- Approval Id
- b2ca4922846dfbd3
- Drug Name
- DIPEPTIVEN INFUSION
- Product Name
- DIPEPTIVEN INFUSION
- Approval Number
- SIN11183P
- Approval Date
- 1999-10-08
- Registrant
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Licence Holder
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- **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.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **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.
- Contraindications
- **Contra-Indications**
Dipeptiven® should not be administered to patients with severe renal insufficiency (creatinine clearance < 25 ml/minute), severe hepatic insufficiency, severe metabolic acidosis or known hypersensitivity to the active substances or to any of the excipients.
- Atc Code
- B05XB02
- Atc Item Name
- alanyl glutamine
- Pharma Manufacturer Name
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/fresenius-kabi-singapore-pte-ltd
