DUODOPA levodopa / carbidopa monohydrate 20mg/mL and 5mg/mL intestinal gel PVC bag

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

carbidopa monohydrate, Quantity: 5 mg/mL; levodopa, Quantity: 20 mg/mL

Доступно од:

Abbvie Pty Ltd

INN (Међународно име):

carbidopa monohydrate,Levodopa

Фармацеутски облик:

Gel

Састав:

Excipient Ingredients: purified water; carmellose sodium

Пут администрације:

Intraintestinal

Јединице у пакету:

7 x 100 mL

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

For the treatment of advanced idiopathic Parkinson?s disease with severe motor fluctuations despite optimised alternative pharmacological treatment.

Резиме производа:

Visual Identification: White to slightly yellow gel.; Container Type: Bag; Container Material: PVC; Container Life Time: 2 Years; Container Temperature: Store below minus 18 degrees Celsius (deep freeze); Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Licence status A

Датум одобрења:

2008-02-27

Информативни летак

DUODOPA
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DUODOPA?
Duodopa contains the active ingredients levodopa and carbidopa.
Duodopa is used to treat advanced Parkinson's disease.
For more information, see Section 1. Why am I using Duodopa? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DUODOPA?
Check the list of ingredients at the end of the CMI. Do not use
Duodopa if you have ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine if he/she is not
aware that you have any other medical conditions, take any other
medicines, or are pregnant or plan to become pregnant or are
breastfeeding.
For more information, see Section 2. What should I know before I use
Duodopa? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Duodopa and affect how it works.
Duodopa may interfere with other medicines and affect how
they work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DUODOPA?
•
The Duodopa dose is calculated by your doctor based on your individual
needs.
•
Duodopa is given directly into the tummy using a pump and tube. The
tube is inserted during a surgical operation.
More instructions can be found in Section 4. How do I use Duodopa? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DUODOPA?
THINGS YOU
SHOULD DO
•
Tell your doctor if you have any problem with the pump or tube,
including the skin where the tube is
located.
•
Tell your doctor if your Parkinson’s symptoms get worse.
•
Tell your doctor if you become pregnant.
•
Remind any doctor or dentist you visit that you are using Duodopa.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly. Always follow the directions
provided from your doctor.
DRIVING
OR USING
MACHINES
•
Use caution when driving or operating machines.
DR

Карактеристике производа

DUODOPA PI
Version 18
26 May 2021
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
DUODOPA
® (LEVODOPA / CARBIDOPA) MONOHYDRATE GEL
1
NAME OF THE MEDICINE
Levodopa and carbidopa monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of Duodopa gel contains levodopa 20 mg and carbidopa
monohydrate 5 mg.
Each Duodopa 100 mL bag contains levodopa 2000 mg and carbidopa
monohydrate 500 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Duodopa gel is a white to slightly yellow gel for continuous
intestinal infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of advanced idiopathic Parkinson’s disease with
severe motor fluctuations
despite optimised alternative pharmacological treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
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 (PEG-J) is placed. In cases where
a physician considers
this assessment is not necessary, the nasojejunal test phase may be
waived and treatment
initiated directly with placement of the PEG-J.
Duodopa is intended for continuous daytime intestinal infusion. For
long-term administration
the gel should be infused with a portable pump directly into the
duodenum or upper jejunum
by a permanent tube via percutaneous endoscopic gastrostomy (PEG) with
an outer
transabdominal tube and an inner intestinal tube, or via direct
percutaneous endoscopic
jejunostomy (PEJ) with a transabdominal tube. Alternatively a
radiological gastrojejunostomy
may be considered if PEG/direct PEJ is not suitable for any reason.
Establishment of the
transabdominal port and dose adjustments should be carried out in
association with a
neurological clinic.
DUODOPA PI
Version 18
26 May 2021
Page 2 of 28
The implantation placement target for the end of the tubing is the
proximal small intestine past
the Ligament of Treitz.
The dose should be adjusted to an