Nephrotect

Package Leaflet: Information for the User

Nephrotect

0.1 g/ml (10%), Solution for Infusion

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
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Keep this leaflet, you may need to read it again.
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In case of any doubts, consult a doctor, pharmacist, or nurse.
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This medicine has been prescribed to you by a doctor and is intended for your use only. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
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If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Nephrotect and what is it used for

Nephrotect is a solution of amino acids intended for parenteral nutrition. It should be used as a component of parenteral nutrition in combination with appropriate amounts of carbohydrate solutions, fat emulsions, electrolytes, vitamins, and trace elements.
The medicine is administered by intravenous infusion.
Indications for use:
Nephrotect is indicated as a source of amino acids in parenteral nutrition for patients with renal failure, in whom oral or enteral nutrition is impossible, insufficient, or contraindicated. Nephrotect can also be used in patients undergoing dialysis.

2. Important information before using Nephrotect

When not to use Nephrotect

Do not use the medicine if:
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the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
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the patient has amino acid metabolism disorders;
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the patient has severe renal disease without the possibility of dialysis;
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the patient is experiencing acute shock;
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the patient has water overload (hyperhydration);
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the patient has fluid in the lungs (pulmonary edema);
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the patient has untreated heart failure;
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the patient has water deficiency in the body (hypotonic dehydration);
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the patient has severe liver disease.

Nephrotect is not recommended for use in children.

Warnings and precautions

Tell your doctor if the patient has:
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decreased sodium levels in the blood (hyponatremia);
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increased levels of electrolytes, proteins, and sugar (glucose).
During the administration of Nephrotect, the doctor will order blood tests (determination of electrolyte, glucose, protein, creatinine, urea, and ammonia levels, as well as liver function tests).
The doctor will also order monitoring of fluid balance (the amount of fluids taken in and excreted by the body) and acid-base balance (the appropriate ratio of acidic and basic compounds in the body).

Nephrotect and other medicines

Tell your doctor or nurse about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between Nephrotect and other medicines have been reported.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
There are no data on the use of Nephrotect in pregnant or breastfeeding women. The doctor will decide whether to use this medicine in pregnant or breastfeeding women after carefully weighing the benefits and risks.

Driving and using machines

This does not apply.

3. How to use Nephrotect

The dose is determined by the doctor individually for each patient, depending on their body weight and test results. Nephrotect is administered only by medical personnel.

Using a higher dose of Nephrotect than recommended

It is unlikely that the patient will receive too high a dose of Nephrotect, as the medicine is administered by medical personnel.
Symptoms of overdose may include:

• nausea;
• vomiting;
• fever;
• chills;
• skin redness.

If the patient experiences any of these symptoms or thinks they have received a higher dose of Nephrotect than recommended, they should immediately inform their doctor or nurse.
In case of any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, Nephrotect can cause side effects, although not everybody gets them.
No side effects are known during proper administration of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Nephrotect

Store the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store the bottle in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month stated.
Do not use this medicine if you notice any particles in it or if the packaging is damaged.
Once opened, the packaging cannot be stored. Any unused medicine is not suitable for further use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nephrotect contains

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The active substances of the medicine are:
1000 ml of solution for infusion contains:
L-isoleucine
5.80 g
L-leucine
12.80 g
L-lysine acetate
16.90 g
(equivalent to L-lysine 12.00 g)
L-methionine
2.00 g
L-phenylalanine
3.50 g
L-threonine
8.20 g
L-tryptophan
3.00 g
L-valine
8.70 g
L-arginine
8.20 g
L-histidine
9.80 g
L-alanine
6.20 g
N-acetyl-L-cysteine
0.54 g
(equivalent to L-cysteine 0.40 g)
glycine
5.31 g
L-proline
3.00 g
L-serine
7.60 g
L-tyrosine
0.60 g
N-glycyl-L-tyrosine, hydrated
3.16 g
(in terms of anhydrous substance glycine/L-tyrosine 0.994 g/2.40 g)
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The other ingredients (excipients) are acetic acid, L-malic acid, water for injections.
Total amino acid content
100 g/l
Total nitrogen content
16.3 g/l
Total energy value
1600 kJ/l = 400 kcal/l
pH
5.5 - 6.5
Acidity of the solution
about 60 mmol NaOH/l
Theoretical osmolality
960 mOsm/l

