Vamin 14 Electrolite-free

Leaflet attached to the packaging: information for the user

Vamin 14 Electrolyte-Free, solution for infusion

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

important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 Vamin 14 Electrolyte-Free and what is it used for
• 2. Important information before using Vamin 14 Electrolyte-Free
• 3. How to use Vamin 14 Electrolyte-Free
• 4. Possible side effects
• 5. How to store Vamin 14 Electrolyte-Free
• 6. Contents of the pack and other information

1. What is Vamin 14 Electrolyte-Free and what is it used for

Vamin 14 Electrolyte-Free is a solution of amino acids used in adult patients for intravenous infusion. It contains both amino acids produced by the body and those not produced by the body, which are found in normal food. Amino acids administered in the form of a solution have nutritional properties. To be fully utilized, the body must also receive an adequate amount of carbohydrates and fats. Vamin 14 Electrolyte-Free maintains a positive nitrogen balance (i.e., more nitrogen is taken in than excreted). This is important for maintaining proper nutrition. Indications for use: Vamin 14 Electrolyte-Free is indicated for use as a source of amino acids in parenteral nutrition in adult patients. The drug is suitable for use especially in patients with moderately increased demand for amino acids.

2. Important information before using Vamin 14 Electrolyte-Free

When not to use Vamin 14 Electrolyte-Free

Do not use the medicine:

• if the patient has congenital disorders of amino acid metabolism;
• if the patient has severe liver dysfunction;
• if the patient has uremia (a syndrome of symptoms caused by extreme impairment of kidney function), and dialysis is not possible.

Warnings and precautions

Before starting treatment with Vamin 14 Electrolyte-Free, discuss it with your doctor or nurse. Intravenous administration of amino acid solutions increases the excretion of trace elements - copper and zinc - in the urine. This is especially important in the case of long-term parenteral nutrition. The doctor should take this into account when determining the dose of copper and zinc in the patient's nutrition.

Vamin 14 Electrolyte-Free and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. No interaction between Vamin 14 Electrolyte-Free and other medicines has been found.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. The doctor will decide whether to use this medicine in women during pregnancy or breastfeeding.

Driving and using machines

Not applicable.

3. How to use Vamin 14 Electrolyte-Free

This medicine is given only by medical personnel. Do not use the medicine yourself. In case of doubts, consult your doctor. The dosage is determined by the doctor individually for each patient, depending on body weight and health status.

Using a higher dose of Vamin 14 Electrolyte-Free than recommended

If a higher dose of the medicine is used, tell your doctor or nurse immediately. If the medicine is administered at a rate greater than recommended, nausea, vomiting, and sweating, as well as thrombophlebitis (when the medicine is administered into peripheral veins), may occur. If symptoms of overdose occur, the doctor will decide on further use of the medicine. If you have any further doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

• allergic reaction (hypersensitivity), which manifests as a skin rash, swelling (especially of the lips, face, eyelids, tongue, and throat), shortness of breath, or fainting. You should then contact your doctor immediately.
• nausea (rarely);
• abnormal liver test results (increased activity of liver enzymes AspAT and AlAT);
• thrombophlebitis, into which the medicine was administered (formation of inflammation and small blood clots, manifested by palpable hardening of the vein, redness around it, pain, and tenderness).

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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vamin 14 Electrolyte-Free

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to protect from light. Do not freeze. Use the medicine immediately after opening the packaging. Unused 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 specified month. Do not use this medicine if visible solid particles are present. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vamin 14 Electrolyte-Free contains

• The active substances of the medicine are:

1000 ml of the solution contains: L-alanine 12.0 g, L-arginine 8.4 g, L-asparagine 2.5 g, L-cysteine (+ L-cystine) 420 mg, L-glutamic acid 4.2 g, glycine (aminooctanoic acid) 5.9 g, L-histidine 5.1 g, L-isoleucine 4.2 g, L-leucine 5.9 g, L-lysine acetate equivalent to L-lysine 6.8 g, L-methionine 4.2 g, L-phenylalanine 5.9 g, L-proline 5.1 g, L-serine 3.4 g, L-threonine 4.2 g, L-tryptophan 1.4 g, L-tyrosine 170 mg, L-valine 5.5 g

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

Total amino acid content: 85 g/l; essential amino acid content: 38.7 g, including cysteine and tyrosine. pH: 5.6 Osmolality: 810 mOsm/kg water Nitrogen content: 13.5 g/l Electrolytes: about 90 mmol of acetate added as acetic acid and lysine acetate Energy value: 1.4 MJ/l (350 kcal/l) Antioxidants: none

