Source: Health Products Regulatory Authority (IE) Revision Year: 2024 Publisher: AbbVie Limited, Citywest Business Campus, Dublin 24, Ireland
Produodopa 240 mg/ml + 12 mg/ml solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion (infusion). Produodopa is a clear to slightly opalescent solution in a glass vial. The solution should be free from particulates. Produodopa may vary from colourless to yellow to brown and may have a purple or red tint. Variations in colour are expected and have no impact on product quality. The solution may become darker in colour after piercing of the vial stopper or while in the syringe. The pH is approximately 7.4. Osmolality is approximately 2200 to 2500 mOsmol/kg but may range up to 2700 mOsmol/kg. |
1 ml contains 240 mg foslevodopa and 12 mg foscarbidopa.
10 ml contain 2400 mg foslevodopa and 120 mg foscarbidopa.
Foslevodopa and foscarbidopa are prodrugs equivalent to approximately 170 mg levodopa and 9 mg carbidopa per 1 ml.
Excipient with known effect:
Produodopa contains approximately 1.84 mmol (42.4 mg) sodium per ml.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Carbidopa is a peripheral aromatic amino acid decarboxylase inhibitor. It prevents metabolism of levodopa to dopamine in the peripheral circulation, ensuring that a higher proportion of the dose reaches the brain, where dopamine exerts its therapeutic effects. A lower dose of levodopa can be used when it is coadministered with carbidopa, reducing the incidence and severity of peripheral side effects. |
|
Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease. |
|
Levodopa is a precursor of dopamine, and is given as replacement therapy in Parkinson's disease. Carbidopa is a peripheral dopa decarboxylase inhibitor. It prevents metabolism of levodopa to dopamine in the peripheral circulation, ensuring that a higher proportion of the dose reaches the brain, where dopamine acts. A lower dose of levodopa can be used, reducing the incidence and severity of side-effects. |
| List of Excipients |
|---|
|
Sodium hydroxide 10N (for pH adjustment) |
Total amount of 10 ml in type I clear, colourless glass vial fitted with a grey rubber stopper, aluminium crimp cap, and turquoise plastic flip-off cap, carton with 7 vials.
Sterile, single-use infusion components (syringe, infusion set, and vial adapter) qualified for use are provided separately.
The Vyafuser pump is provided separately.
AbbVie Limited, Citywest Business Campus, Dublin 24, Ireland
PA1824/002/003
Date of first authorisation: 23rd September 2022
| Drug | Countries | |
|---|---|---|
| PRODUODOPA | Austria, Cyprus, Estonia, Croatia, Israel, Romania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.