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

Manufacture: Baxter
Country: Canada
Condition: Nutrition, Parenteral (Total Parenteral Nutrition)
Class: Nutritional products
Form: Liquid solution, Intravenous (IV)
Ingredients: L-Alanine 800mg, L-Arginine 840mg, L-Aspartic Acid 600mg, L-Cysteine 189mg, L-Glutamic Acid 1000mg, Glycine 400mg, L-Histidine 380mg, L-Isoleucine 670mg, L-Leucine 1000mg, L-Lysine 1100mg, L-Methionine 240mg, L-Ornithine Hydrochloride 318mg, L-Phenylalanine 420mg, L-Proline 300mg, L-Serine 400mg, Taurine 60mg, L-Threonine 370mg, L-Tryptophan 200mg, L-Tyrosine 45mg, L-Valine 760mg, L-Malic acid (for pH adjustment), water for injection

PRIMENE 10%

(Amino Acid Injection 10% w/v)

About this Medication

What the medication is used for

PRIMENE 10% (Amino Acid Injection 10% w/v) is a nutritive supplement used to provide nutrition to infants and young children, through a tube in a vein when normal feeding by mouth or enterally (directly to the stomach through a tube) is not possible or suitable.

PRIMENE product must be administered by a healthcare professional.

What it does

The use of PRIMENE product is a way to ensure that patients (young children and infants) who are unable to eat, get an adequate intake of energy, nitrogen and other nutrients, and helps treat or prevent malnutrition.

When it should not be used

PRIMENE 10% (Amino Acid Injection 10% w/v) should not be used if your child:

  • is allergic to any ingredients (See What the medicinal ingredients are and What the nonmedicinal ingredients are.)
  • has problems processing some amino acids and these amino acids are included in PRIMENE product
  • has liver failure or coma from liver failure
  • has decreased kidney function resulting in absence or defective urine output

What the medicinal ingredient is

Each 100mL of solution contains:
L-Alanine 800mg, L-Arginine 840mg, L-Aspartic Acid 600mg, L-Cysteine 189mg, L-Glutamic Acid 1000mg, Glycine 400mg, L-Histidine 380mg, L-Isoleucine 670mg, L-Leucine 1000mg, L-Lysine 1100mg, L-Methionine 240mg, L-Ornithine Hydrochloride 318mg, L-Phenylalanine 420mg, L-Proline 300mg, L-Serine 400mg, Taurine 60mg, L-Threonine 370mg, L-Tryptophan 200mg, L-Tyrosine 45mg, L-Valine 760mg

What the important nonmedicinal ingredients are

L-Malic acid (for pH adjustment), Water for injection

What dosage forms it comes in

PRIMENE product is a 250 ml solution for infusion (into the vein). It is supplied in a glass bottle.

The 10% amino acid solution will be mixed with other solutions for infusion, by your child's healthcare professional who can tailor the infusion to your child's particular needs.

Warnings and Precautions

Your child's healthcare professional may run tests to determine the status of some conditions. BEFORE PRIMENE product is administered to your child, talk to your child's healthcare professional if your child:

  • is allergic to any ingredients. (See What the medicinal ingredients are and What the nonmedicinal ingredients are).
  • suffers from too much ammonia in the blood
  • suffers from metabolic acidosis (when the blood is excessively acid)
  • suffers from metabolic alkalosis (when the blood is excessively basic)
  • suffers from low phosphate in the blood
  • has kidney or liver problems
  • is taking any other medicines on a regular basis
  • has pulmonary edema (collection of fluid into the lung tissue)
  • has heart failure
  • has fluid overload (too much water in your body)

In all cases, your child's healthcare professional will base his/her decision to treat 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 child's healthcare professional if anything about your child's condition changes.

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

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

Interactions with this Medication

Drugs that may interact with PRIMENE 10% (Amino Acid Injection 10% w/v) include:

No drug interaction studies have been done with PRIMENE.

PRIMENE product must NOT be administered simultaneously with blood through the same infusion tubing.

Let your child's healthcare professional know if your child is receiving tetracycline.

Proper Use of this Medication

Usual dose

PRIMENE 10% (Amino Acid Injection 10% w/v) is in pharmacy bulk package and are not for direct infusion. Your child's pharmacist will mix the products so they can be administered safely by the healthcare professional based on your child's age, body weight and your child's clinical requirements.

Your child's healthcare professional will ensure that your child is getting sufficient calories so that the amino acids from PRIMENE product will be absorbed.

Overdose

If a dose is too high or is infused too quickly, blood may become acidic or your child may suffer fluid overload.

To prevent this, the healthcare professional may monitor your child and test the blood and urine.

In case you feel your child has been administered too much PRIMENE product, contact your child's 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 child's attending healthcare professional.

Side Effects and what to do about them

If you notice any changes in the way your child feels during or after the treatment, tell your child's healthcare professional or another member of your child's medical team immediately.

The tests your child's healthcare professional will perform while your child is taking the intravenous nutritive supplement should reduce the risk of side effects.

If any symptoms of an allergic reaction develop, such as swelling of face or eyelid, skin rash contact your child's attending healthcare professional immediately.

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

Occasional reddening and stinging may occur at the point where the tubing enters the body. If this occurs, tell your child's 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
swelling
(face,
mouth,
throat, or
eyelid),
skin rash,
and
difficulty
breathing

This is not a complete list of side effects. For any unexpected effects while taking PRIMENE 10% (Amino Acid Injection), contact your healthcare professional.

How to store it

The heatlhcare professional will store the PRIMENE product at temperatures between 15°C and 25°C, protected from light and kept from freezing.

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 0701C
      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 be found at: http://www.baxter.ca or by contacting the sponsor, Baxter Corporation, at: 1-888-719-9955.