Patient Information Leaflet: Information for the Patient

Infutraze Concentrate for Infusion Solution

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or nurse.

-If your child experiences any side effects, ask your doctor or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Infutraze and what it is used for

2.What you need to know before starting to use Infutraze

3.How to use Infutraze

4.Possible side effects

5.Storage of Infutraze

6.Contents of the pack and additional information

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

Infutraze is used to meet the basic oligoelement needs of premature and full-term newborns, infants, children, and adolescents who cannot eat or absorb sufficient nutrients through tube feeding and therefore need nutrients infused intravenously (known as intravenous nutrition or parenteral nutrition). Infutraze is added to parenteral nutrition containing all the nutrients the body needs.

Do not use Infutraze if your child:

-is allergic to the active ingredients or to any of the other components of this medication (listed in section 6).

-has Wilson's disease.

Warnings and precautions

Consult your doctor before starting to use Infutraze if your child has:

-kidney problems

-liver problems

-reduced bile excretion

-thyroid problems (hyperthyroidism)

Your doctor will monitor your child's blood oligoelement levels periodically during treatment. Your doctor will adjust the Infutraze dose accordingly.

Children and adolescents

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

Other medications and Infutraze

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

Pregnancy and breastfeeding

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

Infutraze contains sodium and potassium

This medication contains less than 23 mg of sodium (1 mmol) per 10 ml ampoule; it is essentially "sodium-free".

This medication contains less than 39 mg (1 mmol) of potassium per 10 ml ampoule, making it essentially "potassium-free".

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

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

It is recommended to administer a daily iron infusion when parenteral nutrition is administered for more than 3 weeks, and a molybdenum infusion should also be administered when parenteral nutrition is administered for more than 4 weeks.

If your child is given more Infutraze than they should

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 received too much Infutraze, inform your doctor.

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

No adverse effects have been reported.

Reporting Adverse Effects

If your child experiences any type of adverse effect, consult your doctor, pharmacist, or nurse. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: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 store above 25°C. Do not freeze.

Do not use this medication if you observe visible signs of deterioration.

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

Period of Validity After Mixing

The stability of use 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 previous conditions of use are the responsibility of the user and are normally not to exceed 24 hours at 2-8°C.

Composition of Infutraze

The other components are

Hydrochloric acid (for pH adjustment)

Water for injection

Appearance of Infutraze and contents of the container

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

Container sizes:

20 x 10 ml in a cardboard box

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

Holder of the marketing authorization:

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 Barcelona

Spain

This medicinal product is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet:October 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Warnings and special 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 reduced. There is a higher risk of accumulation of oligoelements in these patients.

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

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

It may be necessary to adjust the dose in patients with renal dysfunction and liver 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 adjustment of Infutraze is necessary in case of additional iodine intake through iodinated antiseptics.

Long-term parenteral nutrition

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

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

Dosage

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 oligoelements.

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 oligoelements.

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 oligoelements.

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

In addition to the oligoelements contained in Infutraze, it is recommended to administer daily iron infusions if patients receive parenteral nutrition for more than 3 weeks. It is recommended to add molybdenum to parenteral nutrition if patients receive parenteral nutrition for more than 4 weeks.

Administration

Infutraze should not be administered without dilution. Infutraze will be administered intravenously in a parenteral nutrition solution. The speed and duration of the infusion are determined by the speed and duration of the parenteral nutrition solution infusion.

Infutrazecan only be mixed with other parenteral nutrition products whose compatibility has been documented, see the section Compatibility below.

Special precautions for disposal and other manipulations

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

Compatibility

Dilute before use.

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

Compatibility data are available with 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 data generated 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) first before adding the micronutrients. The additions should be made aseptically.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Shelf life after mixing

The stability in use after mixing (see section Compatibility) 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 previous use conditions are the responsibility of the user and are normally not to exceed 24 hours at 2-8°C.