Israel - English - Ministry of Health

cts ltd - baclofen - solution for infusion - baclofen 2 mg/ml - 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.

Israel - English - Ministry of Health

cts ltd - baclofen - solution for infusion - baclofen 0.5 mg / 1 ml - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - baclofen 2 mg/ml - solution for infusion - 2 mg/ml - active: baclofen 2 mg/ml excipient: sodium chloride water for injection - intrathecal baclofen is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Australia - English - Department of Health (Therapeutic Goods Administration)

boucher & muir pty ltd - baclofen, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - sintetica baclofen intrathecal is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Australia - English - Department of Health (Therapeutic Goods Administration)

boucher & muir pty ltd - baclofen, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - sintetica baclofen intrathecal is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sintetica sa, switzerland - baclofen - solution for injection - 2 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sintetica sa, switzerland - baclofen - solution for injection - 2 mg/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - baclofen 0.5 mg/ml - solution for infusion - 0.5 mg/ml - active: baclofen 0.5 mg/ml excipient: sodium chloride water for injection - intrathecal baclofen is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

New Zealand - English - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - baclofen 0.05 mg/ml - solution for injection - 0.05 mg/ml - active: baclofen 0.05 mg/ml excipient: sodium chloride water for injection - intrathecal baclofen is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Australia - English - Department of Health (Therapeutic Goods Administration)

boucher & muir pty ltd - baclofen, quantity: 0.5 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - sintetica baclofen intrathecal is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.