LYSAKARE Solution for infusion Ref.[49640] Active ingredients: Arginine Lysine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Advanced Accelerator Applications, 20 rue Diesel, 01630 Saint Genis Pouilly, France

Product name and form

LysaKare 25 g/25 g solution for infusion.

Pharmaceutical Form

Solution for infusion (infusion).

Clear, colourless solution, free from visible particles.

pH: 5.1-6.1
Osmolarity: 420-480 mOsm/L

Qualitative and quantitative composition

One 1,000 mL bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Arginine

Arginine is an essential amino acid that is physiologically active in the L-form. It is commonly found as a component of total parenteral nutrition.

Lysine
List of Excipients

Water for injections

Pack sizes and marketing

Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a polyethylene polyamine/aluminium foil.

Marketing authorization holder

Advanced Accelerator Applications, 20 rue Diesel, 01630 Saint Genis Pouilly, France

Marketing authorization dates and numbers

EU/1/19/1381/001

25 July 2019

Drugs

Drug Countries
LYSAKARE Austria, Estonia, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Poland, United Kingdom

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