Description

Addaven is a specialized medicinal solution designed to support parenteral nutrition by providing essential trace elements. It is intended for use in adults and children weighing 15 kg or more, particularly when oral or enteral nutrition is not feasible. This product plays a crucial role in maintaining nutritional balance by supplementing trace elements alongside proteins, fats, carbohydrates, salts, and vitamins in an intravenous diet.

Formulation

• Appearance: Clear, colourless to slightly yellow solution.
• Packaging: Supplied in 10 mL polypropylene ampoules, with each carton containing 20 ampoules.
• Osmolality: 3100 mOsm/kg water.
• pH Level: 2.5.

Active Ingredients

Each 10 mL ampoule of Addaven contains the following active ingredients:

• Chromic chloride hexahydrate
• Cupric chloride dihydrate
• Ferric chloride hexahydrate
• Manganese chloride tetrahydrate
• Potassium iodide
• Sodium fluoride
• Sodium molybdate dihydrate
• Sodium selenite
• Zinc chloride

These components are carefully measured to meet the trace element requirements, ensuring proper nutritional support.

Electrolyte Profile

The solution provides a comprehensive electrolyte profile, including chromium, copper, iron, manganese, iodine, fluoride, molybdenum, selenium, zinc, sodium, and potassium. This profile is essential for preventing or treating deficiencies in trace elements.

Excipients

• Xylitol
• Hydrochloric acid (for pH adjustment)
• Water for injections

Administration

Addaven is administered by healthcare professionals and requires careful dilution in a compatible parenteral nutrition solution or aqueous diluent before intravenous infusion. The recommended dosage is 10 mL daily for adults and children over 15 kg, with specific adjustments for those with liver or kidney impairments. It is intended for single use only, and any residue should be discarded.

Contraindications and Precautions

Addaven should not be used in individuals with hypersensitivity to its components, total biliary obstruction, Wilson’s disease, hemochromatosis, or in children under 15 kg. Caution is advised for patients with liver or renal dysfunction and in elderly patients. Compatibility with other solutions must be documented to avoid adverse interactions.

Potential Adverse Effects

Adverse effects are very rare but may include nausea, vomiting, chills, fever, and headache. Overdose risks involve the accumulation of trace elements, particularly in individuals with renal or biliary impairment.

Storage Instructions

Store Addaven below 30°C in a cool, dry place away from direct sunlight. The shelf life is 36 months as packaged. After dilution, it should be used within 24 hours if kept at 25°C, or stored at 2–8°C for no more than 24 hours if not used immediately. Ensure it is kept out of reach of children.

Disposal

Dispose of any unused product or waste material in accordance with local regulations. Addaven is available by prescription and was first registered in the Australian Register of Therapeutic Goods on 29 July 2016.