FOSFOMICINA LEVEL 1 G POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
How to use FOSFOMICINA LEVEL 1 G POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
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.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist or nurse.
- This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor or pharmacist or nurse, even if they are side effects not listed in this package leaflet. See section 4.
Contents of the package leaflet:
- What Fosfomycin Level is and what it is used for
- What you need to know before using Fosfomycin Level
- How to use Fosfomycin Level
- Possible side effects
- Storage of Fosfomycin Level
- Contents of the pack and further information
1. What Fosfomycin Level is and what it is used for
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:
- the urinary tract
- the heart, sometimes called "endocarditis"
- the bones and joints
- the lungs, called "pneumonia"
- the skin and tissues under the skin
- the central nervous system
- the abdomen
- the blood, when originating from any of the aforementioned conditions.
2. What you need to know before using Fosfomycin Level
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:
- heart problems (heart failure), especially if you are taking digitalis medications (due to possible hypokalemia)
- high blood pressure (hypertension)
- a specific hormonal disorder (hyperaldosteronism)
- high sodium levels in the blood (hypernatremia)
- fluid accumulation in the lungs (pulmonary edema)
- kidney problems. Your doctor may need to adjust the dose of the medicine (see section 3 of this package leaflet)
- previous episodes of diarrhea after taking or being administered any other antibiotic.
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:
- anticoagulants, as fosfomycin and other antibiotics may alter your ability to prevent blood clotting.
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.
3. How to use Fosfomycin Level
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:
- The type and severity of the infection you have
- Your kidney function
In children, it also depends on:
- The child's weight
- The child's age
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.
4. Possible side effects
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:
- Signs of a severe allergic reaction (very rare: may affect up to 1 in 10,000 people). May include: difficulty breathing or swallowing, sudden wheezing, dizziness, swelling of the eyelids, face, lips, or tongue, rash, or itching.
- Severe or persistent diarrhea, which may be accompanied by abdominal pain or fever (frequency not known). May indicate a severe intestinal inflammation. Do not take anti-diarrheal medications that stop intestinal movement (antiperistaltics).
- Yellowing of the skin or the white part of the eye (jaundice, frequency not known). May be an initial sign of liver problems.
- Confusion, muscle cramps, or abnormal heart rhythm. May be caused by high sodium levels in the blood or low potassium levels in the blood (common: may affect up to 1 in 10 people).
Tell your doctor or nurse as soon as possible if you notice any of the following side effects:
- Pain, burning, redness, or swelling around the vein used during the infusion of this medicine (common: may affect up to 1 in 10 people).
- Bleeding or bruising more easily or getting more infections than usual. This could be due to a low number of white blood cells or platelets in the blood (frequency not known).
Other side effects may include:
Common side effects (may affect up to 1 in 10 people)
- Taste disturbance
Uncommon side effects (may affect up to 1 in 100 people)
- Dizziness, vomiting, or mild diarrhea
- Headache
- High levels of liver enzymes in the blood, possibly associated with liver problems
- Rash
- Weakness
Side effects of unknown frequency (cannot be estimated from available data)
- Liver problems (hepatitis)
- Itching, hives
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.
5. Storage of Fosfomycin Level
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.
6. Contents of the pack and further information
Composition of Fosfomycin Level
- The active substance is fosfomycin. Each vial contains 1 g of fosfomycin in the form of fosfomycin sodium.
- The other components are succinic acid and water for injectable preparations.
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:
- Standard pack: 1 vial + 1 ampoule of solvent
- Clinical pack: 100 vials + 100 ampoules of solvent
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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to FOSFOMICINA LEVEL 1 G POWDER AND SOLVENT FOR SOLUTION FOR INFUSIONDosage form: INJECTABLE, 1,320 gActive substance: fosfomycinManufacturer: Laboratorios Ern S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 250 mgActive substance: fosfomycinManufacturer: Laboratorios Ern S.A.Prescription requiredDosage form: INJECTABLE PERFUSION, 4 g/vialActive substance: fosfomycinManufacturer: Laboratorios Ern S.A.Prescription required
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