Details for: CLINOLEIC 20%
Company: BAXTER CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02344327 | CLINOLEIC 20% | OLIVE OIL; SOYBEAN OIL | 16 % / W/W; 4 % / W/W | EMULSION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 is
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 non-medicinal 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 form 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.
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.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Fever | ✔ | ||
| 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
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.
Reporting 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 three 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 Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 .
This leaflet was prepared by Baxter Corporation, Mississauga,
Ontario L5N 0C2
Baxter and Clinoleic are registered trademarks of Baxter
International Inc.
Last revised: July 30, 2014