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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet Contents

1. What Nutrineal is and what it is used for
2. What you need to know before using Nutrineal
3. How to use Nutrineal
4. Possible side effects
5. How to store Nutrineal
6. Contents of the pack and other information

1. What Nutrineal is and what it is used for

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

Nutrineal may be prescribed for you:

• if you suffer from renal failure requiring peritoneal dialysis
• particularly, if you are malnourished.

2. What you need to know before using Nutrineal

Your doctor will assess whether Nutrineal is an appropriate solution for your peritoneal dialysis treatment. Your doctor 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 components of this medicine (listed in section 6)
• if your blood urea level is higher than 38 mmol/l
• if you have a disorder affecting amino acid metabolism
• if your blood potassium level is too low
• if you have symptoms of hyperuricemia 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 (excess acid in the blood)
• if you have an uncorrectable surgical abnormality affecting your abdominal wall or cavity, or an uncorrectable condition 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 discontinue treatment with Nutrineal

• if you experience abdominal pain or notice that the dialysate fluid is cloudy, contains clumps or particles. This may be a sign of peritonitis (inflamed peritoneum) or infection. Contact your medical team urgently. Record the batch number and bring it along with the drained fluid bag to your medical team. The medical team will decide whether treatment should be interrupted or corrective treatment initiated. For example, if you have an infection, your doctor may perform several tests to determine which antibiotic is most appropriate for you. Your doctor may prescribe an antibiotic effective against a wide range of different bacteria until the specific infection is identified. This type of antibiotic is known as 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 whether you need to replace these losses

• if you have conditions affecting the integrity of the abdominal wall or cavity. For example, in case of hernia, chronic infection, or inflammatory bowel disease

• if you have had an aortic graft

• if you have severe lung disease, for example emphysema

• if you have breathing 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 whether you can use a dialysis solution with a low calcium content

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

• inflammation of the abdomen (belly)

• growth of fibrous tissue layers covering and binding organs, affecting their normal movement. In rare cases, this has been fatal

• your doctor will regularly check your potassium levels. If they become too low, potassium chloride may be administered to compensate.

• Your doctor will inform you of any specific precautions applicable to you. Your doctor will monitor blood parameters at regular intervals and ensure they remain appropriate during treatment.

• You, likely together with your doctor, will keep a record of your dietary protein intake, fluid balance, and body weight.

Use of Nutrineal with other medicines

• Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. If you are taking other medicines, your doctor may need to increase your dose, as peritoneal dialysis treatment increases the elimination of certain medicines.

• Be cautious if you are taking heart medications called cardiac glycosides (e.g., digoxin). Your heart medications may become less effective or their toxicity may be increased. You may:

• require potassium and calcium supplements

• develop disturbances in heart rhythm (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 otherwise.

Driving and use of machines:

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

3. How to use Nutrineal

Nutrineal must 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 internal organs such as the intestines or liver.

Nutrineal is not for intravenous use.

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, ask your doctor. If the bag is damaged, it must be discarded.

Dosage and frequency

Your doctor will determine the appropriate number of bags you should use. Normally, this ranges from one 2.0 litre bag to one 2.5 litre bag per day.

Use in children and adolescents

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

Your doctor will reassess the treatment after 3 months if your nutritional status has not improved.

Method of administration

Before use:

• Warm the bag to 37 °C. Use the heating plate specifically designed for this purpose. Never immerse the bag in water to warm it. Do not use a microwave oven to heat the bag.
• Remove the overpouch and administer the solution immediately.
• Use the solution only if it is clear and the container is undamaged.
• Each bag must be used only once. Discard any unused solution.

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

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 administered an excessive dose of Nutrineal, you may experience:

• abdominal distension
• stomach heaviness

Contact your doctor immediately. They will advise you on what to do.

If you interrupt treatment with Nutrineal

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

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• Abdominal pain

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

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

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

• Anaemia
• Depression
• Difficulty breathing
• Abdominal pain
• Decrease in body fluid volume (hypovolemia)
• Decrease in blood potassium levels (hypokalaemia)
• Infection

Adverse effects that have been reported (frequency unknown, affects an unknown number of patients treated with Nutrineal):

• Peritonitis
• Cloudy peritoneal effluent
• Abdominal discomfort
• Fever
• General malaise
• Itching
• Hypersensitivity reaction (an allergic reaction)
• Severe allergic reactions causing swelling of the face or throat (angioedema)

Other adverse effects related to the peritoneal dialysis procedure:

• Infection around the catheter exit site
• Catheter-related complication
• Decrease in blood calcium levels (hypocalcaemia)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines*. By reporting adverse 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 packaging.
• Store below 30 °C and protect from light.
• Do not use this medicine after the expiry date stated on the carton and bag after EXP. The expiry date refers to the last day of the month indicated.

Dispose of Nutrineal as instructed by your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

This leaflet does not contain all the information about this medicine. 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 injections
• Concentrated hydrochloric acid

Appearance of the medicinal product and content of the container

Nutrineal is packed in a PVC plastic bag with a capacity of 2.0, 2.5, 3.0, or 5.0 litres.

Each bag is enclosed in an overpouch and supplied in cardboard boxes.

Some types of bags may not be commercially available.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

VANTIVE HEALTH S.L.

Calle Pouet de Camilo, 2 - Polígono Industrial Sector 14

46394 Ribarroja del Turia (Valencia), Spain

Manufacturing Responsible Party:

Vantive Manufacturing Limited

Moneen Road

Castlebar

County Mayo, Ireland

Date of latest review of this leaflet: May 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS).

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