Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
baclofen (UNII: H789N3FKE8) (baclofen - UNII:H789N3FKE8)
Saol Therapeutics Inc.
baclofen
baclofen 10 mg in 20 mL
INTRATHECAL
PRESCRIPTION DRUG
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
LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows: Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55). LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMed ® Infusion Systems, and associated instructions. Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02). Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02). Does not require refrigeration. Do not store above 86° F (30° C). Do not freeze. Do not heat sterilize.
New Drug Application
LIORESAL (BACLOFEN)- BACLOFEN INJECTION SAOL THERAPEUTICS INC. ---------- LIORESAL INTRATHECAL (BACLOFEN INJECTION) Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS ). DESCRIPTION LIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. LIORESAL INTRATHECAL is a sterile, pyrogen-free, isotonic solution free of antioxidants, ® preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37° C and compatible with CSF. Each milliliter of LIORESAL INTRATHECAL contains baclofen U. S. P. 50 mcg, 500 mcg or 2000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 - 7.0. Each ampule is intended for SINGLE USE ONLY. Discard any unused portion. DO NOT AUTOCLAVE. CLINICAL PHARMAC Prečítajte si celý dokument