PRIMENE 10% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

PRIMENE 10% 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, pharmacist, or nurse.
• If your child experiences any side effects, consult your child's doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

In this leaflet:

1. What is PRIMENE and what is it used for
2. What you need to know before PRIMENE is administered to your child
3. How PRIMENE will be administered
4. Possible side effects
5. Storage of PRIMENE
6. Contents of the pack and other information

This medicine is called PRIMENE 10% Solution for Infusion, but will be referred to as PRIMENE throughout this leaflet.

1. What is PRIMENE and what is it used for

PRIMENE is a sterile solution that contains:

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

PRIMENE is used in children, infants, and newborns, whether premature or full-term, to provide nutrition directly into the bloodstream when they cannot take enough food by mouth. It is usually given with other nutrition solutions and similar compounds such as glucose, minerals, and vitamins.

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

Do not use PRIMENE in the following cases:

• If your child is allergic to any of the ingredients of PRIMENE (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 PRIMENE is administered.

Allergic reactions

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

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 difficulty breathing, inform your child's doctor or nurse. They will decide on the course of action.

Infection and sepsis

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

Changes in blood chemical levels

Your child's doctor will check and review the fluids in the body, blood chemical levels, and other blood levels in your child. Excess fluid in the 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 your child's arm or a large vein in the chest. If it is administered in a smaller vein in the arm, it may cause vein irritation. Talk to your child's doctor or nurse if your child experiences discomfort at or around the injection site.

Monitoring 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 disorders that affect how the body controls sugars, fats, proteins, or salt.

If abnormal signs appear, such as sweating, chills, bruising, or abnormal heart rate, the infusion must be stopped, and your child's doctor or nurse informed.

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

Children and adolescents

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

Use of PRIMENE with other medications:

Tell your child's doctor or pharmacist if you are using or have recently used or might use any other medications.

No problems are known when using PRIMENE with other medications.

Pregnancy and breastfeeding

There is not enough data on the use of PRIMENE in pregnant or breastfeeding women.

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

3. How PRIMENE will be administered

PRIMENE will always be administered to your child exactly as indicated by their doctor. Consult your child's doctor if you have doubts.

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

When used in newborns and children under 2 years, the solution (in the bags and administration equipment) must be protected from light exposure until administration is complete (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 the body's ability to digest and absorb the ingredients of Primene. Additional proteins or nutrition may also be administered orally or enterally.

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

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

No more than 35 milliliters per kilogram of body weight will be administered in a day.

If your child is administered more PRIMENE than they should

If the administered dose is too high or the infusion too rapid, your child may experience increased blood volume, the blood may become too acidic, or the nitrogen content in the blood and urine may increase. Symptoms may include nausea, vomiting, tremors, confusion, and rapid heart rate. In such cases, the infusion must be stopped immediately. Your child's doctor will decide if 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 Toxicology Information Service. Phone 915.620.420

4. Possible side effects

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

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

The tests your child's doctor will perform while your child receives this medication should minimize the risk of side effects.

If symptoms of an allergic reaction appear, the infusion must be stopped, and the doctor contacted immediately. This can be serious, and symptoms may include: abnormally high or low blood pressure, appearance of a blue or purple color on the skin, swelling in the face or eyelids, abnormally high heart rate, difficulty breathing, vomiting, nausea, skin rash, high body temperature, excessive sweating, chills, or tremors.

The following side effects have been reported in similar products:

• High levels of ammonia and nitrogen-containing compounds in the blood.
• Anaphylactic reactions. A severe allergic reaction that is rapid in onset and can be fatal if not treated.
• Impaired liver function with abnormal liver function blood tests.
• Inflammation of the gallbladder with gallstones in the gallbladder.
• Increased blood acidity.
• Formation of small particles that block the blood vessels in the lungs.
• Inflammation of the veins at the infusion site, vein irritation, pain, heat, swelling, and induration.
• In case of leakage of the infusion solution, severe local reactions may occur in the tissues surrounding the infusion site: skin necrosis, blisters, swelling, scarring, and skin discoloration.

Reporting of side effects:

If your child experiences any side effects, consult your child's doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of PRIMENE

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 light exposure until administration is complete (see section 2).

Do not store above 25°C.

Do not use PRIMENE after the expiration date stated on the packaging and outer packaging (MM/YYYY). The expiration date is the last day of the month indicated.

6. Contents of the pack and other information

Composition of PRIMENE

• The active ingredients are: L-Isoleucine 6.70 g, L-Leucine 10.00 g, L-Valine 7.60 g, L-Lysine 11.00 g, L-Methionine 2.40 g, L-Phenylalanine 4.20 g, L-Threonine 3.70 g, L-Tryptophan 2.00 g, L-Arginine 8.40 g, L-Histidine 3.80 g, L-Alanine 8.00 g, L-Aspartic acid 6.00 g, L-Cysteine 1.89 g, L-Glutamic acid 10.00 g, Glycine 4.00 g, L-Proline 3.00 g, L-Serine 4.00 g, L-Tyrosine 0.45 g, L-Ornithine hydrochloride 3.18 g, Taurine 0.60 g.

• The other ingredients are Water for injections and L-Malic acid.

Appearance of the product and pack contents

PRIMENE is a solution for infusion presented in 250 ml glass vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Baxter S.L.

Pouet de Camilo, 2.

46394 Ribarroja del Turia (Valencia)

Spain

Manufacturer

Bieffe Medital S.p.A.

Via Nuova Provinciale, 23034 Grosotto (So)

Italy

Date of last revision of this leaflet: October 2019

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

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This information is intended for healthcare professionals only.

Method of administration:

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

Special warnings and precautions for use:

Exposure to light of parenteral nutrition solutions for intravenous use, especially after mixing with oligoelements or vitamins, can 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 administration is complete.

Special precautions for disposal and other handling:

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