Dipeptiven 100 mL Concentrate for solution for infusion.

DIPEPTIVEN is indicated as part of an intravenous parenteral nutrition regimen as a supplement to amino acid solutions which do not already contain glutamine.

Posology

DIPEPTIVEN IS AN INFUSION SOLUTION CONCENTRATE WHICH IS NOT DESIGNED FOR DIRECT ADMINISTRATION. The duration of use should not exceed 2 weeks.

Adults

Dosage depends on the severity of the catabolic state and on amino acid requirement. A maximum daily dosage of 2 g amino acids per 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 acids supplied through DIPEPTIVEN should not exceed approximately 30 % of the total supply.

Daily Dose: 1,5 u2013 2,5 mL DIPEPTIVEN per kg body weight (equivalent to 0,3 u2013 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)u2013L-alanyl-L-glutamine per kg body weight should be administered in combination with at least 1,0 g amino acids per kg body weight per day. With the amino acids from DIPEPTIVEN included, 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 acids 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 acids 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 acids 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.

Special populations

Children

Safety and efficacy in children have not been established.

Method of administration

DIPEPTIVEN is designed for central venous infusion following ADDITION TO A COMPATIBLE CARRIER SOLUTION.

Patients with total parenteral nutrition

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 should be mixed with a COMPATIBLE amino acid carrier solution or an amino acid containing infusion regimen prior to administration. Refer to section 6.6 for special precautions for disposal and other handling procedures.

DIPEPTIVEN should not be administered to patients with:

• Hypersensitivity to N(2)-L-alanyl-L-glutamine, or to any of the excipients of DIPEPTIVEN listed in section 6.1;
• Renal or hepatic insufficiency;
• Metabolic acidosis;
• Circulatory shock;
• Hypoxia;
• Multiple organ failure;
• Pregnancy and lactation, as the safety has not been demonstrated;
• Children, as the safety has not been demonstrated.

For a safe administration the maximum dose of DIPEPTIVEN should not exceed 2,5 mL (corresponding to 0,5 g N(2)-L-alanyl-L-glutamine) per kg body weight per day (see sections 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. Serum electrolytes, serum osmolarity, fluid balance, acid-base status, creatinine clearance, urea, as well as liver function tests (alkaline phosphatase, ALT, AST, bilirubin) and possible symptoms of hyperammonaemia should be monitored.

No interactions have been reported. Incompatibilities: DIPEPTIVEN must not be mixed with other medicines except those mentioned under u201cMethod of administrationu201d (see section 4.2).

The use of DIPEPTIVEN is contraindicated in pregnancy and lactation (see section 4.3)

It is unlikely that DIPEPTIVEN would produce an effect on the ability to drive or use machinery.

Chills, nausea and vomiting can occur when the infusion rate of DIPEPTIVEN is exceeded. Infusion must be stopped immediately in such a case.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Healthcare providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicineu2019s regulatory authority in the country where the product is marketed.

Refer to u201cUndesirable effectsu201d in section 4.8 above. Treatment is symptomatic and supportive.