Leaflet: information for the user

OligoPlus Concentrate for perfusion solution

Electrolytes and oligoelements

OligoPlus is a concentrate that is diluted before use in an appropriate solution for perfusion.

It is a solution for providing oligoelements used during parenteral nutrition (nutrition through a venous catheter) in adult patients.

Do not use OligoPlus:

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have pronounced cholestasis (reduced bile flow and abnormal liver function tests).
• If you have Wilson's disease (alteration in copper elimination) or certain types of iron storage disorders (hemosiderosis, hemochromatosis).

OligoPlus should not be administered to newborns, infants, and children.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use OligoPlus.

• If you have altered liver function, which may affect the excretion of manganese, copper, and zinc. Your dose may need to be reduced.
• If you have altered renal function, since the excretion of selenium, fluorine, chromium, molybdenum, and zinc may be significantly decreased.
• If you have increased thyroid activity.
• If you are hypersensitive to iodine.

Several tests may be performed while you are receiving this medication to ensure that none of the elements contained in OligoPlus accumulate excessively in the body.

If you have altered liver function or receive blood transfusions, your doctor will regularly monitor your blood for a specific protein involved in iron storage (serum ferritin levels) to prevent iron overload.

In patients undergoing long-term treatment with OligoPlus, zinc and selenium deficiency may develop. Your doctor will adjust your OligoPlus dose as needed or provide additional supplements.

Correcting chromium deficiency leads to improved glucose utilization. This should be taken into account in patients with insulin-dependent diabetes. It may be necessary to adjust insulin doses.

Children and adolescents

This medication should not be used in newborns, infants, and children, as its composition is not suitable for this age group (see "Do not use OligoPlus"). It is not recommended for use in adolescents.

Other medications and OligoPlus

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

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

Pregnancy

There are no data or these are limited regarding the use of OligoPlus in pregnant women. OligoPlus should not be administered during pregnancy, unless the woman's clinical disorder requires treatment with this medication.

Breastfeeding

The components of OligoPlus are unknown to be excreted in breast milk. Therefore, your doctor will carefully weigh whether this medication is appropriate for you.

Driving and operating machinery

This medication is usually administered to immobile patients in a controlled environment, excluding driving and operating machinery.

OligoPlus contains sodium

This medication contains less than 23mg of sodium (1 mmol) per 10ml dose, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is:

Your doctor will decide on the suitable dose for you.

For normal needs, adults will receive 1 vial of OligoPlus per day, and for moderately greater needs, up to 2 vials.

If the need is much greater (such as in patients with higher energy needs, for example, after severe injuries, burns, or major surgery), larger doses may also be needed.

If you have liver or kidney disease, your dose may be reduced in the cases that apply.

Use in children and adolescents

This medication should not be used in newborns, infants, and children, as its composition is not suitable for this age group (see section "Do not use OligoPlus"). It is not recommended to use this medication in adolescents.

If you use more OligoPlus than you should

A overdose is very unlikely, since the oligoelements contained in OligoPlus are far below the toxic values. However, if a overdose is suspected, discontinue the administration of OligoPlus. A overdose can be confirmed by suitable laboratory tests.

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

Unknown frequency (cannot be estimated from available data)

Anaphylactic reactions to intravenously administered iron, with a possible fatal outcome.

Iodine may cause allergic reactions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use.Website: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.

Do not use this medication after the expiration date that appears on the vial and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Do not use this medication if you observethat the solution is not transparent and colorless and the packaging shows damage.

Medications should not be thrown into the drains, nor into the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help to protect the environment.

Composition of OligoPlus

The active principles are salts and oligoelements.

The concentrate for perfusion solution contains:

The other components are hydrochloric acid (for pH adjustment) and water for injection.

Appearance of the product and contents of the container

OligoPlus is a transparent and colorless aqueous solution.

OligoPlus is presented in glass vials of 10 ml.

OligoPlus is available in containers with 5 or 50 glass vials.

Not all container sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen, Germany

Phone: +49 - (0)-5661-71-0

Fax: +49 - (0)-5661-71-4567

This medicinal product is authorized in the Member States of the EEA with the following

names:

Last update of this leaflet:May 2021.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

This information is intended solely for healthcare professionals:

Monitoring measures

During treatment with OligoPlus, regular monitoring of the levels of the oligoelements included in this medicinal product, as well as other parameters, is recommended.

For more information, see section 4.4 of the SmPC.

Incompatibilities

The product should not be added to alkaline solutions with a marked buffering capacity, such as sodium bicarbonate solutions.

Do not add to fatty emulsions.

The degradation of vitamin C in perfusion solutions is accelerated in the presence of oligoelements.

OligoPlus should not be added directly to inorganic phosphate solutions (additives).

It is not possible to present complete information on incompatibilities in this section. For more information, consult the marketing authorization holder.

This medicinal product should not be mixed with other products except those mentioned in section 6.6 of the SmPC.

Form and duration of administration

OligoPlus is a concentrate for perfusion solution. It should only be administered intravenously after dilution with at least 250 ml of a suitable perfusion solution. Suitable perfusion solutions include, for example:

- glucose solutions (glucose 5% p/v, 10% p/v, 20% p/v, 40% p/v, 50% p/v)

- electrolyte solutions (e.g., sodium chloride 0.9% p/v, Ringer's solution)

A compatibility test should be performed before adding it to other perfusion solutions.

The addition to the diluent should be carried out under strict aseptic conditions.

Ensure compatibility with solutions administered simultaneously through a common entry cannula.

OligoPlus should not be used as a diluent for other medicinal products.

The perfusion of the ready-to-use mixture should not be less than 6 hours and should be completed within 24 hours.

Administration may continue throughout the duration of parenteral nutrition.

Notes:

Diarhea may lead to an increase in intestinal zinc loss. In this case, serum concentrations should be checked.

Individual oligoelement deficiencies should be corrected by specific supplementation.

Period of validity after dilution

Chemical and physical stability has been demonstrated in use for 24 hours at 25orC.

From a microbiological point of view, the product should be used immediately. If not used immediately, the times and conditions of storage in use before use are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless the dilution had taken place in controlled and validated aseptic conditions.