


Ask a doctor about a prescription for FOSFOMICINA LEVEL 1 G POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Package Leaflet:information for the patient
Fosfomycin Level 1 g powder and solvent for solution for infusion
Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.
Contents of the package leaflet:
Fosfomycin Level contains the active substance fosfomycin. It belongs to a group of medicines called antibiotics. It works by eliminating certain types of germs (bacteria) that can cause serious infectious diseases. Your doctor has decided to treat you with Fosfomycin Level to help your body fight an infection. It is essential that you receive effective treatment for this condition.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold. It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor. Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash. |
Fosfomycin Level is used in adults, adolescents, and children to treat infections caused by bacteria in:
Do not use fosfomycin level
If you are allergic to fosfomycin or any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Fosfomycin Level if you have any of the following conditions:
Symptoms to which you should pay attention
Fosfomycin Level can cause severe side effects. These include allergic reactions, inflammation of the large intestine, and a decrease in the number of white blood cells. You should pay attention to certain symptoms while taking this medicine to reduce the risk of problems. See "Severe side effects" in section 4.
Other medicines and Fosfomycin Level
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, including those purchased without a prescription.
This is especially important if you are taking:
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Fosfomycin may pass to the baby in the womb or through breast milk. If you are pregnant or breastfeeding, your doctor will only prescribe this medicine when strictly necessary.
Driving and using machines
When Fosfomycin Level is administered, side effects such as confusion and weakness may occur. If these occur, you should not drive or operate machinery.
Fosfomycin Level contains sodium (supplied by the active ingredient)
This medicine contains 333 mg of sodium (main component of table salt/cooking salt) in each vial. This is equivalent to 17% of the maximum recommended daily sodium intake for an adult.
Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Fosfomycin Level is administered intravenously (drip) by a doctor or nurse.
Posology
The dose you receive and the frequency of administration will depend on:
In children, it also depends on:
If you have kidney problems or need dialysis, your doctor may need to reduce the dose of this medicine.
Route and method of administration
For intravenous use.
Fosfomycin Level is administered in a vein (drip) by a doctor or nurse.
Normally, the infusion will last between 15 and 60 minutes, depending on the dose administered. In general, this medicine is administered 2, 3, or 4 times a day.
Duration of treatment
Your doctor will decide how long the treatment should last based on how quickly your condition improves. In the treatment of bacterial infections, it is essential to complete the entire treatment cycle. Treatment should continue for a few days after the fever has disappeared and symptoms have subsided.
Some infections, such as bone infections, may require a longer treatment period after symptoms have subsided.
If you receive more Fosfomycin Level than you should
It is unlikely that your doctor or nurse will administer too much medicine. If you think you have received too much of this medicine, ask them immediately.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Severe side effects
Tell your doctor immediately if you notice any of the following severe side effects: you may need urgent medical treatment:
Tell your doctor or nurse as soon as possible if you notice any of the following side effects:
Other side effects may include:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Side effects of unknown frequency (cannot be estimated from available data)
Reporting side effects
If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.
Composition of Fosfomycin Level
Appearance of the product and contents of the pack
Fosfomycin Level is presented in a glass vial containing a white or almost white powder and a glass ampoule containing 10 ml of water for injectable preparations. The available formats are:
Marketing authorization holder
LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain
Manufacturers
FISIOPHARMA, S.r.l.
Nucleo industriale. 84020
Palomonte (SA)
Tax Code: 02580140651
LABORATORIOS ERN, S.A.
Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona, Spain
Date of the last revision of this package leaflet: January 2023.
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
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This information is intended only for healthcare professionals:
The reconstitution of the solution should be performed at the time of intravenous administration.
Dissolve the contents of the 1 g vial with the 10 ml of the solvent ampoule. Take the volume corresponding to the appropriate dose. Dilute in water for injectable preparations or glucose solution at a ratio of 4 ml per each ml of the previously prepared solution. Administer over a 1-hour period.
When dissolving fosfomycin, an exothermic reaction occurs with the consequent release of heat, causing the vial to warm slightly.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for FOSFOMICINA LEVEL 1 G POWDER AND SOLVENT FOR SOLUTION FOR INFUSION – subject to medical assessment and local rules.