Nutrineal PD4: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Nutrineal™ PD4 is a sterile peritoneal dialysis solution for the treatment of protein malnutrition. It does not contain glucose.

It is prescribed for you for your protein malnutrition and also have kidney failure which requires peritoneal dialysis. It may replace one (or two) of the dextrose-containing dialysis solutions during a one day period.

What it does:

Nutrineal™ PD4 contains amino acids that are absorbed into the blood during peritoneal dialysis and serve as building blocks from which the body can make protein.

Nutrineal™ PD4 draws fluid and wastes from your blood stream 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. The fluids and wastes are removed from your body when the Nutrineal™ PD4 solution is drained.

When it should not be used:

Do not use Nutrineal™ PD4:

• If you are allergic to any of the ingredients
• If your blood urea level is above 38 mmol/L

• If you have uremic symptoms such as loss of appetite, nausea

  or vomiting

• If you suffer from a disorder affecting amino acid metabolism
• If you suffer from liver insufficiency
• If your blood potassium level is too low
• If you have a disorder called metabolic acidosis

• If you have a surgically uncorrectable problem affecting your

  abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections

• If you have documented loss of peritoneal function due to

  severe peritoneal scarring

What the medicinal ingredients are:

Amino Acids:

Histidine Valine

Isoleucine Alanine

Leucine Arginine

Lysine Glycine

Methionine Proline

Phenylalanine Serine

Threonine Tyrosine

Tryptophan

Electrolytes:

Calcium Chloride Dihydrate

Magnesium Chloride Hexahydrate

Sodium Chloride

Sodium Lactate

What the nonmedicinal ingredients are:

Hydrochloric acid (for pH adjustment)

Water for Injection

What dosage forms it comes in:

Nutrineal™ PD4 is a sterile solution available in TwinBag® containers in 2.0 L and 2.5 L sizes and Single Bag containers in 2.5 L size.

WARNINGS AND PRECAUTIONS

What you should tell your doctor before using Nutrineal™ PD4:

• If you have severe disorders affecting fat digestion
• If you have problems affecting your abdominal wall or cavity. For example if you have a hernia or an infection.
• If you had aortic graft placement.
• If you have severe lung disease (e.g. emphysema)
• If you have severe breathing difficulties
• If you use insulin or any other treatments for correcting hyperglycemia. Your doctor may need to adjust their dose.
• If you are undergoing treatment for secondary hyperparathyroidism, your doctor will decide if you can use a dialysis solution with a low calcium content.

• If you are pregnant or breastfeeding. Nutrineal™ PD4 is not recommended during pregnancy or while breast-feeding unless your doctor advises differently.

Tell your doctor immediately if the following occurs while taking Nutrineal™ PD4:

• If you experience loss of appetite, nausea or vomiting. Your doctor may need to reduce the number of Nutrineal™ PD4 exchanges or stop Nutrineal™ PD4 treatment.
• If you experience abdominal pain or notice cloudiness, haziness or particles in the drained fluid. This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and bring it along with the drained fluid bag to your medical team. They will decide if the treatment should be stopped or any corrective treatment started. For example if you have an infection your doctor may perform some tests to find out which antibiotic will be best for you. Until your doctor knows which infection you have, he may give you an antibiotic that is effective against a wide number of different bacteria. This is called a broadspectrum antibiotic.
• If any signs or symptoms of an allergic reaction develop,

intraperitoneal administration of Nutrineal™ PD4 must be stopped immediately. Your doctor might need to treat your allergy immediately.

Other Warnings:

• During peritoneal dialysis your body may lose protein, amino

  acids and vitamins. Your doctor will know if these need to be replaced.

• A rare complication of peritoneal dialysis called encapsulating

  peritoneal sclerosis (EPS), may occur after being treated with perioneal dialysis for an extended period of time. Symptoms and signs are usually nonspecific, but may include severe abdominal pain, inability to remove fluid, persistent nausea and vomiting and intestinal blockage. Diagnosis is confirmed by your doctor.

• Your doctor should check your potassium levels regularly. If

  they fall too low your doctor may give you some potassiumto compensate.

• Your doctor should advise you about particular precautions as

  they apply to you. Your doctor should monitor your blood parameters at regular intervals and ensure that they are adequate during your treatment.

• Together with your doctor, keep a record of your dietary

  protein intake, your fluid balance and your body weight.

INTERACTIONS WITH THIS MEDICATION

• Tell your doctor if you are taking or have recently taken any

  other medications, including medications obtained without a prescription. If you use other medications, your doctor may need to increase their dose. This is because peritoneal dialysis treatment increases the elimination of certain medications.

