40 mg / ml powder for infusion solution
fosfomycin

1. What Fosfomycin Infectopharm is and what it is used for

Phosphomycin Infectopharm contains the active substance phosphomycin. It belongs to a group of medicines called antibiotics. It works by killing certain types of bacteria that cause serious infectious diseases. Your doctor has decided to treat you with Fosfomycin Infectopharm to help your body fight infection. You must receive effective treatment for this disease.

Fosfomycin Infectopharm is used to treat adults, adolescents, and children for infection in:

  • the urinary tract
  • the heart, sometimes called “endocarditis”
  • skeleton and joints
  • the lungs, which is called “pneumonia” or “pneumonia”
  • the skin and tissues under the skin
  • central nervous system
  • stomach
  • blood, when infection in the blood is caused by the diseases listed above

Phosphomycin contained in Fosfomycin Infectopharm may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you take Fosfomycin Infectopharm

Do not use Fosfomycin Infectopharm

Do not take Fosfomycin Infectopharm :

  • if you are allergic to phosphomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

If you have any of the following conditions, talk to your doctor, pharmacist, or nurse before using Fosfomycin Infectopharm:

  • heart problems ( heart failure ), especially if you are taking digitalis medicines (due to the risk of low potassium levels in the blood ( hypokalaemia ))
  • high blood pressure ( hypertension )
  • a specific disease of the hormonal system (hyperaldosteronism)
  • high levels of sodium chloride in the blood ( hypernatremia )
  • fluid accumulation in the lungs ( pulmonary edema )
  • kidney problems. Your doctor may need to change the dose of one of your medicines (see section 3 of this leaflet).
  • Previous periods of diarrhea after taking or receiving any other type of antibiotic

Conditions you need to be aware of

Phosphomycin Infectopharm can cause serious side effects. These include allergic reactions, inflammation of the colo,n and decreased white blood cell count. You need to be aware of certain symptoms while you are using this medicine, to reduce the risk of any problems. See “Serious side effects” in section 4.

Other medicines and Fosfomycin Infectopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• blood thinners ( anticoagulants ), as their ability to prevent your blood from clotting, can be affected by phosphomycin and other antibiotics.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Phosphomycin can pass to the baby in the womb or through breast milk. If you are pregnant or breast-feeding, your doctor will only give you this medicine when necessary.

Driving and using machines

When Fosfomycin Infectopharm is given, you may experience side effects such as confusion and weakness. You should not drive or use machines if these side effects occur.

Important information about some of the ingredients of Fosfomycin Infectopharm

This medicine contains 14 mmol (320 mg) sodium per 1 g phosphomycin. This corresponds to 16% of the maximum recommended daily intake of sodium for adults. One bottle of 2 g phosphomycin contains 28 mmol (640 mg) sodium, one bottle of 4 g phosphomycin contains 56 mmol (1,280 mg) sodium and one bottle of 8 g phosphomycin contains 111 mmol (2,560 mg) sodium. This should be considered if you are on a low salt diet.

When you are treated with this medicine, you should eat a low-salt diet to reduce your sodium intake.

3. How to use Fosfomycin Infectopharm

Phosphomycin Infectopharm is given into a vein (a drip) by a doctor or nurse.

Dosage

The dose you will receive and the frequency of dosing will depend on:

  • The type and severity of the infection you have
  • Your kidney function.

For children, dosage also depends on

  • The child’s weight
  • The age of the child

If you have kidney problems or need dialysis, your doctor may need to reduce your dose of this medicine

How this medicine is given

For intravenous use (given in a blood vessel).

Phosphomycin Infectopharm is given into a vein (a drip) by a doctor or nurse. Infusion one usually takes 15 to 60 minutes, depending on your dose. This medicine is usually given 2, 3, or 4 times a day.

Length of treatment

Your doctor will decide how long your treatment will last depending on how quickly your illness will improve. When treating bacterial infection, it is important to carry out the entire treatment. Treatment should be continued for a few more days even after the fever has subsided and the symptoms have subsided.

Some infections, such as skeletal infections, may require an even longer treatment period after the symptoms have subsided.

It is unlikely that your doctor or nurse will give you too much of the medicine. Ask them immediately if you think you have been given too much of this medicine.

If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.

If you are given too much Fosfomycin Infectopharm

It is unlikely that your doctor or nurse will give you too much of the medicine. Ask them immediately if you think you have been given too much of this medicine.

