Vaminolact

Package Leaflet: Information for the User

Vaminolact

Infusion Solution

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Vaminolact and what is it used for
• 2. Important information before using Vaminolact
• 3. How to use Vaminolact
• 4. Possible side effects
• 5. How to store Vaminolact
• 6. Package contents and other information

1. What is Vaminolact and what is it used for

Vaminolact is an amino acid solution used in children and adolescents for intravenous infusion.
It contains both amino acids produced by the body and those not produced by the body. The composition
of amino acids has been chosen based on the composition of breast milk.
Amino acids administered in the form of a solution have nutritional properties. To be fully absorbed, the body must also receive an adequate amount of carbohydrates and fats.
Vaminolact maintains a positive nitrogen balance (i.e., the intake of more nitrogen than excretion)
in preterm and full-term newborns. This is of great importance for the proper development of the child's body.
Indications for use:
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 congenital amino acid metabolism disorders;
• if the patient has severe liver function disorders;
• if the patient has severe azotemia (a syndrome of symptoms caused by extreme kidney dysfunction), and dialysis is not possible.

Warnings and precautions

Before starting to use Vaminolact, discuss it with a 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 child's nutrition.
During use in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration. Exposure of Vaminolact to light, especially after adding trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be limited by providing protection from light.

Vaminolact and other medicines

Tell a doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
No interaction between Vaminolact and other medicines has been found.

Pregnancy and breastfeeding

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

Driving and using machines

Not applicable.

3. How to use Vaminolact

This medicine is administered only by medical personnel. The medicine must not be used by itself.
In case of doubts, consult a doctor.
The dosage is determined by a doctor individually for each patient, depending on age, body weight, and health status.
During use in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

Using a higher dose of Vaminolact than recommended

In case of using a higher dose of the medicine, inform a doctor or nurse immediately.
In case of too rapid administration of the medicine, vomiting, hot flashes, and sweating may occur.
In case of any further doubts related to the use of this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, Vaminolact 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. In this case, contact a doctor immediately;
• nausea (rarely);
• abnormal liver test results (increased activity of liver enzymes AspAT and AlAT);
• thrombophlebitis (formation of inflammation and small blood clots in the vein into which the medicine was administered, manifested by palpable hardening of the vein, redness around it, pain, and tenderness).

Reporting side effects
If any side effects occur, including those not listed in this package leaflet, inform a 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 to gather more information on the safety of the medicine.

5. How to store Vaminolact

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
The opened package cannot be stored. Unused leftovers of the medicine are not suitable for further use.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the given month.
Do not use this medicine if visible solid particles are present.
During use in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).
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. Package contents and other information

What Vaminolact contains

• The active substances of the medicine are:

1000 ml of the 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
equivalent 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
Essential amino acid content:
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 what the package contains

The medicine is a solution for infusion.
The package is a colorless glass bottle containing 100 ml or 500 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 package leaflet:

Information intended for healthcare professionals only:

Dosage and administration

Recommended dosage ranges
Preterm infants: 38 to 54 ml/kg body weight/day (corresponding to 2.5 to 3.5 g amino acids/kg body weight/day).
The dose 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 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 amino acids/kg body weight/day).
Full-term newborns: 23 to 46 ml/kg body weight/day (corresponding to 1.5 to 3.0 g amino acids/kg body weight/day).
The dose 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 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 amino acids/kg body weight/day).
The infusion time should not be less than 8 hours, preferably 12 hours in the case of cyclic infusion or 24 hours in the case of continuous infusion. In newborns and infants, the recommended continuous infusion time is 24 hours a day.
Administration method
Vaminolact can be administered into the same central or peripheral vein as glucose solution and/or fat emulsion.
During use in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration.

Overdose

If Vaminolact is administered at a rate higher than recommended, vomiting, hot flashes, and sweating are observed.
In case of overdose symptoms, reduce the infusion rate or discontinue the infusion.

Preparing the medicine for use

Use only a solution free from solid particles.
Unused leftovers of the medicine are not suitable for further use.
Follow aseptic procedures.

Special warnings and precautions for use

Exposure to light of parenteral nutrition solutions, especially after adding trace elements and/or vitamins, may have undesirable effects on the clinical response in newborns due to the formation of peroxides and other degradation products. During use in newborns and children under 2 years of age, Vaminolact should be protected from light until the end of administration.

Incompatibilities

Compatibility
Additional substances
Vaminolact can be mixed with other medicinal products, nutrient solutions, or electrolytes only if their pharmaceutical compatibility has been confirmed.
Adding other substances should be performed under aseptic conditions.
Up to 500 ml of Vaminolact can be mixed with, separately or together, 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.
Simultaneous administration of Vaminolact and Intralipid, for example through a three-way valve, reduces the osmolality of the solution administered into the vein, thus reducing the risk of thrombophlebitis during peripheral vein administration.
Stability
Additional substances
If other substances have been added to the infusion solution, the infusion should be completed within 24 hours of preparation to prevent microbial growth.
Unused contents of opened bottles should be discarded; they must not be stored for further use.
Data on the stability and pharmaceutical compatibility of Vaminolact with other parenteral nutrition products are available on request from the representative of the marketing authorization holder.

Storage conditions

Opened packages cannot be stored.
Unused leftovers of the medicine are not suitable for further use.
Store in a temperature below 25°C. Do not freeze.

Disposal of unused medicine

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

Special precautions for disposal and preparation of the medicinal product for use

During use in newborns and children under 2 years of age, protect from light until the end of administration. Exposure of Vaminolact to light, especially after adding trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be limited by providing protection from light.