ProSo - Consumer Medicine Information
|Condition:||Nutrition, Parenteral (Total Parenteral Nutrition)|
|Form:||Liquid solution, Intravenous (IV)|
(Amino Acid Injection 20% w/v)
About this Medication
What the medication is used for
What the medication is used for: 20% ProSol (Amino Acid Injection 20% w/v) when administered with a source of energy is used as a source of amino acid nutrition in patients where:
- the digestive tract cannot or should not be used;
- absorption of protein in the stomach or intestine is impaired, or
- the needs for protein are greatly increased, as with extensive burns.
What it does
The use of 20% ProSol product 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
20% ProSol (Amino Acid Injection 20% w/v) should not be used in the following populations/situations:
- You are allergic to any of the ingredients (see What the medicinal ingredients are and What the nonmedical are)
- Your body has problems processing certain amino acids and these amino acids are included in ProSol product.
- You have liver failure or coma resulting from liver failure
What the medicinal ingredients are
|Ingredients (g)||Per 100mL|
|L-Aspartic Acid,||0.600 g|
|L-Glutamic Acid||1.02 g|
What the nonmedicinal ingredients are
Glacial acetic acid (for pH adjustment), nitrogen, and water for injection.
What dosage forms it comes in
- 20% ProSol (Amino Acid Injection 20% w/v) is a sterile, clear, solution of amino acids. It is supplied in a bag.
- 20% ProSol (Amino Acid Injection 20% w/v) is intended for use in pharmacy preparation programs and should only be used for the preparation of solutions for intravenous infusion, used to provide nutrition through a tube into a vein when normal feeding by mouth is not possible or suitable.
- your healthcare professional can tailor the infusion to your particular needs
Warnings and Precautions
BEFORE you use 20% ProSol (Amino Acid Injection 20% w/v), 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 taking calcium-containing intravenous solutions
- 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)
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.
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
Drugs that may interact with 20% ProSol (Amino Acid Injection 20% w/v) include:
- No drug interaction studies have been performed with 20% ProSol (Amino Acid Injection 20% w/v).
- Let your healthcare professional know if you are receiving corticosteroids or corticotropin.
- Do not give tetracycline at the same time with 20% ProSol (Amino Acid Injection 20% w/v) as it may interfere with the effects of the amino acids
- 20% ProSol (Amino Acid Injection 20% w/v) must not be administered at the same time with blood through the same tubing with blood
- Do not give calcium at the same time as 20% ProSol (Amino Acid Injection 20% w/v) as particles may form which may lead to serious adverse reactions.
Proper Use of this Medication
20% ProSol (Amino Acid Injection 20% w/v) product is in pharmacy bulk package and are not for direct infusion. Your healthcare professional will reconstitute the products so they can be administered safely.
Your healthcare professional will tailor the infusion to your particular needs based on your age and body weight. Your healthcare professional will ensure that you are getting sufficient calories so that the amino acids from 20% ProSol (Amino Acid Injection 20% w/v) product will be absorbed. Your healthcare professional will also specify a flow rate corresponding to your needs and medical condition.
If your dose is too high or is infused too quickly, the amino acid content may make your blood too acidic. 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 ProSol product, contact your healthcare practitioner (e.g. healthcare professional), hospital emergency department or the regional poison control centre, even if there are no symptoms.|
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.
Side effects which have been reported with injectable nutrition products may include symptoms of an allergic reaction, such as fever or chills, shivering, skin rashes, severe headache or breathing difficulties. If you experience any of these symptoms, contact your attending healthcare professional immediately.
Other side effects which have been reported with injectable nutrition products may include rapid heart beat, sweating, nausea, vomiting, abdominal swelling, pain on the right side of your belly area (liver).
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 / effect||Talk with your doctor or pharmacist||Stop the infusion and contact your doctor (or healthcare professional)|
|Only if severe||In all cases|
|Uncommon*||Allergic reactions with symptoms such as fever or chills, shivering, skin rashes, breathing difficulties, severe headache||✓|
* Side effects that have been reported with injectable nutrition products.
This is not a complete list of side effects. For any unexpected effects while taking 20% ProSol (Amino Acid Injection 20% w/v), contact your healthcare professional.
How to store it
The heatlhcare professional will store the 20% ProSol (Amino Acid Injection 20% w/v) at temperatures between 15°C and 25°C, and protected from light.
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
Postal Locator 0701E
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.
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.