Leaflet: information for the patient

Aminoplasmal Paed 1010% solution for infusion

For use in children (0-11 years)

Amino acids

Read this leaflet carefully beforestarting to use this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for your child only, and should not be given to other people even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any side effects, consult your doctor or nurse, even if they are not listed in this leaflet.See section 4.

1. What isAminoplasmal Paed 1010%and what it is used for

2. What you need to know before your child starts usingAminoplasmal Paed 1010%

3. How to useAminoplasmal Paed 1010%

4. Possible side effects

5. Storage ofAminoplasmal Paed 1010%

6. Contents of the pack and additional information

Aminoplasmal Paed 10% is a solution administered to your child through a small tube with a cannula placed in a vein (intravenous perfusion).

The solution contains amino acids, which are essential for the growth and recovery of the body.

The solution is adapted to meet the specific needs of newborns, premature and full-term infants, breastfed babies, and children.

They will receive this medication if they cannot ingest food normally and cannot be fed through a tube placed in the stomach.They may also receive other nutrients such as glucose solutions or fat emulsions in combination with Aminoplasmal Paed 10%.

Do not use Aminoplasmal Paed 10% if your child

• is allergic to the active ingredients or to any of the other components of this medication (listed in section 6)
• has a congenital metabolic disorder of amino acids and/or proteins
• has a severe circulatory disorder (potentially life-threatening (circulatory shock)has insufficient oxygen supply (hypoxia)
• has acidic substances accumulating in the blood (metabolic acidosis)
• has severe liver disease (severe liver insufficiency);
• has severe kidney disease (severe renal insufficiency) not adequately treated with a hemodialysis apparatus or similar treatments;
• has severe heart failure with significant alteration of blood circulation (decompensated heart failure);
• has acute pulmonary edema

Warnings and precautions

When used in children between premature birth and 2years of age, the solution (in bags and administration equipment) must be protected from exposure to light until the end of administration. Exposure of parenteral nutrition solutions containing Aminoplasmal Paed 10% to ambient light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from exposure to light.

Consult your doctor or nurse before using Aminoplasmal Paed 10% if your child

• has a protein and amino acid metabolism disorder produced by a pathology other than those mentioned earlier (see section «Do not use Aminoplasmal Paed 10% if your child...»);
• has a deterioration of liver or kidney function;
• has a deterioration of heart function;
• has an abnormally high serum blood concentration (elevated serum osmolality)

If your child's body water or electrolyte balance is altered, this disorder must be corrected before the child receives this medication. Some examples of this disorder are simultaneous lack of water and electrolytes (hypotonic dehydration) or lack of sodium (hyponatremia) or potassium (hypokalemia).

Both before and while children are receiving this solution, the doctor will check their blood salt and sugar levels, water balance, and acid-base balance. They will also monitor their blood proteins and liver and kidney function. To this end, blood and urine samples will be taken for analysis.

Amino acid solutions are only one component of parenteral nutrition. Normally, children will receive Aminoplasmal Paed 10% as part of intravenous feeding, which also includes non-protein energy supplements (solutions of carbohydrates, fat emulsions), essential fatty acids, electrolytes, vitamins, liquids, and oligoelements.

Use of Aminoplasmal Paed 10% with other medications

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

Pregnancy and breastfeeding

Aminoplasmal Paed 10% is only intended for use in children (under 12 years of age).

Driving and operating machines

Not applicable.

Aminoplasmal Paed 10is administered by healthcare professionals.

In children, the doctor will adjust the dose according to the child's age, level of development, and illness.

The amount administered will be approximately:

Preterm newborns:40ml per kg of body weight per day

Full-term newborns (0 to 27days):30mlper kg of body weight per day

Infants (28days to 23months):25mlper kg of body weight per day

Children (2 to 11years):20ml per kg of body weight per day

For critically ill children, the amount administered may be higher (up to30ml per kilogram of body weight per day).

Patients with liver or kidney disease

Doses will be adjusted according to the individual needs of the child if they have liver or kidney disease.

Treatment duration

This medication may be used as long as the child requires intravenous nutrition.

Administration form

This medication will be administered to your child through a small tube inserted into a vein (intravenous infusion).

When used in children from premature birth to 2years, the solution (in bags and administration equipment) must be protected from exposure to light until the end of administration (see section2).

If your child receives more Aminoplasmal Paed 10than they should

It is unlikely that this will happen, as the doctor will determine the daily doses for your child.

However, if your child receives an overdose or the infusion rate of the solution is too fast, your child may feel nausea, vomit, and have chills or a headache.

Additionally, the blood may contain too many acidic substances (metabolic acidosis) or too much ammonia (hyperammonemia), and your child may lose amino acids in the urine.

Your child may also have too much fluid in their body (hyperhydration), the electrolyte balance of your child's body may be disrupted (electrolyte imbalance), and your child may have fluid in the lungs (pulmonary edema). If this happens, the infusion will be stopped and restarted at a lower infusion rate shortly afterwards.

If you have any other questions about the use of this medication, ask your doctor or nursing staff.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

These adverse effects are not specifically related to Aminoplasmal Paed 10%, but can occur with any type of intravenous nutrition, especially at the beginning.

