PACKAGE LEAFLET: INFORMATION FOR THE USER

Sterofundin ISO infusion solution
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Sterofundin ISO is and what it is used for
Important information before receiving Sterofundin ISO
How to use Sterofundin ISO
Possible side effects
How to store Sterofundin ISO
Contents of the pack and other information

1. WHAT STEROFUNDIN ISO IS AND WHAT IT IS USED FOR

Sterofundin ISO is an infusion solution administered intravenously.
This solution replenishes fluids lost from the circulatory system. It may be used in situations where
blood pH may become or has become slightly acidic.

2. IMPORTANT INFORMATION BEFORE RECEIVING STEROFUNDIN ISO

The patient will not receive Sterofundin ISO
if they have

excess fluid in the circulatory system;
severe heart disease with breathlessness and swelling of the feet or legs;
severe kidney disease and are unable to pass urine at all or almost at all;
tissue swelling due to accumulation of fluids;
high levels of potassium or calcium in the blood;
or if the patient's blood is too alkaline.

Warnings and precautions
Before starting treatment with Sterofundin ISO, discuss this with the doctor or pharmacist.
Special caution should be exercised when administering Sterofundin ISO if the patient has

any condition requiring restriction of salt intake, such as mild or moderate heart impairment, tissue swelling, or fluid accumulation in the lungs;
sarcoidosis (a chronic immune system disorder affecting lymph nodes and connective tissue);
mildly or moderately elevated blood pressure;
acute water deficiency, e.g., following extensive tissue damage due to severe burns, or associated with adrenal gland dysfunction;
high levels of sodium or chloride in the blood; Page 1
pre-eclampsia (a complication occurring during pregnancy);
mild or moderate kidney dysfunction;
respiratory disorders;
any disease or medication the patient is taking that may lead to restricted sodium excretion.

If any of the above conditions apply to the patient, the doctor will carefully assess
whether this solution is appropriate.
During administration of Sterofundin ISO, monitoring of fluid levels in the body and electrolyte concentrations in the blood will be performed to ensure they remain within normal limits.
Sterofundin ISO and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
It is particularly important that the doctor knows about the use, application, or administration of:

medications causing sodium and water retention in the body, such as
- steroid hormones or
- carbenoxolone. If these drugs are used together with Sterofundin ISO, body fluid volume and blood sodium levels may increase, leading to edema and elevated blood pressure.
drugs affecting potassium levels in the blood, such as
- suxamethonium;
- certain diuretics that reduce potassium excretion, e.g., amiloride, spironolactone, triamterene;
- tacrolimus, cyclosporine (medications used, for example, to prevent rejection of transplanted organs). If used together with Sterofundin ISO, blood potassium levels may rise, which could adversely affect heart function. This situation is more likely in patients with impaired kidney function.
digitalis preparations (e.g., digoxin), used in the treatment of heart failure. The effect of these drugs increases if blood calcium levels rise. This may lead to adverse effects such as irregular heartbeat. Therefore, adjustment of digoxin dosage by the doctor will be necessary.
vitamin D supplements: this may lead to increased blood calcium levels.

The doctor is aware of potential adverse effects that may occur when Sterofundin ISO is combined with the above-mentioned drugs. Care will be taken to ensure the infusion is administered at the correct dose.
Some medications must not be mixed with Sterofundin ISO. The doctor will add other medications to Sterofundin ISO only if certain that such combination is safe.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The doctor will decide whether this solution is suitable for the patient during pregnancy.
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This medicine should be used with caution in cases of so-called pregnancy toxemia, a certain complication that may occur during pregnancy.
Driving and operating machinery
Sterofundin ISO has no effect on the ability to drive or operate machinery.
Sterofundin ISO contains sodium
Patients who monitor sodium intake in their diet should be aware that this medicine contains 145 mmol of sodium per 1000 ml.

