Produodopa 240 mg/ml + 12 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Foslevodopa; Foscarbidopa

Available from:

AbbVie Limited

ATC code:

N04BA

INN (International Name):

Foslevodopa; Foscarbidopa

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Dopa and dopa derivatives

Authorization status:

Marketed

Authorization date:

2022-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRODUODOPA 240 MG/ML + 12 MG/ML SOLUTION FOR INFUSION
foslevodopa and foscarbidopa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Produodopa is and what it is used for
2.
What you need to know before you use Produodopa
3.
How to use Produodopa
4.
Possible side effects
5.
How to store Produodopa
6.
Contents of the pack and other information
7.
Instructions for use for Produodopa infusion using the Vyafuser pump
1.
WHAT PRODUODOPA IS AND WHAT IT IS USED FOR
Produodopa contains two active ingredients, foslevodopa and
foscarbidopa, and is used to treat
Parkinson’s disease.
HOW PRODUODOPA WORKS

In the body, foslevodopa is made into ‘dopamine’. This adds to the
dopamine already in your
brain and spinal cord. Dopamine helps transfer signals between nerve
cells.

Too little dopamine causes Parkinson’s disease signs like tremor,
feeling stiff, slow movement,
and problems keeping your balance.

Treatment with foslevodopa increases the amount of dopamine in your
body. This means it
reduces these signs.

Foscarbidopa improves the effect of foslevodopa. It also reduces the
side effects of foslevodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PRODUODOPA
DO NOT USE PRODUODOPA IF YOU

are allergic to foslevodopa, foscarbidopa, or any of the other
ingredients in this medicine (listed
in section 6)

have an eye problem called ‘narrow angle glaucoma’

have severe heart problems

have a severe uneven heartbeat (arrhythm

Summary of Product characteristics

Health Products Regulatory Authority
09 January 2024
CRN00F1PZ
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Produodopa 240 mg/ml + 12 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced levodopa-responsive Parkinson's disease with
severe motor fluctuations and hyperkinesia or dyskinesia
when available combinations of Parkinson medicinal products have not
given satisfactory results.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Produodopa is administered as a continuous subcutaneous infusion, 24
hours per day.
The recommended starting infusion rate of Produodopa is determined by
converting the daytime levodopa intake to levodopa
equivalents (LE) and then increasing it to account for a 24-hour
administration (see Initiation of treatment). The dose may be
adjusted to reach a clinical response that maximises the functional
"On" time and minimises the number and duration of "Off"
episodes and "On" episodes with troublesome dyskinesia. The maximum
recommended daily dose of fo