Baclofen products: information for supporting intrathecal risk assessment

John Minshull, Deputy Director, London Medicines Information Service, Specialist Pharmacy ServicePublished

Baclofen products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Licensed for intrathecal use

Products licensed for intrathecal use are the first line option and should be used wherever suitable.

Aguettant

Strength

0.05mg/mL in 1mL ampoule
0.5mg/mL in 20mL ampoule
2mg/mL in 5mL ampoule
2mg/mL in 20mL ampoule

Novartis (Lioresal®)

Strength

0.05mg/mL in 1mL ampoule
0.5mg/mL in 20mL ampoule
1mg/mL in 5mL ampoule

Piramal Critical Care (Gablofen®)

Strength

0.05mg/mL in 1mL pre-filled syringe
0.5mg/mL in 20mL ampoule
0.5mg/mL in 20mL pre-filled syringe
1mg/mL in 20mL pre-filled syringe
1mg/mL in 20mL via
2mg/mL in 20mL pre-filled syringe
2mg/mL in 20mL vial

Sun Pharmaceutical Industries

Strength

0.05mg/mL in 1mL ampoule
0.5mg/mL in 20mL ampoule
2mg/mL in 5mL ampoule

Unlicensed ‘Special’, specified for intrathecal use

Unlicensed medicines that are manufactured in MHRA-licensed Specials Manufacturing Units, at the request of an authorised healthcare professional specifically for intrathecal use.

Royal Hospitals, Belfast – Victoria Pharmaceuticals

Baclofen intrathecal injection in sodium chloride 0.9%

Strength

1mg/mL in 12mL vial
2mg/mL in 12mL vial
3mg/mL in 12mL vial

Stepping Hill Hospital – Stockport Pharmaceuticals

Baclofen intrathecal injection in sodium chloride 0.9%

Strength

3mg/mL in 5mL amps

All our intrathecal product resources

Understand what to consider when giving medicines via the intrathecal route and use our material to help inform your risk assessment

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Baclofen products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
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