DIPEPTIVEN Concentrate for solution for infusion Ref.[50323] Active ingredients: Alanine glutamine dipeptide

Solution for infusion after mixture with a compatible infusion solution.

Solutions of mixtures with an osmolarity above 800 mosmol/l should be infused by the central venous route.

Adults

Dipeptiven is administered in-parallel with parenteral nutrition or enteral nutrition or a combination of both. Dosage depends on the severity of the catabolic state and on amino acids/protein requirement.

A maximum daily dosage of 2g amino acids and/or protein per kg body weight should not be exceeded in parenteral/enteral nutrition. The supply of alanine and glutamine via Dipeptiven should be taken into consideration in the calculation. The proportion of the amino acids supplied through Dipeptiven should not exceed approximately 30% of the total amino acids/protein supply.

Daily dose: 1.5-2.5 ml of Dipeptiven per kg body weight (equivalent to 0.3-0.5 g N(2)-L-alanyl-L-glutamine per kg body weight). This equates to 100 to 175 ml Dipeptiven for a patient of 70 kg body weight.

Maximum daily dose: 2.5 ml equivalent to 0.5 g N(2)-L-alanyl-L-glutamine of Dipeptiven per kg body weight.

The maximum daily dose of 0.5 g N(2)–L-alanyl-L-glutamine per kg body weight should be administered in combination with at least 1.0 g amino acids/protein, per kg body weight per day. With amino acids from Dipeptiven included, this results in a daily dosage of a least 1.5 g amino acids/protein per kg body weight.

The following adjustments are examples for the supply with Dipeptiven and amino acids through the parenteral nutrition solution, and /or protein through enteral nutrition formula:

Amino acids/protein requirement 1.2 g/kg body weight per day: 0.8 g amino acids/protein + 0.4 g N(2)-L-alanyl-L-glutamine per kg body weight.

Amino acids/protein requirement 1.5 g/kg body weight per day: 1.0 g amino acids/protein + 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight.

Amino acids/protein requirement 2 g/kg body weight per day: 1.5 g amino acids/protein + 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight.

Dipeptiven is an infusion solution concentrate which is not designed for direct administration.

Patients with total parenteral nutrition

The rate of infusion depends on that of the carrier solution and should not exceed 0.1 g amino acids/kg body weight per hour.

Dipeptiven should be mixed with a compatible amino acid carrier solution or an amino acid containing infusion regimen prior to administration.

Patients with total enteral nutrition

Dipeptiven is continuously infused over 20-24 hours per day. For peripheral venous infusion, dilute Dipeptiven to an osmolarity 800 mosmol/l (e.g. 100 ml Dipeptiven + 100 ml saline.)

Patients with combined enteral and parenteral nutrition

The full daily dosage of Dipeptiven should be administered with the parenteral nutrition, i.e. mixed with a compatible amino acid solution or an amino acid containing infusion regimen prior to administration.

The rate of infusion depends on that of the carrier solution and should be adjusted according to the proportions of parenteral and enteral nutrition.

Duration of administration.

The duration of use should not exceed 3 weeks.

Paediatric population

Safety and efficacy in children have not been established.

As with other infusion solutions, chills, nausea and vomiting can occur when the infusion rate of Dipeptiven is exceeded.

Infusion should be stopped immediately in this case.

Experience from a study in critically ill patients with at least two organ failures at admission, receiving the maximum approved daily intravenous infusion of Dipeptiven (0.5 g alanyl-glutamine/kg/day) together with a high dose of enteral glutamine (30 g) provided as a mixture of alanyl-glutamine and glycyl-glutamine and without appropriate clinical nutrition, has shown an increase in serious side effects.

2 years.

To be used immediately after the bottle is opened.

Dipeptiven is not to be stored after addition of other components.

Do not store above 25°C.

Store in the original package.

Glass bottles.

1 × 50 ml, 10 × 50 ml

1 × 100 ml, 10 × 100 ml

Type II, colourless glass.

Rubber closure.

Not all pack sizes may be marketed.

Dipeptiven is an infusion solution concentrate which is not designed for direct administration. The container and the solution should be inspected visually prior to use. Use only clear, particle-free solution and undamaged container. For single use only.

The addition of the concentrate to the amino acid carrier solution prior to application should take place under aseptic conditions.Thorough mixing and compatibility must be ensured. Unused solution should be disposed of.

Dipeptiven is infused with the carrier solution. For details see section 4.2.