Addamel N

Addamel N

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Essential trace elements for IV nutrition.
Description
Each 10 mL of Addamel N ampoule contains the following essential trace elements: Iodine 1 micromole, selenium 0.4 micromole, iron 20 micromole, zinc 100 micromole, chromium 0.2 micromole, copper 20 micromole, fluoride 50 micromole, manganese 5 micromole, molybdenum 0.2 micromole.
Action
Addamel N is formulated to supply trace elements for IV infusion.
Pharmacokinetics: Addamel N is a formulation of trace elements without interest for pharmacokinetic studies.
Toxicology: Preclinical Safety Data: There are no preclinical data of relevance to the prescriber.
Indications/Uses
Addamel N is used as part of complete IV nutrition regimen providing a source of trace elements for adults and children >40 kg.
Dosage/Direction for Use
Adults: 10 mL of Addamel N is added to either 500 mL or 1000 mL of one of the following solutions: Kabiven, Kabiven Peripheral, Glucose 5%-50%. Where higher amounts of trace elements are considered necessary, 2 amps of Addamel N may be added to 1000 mL of solution.
Elderly: No adjustment of the adult dosage is required.
Infants and Children: For infants and children <40 kg body weight, the trace element solution Peditrace should be used.
Addamel N should not be used undiluted.
Overdosage
In general, overdosage with Addamel N is extremely unlikely as the quantity of trace elements per ampoule lies well below known toxic levels of administration.
Chronic overdosage may very rarely occur secondary to an unsuspected idiosyncratic deficiency in metabolism or excretion of a trace element. In this case, signs eg, nail dystrophy and insidious onset of symptoms secondary to hematological changes or tissue deposition, may be observed. Diagnosis would be confirmed by biochemical or hematological tests and treatment with Addamel N should be withdrawn.
Special Precautions
Care should be taken in the administration of Addamel N to patients with impaired liver function (especially cholestasis). Manganese toxicity is more likely to occur in patients with impaired liver function and cholestasis as manganese is almost entirely dependent on the biliary route for excretion. Manganese blood levels and liver function should be monitored regularly (monthly) in such patients. Addamel N should be stopped if manganese levels rise to the potentially toxic range.
Addamel N should be used with caution in patients with impaired renal function when the excretion of some trace elements (zinc, selenium, fluoride, chromium and molybdenum) may be significantly decreased.
Use in pregnancy & lactation: Addamel N is a solution of trace elements indicated as a supplement in total parenteral nutrition (TPN) regimens and contains the elements: Fe3+, Zn2+, Mn2+, Cu2+, Cr3+, Se4+, Mo6+, F-, I- in amounts not exceeding the recommended daily requirements where these exist. No hazard is expected if used in pregnancy at the recommended dosage. No animal studies have been performed. There are, however, published reports on safe and successful use of trace elements as part of a TPN regimen during pregnancy in the human.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: Addamel N is a solution of trace elements indicated as a supplement in total parenteral nutrition (TPN) regimens and contains the elements: Fe3+, Zn2+, Mn2+, Cu2+, Cr3+, Se4+, Mo6+, F-, I- in amounts not exceeding the recommended daily requirements where these exist. No hazard is expected if used in pregnancy at the recommended dosage. No animal studies have been performed. There are, however, published reports on safe and successful use of trace elements as part of a TPN regimen during pregnancy in the human.
Caution For Usage
Instruction for Use/Handling: Must not be given undiluted.
The addition of Addamel N should be performed aseptically immediately before the start of the infusion and the solution should be used within 24 hrs.
Addamel N should not be added directly to Vamin 9 amino acid. Where a regimen includes Vamin 9, Addamel N should be added to the glucose infusion.
Storage
Store at room temperature (below 25°C).
Shelf-Life: 24 months.
ATC Classification
B05XA31 - electrolytes in combination with other drugs ; Belongs to the class of electrolyte solutions used in I.V. solutions.
Presentation/Packing
Amp (conc for IV infusion) 10 mL x 20's.
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