Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
BACLOFEN
PROPHARM LTD
M03BX01
SOLUTION FOR INJECTION
BACLOFEN 10 MG / 5 ML
INTRATHECAL
Required
BIOINDUSTRIA L.I.M. S.P.A., ITALY
BACLOFEN
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.
2023-01-31
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 Lugege kogu dokumenti
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 ( Lugege kogu dokumenti