It's Time for Clorotekal®

Temporary importation of US-labelled Clorotekal (Chloroprocaine HCl, Inj USP 1%) to address a medical need in Canada

^{Indications: Clorotekal®* (chloroprocaine hydrochloride) is indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated procedures include those suitable for CLOROTEKAL’s short duration of action.}

^{Contraindications: Known hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anesthetics or to any of the excipients. General and specific contraindications to spinal anesthesia regardless of the local anesthetic used should be taken into account (e.g., decompensated cardiac insufficiency, hypovolemic shock, coagulopathy). Intravenous regional anesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area). Serious problems with cardiac conduction. Local infection at the site of proposed lumbar puncture and Septicemia.}

^{*Clorotekal is a registered trademark of Sintetica S.A. and is manufactured for B. Braun Medical Inc.} 

EXAMPLES OF SURGICAL PROCEDURES THAT MAY BE SUITABLE FOR CLOROTEKAL’S SHORT DURATION OF ACTION

Adverse drug reactions associated with the use of Clorotekal® should be reported to B. Braun Canada Ltd. at 1-800-227-2862 or to Health Canada at or by calling toll-free at 1-866-234-2345.

^{IMPORTANT SAFETY INFORMATION}

^{INDICATIONS AND USAGE}

^{CLOROTEKAL® (chloroprocaine hydrochloride) is a prescription drug indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated procedures include those suitable for Clorotekal’s short duration of action.}

^{CONTRAINDICATIONS}

^{Known hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anesthetics or to any of the excipients. General and specific contraindications to spinal anesthesia regardless of the local anesthetic used should be taken into account (e.g., decompensated cardiac insufficiency, hypovolemic shock, coagulopathy). Intravenous regional anesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area). Serious problems with cardiac conduction. Local infection at the site of proposed lumbar puncture and Septicemia.}

^{DOSAGE AND ADMINISTRATION}

^{CLOROTEKAL is intended for single-dose administration only. To obtain an effective block to the T 10 level with one single administration in an adult of average height and weight (approximately 70 kg), the recommended dose is 50 mg (5 mL).}

^{WARNINGS AND PRECAUTIONS}

^{Risks with Neuraxial Administration: Local anesthetics should only be administered after insuring the immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies. Cardiovascular System Reactions: hypotension and bradycardia. Central Nervous System Reactions: paresthesia, loss of sensitivity, motor weakness, paralysis, cauda equina syndrome and permanent neurological injury. Allergic Reactions: in patients with a known hypersensitivity to the active substance or to other formulation ingredients. Chondrolysis: in intra-articular infusions in arthroscopic and other surgical procedures.}

^{ADVERSE REACTIONS}

^{Adverse drug reactions associated with the use of Clorotekal® (chloroprocaine hydrochloride 10mg/mL) should be reported B. Braun Canada Ltd. at 1-800-227-2862 or Health Canada at 1-866-234-2345 or Health Canada.}

^{DRUG INTERACTIONS}

^{• Vasopressor and Ergot-Type Oxytocic Drugs: May cause severe, persistent hypertension or cerebrovascular accidents. Avoid concurrent administration.}

^{• Sulfonamide Drugs: Avoid use in any condition in which a sulfonamide drug is being employed.}

^{• Antiarrhythmics: No studies have been performed on interactions between chloroprocaine and class III antiarrhythmics (e.g. amiodarone).}

^{• Local Anesthetics: Avoid combination of various local anesthetics.}

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