OLIGOPLUS CONCENTRATED SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

OligoPlus Concentrate for Solution for Infusion

Electrolytes and Oligoelements

1. What is OligoPlus and what is it used for

OligoPlus is a concentrate that is diluted before use in a suitable solution for infusion.

This is a solution to provide oligoelements used during parenteral nutrition (nutrition through a venous catheter) in adult patients.

2. What you need to know before you use OligoPlus

Do not use OligoPlus:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• if you have severe cholestasis (with 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 kidney 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 being administered this medicine 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, you should regularly check the concentration of a specific iron storage protein (serum ferritin levels) in your blood to avoid iron overload.

In patients undergoing medium- and long-term treatment with OligoPlus, zinc and selenium deficiency may develop. Your doctor will adjust your OligoPlus dose accordingly or administer 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 medicine 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"). The use of this medicine is not recommended in adolescents.

Other Medicines and OligoPlus

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are no data or limited data on the use of OligoPlus in pregnant women. OligoPlus should not be administered during pregnancy unless the clinical disorder of the woman requires treatment with this medicine.

Breastfeeding

It is unknown whether the components of OligoPlus are excreted in breast milk. Therefore, your doctor will carefully consider whether this medicine is suitable for you.

Driving and Using Machines

This medicine is usually administered to immobile patients in a controlled environment. This will exclude driving and using machines.

OligoPlus Contains Sodium

This medicine contains less than 23mg of sodium (1mmol) per 10ml dose, i.e., it is essentially "sodium-free".

3. How to Use OligoPlus

Follow exactly the administration instructions of this medicine 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 ampoule of OligoPlus per day, and for moderately higher needs, up to 2 ampoules.

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

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

Use in Children and Adolescents

This medicine 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"). The use of this medicine is not recommended in adolescents.

If You Use More OligoPlus Than You Should

Overdose is very unlikely, as the oligoelements contained in OligoPlus are well below toxic values. However, if an overdose is suspected, administration of OligoPlus should be discontinued. An overdose can be confirmed by appropriate laboratory tests.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency not known (cannot be estimated from the available data)

Anaphylactic reactions (allergic) to iron administered intravenously, with possible fatal outcome.

Iodine can cause allergic reactions.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OligoPlus

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

Do not use this medicine after the expiry date which is stated on the ampoule and on the outer packaging after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the solution is not transparent and colorless and the packaging is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of OligoPlus

The active substances are salts and oligoelements.

The concentrate for solution for infusion contains:

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

Appearance of the Product and Contents of the Pack

OligoPlus is a clear and colorless aqueous solution.

OligoPlus is presented in 10ml glass ampoules.

OligoPlus is available in packs of 5 or 50 glass ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen, Germany

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

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

This medicine is authorised in the Member States of the EEA under the following names:

Names:

Date of Last Revision of this Leaflet:May 2021.

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended only for healthcare professionals:

Monitoring Measures

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

For more information, consult section 4.4 of the Summary of Product Characteristics.

Incompatibilities

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

Do not add to fat emulsions.

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

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

It is not possible to present complete information on incompatibilities in this section. For more information, consult the Marketing Authorisation Holder.

This medicine should not be mixed with other medicines except those mentioned in section 6.6 of the Summary of Product Characteristics.

Method and Duration of Administration

OligoPlus is a concentrate for solution for infusion. It should only be administered intravenously after dilution with at least 250ml of a suitable infusion solution. Suitable transport 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 to other infusion solutions.

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

Compatibility with solutions administered simultaneously through a common entry cannula should be ensured.

OligoPlus should not be used as a diluent for other medicines.

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

Administration can continue throughout the duration of parenteral nutrition.

Notes:

Diarrhea can lead to increased intestinal loss of zinc. In this case, serum concentrations should be checked.

Deficiencies of individual oligoelements should be corrected by specific supplementation.

Shelf Life After Dilution

Chemical and physical stability has been demonstrated for 24 hours at 25°C.

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