BOTO Genie Vaccine

BOTULINUM TOXIN  TYPE A  FOR INJECTION Ph. Eur.

PURIFIED NEUROTOXIN COMPLEX

BOTO GENIE^®

BOTO GENIE^® (Botulinum toxin Type A) is produced from fermentation of Clostridium botulinum type A and purification of purified neurotoxin complex. It has unique pharmacological properties as a neuromuscular blocking agent by inhibiting the release of acetylcholine resulting in partial, local, flaccid muscle paralysis, which helps to reduce some of the abnormal muscle contractions. The action of BOTO GENIE^® is reversible and can sustain partial chemical denervation for 3 to 6 months. Recovery of impulse transmission occurs gradually as new nerve terminals develop. One unit is defined as the median lethal intraperitoneal dose in mice estimated relative to the reference preparation assayed in parallel. The units of BOTO GENIE^® are product specific and not applicable to other preparations, due to specific testing method such as vehicle dilution scheme, laboratory protocols and difference in species sensitivities. The specific activity of BOTO GENIE^® is approximately 20 units/nanogram of purified neurotoxin complex.

COMPOSITION

(A)     BOTO GENIE® 100 unit vial (Freeze dried)

          •     Botulinum toxin type A...........................100 unit

    Purified Neurotoxin complex

          •    Lactose (Stabilizer).....................................5 mg

(B)     BOTO GENIE® 50 unit vial (Freeze dried)

 •     Botulinum toxin type A...........................50 unit

    Purified Neurotoxin complex

                         ·          Lactose (Stabilizer)...................................5 mg

(C)     Diluent

          •    Sodium chloride injection I.P.