If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

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

Serious side effects are

Contact a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:

  • Signs of a severe allergic reaction (very rare: may affect up to 1 in 10,000 people). These signs may include difficulty breathing or swallowing, sudden wheezing, dizziness, swelling of the eyelids, face, lips, or tongue, rash or itching.
  • Severe and persistent diarrhea, which may occur with abdominal pain or fever (has been reported). This can be a sign of serious inflammation in the intestine. Do not take any medicines for diarrhea that inhibit bowel movements (antiperistaltic medicines).
  • Yellowing of the skin or whites of the eyes (jaundice, unknown frequency). This may be an early sign of liver problems.
  • Confusion, muscle twitching, or abnormal heart rhythm. This can be caused by high levels of sodium in the blood or low levels of potassium in the blood (common: can affect up to 1 in 10 people).

Contact your doctor or nurse as soon as possible if you notice any of the following side effects:

  • Pain, burning sensation, redness, or swelling along the vein used for infusion of this medicine (common: may affect up to 1 in 10 people).
  • You bleed or get bruises more easily or get more infections than usual. This may be because you have a low number of white blood cells or platelets (have been reported).

Other side effects may include:

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

  • Taste disorders

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, possibly associated with liver problems.
  • Rash
  • Weakness

Has been reported (occurs in an unknown number of people):

  • Liver problems (liver inflammation),
  • Itching, hives

5. How to store Fosfomycin Infectopharm

  • Keep this medicine out of the sight and reach of children.
  • No special storage instructions.
  • Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
  • After mixing with liquid, this medicine should be used immediately or stored in a refrigerator (at 2−8 ° C) protected from light for up to 24 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. Contents of the packaging and other information

Content declaration

The active substance is phosphomycin. One ml solution for infusion contains 40 mg phosphomycin.

  • One vial of Fosfomycin Infectopharm 2 g with 2.69 g of powder for solution in 50 ml of liquid contains 2.64 g of phosphomycin sodium, corresponding to 2 g of phosphomycin and 0.64 g of sodium.
  • A bottle of Fosfomycin Infectopharm 4 g with 5.38 g of powder for solution in 100 ml of liquid contains 5.28 g of phosphomycin sodium, corresponding to 4 g of phosphomycin and 1.28 g of sodium.
  • A bottle of Fosfomycin Infectopharm 8 g with 10.76 g of powder for solution in 200 ml of liquid contains 10.56 g of phosphomycin sodium, corresponding to 8 g of phosphomycin and 2.56 g of sodium.

The other ingredient is succinic acid.

What the medicine looks like and the contents of the pack

This medicine is a white to cream solution for infusion solution. The infusion solution is clear and colorless to slightly yellowish.

It is packed in clear glass bottles (type I) with a rubber stopper (bromobutyl rubber) and a removable lid.

The vials are available in three sizes:

  • bottles of 2 g phosphomycin
  • bottles of 4 g phosphomycin
  • bottles with 8 g of phosphomycin

One package contains 10 bottles.

Marketing Authorization Holder and Manufacturer

INFECTOPHARM Arzneimittel und Consilium GmbH

Von-Humboldt-Str. 1

D-64646 Heppenheim

Germany

Tel: 010-130 99 50

This medicinal product is authorized under the European Economic Area under the names:

United Kingdom: Fomicyt 40 mg/ml Powder for solution for infusion

Italy: InfectoFos

Poland: InfectoFos, 40 mg/ml, can be used to make infusions.

Ireland: Fomicyt 40 mg/ml Powder for solution for infusion

Netherlands: Fomicyt 40 mg/ml Powder for solution for infusion

Greece: Fomicyt 40 mg / ml Κόνις για διάλυμα προς έγχυση 

Denmark, Finland, Norway,>Phosphomycin Infectopharm

Croatia: Fomicyt 40 mg / ml prescription for infusion

Austria: Fomicyt 40 mg / ml powder for the preparation of an infusion solution

Belgium: Fomicyt 40 mg / ml powder for solution for infusion /
Fomicyt 40 mg / ml Powder for solution for perfusion /

Fomicyt 40 mg/ml powder for the preparation of an infusion solution

Czech Republic: Fomicyt

Hungary: Fomicyt 40 mg/ml for infusion infusion

Romania: Fomicyt 40 mg / ml powder for perfusion solution

Slovakia: Fomicyt

Muhammad Nadeem

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