Sterofundin

'
Sterofundin infusion solution
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Sterofundin is and what it is used for
2. What you need to know before being given Sterofundin
3. How to use Sterofundin
4. Possible side effects
5. How to store Sterofundin
6. Contents of the pack and other information

1. What Sterofundin is and what it is used for

Sterofundin is an infusion solution for intravenous administration.
This solution replenishes fluids lost from the circulatory system. It can be used in conditions where the blood may become or has become slightly acidic.

2. What you need to know before you are given Sterofundin

Sterofundin will not be administered to you if:

• you have excess fluid in the circulatory system,
• you have severe heart disease with shortness of breath and swelling of feet or legs,
• you suffer from severe kidney disease and urine output is low or absent,
• you have swelling of body tissues due to fluid accumulation,
• you have high levels of potassium or calcium in the blood,
• or your blood is too alkaline.

Warnings and precautions
Talk to your doctor or pharmacist before using Sterofundin.
Exercise particular caution with Sterofundin infusion solution if you have:

• conditions requiring restriction of salt intake, such as mildly or moderately impaired heart function, tissue swelling, or fluid accumulation in the lungs;
• sarcoidosis (a chronic immune system disease affecting lymph nodes and connective tissue);
• mildly or moderately elevated blood pressure;
• acute water deficit, e.g. following extensive tissue destruction such as in severe burns or due to impaired adrenal gland function;
• high levels of sodium or chloride in the blood;
• eclampsia (a complication occurring during pregnancy);
• mild or moderate impairment of kidney function;
• respiratory problems;
• any illness or are taking medications that may cause reduced sodium excretion.

If any of the above conditions apply to you, your doctor will carefully decide whether this solution is suitable for you.
During treatment with Sterofundin, your body fluid levels and blood electrolyte concentrations must be monitored to ensure they remain within normal ranges.

Other medicines and Sterofundin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, it is important that your doctor knows if you are taking, using, or receiving:

• Medicines causing the body to retain sodium and water, such as
• steroid hormones or
• carbenoxolone. If these are taken together with Sterofundin, there may be an increase in body water and sodium levels in the blood, leading to swelling and elevated blood pressure.
• Medicines affecting blood potassium levels, such as
• suxamethonium,
• certain diuretics ("water pills") that reduce potassium excretion, e.g. amiloride, spironolactone, triamterene,
• tacrolimus, cyclosporine (medicines used, for example, to prevent rejection of transplanted organs). If used together with Sterofundin, these may cause an increase in blood potassium levels, potentially leading to adverse effects on heart function. This risk is higher if you have impaired kidney function.
• Preparations containing digitalis (i.e. digoxin), used to treat heart weakness. The effect of these medicines becomes stronger when blood calcium levels rise, possibly causing side effects such as irregular heartbeat. Therefore, your doctor may need to adjust the digoxin dose.
• Vitamin D; this may increase blood calcium levels.

Your doctor is aware of the potential adverse effects that may occur when Sterofundin is combined with the above-mentioned medicines and will ensure you receive the infusion at an appropriate dosage.
Some medicines must not be mixed with Sterofundin. Doctors add medications to Sterofundin only if they are certain that such combination is safe.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before receiving this medicine.
Your doctor will decide whether this solution is suitable for you during pregnancy.
This medicine should be used with caution in so-called pregnancy toxemia, a specific complication that may occur during gestation.

Driving and operating machinery
Sterofundin does not affect the ability to drive or operate machinery.

Sterofundin contains sodium
If you are on a low-sodium diet, please note that this medicine contains 145 mmol of sodium per 1000 mL.

3. How to use Sterofundin

Route of administration
This medicine is administered intravenously by intravenous infusion.
Dosage
Your doctor will determine the amount of solution required.
In adults, elderly patients, and adolescents, the dose may range from 500 milliliters to 3 liters per day. The daily dose for neonates and children should be between 20–100 milliliters per kilogram of body weight per day.
Rate of administration
Your doctor will determine the infusion rate of the solution based on your body weight and clinical condition.
Duration of treatment
Your doctor will determine how long the solution should be administered.
During the infusion, levels of fluids and electrolytes as well as acid-base balance in the blood will be monitored.
If you are given more Sterofundin than you should
Since the dose is controlled by a doctor or nurse, it is unlikely that you will receive an excessive amount of the solution.
However, if you accidentally receive too much solution or if the infusion rate used is too high, you may experience symptoms such as:

• increased skin tension
• venous congestion and swelling
• fluid accumulation in the lungs
• shortness of breath
• abnormalities in the water and electrolyte composition of body fluids.

