LECIGON

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

CARBIDOPA MONOHYDRATE (AS ANHYDROUS); ENTACAPONE; LEVODOPA

Доступно од:

TRUEMED LTD, ISRAEL

АТЦ код:

N04BA01

Фармацеутски облик:

GEL

Састав:

ENTACAPONE 20 MG / 1 ML; CARBIDOPA MONOHYDRATE (AS ANHYDROUS) 5 MG / 1 ML; LEVODOPA 20 MG / 1 ML

Пут администрације:

INTESTINAL

Тип рецептора:

Required

Произведен од:

LOBSOR PHARMACEUTICALS

Терапеутска област:

LEVODOPA

Терапеутске индикације:

Treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results.

Датум одобрења:

2023-05-30

Информативни летак

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
– 1986
This medicine is dispensed with a doctor’s prescription only
LECIGON
INTESTINAL GEL
ACTIVE INGREDIENTS
Each 1 ml of gel contains:
•
20 mg levodopa
•
5 mg carbidopa monohydrate
•
20 mg entacapone
Inactive ingredients and allergens in this medicine: see
section 2 under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional information’
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Lecigon is used to treat advanced Parkinson's disease with severe
motor fluctuations and
hyperkinesia or dyskinesia when oral combinations (medicines taken by
mouth) of Parkinson
medication have not achieved satisfactory results.
THERAPEUTIC GROUP: Parkinson medicines; dopa and dopa derivatives.
Lecigon is a gel for continuous delivery that is supplied through a
pump and tube directly into
your small intestine.
HOW LECIGON WORKS
In a person with Parkinson's disease, the levels of dopamine in the
brain are low. Levodopa
is converted into dopamine in the brain, thereby relieving the
symptoms of Parkinson's
disease. Carbidopa and entacapone improve the effect that levodopa has
on Parkinson's
disease.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
-
you are sensitive (allergic) to the active ingredients (levodopa,
carbidopa,
entacapone) or any of the other ingredients in this medicine (see
section 6).
-
you have an eye problem called narrow-angle glaucoma (an acute type of
glaucoma).
-
you have severe heart failure.
-
you have severely irregular heartbeat (arrhythmia).
-
you recently had a stroke.
-
you have a serious liver dise

Карактеристике производа

1.
NAME OF THE MEDICINAL PRODUCT
Lecigon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 20 mg levodopa, 5 mg carbidopa monohydrate (equivalent
to 4.6 mg of anhydrous
carbidopa) and 20 mg entacapone.
47 ml (1 cartridge) contains 940 mg levodopa, 235 mg carbidopa
monohydrate and 940 mg
entacapone.
Excipients with known effects:
1 ml gel contains 3.5 mg sodium. (1 cartridge contains 166 mg sodium)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intestinal gel.
Yellow or yellowish-red opaque viscous gel.
pH: 4.5-5.5
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of advanced Parkinson's disease with severe motor
fluctuations and hyperkinesia or
dyskinesia when available oral combinations of Parkinson's medicinal
products have not given
satisfactory results.
4.2
Posology and method of administration
Posology
For intestinal use (see section 6.6). The dose should be titrated to
achieve the optimal clinical response
in the individual patient, which involves maximising the functional
ON-time during the day by
minimising the number and duration of OFF episodes (bradykinesia) and
minimising ON-time with
disabling dyskinesia.
The total dose/day of Lecigon is composed of three individually
adjusted doses: the morning bolus
dose, the continuous maintenance dose, and extra bolus doses.
Treatment is usually limited to the
patient's awake period. If medically justified, Lecigon can be
administered up to 24 hours/day. The
maximum recommended daily dose is 100 ml (which corresponds to 2000 mg
levodopa, 500 mg
carbidopa monohydrate and 2000 mg entacapone
–
see also section 4.4).
During the maintenance dose, the plasma concentration/time profile of
levodopa has a somewhat
different appearance, with a gradually increasing levodopa
concentration in plasma over the course of
the day, than previously observed from intestinal gel with
levodopa/carbidopa alone. An example of a
plasma concentration/time profile when using Lecigon can be found in
section 5.2. If individual needs
exist, the