Consumer medicine information

1 Name of Medicine

Chromic chloride hexahydrate, cupric chloride dihydrate, ferric chloride hexahydrate, manganese chloride tetrahydrate, potassium iodide, sodium fluoride, sodium molybdate dihydrate, sodium selenite, zinc chloride.

2 Qualitative and Quantitative Composition

Each 10 mL ampoule of Addaven contains: chromic chloride hexahydrate 53.33 microgram, cupric chloride dihydrate 1.02 mg, ferric chloride hexahydrate 5.40 mg, manganese chloride tetrahydrate 198 microgram, potassium iodide 166 microgram, sodium fluoride 2.10 mg, sodium molybdate dihydrate 48.5 microgram, sodium selenite 173 microgram, zinc chloride 10.5 mg.
The active ingredients per 10 mL of Addaven correspond to the following electrolyte profile: chromium (Cr³⁺) 0.20 micromol (10 microgram), copper (Cu²⁺) 6.0 micromol (380 microgram), iron (Fe³⁺) 20 micromol (1.10 mg), manganese (Mn²⁺) 1.0 micromol (55 microgram), iodine (I^-) 1.0 micromol (130 microgram), fluoride (F^-) 50 micromol (950 microgram), molybdenum (Mo⁶⁺) 0.20 micromol (19 microgram), selenium (Se⁴⁺) 1.0 micromol (79 microgram), zinc (Zn²⁺) 77 micromol (5.0 mg).
The content of sodium and potassium correspond to: sodium content: 52 micromol (1.20 mg), potassium content: 1 micromol (39 microgram).
Excipients with known effect. Xylitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Addaven is a concentrated trace element solution for intravenous infusion which is clear and colourless to slightly yellow.
Osmolality: 3100 mOsm/kg water.
pH: 2.5.

4 Clinical Particulars

4.9 Overdose

In patients with impaired renal or biliary function, there is an increased risk of accumulation of trace elements.
Symptoms of zinc poisoning include hypotension, pulmonary oedema, diarrhoea, vomiting, jaundice and oliguria.
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.
See Section 4.2 Dose and Method of Administration for correct usage.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Studies with Addaven have not been performed to evaluate the genotoxic potential.
Carcinogenicity. Studies with Addaven have not been performed to evaluate the carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Chemical structures of the active ingredients are not provided as these are simple salts.
CAS number. See Table 2.
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7 Medicine Schedule (Poisons Standard)

Australia: Not Scheduled.

Summary Table of Changes

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