Olimel 5.7%: Uses, Side Effects and Dosage

What is OLIMEL used for?

OLIMEL is used to provide nutrition to adults. It is given to you through a tube into a vein when normal feeding by mouth is not possible or suitable.

OLIMEL will only be given to you under medical supervision.

How does OLIMEL work?

OLIMEL is given to you when you are unable to eat to get an adequate intake of energy, nitrogen and other nutrients. This helps treat or prevent malnutrition.

What are the ingredients in OLIMEL?

Medicinal ingredients:

OLIMEL product is an emulsion for infusion, supplied in a bag with three chambers.

one chamber contains a solution of 17 amino acids (L-Alanine, L-Arginine, L-Aspartic Acid, L-Glutamic Acid, Glycine, L-Histidine, L-Isoleucine, L-Leucine, L-Lysine Acetate, L-Methionine, L-Phenylalanine, L-Proline, Serine, L-Threonine, L-Tryptophan, L-Tyrosine, L-Valine) without electrolytes;

one chamber contains a dextrose solution

one chamber contains a lipid emulsion, which is a mix of refined olive oil and refined soybean oil.

Non-medicinal ingredients:

Glacial acetic acid (for pH adjustment)

Glycerol

Hydrochloric acid (for pH adjustment)

Nitrogen

Purified egg phosphatide

Sodium hydroxide (for pH adjustment)

Sodium oleate

Water for injection

OLIMEL comes in the following dosage forms:

OLIMEL 4.4% (4.4% w/v amino acids, 14% w/v dextrose, 4% w/v lipids) Injectable Emulsion

OLIMEL 5.7% (5.7% w/v amino acids, 11% w/v dextrose, 4% w/v lipids) Injectable Emulsion

OLIMEL 7.6 % (7.6% w/v amino acids, 7.3% w/v dextrose, 3.5% w/v lipids) Injectable Emulsion

Do not use OLIMEL if:

• You are allergic to any ingredients (such as egg, soybean or peanut proteins, olive products.) or any ingredients in OLIMEL or components of the container. (See What the medicinal ingredients are and What the important nonmedicinal ingredients are.)
• You have liver failure or coma resulting from liver failure.
• You have kidney failure and are not on dialysis
• You have an allergy to corn or corn products since this product contains dextrose from corn.
• Your body has problems processing certain amino acids that are included in OLIMEL.
• Your body has severe problems metabolizing (breaking down) fat.
• You have especially high levels of fats in your blood.
• You have acute pancreatitis (severe inflammation of pancreas) in association with hyperlipidemia (high blood fat levels).
• You have hyperglycemia (too much sugar in your blood), which is not controlled.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OLIMEL. Talk about any health conditions or problems you may have, including if you:

• are allergic to any ingredients (such as egg, soybean or peanut proteins, olive products, corn.)
• suffer from metabolic acidosis (when the blood is excessively acid)
• have kidney problems
• have liver problems
• have heart problems or have had heart problems
• have lung or breathing problems
• have diabetes
• have a disorder where your body cannot break down fats properly
• have acute respiratory distress syndrome. This is a serious condition where fluid builds up in the lungs.
• are taking any other medicines on a regular basis

• are pregnant or intend to become pregnant

• are breastfeeding or intend to breastfeed
• have hereditary fructose intolerance. This is a condition where your body cannot break down fructose properly. This product may contain small amounts of fructose

Other warnings you should know about:

In all cases, your doctor will give you OLIMEL based on factors such as age, weight, condition, and any tests results that they have done. Always be sure to check with your doctor if anything about your condition changes.

Your doctor will need to monitor how you are doing while you are on this medicine. This means that you will need to have laboratory tests done on a routine basis.

