CLOROTEKAL chloroprocaine hydrochloride injection solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

CHLOROPROCAINE HYDROCHLORIDE (UNII: LT7Z1YW11H) (CHLOROPROCAINE - UNII:5YVB0POT2H)

Inapatikana kutoka:

Sintetica SA

INN (Jina la Kimataifa):

CHLOROPROCAINE HYDROCHLORIDE

Tungo:

CHLOROPROCAINE HYDROCHLORIDE 10 mg in 1 mL

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

New Drug Application

Tabia za bidhaa

CLOROTEKAL- CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION
SINTETICA SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOROTEKAL® SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR CLOROTEKAL®.
CLOROTEKAL® (CHLOROPROCAINE HYDROCHLORIDE) INJECTION FOR INTRATHECAL
USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
CLOROTEKAL® is an ester local anesthetic indicated for intrathecal
injection in adults for the production of subarachnoid
block (spinal anesthesia). ( 1)
DOSAGE AND ADMINISTRATION
CLOROTEKAL is intended for single-dose administration only. ( 2.1)
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). ( 2.3)
DOSAGE FORMS AND STRENGTHS
5 mL Type I clear glass ampoule contains 50 mg of chloroprocaine
hydrochloride (10 mg/mL) equivalent to 44.05 mg/5 mL
(8.81 mg/mL) chloroprocaine. ( 3)
CONTRAINDICATIONS
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 ( 4) ( 11)
General and specific contra-indications to spinal anesthesia
regardless of the local anesthetic used, should be taken into
account ( 4)
Intravenous regional anesthesia ( 4)
Serious problems with cardiac conduction ( 4)
Local infection at the site of proposed lumbar puncture ( 4)
Septicemia. ( 4)
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. ( 5.1) (
6) ( 10)
Cardiovascular System Reactions: hypotension and bradycardia. ( 5.2) (
6) ( 10)
Central Nervous System Reactions: paresthesia, loss of sensitivi