (14 mmol (320 mg) sodium per 1 g fosfomycin). One vial with 2 g fosfomycin contains 28 mmol (640 mg) sodium, one vial with 4 g fosfomycin contains 56 mmol (1280 mg) sodium and one vial with 8 g fosfomycin contains 111 mmol (2560 mg) sodium.
This should be taken in consideration if you are on a controlled sodium diet.
While on treatment with FOSFOMYCIN, you should follow a low-salt diet to reduce your sodium intake.
3. How FOSFOMYCIN 40 mg/ml is given
Administration
FOSFOMYCIN is given to you into a vein (a drip) by a doctor or a nurse. The infusion will normally take 15 to 60 minutes, depending on your dose. Usually FOSFOMYCIN is given 2, 3 or 4 times a day.
Dosage
The dose you will be given, and the frequency of the dose will depend on:
• The type and severity of infection you have
• Y our kidney function.
In children, it also depends on
• The child’s weight
• The child’s age
If you have kidney problems or if you are receiving dialysis your doctor may prescribe a lower dose of FOSFOMYCIN.
The general dosage guidelines for patients with normal kidney function are as follows:
|
Age/weight |
Daily dose |
|
Premature neonates |
100 mg/kg body weight in 2 divided doses |
|
Neonates |
200 mg/kg body weight in 3 divided doses |
|
Infants 1-12 months (up to 10 kg body weight) |
200-300 mg/kg body weight in 3 divided doses |
|
Infants and children aged 1-12 years (10-40 kg body weight) |
200-400 mg/kg body weight in 3-4 divided doses |
|
Adolescents aged 12-18 years and adults (> 40 kg body weight) |
12-24 g in 2-4 divided doses |
Individual doses must not exceed 8 g.
If you have problems with your kidneys or require dialysis, your doctor may need to reduce your dose of FOSFOMYCIN.
Duration of treatment
Your doctor will decide how long your treatment should last depending on how fast your condition will improve. When treating bacterial infections it is important to complete the full course of treatment. Even after the fever has passed and the symptoms have abated, treatment should be continued for a few days more.
If you are given more FOSFOMYCIN than you should
It is unlikely that your doctor or nurse will give you too much medicine. Ask them immediately if you think that you have been given too much FOSFOMYCIN.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, FOSFOMYCIN can cause side effects, although not everybody gets them.
Conditions to look out for
Tell your doctor straight away if you notice any of the following serious side effects - you may need
urgent medical treatment:
• Signs of a serious allergic reaction (very rare, affecting less than 1 person in 10 000). These may include: breathing or swallowing problems, sudden wheezing, dizziness, swelling of eyelids, face, lips or tongue, rash or itching.
• Severe and persistent diarrhoea (which may be associated with abdominal pain or fever). This may be a sign of a serious bowel inflammation. Do not take medicines against diarrhoea that inhibit the bowel movements (antiperistaltics).
• Yellowing of the skin or the whites of your eyes (jaundice). This can be an early sign of liver problems.
• Confusion, muscle twitching or abnormal heart rhythm. This could be caused by high levels of blood sodium or low levels of blood potassium (uncommon, affecting less than 1 person in 100).
Tell your doctor or nurse as soon as possible if you notice any of the following side effects:
• Pain, burning, redness or swelling along the vein which is used during infusion of FOSFOMYCIN (common, affecting less than 1 person in 10).
• You bleed or bruise more easily and get more infections as usual. This could be because you have a low number of white blood cells or blood platelets.
Other side effects can include:
Common side effects (affecting less than 1 person in 10)
• Retching, stomach ache
Uncommon side effects (affecting less than 1 person in 100)
• Feeling sick, vomiting, or mild diarrhoea
• Taste disturbances
• Shortness of breath
• Rash
• Decreased appetite
• Headache
• Feeling of dizziness or “spinning”
• Tiredness
• High levels of blood liver enzymes, possibly associated with liver problems.
Rare side effects (affecting less than 1 person in 1 000)
• Pale skin, weakness or breathlessness (possibly due to a reduction in blood cells)
• High levels of certain white blood cells (eosinophilia), usually associated with allergic diseases.
