Patient leaflet - INTRALIPID 30%
1. what intralipid 30% is and what it is used for
Intralipid30% is used as a source of calories and fatty acids to maintain or increase your weight when you cannot eat normally. Intralipid 30% is particularly useful following trauma, infections or severe burns.
Intralipid 30% may be mixed with carbohydrates, amino acids, salts, vitamins and trace elements which together provide your complete nutritional needs.
-
2. BEFORE YOU RECEIVE INTRALIPID 30%
- are allergic (hypersensitive) to Intralipid 30% or to any of the ingredients of Intralipid 30% mentioned in section 6 (for symptoms of an allergic reaction, please refer to section 4)
- have a disorder of fat metabolism such as in severe liver damage or if you have suffered from shock
Warnings and precautions
Inform your doctor if you suffer from:
- an allergy to products containing egg, soya or peanut oil. Your doctor will carry out an allergy test to make sure you can receive this medicine.
-
reduced liver function
- a condition where your body has problems using fat properly
- impaired kidneys
- any problems with your pancreas
-
untreated diabetes mellitus
- thyroid problems – hypothyroidism
- sepsis (a container in which your body is fighting a severe infection)
This medicine may interfere with certain laboratory tests. It is important to tell any doctor doing tests that you are using Intralipid 30%.
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 Intralipid 10% 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 doctor may want to do regular blood tests to make sure your body is using Intralipid 30% correctly.
Other medicines and Intralipid 30%
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor if you are taking:
- any anticoagulatnts to help prevent blood clots, eg. heparin or warfarin
- insulin for the treatment of diabetes mellitus
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide if you should receive Intralipid 30%.
Driving and using machines
Intralipid 30% may cause tiredness and headache which may affect your ability to drive or use machinery.
Ask your doctor when it would be safe to drive or operate machines.
3. how to use intralipid 30%
You will receive your medicine by intravenous infusion (IV drip).
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).
The amount and rate at which the infusion is given depends on your requirements.
Your doctor will decide on the correct dose for you or your baby to receive.
You may be monitored during your treatment.
If you receive too much Intralipid 30%
It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the treatment. However, if you think that you have received too much Intralipid30%, inform your doctor or nurse immediately. 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 have any further questions on the use of this product, ask your doctor or nurse.
4. possible side effects
Like all medicines, Intralipid 30% can cause side effects, although not everybody gets them.
Intralipid 30% may cause severe allergic reactions. If you get any of the following symptoms after receiving this medicine you should contact your doctor immediately:
- a rash appears on your body
- you have swollen face, tongue and throat
- you have difficulties breathing
- stomach pain
The following side effects have also been reported:
Extremely rarely (occurs in less than one in a million infusions)
- headache
- blood and circulatory problems
- tiredness
- painful erections in men
- cholestasis- a condition in which bile is not flowing properly from the liver to the intestines
- jaundice- skin and whites of eyes turn yellow
- abnormal liver test results- these will get back to normal after the treatment with Intralipid 30% is finished
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly
via the Yellow Card Scheme at:.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store intralipid 30%
Keep out of the sight and reach of children.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Intralipid 30% infusion.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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).
6. contents of the pack and other information
What Intralipid30% contains
One litre (1000 ml) contains Purified Soybean Oil Ph. Eur 300 grams.
The other ingredients are purified egg phospholipids, glycerol, sodium hydroxide and water for injections.
What Intralipid 30% looks like and contents of the pack
Intralipid 30% is a white fat emulsion (a mixture of oil and water).
Intralipid 30% is supplied in sealed glass bottles which contain 100 ml, 333 ml, 500 ml of this emulsion, and in biofine bags containing 100 ml, 333 ml, 500 ml of emulsion. These bags are wrapped in an overpouch with an additional package in between the bag and the overpouch which is an oxygen absorber and integrity indicator.
Not all pack sizes may be marketed
Marketing authorisation holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
Manufacturer
Fresenius Kabi
751 74 Uppsala,
Sweden
This leaflet was last revised in October 2020
The following information is inteded for healthcare professionals only
Instruction for use- Fresenius Kabi infussion bag
Method of administration
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.
Special warnings and precautions for use :
Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. When used in neonates and children below 2 years, Intralipid should be protected from ambient light until administration is completed.
Special precautions for disposal and other handling :
When used in neonates and children below 2 years, protect from light exposure, until administration is completed. Exposure of Intralipid 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.
3. if additives are to be used break off the tamper-evident arrow flag from the white additive port, if no additives (of known compatibility) are to be used go to figure 5.
4. 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 a length of max. 40 mm.
l.The Integrity Indicator (Oxalert) A should be Inspected before removing the overwrap, if the Indicator Is black the overwrap 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.
7. Hold the base of the Infusion port, insert the spike through the Infusion port, by rotating your wrist sllghly until the spike Is Inserted.
6. Break off the tamper-evident arrow flag from the blue Infusion port.
8. Hang the bag In the hanger cut and start Infusion.
5. use a non-vented Infusion set or dose 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.
Closed
Non-ventea vented
7