United States - English - NLM (National Library of Medicine)

remedyrepack inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen tablets usp are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. baclofen tablets usp may also be of some value in patients with spinal cord injuries and other spinal cord diseases. baclofen tablets usp are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of baclofen in stroke, cerebral palsy, and parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. hypersensitivity to baclofen.

United States - English - NLM (National Library of Medicine)

marlex pharmaceuticals inc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of baclofen in stroke, cerebral palsy, and parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. hypersensitivity to baclofen.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

crescent pharma ltd - baclofen - oral solution - 1mg/1ml

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - baclofen 10 mg - tablet - 10 mg - baclofen 10 mg - baclofen

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - baclofen 25 mg - tablet - 25 mg - baclofen 25 mg - baclofen

United States - English - NLM (National Library of Medicine)

akorn - apraclonidine hydrochloride (unii: d2vw67n38h) (apraclonidine - unii:843cen85di) - apraclonidine 5 mg in 1 ml - apraclonidine ophthalmic solution, usp 0.5% as base is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional iop reduction. patients on maximally tolerated medical therapy who are treated with apraclonidine ophthalmic solution, usp 0.5% as base to delay surgery should have frequent follow-up examinations and treatment should be discontinued if the intraocular pressure rises significantly. the addition of apraclonidine ophthalmic solution, usp 0.5% as base to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. this is because apraclonidine ophthalmic solution, usp 0.5% as base is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce iop. the iop lowering efficacy of apraclonidine ophthalmic solution, usp 0.5% as base diminishes over time in some patients.

United States - English - NLM (National Library of Medicine)

sandoz inc - apraclonidine hydrochloride (unii: d2vw67n38h) (apraclonidine - unii:843cen85di) - apraclonidine 5.75 mg in 1 ml - apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional iop reduction. patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the iop rises significantly. the addition of apraclonidine ophthalmic solution 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. this is because apraclonidine ophthalmic solution 0.5% is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce iop. the iop lowering efficacy of apraclonidine ophthalmic solution 0.5% diminishes over time in some patients. this loss of effect, or tachyphylaxis, appears to be an individual occurrence

United States - English - NLM (National Library of Medicine)

saol therapeutics inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen 10 mg in 20 ml - lioresal intrathecal (baclofen injection) is indicated for use in the management of severe spasticity. patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. for spasticity of spinal cord origin, chronic infusion of lioresal intrathecal via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable cns side effects at effective doses. patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. lioresal intrathecal is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the fda specifically for the administration of lioresal intrathecal into the intrathecal space. spasticity of spinal cord origin: evidence supporting the efficacy of li

Israel - English - Ministry of Health

propharm ltd - baclofen - solution for injection - baclofen 10 mg / 5 ml - 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.

United States - English - NLM (National Library of Medicine)

schwarz pharma - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - tablet, orally disintegrating - 10 mg - kemstro™ is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that treatment with kemstro™ will aid in restoring residual function. kemstro™ may also be of some value in patients with spinal cord injuries and other spinal cord diseases. kemstro™ is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of kemstro™ in stroke, cerebral palsy, and parkinson's disease has not been established and, therefore, it is not recommended for these conditions. kemstro™ is contraindicated in patients who are hypersensitive to any component of this product. vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures. in the alert patient, empty the stomach promptly by induced emesis followed by lavage. in the obtunded patient, secure th