Infectofos

1. What is InfectoFos and what is it used for

InfectoFos contains the active substance fosfomycin. It belongs to a group of medicines called
antibiotics. Its action involves killing microorganisms (bacteria) that cause severe infectious diseases. The doctor has decided to administer InfectoFos to help the patient's body fight the infection. Effective treatment of the disease in the patient is very important.
InfectoFos is used in adults, adolescents, and children to treat bacterial infections:

• of the urinary tract;
• of the heart - sometimes called endocarditis;
• of bones and joints;
• of the lungs - called pneumonia;
• of the skin and subcutaneous tissue;
• of the central nervous system;
• of the abdominal cavity;
• of the blood, when caused by the factors listed above.

2. Important information before taking InfectoFos

When not to use InfectoFos

Warnings and precautions

Before starting treatment with InfectoFos, the patient should discuss it with their doctor, pharmacist, or nurse if they have:

• heart problems (heart failure), especially when using digitalis glycosides (due to possible hypokalemia);
• high blood pressure (hypertension);
• certain endocrine disorders (hyperaldosteronism);
• high sodium levels in the blood (hypernatremia);
• fluid accumulation in the lungs (pulmonary edema);
• kidney problems. In such cases, the doctor may need to adjust the dose (see section 3 of this leaflet);
• previous occurrence of diarrhea after taking or administering other antibiotics.

Issues to consider

InfectoFos may cause severe side effects. They may include allergic reactions, inflammation of the colon, and decreased white blood cell count. During treatment with this medicine, the patient should be aware of certain symptoms to minimize the risk of problems.
See "Severe side effects" in section 4.
InfectoFos and other medicines
The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

• anticoagulant medicines, as fosfomycin and other antibiotics may affect their ability to prevent blood clots.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Fosfomycin may pass into the body of the unborn child or into breast milk. The doctor will only prescribe this medicine to a pregnant or breastfeeding woman if it is clearly necessary.

Driving and using machines

Treatment with InfectoFos may be associated with side effects such as confusion or asthenia. If such side effects occur, the patient should not drive or operate machinery.

Important information about some ingredients of InfectoFos

This medicine contains 14 mmol (320 mg) of sodium per 1 g of fosfomycin. This corresponds to 16% of the maximum recommended daily intake of sodium in the diet for adults. One vial with 2 g of fosfomycin contains 28 mmol (640 mg) of sodium, one vial with 4 g of fosfomycin contains 56 mmol (1280 mg) of sodium, and one vial with 8 g of fosfomycin contains 111 mmol (2560 mg) of sodium.
Patients controlling their sodium intake should be considered.
During treatment with this medicine, the patient should follow a low-sodium diet to reduce sodium intake.

3. How to take InfectoFos

InfectoFos is administered to the patient by a doctor or nurse intravenously (in the form of an intravenous infusion).

Dosage

The size and frequency of doses depend on:

• the type and severity of the infection,
• kidney function. In children, dosing also depends on:
• the child's body weight,
• the child's age. In cases of kidney problems or the need for dialysis, the doctor may need to reduce the dose of the medicine. Method and route of administration Intravenous administration. InfectoFos is administered to the patient by a doctor or nurse intravenously (in the form of an intravenous infusion). The infusion usually lasts 15-60 minutes, depending on the dose. The medicine is usually administered two, three, or four times a day.

Duration of treatment

The doctor will decide how long the treatment should last, depending on how quickly the patient's condition improves. During treatment of bacterial infections, it is important to complete the full treatment cycle. Even after the fever has subsided and the symptoms have improved, the treatment should be continued for several more days.
In the case of certain types of infections, such as bone infections, a longer treatment period may be required after the symptoms have subsided.

Taking a higher dose of InfectoFos than recommended

It is unlikely that the doctor or nurse will administer too high a dose of the medicine to the patient. If the patient thinks they have been given too high a dose of the medicine, they should ask them immediately.
If the patient has any further questions about the use of this medicine, they should ask their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, InfectoFos can cause side effects, although not everybody gets them.

Severe side effects

If any of the following severe side effects are observed, the doctor should be notified immediately - urgent treatment may be necessary:

• Symptoms of a severe allergic reaction (very rare: may affect up to 1 in 10,000 people). May include: breathing or swallowing problems, sudden wheezing, dizziness, swelling of the eyelids, face, lips, or tongue, rash, or itching.
• Severe and persistent diarrhea, which may be accompanied by abdominal pain or fever (frequency not known). May be a sign of severe colitis. The patient should not take anti-diarrheal medicines that reduce intestinal motility (antiperistaltic medicines).
• Yellowing of the skin and whites of the eyes (jaundice, frequency not known). May be an early sign of liver problems.
• Confusion, muscle cramps, or irregular heartbeat. May be caused by elevated sodium levels or decreased potassium levels in the blood (common: may affect up to 1 in 10 people).

If any of the following side effects are observed, the patient should contact their doctor or nurse as soon as possible:

• Pain, burning, redness, or swelling along the vein into which the infusion is administered (common: may affect up to 1 in 10 people).
• More frequent than usual bleeding, bruising, or infections. May be caused by a decreased white blood cell or platelet count (frequency not known).

