Temporary importation of US-labelled Clorotekal (Chloroprocaine HCl, Inj USP 1%) to address a medical need in Canada
Clorotekal* is a preservative-free sterile non pyrogenic ester local anesthetic. The recommended dose is 50 mg/5 mL (10 mg/mL) intended for single-dose administration in an ampule. Doses above 50 mg have not been adequately tested for efficacy and safety.
Indications: 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.
Clorotekal may be used for: Indicated procedures include those suitable for Clorotekal’s short duration of action.
Main Ingredients: Clorotekal is 1% chloroprocaine hydrochloride.
Storage Conditions: Store at 20°C to 25°C (68° F to 77° F); excursions permitted between 15°C to 30°C (59°F to 86°F)
• Ampule should be visually inspected before use • Protect from light • Store in Carton • Do not refrigerate or freeze • Do not heat before use • Do not autoclave • The medicinal product has to be used immediately after first opening • Discard any unused portion in an appropriate manner
Shelf-life: 24 Months