Sterofundin Iso

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Sterofundin ISO solution for infusion

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sterofundin ISO and what is it used for
• 2. Important information before receiving Sterofundin ISO
• 3. How to use Sterofundin ISO
• 4. Possible side effects
• 5. How to store Sterofundin ISO
• 6. Contents of the package and other information

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

Sterofundin ISO is a solution for infusion administered intravenously.
The solution replenishes fluids lost from the circulatory system. It can be used in situations where
the 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

• –too much fluid in the circulatory system;
• –severe heart disease with shortness of breath and swelling of the feet or legs;
• –severe kidney disease and are unable to urinate or have greatly reduced urine output;
• –swelling of body tissues due to fluid accumulation;
• –high levels of potassium or calcium in the blood;
• –or if the patient's blood is too alkaline.

Warnings and precautions

Before starting Sterofundin ISO, the doctor or pharmacist should be consulted.
Particular caution should be exercised when using Sterofundin ISOif the patient has

• –any disease that requires sodium restriction, such as mild or moderate heart failure, tissue swelling, or fluid accumulation in the lungs;
• –sarcoidosis (a chronic disease of the immune system affecting lymph nodes and connective tissue);
• –mildly or moderately elevated blood pressure;
• –acute water deficiency, e.g., after extensive tissue damage in severe burns, or accompanying adrenal disorders;
• –high levels of sodium or chloride in the blood; Page 1
• –pre-eclampsia (a complication that can occur during pregnancy);
• –mild or moderate kidney impairment;
• –respiratory disorders;
• –any disease or medication that may lead to restricted sodium excretion.

If any of the above conditions apply to the patient, the doctor will carefully assess whether the solution is suitable for them.
During Sterofundin ISO administration, the fluid and electrolyte balance and acid-base balance of the blood will be monitored to ensure they are normal.

Sterofundin ISO and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any planned medications.
It is particularly important for the doctor to know about the use of:

• ●medicines that cause sodium and water retention in the body, such as
• –steroid hormones or
• –carbenoxolone. If these medicines are used together with Sterofundin ISO, the water content in the body and sodium levels in the blood may increase, leading to swelling and elevated blood pressure.
• ●medicines that affect potassium levels in the blood, such as
• –suxamethonium;
• –certain diuretics that reduce potassium excretion, e.g., amiloride, spironolactone, triamterene;
• –tacrolimus, cyclosporin (medicines used, e.g., to prevent organ rejection) If they are used together with Sterofundin ISO, potassium levels in the blood may increase, which can have a negative effect on heart function. This situation is more likely in the case of kidney impairment.
• ●digitalis preparations (such as digoxin), which are used to treat heart failure The effect of these medicines will be stronger if calcium levels in the blood increase. They may then cause side effects such as irregular heart rhythm. Therefore, it will be necessary to adjust the digoxin dose.
• ●vitamin D: this may lead to increased calcium levels in the blood.

The doctor is aware of the potential side effects that may occur when Sterofundin ISO is combined with the above-mentioned medicines. They will ensure that the infusion is administered with the correct dose.
Certain medicines should not be mixed with Sterofundin ISO. The doctor will only add other medicines to Sterofundin ISO if they are sure it is safe to do so.

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 using this medicine.
The doctor will decide whether the solution is suitable for the patient during pregnancy.
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The medicine should be used with caution in cases of pre-eclampsia, a complication that can occur during pregnancy.

Driving and using machines

Sterofundin ISO has no effect on the ability to drive or operate machines.

Sterofundin ISO contains sodium

Patients on a sodium-restricted diet should be aware that this medicine contains 145 mmol of sodium per 1000 ml.

3. HOW TO USE STEROFUNDIN ISO

Route of administration

The medicine is administered intravenously using a drip.

Dosage

The doctor will determine the required amount of solution.
In adults, the elderly, and adolescents, this may be 500 milliliters to 3 liters per day.
The daily dose in infants and children may be 20 to 100 milliliters per kilogram of body weight per day.

Rate of administration

The doctor will also determine how quickly the solution will be administered in the infusion, depending on the patient's weight and condition.

Duration of therapy

The doctor will determine how long the patient will receive the solution.
During the infusion, the fluid and electrolyte balance and acid-base balance of the blood will be monitored to ensure they are normal.

