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HSA Approval

DIPEPTIVEN INFUSION

SIN11183P

DIPEPTIVEN INFUSION

DIPEPTIVEN INFUSION

October 8, 1999

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION

**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.

INTRAVENOUS

Medical Information

**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.

**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.

B05XB02

alanyl glutamine

Manufacturer Information

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI AUSTRIA GMBH

Active Ingredients

N(2)-L-ALANYL-L-GLUTAMINE

20 g/100ml

Alanyl glutamine

Documents

Package Inserts

Dipeptiven PI.pdf

Approved: April 30, 2012

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