Package leaflet: Information for the user

DEKAMIN

Infusion solution
Amino acid solution with Pyridoxine hydrochloride (Vitamin B )
Read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What DEKAMIN is and what it is used for
What you need to know before using DEKAMIN
How to use DEKAMIN
Possible side effects
How to store DEKAMIN
Contents of the pack and other information

1. What DEKAMIN is and what it is used for

DEKAMIN is a solution containing a group of substances called amino acids in combination with vitamin
B6 (pyridoxine hydrochloride), used for parenteral nutrition (administration of nutrients
directly into the vein).
This medicinal product is indicated:

for the treatment of patients in whom it is necessary to increase nitrogen reserves in order to restore proper protein production in the body (rebuilding of the protein stores);
in the periods before and after surgical procedures or following extensive burns;
for the treatment of severe liver damage (hepatic cirrhosis in decompensated phase), impaired kidney function (nephrotic syndrome without renal insufficiency), or severe kidney disease during dialysis (acute and chronic uraemia undergoing periodic peritoneal dialysis or extracorporeal dialysis);
for the treatment of wasting conditions (malnutrition) due to:
- marked reduction in appetite due to mental disorders (mental anorexia);
- severe wasting due to tumours (neoplastic cachexia);
- prolonged treatment with corticosteroid medicines, antifungal medicines (antimycotics), or medicines used after organ transplants or in autoimmune diseases (immunosuppressants);
- infectious diseases and diseases caused by chronic inflammation, prolonged diarrhoea (profuse diarrhoea), intestinal malabsorption (intestinal malabsorption).

2. What you need to know before using DEKAMIN

Do not use DEKAMIN

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from severe kidney disease (acute and chronic uremia);
if you suffer from severe fluid deficiency in the body (intra- and extracellular dehydration).

DEKAMIN must not be used in cases of coma due to severe liver disease (hepatic coma).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using DEKAMIN.
When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete. Exposure of DEKAMIN to ambient light, especially after addition of trace elements and/or vitamins, may generate peroxides and other degradation products, which can be minimized by protecting from light.
This medicine will be administered to you by intravenous infusion (intravenous infusion) at a controlled rate (see section 3 “How to use DEKAMIN”).
During treatment with DEKAMIN, the following should be monitored:

blood nitrogen levels (azotemia) to prevent excessive increase of ammonia in the blood (hyperammonemia), particularly during prolonged treatments, if you have liver problems, if you are elderly, or if the patient is a young child;
certain specific laboratory tests (serum osmolarity, electrolytes, liver and kidney function tests, blood glucose, and ammonia levels).

Administration of DEKAMIN must be discontinued if chills or signs of intolerance occur.
Children
This medicine must be used with caution in children.
Other medicines and DEKAMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
It is not recommended to add other medicines to the DEKAMIN solution.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered to you.
DEKAMIN will be administered to you with caution and under strict medical supervision if you are pregnant or breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
DEKAMIN contains sodium and sodium metabisulfite
The 250 ml vial contains 0.398 g (17.32 mmol) of sodium, while the 500 ml vial contains 0.796 g (34.65 mmol) of sodium. This should be taken into consideration in individuals with reduced kidney function or those on a low-sodium diet.
This medicine contains sodium metabisulfite, which may rarely cause severe allergic reactions (hypersensitivity reactions) and bronchospasm.

3. How to use DEKAMIN

This medicine will be administered to you by a doctor or other trained medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
The doctor will determine the dose based on your health condition.
In general, the recommended dose does not exceed 750 ml of DEKAMIN per day.
This medicine will be administered as a slow intravenous infusion (endovenous infusion) at a recommended rate of less than 40 drops per minute.
For proper therapy with DEKAMIN, it is advisable to administer 35–45 kcal per kilogram of body weight per day in the form of sugars (glucose) or fats (lipids). In such cases, it may also be appropriate to administer other substances such as insulin, potassium, sodium, chloride, phosphorus, magnesium, and other elements, depending on individual needs.
DEKAMIN must be used immediately after opening the container, for a single and continuous administration; any remaining solution must not be reused.
When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until the infusion is completed (see section 2).
The solution should appear clear, colourless or slightly coloured, and free from visible particles.
If you use more DEKAMIN than you should
Since this medicine is administered by trained personnel, it is unlikely that you will receive an excessive dose.
In case of accidental ingestion/overdose of DEKAMIN, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, 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.
Frequency not known (frequency cannot be estimated from the available data):

fever, chills, nausea and vomiting, especially if administered by intravenous infusion too rapidly;
skin irritation (urticaria) or redness (vasodilation), abdominal pain, seizures; if these symptoms occur, treatment must be discontinued;
inflammation of the veins and risk of blood clot formation (thrombophlebitic reactions) at the injection site. In this case, the injection site should be changed.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DEKAMIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original, unopened packaging stored under the recommended conditions.
Store the medicine protected from light and at a temperature not below 5 °C.
When used in neonates and children under 2 years of age, the solution (in the bags and administration sets) must be protected from light exposure until the end of administration (see section 2).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DEKAMIN contains

The active substances are amino acids and pyridoxine hydrochloride. 1000 ml of the solution contain 12.800 g of glycine, 8.707 g of L-arginine monohydrochloride (equivalent to 7.200 g of L-arginine), 5.900 g of L-phenylalanine, 5.900 g of L-leucine, 5.900 g of L-methionine, 5.600 g of L-serine, 5.298 g of L-lysine monohydrochloride (equivalent to 4.240 g of L-lysine), 5.180 g of L-glutamic acid, 4.400 g of L-alanine, 4.323 g of L-histidine monohydrochloride monohydrate (equivalent to 3.200 g of L-histidine), 4.240 g of L-valine, 4.140 g of L-proline, 3.700 g of L-isoleucine, 3.140 g of L-aspartic acid, 2.640 g of L-threonine, 1.320 g of L-tryptophan, 0.500 g of L-tyrosine and 0.06 g of pyridoxine hydrochloride (equivalent to 0.05 g of pyridoxine).
The other components are: sodium bicarbonate, sodium metabisulfite and water for injections.

Description of the appearance of DEKAMIN and package contents
Glass vials of 250 ml and 500 ml of solution for infusion.
Marketing Authorization Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy

The following information is intended exclusively for physicians or healthcare professionals

Method of administration:
When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until the end of administration.

Special warnings and precautions for use:
Exposure to light of intravenous parenteral nutrition solutions, especially after the addition of trace elements and/or vitamins, may have adverse effects on clinical outcomes in neonates due to the formation of peroxides and other degradation products. When used in neonates and children under 2 years of age, DEKAMIN must be protected from ambient light until the end of administration.

Special precautions for disposal and handling:
When used in neonates and children under 2 years of age, protect from light exposure until completion of administration. Exposure of DEKAMIN to ambient light, particularly after the addition of trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be minimized by protecting the solution from light.