Precipitates (e.g. solid particles) can appear in OLIMEL when a calcium-containing product is added to it. It has been reported that these injected precipitates can block an artery in the lungs, cause breathing difficulties and even death. Your doctor will decide with caution, whether a calcium-containing product will be mixed with OLIMEL.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with OLIMEL:

• OLIMEL must NOT be given at the same time with blood through the same infusion tubing
• Blood thinner medicines such as warfarin.
• Medicines or infusions containing calcium or phosphate.

How to take OLIMEL:

OLIMEL can be given in a hospital or managed care facility, or at home under the supervision of a doctor or other health care professional.

After appropriate training and with the agreement of your medical team, you may be able to administer OLIMEL yourself. Your doctor's instructions must be followed exactly when taking OLIMEL.

Before using the product, the bag must be prepared as shown in the pictures.

Use only if the solutions are clear, colourless or slightly yellow, practically free of visible particles and if the emulsion is homogeneous and milk-like.

Use only if the bag is not damaged and if the non-permanent seals between the chambers are intact (no mixing of the 3 chambers contents).

Make sure the product is at room temperature.

Aseptic conditions must be followed (cleaning of hands).

OLIMEL must be delivered through a central vein.

Your healthcare professional will provide instructions on the preparation of the site and route of administration (central vein).

OLIMEL should only be used once. Discard unused portion, do not use a partially used bag.

1.		2.		3.
	Tear from the top to open the overpouch.		Peel the front of the overpouch to reveal the OLIMEL bag. Discard the overpouch and oxygen absorber.		Place the bag flat on an horizontal and clean surface with handle in front of you.
4.		5.		6.
	Lift the hanger area to remove solution from the upper bag. Roll firmly the upper bag until peal seals are fully open (approximately half way).		Mix by turning the bag upside-down at least 3 times.		Hang the bag. Twist off the protector from the Administration outlet.Firmly plug the spike connector.

Usual adult dose:

Your doctor will select the appropriate OLIMEL for you, based on your body weight. They will also consider how much energy you need and how well your body can handle the amino acids, and lipids in the different solutions

Your doctor will also specify a flow rate corresponding to your needs and medical condition.

Always use OLIMEL exactly as your doctor has told you to. You should check with your doctor if you are not sure.

The product infusion may continue for as long as the doctor advises, depending upon your medical condition. The infusion of one triple-chamber bag usually lasts between 12 and 24 hours. The maximum daily dose should not be exceeded.

Overdose:

If your dose is too high or is infused too quickly, the following may happen:

• the amino acid content may make your blood too acidic;
• the dextrose content may increase the glucose in your blood and urine;
• the lipid content may increase the fats in your blood.

Giving too high a volume may cause nausea, vomiting, headache, hot flush, excessive sweating and shivering.

In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneys get rid of any extra nutrients.

To help prevent these events, your doctor will routinely check your condition, and test your blood and urine.

Missed Dose:

If you miss or forget to take one or more doses of OLIMEL, contact your doctor as soon as possible. Your doctor will instruct you about how to re-start your treatment and what flow rate to use.

DO NOT take a double dose to make up for forgotten individual doses.

What are possible side effects from using OLIMEL?

These are not all the possible side effects you may feel when taking OLIMEL. If you experience any side effects not listed here, contact your healthcare professional.

If you notice any changes in the way you feel during or after the treatment, tell your doctor or another member of your medical team immediately.

OLIMEL can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Side effects may include:

• nausea
• diarrhea
• abdominal pain
• decreased appetite
• vomiting
• rash
• fever
• chills
• itchiness

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Do not freeze. Store the unmixed product in the overpouch at 15°C to 30°C.

Do not use OLIMEL after the expiry date which is printed on the container and the outer packaging (MM/YYYY). The expiry date refers to the last day of that month.

Once the seals between the three chambers have been broken and the product has been mixed, the product should be used immediately.

This medicine must be at room temperature to be administered.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Keep out of reach and sight of children.

If you want more information about OLIMEL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the Baxter website (Baxter.ca), or by calling 1-888-719-9955.

Baxter and Olimel are trademarks of Baxter International Inc.

Last revised: July 19, 2023