Dipeptiven

Active material: The preparation of glutamine
When ATH: B05BA01
CCF: The preparation of glutamine for parenteral nutrition
ICD-10 codes (testimony): E46
When CSF: 21.08.06.01
Manufacturer: FRESENIUS CABINET AUSTRIA GmbH (Austria)

Pharmaceutical form, composition and packaging

Concentrate for solution for infusion clear, colorless to pale yellow.

1 l
N(2)-L-alanine-L-glutamine200 g,
incl. L-alanine82 g,
L-glutamine134.6 g
Theoretical osmolarity 921 mOsm / l
titratable acidity 90-105 mmol NaOH/l
pH 5.4-6.0

Excipients: water d / and.

50 ml – glass bottles (10) – cardboard boxes.
100 ml – glass bottles (10) – cardboard boxes.

 

Pharmacological action

The preparation of glutamine for parenteral use.

Dipeptiven contains dipeptide N(N)-L-alanine-L-glutamine, and is used to add infusion solutions, It is a first source of glutamine. Glutamine is essential not only for the synthesis of a protein as one of the amino acids, but an important component of a variety of metabolic processes, contributing, in particular, a significant reduction in the degree hypercatabolism, normalization of protein metabolism, restore the integrity of the gastrointestinal mucosa and the immune status.

 

Pharmacokinetics

N(N)-L-alanyl-L-glutamine is rapidly hydrolysed in plasma after i / v injection to form alanine and glutamine. Half-life period N(N)-L-alanyl-L-glutamine is 2.4-3.8 m. Infusion dipeptide N(N)-L-alanyl-L-glutamine leads to a rapid increase in the concentration of glutamine and alanine, during the entire period of infusion of only trace amounts of the dipeptide can be detected in plasma. With less urine output 5% of the administered dose of dipeptide, is equal to the loss with the introduction of amino acid drugs. The drug does not cumulate.

 

Testimony

- In adults and children with a deficit of glutamine, at elevated consumption within its complete parenteral nutrition or mixed, incl. when hypermetabolic or giperkatabolicheskom types of metabolism (resulting in multiple injuries, burns, heavy surgery, sepsis, severe inflammation, immunodeficite, malignancies).

 

Dosage regimen

The drug is introduced into / in, drop.

Dipeptiven is a concentrated solution and is not intended for the isolated administration. Before the infusion must be mixed with a compatible amino acid solution (carrier solution) or containing the amino acid infusion preparations or introduce parallel with these solutions or drugs. One part by volume Dipeptivena must be mixed or administered simultaneously with approximately 5 parts by volume solution of the carrier (eg, 100 ml Dipeptivena administered 500 ml amino acid solution).

Selection of the central or peripheral veins for drug administration depends on the final osmolarity when co-administered with other solutions.

Dipeptiven for central venous infusion after addition to a compatible infusion solution. Mixtures of solutions with a final osmolarity 800 mOsmol / l to be entered into the central vein.

The dose depends on the severity of the condition and needs of the catabolic amino acids.

The maximum daily dose of amino acids 2 g / kg body weight. When calculating the amount of the input is necessary to consider the addition of the amino acids alanine and glutamine when administered Dipeptivena. Ratio alanine and glutamine, introduced with the preparation Dipeptiven, should not exceed 20% of total amino acids, input / in and enterally.

The daily dose is 1.5-2 ml / kg body weight, which is equivalent to the introduction of 0.3-0.4 g / kg. This dose corresponds to 100-140 ml product / day for patients with a body weight 70 kg. The maximum daily dose is 2 ml / kg.

Recommended doses Dipeptivena:

- When the need for amino acids 1.5 g / kg body weight / day is recommended to be administered 1.2 g amino acids 0.3 Mr. N(N)-L-alanyl-L-glutamine / kg body weight / day;

- When the need for amino acids 2 g / kg body weight / day is recommended to be administered 1.6 g amino acids 0.4 Mr. N(N)-L-alanyl-L-glutamine / kg body weight / day.

The infusion rate should not exceed 0.1 g amino acid / kg body weight / h. Duration of use – no more 3 weeks.

 

Side effect

Maybe: chills, nausea, vomiting (overspeed infusion).

Rarely: allergic reactions.

If you have any side effects of the drug administration should be stopped immediately.

 

Contraindications

- Severe renal insufficiency (CC less than 25 ml / min);

- Severe hepatic impairment;

- Pronounced metabolic acidosis;

- Hypersensitivity to the drug.

 

Pregnancy and lactation

Data on the use of the drug during pregnancy and lactation (breast-feeding) no. The drug should be administered to pregnant women only if, when the benefit to the mother outweighs the potential harm to the fetus. In applying the drug in mothers breast-feeding should be discontinued.

 

Cautions

With the introduction of Dipeptivena advisable to regularly monitor liver function in patients with compensated liver disease.

It should monitor serum electrolytes, water balance, base state, liver function tests (Alkaline phosphatase, bilirubin) and possible symptoms of hyperammonemia.

 

Overdose

Data on cases of drug overdose Dipeptiven currently available.

 

Drug Interactions

Dipeptiven be mixed with solutions of amino acids, strictly aseptically. When mixed with a carrier solution, ensure compatibility of the solution and to ensure complete mixing.

Do not add to the mixture the other drugs.

 

Conditions of supply of pharmacies

The drug is released only to medical institutions.

 

 

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year.

Use only clear solutions in undamaged bottles.

After the addition of the other components of the drug must not be stored.

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