Duodopa intestinal gel 100ml cassette

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levodopa; Carbidopa monohydrate

Available from:

AbbVie Ltd

ATC code:

N04BA02

INN (International Name):

Levodopa; Carbidopa monohydrate

Dosage:

20mg/1ml ; 5mg/1ml

Pharmaceutical form:

Intestinal gel

Administration route:

Intestinal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 08054083003191

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUODOPA 20 MG/ML + 5 MG/ML INTESTINAL GEL
levodopa/carbidopa monohydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Duodopa is and what it is used for
2.
What you need to know before you use Duodopa
3.
How to use Duodopa
4.
Possible side effects
5.
How to store Duodopa
6.
Contents of the pack and other information
1.
WHAT DUODOPA IS AND WHAT IT IS USED FOR
Duodopa belongs to a group of medicines for Parkinson’s disease.
Duodopa is a gel that goes through a pump and a tube into your gut
(small intestine). In the gel there
are two active substances:

Levodopa.

Carbidopa.
HOW DUODOPA WORKS

In the body, levodopa is made into something called ‘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 levodopa increases the amount of dopamine in your body.
This means it reduces
these signs.

Carbidopa improves the effect of levodopa. It also reduces the side
effects of levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUODOPA
DO NOT USE DUODOPA IF:

You are allergic to levodopa, carbidopa or any of the other
ingredients of this medicine (listed in
section 6).

You have an eye problem called ‘narrow-angle glaucoma’.

You have severe heart problems.

You have a severe uneven

Summary of Product characteristics

OBJECT 1
DUODOPA INTESTINAL GEL
Summary of Product Characteristics Updated 05-Dec-2017 | AbbVie
Limited
1. Name of the medicinal product
Duodopa 20 mg/ml + 5 mg/ml intestinal gel
2. Qualitative and quantitative composition
1 ml contains 20 mg levodopa and 5 mg carbidopa monohydrate.
100 ml contain 2000 mg levodopa and 500 mg carbidopa monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Intestinal gel.
Off white to slightly yellow gel.
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
Duodopa is a gel for continuous intestinal administration. For
long-term administration, the gel should be
administered with a portable pump directly into the duodenum or upper
jejunum by a permanent tube _via_
percutaneous endoscopic gastrostomy with an outer transabdominal tube
and an inner intestinal tube.
Alternatively, a radiological gastrojejunostomy may be considered if
percutaneous endoscopic
gastrostomy is not suitable for any reason. Establishment of the
transabdominal port and dose adjustments
should be carried out in association with a neurological clinic.
A temporary nasoduodenal/nasojejunal tube should be considered to
determine if the patient responds
favourably to this method of treatment before a permanent percutaneous
endoscopic gastrostomy with
jejunal tube (PEG-J) is placed. In cases where the physician considers
this assessment is not necessary,
the nasojejunal test phase may be waived and treatment initiated
directly with placement of the PEG-J.
The dose should be adjusted to an optimal clinical response for the
individual patient, which means
maximizing the functional ON-time during the day by minimizing the
number and duration of OFF
episodes (bradykinesia) and minimizing ON-time with disabling
dyskinesia. See recomm