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

Manufacture: Baxter
Country: Canada
Condition: Total Parenteral Nutrition
Class: Intravenous nutritional products
Form: Liquid solution, Intravenous (IV)
Ingredients: refined olive oil (approximately 160 g), refined soybean oil (approximately 40 g), egg phosphatides, glycerol, sodium oleate and water for injection

CLINOLEIC 20%

Refined Olive Oil and Refined Soybean Oil Lipid Emulsion (approximately 16%/4% w/w)

Lipid Emulsion for Intravenous Nutrition

About this medication

What the medication is used for

CLINOLEIC 20% is as a source of calories and essential fatty acids when you are unable to take food by mouth.

CLINOLEIC 20% must only be used under medical supervision.

What it does

The use of CLINOLEIC 20% is a way to ensure an adequate intake of calories and essential fatty acids and thus helps to prevent or treat malnutrition.

When it should not be used

Do not use CLINOLEIC 20%, if:

  • You are allergic to any ingredients (such as egg and soybean proteins, olive or soybean oil). (See What the important nonmedicinal ingredients are.)
  • Your body has severe problems metabolizing (breaking down) lipids or fats.
  • You have very high levels of fats in your blood.
  • You have acute pancreatitis (severe inflammation of pancreas) in association with hyperlipidemia (high blood fat levels)

What the medicinal ingredient are

CLINOLEIC 20% is a lipid (fat) emulsion for intravenous infusion. Each 1000 mL contains 200 g of a mixture of refined olive oil (approximately 160 g) and refined soybean oil (approximately 40 g).

What the important nonmedicinal ingredients are

Egg Phosphatides, Glycerol, Sodium Oleate and Water for Injection. A small quantity of Sodium Hydroxide may be used to adjust the acidity of the solution.

What dosage forms it comes in

CLINOLEIC 20% is supplied in a bag which contains either 100 mL, 250 mL, 350 mL, 500 mL or 1000 mL of emulsion.

Warnings and precautions

BEFORE you use CLINOLEIC 20%, talk to your doctor or pharmacist if:

  • You are allergic to any ingredients (such as egg and soybean proteins, olive or soybean oil). (See What the important nonmedicinal ingredients are.)
  • You have acute respiratory distress syndrome (difficulty in breathing)
  • You have kidney or liver problems.
  • You have severe problems metabolizing (breaking down) lipids or fats OR you have high levels of fat in your blood.
  • 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.

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 te sts 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.

If you are taking a blood thinning agent of the coumarin type (like warfarin), you should talk to your doctor or pharmacist. Olive and soybean oils in CLINOLEIC 20% have a natural content of Vitamin K1 that may counteract the anticoagulant activity of coumarin derivatives, including warfarin.

Proper use of this medication

CLINOLEIC 20% is 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 CLINOLEIC 20%.

Administration

Preparation

a.) The product is packaged in a multi-layer bag, fitted with an injection port and with an administration port for insertion of the spike of the infusion set. To protect from air contact, the bag packaged in an oxygen barrier overpouch, which contains an oxygen absorber / oxygen indicator sachet. Do not use the EXACTAMIX Inlet H938173 with an EXACTAMIX compounder to transfer CLINOLEIC 20% injection. This inlet spike has been associated with dislodgement of the administration port membrane into the CLINOLEIC 20% injection bag.

b.) Before opening the overpouch, check the colour of the oxygen indicator. Compare it to the reference colour printed next to the OK symbol and shown on 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 the OK symbol.

c.) To open: Remove the protective overpouch.
Discard the oxygen absorber / oxygen indicator sachet.
Confirm the integrity of the bag. Use only if the bag is not damaged and if the lipid emulsion is an evenly distributed liquid with a milky appearance and with no visible oil droplets at the surface.

d.) To administer:

  • Aseptic conditions must be followed (cleaning of hands).
  • Suspend the bag.
  • Remove the plastic protector from the administration set.
  • Insert the spike of the infusion set into the administration port of the bag.
  • Use of a final filter (not less than 1.2 micron pore size) is recommended during administration of all parenteral nutrition solutions
  • Use contents immediately.
  • Never make any additions directly to the bag.
  • Your health care professional will provide instructions on preparation of site, a route of administration (central or peripheral venous route), and specify a flow rate corresponding to your needs and medical condition.
  • ClinOleic should only be used once. Discard unused portion, do not reuse partially used bag, 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.

Usual dose

Your doctor will decide how much of the treatment you will need and how long it will be given to you. The dose will depend on your nutritional requirements and on the reason you are being given the treatment.

The emulsion will usually be given to you via a plastic tube which will be placed very carefully into the vena cava, a larger vein in your chest. Non-nutritional intravenous solutions and blood may be given through this tube (but generally not at the same time).

Your doctor will provide any other specific instructions corresponding to your needs and medical condition.

Always use CLINOLEIC 20% exactly as your doctor has told you to. You should check with your doctor if you are not sure.

Overdose

If your dose is too high CLINOLEIC 20% content may increase the fats in your blood which may result in fever and a worsening of your health that may require hospitalization.

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 CLINOLEIC 20%, contact your doctor, hospital emergency department or the regional poison control centre.

Missed Dose

If you miss or forget to take one or more doses of CLINOLEIC 20%, 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/chills, skin rashes or hives, severe headache or breathing difficulties, you must stop the infusion 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.

You may suffer fat overload syndrome while taking CLINOLEIC 20%. Contact your doctor if you suffer symptoms such as fever, jaundice (yellowing of the skin or eyes).

There have been reports of liver problems and liver failure in patients who take similar products as part of an intravenous nutrition therapy. If you suffer symptoms such as nausea, vomiting, abdominal pain, dark stool, yellowing of the skin or eyes, contact your doctor immediately.

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

The most frequent adverse drug reactions noted for CLINOLEIC 20% in clinical trials were nausea/vomiting and muscle spasm. Other reactions that occurred in at least 1 in every 100 patients included increased blood triglycerides, , hyperglycemia (increased blood sugar), and decreased mean arterial pressure and hypotension (low blood pressure).

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

Serious side effects, how often they happen 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 CLINOLEIC 20%, contact your doctor or a member of your medical team or pharmacist.

How to store it

Store at room temperature (15 to 30°C). Do not freeze. Store in protective overpouch.

Do not use CLINOLEIC 20% 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 you have broken the seal on the administration port, use the bag within 12 hours. Do not keep the unsealed bag longer than 24 hours. Do not re-use a partially empty bag.

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 0701D
                     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 .