SYNTHAMIN 9 REFORMULATED WITHOUT ELECTROLYTES SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SYNTHAMIN 9 REFORMULATED WITHOUT ELECTROLYTES solution for infusion

Read the entire leaflet carefully before you start using 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.
  • If you experience any adverse effects, consult your doctor or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Synthamin is and what it is used for
2. What you need to know before being administered Synthamin
3. How Synthamin will be administered to you
4. Possible adverse effects
5. How to store Synthamin
6. Contents of the pack and other information

1. What Synthamin is and what it is used for

Synthamin is a sterile solution containing a large number of compounds called amino acids. These are the building blocks for proteins, which are vital for your body. It also contains certain chemicals called electrolytes, which are very important for your body to function properly.

Together with other compounds such as minerals and vitamins, it is used to provide you with nutrition (food) directly into your bloodstream when you are unable to take food orally. It is important that you are given this medicine to help you recover.

It is usually administered along with other nutritional solutions.

2. What you need to know before Synthamin is administered to you

Do NOT be given Synthamin if you have any of the following clinical conditions

• If you are allergic to the active substances or to any of the other components of this
  medicinal product (listed in section 6).

• If you have any disorder in amino acid metabolism.

Warnings and precautions

Consult your doctor or nurse before starting to use Synthamin

• Synthamin should only be used if the solution is clear and the container is undamaged.

• If symptoms of pulmonary disorders appear.

• If you have fever or feel unwell.

• You will have regular blood and urine tests to ensure that you are receiving the correct amount of the solution. If necessary, you will be given additional treatments.

• You will be monitored more closely if you have liver, heart, or kidney problems. Please inform your doctor of this.

• You will be carefully monitored if you have diabetes.

• If administered to a very young child, additional monitoring will be performed.

• If necessary, you may also be given a vitamin called folic acid, fatty acids (the building blocks of fats), and sugar solutions (such as glucose) to ensure your body has all the necessary components for good health.

• Synthamin must not be administered simultaneously with, before, or after blood transfusion using the same infusion set.

• Concomitant administration of injectable Synthamin solutions with concentrated glucose solutions may lead to hyperglycemia, glucosuria, and hyperosmolar syndrome. Therefore, routine monitoring of blood and urine glucose levels is required in patients receiving this treatment. In certain patients, exogenous insulin supplementation may be necessary.

• If any abnormal signs or symptoms of hypersensitivity or allergic reaction occur, the infusion must be stopped immediately.

When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until administration is complete. Exposure of Synthamin to ambient light, especially after mixing with trace elements or vitamins, generates peroxides and other degradation products, which can be minimized by protecting the product from light.

Use of Synthamin with other medicines

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

No interaction studies have been conducted with Synthamin.

Pregnancy, breastfeeding, and fertility

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

The safety of amino acid solutions in pregnant or breastfeeding women has not been established. Your doctor will carefully evaluate the benefits and potential risks before prescribing Synthamin.

Driving and use of machines

Synthamin does not affect your ability to drive or operate machinery.

3. How Synthamin will be administered to you

Use in adults

Your doctor will determine an infusion rate based on your needs and clinical condition, which will depend on your body weight, your body's requirements, the amount of sugar solution (such as glucose) that can be given to you, and the reason for your treatment.

The solution will be administered by slow intravenous infusion (called an infusion) through a plastic tube carefully placed into a large vein in the chest (the vena cava). The infusion rate will not exceed 70 ml per hour, and you will not receive more than 40 ml per kg of body weight in one day.

You must not receive blood transfusions through this tube.

Use in children

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

In children, the dose of parenteral nutrition must be individually adjusted according to the patient's requirements for amino acids, electrolytes, and energy.

If you are given more Synthamin than you should

Since your doctor will be administering Synthamin, it is unlikely that you will receive too much. However, if you think you have received more than you should, tell your doctor or nurse immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 915.620.420.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Cases of sharp pain and redness at the site where the medicine is administered into the vein have been reported. Hypersensitivity reactions have also been reported, including a severe allergic reaction called anaphylaxis, as well as skin reactions (urticaria, rash, pruritus, erythema), gastrointestinal disorders, and circulatory (shock) or respiratory manifestations.

The following may occur:

• fever,
• chills,
• high (hypertension) or low (hypotension) blood pressure,
• joint pain (arthralgia),
• muscle pain (myalgia),
• headache (cephalalgia),
• increased levels of nitrogen in the blood (azotemia) or ammonia (hyperammonemia),
• liver disorders,
• venous irritation (thrombus formation, pain, erythema, warmth, swelling, induration).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Synthamin

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

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

Do not store above 25°C.

Protect from light until immediately before use.

Do not refrigerate.

Do not use this medicine after the expiry date stated on the bag and carton
after EXP. The expiry date refers to the last day of the month indicated.

Discard partially used containers. Any remaining solution must be disposed of by healthcare professionals.

6. Contents of the pack and other information

Composition of Synthamin

The active substances per 1000 ml are: Glycine 5.66 g, L-Alanine 11.40 g, L-Arginine 6.32 g, L-Phenylalanine 3.08 g, L-Histidine 2.64 g, L-Isoleucine 3.30 g, L-Leucine 4.02 g, L-Lysine hydrochloride 4.00 g, L-Methionine 2.20 g, L-Proline 3.74 g, L-Serine 2.75 g, L-Tyrosine 22 mg, L-Threonine 2.31 g, L-Tryptophan 99 mg, L-Valine 3.19 g.

