B. Braun Will Launch its First Spinal Anesthetic at ASRA

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BETHLEHEM, Pa., April 16, 2018 (GLOBE NEWSWIRE) -- B. Braun Medical Inc. will introduce its first FDA-approved local anesthetic for spinal anesthesia -- Clorotekal(chloroprocaine hydrochloride) -- at the American Society of Regional Anesthesia (ASRA) and Acute Pain Medicine’s 43 annual conference from April 19-21 in New York City. B. Braun also will showcase, XperiusUltrasound System and the Ultra 360family of nerve block needles.

“B. Braun continues to reimagine regional anesthesia by adding products to our robust regional anesthesia therapy portfolio that address post-operative pain and help reduce the use of opioids,” said Tom Sutton, Vice President, Medical Device and Pharmaceutical Systems at B. Braun.

Clorotekal (chloroprocaine hydrochloride) is indicated for intrathecal injection in adults for the production of subarachroid block (spinal anesthesia). Indicated procedures include those suitable for Clorotekal’s short duration of action. Clorotekal will be available in 50mg/5ml glass ampules in the third quarter. Please see prescribing information attached.

Sintetica SA, will offer an educational presentation at ASRA on Saturday, April 21 titled “Fast Track Spinal Anesthesia: A New Kid in Town.” The presentation will be made by Professor Narinder Rawal, M.D., PhD., Timo Palas, M.D., Benjamin Fox, M.D., and Arthur Atchabahian, M.D. It will be held from noon to 1 p.m. in the Broadway Ballroom North at the Marriott Marquis. B. Braun will provide lunch during the presentation. Pre-registration is not required.

In booth #201 at ASRA, B. Braun will also feature its various regional anesthesia solutions, including:

Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit .

INDICATIONS AND USAGECLOROTEKAL® (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•  CLOROTEKAL® is contraindicated in patients with a 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•  Septicemia

WARNINGS AND PRECAUTIONSLocal anesthetics should only be administered by clinicians who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only 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 . Delay in proper management of dose-related toxicity, underventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and, possibly, death.The clinician should take the appropriate measures to avoid an intravascular injection. In addition, it is essential for the clinician to know how to recognize and treat undesirable effects, systemic toxicity and other complications. If signs of acute systemic toxicity or total spinal block are observed, the injection of the local anesthetic must be stopped immediately .

OVERDOSAGEAcute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use or to underventilation secondary to upward extension of spinal anesthesia. Hypotension is commonly encountered during the conduct of spinal anesthesia due to relaxation of sympathetic tone, and sometimes, contributory mechanical obstruction of venous return .In the case of accidental intravenous administration, the toxic effect occurs within 1 minute. In mice, the intravenous LD50 of chloroprocaine HCl is 97 mg/kg and the subcutaneous LD50 of chloroprocaine HCl is 950 mg/kg. the first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, administration of CLOROTEKAL® must be stopped and oxygen should be administered .The first step in the management of convulsions, as well as underventilation or apnea, consists of immediate attention to the maintenance of a patient airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate or a benzodiazepine may be administered intravenously; the clinician should be familiar, prior to the use of anesthetics, with appropriate anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Recovery has been reported after prolonged resuscitative efforts. Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patient’s airway or if prolonged ventilatory support (assisted or controlled) is indicated.

DESCRIPTIONCLOROTEKAL® is a sterile non pyrogenic local anesthetic.1 mL of solution for injection contains 10 mg of chloroprocaine hydrochloride, equivalent to 44.05 mg/5 mL (8.81 mg/mL) chloroprocaine. It also contains the following inactive ingredients: hydrochloric acid 1N (for pH adjustment), sodium chloride, water for injection.

Rx onlyClorotekal is a registered trademark of Sintetica S.A.

Manufactured for:Bethlehem, PA 18018-3524 USA1-800-227-2862

Made in Switzerland

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Globe Newswire: 20:55 GMT Monday 16th April 2018

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