DIPEPTIVEN Concentrate for solution for infusion Ref.[50323] Active ingredients: Alanine glutamine dipeptide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Fresenius AG, 61343 BAD Homburg v.d.H., Germany

Product name and form

Dipeptiven, concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

A clear colourless solution.

Qualitative and quantitative composition

1 ml contains:

Active substance: N(2)-L-alanyl-L-glutamine

Quantity: 200 mg (= 82.0 mg L-alanine, 134.6 mg L-glutamine)

theoretical osmolarity: 921 mosmol/l
titration acidity: 90–105 mmol NaOH/l
pH value: 5.4-6.0

For the full list of excipients, see section 6.1.

Active Ingredient Description
Alanine glutamine dipeptide

N(2)-L-alanyl-L-glutamine is rapidly split into alanine and glutamine after infusion, which are useful amino acids for the body in dealing with hypercatabolic and/or hypermetabolic conditions.

List of Excipients

Water for injection

Pack sizes and marketing

Glass bottles.

1 × 50 ml, 10 × 50 ml

1 × 100 ml, 10 × 100 ml

Type II, colourless glass.

Rubber closure.

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius AG, 61343 BAD Homburg v.d.H., Germany

Marketing authorization dates and numbers

PA 697/2/1

Date of first authorisation: 20 May 1996
Date of last renewal: 29 March 2010

Drugs

Drug Countries
DIPEPTIVEN Austria, Brazil, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom

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