Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Immedica Pharma AB, 113 63 Stockholm, Sweden
Loargys 5 mg/ml solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion (injection/infusion). Colourless to slightly yellow or slightly pink, clear to slightly opalescent liquid. pH: 7.0-7.6 Osmolality: 250-305 mOsm/kg |
Loargys consists of a cobalt substituted, recombinant human arginase 1 enzyme, produced in Escherichia coli cells, that is covalently conjugated to methoxypolyethylene glycol (mPEG).
The strength of Loargys indicates the quantity of the arginase moiety of pegzilarginase without consideration of the mPEG carrier.
Each 0.4 ml vial contains 2 mg of pegzilarginase (5 mg pegzilarginase per ml).
Each 1 ml vial contains 5 mg of pegzilarginase (5 mg pegzilarginase per ml).
The potency of this medicinal product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class (see section 5.1).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegzilarginase |
Pegzilarginase is a cobalt substituted recombinant human arginase 1 enzyme conjugated with mPEG carriers. The mPEG carrier reduces clearance of pegzilarginase resulting in an extended half-life while maintaining the functions of the enzyme. Pegzilarginase is intended to substitute for the deficient human arginase 1 enzyme activity in patients with ARG1-D. Pegzilarginase has been shown to rapidly and sustainably reduce plasma arginine and convert it to urea and ornithine. |
| List of Excipients |
|---|
|
Sodium chloride |
Each pack contains 1 vial with 0.4 ml or 1 ml solution for injection/infusion.
0.4 ml solution for injection/infusion in a 3 ml type 1 glass vial with a Fluorotec coated chlorobutyl rubber stopper, aluminium seal and a blue flip-off cap.
1 ml solution for injection/infusion in a 5 ml type 1 glass vial with a Teflon coated chlorobutyl rubber stopper, aluminium seal and a white flip-off cap.
Pack size of 1 vial.
Not all pack sizes may be marketed.
Immedica Pharma AB, 113 63 Stockholm, Sweden
EU/1/23/1774/001
EU/1/23/1774/002
| Drug | Countries | |
|---|---|---|
| LOARGYS | Austria, Estonia, France, Croatia, Lithuania, United Kingdom |
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