What Clinimix E Sulfite Free is used for and how to use it
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Clinimix E Sulfite Free - Consumer Medicine Information

Manufacture: Baxter
Country: Canada
Condition: Total Parenteral Nutrition
Class: Intravenous nutritional products
Form: Liquid solution, Intravenous (IV)
Ingredients: dextrose, amino acids, glacial acetic acid (for pH adjustment), nitrogen, water for injection

CLINIMIX E

(amino acids with electrolytes in dextrose injection) products

About this Medication

What the medication is used for

CLINIMIX E (amino acids with electrolytes in dextrose injection) and CLINIMIX (amino acids without electrolytes in dextrose injection) are intravenous nutritive supplements used to provide nutrition through a tube into a vein when normal feeding by mouth is not possible or suitable.

CLINIMIX E / CLINIMIX products must only be used under medical supervision.

What it does

The use of CLINIMIX E / CLINIMIX products 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

CLINIMIX E and CLINIMIX products should not be used if:

  • You are allergic to any ingredients (See What the medicinal ingredients are and What the nonmedicinal ingredients are).
  • Your body has problems processing certain amino acids and these amino acids are included in CLINIMIX E / CLINIMIX products.
  • You are being administered ceftriaxone.
  • You have high plasma concentrations of one of the electrolytes included in CLINIMIX E.
  • You have liver failure or coma resulting from liver failure.
  • You have kidney failure and are not on dialysis.
  • You have hyperglycemia (too much sugar in your blood), which is not controlled.
  • You have an allergy to corn or corn products since this product contains dextrose from corn.

Also, CLINIMIX E products should not be used if:

  • 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 receiving calcium-containing intravenous solutions.

What the medicinal ingredients are

CLINIMIX E products and CLINIMIX products are solutions for infusion, each supplied in a bag with two chambers:

  • one chamber contains a dextrose solution
  • one chamber contains a solution of an amino acids:

Amino acid chamber in CLINIMIX (Blend B) contains

L-alanine, L-arginine, Glycine, L-histidine, L-isoleucine, L-leucine, L-lysine hydrochloride, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine

Amino acid chamber in CLINIMIX E (Blend B) contains

all amino acids listed under CLINIMIX (Blend B) plus electrolytes in the form of sodium chloride, sodium acetate trihydrate, bibasic potassium phosphate and magnesium chloride hexahydrate

Amino acid chamber in CLINIMIX (Blend C) contains

all amino acids listed under CLINIMIX (Blend B) plus L-Serine

Amino acid chamber in CLINIMIX E (Blend C) contains

all amino acids listed under CLINIMIX (Blend C) plus electrolytes in the form of sodium chloride, sodium acetate trihydrate, bibasic potassium phosphate and magnesium chloride hexahydrate

What the nonmedicinal ingredients are

Glacial acetic acid (for pH adjustment), Nitrogen and Water for injection.

What dosage forms it comes in

CLINIMIX E / CLINIMIX products are solutions for infusion (into the veins). It is supplied in a bag with two chambers. The chambers are separated by a non-permanent seal. Just before administration, the contents of the two chambers are mixed together by rolling the top of the bag to open the seals.

The mixed solution for each of the different strengths provides a different amount of amino acids, dextrose, and, with some formulations, electrolytes so that your healthcare professional can tailor the infusion to your particular needs.

Warnings and Precautions

BEFORE you use CLINIMIX E (amino acids with electrolytes in dextrose injection) or CLINIMIX (amino acids without electrolytes in dextrose injection), talk to your healthcare professional if:

  • You are allergic to any ingredients. (See What the medicinal ingredients are and What the nonmedicinal ingredients are).
  • You suffer from metabolic acidosis (when the blood is excessively acid)
  • You have kidney or liver problems
  • 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
  • You have pulmonary edema (collection of fluid into the lung tissue)
  • You have heart failure
  • You have fluid overload (too much water in your body)
  • You are diabetic
  • You have hereditary fructose intolerance as this product may contain small amounts of fructose.

In all cases, your healthcare professional will base his/her decision to treat you or your child on factors such as age, weight and clinical condition, together with the results of any tests. Always be sure to check with your healthcare professional if anything about your condition changes.

In newborns and infants, your healthcare professional will measure blood ammonia frequently to check for the presence of a congenital abnormality of amino acid metabolism.

If you develop breathing problems during CLINIMIX E / CLINIMIX treatment, contact you doctor immediately.

Your healthcare professional will need to monitor how you are doing while you are on this intravenous nutritive supplement. This means that you will need to have laboratory tests done on a routine basis.

Interactions with this Medication

No drug interaction studies have been done with CLINIMIX E (amino acids with electrolytes in dextrose injection) or CLINIMIX (amino acids without electrolytes in dextrose injection).

CLINIMIX E / CLINIMIX products must NOT be administered simultaneously with blood through the same infusion tubing.

Let your healthcare professional know if you are receiving corticosteroids or corticotropin.

There may be interactions between the nutrients in CLINIMIX E / CLINIMIX products and one or more of your medications, for example diuretics, blood pressure drugs, or drugs used to suppress your immune system. You should review your medications with your healthcare professional.

Proper Use of this Medication

Usual dose

Your healthcare professional will select the best CLINIMIX E (amino acids with electrolytes in dextrose injection) or CLINIMIX (amino acids without electrolytes in dextrose injection) product for you, based on your age and body weight. Your healthcare professional will ensure that you are getting sufficient calories so that the amino acids from TRAVASOL E (amino acids with electrolytes injection) and TRAVASOL (amino acids without electrolytes injection) will be absorbed. Your healthcare professional will also specify a flow rate corresponding to your needs and medical condition.

Overdose

If your dose is too high or is infused too quickly, the amino acid content may make your blood too acid, or the dextrose content may increase the glucose in your blood and urine. Giving too high a volume may cause fluid overload.

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

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

Missed dose

If you feel a dose has been missed contact your attending healthcare professional.

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 healthcare professional or another member of your medical team immediately.

The tests your healthcare professional will perform while you are taking the intravenous nutritive supplement should reduce the risk of side effects.

If any symptoms of an allergic reaction develop, such as fever or chills, shivering, skin rashes, severe headache or breathing difficulties, contact your attending healthcare professional immediately.

Other side effects may include rapid heart beat, sweating, nausea, and vomiting.

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

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

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

Symptom / effectTalk with your
healthcare
professional
Stop the
infusion and
contact your
doctor (or
healthcare
professional)
Only if
severe
In all
cases
UncommonAllergic
reactions with
symptoms such
as fever or chills,
shivering, skin
rashes, breathing
difficulties,
severe headache

This is not a complete list of side effects. For any unexpected effects while taking CLINIMIX E (amino acids with electrolytes in dextrose injection) and CLINIMIX (amino acids without electrolytes in dextrose injection), contact your healthcare professional.

How to Store it

The heatlhcare professional will store the CLINIMIX E / CLNIMIX product at temperatures between 15°C and 25°C, protected from light and kept from freezing.
Once the seals between the chambers have been broken and the product has been mixed, it should be administered to you immediately.

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, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form 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 obtained by contacting the sponsor,
Baxter Corporation, at: 1-888-719-9955.