Very rare side effects (affecting less than 1 person in 10 000)
• Fatty liver
• Visual impairment
Side effects with unknown frequency
• Liver problems (hepatitis)
• Shortness of breath, wheezing or a tight feeling in the chest. These may be signs of an asthma attack.
• Faster heart beat
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 FOSFOMYCIN 40 mg/ml
• Keep out of the reach and sight of children.
• Keep the vial in the outer carton in order to protect it from light.
• Do not use FOSFOMYCIN after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.
• After being mixed with solvent FOSFOMYCIN should be used immediately or stored in a refrigerator (at 2-8°C) protected from light for up to 12 hours.
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 help to protect the environment.
6. Content of the pack and other information What FOSFOMYCIN contains
The active substance is fosfomycin. Each ml of the reconstituted solution contains 40 mg of fosfomycin.
• Each vial of FOSFOMYCIN 2 g with 2.69 g of powder for reconstitution in 50 ml solvent contains 2.64 g disodium fosfomycin, corresponding to 2 g fosfomycin and 0.64 g sodium.
• Each vial of FOSFOMYCIN 4 g with 5.38 g of powder for the reconstitution in 100 ml solvent contains 5.28 g disodium fosfomycin, corresponding to 4 g fosfomycin and 1.28 g sodium.
• Each vial of FOSFOMYCIN 8 g with 10.76 g of powder for reconstitution in 200 ml solvent contains 10.56 g disodium fosfomycin, corresponding to 8 g fosfomycin and 2.56 g sodium.
The other ingredient is succinic acid.
What FOSFOMYCIN looks like and contents of the pack
FOSFOMYCIN is a white to cream-coloured powder for solution for infusion. The reconstituted solution is clear and colourless to slightly yellowish.
It is packed in clear glass vials (type II) with a rubber stopper and pull-off cap.
Three sizes of vials are available:
• vials with 2 g fosfomycin
• vials with 4 g fosfomycin
• vials with 8 g fosfomycin
Each pack contains 10 vials.
Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH Von-Humboldt-Str. 1, 64646 Heppenheim Germany
Distributor
Nordic Pharma UK Ltd Abbey House
1650 Arlington Business Park
Theale
Berkshire
RG7 4SA
This leaflet was last revised in: 04/2015
The following information is intended for medical or healthcare professionals only:
FOSFOMYCIN 40 mg/ml powder for solution for infusion is for single use only and any unused solution should be discarded.
The powder must be reconstituted prior to use.
Preparation of the solution for infusion In order to prepare the solution for infusion:
FOSFOMYCIN 2 g should be dissolved in 50 ml of Water for Injections, 5 % Glucose Infusion or 10 % Glucose Infusion.
FOSFOMYCIN 4 g should be dissolved in 100 ml of Water for Injections, 5 % Glucose Infusion or 10 % Glucose Infusion.
FOSFOMYCIN 8 g should be dissolved in 200 ml of Water for Injections, 5 % Glucose Infusion or 10 % Glucose Infusion.
A slight degree of warming occurs when the powder is dissolved.
Displacement value
The displacement values for the reconstituted solutions are 1 ml for the 2 g pack size, 2 ml for the 4 g pack size and 4 ml for the 8 g pack size.
These volumes are equivalent to an increase of volume of 2 %. This has to be considered when preparing the final solution in case of not using the entire content of the vial.
Method of administration
FOSFOMYCIN is intended for intravenous administration. Each infusion should last at least 15 minutes for FOSFOMYCIN 2 g, at least 30 minutes for FOSFOMYCIN 4 g and at least 60 minutes for FOSFOMYCIN 8 g.
As damaging effects can result from inadvertent intra-arterial administration of products not specifically recommended for intra-arterial therapy, it is essential to ensure that FOSFOMYCIN is only administered into veins.
Before administration, the reconstituted solution should be inspected visually. Only clear solutions should be used.
Shelf life of the reconstituted solution
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, unless reconstitution has taken place in controlled and validated aseptic conditions.
A reconstituted solution that has been produced under aseptic conditions is chemically stable in a refrigerator (at 2-8°C) for at least 12 hours if protected from light.
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