Addamel n

Package leaflet: Information for the user

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

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

Table of contents

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

ADDAMEL N contains a mixture of trace element compounds (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 contained in the medicine is similar to that provided by food.
After intravenous administration, the trace elements in the medicine undergo similar processes as those
derived from food.
Indications:
ADDAMEL N is indicated as a supplement to parenteral nutrition in adult patients and in children with body weight of 15 kg or more. The medicine is administered to meet basic or moderately increased requirements for trace elements.

2. Important information before using the medicinal product ADDAMEL N

When not to use ADDAMEL N
Do not use the medicinal product ADDAMEL N if:

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

Warnings and precautions
The medicinal product should be used with caution if:

• the patient has disorders of bile secretion and (or) impaired kidney function, as excretion of trace elements may be significantly reduced;
• the patient has impaired liver function (especially liver cholestasis, i.e. impaired bile flow).

If treatment lasts longer than 4 weeks, the doctor may order blood manganese concentration monitoring.
ADDAMEL N and other medicinal products
Inform the doctor or pharmacist about all medicinal products currently used or recently used, as well as any medicinal products the patient intends to use.
No interactions between ADDAMEL N and other medicinal products have been observed.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicinal product.
The decision on the use of ADDAMEL N in pregnant or breastfeeding women will be made by the doctor.
Adverse effects following administration of this medicinal product to pregnant women are not expected.
Driving and operating machinery
ADDAMEL N has no effect or has negligible effect on the ability to drive vehicles and operate machinery.

3. How to use ADDAMEL N

This medicine is administered exclusively by medical personnel.
You must not use this medicine yourself.
If you have any doubts, consult your doctor.
The dosage is determined individually by the doctor for each patient, depending on age, body weight,
and requirements for trace elements.
Use of a higher than recommended dose of ADDAMEL N
If a higher than recommended dose of the medicine is used, inform the doctor or nurse immediately.
In patients with impaired bile secretion or impaired kidney function, there is an increased risk
of accumulation of trace elements in tissues.
In case of long-term iron overdose, there is a risk of developing haemosiderosis
(excessive iron deposition in tissues).
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 medicine can cause adverse reactions, although not everybody will experience them.
There are no reports of adverse reactions related to the trace elements contained in ADDAMEL N.
After intravenous administration of glucose solution containing ADDAMEL N into peripheral veins, thrombophlebitis (inflammation and small blood clots) has been observed, manifesting as palpable vein hardening, redness around the vein, pain, and tenderness. However, it cannot be determined whether this was caused by the administration of ADDAMEL N or not.
Following local administration of iodine, some patients may experience allergic reactions.
ADDAMEL N contains potassium iodide. However, no adverse reactions have been observed following intravenous administration of iodides (including potassium iodide) at recommended doses.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
e-mail: [email protected].
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 ADDAMEL N

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Do not use this medicine if solid particles are observed in it.
Stability after dilution
Chemical and physical stability has been demonstrated for 24 hours after dilution at 25°C.
From a microbiological standpoint, the medicine should be used immediately. If it is not used immediately, the user is responsible for the duration and conditions of storage prior to use; however, this period should not exceed 24 hours at 2–8°C, unless the dilution was carried out under 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What ADDAMEL N contains

• The active substances in the medicinal product 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 anhydrous and zinc(II) chloride.

Each 1 ml of ADDAMEL N contains:
Active substances: Amount:
chromium(III) chloride hexahydrate 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 anhydrous 6.90 μg
zinc(II) chloride 1.36 mg
corresponding 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 corresponds to:
sodium 118 μg, μmol
potassium μg, μmol

• Other components (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 medicinal product is a concentrate for solution for infusion.
The pack consists of polypropylene ampoules containing 10 ml of concentrate, packed 20 ampoules in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
S-751 74 Uppsala
Sweden
Manufacturer
Fresenius Kabi Norge AS
Svinesundsveien 80
NO-1788 Halden
Norway
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
ADDAMEL N must not be administered in undiluted form.
Dosage is determined individually by the physician according to age, body weight, and requirements for trace elements.
Children with 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 impaired renal function or impaired biliary excretion, there is an increased risk of tissue accumulation of trace elements.
In case of prolonged iron overdose, there is a risk of haemosiderosis, which in severe and rarely occurring cases can be treated with intravenous fluid therapy.

Preparation of the medicinal product for administration
Other medicinal products should be added under aseptic conditions.

Pharmaceutical incompatibilities
Compatibility
ADDAMEL N may be added or mixed only with medicinal products with which compatibility has been documented.

Stability
When additional medicinal products are introduced into the infusion solution, the infusion should be completed within 24 hours after preparation of the solution; this will help avoid microbiological contamination.
Unused contents of opened ampoules must be discarded; they must not be stored for later use.
Data on chemical and physical stability and pharmaceutical compatibility with parenteral nutrition products are available upon request from the representative of the marketing authorization holder.

Storage conditions
Store below 25°C.
Shelf-life after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C after dilution.
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use, but this period should not exceed 24 hours at 2–8°C, unless the dilution was performed under controlled and validated aseptic conditions.

Disposal of unused medicinal product or waste
Any unused residues of the medicinal product or waste material must be disposed of in accordance with local regulations.