The other components are Water for injections and acetic acid.

Approximate electrolyte concentrations (mmol/l) of the solution:

Acetate (1): 44

Chloride (2): 22

Amino acid concentration: 55 g/l

Nitrogen equivalence: 9.1 g/l

Protein equivalence: 57 g/l

Ratio of essential amino acids / total amino acids: 0.45

Approximate pH: 6

Osmolality (mOsm/l): 520

(1) Acetate is added as acetic acid to adjust pH.

(2) Chloride ions are due to L-lysine hydrochloride.

Appearance of the product and contents of the pack

Synthamin is a clear solution, free from visible particles. It is supplied in plastic bags known as Viaflex bags. Each bag is contained within a sealed protective overwrap plastic bag.

Bag sizes may be 500 ml and 1000 ml.

Bags are supplied in cartons, each containing the following quantities:

• 10 bags of 500 ml
• 10 bags of 1,000 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Baxter S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)

Spain

Manufacturer

Baxter S.A.

Boulevard René Branquart, 80

7860 Lessines

Belgium

Date of the most recent revision of this summary: March 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Dosage and method of administration

Dosage

The total daily dose of these solutions depends on the patient's metabolic requirements and clinical response.

The most appropriate method for determining individual nitrogen requirements is likely to be assessment of fluid balance. Daily doses of amino acids of approximately 1.0–1.5 g/kg body weight in adults and 2–3 g/kg body weight in children, together with an adequate caloric intake (approximately 180 kcal per g of nitrogen or +/-30 kcal per g of amino acids), are generally sufficient to meet protein requirements and promote a positive nitrogen balance.

The use of higher doses, particularly in children, should be monitored with more frequent laboratory tests. The infusion rate should not exceed 0.1 g/kg per hour. The maximum infusion rate depends on the concentration of amino acids used. For Synthamin 9 (5.5% Amino Acids), the maximum rate is 140 ml/h.

Serum potassium levels must be maintained. A potassium intake equivalent to 60–180 mEq/day may be appropriate. Electrolytes, including potassium, may need to be added depending on the amount of carbohydrates administered and metabolized by the patient. Frequent monitoring of serum electrolyte levels is important, particularly phosphate, magnesium, and chloride. When administering a solution without electrolytes, the patient must be closely monitored to assess electrolyte requirements.

Vitamins, trace elements, and other components (including glucose and lipids) may be individually added to the parenteral nutrition regimen to meet nutritional needs and prevent deficiencies and complications.

Co-administration of a lipid emulsion should be considered when prolonged parenteral nutrition is required, in order to prevent essential fatty acid deficiency (EFAD).

In the case of peripheral administration, the osmolality of the solution must be taken into account.

The solution should be visually inspected for particulate matter and discoloration prior to administration.

The infusion rate should be gradually increased during the first hour and adjusted according to the dose to be administered, the daily volume prescribed, and the duration of infusion.

Use of an in-line filter is recommended during administration of parenteral nutrition solutions.

Method of administration

Hypertonic mixtures of amino acids and glucose are preferably administered via a central catheter. If a central route is not indicated, peripheral administration may be used in patients requiring parenteral nutrition, with amino acid solutions given simultaneously with appropriately concentrated glucose solutions and lipid emulsions.

Do not administer unless the solution is clear and colorless or slightly yellow and the container is intact.

When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete.

Warnings and special precautions for use:

Exposure to light of intravenous parenteral nutrition solutions, especially after addition of trace elements or vitamins, may have adverse effects on clinical outcomes in neonates due to the formation of peroxides and other degradation products.

When used in neonates and children under 2 years of age, Synthamin must be protected from ambient light until administration is complete.

Handling and preparation

Instructions for use of the Viaflex bag

Use an aseptic technique.

1. Remove the Viaflex bag from its protective overwrap at the time of use. Discard the oxygen-absorbing sachet.

2. Check for leaks by squeezing the Viaflex bag. Inspect the solution for clarity and absence of foreign particles.

3. Hang the Viaflex bag. Prepare the administration set and close the flow regulator.

4. Remove the protector from the outlet tube of the Viaflex bag and the protector from the spike of the administration set. Insert the spike of the administration set into the outlet tube of the Viaflex bag.

5. Follow the administration set instructions to purge the set and administer the solution.

In case of additions to the bag:

Use an aseptic technique.

Verify the stability and compatibility of additives.

Prepare the injection site on the bag.

Puncture the injection site and inject additives using a syringe or reconstitution device.

Mix the contents of the bag and additives thoroughly.

Inspect the final mixture for discoloration and presence of foreign particles.

Check the bag for leaks.

Ensure that appropriate storage conditions for the additive are met.

Administration of the infusion:

Do not administer blood before, simultaneously, or after through the same administration set due to the risk of pseudoagglutination.

Do not connect bags in series to avoid gas embolism from residual air in the primary container.

Discard after single use.

Discard any unused portion.

Do not reconnect partially used bags.

Special precautions for disposal and other handling:

When used in neonates and children under 2 years of age, the product must be protected from exposure to light until administration is complete. Exposure of Synthamin to ambient light, especially after mixing with trace elements or vitamins, generates peroxides and other degradation products. These can be minimized by protecting the product from light exposure.

Baxter, Viaflex and Synthamin are registered trademarks of Baxter International Inc.