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Addamel N
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  • FDA PI

Addamel N

Generic name: chromic chloride, cuprous chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate dihydrate, sodium selenite and zinc chloride
Dosage form: injection, solution
Drug class:Intravenous nutritional products

Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.

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1. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of Addamel N contains:

Active ingredientsQuantity

Chromic chloride 6 H2O 5.33 µg

Copper chloride 2 H2O 0.34 mg

Ferric chloride 6 H2O 0.54 mg

Manganese chloride 4 H2O 99.0 µg

Potassium iodide 16.6 µg

Sodium fluoride 0.21 mg

Sodium molybdate 2 H2O 4.85 µg

Sodium selenite anhydrous 6.90 µg

Zinc chloride 1.36 mg

The active ingredients in 1 ml of Addamel N correspond 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 content of sodium and potassium correspond to

Sodium 118 µg 5.12 µmol

Potassium 3.9 µg 0.1 µmol

PRODUCT PROPERTIES

• Osmolality: approx. 3100 mosm/kg water

• pH: 2.2

2. PHARMACEUTICAL FORM

Concentrate for solution for infusion

3. CLINICAL PARTICULARS

3.1 Therapeutic indications

Addamel N is indicated in patients as a supplement in intravenous nutrition to meet basal to moderately increased requirements of trace elements.

3.2 Posology and method of administration

Addamel N must not be given undiluted.

The recommended daily dosage of Addamel N in adult patients with basal to moderately increased requirements is 10 ml (one ampoule).

For children weighing 15 kg or more, the recommended dosage is 0.1 ml Addamel N/kg body weight/day.

3.3 Contraindications

Total biliary obstruction.

3.4 Special warnings and special precautions for use

Addamel N should be used with caution in patients with impaired biliary and/or renal f...