Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SYNTHAMIN 17 REFORMULATED 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 reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

What Synthamin is and what it is used for
What you need to know before Synthamin is administered to you
How Synthamin will be administered to you
Possible side effects
How to store Synthamin
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 the proper functioning of your body.

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 by mouth. It is important that you are given this medicine to help you recover.

It is usually administered together 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
medicine (listed in section 6).
If you have any disorder in amino acid metabolism.
If you have high blood levels of sodium, potassium, magnesium and/or phosphorus.

Warnings and precautions

Consult your doctor or nurse before starting to use Synthamin

Synthamin will 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.
Regular blood and urine tests will be performed to ensure you are receiving the correct amount of solution. If necessary, additional treatments may be given.
Closer monitoring will be required if you have liver, heart or kidney problems. Please inform your doctor of this.
Careful monitoring will be carried out if you have diabetes.
If administered to a very young child, additional controls 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 must be performed in patients receiving this treatment. In certain patients, exogenous insulin may be required.
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 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, which can be minimized by protecting the product from light exposure.

Use of Synthamin with other medicines

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

No interaction studies have been conducted with Synthamin.

Due to the potassium content of Synthamin, special caution is required in patients treated with potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene), angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, or immunosuppressants such as tacrolimus or cyclosporine, due to the risk of hyperkalemia.

Pregnancy, breastfeeding and fertility

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

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 (drip infusion) through a plastic tube carefully inserted 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 your 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 Synthamin will be administered by your doctor, it is unlikely that you will be given 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, hardening).

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products 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 the 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 CAD. The expiry date refers to the last day of the month indicated.

Dispose of partially used containers. Any remaining solution must be discarded by healthcare professionals.

6. Contents of the pack and other information

Composition of Synthamin

The active ingredients per 1000 ml are: Glycine 10.30 g, L-Alanine 20.70 g,
L-Arginine 11.50 g, L-Phenylalanine 5.60 g, L-Histidine 4.80 g, L-Isoleucine 6.00 g, L-Leucine 7.30 g, L-Lysine hydrochloride 7.26 g, L-Methionine 4.00 g, L-Proline 6.80 g, L-Serine 5.00 g,
L-Tyrosine 400 mg, L-Threonine 4.20 g, L-Tryptophan 1.80 g, L-Valine 5.80 g, Sodium acetate
trihydrate 6.80 g, Dibasic potassium phosphate 5.22 g, Sodium chloride 1.18 g, Magnesium chloride hexahydrate 1.02 g.

The other components are Water for injections and acetic acid.

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

Sodium: 70
Potassium: 60
Magnesium: 5
Acetate (1): 150
Chloride: 70
Phosphate (as HPO4^2-): 30

Amino acid concentration: 100 g/l
Nitrogen equivalence: 16.5 g/l
Protein equivalence: 103 g/l
Ratio of essential amino acids/total amino acids: 0.45
Approximate pH: 6
Calculated osmolarity (mOsm/l): 1300

(1) Acetate is added as sodium acetate and/or acetic acid for pH adjustment.

Appearance of the product and pack contents

Synthamin is a clear, particle-free solution. It is supplied in plastic bags known as Viaflex. Each bag is enclosed in a sealed protective overwrap.

Bag sizes may be 500 ml and 1000 ml.

The 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 review of this summary: March 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (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 best approach to determine individual nitrogen requirements is likely to be the 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, especially 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 17 (10% amino acids), the maximum rate is 70 ml/h.

Serum potassium levels must be maintained. A potassium intake equivalent to 60–180 mEq/day may be appropriate. It may be useful to add electrolytes and potassium, depending on the amount of carbohydrates administered and metabolized by the patient. Serum electrolyte levels, particularly phosphate, magnesium, and chloride, should be monitored frequently. In cases where a solution without electrolytes is administered, the patient must be closely monitored to assess electrolyte requirements.

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

When administering peripherally, the osmolarity of the solution must be taken into account.

The solution should be visually inspected for particles and discoloration before administration.

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

The 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 central access 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 undamaged.

When used in newborns 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 mixing with trace elements or vitamins, may have adverse effects on clinical outcomes in newborns due to the formation of peroxides and other degradation products.

When used in newborns 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.

Remove the Viaflex bag from its protective overwrap at the time of use. Discard the oxygen-absorbing sachet.
Check the Viaflex bag for leaks by squeezing it gently. Inspect the solution for clarity and absence of foreign particles.
Hang the Viaflex bag. Prepare the administration set and close the flow regulator.
Remove the protector from the outlet tube of the Viaflex bag and the protector from the spike of the administration set. Insert the spike into the outlet tube of the bag.
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 foreign particles.

Check the bag for leaks.

Ensure appropriate storage conditions for the additive are met.

Infusion administration:

Do not administer blood before, simultaneously, or immediately 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 newborns 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, which can be minimized by protecting the product from light.

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

Synthamin 17 Reformulated solution for infusion