Caneal Peritoneal Dialysis Solution: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• have an aortic graft placement.
• have breathing problems.

• 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, using drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)).

• 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 high or low levels of calcium in your

  blood.

• are pregnant or intend to become pregnant.

• are breastfeeding.

What is the CANEAL™ Peritoneal Dialysis Solution used for?

CANEAL™ Peritoneal Dialysis 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.

CANEAL™ Peritoneal Dialysis Solution can also be used in some cases of drug intoxication and to correct fluid and electrolyte imbalances.

CANEAL™ Peritoneal Dialysis Solution has not been studied for use in children

(younger than 18 years old).

How does CANEAL™ Peritoneal Dialysis Solution work?

CANEAL™ Peritoneal Dialysis 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 CANEAL™ solution is drained.

What are the ingredients in CANEAL™ Peritoneal Dialysis Solution?

Medicinal ingredients: calcium chloride, dextrose, sodium chloride, sodium lactate and magnesium chloride.

Non-medicinal ingredients: water for injection, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment)

CANEAL™ Peritoneal Dialysis Solution comes in the following dosage forms:

Sterile Solution only.

Do not use CANEAL™ Peritoneal Dialysis Solution if:

• have a problem involving your abdominal

  wall or cavity that cannot be corrected by surgery (e.g. hernia, ileus, adhesions, imperfections in the muscle that separate the abdomen from the chest, or 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 high levels of lactic acid in your blood

  (lactic acidosis)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CANEAL™ Peritoneal Dialysis Solution. Talk about any health conditions or problems you may have, including if you:

• have an aortic graft placement.
• have breathing problems.

• 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, using drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)).

• 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 high or low levels of calcium in your

  blood.

• are pregnant or intend to become pregnant.

• are breastfeeding.

  Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or

  alternative medicines.

The following may interact with CANEAL™ Peritoneal Dialysis Solution:

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.

Patients on CANEAL™ Peritoneal Dialysis 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.

Driving and using machines: Before doing tasks which require special attention, wait until you know how you respond to CANEAL™ Peritoneal Dialysis Solution. Do not drive or operate machinery if you experience weakness, blurred vision or dizziness.

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.

If you are taking heart medicines known as cardiac glycosides (such as digoxin), or insulin your doctor will monitor you closely during treatment.

Proper Use of This Medication

CANEAL™ Peritoneal Dialysis 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 intraperitoneal usage, and will be administered 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 specialized in peritoneal dialysis. Check with them if you are not sure.

Usual adult dose:

The kind of treatment (Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory

Peritoneal Dialysis [CAPD] or Automated Peritoneal Dialysis [APD]), 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 CANEAL™ Peritoneal Dialysis Solution at a rate that is comfortable for you.

Patients on intermittent peritoneal dialysis (IPD) typically perform 3 to 5 cycles in a week. 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 CANEAL™ 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 CANEAL™ Peritoneal

  Dialysis 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 CANEAL™ in water to heat the bags. Do not microwave.

• Tear the overpouch down the side at the slit and remove the solution container. The container should be squeezed firmly to check for leaks. If leaks are found, discard the bag.

• 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 CANEAL™ Peritoneal Dialysis Solution bag. In that situation, add the drug through the medication port. If the resealable rubber plug on the medication port is missing or partially removed do not use the CANEAL™ bag if medication is to be added.

• You must use infection free technique when

  adding any medications to CANEAL™ Peritoneal Dialysis Solution.

• Prepare the medication site.

• Using a syringe with a 1 inch long 19 to 25

  gauge needle, puncture the resealable medication port and inject

• Position the container with ports up and

  evacuate the medication port by squeezing and tapping it.

• Mix the solution and medication thoroughly.

• Use the product immediately after addition

  of the drug.

  CANEAL™ Peritoneal Dialysis Solution is for single use only. Discard any unused

  remaining solution.

Overdose:

If you think you have taken too much CANEAL™ Peritoneal Dialysis Solution, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

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

What are possible side effects from using CANEAL™ Peritoneal Dialysis Solution?

These are not all the possible side effects you may feel when using Peritoneal Dialysis Solution. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Side effects may include:

• Rash, itching
• Vomiting, nausea, diarrhea, constipation
• Abdominal pain, distention and/or discomfort
• Muscle pain/cramps pain/cramps

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

Sometimes too much Peritoneal Dialysis 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 using Peritoneal Dialysis 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.

Serious Side Effects, How Often They Happen, and What to Do About Them

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.

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.

This is not a complete list of side effects while taking CANEAL, contact your doctor, nurse or pharmacist.

Storage:

Store between 15°C to 30°C.

Keep out of reach and sight of children. Store in original package.

Avoid excessive heat. Protect from freezing. DO NOT USE AFTER EXPIRY DATE

Do not use CANEAL unless the solution is clear and the container undamaged. Any unused portion should be discarded.

If you want more information about CANEAL™ Peritoneal Dialysis 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.

Last revised: March 5, 2018

Chief Medical Supplies Ltd.

Calgary, AB CANADA T2E 6J7

1 866 620-6034