NUTRINEAL PD4 with 1.1% Amino Acids with Integrated Disconnect System, Solution for Peritoneal Dialysis

Introduction

Package Leaflet: Information for the User

Nutrineal PD4 with 1.1% Amino Acids with Integrated Disconnection System, Solution for Peritoneal Dialysis

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience side effects, consult your doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Nutrineal and what is it used for.
2. What you need to know before starting to use Nutrineal
3. How to use Nutrineal
4. Possible side effects
5. Storage of Nutrineal
6. Package Contents and Additional Information

1. What is Nutrineal and what is it 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 for you:

• especially if you are malnourished.

2. What you need to know before starting to use Nutrineal

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

Do not use Nutrineal

You should not use Nutrineal:

Warnings and Precautions

Consult your doctor before starting to use Nutrineal:

• during peritoneal dialysis, your body may lose proteins, amino acids, and vitamins. Your doctor will determine if you need to replace these losses.

• 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 adequate during treatment.
• You, probably together with your doctor, will keep a record of your protein intake in your diet, your fluid balance, and your body weight.

Using Nutrineal with other medications

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

• need potassium and calcium supplements
• develop cardiac arrhythmias

• 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 medication. The use of Nutrineal is not recommended during pregnancy or breastfeeding, unless your doctor advises 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 medication exactly. If in doubt, ask your doctor.If the bag is damaged, it should 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 should use an aseptic technique during the entire administration of the solution, as you have been taught.

Compatibility with other medications

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

If you use more than one Nutrineal bag in 24 hours

If you are given an excessive dose of Nutrineal, you may experience:

• abdominal distension

• stomach heaviness

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

If you interrupt treatment with Nutrineal

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

If you experience side effects, consult your doctor, even if they are not listed in this package leaflet.

If you notice any of the following side effects, inform 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

Side effects that have been reported (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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them 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 medication.

5. Storage of Nutrineal

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

Discard Nutrineal as instructed.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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

Composition of Nutrineal PD4 with 1.1% Amino Acids

The active substances are:

The other components are:

• Water for injectable preparations
• Concentrated hydrochloric acid.

Appearance of the Product and Package Contents

• Nutrineal is packaged in a 1.5, 2.0, or 2.5-liter PVC plastic bag.
• Each bag is wrapped in an overbag and supplied in cardboard boxes.

Not all types of bags 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 the last revision of this package leaflet: May 2016.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS). http://www.aemps.gob.es/