What Olimel is used for and how to use it
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Olimel - Consumer Medicine Information

Manufacture: Baxter
Country: Canada
Condition: Nutrition, Parenteral (Total Parenteral Nutrition)
Class: Nutritional products
Form: Liquid solution, Intravenous (IV)
Ingredients: 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) with or without electrolytes (sodium, potassium, magnesium, phosphate), dextrose solution with or without calcium, lipid emulsion, which is a mix of refined olive oil and refined soybean oil, purified egg phosphatide, glycerol, sodium oleate, sodium hydroxide (for pH adjustment), glacial acetic acid (for pH adjustment), hydrochloric acid (for pH adjustment), nitrogen and water for injections

OLIMEL 3.3% E
Amino acids WITH electrolytes, dextrose, lipids Injectable Emulsion
3.3% w/v & 0.7% w/v, 11.5% w/v, 4% w/v

OLIMEL 4.4%
Amino acids, dextrose, lipids Injectable Emulsion
4.4% w/v, 14% w/v, 4% w/v

OLIMEL 4.4% E
Amino acids WITH electrolytes, dextrose, lipids Injectable Emulsion
4.4% w/v & 0.7% w/v, 14% w/v, 4% w/v

OLIMEL 5.7%
Amino acids, dextrose, lipids Injectable Emulsion
5.7% w/v, 11% w/v, 4% w/v

OLIMEL 5.7% E
Electrolytes
Amino acids WITH electrolytes, dextrose, lipids Injectable Emulsion
5.7% w/v & 0.7% w/v, 11% w/v, 4% w/v

PeriOLIMEL 2.5% E
Amino acids WITH electrolytes, dextrose, lipids Injectable Emulsion
2.5% w/v & 0.4% w/v, 7.5% w/v, 3% w/v

About this medication

What the medication is used for

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

OLIMEL / PeriOLIMEL must only be used under medical supervision.

What it does

The use of OLIMEL / PeriOLIMEL is a way to ensure that patients who are unable to eat get an adequate intake of energy, nitrogen and other nutrients, and helps to treat or prevent malnutrition.

When it should not be used

Do not use OLIMEL / PeriOLIMEL, if:

  • You are allergic to any ingredients (such as egg, soybean proteins, olive products.) (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 / PeriOLIMEL.
  • 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.
  • You have high plasma concentrations of one of the electrolytes included in some of the OLIMEL products and in PeriOLIMEL.
  • You have a disorder resulting in high blood levels of substances such as potassium (hyperkalemia), calcium (hypercalcemia), phosphorus (hyperphosphatemia), sodium (hypernatremia) and magnesium (hypermagnesemia)
  • You are being simultaneoulsy administered ceftriaxone with intravenous calcium-containing solutions, including OLIMEL / PeriOLIMEL, through the same infusion line.

What the medicinal ingredient is

OLIMEL / PeriOLIMEL 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) with or without electrolytes (sodium, potassium, magnesium, phosphate);
  • one chamber contains a dextrose solution with or without calcium;
  • one chamber contains a lipid emulsion, which is a mix of refined olive oil and refined soybean oil.

What the important nonmedicinal ingredients are

Purified egg phosphatide, Glycerol, Sodium oleate, Sodium hydroxide (for pH adjustment), Glacial acetic acid (for pH adjustment), Hydrochloric acid (for pH adjustment), Nitrogen and Water for injections.

What dosage forms it comes in

OLIMEL / PeriOLIMEL is an emulsion for infusion. It is supplied in a bag with three chambers. The chambers are separated by non-permanent seals. Just before administration, the contents of the three chambers are mixed together by rolling the top of the bag to open the seals.

After the contents of the three chambers have been mixed, the mixture will look like milk.

The mixed emulsion for each of the different bag presentations provides a different amount of lipid, amino acids, dextrose, and, with some formulations, electrolytes and calcium as well so that your doctor can tailor the infusion to your particular needs.

Warnings and precautions

BEFORE you use OLIMEL / PeriOLIMEL, talk to your doctor or pharmacist if:

  • You are allergic to any ingredients (such as egg, soybean proteins, olive products.) (See What the medicinal ingredients are and What the important nonmedicinal ingredients are.)
  • You suffer from metabolic acidosis (when the blood is excessively acid)
  • You have kidney or liver problems
  • You have acute respiratory distress syndrome
  • You are taking any other medicines on a regular basis. You are pregnant or intend to become pregnant
  • You are breastfeeding or intend to breastfeed

Sometimes treatment with this medicine is not suitable, such as if you have:

  • Acute pulmonary oedema (collection of fluid into the lung tissue), hyperhydration (too much water in your body), heart failure, dehydration, untreated diabetes mellitus, severe metabolic acidosis (when the blood is excessively acid), severe disorders of fat metabolism, liver disease, or kidney disease. You may not be able to tell if you have some of these conditions, so be sure to check with your doctor first.
  • Precipitates (e.g. solid particles) can appear in the OLIMEL / PeriOLIMEL formulation when a calcium-containing product is added to OLIMEL / PeriOLIMEL formulation. 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 / PeriOLIMEL.

