Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
BACLOFEN
CTS LTD
M03BX01
SOLUTION FOR INFUSION
BACLOFEN 0.5 MG / 1 ML
INTRATHECAL
Required
SINTETICA SA , SWITZERLAND
BACLOFEN
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.
2022-08-14
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 Przeczytaj cały dokument
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 Przeczytaj cały dokument