Label: information for the user

Nutrineal PD4 with 1.1% amino acids, peritoneal dialysis solution

6. Contents of the package and additional information

Nutrineal is a glucose-free peritoneal dialysis solution. It removes water and waste products from the blood and corrects abnormal levels of the different blood components.

Nutrineal may be prescribed:

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

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

Do not use Nutrineal

Do not use Nutrineal

• if you are allergic to the active ingredients or to any of the other components of this medication (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 insufficiency
• if you have severe lactic acidosis (too much acid in the blood)
• if you have any irreversible surgical alteration that affects your abdominal wall or cavity or an irreversible alteration that increases the risk of abdominal infections.

Warnings and precautions

Consult your doctor before starting to use 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 feel abdominal pain or notice that the drainage liquid is cloudy, has lumps, or has 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 the bag of drained liquid with you to the medical team. Your doctor will decide whether to interrupt treatment or initiate 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 an antibiotic that is effective against a wide range of bacteria until they know what infection you have. This type of antibiotic is called a broad-spectrum antibiotic
• 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 if you need to replace those losses
• if you have problems that affect the integrity of your abdominal wall or cavity.For example, in the case of hernia or chronic infection or inflammatory disease affecting the intestines
• if you have had an aortic graft
• if you have severe pulmonary disease, for example, emphysema
• if you have respiratory difficulties
• if you are using 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 if you can use a dialysis solution with low calcium content

• You should also be aware thata disorder called encapsulating peritoneal sclerosis (EPS) is a known and rare complication of peritoneal dialysis therapy. You, probably in conjunction with your doctor, should be aware of this possible complication. EPS causes:
• inflammation of the abdomen (stomach)

• growth of fibrous tissue layers that cover and connect the organs, affecting your normal movement. In rare cases, it has been fatal
• Your doctor will check your potassium levels regularly. If they drop too low, your doctor may administer 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 in conjunction with your doctor, will keep a record of your protein intake in your diet, your fluid balance, and your body weight.

Use of Nutrineal with other medications

• Inform your doctor if you are using, have used recently, or may need to use any other medication.If you use othermedications, your doctor may need to increase your dosesince peritoneal dialysis treatment increases the elimination of certain medications.
• Be careful if you use medications for the heart called cardiac glycosides,(e.g., digoxin). Your heart medications maynot be as effective or their toxicitymay be increased. You may need:

• potassium and calcium supplements
• develop arrhythmias (abnormal heart rhythms)

• Your doctor will perform a thorough check during treatment,especially of your potassium and magnesium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consultyour doctor before using this medication.This medication is not recommended during pregnancy or breastfeeding, unless your doctor tells you otherwise.

Driving and operating machinery:

This treatment may cause weakness, general discomfort, or a decrease in the fluid volume in your body (hypovolemia). Do not drive or operate machinery if affected.

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

Nutrineal is not for intravenous use.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, ask your doctor.If the bag is damaged, it must be discarded.

Quantity and frequency

Your doctor will indicate the appropriate number of bags you should use. Normally, it varies between a 2.0-liter bag and a 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 administered Nutrineal.

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

Administration form

Before use:

• Warm the bag to 37 °C. Use the specially designed warming 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 container is not damaged.
• Use each bag only once.Discard the remaining solution that you do not use.

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

Compatibility with other medications

Your doctor may prescribe other injectable medications to be added 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 with your doctor if you are unsure.

If you use more than one Nutrineal bag in 24 hours

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

• abdominal distension
• heaviness in the stomach

Immediately contact your doctor.They will inform you of what to do.

If you interrupt the treatment with Nutrineal

Do not interrupt peritoneal dialysis without your doctor's consent.The interruption of treatment may have life-threatening consequences.

If you have any other doubts about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience side effects, consult your doctor, even if they are side effects that do not appear in this leaflet.

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

• Abdominal pain

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

• Nausea, vomiting
• Anorexia (prolonged disorder of eating due to loss of appetite)
• Gastritis(stomach inflammation)
• Feeling of weakness
• Increased volume of body fluid (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
• Difficulty breathing
• Abdominal pain
• Decreased volume of body fluid (hypovolemia)
• Decreased levels of potassium salts in blood (hypokalemia)
• Infection

Side effects 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 causing facial or throat inflammation (angioedema)

Other side effects related to the peritoneal dialysis procedure:

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use*.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Dispose of Nutrineal as instructed.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

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

Composition ofNutrinealPD4 with 1.1% amino acids

The active ingredients are:

The other components are:

• Water for injection
• Concentrated hydrochloric acid.

Appearance of the product and contents of the container

Nutrineal is packaged in a PVC plastic bag with a capacity of 2.0; 2.5; 3.0 or 5.0 liters.

Each bag is wrapped in a pouch and supplied in cardboard boxes.

Only some types of bags may be commercially available.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder:

VANTIVE HEALTH S.L.

Calle Pouet de Camilo, 2 - Industrial Sector 14

46394 Ribarroja del Turia (Valencia) Spain

Responsible for manufacturing:

Vantive Manufacturing Limited

Moneen Road

Castlebar

County Mayo, Ireland

Last review date of this leaflet: May 2016

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS).

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