    In addition to inspection of the solution or emulsion, the infusion set and catheter should also periodically be checked for precipitates.

    If you have difficulties breathing, stop the infusion and contact your healthcare professional immediately.

In all cases, your doctor will base his/her decision to give you this medicine on factors such as age, weight and clinical condition, together with the results of any tests that he/she has performed. 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.

Interactions with this medication

No interaction studies have been performed.

Soybean oil in OLIMEL / PeriOLIMEL has a natural content of vitamin K that may counteract the blood-thinning (anticoagulant) activity of anticoagulants such as warfarin. Discuss with your doctor if you are taking warfarin.

There may also be an interaction between the OLIMEL / PeriOLIMEL products containing electrolytes and the antibiotic ceftriaxone.

OLIMEL / PeriOLIMEL must NOT be administered simultaneously with blood through the same infusion tubing.

There may be interactions between the nutrients in OLIMEL / PeriOLIMEL and one or more of your medications, for example blood thinners. You should review your medications with your doctor.

Proper use of this medication

OLIMEL / PeriOLIMEL 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 the product yourself. Your doctor's instructions must be followed exactly when taking OLIMEL / PeriOLIMEL.

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

Before opening the overpouch, check the colour of the oxygen indicator. Compare it to the reference colour printed next to the OK symbol and depicted in the printed area of the indicator label.

DO NOT USE the product if the colour of the oxygen indicator does not correspond to the reference colour printed next to OK symbol.

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. PeriOLIMEL 2.5% E may be delivered through a central or peripheral vein.

Your health professional will provide instructions on the preparation of the site, route of administration (central or peripheral vein).

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


Tear from the top to open the overpouch.


Peel the front of the overpouch to reveal the OLIMEL / PeriOLIMEL bag. Discard the overpouch and oxygen sachet.


Place the bag flat on an horizontal and clean surface with handle in front of you.


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 PeriOLIMEL or the best OLIMEL product for you, based on your body weight. He/she will also consider how much energy you need and how well your body can handle the amino acids, lipids, and electrolytes in the different solutions

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

Always use OLIMEL / PeriOLIMEL 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 amino acid content may make your blood too acid, the dextrose content may increase the glucose in your blood and urine, or the lipid content may increase the fats in your blood. Giving too high a volume may cause nausea, vomiting and shivering.

In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneys eliminate any excess nutrients.

To prevent these events occurring, your doctor will regularly monitor your condition and test your blood and urine parameters.

In case you feel you have been administered too much or have taken too much OLIMEL / PeriOLIMEL, contact your healthcare practitioner (e.g. doctor), hospital emergency department or the regional poison control centre, even if there are no symptoms.

Missed Dose

If you miss or forget to take one or more doses of OLIMEL / PeriOLIMEL, 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.

Side effects and what to do about them

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.

The tests your doctor will perform while you are taking the medicine should minimise the risk of side effects.

If any abnormal signs or symptoms of an allergic reaction develop, such as fever, shivering, skin rashes, severe headache or breathing difficulties, stop the infusion and contact your doctor immediately (or obtain medical help immediately).

If any side effect gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or a member of your medical team right away.

Side effects may include nausea, diarrhea and abdominal pain.

Other side effects could occur as listed. Notify your doctor immediately should other side effects be encountered:

The following side effect could happen but is rare (less than 1 case out of 1000 prescriptions) in patients taking this medicine:

  • Allergic reactions (hypersensitivity to egg or soybean protein).

The following side effects occur very rarely (less than 1 case out of 10,000 prescriptions) in patients taking this medicine:

  • Abnormal blood test for the liver function.
  • Increase in the size of the liver and spleen (hepatosplenomegaly)
  • Icterus (jaundice, yellowing of the skin and eyes)
  • Decrease in the number of platelets
  • Reduced ability to remove the lipids contained in OLIMEL / PeriOLIMEL may result in a "fat overload syndrome" which may be caused by overdose but may also occur even when the product is administered according to instructions. It is characterised by too much fat in the blood, fever, jaundice (yellowing of the skin and eyes), anemia, a fall in white blood cells and blood platelets, spleen and liver enlargement, problems with blood clotting and low oxygen levels. All of these symptoms are usually reversible when the lipid emulsion infusion is stopped.
  • Precipitates in the blood vessels leading to or from the lungs causing a blockage of an artery in the lungs and difficulty in breathing.

Occasional reddening and stinging may occur at the point where the tubing enters the body. If this occurs, tell your doctor or nurse immediately.

Serious side effects, how often theyhappen and what to do about them

Symptom / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
UncommonFever
Shivering
Skin rashes
Breathing difficulties
Severe headache

This is not a complete list of side effects. For any unexpected effects while taking OLIMEL / PeriOLIMEL, contact your doctor or a member of your medical team or pharmacist.

How to store it

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

Do not use OLIMEL / PeriOLIMEL 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.

Reporting suspected side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701E
                     Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Baxter Corporation at 1-888-719-9955.