Gabaxa

N(2)-L-alanyl-L-glutamine.

Each ml contains: N(2)-L-alanyl-L-glutamine 200 mg.

Pharmacology: N(2)-L-Alanyl-L-Glutamine is endogenously split info the amino acids glutamine and amine and allows possible the supply of glutamine with infusion solution 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 needs parenteral nutrition.

Gabaxa is indicated as part of an intravenous parenteral nutrition regimen as a supplement to amino acid solution and or amino acid containing infusion regimen in patients whose condition requires additional glutamine. Such patients include those in hypercatabolic and hypermetabolic states.

Gabaxa is designed for intravenous infusion following additional to a compatible carrier solution. Dosage Gabaxa depends of the severity of the catabolic state and or amino acid patient requirements.
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 Gabaxa should be taken into consideration in the calculation; the proportion of the amino acid supplied through Gabaxa should not exceed approx. 20% of the total supply.
Daily Dose: 1.5-2.0 ml Gabaxa per kg body weight (equivalent to 3.0-0.4 g N(2)-L-Alanyl-L-Glutamine per kg body weight), equivalent with 100-140 ml Gabaxa for a patient of 70 kg body weight.
Maximum daily dose: 2.0 ml Gabaxa per kg body weight.
The following adjustments thus result for the amino acids supply through the carrier solution: Amino acid requirement 1.5 g/kg body weight per day: 1.2 g amino acid + 0.3 g N(2)-L-Alanyl-L-Glutamine per kg body weight.
Amino acid requirement 2 g/kg body weight per day: 1.6 Amino acid + 0.4 g N(2)-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 gram Amino acid/kg body weight per hour.
Gabaxa is an infusion solution concentrate which is not designed for direct administration.
Gabaxa should be mixed with a compatible Amino acid carrier solution or an Amino acid containing infusion regiment prior to administration. One volume part Gabaxa is to be mixed with at least 5 volume part carrier solution (e,g. 100 ml Gabaxa + at least 500 ml Amino acid solution). The maximum concentration should not exceed 3.5%.
The duration of use should not exceed 3 weeks.

Gabaxa should not be administered to patients with severe renal insufficiency (creatinine clearance <25 mL/minute), or severe hepatic insufficiency. It is advisable to regularly monitor liver function parameters in patients with compensated hepatic insufficiency. Gabaxa is not suggestion for pregnant women, nursing mothers, children.

The enzymes alkaline phosphatase, SGPT, SGOT and Acid-base balance should be monitored. When mixed with a carrier solution, it is imperative to ensure injection under hygienic conditions, through mixing and compatibility. Further drugs should not be added to the mixture. Gabaxa is not to be stored after addition of other components.

Gabaxa is not suggestion for pregnant women, nursing mothers.

None known when N(2)-L-Alanyl-L-Glutamine correctly administered.

No interactions with other drugs have been observed to date.

Store below 30°C.

Parenteral Nutritional Products

B05XB02 - alanyl glutamine ; Belongs to the class of amino acids solutions used in I.V. solutions.

G