BACLOFEN SINTETICA 2 MG ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BACLOFEN

Available from:

CTS LTD

ATC code:

M03BX01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

BACLOFEN 2 MG/ML

Administration route:

INTRATHECAL

Prescription type:

Required

Manufactured by:

SINTETICA SA , SWITZERLAND

Therapeutic area:

BACLOFEN

Therapeutic indications:

Baclofen Sintetica 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.Baclofen Sintetica 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.Paediatric population: Baclofen Sintetica 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.

Authorization date:

2021-07-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
BACLOFEN SINTETICA 0.5 MG/ML BACLOFEN SINTETICA 2 MG/ML
Solution for intrathecal infusion
ACTIVE INGREDIENT
BACLOFEN SINTETICA 0.5 MG/ML: 1 ml contains 0.5 mg baclofen
Each 20 ml ampoule contains 10 mg of baclofen.
BACLOFEN SINTETICA 2 MG/ML: 1 ml contains 2 mg baclofen
Each 5 ml ampoule contains 10 mg of baclofen.
Each 20 ml ampoule contains 40 mg of baclofen.
Inactive ingredients and allergens: See the paragraph in 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 any further
questions, refer to the doctor
or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It may
harm them even if it seems to you that their ailment is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Adults:
For the treatment of patients with severe chronic spasticity resulting
from trauma, multiple
sclerosis or other spinal disorders, who are unresponsive to oral
baclofen or other orally
administered antispastic agents and/or those patients who experience
unreasonable side
effects at effective oral doses.
Baclofen Sintetica is effective in 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
disorders), who are unresponsive to oral baclofen or other orally
administered antispastic
agents and/or those patients who experience unreasonable side effects
at effective oral
doses.
THERAPEUTIC

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Baclofen Sintetica 0.5 mg/ml
Baclofen Sintetica 2 mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
baclofen
BACLOFEN SINTETICA 0.5 MG/ML
1 ml of solution for infusion contains 0.5 mg (500 micrograms)
baclofen.
20 ml ampoule contains 10 mg (10,000 micrograms) baclofen.
Excipient with known effect
20 ml ampoule contains 69.3 mg sodium.
BACLOFEN SINTETICA 2 MG/ML
1 ml of solution for infusion contains 2.0 mg (2000 micrograms)
baclofen, 3.5 mg sodium
1 ampoule contains 10 mg (10,000 micrograms) baclofen, 17.5 mg sodium
20 ml ampouleBaclofen Sintetica ampoules 40 mg/20 ml solution for
infusion
1 ml of solution for infusion contains 2.0 mg (2000 micrograms)
baclofen, 3.5 mg sodium
1 ampoule contains 40 mg (40,000 micrograms) baclofen 69.3 mg sodium
Excipient with known effect
5 ml ampoule contains 17.5 mg sodium.
20 ml ampoule contains 69.3 mg sodium.
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Solutions for intrathecal infusion.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Baclofen Sintetica 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.
Baclofen Sintetica 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:
Baclofen Sintetica 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
Intrath