Label: information for the user

PRIMENE 10% solution for perfusion

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If your child experiences adverse effectsconsult your child's doctor, pharmacist, or nurse,even if it is for adverse effects not listed in this label. See section 4.

In this label:

1.What PRIMENE is and for what it is used

2.What you need to know before PRIMENE is administered to your child

3.How PRIMENE will be administered

4.Possible adverse effects

5.Storage of PRIMENE

6.Contents of the package and additional informationl

This medication is called PRIMENE 10% solution for perfusionbut it will be referred to asPRIMENEin the rest of this label.

PRIMENEis a sterile solution that contains:

• amino acids: these are the basic components that the body uses to produce proteins.

PRIMENEis used in children, infants, and full-term or premature newborns to provide nutrition directly to the blood when not enough food can be taken by mouth. It is generally given with other nutrition solutions and similar compounds such as glucose, minerals, and vitamins.

Do not use PRIMENE in the following cases:

• If your child is allergic to any of the ingredients of PRIMENE (including those listed in section 6).
• If your child has a problem metabolizing one or more amino acids.

Warnings and precautions

Consult your child's doctor or nurse before administering PRIMENE.

Allergic reactions

The infusion must be stopped immediately if any sign or symptom of an allergic reaction (such as fever, sweating, chills, headache, skin rash, or difficulty breathing) appears.

Formation of small particles in the blood vessels of the lungs:

Difficulty breathing could be a sign that small particles have formed blocking the blood vessels in the lungs (pulmonary vascular precipitates).If your child has any difficulty breathing, inform your child's doctor or nurse.They will decide on the course of action.

Infection and sepsis

Occasionally, children may develop infections and sepsis (bacteria in the blood) when they have a tube connected to a vein (intravenous catheter). Certain medications and diseases may increase the risk of developing sepsis or infection. Your child's doctor will closely monitor your child for any signs of infection.

Change in blood chemistry levels

Your child's doctor will check and review the body fluids, blood chemistry levels, and other blood levels in your child.Fluid accumulation in tissues and swelling may also occur.It is recommended to start parenteral nutrition slowly and under supervision.

Hypertonic solution (high concentration of dissolved amino acids)

PRIMENE is a solution that contains a high concentration of dissolved amino acids.It is administered through a plastic tube connected to a vein in the arm or a large vein in the chest of your child.If administered in a smaller vein in the arm, it may cause irritation of the vein.Talk to your child's doctor or nurse if your child experiences discomfort at or around the injection site.

Control and adjustment:

Your child's doctor will monitor your child's condition at the beginning and during the infusion.Ensure that the doctor is informed if your child has severe metabolic alterations that affect the way their body controls sugars, fats, proteins, or salt.

In case abnormal signs appear, such as sweating, chills, bruises, or abnormal heart rhythm, the infusion must be stopped and your child's doctor or nurse informed.

To check the continued efficacy and safety of administration, your child's doctor will regularly check your child's blood, especially if they currently have liver, kidney, adrenal, heart, or circulation problems.

Children and adolescents

When used in newborns and children under 2 years, the solution (in bags and administration equipment) must be protected from exposure to light until the administration is complete. Exposure of Primene 10% to ambient light, especially after mixing it with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from exposure to light.

Use of PRIMENE with other medications:

Inform your child's doctor or pharmacist if your child is using or has used recently or may need to use any medication.

No problems are known when PRIMENE is used with other medications.

Pregnancy and lactation

There are insufficient data on the use of PRIMENE in pregnant women or during lactation.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your child's doctor before using this medication.

Your child must always be given PRIMENE exactly as directed by their doctor. Consult with your doctor if you have any doubts.

This medication is a solution for infusion. It is administered through a plastic tube connected to a vein in the arm or a large vein in the chest of your child.

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

Dosage and Duration of Treatment

Your child's doctor will decide on the dose your child needs and how long it will be administered. The dose depends on your child's nutritional needs and will be based on their weight, medical condition, protein needs, and their body's ability to digest and absorb the ingredients of Primene. Additional proteins or nutrition may also be administered orally or intravenously.

The usual dose is 15 to 35 ml of PRIMENE per kilogram of body weight. These are the recommended doses per day, but you may receive more or less at the discretion of your doctor.

The solution is administered slowly at a rate not exceeding 0.05 ml per kilogram per minute.

They will not administer more than 35 milliliters per kilogram of your body weight in a day.

If Your Child Receives More Primene Than They Should

If the administered dose is too high or the infusion is too rapid, it is possible that your child may have an increased volume of circulating blood, the blood may become too acidic, or the blood and urine may have an increased nitrogen content. Symptoms may include nausea, vomiting, shakiness, confusion, and rapid heart rate. In these cases, the infusion should be stopped immediately. Your child's doctor will decide if any further action is necessary.

To avoid these reactions, your child's doctor will regularly monitor your child's condition and analyze their blood levels during treatment.

In case of overdose or accidental ingestion, consult the Poison Control Service. Phone 915.620.420

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

If you notice any change in how your child feels during treatment or after it, inform your doctor or nurse immediately.

The tests the doctor will perform on your child while receiving this medication should minimize the risk of side effects.

If symptoms of an allergic reaction occur, the infusionshould be stoppedand your doctor will be contacted immediately. This can be serious and symptoms may include:abnormallyhigh or lowblood pressure,appearance ofa blueor purplecolorationon the skin,swelling onthe face or onthe eyelids,abnormally high heart rate, difficulty breathing,vomiting,nausea,skin eruptions,elevated body temperature,excessive sweating, chills orshivering.

In similar products, the following side effects have been reported:

• Elevated levels ofammonia andcompounds containing nitrogen in the blood.
• Anaphylactic reactions. A severeallergic reactionthatisrapid in onsetand thatif not treatedcanbe fatal.
• Deterioration ofliver functionwithabnormal blood testsof liver function.
• Inflammation of thebile duct withpresence ofgallstonesin the bile duct.
• Increased acidity of the blood.
• Formation ofsmallparticlesthat blockthe blood vesselsof the lungs.
• Inflammation of the veinsat the infusion site, venous irritation,pain, heat, swellingand induration.
• In theevent ofinfusion solution leakageserious local reactions may occur in the tissues surrounding the infusion site:skin tissue death, blisters, swelling,scars,skin discoloration.

Reporting of side effects:

If your child experiences any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

When used in newborns and children under 2 years, 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 store at a temperature above 25°C.

Do not usePRIMENEafter the expiration date appearing on the container and outer packaging (MM/YYYY).The expiration date is the last day of the month indicated.

Composition of PRIMENE

Appearance of the product and contents of the container

PRIMENEis a perfusion solution that is presented in 250 ml glass bottles.

Only some sizes of containers may be commercially available.

Marketing Authorization Holder

Baxter S.L.

Camilo Street, 2.

46394 Ribarroja del Turia (Valencia)

Spain

Responsible for manufacturing

Bieffe Medital S.p.A.

New Provincial Road, 23034 Grosotto (So)

Italy

Last review date of this leaflet: October 2019

The detailed and updated information on this medicine 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.

Administration form:

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

Warnings and special precautions for use:

Exposure to light of parenteral nutrition solutions for intravenous use, especially after mixing with oligoelements 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 newborns and children under 2 years, Primene 10% must be protected from ambient light until the end of administration.

Special precautions for disposal and other manipulations:

When used in newborns and children under 2 years, it must be protected from exposure to light until the end of administration. Exposure of Primene 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.