Label:Information for the User

Nephrotect Infusion Solution

Amino Acid Solution

Read this label carefully before starting to use this medication,because it contains important information for you.

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

-If you experience any adverse effects,consult your doctor, pharmacist or nurse,evenifthey are not listed in this label. See section 4.

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 receiving dialysis treatment.

You should not be given Nephrotect:

- if you areallergic (hypersensitive)to the active ingredients or to any of the other components of this medication (listed in section 6)

- if your bodyhas difficulty using amino acids

- if you have aserious kidney diseasewithout the possibility of undergoing dialysis

- if you have anacute shock

- if you havetoo much fluid in your body(hyperhydration)

- if you havefluid in your lungs(pulmonary edema)

- if you haveuntreated heart failure

- if youdo not have enough bodily fluid(hypotonic dehydration)

- if you have aserious liver disease

Warnings and precautions

Consult your doctorbefore Nephrotect is administered to you:

- if you have an abnormally low concentration of sodium 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.

Use of Nephrotect with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use anyother medication.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor before using this medicationYour doctor will decide whether Nephrotect should be administered to you.

Driving and operating machinery

Not applicable as the product is administered in a hospital.

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 administered more Nephrotect than you should be

It is unlikely that you will receive too much Nephrotect since 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 medication, ask your doctor or nurse.

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

- Store the packaging in the outer packaging.

- Do not store at a temperature above 25°C

-Do not use Nephrotect after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

- Use only transparent solutions and intact packaging.

-Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Nephrotect

The active principles 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 acids100 g/l

Total nitrogen16.3 g/l

Total energy content400 Kcal/l

pH5.5-6.5

Acidity titrationapprox. 60 mmol NaOH/l

Theoretical osmolality960 mosm/l

Appearance of the product and contents of the container

Clear, colorless to slightly yellowish solution presented in glass bottles of 250 ml and 500 ml with rubber stopper and aluminum closure cap.

Size of the containers:

1× 250 ml, 10 × 250 ml

1× 500 ml, 10 × 500 ml

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg Germany

Responsible manufacturer

Fresenius Kabi Austria GMBH, 8055 Graz Austria

Local representative

Fresenius Kabi España, S.A.U

Marina, 16-18

08005 Barcelona

Last review date of this leaflet: January 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

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This information is intended solely for healthcare professionals:Contraindications

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

Warnings and precautions for use

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

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

At present, there is no clinical experience with the use of Nephrotect in children.

Dosage and administration

For intravenous continuous infusion.

Your doctor will adjust the dose to be administered according to 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

Amino acids should generally 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.

Nephrotect can be administered using separate infusion lines with other nutrients.

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

From a microbiological point of view, the product should be used immediately after additions have been made. If not used immediately, the consumer is responsible for 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 once it has been guaranteed 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 being used, ensuring that compatibility has been demonstrated. After removing the mixture from storage at 2-8°C, it must be infused within 24 hours.

Any unused portion of the mixture should be discarded after infusion.

Manipulations 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 for 24 hours).

When used in intradialytic nutrition, Nephrotect can be infused into the venous part of the dialyzer, and therefore it is not necessary to place a venous line.

The manufacturer has available on 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 prepare multiple doses from a single bottle.