Duodopa

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Carbidopa monohydrate 5 mg/mL;  ; Levodopa 20 mg/mL;  

זמין מ:

AbbVie Limited

INN (שם בינלאומי):

Carbidopa monohydrate 5 mg/mL

כמות:

20 mg/ml, 5 mg/ml

טופס פרצבטיות:

Intestinal gel

הרכב:

Active: Carbidopa monohydrate 5 mg/mL   Levodopa 20 mg/mL   Excipient: Carmellose sodium Purified water

סוג מרשם:

Prescription

תוצרת:

Divi's Laboratories Limited

סממני תרפויטית:

Treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations despite optimised alternative pharmacological treatment.

leaflet_short:

Package - Contents - Shelf Life: Bag, plastic, Transparent PVC with delivery tube and cap in plastic cassette, 7 x 100mL units in carton - 700 mL - 15 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 months from date of manufacture stored below -20°C (Deep freeze) protect from light

תאריך אישור:

2014-06-10

עלון מידע

Duodopa®
1
DUODOPA®
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.
DRINKING

מאפייני מוצר

DUODOPA Data Sheet
Version 7
1
5 January 2021
Page 1 of 27
NEW ZEALAND DATA SHEET
1.
DUODOPA
® LEVODOPA 20 MG/ML, CARBIDOPA MONOHYDRATE 5 MG/ML
INTESTINAL GEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DUODOPA 20/5
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.
Levodopa
Mol. Wt:
197.2
Molecular Formula:
C
9
H
11
NO
4
Chemical name:
(2
_S_
)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
Levodopa is an aromatic amino acid, the metabolic pre-cursor to
dopamine. Levodopa is also a white
or slightly cream-coloured crystalline powder, slightly soluble in
water, practically insoluble in
alcohol and in ether. It is freely soluble in 1 M HCl and sparingly
soluble in 0.1 M HCl, and is light
and oxygen sensitive.
Carbidopa monohydrate
DUODOPA Data Sheet
Version 7
1
5 January 2021
Page 2 of 27
Mol. Wt:
244.2
Molecular Formula:
C
10
H
14
N
2
O
4
.H
2
O
Chemical name:
(2
_S_
)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropanoic acid,
monohydrate
Carbidopa
monohydrate
is
an
inhibitor
of
aromatic
amino
acid
decarboxylase.
Carbidopa
monohydrate is a white or yellowish-white powder, slightly soluble in
water, very slightly soluble in
alcohol, practically insoluble in methylene chloride. It dissolves in
dilute solutions of mineral acids,
and is light and oxygen sensitive.
3.
PHARMACEUTICAL FORM
Duodopa intestinal 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 ph