Primene 10% solution for infusion

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

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

Throughout this leaflet Primene 10% Solution for Infusion will be called Primene.

• your child is allergic (hypersensitive) to any of the ingredients of Primene (see section 6)
• Your child's body has problems using the building blocks of proteins.

Your child will not be given Primene if any of the above applies.

Talk to the doctor or nurse before Primene is given to your child.

• When used in neonates and children below 2 years of age, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed. Exposure of Primene 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.
• Your child will have regular blood and urine tests while being given Primene. This will make sure that your child is getting the right amount of solution and if necessary your child will be given other treatments
• Your child will be monitored more closely if you have kidney, heart, liver or breathing problems. Please tell your doctor if your child has any problems with his or her kidneys, heart, liver or breathing.
• 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.
• Primene can cause the formation of small particles in your blood. If your child starts to have difficulty breathing or feel short of breath, tell the doctor or the nurse: the infusion will be stopped immediately and your child 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 child's vein. The doctor will carefully watch your child 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 your child is severely malnourished such that they need to receive feeding through a vein, it is recommended that parenteral nutrition is started slowly and carefully.
• Amino acid solutions can increase the level of ammonia or nitrogen-containing compounds in your child's blood. The doctor will check your child's blood tests for this.
• The doctor should also be aware of severe conditions affecting how your child's body handles fluid, sugars, fats, proteins or salt (metabolic disorders). These conditions will be corrected before your child is given Primene.
• your child will not have Primene through the same tubes and equipment used for any blood tranfusion.

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

If your child is pregnant, think she might be pregnant or is breast-feeding, tell the doctor. They will decide if she can be given Primene.

The doctor will give your child Primene so it is unlikely that your child will be given too much. If you are worried that your child has had too much, tell the doctor or nurse.

If the dose given is too high or the infusion too fast, your child may have an increased volume of circulating blood, your child's blood may become too acidic or the nitrogen content in your child's blood and urine may increase.

Symptoms may include nausea, vomiting, shivering, confusion and rapid heart rate. In such situations, the infusion must be stopped immediately.

The doctor will decide if additional actions are required.

To prevent these events from occurring, the doctor will regularly monitor your child's condition and test your child's blood levels during treatment.

• The active substances 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 0.6 g in 1000 ml of solution.
• The other ingredients are sterile water (called ‘water for injections’) and L-Malic acid.

Primene is a solution for infusion. It is a clear sterile solution. It is available in glass bottles containing 100 ml, 125 ml, 200 ml, 250 ml, 500 ml, 1,000 ml or 2,000 ml of solution.

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