Drug Information for LioresalIntrathecal (Medtronic Neuromodulation): HOW SUPPLIED

LIORESAL INTRATHECAL (baclofen injection) is available in single use ampules of 10 mg/20 ml (500 mcg/ ml) or 10 mg/ 5 ml (2000 mcg/ml) or 40 mg/20 ml (2000 mcg/ml) packaged in a Refill Kit for intrathecal administration. For screening, LIORESAL INTRATHECAL is available in a single use ampule of 0.05 mg/ 1 ml.

Model 8561 LIORESAL INTRATHECAL Refill Kit contains one ampule of 10 mg/ 20 ml (500 mcg/ml) (NDC 58281-560-01).

Model 8562 LIORESAL INTRATHECAL Refill Kit contains two ampules of 10 mg/ 5 ml (2000 mcg/ml) (NDC 58281-561-02).

Model 8563s LIORESAL INTRATHECAL contains one ampule of 0.05 mg/ 1 ml (NDC 58281-562-01).

Model 8564 LIORESAL INTRATHECAL Refill Kit contains four ampules of 10 mg/ 5 ml (2000 mcg/ml) (NDC 58281-561-04) or one ampule of 40 mg/20 ml (2000 mcg/ml) (NDC 58281-563-01).

Model 8565 LIORESAL INTRATHECAL Refill Kit contains two ampules of 10 mg/ 20 ml (500 mcg/ml) (NDC 58281-560-02).

Model 8566 LIORESAL INTRATHECAL Refill Kit contains eight ampules of 10 mg/ 5 ml (2000 mcg/ml) (NDC 58281-561-08) or two ampules of 40 mg/20 ml (2000 mcg/ml) (NDC 58281-563-02).

Manufactured by Novartis Pharma Stein AG, Stein , Switzerland, for Medtronic, Inc., Minneapolis, Minnesota 55432- 5604 USA.

Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432- 5604 USAInternet: www.medtronic.com Tel. 763-505-5000Toll- free 1-800-328-0810 Fax 763-505-1000