The following adverse effects may be serious. If your child experiences any of the following adverse effects, inform your doctor immediately, who will stop administering this medication to your child:

Unknown Frequency(cannot be estimated from available data)

?Allergic reactions.

Other Adverse Effects

Rare(may affect up to 1 in 100people)

?Vomiting, nausea.

Reporting Adverse Effects

If your child experiences any type of adverse effect, consult your doctor or nurse,even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theHuman Medicines Pharmacovigilance Systemwww.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.

When used in children from premature birth to 2 years of age, the solution (in the bags and administration equipment) must be protected from exposure to light until the administration is completed (see section 2).

Do not usethis medication after the expiration datethatappears on the labels of the bag and the box. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not freeze.

After infusion, the remaining solution must never be stored for future use.

Composition of Aminoplasmal Paed 10%

The active principles are amino acids.

This medicinal product contains:

The other components are citric acid monohydrate (for pH adjustment) and water for injection preparations.

Aspect of the product and content of the packaging

Aminoplasmal Paed 10% is a transparent, colorless to light yellow solution.

It is supplied in flexible bags containing100ml or 250ml of amino acid solution.The bags are made of a multi-layer material. The inner layer in contact with the solution is composed of polypropylene.

The packaging does not contain PVC, DEHP, or latex.

The bag is packaged in a protective wrapper. An oxygen absorber and an oxygen indicator have been placed between the bag and the wrapper; the oxygen indicator is a thermosealed blister containing resorufin sodium, an oxygen-sensitive dye; the oxygen absorber is a non-reactive material containing iron hydroxide.

The different packaging sizes are presented in boxes of 12bags. Packaging sizes: 12 x 100 ml and 12 x 250 ml

Only some packaging sizes may be commercially available.

Holder of the marketing authorization andresponsible for manufacturing

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

Telephone:+49/5661/71-0

Fax:+49/5661/71-4567

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

AustriaAminoplasmal Paed 10% Infusionslösung

Czech RepublicAmiped

DenmarkAmiped

GermanyAminoplasmal Paed 10% Infusionslösung

GreeceAminoplasmal Paed 10%

ItalyAmiped

LuxembourgAminoplasmal Paed 10%

NetherlandsAminoplasmal Paed 100mg/ml, oplossing voor infusie

NorwayAmiped

PolandAminoplasmal Paed 10%

PortugalAminoplasmal Paed 100mg/ml, Solução para perfusão

Slovak RepublicAmiped 10% infuzny roztok

SloveniaAminoplasmal Paed 100mg/ml, raztopina za infundiranje

SpainAminoplasmal Paed 10 % solución para perfusión

United KingdomAminoplasmal Paediatric 10% solution for infusion

Date of the last review of this leaflet:January 2020.

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Dosage

Administration route

Intravenous.

Only for central venous perfusion.

When used in children aged between premature birth and 2 years, the solution (in the bags and administration equipment) must be protected from exposure to light until the end of administration. During the preparation of the mixtures, the light-protective wrapper may not be adequate. Nevertheless, attention should be paid to reducing exposure to light to a minimum during the preparation of the mixtures.

Pediatric population

The doses for the groups indicated below are average guidance values. The exact dose must be adjusted individually according to age, degree of development, and predominant disease.

Administration should begin below the target perfusion rate and increase to the same rate during the first hour.

The parenteral amino acid supply considered adequate for most pediatric patients:

Daily dose for premature newborns:

1.5-4.0g of amino acids/kg body weight?15-40ml/kg body weight

Daily dose for term newborns (0-27 days):

1.5-3.0g/kg body weight?15-30ml/kg body weight

Daily dose for infants (28 days to 23 months):

1.0-2.5g/kg body weight?10-25ml/kg body weight

Daily dose for children (2-11 years):

1.0-2.0g/kg body weight?10-20ml/kg body weight

Warnings and precautions for special use:

Exposure to lightof parenteral nutrition solutions for intravenous administration, especially after mixing with oligoelements and/or vitamins, may have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in children aged between premature birth and 2 years, Aminoplasmal Paed 10% must be protected from ambient light until the end of administration.

Special precautions for disposal and other manipulations

Use a sterile administration equipment for the administration of Aminoplasmal Paed 10%.

Before opening the protective wrapper, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has turned pink. Use only if the oxygen indicator is yellow.

When adding medications, prepare the medication port (transparent color) by removing the aluminum foil (Figure2a). Note that the area below the aluminum foil of the medication port is sterile.

1. Prepare the medication port (transparent color) by removing the aluminum foil (Figure2a). Note that the area below the aluminum foil of the medication port is sterile.
2. Pierce the medication port and inject the (additive(s) (Figure2b).
3. Mix the solution and medication thoroughly (Figure3a).
4. The medication port can be cleaned with a disinfectant (e.g., isopropanol) before re-piercing it.
5. Visually check the mixture for particles (Figure3b).

During the preparation of the mixtures

During the preparation of the mixtures, the light-protective wrapper may not be adequate. Nevertheless, attention should be paid to reducing exposure to light to a minimum during the preparation of the mixtures.

Preparation for administration:

1. Remove the aluminum foil from the infusion port (green color) from the bottom of the container (Figure4a) and connect the administration equipment (Figure4b): use a perfusion equipment without air intake or close the air intake of an equipment that has it.Suspend the bag in an IV pole (Figure5).