Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Tetris Pharma B.V, Bargelaan 200, Element Offices, 2333 CW Leiden, Netherlands
Ogluo 0.5 mg solution for injection in pre-filled pen.
Ogluo 1 mg solution for injection in pre-filled pen.
Ogluo 0.5 mg solution for injection in pre-filled syringe.
Ogluo 1 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). A clear, colourless to pale yellow solution. |
Ogluo 0.5 mg solution for injection in pre-filled pen: Each pre-filled pen contains 0.5 mg glucagon in 0.1 mL.
Ogluo 1 mg solution for injection in pre-filled pen: Each pre-filled pen contains 1 mg glucagon in 0.2 mL.
Ogluo 0.5 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 0.5 mg glucagon in 0.1 mL.
Ogluo 1 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 1 mg glucagon in 0.2 mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glucagon |
Glucagon is a hyperglycaemic agent that mobilises hepatic glycogen, which is released into the blood as glucose. Glucagon inhibits the tone and motility of the smooth muscle in the gastrointestinal tract. |
| List of Excipients |
|---|
|
Trehalose dihydrate |
Ogluo 0.5 mg solution for injection in pre-filled pen:
A pre-filled, single-dose pen containing a 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle,bromo butyl rubber flexible needle shield, and a red cap.
Each pre-filled pen contain 0.1 mL of solution for injection and is individually packaged in a predominantly red-coloured foil pouch, in a red on white carton displaying a pre-filled pen image.
Pack sizes of one and two single-dose pre-filled pens.
Ogluo 1 mg solution for injection in pre-filled pen:
A pre-filled, single-dose pen containing a 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle,bromo butyl rubber flexible needle shield, and a red cap.
Each pre-filled pen contains 0.2 mL of solution for injection and is individually packaged in a predominantly blue-coloured foil pouch, in a blue on white carton displaying a pre-filled pen image.
Pack sizes of one and two single-dose pre-filled pens.
Ogluo 0.5 mg solution for injection in pre-filled syringe:
A pre-filled 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle, and bromo butyl rubber rigid needle shield. Each syringe contains 0.1 mL of solution for injection and is individually packaged in a predominantly red-coloured foil pouch, in a red on white carton displaying a pre-filled syringe image.
Pack sizes of one and two single-dose pre-filled syringes.
Ogluo 1 mg solution for injection in pre-filled syringe:
A pre-filled 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle, and bromo butyl rubber rigid needle shield. Each syringe contains 0.2 mL of solution for injection and is individually packaged in a predominantly blue-coloured foil pouch, in a blue on white carton displaying a pre-filled syringe image.
Pack sizes of one and two single-dose pre-filled syringes.
Not all pack sizes may be marketed.
Tetris Pharma B.V, Bargelaan 200, Element Offices, 2333 CW Leiden, Netherlands
EU/1/20/1523/001
EU/1/20/1523/002
EU/1/20/1523/003
EU/1/20/1523/004
EU/1/20/1523/005
EU/1/20/1523/006
EU/1/20/1523/007
EU/1/20/1523/008
Date of first authorisation: 11 February 2021
| Drug | Countries | |
|---|---|---|
| OGLUO | Estonia, Croatia, Ireland, Lithuania, Poland |
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