Details for: 20% PROSOL
Company: BAXTER CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02141450 | 20% PROSOL | LYSINE (LYSINE ACETATE); HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; DL-METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; L-ASPARTIC ACID; TYROSINE; VALINE | 1.35 G / 100 ML; 1.18 G / 100 ML; 1.08 G / 100 ML; 1.08 G / 100 ML; 1 G / 100 ML; 0.98 G / 100 ML; 0.76 G / 100 ML; 0.32 G / 100 ML; 2.76 G / 100 ML; 2.06 G / 100 ML; 1.96 G / 100 ML; 1.34 G / 100 ML; 1.02 G / 100 ML; 1.02 G / 100 ML; 0.6 G / 100 ML; 0.05 G / 100 ML; 1.44 G / 100 ML | LIQUID | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
20% ProSol is given to you with other products that contain a source of energy as a source of amino acids. These are nutrients your body needs to make proteins. 20% ProSol is given to you where:
- You cannot or should not eat normally.
- Your stomach cannot absorb amino acids properly, or
- Your body needs more proteins than usual. An example is when you have extensive burns.
What it does
20% ProSol is given to you with other products through an infusion into your vein. It contains amino acids, which are used by your body to make proteins.
When it should not be used
Do not use 20% ProSol if:
- You are allergic to any of the ingredients in 20% ProSol or components of the container. (See What are the ingredients in 20% ProSol).
- Your body has problems processing certain amino acids and these amino acids are included in this 20% ProSol product.
- You have liver failure or coma resulting from liver failure.
- You have kidney failure and you are not currently getting any treatment for it.
What the medicinal ingredient is
| Ingredients (g) | Per 100mL |
|---|---|
| Essential Amino Acids | |
| L-Valine | 1.44 g |
| L-Histidine | 1.18 g |
| L-Isoleucine | 1.08 g |
| L-Leucine | 1.08 g |
| L-Phenylalanine | 1.00 g |
| L-Threonine | 0.980 g |
| L-Lysine | 0.957 g |
| L-Methionine | 0.760 g |
| L-Tryptophan | 0.320 g |
| Non-Essential Amino Acids | |
| L-Alanine | 2.76 g |
| Glycine | 2.06 g |
| L-Arginine | 1.96 g |
| L-Proline | 1.34 g |
| L-Glutamic Acid | 1.02 g |
| L-Serine | 1.02 g |
| L-Aspartic Acid | 0.600 g |
| L-Tyrosine | 0.050 g |
What the non-medicinal ingredients are
Glacial acetic acid (for pH adjustment), and water for injection.
What dosage form it comes in
Solution for infusion supplied in bags, 20% w/v amino acids.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take 20% ProSol. Talk about any health conditions or problems you may have, including if you:
- You suffer from metabolic acidosis (when the blood is very acidic).
- Have diabetes.
- Have problems with your metabolism.
- You have kidney problems.
- You have liver problems.
- 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) or problems with water and electrolytes.
Other warnings you should know about
In all cases, your healthcare professional will base their decision to treat you or your child on
factors such as age, weight and clinical condition, together with the results of any tests.
Always check with your healthcare professional if anything about your condition changes.
20% ProSol can cause serious allergic reactions. Tell your healthcare professional right away if
you have symptoms such as difficulty swallowing or breathing, fever, headache, shivering, skin
rash or hives, shortness of breath, swelling of the face, lips, tongue or throat.
In newborns and infants, your healthcare professional will measure blood ammonia often to
check for a condition called “congenital abnormality of amino acid metabolism.” This is a
condition from birth where your child cannot metabolize amino acids properly.
Your healthcare professional will need to monitor how you are doing while you are on 20%
ProSol. This means that you will need to have laboratory tests done on a routine basis.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with 20% ProSol:
- corticosteroids or corticotropin.
- tetracycline.
- medicines or infusions containing calcium.
Proper use of this medication
How to take 20% ProSol:
- 20% ProSol will be given to you by a healthcare professional.
- Your healthcare professional will make sure that 20% ProSol is prepared correctly before it is given to you.
- 20% ProSol will be infused into your vein.
- 20% ProSol will be given to you with other with other products that contain a source of energy.
Usual Dose
Your healthcare professional will decide about the amount of 20% ProSol you should receive based on your age, bodyweight, and medical condition.
Overdose
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. This may cause severe side
effects or death.
To prevent these events occurring, your healthcare professional will regularly monitor your
condition and test your blood and urine levels.
In case you feel you have been administered too much 20% 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.
Missed Dose
If you feel a dose has been missed, contact your attending healthcare professional.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking 20% ProSol. If you
experience any side effects not listed here, contact your healthcare professional.
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.
Side effects may include:
- rapid heart beat
- sweating
- nausea
- vomiting
- stomach swelling
- pain on the right side of your stomach area (liver)
- muscle and joint pain
| 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 reaction: difficulty swallowing or breathing, fever, headache, shivering, skin rash or hives, shortness of breath, swelling of the face, lips, tongue or throat. | ✔ | ||
| Hyperammonemia (high ammonia levels in the blood): headache, vomiting, confusion, irritability | ✔ | ||
| Azotemia (high nitrogen levels in the body): fatigue, fever, chills, nausea, swelling of feet or ankles, dark or red-coloured urine, change in how often you urinate | ✔ | ||
| Pulmonary vascular precipitates (a condition where solids from the solution form in the lungs): chest pain, cough, shortness of breath | ✔ | ||
| Liver Problems: yellow colour to skin, whites of the eyes (jaundice), Abdominal pain, itching, fatigue, fever, confusion, sleepiness | ✔ | ||
| Infusion site reaction: redness, pain, swelling, and stinging at the point where the tubing enters the body for infusion. | ✔ | ||
* Side effects that have been reported with injectable nutrition products.
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.
How to store
The heatlhcare professional will store 20% ProSol at temperatures between 15°C and 25°C,
protected from light, excessive heat, and freezing.
Keep out of reach and sight of children.
Reporting side effects
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
If you want more information about 20% ProSol:
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.baxter.ca, or by calling 1-800-719-9955.
This leaflet was prepared by Baxter Corporation, Mississauga, Ontario L5N 0C2, Canada.
Baxter, ProSol and Viaflex are registered trademarks of Baxter International Inc.
Last Revised April 13, 2021