Smofkabiven Electrolyte Free: Uses, Side Effects and Dosage

What are SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free used for:

SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free deliver nutrition directly into your blood, when normal eating is not possible or appropriate for you.

How do SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free work?

SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free contain a mixture of fats, sugar and amino acids (building blocks for proteins). These are used to provide energy and nutrients when other forms of feeding are not enough or possible.

Your healthcare professionals may add salts, vitamins and trace elements to SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free.

What are the ingredients in SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free?

Medicinal ingredients:

Each 100 mL of mixed product for SmofKabiven Electrolyte Free contains:

Amino acids (building blocks for proteins)

Alanine 710 mg, arginine 610 mg, glycine 560 mg, histidine 150 mg, isoleucine 250 mg, leucine 380 mg, lysine acetate 340 mg, methionine 220 mg, phenylalanine 260 mg, proline 570 mg, serine 330 mg, taurine 50 mg, threonine 220 mg, tryptophan 100 mg, tyrosine 20 mg and valine 310 mg.

Lipids (fats)

Soybean oil 1140 mg, medium-chain triglycerides 1140 mg, olive oil 950 mg and fish oil 570 mg

Dextrose (sugar)

As glucose monohydrate 12.7 g

Electrolytes from the amino acid solution and the lipid emulsion

Acetate 7.5 mmol, phosphate 0.28 mmol

Each 100 mL of mixed product for SmofKabiven extra Nitrogen Electrolyte Free contains:

Amino acids (building blocks for proteins)

Alanine 920 mg, arginine 790 mg, glycine 720 mg, histidine 200 mg, isoleucine 330 mg, leucine 480 mg, lysine acetate 430 mg, methionine 280 mg, phenylalanine 330 mg, proline 730 mg, serine 430 mg, taurine 65 mg, threonine 290 mg, tryptophan 130 mg, tyrosine 26 mg and valine 410 mg.

Lipid (fats)

Soybean oil 870 mg, medium-chain triglycerides 870 mg, olive oil 720 mg and fish oil 430 mg

Dextrose (sugar)

As glucose monohydrate 8.5 g

Electrolytes from the amino acid solution and the lipid emulsion

Acetate 9.6 mmol, phosphate 0.22 mmol

Non-medicinal ingredients in SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free: Glycerol

Purified egg phospholipids

all-rac-α-Tocopherol

Sodium hydroxide (pH adjuster)

Sodium oleate

Acetic acid, glacial (pH adjuster)

Hydrochloric acid (pH adjuster)

Water for injection

SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free come in the following dosage forms:

SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free consist of three separate chambers:

• One chamber with a mixture of fats which is:

  • Like milk
  • Consistent

• One chamber with a solution of amino acids (building blocks for proteins) which is:

  • Clear
  • Colourless to slightly yellow

• One chamber with a sugar solution which is:

  • Clear
  • Colourless to slightly yellow

Before use, break the seals between the chambers to mix the components together. The mixture will be:

• Cloudy
• White
• Consistent

Do not use SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free if:

• You are allergic (hypersensitive) to fish, eggs, peanuts, soya or any of the ingredients of SmofKabiven Electrolyte

  Free and SmofKabiven extra Nitrogen Electrolyte Free (see What are the ingredients in SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free)

• You have very high amounts of fats in your blood (severe hyperlipidemia)
• Your liver does not work properly
• Your body cannot use amino acids properly since birth
• You have a severely reduced ability to stop bleeding
• Your kidneys do not work properly and you are not on any type of blood purification (dialysis or hemofiltration)
• You have such a drop in blood pressure that you could die (shock)
• Your blood sugar is out of control
• You have a disease affecting your blood and immune system, called hemophagocytotic syndrome
• You have water build-up in your lungs (acute pulmonary edema)
• You have excess water in your body (hyperhydration)
• You have acute heart failure
• You have an unstable medical condition

To help avoid side effects and ensure proper use, talk to your doctor or pharmacist before you take SmofKabiven Electrolyte Free or SmofKabiven extra Nitrogen Electrolyte Free. Talk about any health conditions you may have, including if:

• You have high amounts of fats in your blood
• You have an allergy to soybean, fish or eggs, which may rarely cause allergic reactions. Soybean may also cause reactions in patients who are allergic to peanuts.

