Patient Medication Information: uses, side effects, how to take - Clinoleic 20%
What is CLINOLEIC 20% 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.
How does CLINOLEIC 20% work?
CLINOLEIC 20% ensures there is an adequate intake of calories and essential fatty acids. This helps to prevent or treat malnutrition.
What are the ingredients in CLINOLEIC 20%?
Medicinal ingredients: 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).
Non-medicinal ingredients: Purified 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.
CLINOLEIC 20% comes in the following dosage forms:
CLINOLEIC 20% is supplied in a bag which contains either 250 mL or 500 mL of emulsion.
Do not use CLINOLEIC 20% if:
- You are allergic to any ingredients (such as egg and soybean or peanut proteins, olive or soybean oil). (See What are the ingredients in CLINOLEIC 20%)
- 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)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLINOLEIC 20%. 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 or soybean oil.)
- have acute respiratory distress syndrome/pulmonary edema. This is a serious condition where fluid builds up in your lungs.
- have liver problems
- have an electrolyte imbalance (too much or too little electrolytes in the blood)
- suffer from metabolic disorders (such as where your body cannot break down fats properly)
- have fluid overload (too much water in your body)
- have heart problems
- have kidney problems
are pregnant or intend to become pregnant
- are breastfeeding or intend to breastfeed
Other warnings you should know about:
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.
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 CLINOLEIC 20%:
- Blood thinner medicines such as warfarin
How to take CLINOLEIC 20%:
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 CLINOLEIC 20%yourself. Your doctor's instructions must be followed exactly when taking CLINOLEIC 20%.
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.
Administration:
Preparation:
CLINOLEIC 20% is a multi-layer bag, which includes:
- Multi-layer bag with 2 port tubes (1 injection site and 1 administration port)
- an oxygen absorber / oxygen indicator sachet
- an overpouch
To protect from air contact, the bag is packaged in an oxygen barrier overpouch. The overpouch contains an oxygen absorber / oxygen indicator sachet.
Before you open 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 is not the same as the colour printed next to the OK symbol.
To open:
- Remove the protective overpouch.
- Discard the overpouch and oxygen absorber.
- Use only if the bag is not damaged and the product has a consistent milky appearance and with no visible oil droplets at the surface.
To administer:
- Aseptic conditions must be followed (cleaning of hands).
- Hang the bag.
- Twist off the protector from the administration outlet.
- Firmly plug the spike connector.
- Use contents immediately. Never make any additions directly to the bag.
- Your health care professional will provide instructions on preparation of the injection site, a route of administration (central or peripheral vein) and specify a flow rate corresponding to your needs and medical condition.
- Clinoleic should only be used once. Throw away any medication that has not been used. Do not reuse partially used bag.
Usual dose:
Your doctor will decide how much CLINOLEIC 20% you will need and how long it will be given to you. The dose will depend on your body weight, nutritional requirements and on the reason you are being given the treatment.
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% may increase the fats in your blood. This may result in fever and a worsening of your health that may require hospitalization.
To help prevent these events, your doctor will regularly monitor your condition, and test your blood and urine.
| If you think you, or a person you are caring for, have been given too much or taken too much CLINOLEIC 20%, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
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.
What are possible side effects from using CLINOLEIC 20%?
These are not all the possible side effects you may have when taking CLINOLEIC 20%. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include
- Nausea
- Vomiting
- Diarrhea
- Muscle spasm
- Abdominal pain
- Bloating
- Weakness and lack of energy
- Low blood pressure
- Back pain
- Fever
- Hot flashes
- Rash
- Itchiness
- Chills
CLINOLEIC 20% can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
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 and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Allergic reaction: difficulty swallowing or breathing, fever, headache, shivering, skin rash or hives, shortness of breath, swelling of the face, lips, tongue or throat. | √ | ||
| RARE | |||
| Liver Problems: yellow colour to skin, whites of the eyes (jaundice), Abdominal pain, itching, fatigue, fever, confusion, sleepiness, nausea, vomiting, dark stool | √ | ||
| Fat Overload Syndrome (too much fat in the blood): fever, jaundice (yellowing of the skin and eyes), blood clotting, fatigue, irregular heartbeats, pale complexion, trouble breathing, coma | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature (15 to 30oC). 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.
Keep out of reach and sight of children.
If you want more information about CLINOLEIC 20%:
- 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/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.baxter.ca), or by calling 1-800-719-9955.
Baxter and Clinoleic are registered trademarks of Baxter International Inc.