Vamin 18 electrolyte-free

Package leaflet: Information for the user

Vamin 18 Electrolyte-Free, infusion solution
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Vamin 18 Electrolyte-Free is and what it is used for
2. Important information before using Vamin 18 Electrolyte-Free
3. How to use Vamin 18 Electrolyte-Free
4. Possible side effects
5. How to store Vamin 18 Electrolyte-Free
6. Contents of the package and other information

1. What Vamin 18 Electrolyte-Free is and what it is used for

Vamin 18 Electrolyte-Free is an amino acid solution for intravenous infusion in adult patients. It contains both amino acids produced by the body and those not produced by the body, which are normally present in regular nutrition.
Amino acids administered in solution form have nutritional properties. To be fully utilized, the body must also receive an adequate amount of carbohydrates and fats.
Vamin 18 Electrolyte-Free maintains a positive nitrogen balance (i.e. intake of more nitrogen than excretion), which is important for maintaining the patient's proper nutritional status.
Indications:
Vamin 18 Electrolyte-Free is indicated as a source of amino acids for parenteral nutrition in adult patients. The product is particularly suitable for patients with significantly increased amino acid requirements and/or restricted fluid intake.

2. Important information before using Vamin 18 Electrolyte-Free

When not to use Vamin 18 Electrolyte-Free
Do not use this medicine:

• if the patient has congenital disorders of amino acid metabolism;
• if the patient has severe liver function impairment;
• if the patient has uremia (a syndrome caused by end-stage renal failure) and dialysis is not possible.

Warnings and precautions
Before starting treatment with Vamin 18 Electrolyte-Free, discuss this with the doctor or
nurse.
Intravenous administration of amino acid solutions increases urinary excretion of trace elements—copper and zinc. This is particularly important in cases of long-term parenteral nutrition. The doctor should take this into account when determining the dosage of copper and zinc in the patient's nutrition.

Vamin 18 Electrolyte-Free and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions between Vamin 18 Electrolyte-Free and other medicines have been observed.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will decide whether this medicine should be used in pregnant or breastfeeding women.

Driving and operating machinery
Not applicable.

3. How to use Vamin 18 Electrolyte-Free

This medicine is administered exclusively by medical personnel.
Do not use this medicine on your own.
If you have any doubts, consult your doctor.
The dosage is determined individually by a doctor for each patient, depending on body weight and health condition.
Administration of a higher than recommended dose of Vamin 18 Electrolyte-Free
If a higher than recommended dose is administered, inform the doctor or nurse immediately.
If the medicine is administered at a faster rate than recommended, nausea, vomiting, sweating, and thrombophlebitis (when administered into peripheral veins) may occur.
If symptoms of overdose occur, the doctor will decide on further treatment with the medicine.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:

• allergic reaction (hypersensitivity), presenting as skin rash, swelling (particularly of the lips, face, eyelids, tongue, and throat), shortness of breath, or fainting. In such cases, contact a doctor immediately.
• nausea (rare);
• abnormal liver function tests (increased activity of liver enzymes AspAT and AlAT);
• thrombophlebitis of the vein into which the medicine was administered (inflammation and small blood clots causing palpable hardening of the vein, redness around it, pain, and tenderness).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Vamin 18 Electrolyte-Free

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light. Do not freeze.
The medicine should be used immediately after opening the container.
Any unused portion of the medicine is not suitable for further use.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if visible particles are present.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Vamin 18 Electrolyte-Free contains

• The active substances are:

1000 ml of solution contains:
L-alanine 16.0 g
L-arginine 11.3 g
L-aspartic acid 3.4 g
L-cysteine (+ L-cystine) 560 mg
L-glutamic acid 5.6 g
glycine (aminoacetic acid) 7.9 g
L-histidine 6.8 g
L-isoleucine 5.6 g
L-leucine 7.9 g
L-lysine acetate
corresponding to 9.0 g of L-lysine
L-methionine 5.6 g
L-phenylalanine 7.9 g
L-proline 6.8 g
L-serine 4.5 g
L-threonine 5.6 g
L-tryptophan 1.9 g
L-tyrosine 230 mg
L-valine 7.3 g

• Other components (excipients) are: glacial acetic acid, water for injections.

