Physioneal 40 Glucose 1.36%: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PHYSIONEAL 40 solution is a sterile peritoneal dialysis solution used in patients whose kidneys are not working properly. It removes waste products and water from the blood.

PHYSIONEAL 40 solution can also be used in some cases of drug intoxication.

PHYSIONEAL 40 solution has not been studied for use in children (younger than 18 years old). If PHYSIONEAL 40 solution is considered for use in these patients, the doctor will weigh the risks of side effects against the benefits for the patient.

What it does:

PHYSIONEAL 40 solution contains glucose which draws fluid and wastes from your blood stream into your peritoneal cavity (the space inside your abdomen). The fluids and wastes are removed from your body when the PHYSIONEAL 40 solution is drained.

When it should not be used:

Do not use PHYSIONEAL 40 solution if you:

• have a problem involving your abdominal wall or cavity that cannot be corrected by surgery (e.g. hernia, ileus, adhesions, imperfections in the muscle

  • tumours)
  • have a problem that increases your risk of an abdominal infection (e.g., skin infections, burns, bowel perforations or recent abdominal surgery)
  • have severe peritoneal scarring
  • have severe shortness of breath
  • are malnourished
  • cannot break down fats

  • are pregnant, unless under the close supervision of a doctor

What the medicinal ingredients are:

Glucose

Calcium Chloride

Magnesium Chloride

Sodium Chloride

Sodium Bicarbonate

Sodium Lactate

What the nonmedicinal ingredients are:

Hydrochloric acid concentrated (for pH adjustment),

Sodium hydroxide (for pH adjustment)

Carbon Dioxide

Water for injection

What dosage forms it comes in:

PHYSIONEAL 40 solution is available in a Viaflex bag with 2 chambers holding 5000 mL of final solution after mixing. The number 40 in the name specifies the buffer concentration of the solution (15 mmol/L of lactate + 25 mmol/L of bicarbonate = 40 mmol/L)

WARNINGS AND PRECAUTIONS

BEFORE you use PHYSIONEAL 40 solution talk to your doctor, nurse or pharmacist if you:

• have diabetes. Blood glucose levels should be monitored and your dosage of insulin or other treatment for hyperglycemia should be adjusted by your doctor.
• have secondary hyperparathyroidism, the benefits and risks of the use of dialysis solution with 1.25mmol/L calcium content should be carefully considered with your doctor as it might worsen hyperparathyroidism.
• have elevated lactate levels or have a condition known to increase the risk of lactic acidosis (severe low blood pressure, sepsis, liver or kidney failure, inborn errors of metabolism, taking drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs))
• take cardiac glycosides, such as digoxin.
• are breastfeeding.

If you are allergic to corn or corn products, undesirable allergic reactions, including development of rash, hives, throat and/or facial swelling, wheezing, shortness of breath, low blood pressure, and other anaphylactic/anaphylactoid reactions, may occur. Stop the infusion immediately and drain the solution from the peritoneal cavity if any signs or symptoms of a suspected allergic reaction develop and seek immediate medical help.

Tell your doctor, nurse or pharmacist about any other conditions you have that may affect the inside, outside or the wall of your abdomen.

Patients on PHYSIONEAL 40 solution may experience high or low levels of potassium, calcium, or magnesium in their blood. Your doctor will monitor your blood test results.

Keep a written note of your weight, a record of the volume liquids added to your body including peritoneal dialysis solutions infused and liquids drunk and the volume of liquids removed from your body including the volume of the peritoneal dialysis solution drained and urine volume, together with any other measurements which your doctor has asked you to record. Contact your doctor, nurse or pharmacist if your drained volume is more than expected.

Protein, amino acids, water soluble vitamins and other medicines may be removed during peritoneal dialysis. Your doctor may recommend supplementation to your diet and other changes.

Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis (inflamed peritoneum) or infection.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The blood concentration of drugs that can be removed from the body using dialysis may be reduced by peritoneal dialysis.

Tell your doctor, nurse of pharmacist about all the medicines you take, including insulin, blood pressure medicines and heart medicines called cardiac glycosides (such as digoxin). Your dose of these medicines may need to be changed when you use PHYSIONEAL 40 solution.

PROPER USE OF THIS MEDICATION

PHYSIONEAL 40 solution is to be administered into your peritoneal cavity. This is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver. This solution is only for intrapertioneal usage, and will be adminisered via a catheter directly to the peritoneal cavity. It is not for intravenous use.

