LIORESAL (BACLOFEN)- baclofen injection

Lioresal (baclofen) by

Drug Labeling and Warnings

Lioresal (baclofen) by is a Prescription medication manufactured, distributed, or labeled by Saol Therapeutics Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • PRINCIPAL DISPLAY PANEL - 10 mg/20 mL Ampule Label

    Lioresal®Intrathecal
    (baclofen injection)

    10 mg/20 mL
    (500 mcg/mL)

    Sterile solution for intrathecal injection.
    Distributed by Saol Therapeutics Inc.,
    Roswell, GA 30076

    NDC: 70257-560-20
    68947 01
    LA56002

    LOT

    EXP

    PRINCIPAL DISPLAY PANEL - 10 mg/20 mL Ampule Label
  • PRINCIPAL DISPLAY PANEL - 10 mg/20 mL Outer Box Label

    SAOL
    NDC 70257-560 -01

    LIORESAL ® INTRATHECAL
    (baclofen injection) Refill Kit

    For use with SynchroMed ® Infusion Systems

    8561

    10 mg/20 mL
    (500 mcg/mL)

    CONTENTS:

    • Refill Instructions

    Drug Box:

    • One 20-mL Lioresal Intrathecal
      Ampule
    • Drug prescribing information

    Refill Kit*:

    • 20-mL syringe
    • Extension set with a clamp
    • Two 22-gauge noncoring needles
    • Template
    • 0.2-micron filter
    • Accessories

    Drug Preparation Kit*:

    • 20-mL syringe
    • Filter Straw ® tube
    • Accessories
    • Drug preparation instructions

    TOTAL VOLUME: 20 mL (One 20-mL Ampule)

    *The contents of these kits have been sterilized by ethylene oxide gas.

    Do not use if the seals or packages
    are damaged.
    Does not require refrigeration.
    Do not store above 86 °F (30 °C).
    Do not freeze.
    Do not heat sterilize.
    The device has no components
    made of natural rubber latex.

    GTIN (01)00000000000000

    Lot (10)0000000000

    EXP (17)YYYY-MM-DD

    SN (21)0000000000

    Rx only

    NOTE: Individual kits within this
    package may have a later use-by
    date than the one listed above.

    Lioresal Intrathecal number of billing units: 1

    Read and follow all enclosed instructions

    Saol Therapeutics Inc.
    Roswell, GA 30076

    PRINCIPAL DISPLAY PANEL - 10 mg/20 mL Outer Box Label
  • PRINCIPAL DISPLAY PANEL - 10 mg/5 mL Ampule Label

    Lioresal ® Intrathecal
    (baclofen injection)

    10 mg/5 mL
    (2000 mcg/mL)

    Sterile solution for intrathecal injection.
    Distributed by Saol Therapeutics Inc.,
    Roswell, GA 30076

    NDC: 70257-561-05
    68946 01
    LA56102

    LOT

    EXP

    PRINCIPAL DISPLAY PANEL - 10 mg/5 mL Ampule Label
  • PRINCIPAL DISPLAY PANEL - 10 mg/5 mL Outer Box Label

    SAOL
    NDC 70257-561 -02

    LIORESAL ® INTRATHECAL
    (baclofen injection) Refill Kit

    For use with SynchroMed ® Infusion Systems

    8562

    10 mg/5 mL
    (2000 mcg/mL)

    CONTENTS:

    • Refill Instructions

    Drug Box:

    • Two 5-mL Lioresal Intrathecal
      Ampules
    • Drug prescribing information

    Refill Kit*:

    • 20-mL syringe
    • Extension set with a clamp
    • Two 22-gauge noncoring needles
    • Template
    • 0.2-micron filter
    • Accessories

    Drug Preparation Kit*:

    • 20-mL syringe
    • Filter Straw ® tube
    • Accessories
    • Drug preparation instructions

    TOTAL VOLUME: 10 mL (Two 5-mL Ampules)

    *The contents of these kits have been sterilized by ethylene oxide gas.

    Do not use if the seals or packages
    are damaged.
    Does not require refrigeration.
    Do not store above 86 °F (30 °C).
    Do not freeze.
    Do not heat sterilize.
    The device has no components
    made of natural rubber latex.

    GTIN (01)00000000000000

    Lot (10)0000000000

    EXP (17)YYYY-MM-DD

    SN (21)0000000000

    Rx only

    NOTE: Individual kits within this
    package may have a later use-by
    date than the one listed above.

