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INTRALIPID 30% - patient leaflet, side effects, dosage

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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

Frequently Asked Questions

What is INTRALIPID 30% used for?

INTRALIPID 30% is a fat emulsion used to provide essential fatty acids and calories to patients who are unable to obtain adequate nutrition through eating.

Who can benefit from INTRALIPID 30%?

Patients who are on total parenteral nutrition (TPN), those with malabsorption issues, or individuals recovering from surgery may benefit from INTRALIPID 30%.

How is INTRALIPID 30% administered?

INTRALIPID 30% is usually given through an intravenous (IV) line under the supervision of a healthcare professional.

Can I administer INTRALIPID 30% at home?

Administration of INTRALIPID 30% should only be done in a clinical setting unless specifically instructed by your healthcare provider.

Are there any common side effects of INTRALIPID 30%?

Some patients may experience mild side effects like nausea, vomiting, or fever. Severe reactions are rare but can occur.

How long can I receive INTRALIPID 30% treatment?

The duration of treatment with INTRALIPID 30% will depend on your specific nutritional needs and the recommendation of your healthcare provider.

Can I take other medications while receiving INTRALIPID 30%?

It’s important to inform your doctor about all medications you are taking, as some drugs may interact with the use of INTRALIPID 30%.

Is it safe for pregnant or breastfeeding women to use INTRALIPID 30%?

Pregnant or breastfeeding women should consult their doctor before using INTRALIPID 30%, as safety during these periods has not been established.

What should I do if I miss a dose of INTRALIPID 30%?

If you miss a dose of INTRALIPID 30%, contact your healthcare provider immediately for guidance on how to proceed.

Can vegetarians or vegans use INTRALIPID 30% safely?

INTRALIPID contains soy oil; therefore, it may not be suitable for strict vegans or those with soy allergies. Consult your doctor for alternatives.

Does INTRALIPID 30% contain allergens?

Yes, INTRALIPID may contain allergens such as egg phospholipids and soy oil. Always check the ingredients and consult your doctor if you have concerns.

How does my body process INTRALIPID 30%?

INTRALIPID provides essential fatty acids that are metabolized by your body for energy and cellular functions when oral intake is insufficient.

Can children use INTRALIPID 30%?

Yes, children who require nutritional support may receive INTRALIPID, but it must be prescribed and monitored by a pediatrician.

What are the signs of an allergic reaction to INTRALIPID 30%?

Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or trouble breathing. Seek immediate medical attention if these occur.

How should I store INTRALIPID 30% before use?

Store unopened bottles of INTRALIPID at room temperature away from light. After opening, it should be used promptly as directed.

Is there a specific diet I need to follow while using INTRALIPID 30%?

Your healthcare provider will guide you on any dietary restrictions or recommendations while you are receiving nutritional support with INTRALIPID.

Will using INTRALIPID affect my lab test results?

Some laboratory tests can be affected by intravenous lipid emulsions like INTRALIPID. Inform your lab technician that you are receiving this treatment.

Can I drink alcohol while on INTRALIPID therapy?

Alcohol consumption while on nutritional IV therapy should be discussed with your healthcare provider due to potential interactions and health risks.

What happens if my IV line gets clogged during INFTRLAPD administration?

If the IV line becomes clogged, alert the healthcare staff immediately as they will have protocols in place to address this issue safely.

Where can I find more information about my treatment with INTRALIPID 30%?

For more detailed information about your treatment plan and guidance on using INTRALIPID, it's best to consult directly with your healthcare provider.