Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

For a safe administration the maximum dose of Dipeptiven should not exceed 2.0 ml (corresponding to 0.4 g N(2)-L-alanyl-L-glutamine) per kg body weight per day (see section 4.2, 4.9 and 5.1).

Dipeptiven should only be used as part of clinical nutrition, and its dosage is limited by the amount of protein/amino acids provided by nutrition (see section 4.2). Whenever the clinical condition does not allow nutrition (e.g., circulatory shock, hypoxia, unstable critically ill patients, severe metabolic acidosis) Dipeptiven should not be administered.

Oral/enteral intake of glutamine-supplemented formulas in combination with parenteral nutrition should be taken into consideration for calculation of the prescribed dose of Dipeptiven.
It is advisable to regularly monitor liver function parameters in patients with compensated hepatic insufficiency.

As there is currently insufficient data on administration of Dipeptiven to pregnant women, nursing mothers and children, administration of the preparation in these patient groups is not recommended.

Serum electrolytes, serum osmolarity, water balance, acid-base status, creatinine clearance, urea, as well as liver function tests (alkaline phospatase, ALT, AST), and possible symptoms of hyperammonaemia should be controlled.

The enzymes alkaline phosphatase, GPT, GOT, bilirubin level and the acid-base status should be monitored.

The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The generally accepted limit for peripheral infusion is about 800 mosmol/l but it varies considerably with the age and general condition of the patient and the characteristics of the peripheral veins.
Experience with the use of Dipeptiven for longer periods than nine days is limited.

Effects on Driving

4.7 Effects on ability to drive and use machines
Not applicable