Intralipid ® 20 % Infusion

INTRALIPID 20 % provides energy and fats needed by your body straight into your bloodstream when you cannot eat normally. They are used as part of a balanced intravenous diet, together with proteins, carbohydrates, salts and vitamins. INTRALIPID 20 % is particularly useful following severe injury, burns or in patients with serious infections.

INTRALIPID 20 % should not be administered to you:

• if you are hypersensitive (allergic) to egg -, soy- or peanut protein or to soybean oil or any of the other ingredients of INTRALIPID 20 % (listed in section 6).
• if your body is currently in shock (resulting from heavy blood loss or allergic reaction) or if you have problems with fat metabolism.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection: Take special care with INTRALIPID 20 %:

• if you have problems with your liver, kidneys or pancreas
• if you have high cholesterol
• if you have high blood sugar (diabetes mellitus)
• if you currently have an infection
• if you have thyroid problems.

Your doctor may want to do regular blood tests to make sure your body is using INTRALIPID 20 % correctly. No other medicines should be added to INTRALIPID 20 % unless it is safe to do so.

Children

Tell your doctor if your baby has jaundice (yellowing of the skin and/or eyes) or lung problems such as pulmonary hypertension. Your doctor may want to do regular blood tests. Your healthcare provider will ensure that INTRALIPID 20 % is protected from light exposure during administration to babies younger than 2 years.

Other medicines and INTRALIPID 20 %

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are using or taking the following:

• Insulin for the treatment of high blood sugar (diabetes mellitus)
• Heparin for treatment and prevention of blood clots in veins, arteries or lungs
• Warfarin for prevention of blood clots from forming or growing larger in your blood and blood vessels.

INTRALIPID 20 % with food, drink and alcohol

Not applicable

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before you receive INTRALIPID 20 %.

Driving and using machines

No effects on the ability to drive and use machines are to be expected. It is not always possible to predict to what extent INTRALIPID 20 % may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which INTRALIPID 20 % affects them.

INTRALIPID 20 % contains: INTRALIPID 20 % contains soybean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reactions have been observed between soybean and peanuts (see “INTRALIPID 20 % should not be administered to you”).

You will not be expected to give yourself INTRALIPID 20 %. It will be given to you by a person who is qualified to do so. INTRALIPID 20 % is usually given through a vein with other solutions, such as amino acids (proteins), sugars, salts and vitamins.

Dosage

Your doctor will prescribe the appropriate volume of INTRALIPID 20 % to be administered to you. If you have the impression that the effect of INTRALIPID 20 % is too strong or too weak, tell your doctor or pharmacist.

Method of administration

INTRALIPID 20 % is given slowly by drip through a small plastic tube (a catheter) straight into your bloodstream. An electronic pump may be used to control the speed of your drip.

How often will your medicines be given

INTRALIPID 20 % will usually be given every day until you can start eating again.

Duration of treatment

Your doctor will tell you how long your treatment with INTRALIPID 20 % will last. If INTRALIPID 20 % is given for more than one week, your doctor will monitor the levels of fats in your blood.

If INTRALIPID 20 % is given for more than one week

Since a healthcare provider will administer INTRALIPID 20 %, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive INTRALIPID 20 %

Since a healthcare provider will administer INTRALIPID 20 %, it is unlikely that the dose will be missed.

If you stop using INTRALIPID 20 %

Not applicable

INTRALIPID 20 % can have side effects. Not all side effects reported for INTRALIPID 20 % are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving INTRALIPID 20 %, please consult your healthcare provider for advice.

Less frequently, some patients feel shivery and hot or cold. You may feel sick or actually be sick. If this happens to you, tell your doctor straight away. Other side effects do occur. These include a severe allergic reaction, causing rash and problems with breathing. Stomach pain, headache, blood and circulatory problems, tiredness and prolonged, painful erections in men have also been reported, occurring immediately after receiving INTRALIPID 20 %.

INTRALIPID 20 % contains soybean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reactions have been observed between soybean and peanuts (see “INTRALIPID 20 % should not be administered to you”). Some substances produced by the liver may increase in the blood and will be found on blood testing. One of these chemicals may cause jaundice – your skin and whites of eyes turn yellow. This form of jaundice is not infectious. Prolonged treatment with INTRALIPID 20 % in infants has been reported to cause bleeding disorders.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of INTRALIPID 20 %. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicines regulatory authority in the country where the product is marketed.

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Do not freeze.
• If INTRALIPID 20 % has been stored for a while, gently tip it upside down two or three times before using it.
• The package label has an expiry date. Do not use INTRALIPID 20 % after this date.
• Do not use if the container has been leaking.
• 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 (see section 2).
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).