Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: BrePco Biopharma Ltd., Suite One, The Avenue, Beacon Court, Sandyford, Dublin D18HX31, Ireland
Neoatricon 1.5 mg/mL solution for infusion.
Neoatricon 4.5 mg/mL solution for infusion.
| Pharmaceutical Form |
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Solution for infusion. The solution is clear and colourless to pale yellow with a pH of 2.5 to 5.5. Neoatricon 1.5 mg/ mL solution for infusion: Osmolarity is 20 mOsmol/kg. Neoatricon 4.5 mg/ mL solution for infusion: Osmolarity is 50 mOsmol/kg. |
Each mL of solution contains 1.5 mg of dopamine hydrochloride.
Each vial contains 45 mg of dopamine hydrochloride in 30 mL.
Excipient with known effect: Each vial contains 9 mg sodium metabisulfite.
Each mL of solution contains 4.5 mg of dopamine hydrochloride.
Each vial contains 225 mg of dopamine hydrochloride in 50 mL.
Excipient with known effect: Each vial contains 15 mg of sodium metabisulfite.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dopamine |
Dopamine hydrochloride stimulates adrenergic receptors of the sympathetic nervous system. Dopamine hydrochloride has principally a direct stimulatory effect on β1-adrenergic receptors, but also appears to have an indirect effect by releasing norepinephrine from its storage sites. Dopamine hydrochloride also appears to act on specific dopaminergic receptors in the renal, mesenteric, coronary, and intracerebral vascular beds to cause vasodilation. |
| List of Excipients |
|---|
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Sodium metabisulfite (E223) |
Type I clear glass vial with bromobutyl rubber stopper, sealed with flip-off aluminium seal.
Pack size:
Neoatricon 1.5 mg/mL solution for infusion: single carton containing 30 mL vial.
Neoatricon 4.5 mg/mL solution for infusion: single carton containing 50 mL vial.
Not all pack sizes may be marketed.
BrePco Biopharma Ltd., Suite One, The Avenue, Beacon Court, Sandyford, Dublin D18HX31, Ireland
EU/1/24/1804/001 – 1.5 mg / ml 1 vial
EU/1/24/1804/002 – 4.5 mg / ml 1 vial
| Drug | Countries | |
|---|---|---|
| NEOATRICON | Lithuania |
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