CARNITINE SOLUTION 30%

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LEVOCARNITINE

متاح من:

ABIC MARKETING LTD, ISRAEL

ATC رمز:

A16AA01

الشكل الصيدلاني:

SOLUTION

تركيب:

LEVOCARNITINE 30 %

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ALFASIGMA S.P.A., ITALY

المجموعة العلاجية:

LEVOCARNITINE

المجال العلاجي:

LEVOCARNITINE

الخصائص العلاجية:

Systemic and myopathic carnitine deficiency.

تاريخ الترخيص:

2020-06-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
CARNITINE SOLUTION 30%
Oral Solution
Composition
Each 1 ml contains:
L-carnitine 300 mg (30%)
For information about inactive and allergenic ingredients, see section
2 –
“Important information about some of the ingredients of the
medicine” and
section 6 – “Further Information”.
Read the 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
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Carnitine Solution 30% is intended for the treatment of carnitine
deficiencies.
The solution is intended for oral use only, and not for injection.
Therapeutic group
Amino acids and derivatives.
Carnitine is found naturally in the cells of the human body, and plays
a
fundamental role in producing and transporting energy.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
you are sensitive (allergic) to the active ingredient L-carnitine or
any of the
additional ingredients contained in the medicine.
Special warnings regarding use of the medicine
Before treatment with Carnitine Solution 30%, tell the doctor:
•
If
you
have
diabetes
and
are
being
treated
with
insulin
or
oral
antidiabetic
medicines
to
reduce
blood
sugar
levels.
Using
this
medicine causes a further reduction in blood sugar levels. In this
case,
you will have to perform frequent blood tests, and the doctor may
change the dosage of insulin or of oral antidiabetic medicines.
•
If you have a predisposition to seizures. Treatment with this medicine
may cause seizure episodes. If you already suffer from convulsive
attacks, this medicine may increase their number and intensity.
•
If
you
suffer
from

خصائص المنتج

Carnitine solution 30% SPC Minor Updates ME 11.2023
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CARNITINE SOLUTION 30%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Carnitine Solution 30% contains 300 mg of L-Carnitine.
One bottle of 20 ml of Carnitine Solution 30% contains:
Active Ingredient: L-Carnitine 6 g.
Excipients with known effect:
Sorbitol content: 1.4 g per 20 ml solution.
Sucrose content: 0.56 g per 20 ml solution.
Sodium content: 0.00375 g per 20 ml solution.
Sodium methyl-p-hydroxybenzoate 0.02 g per 20 ml solution
Sodium propyl-p-hydroxybenzoate 0.0098 g per 20 ml solution
Ethanol 0.104 g per 20 ml solution.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution.
Clear liquid, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Systemic and myopathic carnitine deficiency.
4.2
Posology and method of administration
_Adults _
Give 1 to 3 g/day in 2 or 3 divided doses for a 50 kg subject
. Use higher doses with caution and
only where clinical and biochemical considerations make it seem likely
that higher doses will be of
benefit.. Start dosage at 1 g/day, and increase slowly while assessing
tolerance and response.
Monitoring should include periodic blood chemistries, vital signs,
plasma carnitine concentrations,
and overall clinical condition.
_ _
_Children_
50 to 100 mg/kg/day. Give higher doses with caution and only where
clinical and biochemical
considerations make it seem likely that higher doses will be of
benefit.
Start dosage at 50
mg/kg/day, and increase slowly to a maximum of 3 g/day while assessing
tolerance and therapeutic
response.
Monitoring
should
include
periodic
blood
chemistries,
vital
signs,
plasma
carnitine
concentrations, and overall clinical condition.
Give alone or dissolve in drinks or liquid food. Space doses evenly
(every 3 or 4 hours), preferably
with or after meals; consume slowly to maximize tolerance.
4.3
Contraindications
Hypersensitivity to the active substance or to a