Always use this medicine exactly as instructed by the medical team specialised in peritoneal dialysis. Check with them if you are not sure.

Usual adult dose:

• The kind of treatment, frequency of treatment, exchange volume, the time that the dialysis solution remains in the abdominal cavity and length of dialysis will be selected by your doctor. Infuse PHYSIONEAL 40 solution at a rate that is comfortable for you.
• Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours).
• Patients on automated peritoneal dialysis (APD) typically perform 3-5 cycles at night and up to 2 cycles during the day.
• The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73 m².To reduce the risk of dehydration, it is important to use the solution(s) your doctor has chosen for you.

Directions for use:

• Detailed instructions and training on the peritoneal dialysis exchange procedure will be given to you, in a specialized training centre, before you use PHYSIONEAL 40 solution at home.
• You should practice infection free technique throughout the bag change procedure.
• Examine the bag before use and discard the package if it is broken, damaged, or the solution is discoloured, cloudy or any solids are floating in the solution.
• To make using PHYSIONEAL 40 solution more comfortable, you can warm it to 37˚C (98.6˚F) before use. This should only be done using dry heat, such as a heating pad or cycler warming plate. To avoid increased risk of infection, do not place PHYSIONEAL 40 solution in water to heat the bags. Do not microwave.
• After the removal of the overpouch, check that the interchamber frangible pin is not broken. If the seal is already broken, even partially, discard the bag.
• Just before infusion prepare the solution by breaking the interchamber fragile pin. Wait until the glucose chamber A has completely drained into the buffer chamber B before you start the infusion. Mix gently by pushing with both hands on the lower chamber walls. Do not infuse without breaking the interchamber fragile pin. If the solution is accidently infused without breaking the interchamber fragile pin immediately drain the solution and use a newly mixed bag. Inform your doctor.
• The solution should be infused within 24 hours after mixing.
• When draining the fluid after the dwell, always check your drained fluid for cloudiness or fibrin. Fibrin looks like clumps or stringy material in the drained solution. Cloudy drained fluid or fibrin may mean you have an infection. Call your doctor if your drained fluid is cloudy or contains fibrin.
• Your doctor may prescribe other injectable drugs to be added directly into the PHYSIONEAL 40 bag. In that situation, add the drug through the medication port in the SMALL chamber before breaking the interchamber pin. Use the product immediately after addition of the drug. You should use infection free technique when adding any medications to PHYSIONEAL 40 solution.
• PHYSIONEAL 40 solution is for single use only. Discard any unused remaining solution.

Overdose:

Missed Dose:

If you have missed an exchange, continue with the next scheduled treatment.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• Rash, itching
• Weakness, fatigue, tiredness
• Headache

If any of these affects you severely, tell your doctor, nurse or pharmacist.

Sometimes, too much PHYSIONEAL 40 solution can get into your peritoneal cavity. If you experience abdominal distention, feeling of fullness and, or shortness of breath, contact your doctor, nurse, pharmacist or peritoneal dialysis unit.

Encapsulating Peritonitis Sclerosis (EPS) is a rare but serious side effect that happens to patients taking PHYSIONEAL 40 solution. In EPS the bowels become blocked due to the growth of a thick layer of fibrin within the peritoneum. Symptoms include fever, abdominal discomfort, constipation, nausea, vomiting or lack of appetite, lack or decreased bowel movements or of passing gas. If this happens to you seek immediate medical help.

This is not a complete list of side effects. For any unexpected effects while taking PHYSIONEAL 40 solution, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store in the original package. Store at 15°C to 25°C. Do not freeze. Do not use PHYSIONEAL 40 solution after the expiry date on the label.

Keep PHYSIONEAL 40 solution out of reach and sight of children.

Do not use PHYSIONEAL 40 solution unless the solution is clear and the container undamaged. Once PHYSIONEAL 40 is removed from its overpouch and mixed it should be used within 24 hours. Any unused portion should be discarded.

REPORTING SIDE EFFECTS

MORE INFORMATION

If you want more information about PHYSIONEAL 40 solution:

• 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 (http://hc-sc.gc.ca/index-eng.php); or by contacting the sponsor, Vantive ULC, at 1-800-387-8399

Mississauga ON L5N 5M4

Vantive and Physioneal, are trademarks of Vantive Health Inc. or its subsidiaries.

Viaflex is a trademark of Baxter International Inc.

Last revised: May 23, 2024