BACLOFENE BIOINDUSTRIA L.I.M 10 MG5 ML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BACLOFEN

متاح من:

PROPHARM LTD

ATC رمز:

M03BX01

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

BACLOFEN 10 MG / 5 ML

طريقة التعاطي:

INTRATHECAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BIOINDUSTRIA L.I.M. S.P.A., ITALY

المجال العلاجي:

BACLOFEN

الخصائص العلاجية:

Baclofene Bioindustria L.I.M. 10mg/5ml is indicated in patients with severe chronic spasticity resulting from trauma, multiple sclerosis or other spinal cord disorders, who are unresponsive to oral baclofen or other orally administered antispastic agents and/or those patients who experience unacceptable side effects at effective oral doses.Baclofene Bioindustria L.I.M. 10mg/5ml is effective in adult patients with severe chronic spasticity of cerebral origin, resulting e.g. from cerebral palsy, brain trauma or cerebrovascular accident; however, clinical experience is limited.Pediatric population:Baclofene Bioindustria L.I.M. 10mg/5ml is indicated in patients aged 4 to <18 years with severe chronic spasticity of cerebral origin or of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

تاريخ الترخيص:

2023-01-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
- 1986
This medicine is to be supplied by physician’s prescription only
BACLOFENE BIOINDUSTRIA L.I.M. 10 MG/5 ML
Solution for intrathecal infusion
ACTIVE INGREDIENT
1 ml contains 2 mg baclofen
Inactive ingredients and allergens: See section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains essential information about this medicine. If you have any
further questions,
refer to the physician or the 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.
1.
WHAT IS THIS MEDICINE USED FOR?
Adults:
For the treatment of patients with severe chronic spasticity resulting
from trauma,
multiple sclerosis or other spinal cord disorders, who are
unresponsive to oral baclofen
or other orally administered antispastic agents and/or those patients
who experience
unacceptable side effects at effective oral doses.
Baclofene Bioindustria L.I.M. 10 mg/5 ml is effective in treatment of
patients with
severe chronic spasticity of cerebral origin, resulting e.g. from
cerebral palsy, brain
trauma or cerebrovascular accident (clinical experience with the
treatment of those
cases is limited).
Children:
For the treatment of children aged 4 years and above with severe
chronic spasticity of
cerebral origin or of spinal origin (associated with injury, multiple
sclerosis, or other
spinal cord disorders) who are unresponsive to oral baclofen or to
other orally
administered antispastics, and/or patients who experience unacceptable
side effects
at effective oral doses.
THERAPEUTIC GROUP: muscle relaxant.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients that this medicine contains (see section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
•
It is important to make sure

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Baclofene Bioindustria L.I.M. 10 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: baclofen 2 mg/ml
1 ml of solution for injection contains 2.0 mg (2000 micrograms)
baclofen, 9 mg sodium
chloride.
1 ampoule contains 10 mg (10,000 micrograms) baclofen, 45 mg sodium
chloride.
Excipient with known effect
5 ml ampoule contains 17.70 mg sodium.
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Solution for intrathecal injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baclofene Bioindustria L.I.M. 10 mg/5 ml is indicated in patients with
severe chronic spasticity
resulting from trauma, multiple sclerosis or other spinal cord
disorders, who are unresponsive to oral
baclofen or other orally administered antispastic agents and/or those
patients who experience
unacceptable side effects at effective oral doses.
Baclofene Bioindustria L.I.M. 10 mg/5 ml is effective in adult
patients with severe chronic spasticity of
cerebral origin, resulting e.g. from cerebral palsy, brain trauma or
cerebrovascular accident; however,
clinical experience is limited.
Pediatric population
Baclofene Bioindustria L.I.M. 10 mg/5 ml is indicated in patients aged
4 to <18 years with severe chronic
spasticity of cerebral origin or of spinal origin (associated with
injury, multiple sclerosis, or other spinal
cord diseases) who are unresponsive to orally administered
antispastics (including oral baclofen) and/or
who experience unacceptable side effects at effective oral doses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Intrathecal administration of baclofen through an implanted delivery
system should only be undertaken by
physicians with the necessary knowledge and experience. Specific
instructions for implantation,
programming and/or refilling of the implantable pump are given by the
pump manufacturers, and must be
strictly adhered to.
Baclofene Bioindustria L.I.M. 10 mg/5ml is intended for administration
in single bolus test doses (