Label: information for the user

Isofundin solution for infusion

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1. What Isofundin is and how it is used

2. What you need to knowbefore starting to use Isofundin

3. How to use Isofundin

4. Possible adverse effects

5. Storage of Isofundin

6. Contents of the package andadditional information

Isofundin is an intravenous perfusion solution.

This solution is used for the substitution of fluid losses from the circulation. It can be used in conditions where your blood may become or has become slightly acidic.

No use Isofundin

If you have:

?too much fluid in your circulation,

?severe heart disease with difficulty breathing and swelling in your feet and legs,

?severe kidney disease with inability or difficulty to urinate,

?swelling of body tissues due to a buildup of fluids,

?high levels of potassium or calcium in your blood,

?or if your blood is too alkaline.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Isofundin.

Be especially careful with Isofundin if you have:

?any disease in which a reduced salt intake is needed, such as mild or moderate heart failure, swelling of tissues, or fluid accumulation in the lungs,

?sarcoidosis (a chronic disorder of the immune system that affects lymph nodes and connective tissue),

?mild or moderate increase in blood pressure,

?acute dehydration, for example, after massive destruction of tissues due to severe burns, or due to an alteration in the function of the adrenal glands,

?high levels of sodium and chloride in your blood,

?eclampsia (a complication that can occur during pregnancy),

?mild or moderate alteration of your renal function,

?respiratory problems,

?any disease or medication that may reduce the excretion of sodium,

If any of the warnings mentioned above apply to you, your doctor will carefully decide if the solution is suitable for you.

Your doctor will monitor your fluid levels and the concentration of salts in your blood while you are receiving Isofundin to ensure they are normal.

Use of Isofundin with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

It is particularly important for your doctor to know if you are taking, using, or receiving:

?Medications associated with sodium and water retention, such as:

-steroid hormones, or

-carbenoxolone.

If these medications are used with Isofundin, your fluid levels and sodium levels in your blood may increase, causing edema and an increase in blood pressure.

?Medications associated with potassium levels in the blood, such as

-suxamethonium

-some diuretics (tablets that help eliminate water) that reduce your excretion of potassium, for example, amiloride, spironolactone, triamterene

-tacrolimus, cyclosporine (medications used, for example, to prevent rejection of transplanted organs).

If these medications are used with Isofundin, your potassium levels in the blood may increase, which can cause adverse effects on your cardiac function. This is more likely to occur if you have kidney insufficiency.

?Digitalis glycoside preparations(e.g., digoxin), which are used to treat heart weakness.

Their effects are potentiated by an increase in calcium levels in the blood and may cause adverse effects such as irregular heartbeat. Therefore, your doctor will need to adjust your dose of digoxin.

?Vitamin D; which can produce an increase in calcium levels in the blood.

Your doctor will be aware of the adverse effects that may occur after the combination of Isofundin and the medications mentioned above. They will also control that the infusion you receive is correctly dosed.

Some medications do not mix with Isofundin. Doctors will only administer medications with Isofundin if they are sure the mixture is safe.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Your doctor will decide if this solution is suitable for you when you are pregnant.

This medication will be used with caution in toxemia of pregnancy, a special complication that can occur during pregnancy.

Driving and operating machinery

The influence of Isofundin on the ability to drive and operate machinery is zero.

Isofundin contains sodium

If you are following a low-sodium diet, note that this medication contains 145mmol of sodium per 1000ml.

Route of administration

This medication will be administered intravenously by infusion.

Dose

Your doctor will determine the amount of solution you need.

In adults, elderly patients, and adolescents, this may be 500 milliliters to 3 liters per day. The daily dose in infants and children may range from 20 to 100 milliliters per kilogram of body weight per day.

Infusion rate

Your doctor will determine the infusion rate of the solution, depending on your body weight and condition.

Treatment duration

Your doctor will determine for how long you should receive this solution.

While receiving the infusion, your fluid and electrolyte levels and blood acid-base balance should be monitored.

If you receive more Isofundin than you should

Since the dose you receive will be controlled by your doctor or nurse, it is unlikely that you will receive an excess of this solution.

However, if you accidentally receive more solution than you should or the solution flows too quickly, you may experience symptoms such as:

- increased skin tension,

- venous congestion or swelling,

- fluid accumulation in the lungs,

- shortness of breath,

- abnormalities in the composition of water and electrolytes in bodily fluids

Excessively high levels of any of the individual components of Isofundin may be associated with specific symptoms to which your doctor should pay attention.