What Nephrotect looks like and what the pack contains

The medicine is a solution for infusion.
The packaging of the medicine is a glass bottle containing 250 ml or 500 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
Date of last revision of the leaflet:04.11.2024

Information intended for healthcare professionals only:

Dosage and administration

The medicine should be administered in continuous intravenous infusion.
Dosage should be adjusted to the individual needs of the patient.
If there are no other recommendations, the following dosages are used for patients with acute or chronic renal failure:

• in patients not undergoing dialysis: 0.6 to 0.8 g of amino acids/kg body weight/day = 6 to 8 ml/kg body weight/day
• in patients undergoing dialysis: 0.8 to 1.2 g of amino acids/kg body weight/day = 8 to 12 ml/kg body weight/day
• in nutrition used during dialysis in patients undergoing long-term hemodialysis: 0.5 to 0.8 g of amino acids/kg body weight/dialysis = 5 to 8 ml/kg body weight/dialysis

Maximum recommended daily dose:
0.8 to 1.2 g of amino acids/kg body weight
= 8 to 12 ml/kg body weight or 560 to 840 ml in a patient with a body weight of 70 kg
Maximum recommended infusion rate:

• parenteral nutrition: 0.1 g of amino acids/kg body weight/hour
• nutrition used during dialysis: 0.2 g of amino acids/kg body weight/hour

Amino acids should be used in combination with infusion solutions that provide the patient's energy needs during parenteral nutrition.
Nephrotect can be used as a component of total parenteral nutrition in combination with appropriate amounts of carbohydrate solutions, fat emulsions, electrolytes, vitamins, and trace elements.
Nephrotect can be administered into central or peripheral veins after proper mixing with other nutrients.
Nephrotect can be administered in different infusion lines together with other nutrients (multi-bottle or single-bag method) or can be mixed in one container with other solutions to obtain a mixture for total parenteral nutrition containing all the components.
In nutrition used during dialysis, Nephrotect can be injected directly into the venous chamber of the dialysis apparatus, so there is no need for intravenous infusion.
Data on the chemical and physical stability of individual mixtures are available on request from the representative of the marketing authorization holder.
Any additives should be combined with the medicine under aseptic conditions.
Only use clear solutions from undamaged bottles.
Do not take multiple doses from one bottle.

Overdose

The primary symptoms of overdose or infusion of the solution at a rate higher than recommended may include nausea, fever, chills, skin redness, vomiting, hyperammonemia, hyperaminoacidemia, and acidosis. If any of these symptoms occur, the infusion should be stopped immediately.

Preparation of the medicine for use

Nephrotect should be administered using a sterile infusion set immediately after opening the packaging.
Any unused solution should be destroyed.
In accordance with therapeutic requirements, Nephrotect should be used in combination with appropriate amounts of carbohydrate solutions, fat emulsions, electrolytes, vitamins, and trace elements, if necessary, into central veins (preferably continuously for 24 hours).
In nutrition used during dialysis, Nephrotect can be injected directly into the venous chamber of the dialysis apparatus, so there is no need for intravenous infusion.
Data on the chemical and physical stability of individual mixtures are available on request from the representative of the marketing authorization holder.
Any additives should be combined with the medicine under aseptic conditions.
Only use clear solutions from undamaged bottles.

Incompatibilities

Nephrotect can only be mixed with medicines necessary for parenteral nutrition, such as carbohydrate solutions, fat emulsions, electrolytes, trace elements, and vitamins, whose pharmaceutical compatibility has been established.
After adding other substances, the solution should be well mixed.
See section 6.4 of the Summary of Product Characteristics.

Storage conditions

Store in a temperature below 25°C. Store the bottle in the outer packaging to protect it from light.

Disposal of unused medicine

Any unused medicine or waste should be disposed of in accordance with local regulations.