Oligoplus concentrate for infusion solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OligoPlus Concentrate for solution for infusion

Electrolytes and trace elements

1. What OligoPlus is and what it is used for

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

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

2. What you need to know before starting to 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 (a disorder affecting copper elimination) or certain types of iron storage disorders (haemosiderosis, haemochromatosis).

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

Warnings and precautions

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

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

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

If you have impaired liver function or receive blood transfusions, serum ferritin levels (a specific protein involved in iron storage) should be monitored regularly in your blood to prevent iron overload.

In patients undergoing medium- to long-term treatment with OligoPlus, deficiency of zinc and selenium may develop. Your doctor will adjust your dose of OligoPlus accordingly or additional supplements will be administered.

Correcting a chromium deficiency leads to improved glucose utilization. This should be taken into account in insulin-dependent diabetic patients. Adjustment of insulin doses may be necessary.

Children and adolescents

This medicine must 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

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

Pregnancy and breastfeeding

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

Pregnancy

There are no data or the data are limited regarding the use of OligoPlus in pregnant women. OligoPlus should not be administered during pregnancy unless the woman's clinical condition 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 appropriate for you.

Driving and use of machines

This medicine is typically administered to immobile patients in a controlled setting. This will preclude driving and operating machinery.

OligoPlus contains sodium

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

3. How to use OligoPlus

Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is:

Your doctor will decide the appropriate dose for you.

For normal requirements, adults should receive 1 ampoule of OligoPlus per day, and for moderately increased requirements, up to 2 ampoules per day.

If requirements are substantially higher (for example, in patients with increased energy needs, such as 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 as appropriate.

Use in children and adolescents

This medicine must not be used in newborns, infants, or 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

An overdose is highly unlikely, as the trace elements contained in OligoPlus are well below levels that could be toxic. However, if an overdose is suspected, administration of OligoPlus should be discontinued. An overdose can be confirmed through appropriate laboratory tests.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Frequency not known (cannot be estimated from available data)

Allergic (anaphylactic) reactions to intravenously administered iron, which may result in fatal outcomes.

Iodine may cause allergic reactions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es

By reporting adverse 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 stated on the ampoule and on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if the solution is not clear and colourless, or if the container shows any damage.

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

6. Contents of the container and other information

Composition of OligoPlus

The active substances are salts and trace elements.

The concentrate for solution for infusion contains:

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

Appearance of the medicinal product and content of the container

OligoPlus is a clear, colourless aqueous solution.

OligoPlus is supplied in 10 ml glass ampoules.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

• 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 EEA Member States under the following names:

Date of the most recent review of this leaflet: May 2021.

Other sources of information

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

This information is intended for healthcare professionals only:

Monitoring measures

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

For further information, please refer to section 4.4 of the Summary of Product Characteristics.

Incompatibilities

The product must not be added to alkaline solutions with a strong 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 trace elements.

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

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

This medicinal product must not be mixed with others 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 must only be administered intravenously after dilution with at least 250 ml of a suitable infusion solution. Suitable carrier solutions include, for example:

• Glucose solutions (5% w/v, 10% w/v, 20% w/v, 40% w/v, 50% w/v glucose)
• Electrolyte solutions (e.g., 0.9% w/v sodium chloride, Ringer's solution)

A compatibility test must be performed before adding to other infusion solutions.

Addition to the diluent solution must be carried out under strict aseptic conditions.

Compatibility must be ensured with solutions administered simultaneously through a common infusion line.

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

The infusion of the ready-to-use mixture must take no less than 6 hours and must be completed within 24 hours.

Administration may continue throughout the duration of parenteral nutrition.

Notes:

Diarrhea may lead to increased intestinal loss of zinc. In such cases, serum concentrations should be checked.

Individual trace element deficiencies should be corrected by specific supplementation.

Stability after dilution

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

From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for in-use storage times and conditions prior to use, which should not exceed 24 hours between 2 and 8°C, unless dilution has taken place under controlled and validated aseptic conditions.