INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Infutraze concentrated solution for infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If your child experiences any side effects, talk to your doctor or nurse, even if you think they might be unrelated to this medicine. See section 4.

Contents of the Package Leaflet

1. What is Infutraze and what is it used for
2. What you need to know before you use Infutraze
3. How to use Infutraze
4. Possible side effects
5. Storage of Infutraze
6. Contents of the pack and other information

1. What is Infutraze and what is it used for

Infutraze is a mixture of trace elements administered into the blood by drip (intravenous perfusion). Infutraze contains five trace elements (zinc, copper, manganese, selenium, and iodine) in very small amounts that are normally absorbed from food. These trace elements are necessary for the normal functioning of the body.

Infutraze is used to cover the basic needs of trace elements in premature and full-term newborns, infants, children, and adolescents who cannot eat or absorb enough food through tube feeding and therefore need intravenous nutrition (so-called parenteral nutrition). Infutraze is added to parenteral nutrition containing all the nutrients the body needs.

2. What you need to know before you use Infutraze

Do not use Infutraze if your child:

• is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• has Wilson's disease.

Warnings and precautions

Talk to your doctor before starting Infutraze if your child has:

• kidney problems
• liver problems
• reduced bile excretion
• thyroid problems (hyperthyroidism)

During treatment, your doctor will periodically check the levels of trace elements in the blood. Your doctor will adjust the dose of Infutraze accordingly.

Children and adolescents

Infutraze is indicated for premature and full-term newborns, infants, children, and adolescents.

Other medicines and Infutraze

Tell your doctor if your child is taking, has recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, talk to your doctor before using Infutraze.

Infutraze contains sodium and potassium

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml ampoule; this is essentially 'sodium-free'.

This medicine contains less than 39 mg (1 mmol) of potassium per 10 ml ampoule, which is considered essentially 'potassium-free'.

3. How to use Infutraze

Infutraze will be administered to your child in the form of intravenous perfusion (into the blood through a drip) by a healthcare professional. Infutraze will always be diluted in another parenteral nutrition solution.

Your doctor will decide on the individual dose for your child based on body weight and activity.

A daily infusion of iron is recommended when parenteral nutrition is administered for more than 3 weeks, and a perfusion of molybdenum should also be administered when parenteral nutrition is administered for more than 4 weeks.

If too much Infutraze is administered

It is unlikely that your child will receive too much Infutraze, as the perfusion will be controlled by a healthcare professional. If you think your child has received too much Infutraze, talk to your doctor.

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

4. Possible side effects

No side effects have been reported.

Reporting of side effects

If your child experiences any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Infutraze

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

Do not store above 25°C. Do not freeze.

Do not use this medicine if you notice visible signs of deterioration.

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

Shelf-life after mixing

Stability after mixing has been demonstrated for a maximum of 7 days at 2-8°C followed by 48 hours at 20°C-25°C, including the duration of administration. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.

6. Contents of the pack and other information

Composition of Infutraze

The other ingredients are

Hydrochloric acid (for pH adjustment)

Water for injections

Appearance of Infutraze and pack contents

Infutraze, concentrated solution for infusion, is a clear and almost colorless solution. It is presented in 10 ml transparent ampoules made of polypropylene.

Package sizes:

20 x 10 ml in a cardboard box

Marketing authorisation holder and manufacturer

Manufacturer:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

Marketing authorisation holder:

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:October 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Special warnings and precautions for use

Infutraze should be used with caution in patients with renal dysfunction, in whom the excretion of selenium, zinc, and iodine may be significantly decreased. There is a higher risk of accumulation of trace elements in these patients.

Infutraze should be used with caution in patients with hepatic dysfunction (especially cholestasis) in whom the excretion of copper and manganese may be decreased.

In patients with altered bile excretion, the elimination of manganese, copper, and zinc may be reduced. Clinical signs of accumulation of trace elements may require a reduction in the dose or discontinuation of Infutraze in these patients.

Dose adjustment may be necessary in patients with renal dysfunction and hepatic dysfunction or mild cholestasis.

Infutraze should be used with caution in patients with hyperthyroidism. In these patients, iodine may increase the symptoms of hyperthyroidism (e.g., goiter).

No dose adjustment of Infutraze is necessary in case of additional iodine intake through iodized antiseptics.

Long-term parenteral nutrition

In patients receiving long-term parenteral nutrition, accumulation of trace elements may occur, especially manganese. If treatment is prolonged for more than 4 weeks, manganese levels should be monitored. The appearance of neurological signs (e.g., anxiety, rapid eye movements) may indicate possible manganese overload, which may also be derived from certain medical conditions and parenteral nutrition. Manganese accumulation may require a reduction in the dose or discontinuation of Infutraze.

In patients receiving long-term parenteral nutrition, a deficiency of trace elements may occur, especially copper, zinc, and selenium. In case of deficiency, these individual trace elements should be supplied separately.

Posology

Preterm neonates:

A maximum recommended daily dose of 1.0 ml of Infutraze per kg of body weight covers the basic needs of the included trace elements.

Full-term neonates, infants, and children weighing less than 20 kg:

A maximum recommended daily dose of 0.5 ml of Infutraze per kg of body weight covers the basic needs of the included trace elements.

Children weighing more than 20 kg and adolescents:

A maximum recommended daily dose of 10 ml of Infutraze covers the basic needs of the included trace elements.

The following amounts of trace elements are contained in 0.5 ml, 1.0 ml, and 10 ml of Infutraze:

In addition to the trace elements contained in Infutraze, daily infusions of iron are recommended if patients receive parenteral nutrition for more than 3 weeks. A perfusion of molybdenum should also be administered if patients receive parenteral nutrition for more than 4 weeks.

Method of administration

Infutraze must not be administered undiluted. Infutraze will be administered in intravenous perfusion, diluted in a parenteral nutrition solution/emulsion. The speed and duration of the perfusion are determined by the speed and duration of the perfusion of the parenteral nutrition solution.

Infutraze can only be mixed with other nutritional products whose compatibility has been documented, see the Compatibility section below.

Special precautions for disposal and other handling

Before use, check visually that the concentrated solution for infusion is transparent and free of particles.

Compatibility

Dilute before use.

Infutraze is used as an additive for parenteral nutrition mixtures when compatibility data are available.

Compatibility data are available for the following products: Aminoven Infant, Vaminolact, Vamin 14, Vamin 18, Smoflipid, Intralipid, Vitalipid adult, Vitalipid infant, Soluvit N, Addiphos, and Glycophos in defined quantities, combined with generic glucose and electrolytes in defined quantities. Infutraze can also be added to SmofKabiven and SmofKabiven EF with or without Vitalipid N Infant/Adult and Soluvit N and electrolytes. The generated data support the additions according to the following summary table:

Infutraze should never be added directly to a lipid emulsion due to its destabilizing effects. It is recommended to mix the macronutrients (amino acid solution and glucose with or without lipid emulsion) before adding the micronutrients. Additions should be made aseptically.

The disposal of unused medicine and all materials that have been in contact with it should be done in accordance with local regulations.

Shelf-life after mixing

Stability after mixing (see Compatibility section) has been demonstrated for a maximum of 7 days at 2-8°C followed by 48 hours at 20°C-25°C, including the duration of administration. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.