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Myobloc

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Myobloc

Indications
Dosage
How Supplied

INDICATIONS

MYOBLOC (botulinum toxin type b) is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

DOSAGE AND ADMINISTRATION

The recommended initial dose of MYOBLOC (botulinum toxin type b) for patients with a prior history of tolerating botulinum toxin injections is 2,500 to 5,000 Units divided among affected muscles (see Clinical Studies). Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dose. Subsequent dosing should be optimized according to the patient's individual response. MYOBLOC (botulinum toxin type b) should be administered by physicians familiar and experienced in the assessment and management of patients with CD.

The method described for performing the potency assay is specific to Solstice Neurosciences' manufacture of MYOBLOC (botulinum toxin type b) . Due to differences in the specific details of this assay such as the vehicle, dilution scheme and laboratory protocols for various potency assays, Units of biological activity of MYOBLOC (botulinum toxin type b) cannot be compared to or converted into units of any other botulinum toxin or any toxin assessed with any other specific assay method. Therefore, differences in species' sensitivities to different botulinum neurotoxin serotypes preclude extrapolation of animal dose-activity relationships to human dose estimates.

The duration of effect in patients responding to MYOBLOC (botulinum toxin type b) treatment has been observed in studies to be between 12 and 16 weeks at doses of 5,000 Units or 10,000 Units (see Clinical Studies).

HOW SUPPLIED

MYOBLOC (botulinum toxin type b) is provided as a clear and colorless to light-yellow sterile injectable solution in single-use 3.5-mL glass vials. Each single-use vial of formulated MYOBLOC contains 5,000 Unitsa of botulinum toxin type B per milliliter in 0.05% human serum albumin, 0.01 M sodium succinate, 0.1 M sodium chloride at approximately pH 5.6.

MYOBLOC (botulinum toxin type b) is available in the following three presentations.

Dosage Strength Volume Per Vial Single-Vial Carton
2,500 Units 0.5 mL NDC 10454-710-10
5,000 Units 1 mL NDC 10454-711-10
10,000 Units 2 mL NDC 10454-712-10

Store under refrigeration at 2°- 8°C (36°- 46°F).

DO NOT FREEZE. DO NOT SHAKE.

Protect from light. No U.S. Standard of Potency.

Ready to use; no reconstitution required. The recommended storage condition for MYOBLOC (botulinum toxin type b) is refrigeration at 2°-8°C.

MYOBLOC (botulinum toxin type b) may be diluted with normal saline. Once diluted, the product must be used within 4 hours as the formulation does not contain a preservative.

All vials of expired MYOBLOC (botulinum toxin type b) and equipment used in the administration of MYOBLOC (botulinum toxin type b) should be carefully discarded according to standard medical waste practices.

Do not use after the expiration date stamped on the vial.

Discard unused portion. Single-use vial.

a See DOSAGE AND ADMINISTRATION

Manufactured By: Solstice Neurosciences, Inc., South San Francisco, CA 94080. Rev. 07/09

Last reviewed on RxList: 8/14/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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