Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: SciPharm SÃ rl, 7, Fausermillen, L-6689, Mertert, Luxembourg
Trepulmix 1 mg/ml solution for infusion.
Trepulmix 2.5 mg/ml solution for infusion.
Trepulmix 5 mg/ml solution for infusion.
Trepulmix 10 mg/ml solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. Clear colourless to slightly yellow solution, free from visible particles with a pH of 6.0–7.2 and an osmolality between 253 and 284 mOsm/kg. |
One ml of solution contains 1 mg treprostinil (as sodium salt). Each 10 ml vial of solution contains 10 mg treprostinil (as sodium salt).
Excipients with known effect: Each 10 ml vial contains 36.8 mg (1.60 mmol) sodium.
One ml of solution contains 2.5 mg treprostinil (as sodium salt). Each 10 ml vial of solution contains 25 mg treprostinil (as sodium salt).
Excipients with known effect: Each 10 ml vial contains 37.3 mg (1.62 mmol) sodium.
One ml of solution contains 5 mg treprostinil (as sodium salt). Each 10 ml vial of solution contains 50 mg treprostinil (as sodium salt).
Excipients with known effect: Each 10 ml vial contains 39.1 mg (1.70 mmol) sodium.
One ml of solution contains 10 mg treprostinil (as sodium salt). Each 10 ml vial of solution contains 100 mg treprostinil (as sodium salt).
Excipients with known effect: Each 10 ml vial contains 37.4 mg (1.63 mmol) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Treprostinil |
Treprostinil is a vasodilator that is used for the treatment of pulmonary arterial hypertension. Treprostinil is a potent oral antiplatelet agent. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation. Other studies have shown that treprostinil causes a dose-related negative inotropic and lusitropic effect. Treprostinil had high affinity for the Prostaglandin D2 receptor (DP1), Prostaglandin E2 receptor EP2 subtype (EP2) and Prostaglandin D2 receptor (IP) receptors (Ki 4.4, 3.6 and 32 nM, respectively), low affinity for EP1 and EP4 receptors and even lower affinity for EP3, Prostaglandin F (FP) and thromboxane (TP) receptors. Treprostinil has demonstrated a unique effect on PPAR gamma, a transcription factor important in vascular pathogenesis as a mediator of proliferation, inflammation and apoptosis. |
| List of Excipients |
|---|
|
Sodium citrate |
Trepulmix 1 mg/ml solution for infusion: 10 ml type I clear glass vial sealed with a rubber teflon- coated stopper and fitted with a yellow cap.
Trepulmix 2.5 mg/ml solution for infusion: 10 ml type I clear glass vial sealed with a rubber teflon-coated stopper and fitted with a blue cap.
Trepulmix, 5 mg/ml solution for infusion: 10 ml type I clear glass vial sealed with a rubber teflon-coated stopper and fitted with a green cap.
Trepulmix, 10 mg/ml solution for infusion: 10 ml type I clear glass vial sealed with a rubber teflon-coated stopper and fitted with a red cap.
Each carton contains one vial.
Not all pack sizes may be marketed.
SciPharm SÃ rl, 7, Fausermillen, L-6689, Mertert, Luxembourg
EU/1/19/1419/001
EU/1/19/1419/002
EU/1/19/1419/003
EU/1/19/1419/004
| Drug | Countries | |
|---|---|---|
| TREPULMIX | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland, Romania |
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