• You cannot use fats and amino acids (building blocks for proteins) properly because you have:

  • Kidney or liver problems
  • High levels of sugar in your blood (diabetes)
  • An inflamed pancreas (pancreatitis)
  • Low amounts of thyroid hormones (hypothyroidism)
  • A full-body infection (sepsis) that can lead to death
• You have heart problems

• You are pregnant or planning to become pregnant

• You are breast feeding or planning to breastfeed
• You are taking any other medications.

Other warnings you should know about:

Severe allergic reaction: If you develop any symptoms of an allergic reaction while taking SmofKabiven Electrolyte Free or SmofKabiven extra Nitrogen Electrolyte Free stop the infusion and seek immediate medical help. Symptoms may include:

• Fever
• Shivering
• Sweating
• Headache
• Skin rashes
• Trouble breathing

Fat overload syndrome: This might happen if your body has problems using fats and you received too much SmofKabiven Electrolyte Free or SmofKabiven extra Nitrogen Electrolyte Free. It may also happen if there is a sudden change in your condition, such as kidney problems or an infection. Contact your healthcare professional immediately if you experience any of the following symptoms:

• Fever
• High levels of fats in your blood
• Yellowing of the skin and eyes
• A drop in the number of red blood cells
• Difficulty to stop bleeding
• A drop in the number of white blood cells and platelets
• Increase in the size of the liver and spleen
• Coma

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 SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free:

• Blood-thinning substances

  Inform your doctor if you are taking any blood-thinning substances such as heparin or coumarin derivates (warfarin) that help prevent blood clots.

  Soybean oil has a natural content of vitamin K1 which promotes blood clotting. However, the amount of soybean oil in SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free is very low and not expected to significantly prevent the blood-thinning effect of coumarins.

• Laboratory tests

  SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free may interfere with certain

  laboratory tests. It is important to tell any doctor doing tests that you are using SmofKabiven Electrolyte Free or SmofKabiven extra Nitrogen Electrolyte Free.

How to take SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free:

• SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free can be given:

  • In a hospital
  • In a managed care facility

  • At home

    • under the supervision of a healthcare professional.
    • by yourself, after appropriate training and with the agreement of your healthcare team.
• Additional nutrients may be added by pharmacy professionals.
• Use SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free only if the mixture is consistent and looks like milk.
• Use only if the bag is not damaged.
• Use germ-free (aseptic) procedures.
• The bag should only be used once.
• Throw away any unused product.

Usual adult dose:

• You will receive your medicine by injection directly into your blood.

• Your healthcare professional will control how much and how fast SmofKabiven Electrolyte Free and

  SmofKabiven extra Nitrogen Electrolyte Free are given, based on your needs and medical condition.

• SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free should be given continuously, over 14 to 24 hours.
• Your doctor will monitor your condition and periodically test your blood and urine.

Instructions for use and handling

Before administering the product in the plastic bag to the patient, intravenously, review these directions:

These instructions are only intended as guidelines for product use. Please ask your healthcare professional for detailed instructions on handling.

Overdose:

If you think that the dose you have received was too high or was infused too quickly, inform your healthcare professional immediately. In case of overdose there is a risk of receiving too much fat. This is called “fat overload syndrome”. In these cases, the infusion should be stopped or, if necessary, continued at a reduced dosage. See section “Other warnings you should know about” for more information.

If you have any further questions on the use of this product, ask your healthcare professional.

If you think you have taken too much SmofKabiven Electrolyte Free or SmofKabiven extra Nitrogen Electrolyte Free, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

What are possible side effects from using SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen

Electrolyte Free?

These are not all the possible side effects you may feel when taking SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Nausea
• Vomiting
• Chills

SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

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.

Storage:

Store below 25 °C. Do not freeze.

Store bags in overwrap. Keep out of reach and sight of children.

Do not use SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free after the expiry date which is printed on the bag (YYYY-MM). The expiry date refers to the last day of the month.

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

For patient comfort, SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free should be at room temperature before administration.

Reporting Side Effects

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.

If you want more information about SmofKabiven Electrolyte Free or SmofKabiven extra Nitrogen Electrolyte Free:

• 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (http://www.fresenius-kabi.ca), or by calling 1-877-821-7724 (toll-free-telephone).

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd., Suite 100

Toronto, ON M9W 0C8

Last revised: July 9, 2020

Fresenius Kabi, is a registered trademark of Fresenius SE,

SmofKabiven and SMOFlipid are registered trademarks of Fresenius Kabi AG, and Biofine is a registered trademark of Fresenius Medical Care.