In case of overdose, the infusion should be stopped immediately and appropriate corrective treatment initiated.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Some adverse effects may be due to the administration technique. These may include feverish states, infections at the injection site, local reaction or pain, venous irritation, blood clots in veins, or inflammation of veins extending from the injection site.

Occasional allergic reactions characterized by urticaria have been described after the perfusion of magnesium salts.

The frequency of these reactions cannot be estimated from the available data.

In rare cases, intestinal paralysis has been described after the perfusion of magnesium sulfate. This may affect up to 1 in 1000 people.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Glass bottles and polyethylene plastic bottles: Do not refrigerate or freeze.
Plastic bags: Do not store at a temperature above 25°C. Do not refrigerate or freeze.

Do not use this medication if the solution contains particles, is cloudy or discolored. Do not use this product if the container shows signs of loss or other signs of deterioration. This product is for single use only, partially used containers should not be reconnected.

Do not use this medication after the expiration date appearing on the label or box after CAD.

Composition of Isofundin

The active principles of Isofundin infusion solution are:

Per 1000 ml, this medication contains:

Sodium chloride6.8 g

Potassium chloride0.3 g

Magnesium chloride hexahydrate0.2 g

Calcium chloride dihydrate0.37 g

Sodium acetate trihydrate3.27 g

Maleic acid0.67 g

The other components are: Water for injection preparations, sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the package

Isofundin is an infusion solution (for administration via a vein with a drip). It is a transparent and colorless solution.

It is presented in:

-Plastic bottles containing 250 ml, 500 ml or 1000 ml and available in packs of 1 or 10 bottles

-Plastic bags containing 250 ml, 500 ml or 1000 ml and available in packs of 1 or 20 bags (250 ml and 500 ml) or of 1 or 10 bags (1000 ml)

-Glass bottles containing 250 ml, 500 ml or 1000 ml and available in packs of 1 or 10 bottles (250ml and 500ml) or of 1 or 6bottles (1000ml).

Marketing Authorization Holder

B|BRAUN

B. Braun Melsungen AG

Carl-Braun Strasse, 1Postal address:

34212 Melsungen34209 Melsungen

Germany

Phone: + 49-5661-71-0

Fax: +49-5661-71-4567

Responsible for manufacturing

B.Braun Melsungen AG

Carl-Braun Strasse, 1

34212 Melsungen

Germany

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

B. Braun Avitum AG

Schwarzenberger Weg 73-79

34212 Melsungen

Germany

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

Last review date of this prospectus: February 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

---------------------------------------------------------------------------------------------------------------This information is intended solely for healthcare professionals:

Associated symptoms with excessive overdose of individual components of the solution:

-Symptoms of hyperkalemia:

Paraesthesia in the limbs, muscle weakness, paralysis, cardiac arrhythmia, asystole, and mental confusion.

-Symptoms of hypermagnesemia:

Loss of tendon reflexes and respiratory depression, nausea, vomiting, skin flushing, thirst, decreased blood pressure, drowsiness, confusion, muscle weakness, bradycardia, coma, and cardiac arrest.

-Symptoms of hyperchloremia:

Loss of bicarbonate and acidosis.

-Symptoms of hypercalcemia:

Anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disorders, polydipsia, polyuria, nephrocalcinosis, and, in severe cases, cardiac arrhythmias and coma. Rapid intravenous injection of calcium salts can cause a metallic taste and hot flashes.

-Symptoms of excessive overdose of acetate and malate:

Metabolic alkalosis, which can cause mood changes, fatigue, shortness of breath, muscle weakness, and cardiac arrhythmia, and, in the presence of low calcium levels, also spasms and cramps.

Handling

The solution should be administered with a sterile equipment using an aseptic technique. The equipment should be prepared with the solution to prevent air entry into the system.

If plastic bags are used, only the outer bag should be removed immediately before use.

If rapid infusion under pressure is performed, all air should be removed from the plastic container and the infusion equipment before infusion, as otherwise there is a risk of producing gas embolism during infusion.

During administration, the fluid balance, plasma electrolyte concentrations, and pH should be monitored. Isofundin can be administered as long as the indication for fluid substitution is maintained.