Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: sanofi-aventis groupe, 54, rue La Boétie, F 75008 Paris, France
Truvelog Mix 30 100 units/mL suspension for injection in cartridge.
Truvelog Mix 30 100 units/mL suspension for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Truvelog Mix 30 100 units/mL suspension for injection in cartridge: Suspension for injection. Truvelog Mix 30 100 units/mL suspension for injection in pre-filled pen: Suspension for injection in pre-filled pen (SoloStar). The suspension is cloudy and white. |
One mL suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg).
Truvelog Mix 30 100 units/mL suspension for injection in cartridge:
Each cartridge contains 3 mL equivalent to 300 units.
Truvelog Mix 30 100 units/mL suspension for injection in pre-filled pen:
Each pre-filled pen contains 3 mL equivalent to 300 units.
Each pre-filled pen injection delivers 1-80 units in steps of 1 unit.
* Produced in Escherichia coli by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin aspart |
The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Insulin aspart produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal. Insulin aspart has a shorter duration of action compared to soluble human insulin after subcutaneous injection. |
| List of Excipients |
|---|
|
Glycerol |
Type 1 colourless glass cartridge with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber). Each cartridge contains 3 mL of suspension. The cartridge contains steel balls to facilitate resuspension.
Pack sizes: 5 or 10 cartridges. Not all pack sizes may be marketed.
Type 1 colourless glass cartridge with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber) sealed in a disposable pen injector (SoloStar). The cartridge contains steel balls to facilitate resuspension.
Each pre-filled pen contains 3 mL of suspension.
Pack sizes: 1, 5 or 10 pre-filled pens. Not all pack sizes may be marketed.
sanofi-aventis groupe, 54, rue La Boétie, F – 75008 Paris, France
EU/1/22/1639/001
EU/1/22/1639/002
EU/1/22/1639/003
EU/1/22/1639/004
EU/1/22/1639/005
| Drug | Countries | |
|---|---|---|
| TRUVELOG MIX 30 | Estonia, Croatia, Lithuania, Poland |
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