Consumer Information for: PRIMENE 10%
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
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 non-medicinal ingredients are
L-Malic acid (for pH adjustment), Water for injection
What dosage form 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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Allergic 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
The heatlhcare professional will store the PRIMENE product at temperatures between 15°C and 25°C, protected from light and kept from freezing.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
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.
This leaflet was prepared by Baxter Corporation, Mississauga, Ontario L5N 0C2, Canada.
Baxter and Primene are registered trademarks of Baxter International Inc.
Last revised: December 23, 2019
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|---|---|---|---|
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| APO-SOLIFENACIN | 02423375 | APOTEX INC | SOLIFENACIN SUCCINATE 5 MG |