PACKAGE LEAFLET: INFORMATION FOR THE USER

Kabiven™ Peripheral

emulsion for infusion

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1.    What is Kabiven Peripheral and what it is used for

2.    Before you receive Kabiven Peripheral

3.    How you are given Kabiven Peripheral

4.    Possible side effects

5.    How Kabiven Peripheral is stored

6.    Further information

1. WHAT IS KABIVEN PERIPHERAL AND WHAT IT IS USED FOR

Kabiven Peripheral comes in a three chamber bag in an overpouch. Kabiven Peripheral contains the following medicines: amino acids (components used to build proteins), fat, glucose and electrolyte solutions.

It provides energy (as sugar and fat) and amino acids into your bloodstream when you cannot eat normally.

It is used as part of a balanced intravenous diet, together with salts, trace elements and vitamins which together provide your complete nutritional needs.

The full name of this medicine is Kabiven Peripheral Emulsion for Infusion. It will be referred to as Kabiven Peripheral throughout this leaflet.

2. BEFORE YOU RECEIVE KABIVEN PERIPHERAL

You should not receive Kabiven Peripheral if you:

•    have ever had an allergic reaction to Kabiven Peripheral or any of the ingredients of Kabiven Peripheral mentioned in section 6. (for symptoms of an allergic reaction please refer to section 4).

•    are allergic to products containing egg, soya or peanut

•    have too many fatty substances (like cholesterol) in your blood

•    have seriously reduced liver function

•    suffer from acute shock (resulting from heavy blood loss or allergic reaction)

•    have a bleeding disorder associated with a condition known as haemophagocytotic syndrome or if your blood is not clotting properly.

•    have a condition where your body has problems using proteins or amino acids

•    have severe problems with your kidneys

•    have hyperglycaemia (too much sugar in your blood) where the administration of more than 6 units of insulin per hour is required

•    have raised levels of electrolytes (salts) in your blood

•    have metabolic acidosis (the acid levels of your body fluids and tissues become too high)

•    have too much fluid in your body - hyperhydration

•    have fluid on your lungs (acute pulmonary oedema)

•    are dehydrated with low levels of salts

•    have heart problems

•    are in a coma

•    have severe sepsis (a condition in which your body is fighting a severe infection)

Care should be taken when administering Kabiven Peripheral

Inform your doctor if you suffer from:

•    reduced liver function

•    untreated diabetes

•    a condition where your body has problems using fat properly

•    kidney problems

•    any pancreas problems

•    thyroid problems - hypothyroidism

•    sepsis (a condition in which your body is fighting an infection)

•    your body has problems eliminating electrolytes

•    a condition where there is not enough oxygen in your body cells

•    dehydration, as not drinking enough water causes the concentration of chemicals in your blood to increase (increased serum osmolarity).

This medicine may affect the results of other tests you may have. It is important to tell any doctor doing tests that you are using Kabiven Peripheral.

Your doctor may want to do regular blood tests to make sure that the treatment with Kabiven Peripheral is working correctly.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Inform your doctor if you are taking

•    a drug known as heparin which is used to prevent the formation and aid in the dispersion of blood clots

•    warfarin, because Vitamin Ki, which is contained in soybean oil, could affect the blood clotting ability

•    Insulin for the treatment of diabetes

Pregnancy and breast-feeding

The safety of using Kabiven Peripheral while pregnant or breast-feeding has not been looked into. If feeding directly into your vein (parenteral nutrition) becomes necessary during pregnancy or breast-feeding, your doctor will give you Kabiven Peripheral only after careful consideration.

3. HOW YOU ARE GIVEN KABIVEN PERIPHERAL

You will receive your medicine by infusion (IV drip).

The dose of Kabiven Peripheral and which bag size is used depends on your bodyweight in kilograms and your body's ability to use fat and sugar. Kabiven Peripheral will be infused slowly over a period of 12-24 hours. Your doctor will decide on the correct dose for you or your child to receive.

You may be monitored during your treatment.

Kabiven Peripheral is not suitable for use in newborns or children under two years of age.

If you receive too much Kabiven Peripheral

It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the treatment.

The effects of an overdose may include nausea, vomiting, sweating and fluid retention. Hyperglycaemia (too much sugar in your blood) and electrolyte disturbances have also been reported. In case of overdose there is a risk of taking in too much fat. This is called 'fat overload syndrome'. See section 4 "Possible side effects" for more information. If you experience any of the symptoms described above or believe that you have received too much Kabiven Peripheral inform your doctor or nurse immediately. The infusion may either be stopped immediately or continued with a reduced dosage. These symptoms will usually disappear on reducing the rate or stopping the infusion.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist

4. POSSIBLE SIDE EFFECTS

Like all medicines, Kabiven Peripheral can cause side effects, although not everybody gets them.

