NEPHROTECT SOLUTION FOR INFUSION

Introduction

Leaflet: information for the user

Nephrotect solution for infusion

Amino acid solution

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.

• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Nephrotect and what is it used for
2. What you need to know before you are given Nephrotect
3. How you will be given Nephrotect
4. Possible side effects
5. Storage of Nephrotect
6. Contents of the pack and further information

1. What is Nephrotect and what is it used for

Nephrotect is a solution that provides amino acids as part of parenteral nutrition in patients with renal failure when other types of nutrition are not convenient. The solution can be used in patients with acute or chronic renal failure, including patients undergoing dialysis treatment.

2. What you need to know before you are given Nephrotect

You should not be given Nephrotect:

• if you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6)
• if your body has problems using amino acids
• If you have a severe kidney disease without the possibility of dialysis
• If you are in acute shock
• If you have too much fluid in your body (hyperhydration)
• If you have fluid in your lungs (pulmonary edema)
• If you have untreated heart failure
• If you do not have enough body fluid (hypotonic dehydration)
• If you have severe liver disease

Warnings and precautions

Consult your doctor before you are given Nephrotect:

• if you have an abnormally low sodium level in your blood (hyponatremia)
• if you have high levels in your blood of the following components: sodium, chloride, bicarbonate, proteins, and sugar (glucose). Your doctor will monitor these levels during treatment with Nephrotect.

Normally, a blood or urine test will allow these levels to be verified.

Children

Nephrotect is not recommended for use in children.

Using Nephrotect with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy and breastfeeding

There is no sufficient experience with the use of Nephrotect during pregnancy and breastfeeding. Your doctor will assess the need to use this medicine.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you should be given Nephrotect.

Driving and using machines

Not applicable, as the product is administered in a hospital.

3. How you will be given Nephrotect

Your doctor will decide on the dose to be administered to you individually, based on your body weight and function.

A healthcare professional will administer Nephrotect to you.

If you are given too much Nephrotect

It is unlikely that you will receive too much Nephrotect, as the product is administered by healthcare professionals.

The basic symptoms of an overdose or too rapid infusion of the solution may include:

• nausea
• vomiting
• fever
• chills
• redness

If any of these symptoms appear, or if you think you have received too much Nephrotect, you should inform your doctor immediately, who will stop the infusion and take the necessary measures.

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

4. Possible side effects

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nephrotect

Keep this medicine out of the sight and reach of children.

• Store the container in the outer packaging.
• Do not store above 25°C.
• Do not use Nephrotect after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.
• Use only clear solutions and intact containers.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Nephrotect

The active substances are:

1 liter contains:

= 0.994 g glycine

= 2.40 g tyrosine

The other components are: acetic acid, L-malic acid, and water for injectable preparations.

Total amino acids 100 g/l

Total nitrogen 16.3 g/l

Total energy content 400 Kcal/l

pH 5.5-6.5

Acidity titration approx. 60 mmol NaOH/l

Theoretical osmolality 960 mosm/l

Appearance of the product and contents of the pack

Clear, colorless to slightly yellowish solution presented in 250 ml and 500 ml glass vials with a rubber stopper and an aluminum cap.

Size of the packs:

1 × 250 ml, 10 × 250 ml

1 × 500 ml, 10 × 500 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg Germany

Manufacturer

Fresenius Kabi Austria GMBH, 8055 Graz Austria

Local representative

Fresenius Kabi España, S.A.U

Marina, 16-18

08005 Barcelona

Date of last revision of this leaflet: January 2015

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

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This information is intended only for healthcare professionals: Contraindications

• Congenital disorders of amino acid metabolism
• Severe renal insufficiency, without the possibility of hemofiltration or dialysis
• Acute shock
• General contraindications for infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure, and hypotonic dehydration
• Severe liver failure

Special warnings and precautions for use

Be particularly careful with patients with hyponatremia or elevated serum osmolality.

During treatment, it is necessary to monitor fluid balance, serum electrolyte levels, acid-base balance, serum urea, and blood ammonia levels. Laboratory monitoring should also include blood glucose, serum protein, creatinine, and liver function tests.

