Addamel N: Indications, Dosage, Precautions, Adverse Effects
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Addamel N - Product Information

Manufacture: Fresenius Kabi USA, LLC
Country: United States
Condition: Total Parenteral Nutrition
Class: Intravenous nutritional products
Form: Liquid solution, Intravenous (IV)
Ingredients: chromium, copper, iron, manganese, iodine, fluorine, molybdenum, selenium, and zinc injection, solution, xylitol, hydrochloric acid 1 M, water for injections

Qualitative and Quantitative Composition

Active ingredientsQuantity
Chromic chloride 6 H2O5.33 µg
Copper chloride 2 H2O0.34 mg
Ferric chloride 6 H2O0.54 mg
Manganese chloride 4 H2O99.0 µg
Potassium iodide16.6 µg
Sodium fluoride0.21 mg
Sodium molybdate 2 H2O4.85 µg
Sodium selenite anhydrous6.90 µg
Zinc chloride1.36 mg

The active ingredients in 1 ml of Addamel N correspond to:

Cr0.02µmol
Cu2µmol
Fe2µmol
Mn0.5µmol
I0.1µmol
F5µmol
Mo0.02µmol
Se0.04µmol
Zn10µmol

The content of sodium and potassium correspond to

Sodium118 µg5.12 µmol
Potassium3.9 µg0.1 µmol

PRODUCT PROPERTIES

  • Osmolality: approx. 3100 mosm/kg water
  • pH: 2.2

Pharmaceutical Form

Concentrate for solution for infusion

Clinical Particulars

Therapeutic Indications

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

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.

Contraindications

Total biliary obstruction.

Special Warnings and Special Precautions for Use

Addamel N should be used with caution in patients with impaired biliary and/or renal function in whom the excretion of trace elements may be significantly decreased.

Addamel N should also be used with caution in patients with biochemical or clinical evidence of liver dysfunction (especially cholestasis).

If the treatment is continued for more than 4 weeks, checking of manganese levels is required.

Addamel N must not be given undiluted.

Interaction with Other Medicaments and Other Forms of Interaction

No interactions with other drugs have been observed.

Pregnancy and Lactation

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Addamel N. However, the requirements of trace elements in a pregnant woman are slightly increased compared to non-pregnant women.

No adverse events are to be expected when Addamel N is administered during pregnancy.

Effects on Ability to Drive and Use Machines

No effects on the ability to drive and use machines are to be expected.

Undesirable Effects

No adverse effects related to the trace elements in Addamel N have been reported.

Superficial thrombophlebitis has been observed when glucose containing Addamel N was given. However, it is not possible to deduce whether this reaction is attributable to the infused trace elementsor not.

Allergic reactions to iodine may occur following topical application. No adverse reactions are known to occur as a consequence of using the recommended intravenous iodide dosage levels.

Overdose

In patients with impaired renal or biliary function, there is an increased risk for accumulation of trace elements.

In case of a chronic overload of iron there is a risk of haemosiderosis, which in severe and rare cases can be treated by venesection.

Pharmacological Properties

Pharmacodynamic Properties

Addamel N is a mixture of trace elements in amounts normally absorbed from the oral diet and should have no pharmacodynamic effect besides maintaining or repleting the nutritional status.

Pharmacokinetic Properties

When infused intravenously, the trace elements in Addamel N are handled in a similar way to trace elements from an oral diet. Individual trace elements will be taken up by tissues to different extents,depending on the requirements within each tissue to maintain or restore the concentration of each element for the metabolic requirements of that tissue.

Copper and manganese are normally excreted via the bile, whereas selenium, zinc and chromium (especially in patients receiving intravenous nutrition) are mainly excreted via the urine.

The main route of molybdenum excretion is the urine, although small amounts are excreted in the bile.

Iron is eliminated in small amounts by superficial loss and desquamation of gut cells. Premenopausal women can lose 30-150 mg of iron in the monthly blood loss. Iron excretion follows all kinds ofbleedings.

Preclinical Safety Data

The safety evaluation is based mainly on clinical experience and documentation.

Pharmaceutical Particulars

List of Excipients

Other ingredientsQuantityReference to standards
Xylitol300 mgPh. Eur. + USP
Hydrochloric acid 1 Mto pH 2.2Ph. Eur.
Water for injectionsto 1 mlPh. Eur.

Incompatibilities

Addamel N may only be added to or mixed with other medicinal products for which compatibility has been documented. See 5.6.

Shelf Life

24 months

Special Precautions for Storage

Store below 25°C. Do not freeze.

Nature and Contents of Container

Ampoule, polypropylene

Pack size: 20 x 10 ml

Instructions for Use/Handling

Addamel N must not be given undiluted.

Compatibility

Additions should be made aseptically.

Up to 20 ml Addamel N can be added to 1000 ml Vamin Glucose, Vamin 14 Electrolyte Free, Vamin 18 Electrolyte Free and glucose solutions 50 mg/ml-500 mg/ml.

Stability

When additions are made to an infusion solution, the infusion should be completed within 24 hours from preparation to prevent microbiological contamination. The left over contents of opened bottles/vials/ampoules should be discarded and not kept for later use.