Total amino acid content: 114 g/l; essential amino acid content: 51.6 g,
including cysteine and tyrosine.
pH: 5.6
Osmolality: 1130 mOsm/kg water
Nitrogen content: 18 g/l
Electrolytes: approximately 110 mmol of acetate provided as acetic acid and lysine acetate
Energy value: 1.9 MJ/l (460 kcal/l)
Antioxidants: none

What Vamin 18 Electrolyte-Free looks like and contents of the pack
The medicine is a clear, colourless to slightly yellow solution.
The medicine is packed in a colourless glass bottle containing 500 ml or 1000 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria

For further information, please contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Information intended exclusively for medical professionals:

Dosage and administration
Adult patients: nitrogen requirements necessary to maintain protein mass depend on the patient's
health status (nutritional state and degree of metabolic stress).
The requirements are as follows:
0.10 – 0.15 g nitrogen/kg body weight/day (no or mild metabolic stress and normal nutritional status),
0.15 – 0.20 g nitrogen/kg body weight/day (moderate metabolic stress with or without malnutrition),
0.20 – 0.25 g nitrogen/kg body weight/day (severe catabolism, such as in burns, sepsis, and trauma).
The dosage range of 0.10 – 0.25 g nitrogen/kg body weight/day corresponds to 5 – 14 mL of Vamin 18 Electrolyte-Free/kg body weight/day.
In obese patients, the dose should be calculated based on estimated ideal body weight.
Depending on the patient's requirements, up to 1000 mL of Vamin 18 Electrolyte-Free may be administered daily by intravenous infusion. In patients with basic or moderately increased amino acid requirements, the less concentrated Vamin 14 Electrolyte-Free may be used.
Vamin 18 Electrolyte-Free must be administered slowly, at a rate not exceeding 1000 mL over 8 hours, corresponding to approximately 2 mL per minute (see Overdose section).

Overdose
If Vamin 18 Electrolyte-Free was administered at a rate exceeding the recommended rate, an increased risk of nausea, vomiting, and sweating has been observed. When administered via peripheral veins, thrombophlebitis may occur.
In case of symptoms of overdose, the infusion rate should be reduced or the infusion discontinued.

Preparation of the medicinal product for use
The product should be used immediately after opening the packaging. Any unused residue of the medicinal product is not suitable for further use.

Pharmaceutical incompatibilities
Compatibility
Excipients
Only medicinal products, nutrient solutions, or electrolyte solutions whose pharmaceutical compatibility has been confirmed may be added to Vamin 18 Electrolyte-Free. Addition of other substances must be performed under aseptic conditions.
To 1000 mL of Vamin 18 Electrolyte-Free, the following may be added, either individually or in combination: up to 20 mL of Addamel N, 480 mmol NaCl, 480 mmol KCl, 24 mmol calcium gluconobionate, and 48 mmol MgSO₄.
If phosphate supplementation is required, up to 60 mL of Addiphos may be added to 1000 mL of Vamin 18 Electrolyte-Free, either alone or in combination with 480 mmol NaCl, 430 mmol KCl, and 48 mmol MgSO₄.
Note that Addamel N must not be added to solutions containing inorganic phosphate due to the risk of precipitate formation.

Mixing in a plastic bag (not containing phthalate) – example of a total parenteral nutrition mixture:
Mixing must be performed under strict aseptic conditions in a laminar airflow cabinet, following the sequence below:

1. To Vamin 18 Electrolyte-Free, the following may be added:
   • Addamel N;
   • Glycophos;
   • Electrolytes.
2. To glucose solution, the following may be added:
   • Addiphos or another source of inorganic phosphate.
3. To Intralipid, the following may be added:
   • Soluvit N;
   • Vitalipid N Adult.

Mixtures 1 and 2 should be transferred into a plastic bag (not containing phthalate), followed by careful addition of mixture 3, gently rotating the bag until a homogeneous mixture is obtained.

Stability
The product should be used immediately after opening the packaging. Any unused residue of the medicinal product is not suitable for further use.

Excipients
When additional medicinal products are added to the infusion solution, the infusion should be completed within 24 hours after preparation to avoid microbiological contamination.

Mixing in a plastic bag (not containing phthalate)
Mixtures prepared under aseptic conditions should be used within 7 days. Mixtures may be stored for up to 6 days in a refrigerator (2 – 8°C), then administered by intravenous infusion within 24 hours.
Data on stability and pharmaceutical compatibility with other medicinal products used in parenteral nutrition are available upon request from the responsible entity's representative.

Storage conditions
Store below 25°C. Keep in the original packaging to protect from light. Do not freeze.

Disposal of unused medicinal product
Any unused residues or waste of the medicinal product must be disposed of in accordance with local regulations.