Full Prescribing Info
Each 100 mL contains: L-Alanyl-L-Glutamine 20 g.
Pharmacology: L-Alanyl-L-Glutamine is endogenously split into the amino acids glutamine and amine hereby supplying glutamine with infusion solutions for parenteral nutrition. The released amino acids flow as nutrients into their respective body pools and are metabolized according to the needs of the organism. Many disease conditions, in which parenteral nutrition is indicated, are accompanied by a glutamine depletion, which L-Alanyl-L-Glutamine counteracts.
GLUTALAN is indicated as part of an intravenous parenteral nutrition regimen as a supplement to amino acid solution or and amino acid containing infusion regimen in patients whose condition requires additional glutamine. Such patients include those in hypercatabolic and hypermetabolic states.
Dosage/Direction for Use
GLUTALAN is designed for intravenous infusion following additional to a compatible carrier solution. Dosage depends on the severity of the catabolic state and or amino acids requirement. A maximum daily dosage of 2 g amino acids/kg body weight should not be exceeded in parenteral nutrition. The supply of alanine and glutamine via GLUTALAN should be taken into consideration in the calculation. The proportion of the amino acids supplied through GLUTALAN should not exceed approximately 20% of the total supply.
Daily dose: 1.5-2.0 mL of GLUTALAN per kg body weight (equivalent to 0.3-0.4 g L-Alanyl-L-Glutamine per kg body weight).
This equate to 100 to 140 mL GLUTALAN for a patient of 70 kg body weight.
Maximum daily dose: 2.0 mL GLUTALAN per kg body weight. The following adjustments thus result for the amino acids supply through the carrier solution: Amino acids requirement 1.5 g/kg body weight per day: 1.2 g amino acids + 0.3 g L-Alanyl-L-Glutamine per kg body weight.
Amino acids requirement 2 g/kg body weight per day: 1.6 g amino acids + 0.4 g L-Alanyl-L-Glutamine per kg body weight.
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.
GLUTALAN is an infusion solution concentrate which is not designed for direct administration.
It should be mixed with a compatible amino acid carrier solution or and amino acid containing infusion regimen prior to administration. One volume part GLUTALAN is to be mixed with at least 5 volume part carrier solution (e.g. 100 mL GLUTALAN + at least 500 mL amino acid solution).
The maximum infusion concentration should not exceed 3.5%.
The duration of use should not exceed 3 weeks.
Patients with severe renal insufficiency (creatinine clearance < 25 mL/min) or severe hepatic insufficiency.
It is advisable to regularly monitor liver function parameters in patients with compensated hepatic insufficiency. As there is currently insufficiency data on administration of L-Alanyl-L-Glutamine to pregnant women, nursing mothers, and children, administration of the preparation in these patient groups is not recommended.
Special Precautions
The enzymes alkaline phosphatase, SGPT, SGOT and acid-base balance should be monitored. When mixed with carrier solution, it is imperative to ensure injection under hygienic conditions, through mixing and compatibility. Further drugs should not be added to the mixture. Do not store after addition of other components.
Adverse Reactions
No known when correctly administered.
Drug Interactions
No interactions with other drugs have been observed to date.
Store below 30°C.
MIMS Class
Intravenous & Other Sterile Solutions
ATC Classification
B02AA - Amino acids ; Used in the treatment of hemorrhage.
Infusion 20 g/100 mL x 100 mL x 1's.
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