DUODOPA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CARBIDOPA AS MONOHYDRATE; LEVODOPA

متاح من:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC رمز:

N04BA01

الشكل الصيدلاني:

GEL

تركيب:

LEVODOPA 20 MG/ML; CARBIDOPA AS MONOHYDRATE 5 MG/ML

طريقة التعاطي:

INTESTINAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY

المجموعة العلاجية:

LEVODOPA

المجال العلاجي:

LEVODOPA

الخصائص العلاجية:

Treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

تاريخ الترخيص:

2015-04-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
DUODOPA
Gel for a continuous infusion directly into the digestive system
with the help of a designated device
Active ingredients:
Levodopa 20 mg/ml
Carbidopa (as monohydrate) 5 mg/ml
Inactive ingredients: See section 6 ‘Further Information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them even if it
seems to you that their ailment is similar.
The medicine is not intended for children and adolescents below
the age of 18.
In addition to the leaflet, Duodopa has a patient safety information
card. This card contains important safety information, which
you should know before starting and during the treatment
with Duodopa and act accordingly. Read the patient safety
information card and the patient leaflet before start using the
preparation. Keep the card for further reference if needed.
1. WHAT IS THE MEDICINE INTENDED FOR?
Duodopa is intended for the treatment of advanced levodopa-
responsive Parkinson’s disease accompanied by severe motor
fluctuations and hyper-/dyskinesia when available combinations
of medicinal products for the treatment of Parkinson’s have not
given satisfactory results.
THERAPEUTIC GROUP: anti-Parkinson’s components
Levodopa – a dopamine derivative
Carbidopa (as monohydrate) – dopa-decarboxylase enzyme
inhibitor
Duodopa belongs to a group of medicines to treat Parkinson’s
disease. It is a gel that goes through a pump and a tube into your
gut (small intestine).
Duodopa contains two active substances: levodopa and carbidopa
(as monohydrate).
HOW THE MEDICINE WORKS:
∙ In the body, levodopa is made into “dopamine”. This adds to
the dopamine already in your brain

خصائص المنتج

1
DUO API JAN 24 CL
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Duodopa
_ _
_ _
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 mot
or
fluctuations and hyper-/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 recommendations under _Dosage. _
PATIENT SAFETY INFORMATION CARD
The marketing of Duodopa is sub