Patient Medication Information: uses, side effects, how to take - Dianeal PD101 Capd Solution with 2.5% Dextrose
ABOUT THIS MEDICATION
What the medication is used for:
DIANEAL is a sterile peritoneal dialysis solution used in patients whose kidneys are not working properly. It removes waste products and water from the blood.
DIANEAL can also be used in some cases of drug intoxication and to correct fluid and electrolyte imbalances.
DIANEAL has not been studied for use in children (younger than 18 years old).
What it does:
DIANEAL 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 DIANEAL solution is drained.
When it should not be used:
Do not use DIANEAL 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 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)
What the medicinal ingredients are:
Glucose
Sodium chloride
Calcium chloride
Magnesium chloride
Sodium lactate
What the nonmedicinal ingredients are:
Water for injection
What dosage forms it comes in:
DIANEAL PD4 and PD101 solutions for peritoneal dialysis are available in 1.5L, 2L, 2.5L, 3L and 5L Viaflex plastic containers.
WARNINGS AND PRECAUTIONS
BEFORE you use DIANEAL talk to your doctor, nurse or pharmacist 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, taking 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.
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 DIANEAL 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 DIANEAL. 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
DIANEAL 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 (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 DIANEAL 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 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 DIANEAL 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 DIANEAL 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 DIANEAL 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 DIANEAL 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 DIANEAL bag if medication is to be added.
- You must use infection free technique when adding any medications to DIANEAL.
- 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 thourghouly.
- Use the product immediately after addition of the drug.
- DIANEAL is for single use only. Discard any unused remaining solution.
Overdose:
If you think you have taken too much DIANEAL, 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- Rash, itching
- Vomiting, nausea, diarrhea, constipation
- Abdominal pain, distention and/or discomfort
- Muscle pain/cramps
If any of these affects you severely, tell your doctor, nurse or pharmacist.
Sometimes, too much DIANEAL 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 DIANEAL. 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 | |||
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Seek immediate medical help | |
| Only if severe | In all cases | ||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
Dehydration: dizziness, weakness, fainting, thirst, dry mouth, constipation, muscle cramps | √ | ||
Catheter Blockage/ Infection: Redness, pus, swelling or pain around exit site of your catheter | √ | ||
Peritonitis (infection in the peritoneal cavity): cloudy or bloody drained fluid, abdominal pain, fever, redness, nausea, upset stomach, vomiting, lack of appetite, weight loss, constipation | √ | ||
| Edema: Swollen ankles or legs, swelling of the eyes or face | √ | ||
Steven-Johnson Syndrome: painful red or purple rash, blisters on your skin, mouth, nose, eyes and genitals | √ | ||
| High Blood Pressure: headaches, vision problems, dizziness, shortness of breath | √ | ||
| Shortness of breath or chest pain | √ | ||
| Abnormal Bleeding | √ | ||
| Increased Blood Sugar: frequent urination, thirst, and hunger | √ | ||
Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking DIANEAL, 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 DIANEAL after the expiry date on the label.
Keep DIANEAL out of reach and sight of children.
Do not use DIANEAL unless the solution is clear and the container undamaged. Any unused portion should be discarded.
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.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 healthcare 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 DIANEAL 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: 1-888-719-9955
Mississauga ON L5N 5M4
Vantive is a trademark of Vantive Health Inc. or its subsidiaries.
VIAFLEX is a trademark of Baxter International Inc. or its subsidiaries.