Receiving more than the recommended dose of Sterofundin ISO

Since the dosage is checked by the doctor or nurse, it is unlikely that the patient will receive too much solution.
However, if the patient accidentally receives too much solution, or if the solution is administered too quickly, the patient may experience symptoms such as:

• –increased skin tension;
• –blood stasis in the veins and swelling;
• –fluid accumulation in the lungs;
• –shortness of breath;
• –abnormal water and electrolyte content in bodily fluids.

Excessive levels of Sterofundin ISO components in the blood may be associated with specific symptoms that the doctor will look out for.
In the event of an overdose, the infusion will be stopped immediately, and appropriate corrective treatment will be initiated.
If there are any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. POSSIBLE SIDE EFFECTS

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Like all medicines, Sterofundin ISO can cause side effects, although not everybody gets them.
Some side effects may be caused by the method of administration. These may include feverish reactions, infection at the infusion site, local pain or reaction, vein irritation, blood clots in the veins, or spreading vein inflammation.
There have been reports of allergic reactions in the form of a rash caused by the magnesium salts administered in the infusion. The frequency of these reactions cannot be determined from the available data.
Rarely, intestinal paralysis has been reported after magnesium sulfate administration in the infusion. This side effect may occur in up to 1 in 1000 people.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to
the Department of Medicinal Product 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. HOW TO STORE STEROFUNDIN ISO

The medicine should be stored out of sight and reach of children.
Glass bottles and polyethylene bottles: do not store in the refrigerator or freeze.
Polyethylene bags: do not store above 25°C. Do not store in the refrigerator or freeze.
The medicine should not be used if the solution contains solid particles, is cloudy, or discolored. The medicine should not be used if the container is leaking or damaged in any way.
This medicine is for single use only; partially used containers should not be reconnected.
Do not use this medicine after the expiry date stated on the label or carton after: EXP.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Sterofundin ISO contains

The active substances of Sterofundin ISO are:

1000 ml of the medicine contains:
sodium chloride
6.8 g
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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 ingredients are:

water for injections, sodium hydroxide (for pH adjustment)

What Sterofundin ISO looks like and what the package contains

Sterofundin ISO is a solution for infusion (administered intravenously using a drip). It is a clear, colorless solution.
Sterofundin ISO is available in the following types and package sizes:

• polyethylene bottles with a capacity of 250 ml, 500 ml, or 1000 ml, available in packs containing 1 or 10 bottles;
• polyethylene 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 authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Straße 1 Mailing address:34212 Melsungen 34209 Melsungen

Phone: +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 Member States of the European

Economic Area under the following names:

Austria
Sterofundin ISO Infusionslösung
Belgium
Sterofundin ISO oplossing voor infusie
Bulgaria
Sterofundin ISO
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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, solución para perfusión
Romania
Sterofundin ISO soluţie perfuzabilă
Slovenia
Sterofundin ISO raztopina za infundiranje
Slovakia
Ringerfundin
Spain
Isofundin, solución para perfusión
Sweden
Ringerfundin infusionsvästka, lösning
United Kingdom
Sterofundin ISO solution for infusion

Date of the last update of the leaflet: February 2018

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Information intended for healthcare professionals only:
Symptoms associated with overdose of individual solution components

• ●Symptoms of hyperkalemia: paresthesia of the limbs, muscle weakness, paralysis, arrhythmia, asystole, confusion.
• ●Symptoms of hypermagnesemia: loss of tendon reflexes and shortness of breath, nausea, vomiting, flushing of the skin, 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 disorders, excessive thirst, polyuria, kidney calcification, and in severe cases, arrhythmia and coma. Too rapid administration of calcium salts can lead to a chalky taste and flushing.
• ●Symptoms of acetate and malate overdose: metabolic alkalosis, which can lead to changes in mood, fatigue, shortness of breath, muscle weakness, and arrhythmia, and at low calcium levels, also to tremors and cramps.

Administration
The solution should be administered using sterile infusion lines with aseptic technique.
The infusion line should be filled with the solution to prevent air from entering the system.
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If using polyethylene bags, the outer bag should be removed immediately before use.
If administration is by rapid infusion under pressure, all air should be removed from the container and infusion set before infusion. Otherwise, there is a risk of air embolism during infusion.
During administration, fluid balance, serum electrolyte levels, and blood pH should be monitored.
Sterofundin ISO can be administered as long as there are indications for fluid replacement.
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