Vaminolact

Package leaflet: Information for the user

Vaminolact
concentrate for infusion solution
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Vaminolact is and what it is used for

Vaminolact is an amino acid solution intended for intravenous infusion in children and adolescents.
It contains both amino acids that are synthesized by the body and those that are not synthesized in the body. The composition of amino acids has been formulated based on the composition of human breast milk.
Amino acids administered in solution form have nutritional properties. For complete utilization, the body must also receive an adequate amount of carbohydrates and fats.
Vaminolact maintains a positive nitrogen balance (i.e., intake of nitrogen exceeds nitrogen excretion) in preterm infants and full-term newborns. This is highly important for the proper development of a child's body.
Indications:
Vaminolact is indicated as a source of amino acids in parenteral nutrition of children and adolescents.

2. Important information before using Vaminolact

When not to use Vaminolact
Do not use the medicine:

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

Warnings and precautions
Before starting treatment with Vaminolact, 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 the case of long-term parenteral nutrition.
The doctor should take this into account when determining the dosage of copper and zinc in the child's nutrition.
When administering to neonates and children under 2 years of age, the solution (in the bag and administration set)
must be protected from light until the end of administration. Exposure of Vaminolact to light, especially after addition of trace elements and (or) vitamins,
leads to the formation of peroxides and other degradation products, which can be minimized by protecting from light.

Vaminolact and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
No interaction between Vaminolact and other medicines has been reported.

Pregnancy and breastfeeding
This information does not apply to Vaminolact, as it is intended for use in children and adolescents.

Driving and operating machinery
Not applicable.

3. How to use Vaminolact

This medicine is administered exclusively by medical personnel. Do not use this medicine on your own.
If in doubt, consult your doctor.
The dosage is determined individually by the doctor for each patient depending on age, body weight, and health status.
When administering to newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration (see section 2).
Administration of a higher than recommended dose of Vaminolact
If a higher dose than recommended has been administered, inform the doctor or nurse immediately.
If the medicine is administered too rapidly, vomiting, hot flushes, and sweating may occur.
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 product may cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:

• allergic reaction (hypersensitivity), manifesting 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 used for administration (inflammation and small blood clots causing palpable vein hardening, redness around the vein, pain, and tenderness).

Reporting of adverse reactions
If any adverse effects occur, including those not listed in this leaflet, inform a 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 safety of the medicine.

5. How to store Vaminolact

Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Once opened, the container must not be stored. Any unused portion of the medicine is not suitable for
further use.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not use this medicine if visible solid particles are present.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration (see section 2).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Vaminolact contains

• The active substances in the medicine are:

1000 ml of solution contains:
L-alanine 6.3 g
L-arginine 4.1 g
L-aspartic acid 4.1 g
L-cysteine (+L-cystine) 1.0 g
L-glutamic acid 7.1 g
Glycine (aminoacetic acid) 2.1 g
L-histidine 2.1 g
L-isoleucine 3.1 g
L-leucine 7.0 g
L-lysine monohydrate
corresponds to L-lysine 5.6 g
L-methionine 1.3 g
L-phenylalanine 2.7 g
L-proline 5.6 g
L-serine 3.8 g
Taurine 300 mg
L-threonine 3.6 g
L-tryptophan 1.4 g
L-tyrosine 500 mg
L-valine 3.6 g

• The other ingredient is water for injections.

Total amino acid content: 65.3 g/l
Content of essential amino acids: 31.9 g, including cysteine, histidine and tyrosine
pH: 5.2
Osmolality: 510 mOsm/kg water
Nitrogen content: 9.3 g/l
Electrolytes: none
Energy value: 1.0 MJ/l (240 kcal/l)
Antioxidants: none

What Vaminolact 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 100 ml or 500 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 healthcare professionals:

Dosage and method of administration
Recommended dosage ranges
Preterm infants: 38 to 54 mL/kg body weight/day (corresponding to 2.5 to 3.5 g of amino acids/kg body weight/day).
Dosage should be gradually increased during the first days of infusion, starting on the first day with a dose of
23 to 38 mL/kg body weight/day (corresponding to 1.5 to 2.5 g of amino acids/kg body weight/day) and increasing from the second
day to 38 to 54 mL/kg body weight/day (corresponding to 2.5 to 3.5 g of amino acids/kg body weight/day).
Term newborns: 23 to 46 mL/kg body weight/day (corresponding to 1.5 to 3.0 g of amino acids/kg
body weight/day).
Dosage should be gradually increased to the target dose during the first days of infusion.
Infants: 15 to 38 mL/kg body weight/day (corresponding to 1.0 to 2.5 g of amino acids/kg body weight/day).
Children and adolescents: 15 to 31 mL/kg body weight/day (corresponding to 1.0 to 2.0 g of amino acids/kg body weight/day).
The duration of infusion should not be shorter than 8 hours; preferably 12 hours in the case of cyclic infusion or 24 hours for continuous infusion. For newborns and infants, the recommended duration of continuous infusion is 24 hours per day.
Method of administration
Vaminolact may be administered via the same central or peripheral vein as glucose solution and (or) fat emulsion.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until administration is completed.
Overdose
If Vaminolact is administered at a rate higher than recommended, symptoms such as vomiting, hot flushes, and sweating may occur.
In case of symptoms of overdose, reduce the infusion rate or discontinue the infusion.
Preparation of the medicinal product for administration
Use only solutions free from particulate matter.
Any unused portion of the medicinal product must not be retained for later use.
Follow aseptic procedures.
Special warnings and precautions for use
Exposure of parenteral nutrition solutions, particularly after addition of trace elements and (or) vitamins, to light may lead to undesirable clinical effects in newborns due to the formation of peroxides and other degradation products. When used in newborns and children under 2 years of age, Vaminolact must be protected from light until administration is completed.
Pharmaceutical incompatibilities
Compatibility
Excipients
Only medicinal products, nutrient solutions, or electrolytes whose pharmaceutical compatibility has been confirmed may be added to Vaminolact.
Addition of excipients must be performed under aseptic conditions.
To 500 mL of Vaminolact, up to 200 mmol of sodium ions, 160 mmol of potassium chloride, 35 mmol of calcium gluconate, 15 mmol of magnesium sulfate, and up to 30 mL of Peditrace may be added, either in combination or separately.
Simultaneous administration of Vaminolact and Intralipid, for example via a three-way valve, reduces the osmolality of the solution infused into the vein. This reduces the risk of thrombophlebitis during peripheral vein administration.
Stability
Excipients
If additional substances have been added to the infusion solution, the infusion must be completed within 24 hours after preparation of the mixture to prevent microbial growth.
Any unused content of opened bottles must be discarded; it must not be stored for later use.
Data on stability and pharmaceutical compatibility with parenteral nutrition products are available upon request from the responsible entity's representative.
Storage conditions
The package must not be stored after opening.
Any unused portion of the medicinal product must not be retained for later use.
Store below 25°C. 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.
Special precautions for disposal and preparation of the medicinal product for use
When used in newborns and children under 2 years of age, protect from light until administration is completed. Exposure of Vaminolact to light, particularly after addition of trace elements and (or) vitamins, leads to the formation of peroxides and other degradation products, which can be minimized by ensuring protection from light.