• Be cautious if you use heart medications known as cardiac

  glycosides (e.g. digoxin). Your heart medications may not be as effective or its toxicity may be increased. You may:

  • need potassium and calcium supplements
  • develop an irregular heartbeat (an arrhythmia)

Your doctor should monitor you closely during treatment, especially your potassium levels.

PROPER USE OF THIS MEDICATION

Usual Adult dose:

Your doctor should prescribe you the appropriate number of bags you must use. Usually, it varies from one bag of 2.0 litres to one bag of 2.5 litres every day.

If you are below 18 years of age, your doctor should assess carefully the prescription of Nutrineal™ PD4.

Your doctor should re-evaluate your treatment after 3 months if there is no improvement in your nutritional status.

Aministration Instructions:

• To do your Nutrineal™ PD4 exchange, it is very important

  that you follow the steps shown to you in your training. All surfaces and connecting parts must be clean to avoid serious infection. If you need more help or have any questions, you

  should contact your doctor.

  • Before use, warm the bag to 37°C. Use only dry heat (for example, a heating pad or warming plate). Never immerse in water to warm the bag. Never use a microwave oven to warm the bag.
  • Use only if the solution is clear and the container undamaged.
  • Use aseptic technique throughout the administration of the solution. Aseptic technique is the effort taken to keep yourself from micro-organisms infection.
  • Use each bag only once.
  • Discard any unused remaining solution.

Preparation and Administration for the Single Bag Container: Follow the instructions in user manual or directions accompanying tubing sets and devices for automated peritoneal dialysis.

Preparation and Administration for the TWIN BAG^® Container:

1. 1. Do not remove from the carton until ready for use.
2. 2. Remove container from overpouch.
3. 3. Inspect solution container and frangible to ensure that there are no leaks, and the solution has not expired. If leaks are detected, or the expiration date has lapsed, discard container.
4. 4. Inspect the patient connector to ensure the pull ring is attached. Do not use if pull ring is not attached to the connector.
5. 5. Inspect tubing and drainage container for presence of solution. If solution is noted, discard unit. NOTE: Small water droplets are acceptable.
6. 6. Ensure patient transfer set is closed.
7. 7. Break frangible at patient connector.
8. 8. Remove pull ring from the patient connector.
9. 9.

   Remove disconnect cap from patient transfer set.

   Immediately attach patient transfer set connector to the patient connector by twisting the connector until firmly secured.

10. 10. Clamp new bag solution line.
11. 11. Break frangible at container port.
12. 12. Hang the new solution container.
13. 13. Place the drainage container below the level of the peritoneum.

Proceed with either Procedure A or Optional: Procedure B

Procedure A

1. 14. Open transfer set clamp to drain solution from the peritoneal cavity.
2. 15. Close transfer set line clamp after drainage is complete.
3. 16. Open new solution line clamp and allow the new solution to flow into the drainage container for five seconds.
4. 17. Clamp drain line.
5. 18. Open transfer set clamp and allow the solution to flow into the peritoneal cavity.
6. 19. Close transfer set clamp when infusion is complete.
7. 20. Open a new disconnect cap following the directions accompanying the cap.
8. 21. Disconnect the patient transfer set from the TWIN BAG^® set and attach the new disconnect cap to the transfer set.

Optional: Procedure B

1. 14. Open new solution line clamp and allow the new solution to flow into the drainage container for five seconds.
2. 15. Clamp new solution line.
3. 16. Open transfer set clamp to drain solution from the peritoneal cavity.
4. 17. Clamp drain line.
5. 18. Open new solution line and allow solution to flow into the peritoneal cavity.
6. 19. Close transfer set clamp when infusion is complete.
7. 20. Open a new disconnect cap following the directions accompanying the cap.
8. 21. Disconnect the patient transfer set from the TWIN BAG^® set and attach the new disconnect cap to the transfer set.
9. ▪ Nutrineal™ PD4 should be infused based on your need for adequate dialysis, as determined by your doctor. 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.
10. ▪

    If you infuse too much NUTRINEAL you may get:

    • abdominal distension
    • a feeling of fullness

Contact your doctor immediately. He will advise what to do.

Overdose:

Overdose may result in fluid overload and/or electrolyte imbalances.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, Nutrineal™ PD4 may cause side effects. Side effects may inlcude feeling of weakness, headache, fever, malaise and asthenia.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

HOW TO STORE IT

Protect from light until ready to use. Store at 15-25°C. Protect Nutrineal™ PD4 from freezing. Do not remove from the carton until ready for use. Any unused portion of the solution should be discarded.

Keep out of sight and reach of children.

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:

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• 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 Health Canada

    Postal Locator 0701C

    Ottawa, ON K1A 0K9

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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.baxter.ca

or by contacting the sponsor, Baxter Corporation, at: 1-800-387-8399

Last revised: July 30, 2012