    Lioresal Intrathecal number of billing units: 2

    Read and follow all enclosed instructions

    Saol Therapeutics Inc.
    Roswell, GA 30076

    PRINCIPAL DISPLAY PANEL - 10 mg/5 mL Outer Box Label
  • PRINCIPAL DISPLAY PANEL - 40 mg/20 mL Ampule Label

    Lioresal ® Intrathecal
    (baclofen injection)

    40 mg/20 mL
    (2000 mcg/mL)

    Sterile solution for intrathecal injection.
    Distributed by Saol Therapeutics Inc.,
    Roswell, GA 30076

    NDC: 70257-563-20
    68948 01
    LA56302

    LOT

    EXP

    PRINCIPAL DISPLAY PANEL - 40 mg/20 mL Ampule Label
  • PRINCIPAL DISPLAY PANEL - 40 mg/20 mL Outer Box Label

    SAOL
    NDC 70257-563 -01

    LIORESAL ® INTRATHECAL
    (baclofen injection) Refill Kit

    For use with SynchroMed ® Infusion Systems

    8564

    40 mg/20 mL
    (2000 mcg/mL)

    CONTENTS:

    • Refill Instructions

    Drug Box:

    • One 20-mL Lioresal Intrathecal
      Ampule
    • Drug prescribing information

    Refill Kit*:

    • 20-mL syringe
    • Extension set with a clamp
    • Two 22-gauge noncoring needles
    • Template
    • 0.2-micron filter
    • Accessories

    Drug Preparation Kit*:

    • 20-mL syringe
    • Filter Straw ® tube
    • Accessories
    • Drug preparation instructions

    TOTAL VOLUME: 20 mL (One 20-mL Ampule)

    *The contents of these kits have been sterilized by ethylene oxide gas.

    Do not use if the seals or packages
    are damaged.
    Does not require refrigeration.
    Do not store above 86 °F (30 °C).
    Do not freeze.
    Do not heat sterilize.
    The device has no components
    made of natural rubber latex.

    GTIN (01)00000000000000

    Lot (10)0000000000

    EXP (17)YYYY-MM-DD

    SN (21)0000000000

    Rx only

    NOTE: Individual kits within this
    package may have a later use-by
    date than the one listed above.

    Lioresal Intrathecal number of billing units: 4

    Read and follow all enclosed instructions

    Saol Therapeutics Inc.
    Roswell, GA 30076

    PRINCIPAL DISPLAY PANEL - 40 mg/20 mL Outer Box Label
  • PRINCIPAL DISPLAY PANEL - 10 mg/20 mL Outer Box Label

    SAOL
    NDC 70257-560 -02

    LIORESAL ® INTRATHECAL
    (baclofen injection) Refill Kit

    For use with SynchroMed ® Infusion Systems

    8565

    10 mg/20 mL
    (500 mcg/mL)

    CONTENTS:

    • Refill Instructions

    Drug Box:

    • Two 20-mL Lioresal Intrathecal
      Ampules
    • Drug prescribing information

    Refill Kit*:

    • 20-mL syringe
    • Extension set with a clamp
    • Two 22-gauge noncoring needles
    • Template
    • 0.2-micron filter
    • Accessories

    Drug Preparation Kit*:

    • Two 20-mL syringes
    • Two Filter Straw ® tubes
    • Accessories
    • Drug preparation instructions

    TOTAL VOLUME: 40 mL (Two 20-mL Ampules)

    *The contents of these kits have been sterilized by ethylene oxide gas.

    Do not use if the seals or packages are damaged.
    Does not require refrigeration.
    Do not store above 86 °F (30 °C).
    Do not freeze.
    Do not heat sterilize.
    The device has no components made of natural rubber latex.

    GTIN (01)00000000000000

    Lot (10)0000000000

    EXP (17)YYYY-MM-DD

    SN (21)0000000000

    Rx only

    NOTE: Individual kits within this
    package may have a later use-by
    date than the one listed above.

    Lioresal Intrathecal number of billing units: 2

    Read and follow all enclosed instructions

    Saol Therapeutics Inc.
    Roswell, GA 30076

    image description
  • PRINCIPAL DISPLAY PANEL - 40 mg/20 mL Outer Box Label

    SAOL
    NDC 70257-563 -02

    LIORESAL ® INTRATHECAL
    (baclofen injection) Refill Kit

    For use with SynchroMed ® Infusion Systems

    8566

    40 mg/20 mL
    (2000 mcg/mL)

    CONTENTS:

    • Refill Instructions

    Drug Box:

    • Two 20-mL Lioresal Intrathecal
      Ampules
    • Drug prescribing information

    Refill Kit*:

    • 20-mL syringe
    • Extension set with a clamp
    • Two 22-gauge noncoring needles
    • Template
    • 0.2-micron filter
    • Accessories

    Drug Preparation Kit*:

    • Two 20-mL syringes
    • Two Filter Straw ® tubes
    • Accessories
    • Drug preparation instructions

    TOTAL VOLUME: 40 mL (Two 20-mL Ampules)

    *The contents of these kits have been sterilized by ethylene oxide gas.

