Addamel N

Package Leaflet: Information for the User

ADDAMEL N

Concentrate for solution for infusion

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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. 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 package leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is ADDAMEL N and what is it used for

ADDAMEL N contains a mixture of trace elements (present in the body in very small amounts), such as: chromium, copper, iron, manganese, iodine, fluorine, molybdenum, selenium, zinc, potassium, and sodium. The medicine is administered by intravenous infusion.
The amount of trace elements in the medicine is similar to the amount provided by food.
After intravenous administration, the trace elements in the medicine undergo similar processes as those from food.
Indications for use:
ADDAMEL N is indicated for use as a supplement to parenteral nutrition in adult patients and in children with a body weight of 15 kg or more. The medicine is administered to meet the basic or moderately increased need for trace elements.

2. Important information before using ADDAMEL N

When not to use ADDAMEL N

Do not use the medicine if:

• the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• the patient has complete bile flow obstruction.

Warnings and precautions

The medicine should be used with caution if:

• the patient has bile secretion disorders and/or kidney function disorders, as the excretion of trace elements may be significantly reduced;
• the patient has liver function disorders (especially with cholestasis, a condition where bile flow is reduced or blocked).

If treatment lasts longer than 4 weeks, the doctor may order a blood test to check the manganese level.

ADDAMEL N and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions have been reported between ADDAMEL N and other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before using this medicine.
The doctor will decide whether to use ADDAMEL N in pregnant or breastfeeding women.
No adverse effects are expected when using this medicine in pregnant women.

Driving and using machines

ADDAMEL N has no or negligible influence on the ability to drive and use machines.

3. How to use ADDAMEL N

This medicine is administered only by medical personnel. Do not use it yourself.
In case of doubts, consult your doctor.
The dosage is determined individually by the doctor for each patient, depending on age, body weight, and the need for trace elements.

Using a higher dose of ADDAMEL N than recommended

If a higher dose of the medicine is used than recommended, inform your doctor or nurse immediately.
In patients with bile secretion disorders or kidney function disorders, there is an increased risk of accumulation of trace elements in the tissues.
In the case of long-term overdose of iron, there is a risk of hemosiderosis (excessive iron deposition in tissues).
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.
No adverse effects have been reported with the trace elements contained in ADDAMEL N.
After administration of the glucose solution containing ADDAMEL N into a peripheral vein, superficial thrombophlebitis (formation of inflammation and small blood clots, manifesting as palpable hardening of the vein, redness around it, pain, and tenderness) has been observed.
However, it cannot be determined whether this was caused by the administration of ADDAMEL N or not.
After local administration of iodine, allergic reactions may occur in some patients.
ADDAMEL N contains potassium iodide. However, no adverse effects have been observed after intravenous administration of iodides (including potassium iodide) in the recommended doses.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
e-mail: adr@urpl.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 this medicine.

5. How to store ADDAMEL N

Store the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use this medicine if you notice any solid particles in it.
Shelf-life of the medicine after dilution
Chemical and physical stability has been demonstrated after dilution for 24 hours at 25°C.
From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage time and conditions before use, but this period should not exceed 24 hours at 2-8°C, unless the mixing is performed in controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ADDAMEL N contains

• The active substances of the medicine are: chromium(III) chloride hexahydrate, copper(II) chloride dihydrate, iron(III) chloride hexahydrate, manganese(II) chloride tetrahydrate, potassium iodide, sodium fluoride, sodium molybdate dihydrate, sodium selenite, and zinc(II) chloride.

1 ml of ADDAMEL N contains:
active substances:
chromium(III) chloride hexahydrate
amount:
5.33 μg
copper(II) chloride dihydrate
0.34 mg
iron(III) chloride hexahydrate
0.54 mg
manganese(II) chloride tetrahydrate
99.0 μg
potassium iodide
16.6 μg
sodium fluoride
0.21 mg
sodium molybdate dihydrate
4.85 μg
sodium selenite
6.90 μg
zinc(II) chloride
1.36 mg
which corresponds to:
Cr
0.02
μmol
Cu
2
μmol
Fe
2
μmol
Mn
0.5
μmol
I
0.1
μmol
F
5
μmol
Mo
0.02
μmol
Se
0.04
μmol
Zn
10
μmol
The sodium and potassium content is:
sodium
118
μg
μmol
potassium
μg
μmol

• The other ingredients (excipients) are: xylitol, hydrochloric acid 1M (for pH adjustment), and water for injections.

The osmolality of the concentrate is: approximately 3100 mOsm/kg water, pH: 2.4 - 2.5.

What ADDAMEL N looks like and contents of the pack

The medicine is a concentrate for solution for infusion.
The pack contains polypropylene ampoules with 10 ml of concentrate, packed in 20 pieces in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Manufacturer

Fresenius Kabi Norge AS
Svinesundsveien 80
NO-1788 Halden
Norway
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

ADDAMEL N should not be administered undiluted.
The dosage is determined individually by the doctor for each patient, depending on age, body weight, and the need for trace elements.
Children with a body weight of 15 kg or more
0.1 ml of ADDAMEL N per kg of body weight per day.
Adults
10 ml (one ampoule) of ADDAMEL N.
Method of administration
Intravenous infusion.

Overdose

In patients with kidney function disorders or bile secretion disorders, there is an increased risk of accumulation of trace elements in the tissues.
In the case of long-term overdose of iron, there is a risk of hemosiderosis, which can be treated with intravenous fluid therapy in severe and rare cases.

Preparation of the medicine for use

Other medicines should be added under aseptic conditions.

Incompatibilities

Compatibility
ADDAMEL N can be added or mixed only with those medicines for which compatibility has been documented.
Stability
In the case of introducing additional medicines into the infusion solution, the infusion should be completed within 24 hours of preparation; this will prevent microbiological contamination.
Unused contents of opened ampoules should be discarded; they should not be stored for further use.
Data on stability and compatibility with 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.
Shelf-life of the medicine after dilution
Chemical and physical stability has been demonstrated after dilution for 24 hours at 25°C.
From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage time and conditions before use, but this period should not exceed 24 hours at 2-8°C, unless the mixing is performed in controlled and validated aseptic conditions.

Disposal of unused medicine

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