Document: SMOFlipid emulsion for infusion ENG PL change

• SMOFlipid emulsion for infusion PL
• SMOFlipid emulsion for infusion ENG PL

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Package leaflet: Information for the user

SMOFlipid 200 mg/ml, emulsion for infusion

Soya-bean oil, medium chain triglycerides, olive oil, fish oil

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

What is in this leaflet

1. What SMOFlipid is and what it is used for

2. What you need to know before you are given SMOFlipid

3. How you are given SMOFlipid

4. Possible side effects

6. Contents of the pack and other information

SMOFlipid contains four different lipids (fats); soya-bean oil, medium chain triglycerides, olive oil and fish oil which is rich in omega-3 fatty acids. The liquid is a mixture of fats and water which is called a ‘lipid emulsion’.

• It works by providing energy and fatty acids for your body

• It is put into your blood by a drip or an infusion pump

A health care professional will give you SMOFlipid when other forms of feeding are not good enough or have not worked.

You should not be given SMOFlipid:

• if you are allergic to soya-bean oil, medium-chain tryglycerides, olive oil, fish oil or any of the other ingredients of this medicine (listed in section 6).

• if you are allergic (hypersensitive) to any other products containing fish, egg, soy or peanut.

• if you have too much fat in the blood (called ‘severe hyperlipemia’).

• if you have serious kidney or liver problems.

• if you have severe blood clotting problems (called ‘coagulation disorders’).

• if you are in acute shock.

• f you have fluid in the lungs (called ‘pulmonary oedema’) , too much body fluid (called ‘hyperhydration’) or have heart failure (due to too much body fluid).

• if you are in an unstable condition, for example shortly after serious injury, heart attack, stroke, blood clot (thrombosis), metabolic acidosis (metabolic disturbance which results in high acid levels in the blood), or untreated diabetes, blood poisoning and dehydration.

Warnings and precautions

Talk to your doctor or nurse before having this medicine if you have a problem with high levels of lipids in the blood due to that your body cannot use fat properly (called ‘impaired lipid metabolism’).

Allergic reactions

If you have an allergic reaction while having SMOFlipid, it needs to be stopped straight away. Tell the doctor or nurse straight away if you get any of the following while you are having the infusion:

• fever (high temperature)

• shivering

• rash

• difficulty breathing

Children

Talk to your doctor or nurse if this medicine is being given to your newborn child and they have:

• too much of a substance called “bilirubin” in their blood (hyperbilirubinemia)

• a high pressure in their lungs (pulmonary hypertension)

If your newborn child has SMOFlipid for a long time the doctor will take blood tests to see how it is working.

Other medicines and SMOFlipid

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

In particular, tell your doctor if you are taking or have recently taken drugs used to stop blood clotting, such as warfarin and heparin.

• SMOFlipid naturally contains vitamin K₁, which can affect warfarin. However, the vitamin K₁ content in SMOFlipid is so low that such problems are unlikely.

• Heparin given in clinical doses may at first cause higher levels of fatty acids in the blood due to liberation of fatty acids from the tissues into the bloodstream and then less fatty acids are removed from your blood (decreased triglyceride clearance).

Pregnancy and breast-feeding

It is not known whether it is safe to have SMOFlipid while you are pregnant or breast-feeding. If you need to have direct feeding into your vein during pregnancy or breast-feeding, your doctor will give you SMOFlipid only after careful consideration.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

Driving and using machines

Not relevant as the medicine is given at the hospital.

SMOFlipid containssodium

This medicinal product contains 5 mmol (115 mg) sodium per 1000 ml. To be taken into consideration by patients on a controlled sodium diet.

SMOFlipid is put into your blood by a drip or an infusion pump. Your doctor will decide your dose depending on your body weight and your ability to utilise the amount of fat infused.

For medical and health care professionals, please see “Method of administration” at the end of this leaflet for more details regarding dosage and administration.

If you are given more SMOFlipid than you should

In case the dose SMOFlipid given to you is too high, there is a risk of taking in more fat than your body can handle. This is called ‘fat overload syndrome’. See section 4, Possible side effects, for more information.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Fat overload syndrome

This might happen when your body has problems using fat, because of having too much SMOFlipid. It may also happen because of a sudden change in your condition (such as kidney problems or infection). The fat overload syndrome is characterized by high levels of fat in the blood (hyperlipidemia), fever, more fat in your tissues than normal (fat infiltration) and disorders in various organs of the body and coma. All symptoms will usually disappear when you stop having the infusion.

Common(may affect up to 1 in 10 people)

Uncommon(may affect up to 1 in 100 people)

• shivering

• loss of appetite

• feeling sick (nausea)

• being sick (vomiting)

Rare(may affect up to 1 in 1,000 people)

• allergic reactions (e.g. high temperature, swelling, lowering of blood pressure, skin rash, redness, headache)

• feelings of hot and cold

• paleness

• bluish discolouration of skin and mucous membranes (due to reduced oxygen content in the blood)

• pains in neck, back, bones, chest and lower back

• raised or lowered blood pressure

• shortness of breath

Very rare (may affect up to 1 in 10,000 people)

Reporting of side effects

If you notice any side effects, please tell your doctor or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

[To be completed nationally]

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

Do not store above 25°C. Do not freeze.