    Do not use if the seals or packages are damaged.
    Does not require refrigeration.
    Do not store above 86 °F (30 °C).
    Do not freeze.
    Do not heat sterilize.
    The device has no components made of natural rubber latex.

    GTIN (01)00000000000000

    Lot (10)0000000000

    EXP (17)YYYY-MM-DD

    SN (21)0000000000

    Rx only

    NOTE: Individual kits within this
    package may have a later use-by
    date than the one listed above.

    Lioresal Intrathecal number of billing units: 8

    Read and follow all enclosed instructions

    Saol Therapeutics Inc.
    Roswell, GA 30076

    image description
  • PRINCIPAL DISPLAY PANEL - 0.05 mg/1 mL Ampule Label

    Lioresal ® Intrathecal
    (baclofen injection)

    0.05 mg/1 mL
    (50 mcg/mL)

    Sterile solution for
    intrathecal injection.

    NDC: 70257-562-11

    Distributed by Saol
    Therapeutics Inc.,
    Roswell, GA 30076

    68945 01
    LA56202

    LOT

    EXP

    Rx only

    PRINCIPAL DISPLAY PANEL - 0.05 mg/1 mL Ampule Label
  • PRINCIPAL DISPLAY PANEL - 0.05 mg/1 mL Ampule Box Label

    Distributed by Saol Therapeutics Inc., Roswell, GA 30076

    SAOL

    8563s
    NDC 70257- 562 -55

    contains five x 1 mL ampules

    Lioresal ® Intrathecal
    (baclofen injection)

    0.05 mg/1 mL
    (50 mcg/mL)

    Sterile solution for intrathecal injection only.

    NDC: 70257-562-55

    LOT
    EXP MM/YYYY

    PRINCIPAL DISPLAY PANEL - 0.05 mg/1 mL Ampule Box Label

    PRINCIPAL DISPLAY PANEL - NDC: 70257-561-05 - Drug box

    Drug box



    PRINCIPAL DISPLAY PANEL - NDC: 70257-560-20 - Drug box

    Drug box



    PRINCIPAL DISPLAY PANEL - NDC: 70257-563-20 - Drug box

    Drug box



  • INGREDIENTS AND APPEARANCE
    LIORESAL (BACLOFEN) 
    baclofen injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70257-560
    Route of AdministrationINTRATHECAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    baclofen (UNII: H789N3FKE8) (baclofen - UNII:H789N3FKE8) baclofen10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70257-560-011 in 1 BOX07/05/2017
    1NDC: 70257-560-2020 mL in 1 AMPULE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    2NDC: 70257-560-022 in 1 BOX07/05/2017
    2NDC: 70257-560-2020 mL in 1 AMPULE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007507/05/2017
    LIORESAL (BACLOFEN) 
    baclofen injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70257-561
    Route of AdministrationINTRATHECAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    baclofen (UNII: H789N3FKE8) (baclofen - UNII:H789N3FKE8) baclofen10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70257-561-022 in 1 BOX07/05/2017
    1NDC: 70257-561-055 mL in 1 AMPULE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007507/05/2017
    LIORESAL (BACLOFEN) 
    baclofen injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70257-563
    Route of AdministrationINTRATHECAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    baclofen (UNII: H789N3FKE8) (baclofen - UNII:H789N3FKE8) baclofen40 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70257-563-011 in 1 BOX07/05/2017
    1NDC: 70257-563-2020 mL in 1 AMPULE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    2NDC: 70257-563-022 in 1 BOX07/05/2017
    2NDC: 70257-563-2020 mL in 1 AMPULE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007507/05/2017
    LIORESAL (BACLOFEN) 
    baclofen injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70257-562
    Route of AdministrationINTRATHECAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    baclofen (UNII: H789N3FKE8) (baclofen - UNII:H789N3FKE8) baclofen0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70257-562-555 in 1 BOX07/05/2017
    1NDC: 70257-562-111 mL in 1 AMPULE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007507/05/2017
    Labeler - Saol Therapeutics Inc. (080040201)

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