What Vamin 14 Electrolyte-Free looks like and what the pack contains

The medicine is a solution for infusion. The packaging of the medicine is a glass bottle containing 500 ml or 1000 ml of the solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi AB, S-751 74 Uppsala, Sweden

Manufacturer

Fresenius Kabi Austria GmbH, Hafnerstrasse 36, A-8055 Graz, Austria For more detailed information, please 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:

Information intended only for healthcare professionals:

Dosage and administration

Adult patients: the need for nitrogen necessary to maintain muscle mass depends on the patient's health status (nutritional status and degree of metabolic stress). The need is: 0.10 - 0.15 g of nitrogen/kg body weight/day (no or slight metabolic stress and normal nutritional status), 0.15 - 0.20 g of nitrogen/kg body weight/day (moderate metabolic stress with or without malnutrition), 0.20 - 0.25 g of nitrogen/kg body weight/day (severe catabolism, such as in burns, sepsis, and injuries). The dose range of 0.10 - 0.25 g of nitrogen/kg body weight/day corresponds to 7 - 18 ml of Vamin 14 Electrolyte-Free/kg body weight/day. In obese patients, the dose should be calculated based on the estimated normal body weight. Depending on the patient's needs, up to 1000 ml of Vamin 14 Electrolyte-Free can be administered per day by intravenous infusion. In patients with significantly increased demand for amino acids, a more concentrated Vamin 18 Electrolyte-Free can be used. Vamin 14 Electrolyte-Free should be administered slowly, at a rate not exceeding 1000 ml in 8 hours, which corresponds to approximately 2 ml per minute (see Overdose section).

Overdose

If Vamin 14 Electrolyte-Free is administered at a rate greater than recommended, an increased risk of nausea, vomiting, and sweating, as well as thrombophlebitis (when the medicine is administered into peripheral veins), has been observed. If symptoms of overdose occur, the infusion rate should be reduced or the infusion stopped.

Preparation of the medicine for use

The medicine should be used immediately after opening the packaging. Unused medicine is not suitable for further use.

Incompatibilities

Compatibility Other medicinal products can be added to Vamin 14 Electrolyte-Free only if their pharmaceutical compatibility has been confirmed. The introduction of additional substances should be carried out in accordance with aseptic principles. Up to 1000 ml of Vamin 14 Electrolyte-Free can be added: up to 20 ml of Addamel N, 480 mmol of NaCl, 480 mmol of KCl, 24 mmol of calcium glubionate, and 48 mmol of MgSO4. If phosphate administration is necessary, up to 60 ml of Addiphos can be added to 1000 ml of Vamin 14 Electrolyte-Free, alone or in combination with 480 mmol of NaCl, 480 mmol of KCl, and 48 mmol of MgSO4. Note that inorganic phosphate-containing solutions should not be mixed with Addamel N due to the risk of precipitate formation. Mixing in a plastic bag (not containing phthalate) - example mixture for total parenteral nutrition: Mixing should be carried out in accordance with strict aseptic principles, in a laminar flow cabinet, and in the following order:

• 1. To Vamin 14 Electrolyte-Free can be added:
• Addamel N;
• Glycophos;
• electrolytes.
• 2. To glucose can be added:
• Addiphos or other inorganic phosphate source.
• 3. To Intralipid can be added:
• Soluvit N;
• Vitalipid N Adult.

Mixtures 1 and 2 should be transferred to a plastic bag (not containing phthalate), to which mixture 3 is then added, gently shaking the bag until a homogeneous mixture is obtained. Stability The medicine should be used immediately after opening the packaging. Unused medicine is not suitable for further use. Other medicinal products If additional medicinal products are introduced into the infusion solution, the infusion should be completed within 24 hours of preparation; this will prevent microbiological contamination. Mixing in a plastic bag (not containing phthalate) Mixtures prepared under aseptic conditions should be used within 7 days. Mixtures can be stored for up to 6 days in a refrigerator (2 - 8°C) and then administered by intravenous infusion within 24 hours. Data on stability and pharmaceutical compatibility with other medicines used for parenteral nutrition are available on request from the representative of the marketing authorization holder.

Storage conditions

Store in a temperature below 25°C. Store in the original packaging to protect from light. Do not freeze.

Disposal of unused medicine

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