Infutraze concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Infutraze concentrate for 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 questions, ask your doctor or nurse.
• If your child experiences any side effects, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Infutraze is and what it is used for

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

Infutraze is used to meet the basic trace element requirements of premature and full-term newborns, infants, children and adolescents who cannot eat or absorb sufficient nutrients through enteral feeding and therefore require nutrients to be administered intravenously (known as intravenous or parenteral nutrition). Infutraze is added to parenteral nutrition solutions containing all the nutrients the body needs.

2. What you need to know before starting Infutraze

Do not use Infutraze if your child:

• is allergic to the active substances or to any of the other components 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 biliary excretion
• thyroid problems (hyperthyroidism)

During treatment, your doctor will periodically monitor blood levels of trace elements. 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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult 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; therefore, it is essentially "sodium-free".

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

3. How to use Infutraze

Infutraze will be administered to your child as an intravenous infusion (into the blood via an infusion drip) by a healthcare professional. Infutraze is always administered diluted in another parenteral nutrition solution.

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

An iron infusion is recommended daily when parenteral nutrition is administered for longer than 3 weeks, and a molybdenum infusion should additionally be administered when parenteral nutrition is given for longer than 4 weeks.

If more Infutraze is administered than should be

It is unlikely that your child will receive too much Infutraze, as the infusion will be controlled by a healthcare professional. If you think your child has been given too much Infutraze, inform your doctor.

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

4. Possible adverse effects

No adverse effects have been reported.

Reporting of adverse effects

If your child experiences any type of adverse effect, consult your doctor, pharmacist, or nurse. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the carton and on the label of the ampoule after EXP. The expiry date refers to the last day of the month indicated.

Stability period after reconstitution

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

6. Contents of the container and other information

Composition of Infutraze

The other components are

Hydrochloric acid (for pH adjustment)

Water for injections

Appearance of Infutraze and contents of the container

Infutraze, concentrate for solution for infusion, is a transparent and almost colourless liquid. It is supplied in transparent 10 ml ampoules made of polypropylene.

Pack sizes:

20 x 10 ml in 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 medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this summary: October 2023

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

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This information is intended for healthcare professionals only:

Warnings and special precautions for use

Infutraze should be used with caution in patients with renal dysfunction, in whom excretion of selenium, zinc, and iodine may be significantly reduced. There is an increased risk of trace element accumulation in these patients.

Infutraze should be used with caution in patients with hepatic dysfunction (especially cholestasis), in which excretion of copper and manganese may be reduced.

In patients with impaired biliary excretion, elimination of manganese, copper, and zinc may be reduced. Clinical signs of trace element accumulation may require dose reduction or discontinuation of Infutraze in such patients.

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

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

Adjustment of Infutraze is not required when additional iodine is administered via iodinated antiseptics.

Long-term parenteral nutrition

In patients receiving long-term parenteral nutrition, accumulation of trace elements may occur, particularly of manganese. If treatment lasts longer 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 result from certain medical conditions and parenteral nutrition. Manganese accumulation may require dose reduction or discontinuation of Infutraze.

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

Dosage

Preterm neonates:

A maximum recommended daily dose of 1.0 ml of Infutraze per kg body weight meets the basal requirements of the included trace elements.

Term neonates, infants, and children weighing less than 20 kg:

A maximum recommended daily dose of 0.5 ml of Infutraze per kg body weight meets the basal requirements of the included trace elements.

Children weighing more than 20 kg and adolescents:

A maximum recommended daily dose of 10 ml of Infutraze meets the basal requirements 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 iron infusions are recommended if patients receive parenteral nutrition for more than 3 weeks. Molybdenum supplementation is recommended in parenteral nutrition if patients receive parenteral nutrition for more than 4 weeks.

Method of administration

Infutraze must not be administered without prior dilution. Infutraze should be administered by intravenous infusion after dilution in a parenteral nutrition solution/emulsion. The rate and duration of infusion are determined by the rate and duration of infusion of the parenteral nutrition solution.

Infutraze may only be mixed with other nutritional products whose compatibility has been documented; see the section "Compatibility" below.

Special precautions for disposal and other handling

Before use, visually inspect the concentrate for infusion solution to ensure it is clear and free from particulate matter.

Compatibility

Dilute before use.

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

Compatibility data are available for the following branded 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 may also be added to SmofKabiven and SmofKabiven EF with or without Vitalipid N Infant/Adult and Soluvit N and electrolytes. Generated data support additions according to the summary table below:

Infutraze must never be added directly to a lipid emulsion due to its destabilizing effects. It is recommended to first mix the macronutrients (amino acid and glucose solutions, with or without lipid emulsion) before adding the micronutrients. All additions must be performed aseptically.

Disposal of unused medicinal product and of all materials that have come into contact with it must be carried out in accordance with local regulations.

Shelf life after mixing

In-use stability after mixing (see section on compatibility) has been demonstrated for up to 7 days at 2-8°C followed by 48 hours at 20°C-25°C, including the duration of administration. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.