So far, there is no clinical experience with the use of Nephrotect in children.

Posology and method of administration

For administration as a continuous intravenous infusion.

Your doctor will adjust the dose to be administered to you based on your needs.

Unless otherwise indicated, in patients with acute and chronic renal insufficiency

- patients not receiving dialysis:

0.6 - 0.8 g AAs / kg body weight / day

= 6 - 8 ml / kg body weight / day

- patients receiving dialysis

0.8 - 1.2 g AAs / kg body weight / day

= 8 - 12 ml / kg body weight / day

- for intradialytic nutrition in patients treated with long-term hemodialysis

0.5 - 0.8 g AAs / kg body weight / dialysis

= 5 - 8 ml / kg body weight / dialysis

Recommended maximum daily dose:

0.8 - 1.2 g AAs / kg body weight

= 8 - 12 ml / kg body weight, or 560 - 840 ml in a 70 kg patient

Recommended maximum infusion rates:

Parenteral nutrition:

0.1 g AAs / kg body weight / hour

Intradialytic nutrition:

0.2 g AAs / kg body weight / hour

Generally, amino acids should be administered in combination with infusion solutions, providing the patient's energy requirements during parenteral nutrition.

Nephrotect can be used for total parenteral nutrition if administered in combination with energy carriers, electrolytes, vitamins, and trace elements.

For central or peripheral venous infusion, it can be mixed with other nutrients if appropriate.

Nephrotect can be administered using separate infusion lines along with other nutritional substrates (multi-bottle / bag system), or it can be mixed in a container with other solutions to produce a total nutrient solution containing all components.

If Nephrotect is used for intradialytic nutrition, it can be injected directly into the venous drip chamber of the dialysis apparatus.

Amino acid solutions, including Nephrotect, are generally administered in combination with carbohydrates and lipids to ensure the anabolic use of amino acids. An exception is the use of amino acid supplements in intradialytic nutrition, during which a dialysate containing glucose can be used.

The duration of treatment depends on the patient's clinical condition.

If serum creatinine decreases below 300 umol / l, a conventional amino acid solution can be used.

So far, there is no clinical experience with the use of Nephrotect in children.

Compatibility

Only those medicines necessary for parenteral nutrition, such as energy carriers, electrolytes, trace elements, and vitamins, for which compatibility with Nephrotect has been studied, can be mixed with it.

The mixture must be prepared correctly.

Stability

Shelf life of the medicine in the packaged form for sale:

24 months. Store the container in its outer packaging.

Do not store above 25°C.

Shelf life after first opening of the container

The solution should be used immediately.

Any unused solution should be discarded after infusion.

Shelf life after addition of other nutritional elements

Nephrotect can be mixed with other solutions for nutrition, such as lipid emulsions, carbohydrates, electrolyte solutions, trace elements, and vitamins. Compatibility data are available upon request.

From a microbiological point of view, the product should be used immediately after the additions have been made. If it is not used immediately, the user is responsible for the storage conditions and the duration of the mixture until use. Normally, the mixture should not be stored for more than 24 hours at 2-8°C, unless the mixture has been prepared under controlled and validated aseptic conditions. If storage cannot be avoided and provided that the mixture has been prepared under controlled and validated aseptic conditions, it can be stored for a period longer than 2-8°C before use, ensuring that compatibility has been demonstrated. After removal from storage at 2-8°C, it must be infused within 24 hours.

Any unused mixture should be discarded after infusion.

Handling and disposal

Nephrotect should be used with a sterile transfer line immediately after opening. Any unused portion of the solution should be discarded.

Nephrotect is generally administered through a central venous access (preferably continuously over 24 hours).

When used for intradialytic nutrition, Nephrotect can be infused into the venous drip chamber of the dialysis apparatus, and it is not necessary to place a venous line.

The manufacturer has available, upon request, data on the chemical and physical stability of various mixtures.

Additions should be made aseptically.

Use only clear solutions and intact containers.

Do not use multiple doses from one vial.