Country: Israel
Language: English
Source: Ministry of Health
LIDOCAINE HYDROCHLORIDE
RAFA LABORATORIES LTD
N01BB02
SOLUTION FOR INJECTION
LIDOCAINE HYDROCHLORIDE 10 MG/ML
I.M, EPIDURAL, S.C, INTRADERMAL, SUBMUCOSAL, SPINAL, PERINEURAL, I.V REGIONAL ANAESTHESIA
Required
RAFA LABORATORIES LTD, JERUSALEM
LIDOCAINE
LIDOCAINE
Local and regional anesthesia.
2021-11-30
Esracaine Injection 1% -DL-SPC-December 2023-02 Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Esracain Injection 1% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of Esracain Injection 1% contains 10 mg lidocaine hydrochloride (monohydrate). _Excipients with known effect:_ Sodium (as sodium chloride and sodium hydroxide): about 1.2 mmol (28 mg) sodium per 10 ml solution. See also section 4.4. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless aqueous solution in clear ampoules. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Local and regional anaesthesia. 4.2 Posology and method of administration Posology _Local and regional anaesthesia_ As a matter of principle the smallest possible dose that produces adequate anaesthesia should be administered. The dosage should be adjusted individually according to the particulars of each case. Adults: When injected into tissues with marked systemic absorption, without combination with a vasoconstrictor, a single dose of lidocaine hydrochloride monohydrate should not exceed 4.5 mg/kg body weight (BW) (or 300 mg). If combined with a vasoconstrictor, 7 mg/kg BW (or 500 mg) of lidocaine hydrochloride monohydrate per single dose should not be exceeded. For the clinical uses listed below, recommendations for single doses and strengths of the injection solution to be administered to adults with average body weight (70 kg) are as follows: Type of anaesthesia Concentration [%] Usual volume [ml] Maximum dose [mg] Infiltration 0.5-1 300 500 (with epinephrine) Major nerve blocks 1-2 30-50 500 (with epinephrine) Minor nerve blocks 1 5-20 200 Epidural 1-2 15-30* 500 (with epinephrine) Spinal 1.5 or 5 in 7.5% glucose 1-2 100 Intravenous regional anaesthesia (IVRA) -upper limb -lower limb 0.5 0.25 40 50-100 *1.5 ml per segment in average For prolongation of anaesthesia lidocaine may be combined with a vasoconstrictor, e.g. epinephrine. Addition of epinephrine at a concentration of 1:100 000 to 1:200 00 Read the complete document