3. HOW TO USE STEROFUNDIN ISO

Route of administration
This medicinal product is administered intravenously by infusion.
Dosage
The required amount of solution will be determined by the physician.
In adults, elderly patients, and adolescents, the dosage may range from 500 millilitres to 3 litres per day.
The daily dose in infants and children may be 20 to 100 millilitres per kilogram of body weight.
Rate of administration
The physician will also determine the rate at which the solution is infused, depending on the patient's body weight and clinical condition.
Duration of therapy
The physician will determine how long the patient will receive this solution.
During the infusion, fluid and electrolyte levels as well as the acid-base balance in the blood will be monitored.
Accidental overdose of STEROFUNDIN ISO
Since the dosage is controlled by a physician or nurse, it is unlikely that the patient will receive too much solution.
However, if the patient accidentally receives an excessive amount of solution, or if the solution is infused too rapidly, the following symptoms may occur:

increased skin tension;
venous congestion and edema;
fluid accumulation in the lungs;
shortness of breath;
disturbances in body fluid water and electrolyte content.

Excessive blood levels of the components of Sterofundin ISO may lead to specific symptoms which the physician will monitor for.
In case of overdose, the infusion will be immediately discontinued and appropriate corrective treatment will be initiated.
If you have any further questions regarding the use of this medicinal product, consult your physician or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Some adverse reactions may be caused by the method of administration. These may include febrile reactions, infection at the injection site, local pain or reaction, vein irritation, blood clots in veins, or thrombophlebitis spreading from the injection site.
Allergic reactions in the form of skin rash have been reported following infusion of magnesium salts. The frequency of these reactions cannot be determined from the available data.
Intestinal paralysis has been reported rarely after intravenous administration of magnesium sulfate. This adverse reaction may occur in up to 1 in 1,000 individuals.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE STEROFUNDIN ISO

Keep the medicine out of the sight and reach of children.
Glass bottles and polyethylene bottles: do not store in the refrigerator or freeze.
Plastic bags: do not store at temperatures above 25°C. Do not store in the refrigerator or freeze.
Do not use the medicine if solid particles are present in the solution, if the solution is cloudy or discolored.
Do not use the medicine if the container is leaking or otherwise damaged.
This medicine is for single use only; partially emptied containers must not be reconnected.
Do not use this medicine after the expiry date stated on the label or carton following: EXP.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Sterofundin ISO contains

The active substances in Sterofundin ISO are: 1000 ml of the solution 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)

What Sterofundin ISO looks like and contents of the package
Sterofundin ISO is an infusion solution (administered intravenously via an infusion drip). It is a clear, colourless solution.
Sterofundin ISO is available in the following pack types and sizes:

plastic bottles with a capacity of 250 ml, 500 ml or 1000 ml, available in packs containing 1 or 10 bottles;
plastic bags with a capacity of 250 ml, 500 ml or 1000 ml, available in packs containing 1 or 20 bags (250 ml and 500 ml), or containing 1 or 10 bags (1000 ml);
glass bottles with a capacity of 250 ml, 500 ml or 1000 ml, available in packs containing 1 or 10 bottles (250 ml and 500 ml), or containing 1 or 6 bottles (1000 ml);

Marketing Authorisation Holder and Manufacturer
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 authorised for marketing in the European Economic Area 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

Information intended exclusively for medical professionals:

Symptoms associated with overdose of individual solution components

Symptoms of hyperkalemia: paresthesia of extremities, muscle weakness, paralysis, arrhythmia, asystole, confusion.
Symptoms of hypermagnesemia: loss of tendon reflexes and dyspnea, nausea, vomiting, skin flushing, thirst, hypotension, drowsiness, confusion, muscle weakness, bradycardia, coma, cardiac arrest.
Symptoms of hyperchloremia: loss of bicarbonates, acidosis.
Symptoms of hypercalcemia: anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, psychiatric disturbances, excessive thirst, polyuria, nephrocalcinosis, and in severe cases, arrhythmia and coma. Too rapid injection of calcium salts may cause a chalky taste and hot flushes.
Symptoms of overdose of acetate and malate: metabolic alkalosis, which may lead to mood changes, fatigue, dyspnea, muscle weakness and arrhythmia, as well as tremors and cramps in case of low calcium levels.

Administration
The solution should be administered using sterile infusion sets with aseptic technique.
The infusion line must be primed with the solution to prevent air from entering the circulatory system.
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When using bags made of plastic material, the outer protective bag should be removed immediately before use.
If administration is carried out by rapid infusion under pressure, all air must be removed from both the plastic container and the infusion set prior to infusion. Otherwise, there is a risk of air embolism during infusion.
During administration, fluid balance, serum electrolyte concentrations, and pH should be monitored.
The medicinal product Sterofundin ISO may be administered as long as there are indications for fluid replacement.
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