ESRACAIN INJECTION 1%

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LIDOCAINE HYDROCHLORIDE

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

N01BB02

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

LIDOCAINE HYDROCHLORIDE 10 MG/ML

طريقة التعاطي:

I.M, EPIDURAL, S.C, INTRADERMAL, SUBMUCOSAL, SPINAL, PERINEURAL, I.V REGIONAL ANAESTHESIA

نوع الوصفة الطبية :

Required

المصنعة من قبل:

RAFA LABORATORIES LTD, JERUSALEM

المجموعة العلاجية:

LIDOCAINE

المجال العلاجي:

LIDOCAINE

الخصائص العلاجية:

Local and regional anesthesia.

تاريخ الترخيص:

2021-11-30

خصائص المنتج

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