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DIPEPTIVEN INFUSION [SIN11183P]
Active ingredients: DIPEPTIVEN INFUSION
Product Info
DIPEPTIVEN INFUSION
[SIN11183P]
Product information
Active Ingredient and Strength | N(2)-L-ALANYL-L-GLUTAMINE - 20 G/100ML |
Dosage Form | INJECTION |
Manufacturer and Country | FRESENIUS KABI AUSTRIA GMBH - AUSTRIA |
Registration Number | SIN11183P |
Licence Holder | FRESENIUS KABI (SINGAPORE) PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B05XB02 |
Therapeutical indication
Dipeptiven® is indicated as part of an intravenous parenteral nutrition regimen as a supplement to amino acid solutions or an amino acid containing infusion regimen, e.g. in patients in hypercatabolic and/or hypermetabolic states.
Posology and method of administration
For central venous infusion after addition to a compatible infusion solution. Solutions of mixtures with an osmolarity above 800 mosmol/l should be infused by the central venous route.
Adults
Dosage depends on the severity of the catabolic state and on amino acid 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 Dipeptiven® should be taken into consideration in the calculation. The proportion of the amino acid supplied through Dipeptiven should not exceed approx. 30% of the total amino acid 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 a compatible amino acid solution providing at least 1.0 g amino acids per kg body weight and day. This results in a daily dosage of at least 1.5 g amino acids per kg body weight.
The following adjustments are examples for the supply with Dipeptiven and other amino acids through the carrier solution:
Amino acid requirement 1.2 g/kg body weight per day: 0.8 g amino acids + 0.4 g N(2)-L-alanyl-L-glutamine per kg body weight.
Amino acid requirement 1.5 g/kg body weight per day: 1.0 g Amino acids + 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight.
Amino acid requirement 2 g/kg body weight per day: 1.5 g amino acids + 0.5 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 g amino acids/kg body weight per hour.
Dipeptiven® is an infusion solution concentrate which is not designed for direct administration. It should be mixed with a compatible amino acid carrier solution or an amino acid containing infusion regimen prior to administration.
One volume part Dipeptiven® is to be mixed with at least 5 volume parts carrier solution (e.g. 100 ml Dipeptiven® + at least 500 ml amino acid solution).
3.5 % of the active ingredient should be the maximum concentration during therapy.
The duration of use should not exceed 3 weeks.
Children
Safety and efficacy in children have not been established.
Contra-Indications
Dipeptiven® should not be administered to patients with severe renal insufficiency (creatinine clearance < 25 ml/minute), severe hepatic insufficiency, circulatory shock, hypoxia, multiple organ failure, severe metabolic acidosis or known hypersensitivity to the active substances or to any of the excipients.
