Vamin 18 Electrolite-free

Package Leaflet: Information for the User

Vamin 18 Electrolyte-Free, Solution for Infusion

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

important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Vamin 18 Electrolyte-Free and what is it 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 pack and other information

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

Vamin 18 Electrolyte-Free is an amino acid solution for infusion in adults. It contains both essential and non-essential amino acids found in normal nutrition. Amino acids administered as a solution 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., more nitrogen is ingested than excreted). This is crucial for maintaining the patient's nutritional status. Indications for use: Vamin 18 Electrolyte-Free is indicated as a source of amino acids in parenteral nutrition for adult patients. The medicine is particularly suitable for patients with significantly increased amino acid requirements and/or fluid restrictions.

2. Important information before using Vamin 18 Electrolyte-Free

When not to use Vamin 18 Electrolyte-Free

Do not use the medicine:

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

Warnings and precautions

Before starting treatment with Vamin 18 Electrolyte-Free, discuss it with a doctor or nurse. Intravenous administration of amino acid solutions increases the urinary excretion of trace elements - copper and zinc. This is particularly 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 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 take. No interactions between Vamin 18 Electrolyte-Free and other medicines have been found.

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 before using this medicine. The doctor will decide whether to use this medicine in pregnant or breastfeeding women.

Driving and using machines

Not applicable.

3. How to use Vamin 18 Electrolyte-Free

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

Using a higher dose of Vamin 18 Electrolyte-Free than recommended

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

4. Possible side effects

Like all medicines, Vamin 18 Electrolyte-Free 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), difficulty breathing, or fainting. In this case, contact a doctor immediately;
• nausea (rarely);
• abnormal liver test results (increased activity of liver enzymes AspAT and AlAT);
• thrombophlebitis, which is the formation of inflammation and small blood clots in the vein into which the medicine was administered, manifesting as a palpable hardening of the vein, redness around it, pain, and tenderness.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform the 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. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Vamin 18 Electrolyte-Free

Store the medicine out of 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 a 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 18 Electrolyte-Free contains

• The active substances of the medicine are:

1000 ml of the solution contains:
L-alanine
16.0 g
L-arginine
11.3 g
L-asparagine
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
equivalent to L-lysine
9.0 g
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 ingredients (excipients) are: 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 added 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 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
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:

Information intended for healthcare professionals only:

Dosage and administration

Adult patients: the nitrogen requirement necessary to maintain nitrogen balance depends on the patient's health status (nutritional status and degree of metabolic stress). The requirement is:
0.10 – 0.15 g nitrogen/kg body weight/day (no or minimal 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 dose 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 the estimated ideal body weight.
Depending on the patient's requirements, up to 1000 ml of Vamin 18 Electrolyte-Free can be administered per day. In patients with basic or moderately increased amino acid requirements, a less concentrated Vamin 14 Electrolyte-Free can be used.
Vamin 18 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).

Overdose

If Vamin 18 Electrolyte-Free is administered at a rate higher than recommended, there is an increased risk of nausea, vomiting, and sweating, as well as thrombophlebitis (when the medicine is administered into peripheral veins). 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
Additional substances
Vamin 18 Electrolyte-Free can only be mixed with medicinal products, nutritional solutions, or electrolyte solutions whose pharmaceutical compatibility has been confirmed. The introduction of additional substances should be carried out under aseptic conditions.
Up to 1000 ml of Vamin 18 Electrolyte-Free can be mixed with: up to 20 ml of Addamel N, 480 mmol NaCl, 480 mmol KCl, 24 mmol calcium gluconate, and 48 mmol MgSO.
If phosphate administration is necessary, up to 60 ml of Addiphos can be added to 1000 ml of Vamin 18 Electrolyte-Free, alone or in combination with 480 mmol NaCl, 430 mmol KCl, and 48 mmol MgSO.
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 (without phthalate) – example of a mixture for total parenteral nutrition:
Mixing should be carried out under strict aseptic conditions, in a laminar flow cabinet, and in the following order:

• 1. The following can be added to Vamin 18 Electrolyte-Free:
• Addamel N;
• Glycophos;
• electrolytes.
• 2. The following can be added to glucose:
• Addiphos or other inorganic phosphate source.
• 3. The following can be added to Intralipid:
• Soluvit N;
• Vitalipid N Adult.

Mixtures 1 and 2 should be transferred to a plastic bag (without 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.
Additional substances
In the event of introducing additional medicinal products into the infusion solution, the infusion should be completed within 24 hours of preparing the solution; this will prevent microbiological contamination.
Mixing in a plastic bag (without phthalate)
Mixtures prepared under aseptic conditions can be used within 7 days.
Mixtures can be stored for up to 6 days in a refrigerator (2 – 8°C) and then administered in an 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 should be disposed of in accordance with local regulations.