Very rarely (occurs in the less than 1 in 10000 patients) Kabiven Peripheral may cause an allergic reaction. Tell your doctor immediately if:

•    a bumpy and itchy rash appears on your body

•    you have very high temperature

•    you have difficulties breathing

•    you get a fever

•    you experience shivering

Common side effects (occurs in more than 1 in 100 patients)

•    a slightly raised body temperature

•    inflammation of the vein where infusion is given

The following uncommon side effects (occurs in less than 1 in 100 patients but in more than 1 in 1000 patients) have been observed

•    chills and shivers

•    tiredness

•    stomach pain

•    headache

•    feeling sick or being sick

•    increase of liver enzymes. Your doctor will tell you if this happens.

Other side effects are very rare (occurs in less than 1 in 10000 patients)

•    high or low blood pressure

•    difficulty in breathing

•    prolonged, painful erections in men

•    problems with your blood

Fat overload syndrome

This might happen when your body has problems using fat, because of having too much Kabiven Peripheral. It may also happen because of a sudden change in your condition (such as kidney problems or infection). Possible symptoms are fever, increased levels of fat in your blood, your cells and your tissues, disorders in various organs and coma. All these symptoms will usually disappear if the infusion is discontinued.

If any of the side effects becomes serious or if you notice a side effect not listed in this leaflet, please tell your doctor, nurse or pharmacist.

The following information is intended for medical or health care professionals only:

Warnings and precautions for use

To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible by using a volumetric pump.

Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination especially during catheter insertion.

Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver and enzyme tests should be monitored.

Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.

Kabiven Peripheral should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

Thrombophlebitis may occur if peripheral veins are used for infusions. The catheter insertion site should be evaluated daily for local signs of thrombophlebitis.

Method of administration

Intravenous use, infusion into a peripheral or a central vein.

To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in Kabiven Peripheral) should be added to Kabiven Peripheral according to the patients need.

Infusion rate

The maximum infusion rate for glucose is 0.25 g/kg/h.

Amino acid dosage should not exceed 0.1 g/kg/h.

Fat dosage should not provide more than 0.15 g/kg/h.

The infusion rate should not exceed 3.7 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acids, 0.13 g fat per kg body weight). The recommended infusion period for individual bags of Kabiven Peripheral is 12-24 hours.

Precautions for disposal

Do not use if package is damaged.

Use only if the amino acid and glucose solutions are clear and colourless or slightly yellow and the lipid emulsion is white and homogenous. The contents of the three separate chambers have to be mixed before use, and before any additions are made via the additive port.

After separation of the peelable seals the bag should be inverted three times to ensure a homogenous mixture, which does not show any evidence of phase separation.

For single use only. Any unused solution remaining after infusion should be discarded.

Compatibility

Only medicinal or nutrition solutions for which compatibility has been documented may be added to Kabiven Peripheral. Compatibility for different additives and the storage time of the different admixtures will be available upon reguest.

Additions should be made aseptically.

Kabiven Peripheral Instructions for use

To remove the cover wrap hold the bag upright and tear from the notch along the upper edge, then simply tear open the long side, pull off the plastic covering and discard it along with the oxygen absorber.

2.

To mix the contents of the bag, place your fingertips on the upper compartment just on the seal as shown on the picture.

Alternative technique (3): Put the bag on a flat surface. Roll up the bag by using the handle until the seals are opened. Mix thoroughly by inverting the bag.

Grip the sides of the upper chamber with your fingertips and your thumbs and gently roll your knuckles together until the seal breaks.

To peel open the lower seal, use the same technigue as described above. Mix thoroughly by gently inverting the bag end-over-end several times.

Support the base of the additive port. Fully insert the needle and inject the additives (with known compatibility) through the centre of the injection site. Mix thoroughly between each addition by inverting the bag several times.

Use a non-vented infusion set or close the air-inlet on a vented set. Remove the set port cover by pulling the ring upwards. Support the base of the infusion port. Insert the spike straight into the infusion port. Twist and push the spike through the diaphragm. The spike should be fully inserted to secure it in place.

5. HOW KABIVEN PERIPHERAL IS STORED

Keep out of the reach and sight of children.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Kabiven Peripheral.

Do not store above 25°C. Do not freeze and always keep the container in the outer container. The emulsion must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month. Do not use if the bag is leaking. For single use only. Any remaining emulsion should be disposed of using the approved hospital procedures.

The other ingredients are purified egg phospholipids, glycerol, sodium hydroxide, glacial acetic acid and water for injections.

What Kabiven Peripheral looks like and contents of the pack

Glucose and amino acid solutions are clear and colourless or slightly yellow and the fat emulsion is white. Kabiven Peripheral consists of a three chamber bag and an overpouch. An oxygen absorber is placed between the inner bag and the overpouch, which should be discarded before use.

The inner bag is separated into three chambers by peelable seals. The contents of the three chambers have to be mixed before use, by opening the peelable seals.