Canada - English - Health Canada

teva canada limited - baclofen - tablet - 10mg - baclofen 10mg - gaba-derivative skeletal muscle relaxants

Canada - English - Health Canada

teva canada limited - baclofen - tablet - 20mg - baclofen 20mg - gaba-derivative skeletal muscle relaxants

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

sintetica s.a. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen 10 mg in 20 ml

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

mylan institutional llc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen injection (intrathecal) 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 baclofen injection (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. baclofen injection (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 baclofen injection (intrathecal) into the intrathecal space. spasticity of spinal cord origin: evidence su

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

mylan institutional llc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. 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 baclofen injection 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. baclofen injection  is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the medtronic synchromed®  ii programmable pump or other pumps labeled for intrathecal administration of baclofen injection [see clinical studies (14)] . prior to implan

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

mala pharmaceuticals, inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. 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 baclofen injection 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.  baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the medtronic synchromed® ii programmable pump or other pumps labeled for intrathecal administration of baclofen injection [see clinical studies (14)] . prior to implan

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

mala pharmaceuticals, inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - 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 baclofen injection 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. baclofen injection 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 baclofen injection into the intrathecal space. spasticity of spinal cord origin: evidence supporting the efficacy of baclofen injection was obta

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

sagent pharmaceuticals - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. 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 baclofen injection 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. baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the medtronic synchromed® ii programmable pump or other pumps labeled for intrathecal administration of baclofen injection [see clinical studies (14)] . prior to implant

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

palmetto pharmaceuticals inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. limitations of use baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. baclofen oral solution is contraindicated in patients with hypersensitivity to baclofen. risk summary there are no adequate data on the developmental risk associated with the use of baclofen oral solution in pregnant women. oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose which was also associated with maternal toxicity. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background ri

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

advagen pharma limited - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. 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 baclofen injection 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. baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the medtronic synchromed® ii programmable pump or other pumps labeled for intrathecal administration of baclofen injection [see clinical stud