Do not use SMOFlipid after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Do not use SMOFlipid if you notice that the package is damaged. Use only if the solution is white and homogenous. For single use only. Any unused product should be thrown away. Do not re-use it.

What SMOFlipid contains

Refined soya-bean oil 60 mg/ml

Medium-chain triglycerides 60 mg/ml

Refined olive oil 50 mg/ml

Fish oil, rich in omega-3 fatty acids 30 mg/ml

Glycerol

Egg lecithin

All-rac-α-tocopherol (vitamin E)

Water for injections

Sodium hydroxide (pH adjustment)

Sodium oleate

What SMOFlipid looks like and contents of the pack

SMOFlipid is a white, homogenous emulsion and is available in glass bottles or plastic bags.

Package sizes

Glass bottle	Plastic bag
100 ml	100 ml
10x100 ml	10x100 ml
250 ml	250 ml
10x250 ml	10x250 ml
500 ml	500 ml
10x500 ml	12x500 ml

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

[To be completed nationally]

Manufacturer:

Fresenius Kabi AB, SE-751 74 Uppsala, Sweden (plastic bags)

Fresenius Kabi Austria GmbH, A-8055 Graz, Austria (glass bottles)

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Finland, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Slovenia, Sweden, United Kingdom: SMOFlipid 200 mg/ml

Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Luxembourg, Spain: SMOFlipid 20%

Denmark, Poland, Portugal, Slovakia: SMOFlipid

This leaflet was last revised in 2016-09-19

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The following information is intended for healthcare professionals only:

Warnings and precautions

The concentration of triglycerides in serum should not exceed 3 mmol/l during infusion. An overdose may lead to fat overload syndrome. Special caution should be taken in patients with a marked risk for hyperlipidema (e.g. patients with high lipid dosage, severe sepsis and extremely low birth weight infants).

Administration of medium-chain fatty acids alone can result in metabolic acidosis. This risk is to a great extent eliminated by the simultaneous infusion of the long chain fatty acids included in SMOFlipid. Concomitant administration of carbohydrates will further eliminate this risk. Hence, simultaneous infusion of carbohydrate or a carbohydrate-containing amino acid solution is recommended. Laboratory test generally associated with monitoring of intravenous nutrition should be checked regularly. These include blood glucose levels, liver functions tests, acid base metabolism, fluid balance, full blood count and electrolytes.

This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.

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

SMOFlipid should be given with caution to neonates and prematures with hyperbilirubinemia and cases with pulmonary hypertension. In neonates, particularly prematures on long term parenteral nutrition, blood platelet counts, liver function tests and serum triglycerides should be monitored.

SMOFlipd contains up to 5 mmol sodium per 1000 ml. To be taken into consideration by patients on a controlled sodium diet.

The addition of other medicaments or substances to SMOFlipid should generally be avoided unless compatibility is known.

Method of administration

Intravenous infusion into a peripheral or central vein.

Instructions for use and handling

Use only if the emulsion is homogeneous.

Infusion bag: The integrity indicator (Oxalert) should be inspected before removing the over-pouch. If the indicator is black, oxygen has penetrated the over-pouch and the product should be discarded. Inspect the emulsion visually for phase separation prior to administration. Ensure that the final emulsion for infusion does not show any evidence of phase separation. For single use only. Any unused emulsion should be discarded.

Additives: SMOFlipid may be aseptically admixed with amino acid, glucose, and electrolyte solutions to produce "All-In-One" Total Parenteral Nutrition (TPN) admixtures. Compatibility for different additives and the storage time of the different admixtures will be available upon request from the marketing authorisation holder. Additions should be made aseptically. Any mixture remaining after infusion must be discarded.

Do not store above 25^oC. Do not freeze.

Storage after mixing
If additions are made to SMOFlipid, the admixtures should be used immediately from a microbiological point of view. If admixtures are not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless additions have taken place in controlled and validated aseptic conditions.

Instructions for use – applicable for the infusion bag

If the indicator is black the overpouch is damaged and the product should be discarded.

2. Remove the overwrap by tearing at the notch and pulling down along the container. The Oxalert sachet (A) and the oxygen absorber (B) should be disposed.

3. If no additives are to be used go to figure 5.

If additives are to be used, break off the tamper-evident arrow flag from the white additive port.

4. Take the syringe containing the additives. Hold the base of the additive port. Insert the needle horizontally through the centre of the septum of the additive port and inject the additives (with known compatibility). Use syringes with needles of 18 – 23 gauge and length of max. 40 mm

5. Use a non-vented infusion set or close the air vent on a vented set. Follow the instructions for use for the infusion set. Use a spike with diameter as specified in ISO 8536-4, 5.6 +/- 0.1 mm.

6. Break off the tamper-evident arrow flag from the blue infusion port.