Other side effects may include:

Common side effects (may affect up to 1 in 10 people)

• Taste disturbances Uncommon side effects (may affect up to 1 in 100 people)
• Nausea, vomiting, or mild diarrhea
• Headache
• High levels of liver enzymes in the blood, potentially related to liver problems
• Rash
• Weakness Side effects with unknown frequency (frequency cannot be estimated from the available data)
• Liver problems (hepatitis)
• Itching, hives

Reporting side effects

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If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store InfectoFos

• The medicine should be stored out of sight and reach of children.
• There are no special precautions for storage of the medicinal product.
• Do not use this medicine after the expiry date stated on the carton and label after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
• After mixing with the solvent, the medicine should be used immediately or stored in the refrigerator (at a temperature of 2 - 8°C), protected from light, for up to 24 hours.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What InfectoFos contains

The active substance of InfectoFos is fosfomycin. Each ml of the solution for infusion contains 40 mg of fosfomycin.

• Each vial of InfectoFos 2 g with 2.69 g of powder for solution for infusion in 50 ml of solvent contains 2.64 g of fosfomycin sodium, equivalent to 2 g of fosfomycin and 0.64 g of sodium.
• Each vial of InfectoFos 4 g with 5.38 g of powder for solution for infusion in 100 ml of solvent contains 5.28 g of fosfomycin sodium, equivalent to 4 g of fosfomycin and 1.28 g of sodium.
• Each vial of InfectoFos 8 g with 10.76 g of powder for solution for infusion in 200 ml of solvent contains 10.56 g of fosfomycin sodium, equivalent to 8 g of fosfomycin and 2.56 g of sodium.

The other ingredient is succinic acid.

What InfectoFos looks like and contents of the pack

The medicine is a white or cream-colored powder for solution for infusion. The solution for infusion is clear and colorless or slightly yellowish.
It is packed in colorless glass (type I) vials with a bromobutyl rubber stopper and an aluminum cap of the pull-offtype.
Three vial sizes are available:

• vials containing 2 g of fosfomycin, each pack contains 10 vials,

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• vials containing 4 g of fosfomycin, each pack contains 10 vials,
• vials containing 8 g of fosfomycin, each pack contains 1 or 10 vials.

Marketing authorization holder and manufacturer

InfectoPharm Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany

Representative of the marketing authorization holder:

Zakłady Farmaceutyczne Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom (Northern Ireland):
Fomicyt 40 mg/ml Powder for solution for infusion
Italy:
InfectoFos
Poland:
InfectoFos, 40 mg/ml, powder for solution for infusion
Ireland:
Fomicyt 40 mg/ml Powder for solution for infusion
Netherlands:
Fomicyt 40 mg/ml Poeder voor oplossing voor infusie
Greece:
Fomicyt 40 mg/ml Κόνις για διάλυμα προς έγχυση
Croatia:
Fomicyt 40 mg/ml prašak za otopinu za infuziju
Denmark/Finland/Norway/Sweden:
Fosfomycin Infectopharm
Austria:
Fomicyt 40 mg/ml Pulver zur Herstellung einer Infusionslösung
Belgium:
Fomicyt 40 mg/ml poeder voor oplossing voor infusie/
Fomicyt 40 mg/ml Poudre pour solution pour perfusion/
Fomicyt 40 mg/ml Pulver zur Herstellung einer Infusionslösung
Czech Republic:
Fomicyt
Hungary:
Fomicyt 40 mg/ml por oldatos infúzióhoz
Romania:
Fomicyt 40 mg/ml pulbere pentru soluție perfuzabilă
Slovakia:
Fomicyt

Date of last revision of the leaflet: December 2022.

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Information intended for healthcare professionals only:

InfectoFos 40 mg/ml powder for solution for infusion is intended for single use. Unused solution should be discarded.
Preparation of the solution for infusion

The medicinal product InfectoFos should be dissolved and diluted before administration.

Water for injections and 5% glucose solution for infusion (50 mg/ml) or 10% glucose solution for infusion (100 mg/ml) can be used as solvents for dissolution and dilution. Solvents containing sodium chloride should not be used.
Dissolution
Shake the vial before dissolution to loosen the powder. Dissolve the contents of the 2 g or 4 g vial with 20 ml, and the contents of the 8 g vial with 40 ml of solvent. Shake vigorously to dissolve.
During dissolution of the powder, there is a slight increase in temperature.
Note:This intermediate solution is not intended for direct infusion. Take the entire solution from the original vial. Transfer the taken solution to an infusion bag or other suitable container for infusion for further dilution, as described below.
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Dilution
Transfer the dissolved contents of the 2 g vialto an infusion container containing an additional 30 mlof solvent.
Transfer the dissolved contents of the 4 g vialto an infusion container containing an additional 80 mlof solvent.
Transfer the dissolved contents of the 8 g vialto an infusion container containing an additional 160 mlof solvent.
Overfill volumes
The overfill volumes for the 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 correspond to an increase in volume of 2%. This should be taken into account if the entire volume of the prepared diluted solution is not used.
Method of administration
InfectoFos is intended for intravenous administration.
The infusion time should be at least 15 minutes for the 2 g pack size, at least 30 minutes for the 4 g pack size, and at least 60 minutes for the 8 g pack size.
Since accidental intra-arterial administration of products not specifically recommended for intra-arterial administration can cause harmful effects, it is very important to administer fosfomycin only intravenously.
Shelf life of the solution for infusion
The chemical and physical stability of the prepared diluted solution has been demonstrated for 24 hours at 25°C, protected from light.
From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions prior to use, which should not exceed 24 hours at 2-8°C, unless the solution has been prepared in controlled and validated aseptic conditions.