Excessively high blood levels of any individual component of Sterofundin may be associated with specific symptoms that your doctor must monitor.
In case of overdose, the infusion must be stopped immediately and appropriate corrective therapy should be initiated.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects may be related to the administration technique. These include feverish reactions, infection at the injection site, pain or local reaction, venous irritation, blood clots in the veins, or venous inflammation extending from the injection site.
Allergic reactions to infused magnesium salts have been reported occasionally, presenting also as skin rash. The frequency of these reactions cannot be determined from the available data.
Rarely, intestinal paralysis has been reported following magnesium sulfate infusion. This may occur in up to 1 in 1,000 people.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sterofundin

Keep this medicine out of the sight and reach of children.
Glass and polyethylene plastic bottles: do not refrigerate or freeze.
Plastic bag: do not store at temperatures above 25 °C. Do not refrigerate or freeze.
This medicine must not be used if the solution contains particles, is cloudy, or has changed colour.
The product must not be used if the container is leaking or damaged. Single-use product. Partially used
containers must not be reconnected.
Do not use this medicine after the expiry date stated on the label or packaging following
EXP.

6. Package contents and other information

What Sterofundin contains

• The active substances in Sterofundin infusion solution are:

Each 1000 mL of medicinal product contains:
Sodium chloride 6.8 g
Potassium chloride 0.3 g
Magnesium chloride hexahydrate 0.2 g
Calcium chloride dihydrate 0.37 g
Sodium acetate trihydrate 3.27 g
Malic acid 0.67 g

• Other components are:

Water for injections, sodium hydroxide (for pH adjustment)

Description of the appearance of Sterofundin and package contents
Sterofundin is an infusion solution (to be administered by intravenous infusion). It is a clear, colourless solution.
It is available in:

• Plastic bottles of 250 mL, 500 mL or 1000 mL, available in packs of 1 or 10 bottles
• Plastic bags of 250 mL, 500 mL or 1000 mL, available in packs of 1 or 20 bags (250 mL and 500 mL) or 1 or 10 bags (1000 mL)
• Glass bottles of 250 mL, 500 mL or 1000 mL, available in packs of 1 or 10 bottles (250 mL and 500 mL) or 1 or 6 bottles (1000 mL)

Marketing Authorization Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1 Postal address:
34212 Melsungen 34209 Melsungen
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

Manufacturers
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen, Germany
B. Braun Medical S. A.
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria Sterofundin ISO Infusionslösung
Belgium Sterofundin ISO oplossing voor infusie
Bulgaria Sterofundin ISO
Cyprus Sterofundin ISO
Czech Republic Ringerfundin B.Braun
Denmark Ringerfundin
Estonia Sterofundin ISO
Finland Ringerfundin infuusioneste, liuos
France Isofundine, solution pour perfusion
Germany Sterofundin ISO Infusionslösung
Greece Sterofundin ISO
Hungary Ringerfundin B. Braun infúzio
Italy Sterofundin
Latvia Sterofundin ISO
Lithuania Sterofundin ISO infuzinis tirpalas
Luxembourg Sterofundin Iso solution pour perfusion
Malta Sterofundin ISO
Netherlands Sterofundin ISO
Norway Ringerfundin infusjonsvaeske
Poland Sterofundin ISO
Portugal Isofundin, solução para perfusão
Romania Sterofundin ISO soluţie perfuzabilă
Slovenia Sterofundin ISO raztopina za infundiranje
Slovakia Ringerfundin
Spain Isofundin, solución para perfusión
Sweden Ringerfundin infusionsvätska, lösning
United Kingdom Sterofundin ISO solution for infusion

The following information is intended exclusively for physicians or healthcare professionals:
Symptoms associated with excessive overdose of individual components of the solution.

• Symptoms of hyperkalemia: paresthesia in limbs, muscle weakness, paralysis, cardiac arrhythmia, asystole, mental confusion.
• Symptoms of hypermagnesemia: loss of tendon reflexes and dyspnea, nausea, vomiting, skin flushing, thirst, decreased blood pressure, drowsiness, confusion, muscle weakness, bradycardia, coma, cardiac arrest.
• Symptoms of hyperchloremia: loss of bicarbonate, acidosis.
• Symptoms of hypercalcemia: anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, nephrocalcinosis and, in severe cases, cardiac arrhythmia and coma. Rapid injection of calcium salts may cause a chalky taste and hot flushes.
• Symptoms of excessive overdose of acetate and malate: metabolic alkalosis, which may cause mood changes, fatigue, dyspnea, muscle weakness and cardiac arrhythmia and, in the presence of elevated calcium levels, also muscle spasms and cramps.

Handling
The solution must be administered using sterile equipment and aseptic technique. The equipment should be filled with the solution to prevent introduction of air into the system.
If plastic bags are used, the outer wrapper must be removed immediately before use.
If administration is performed by rapid infusion under pressure, all air must be removed from the plastic container and infusion set prior to infusion, otherwise there is a risk of gas embolism during infusion.
Fluid balance, plasma electrolyte concentrations and pH must be monitored during administration.
Sterofundin may be administered as long as there is an indication for fluid replacement.