VAMIN

What it is

VAMIN is a parenteral nutrition product containing amino acids (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine), electrolytes, glucose, lipids and trace elements. It is presented as an emulsion for intravenous infusion.

Approved indications

— Parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosing overview

Dosage should be individualised depending on energy expenditure, the patient's clinical status, body weight, and ability to metabolise constituents of VAMIN, as well as additional energy or proteins given orally or enterally, and the bag size should be chosen accordingly. In patients with normal nutritional state or in conditions with mild catabolic stress, the average daily requirement is 0.6–0.9 g amino acids per kilogram body weight per day. In patients with moderate to high metabolic stress with or without malnutrition, it is 0.9–1.6 g amino acids per kilogram body weight per day. The dosage range of 13–31 ml per kilogram body weight per day will provide 0.7–1.6 g amino acids per kilogram body weight per day and 14–33 kcal per kilogram body weight per day of total energy. The recommended infusion period is 14–24 hours.

Key safety warnings

VAMIN must only be administered through a central vein. The infusion must be stopped immediately if any signs or symptoms of an allergic reaction such as fever, shivering, rash or dyspnoea develop, as VAMIN contains soya oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition, and in some cases fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. The infusion set and catheter should periodically be checked for precipitates, and if signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated. Fat overload syndrome has been reported with similar products and may be caused by inappropriate administration, but signs and symptoms of this syndrome may also occur when the product is administered according to instructions due to reduced or limited ability to metabolise the lipids. The syndrome is characterised by findings such as fever, anaemia, leucopoenia, thrombocytopenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration, deteriorating liver function, and central nervous system manifestations. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped. Refeeding severely undernourished patients may result in refeeding syndrome characterised by the shift of potassium, phosphorus and magnesium intracellularly, and thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. Patients on parenteral nutrition may experience hepatic complications including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis, and should be monitored accordingly.

Contraindications

VAMIN is contraindicated in the following situations: hypersensitivity or known allergy to corn or corn products, fish, egg, soya or peanut proteins or to any of the active substances or excipients. Severe hyperlipidaemia, severe hepatic impairment, severe blood coagulation disorders, congenital abnormalities of amino acid metabolism, severe renal impairment without access to haemofiltration or dialysis, uncontrolled hyperglycaemia, pathologically elevated serum levels of any of the included electrolytes, and general contraindications to infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency. Unstable conditions such as severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma.

Regulatory history

VAMIN 18 Electrolyte Free 500 mL injection bottle was first registered on the ARTG on 5 September 1991, and VAMIN 18 Electrolyte Free 1000 mL injection bottle was first registered on 8 March 1994.