PRODUODOPA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FOSCARBIDOPA; FOSLEVODOPA

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

FOSLEVODOPA 240 MG / 1 ML; FOSCARBIDOPA 12 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ABBVIE INC., USA

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.

Authorization date:

2023-06-18

Patient Information leaflet

PRODUDOPA
®
(FOSLEVODOPA/FOSCARBIDOPA)
FOR ADVANCED PARKINSON’S DISEASE
THIS PATIENT GUIDE CONTAINS IMPORTANT
SAFETY INFORMATION YOU SHOULD BE AWARE OF.
PLEASE KEEP THIS GUIDE AVAILABLE WHEN
YOU ARE PREPARING TO USE THIS MEDICINE.
- 2 -
WHY SHOULD I READ THIS PATIENT GUIDE?
PRODUODOPA
®
is a medicine to treat the symptoms of
advanced Parkinson’s disease.
It is used when other medicines no longer work as well as
they did to treat the symptoms of the disease.
You or your caregiver will deliver this medicine under your
skin through a small plastic tube (cannula) in the area around
the belly button. This area is your infusion site.
It is delivered through this tube continuously 24 hours a day.
SOME PEOPLE USING THIS MEDICINE MAY HAVE PROBLEMS
AROUND THE SKIN WHERE THE CANNULA GOES INTO THEIR BODY.
THESE COULD BE:
- A SKIN INFECTION.
A skin infection can become serious when it enters the blood and
spreads all over the body. This is called sepsis.
- A SKIN REACTION. This is when the skin becomes irritated / inflamed.
- 3 -
THIS PATIENT GUIDE WILL HELP YOU AND YOUR
CAREGIVER LEARN ABOUT:
How to choose your infusion site
How to recognize an infusion site infection or
infusion site reaction
What you can do to help reduce the chance of an
infusion site infection or infusion site reaction
What you should do if you have an infusion site
infection or infusion site reaction
Where you can find more information about
your medicine
- 4 -
•
•
•
•
Avoid your belt line because this area may be irritated by
the pressure of the belt against the skin
Avoid any skin that is scarred, hard, or has stretch marks
Avoid any skin folds or creases on your skin where
it naturally bends a lot
Use a new infusion set (cannula/tubing), every time you
change your infusion site.
HOW TO CHOOSE YOUR INFUSION SITE
Changing your infusion site regularly is important. This is
because it helps your skin stay healthy and lets the medicine
be delivered correctly.
You can use your stomach for the infusion site unless your
doctor tells you to use

Summary of Product characteristics

1
PRD API DEC 23 CL
1.
NAME OF THE MEDICINAL PRODUCT
Produodopa
™
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
PATIENT SAFETY INFORMATION CARD
The marketing of Produodopa is subject to a risk management plan
(RMP) including a ‘Patient safety information card’. The
‘Patient
safety information card’, emphasizes important
safety information that
the patient should be aware of before and during treatment. Please
explain to the patient the need to review the card before starting
treatment.
2
PRD API DEC 23 CL
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