Synthamin 9, 5.5% Amino Acid Intravenous Infusion without Electrolytes

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet, see section 4.

1 What SYNTHAMIN is and what it is used for
2 What you need to know before you are given SYNTHAMIN
3 How SYNTHAMIN is given
4 Possible side effects
5 How SYNTHAMIN is stored
6 Contents of the pack and other information

Throughout this leaflet SYNTHAMIN 9, 5.5% Amino Acid Intravenous Infusion without electrolytes will be called SYNTHAMIN.

• you are allergic (hypersensitive) to any of the ingredients of SYNTHAMIN (listed in section 6) or components of the container
• your body has problems using certain amino acids.

You will not be given SYNTHAMIN if any of the above apply to you.

Talk to your doctor or nurse before SYNTHAMIN is given to you.

SYNTHAMIN will only be used if the solution is clear, free from particles and the container is not damaged.

You will have regular blood and urine tests while being given SYNTHAMIN. This will make sure that you are getting the right amount of solution and if necessary, you will be given other treatments. More checks are made if SYNTHAMIN is being given to a very young child.

If any abnormal signs or symptoms of an allergic reaction develop, such as fever, chills, skin rashes or difficulty in breathing, excessive sweating, nausea, or headache, tell the doctor or the nurse: the infusion will be stopped immediately.

SYNTHAMIN can cause the formation of small particles in your blood. If you start to have difficulty breathing or feel short of breath, tell the doctor or the nurse: the infusion will be stopped immediately, and you may need other treatment.

Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in the blood). There is a particular risk of infection or sepsis when a tube (intravenous catheter) is placed in your vein. Your doctor will carefully watch you for any signs of infection. Using aseptic “germ free” techniques when placing and maintaining the catheter and when making the nutritional formula can reduce the risk of infection.

If you are severely malnourished such that you need to receive feeding through a vein, it is recommended that parenteral nutrition is started slowly and carefully.

SYNTHAMIN may cause a stinging pain and redness at the place where it goes into your vein if given into your arm.

Your doctor will monitor your condition at the onset of the infusion, particularly if you currently have liver, kidney, heart, or circulation problems.

Amino acid solutions can increase the level of ammonia or nitrogen-containing compounds in your blood. Your doctor will check your blood tests for this. Your doctor should also be aware of severe conditions affecting how your body handles fluid, sugars, fats, proteins, or salt (metabolic disorders). These conditions will be corrected before you are given SYNTHAMIN.

When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed.

Exposure of SYNTHAMIN to ambient light, especially after admixtures with trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure.

There are no known problems when SYNTHAMIN is used with other medicines.

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

If you are pregnant, think you might be pregnant or are breast-feeding, tell your doctor. They will decide if you can be given SYNTHAMIN.

Your doctor will give you SYNTHAMIN so it is unlikely that you will be given too much. If you are worried that you have had too much, tell your doctor or nurse.

If the dose given is too high or the infusion too fast, the amino acid content may make your blood too acid, and you may have too much fluid in the circulation. Giving a volume of SYNTHAMIN that is too large may cause nausea, vomiting, chills, and electrolyte disturbances, in such situations the infusion should be stopped immediately.

In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneys eliminate the excess product.

To prevent these events occurring, your doctor will regularly monitor your condition and test your blood parameters.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are L-Leucine 0.402% w/v, L-Isoleucine 0.330% w/v, L-Lysine (as hydrochloride salt) 0.319% w/v, L-Valine 0.319% w/v, L-Phenylalanine 0.308% w/v, L-Histidine 0.264% w/v, L-Threonine 0.231% w/v, L-Methionine 0.220% w/v, L-Tryptophan 0.099% w/v, L-Alanine 1.138% w/v, L-Arginine 0.632% w/v, Amino acetic acid (glycine) 0.566% w/v, L-Proline 0.374% w/v, L-Serine 0.275% w/v, L-Tyrosine 0.022% w/v.
• The other ingredient is sterile water (called ‘water for injections’). SYNTHAMIN can also sometimes contain a very small amount of glacial acetic acid to adjust the pH of the solution.

SYNTHAMIN is a solution for infusion (a slow drip injection). It is a clear sterile solution. It is available in sealed plastic bags containing 250 ml, 500 ml, 1,000 ml, 2,000 ml* and 3,000 ml*.

* The 2,000 ml and 3,000 ml bags are bulk bags for a compounding unit to use. They are not meant for use directly in patients.

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