NUTRINEAL PD4 WITH 1.1% AMINO ACIDS, SOLUTION FOR PERITONEAL DIALYSIS

Introduction

Package Leaflet: Information for the User

Nutrineal PD4 with 1.1% amino acids, solution for peritoneal dialysis

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience any side effects, talk to your doctor, even if you think they might be unrelated to this medicine. See section 4.

Contents of the pack

1. What Nutrineal is and what it is used for.
2. What you need to know before you start using Nutrineal.
3. How to use Nutrineal.
4. Possible side effects.
5. Storage of Nutrineal.

1. Contents of the pack and further information.

1. What Nutrineal is and what it is used for

Nutrineal is a peritoneal dialysis solution that does not contain glucose. It removes water and waste products from the blood and corrects abnormal levels of various blood components.

Nutrineal may be prescribed to you:

• if you have kidney failure that requires peritoneal dialysis.
• especially if you are malnourished.

2. What you need to know before you start using Nutrineal

Your doctor will assess whether Nutrineal is a suitable solution for your peritoneal dialysis treatment. They will consider any factors in your medical history that may exclude the use of peritoneal dialysis solutions.

Do not use Nutrineal

You must not use Nutrineal:

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• if your blood urea level is higher than 38 mmol/l.
• if you have a disorder that affects amino acid metabolism.
• if your blood potassium level is too low.
• if you show symptoms of hyperuremia such as loss of appetite, nausea, or vomiting.
• if your blood bicarbonate levels are too low.
• if you have liver failure.
• if you have severe lactic acidosis (too much acid in the blood).
• if you have any uncorrectable surgical condition that affects your abdominal wall or cavity, or an uncorrectable condition that increases the risk of abdominal infections.

Warnings and precautions

Talk to your doctor before starting Nutrineal:

• if you notice loss of appetite, nausea, or vomiting. Your doctor may need to reduce the number of Nutrineal exchanges or interrupt treatment with Nutrineal.
• if you experience abdominal pain or notice that the drainage fluid is cloudy, has clumps, or contains particles. This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and take it along with the drained fluid bag to the medical team. The medical team will decide whether to interrupt treatment or start corrective treatment. For example, if you have an infection, your doctor may perform several tests to determine which antibiotic is most suitable for you. Your doctor may give you a broad-spectrum antibiotic that is effective against a wide range of different bacteria until they know what infection you have.
• if you experience a hypersensitivity reaction (an allergic reaction) – see also section 4. Your doctor may need to stop treatment with Nutrineal.
• during peritoneal dialysis, your body may lose proteins, amino acids, and vitamins. Your doctor will determine whether you need to replace these losses.
• if you have problems that affect the integrity of the abdominal wall or cavity. For example, in the case of a hernia or chronic infection or inflammatory disease that affects the intestines.
• if you have had an aortic graft.
• if you have severe lung disease, such as emphysema.
• if you have breathing difficulties.
• if you use insulin or any other treatment to correct hyperglycemia. Your doctor may need to adjust your dose.
• if you are receiving treatment for secondary hyperparathyroidism, your doctor will decide whether you can use a dialysis solution with low calcium content.

• You should also be aware that a disorder called encapsulating peritoneal sclerosis (EPS) is a rare and known complication of peritoneal dialysis therapy. You, probably together with your doctor, should be aware of this possible complication. EPS causes:
• abdominal inflammation (belly).

• growth of the layers of fibrous tissue that cover and connect the organs, which will affect their normal movement. In rare cases, it has been fatal.
• your doctor will regularly check your potassium levels. If they drop too low, you may be given potassium chloride to compensate.

• Your doctor will inform you of the specific precautions for you. Your doctor will monitor your blood parameters at regular intervals and ensure they are suitable during treatment.
• You, probably together with your doctor, will keep a record of your dietary protein intake, fluid balance, and body weight.

Using Nutrineal with other medicines

• Tell your doctor if you are using, have recently used, or might use any other medicines. If you use other medicines, your doctor may need to increase your dose since peritoneal dialysis treatment increases the elimination of certain medicines.
• Be careful if you use heart medicines called cardiac glycosides (e.g., digoxin). Your heart medicines may not be as effective, or their toxicity may increase. You may:

• need potassium and calcium supplements.
• develop heart rhythm disturbances (arrhythmia).

• Your doctor will closely monitor you during treatment, especially your potassium and magnesium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The use of Nutrineal is not recommended during pregnancy or breastfeeding unless your doctor advises you otherwise.

Driving and using machines

This treatment can cause weakness, general discomfort, or decreased fluid volume in your body (hypovolemia). Do not drive or use machines if you are affected.

3. How to use Nutrineal

Nutrineal should be administered into your peritoneal cavity. This cavity is located in the abdomen (belly) between the skin and the peritoneum. The peritoneum is the membrane that surrounds the internal organs, such as the intestines or liver.

Nutrineal is not for intravenous use.

Follow your doctor's instructions for administering this medicine exactly. If in doubt, ask your doctor.If the bag is damaged, it must be discarded.

Dose and frequency

Your doctor will tell you the appropriate number of bags to use. Normally, it varies between one 2.0-liter bag and one 2.5-liter bag per day.

Use in children and adolescents

If you are under 18 years old, your doctor will carefully evaluate whether you should be given Nutrineal.

Your doctor will re-evaluate the treatment after 3 months if your nutritional status does not improve.

Method of administration

Before use:

• Warm the bag to 37 °C. Use the specially designed heating plate for this purpose. Never submerge the bag in water to warm it. Never use a microwave oven to warm the bag.
• Remove the overbag and administer the solution immediately.
• Only use the solution if it is transparent and the packaging is not damaged.
• Use each bag only once. Discard any unused solution.

You must use an aseptic technique during the entire administration of the solution, as you have been taught.

Compatibility with other medicines

Your doctor may prescribe other injectable medicines to be added directly to the Nutrineal bag. In this case, add the medicine through the medication addition site. Use the product immediately after adding the medicine. Consult your doctor if you are unsure.

If you use more than one bag of Nutrineal in 24 hours

If you are given too much Nutrineal, you may experience:

• abdominal distension.
• stomach heaviness.

Contact your doctor immediately. They will inform you of what to do.

If you stop treatment with Nutrineal

Do not stop peritoneal dialysis without your doctor's consent. Stopping treatment can have life-threatening consequences.

If you have any further questions about using this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience side effects, talk to your doctor, even if you think they might be unrelated to this medicine.

If you notice any of the following side effects, tell your doctor or peritoneal dialysis unit immediately:

• Abdominal pain.

Very common side effects (affect more than 1 in 10 patients treated with Nutrineal):

• Nausea, vomiting.
• Anorexia (prolonged eating disorder due to loss of appetite).
• Gastritis (stomach inflammation).
• Feeling of weakness.
• Increased fluid volume in the body (hypervolemia).
• High levels of acidic substances in the body (acidosis).

Common side effects (affect more than 1 in 100 patients treated with Nutrineal):

• Anemia.
• Depression.
• Breathing difficulties.
• Abdominal pain.
• Decreased fluid volume in the body (hypovolemia).
• Decreased potassium levels in the blood (hypokalemia).
• Infection.

Uncommon side effects (affect an unknown number of patients treated with Nutrineal):

• Peritonitis.
• Cloudy peritoneal effluent.
• Abdominal discomfort.
• Fever.
• General discomfort.
• Itching.
• Hypersensitivity reaction (an allergic reaction).
• Severe allergic reactions that cause inflammation of the face or throat (angioedema).

Other side effects related to the peritoneal dialysis procedure:

• Infection around the catheter exit site.
• Catheter-related complications.
• Decreased calcium levels (hypocalcemia) in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think they might be unrelated to this medicine. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nutrineal

• Keep this medicine out of the sight and reach of children.
• Store in the original package.
• Store below 30 °C and protect from light.
• Do not use this medicine after the expiry date stated on the carton and on the bag after EXP. The expiry date is the last day of the month indicated.

Discard Nutrineal as instructed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

This leaflet does not contain all the information about this medicine. If you have any further questions, ask your doctor.

Composition of Nutrineal PD4 with 1.1% amino acids

The active substances are:

The other ingredients are:

• Water for injections.
• Concentrated hydrochloric acid.

Appearance of the product and pack contents

Nutrineal is packaged in a 2.0, 2.5, 3.0, or 5.0-liter PVC plastic bag.

Each bag is wrapped in an overbag and supplied in cardboard boxes.

Not all bag types may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

VANTIVE HEALTH S.L.

Calle Pouet de Camilo, 2 - Polígono Industrial Sector 14.

46394 Ribarroja del Turia (Valencia) Spain.

Manufacturer:

Vantive Manufacturing Limited.

Moneen Road.

Castlebar.

County Mayo, Ireland.

Date of last revision of this leaflet: May 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS).

http://www.aemps.gob.es/