LIDOCAINE B.BRAUN 2%

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

LIDOCAINE HYDROCHLORIDE MONOHYDRATE

Tilgængelig fra:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC-kode:

D04AB01

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

LIDOCAINE HYDROCHLORIDE MONOHYDRATE 20 MG/ML

Indgivelsesvej:

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

Recept type:

Required

Fremstillet af:

B.BRAUN MELSUNGEN AG, GERMANY

Terapeutisk område:

LIDOCAINE

Terapeutiske indikationer:

Local and regional anaesthesia.Severe symptomatic ventricular tachycardia or tachy-arrhythmia, if assessed to be life-threatening.

Autorisation dato:

2021-05-31

Indlægsseddel

This leaflet format has been determined by the Ministry of Health and
the content thereof has been
checked and approved
in June 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Lidocaine B. Braun 2%
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine B. Braun is a sterile, nonpyrogenic solution of lidocaine
hydrochloride in water for injection for
parenteral administration with characteristics as follows:
Each mL contains: Lidocaine HCl 20 mg; Sodium Chloride 7.1mg/5.3 mg;
Water for Injection q.s. Sodium
hydroxide may have been added for pH adjustment
Lidocaine is a local anesthetic of the amide type.
Lidocaine B. Braun is chemically designated
2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohy-
drochloride monohydrate, a white powder freely soluble in water. The
molecular weight is 288.82. It has the
following structural formula:
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless aqueous solution
The pH is 6.5 (5.0 to 7.0)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local and regional anaesthesia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Local and regional anaesthesia _
In order to guard against systemic toxicity, the lowest effective
concentration and lowest effective dose
should be used at all times.
These recommended doses serve only as a guide to the amount of
anesthetic required for most routine pro-
cedures. The actual volumes and concentrations to be used depend on a
number of factors such as type and
extent of surgical procedure, depth of anesthesia and degree of
muscular relaxation required, duration of
anesthesia required, and the physical condition of the patient. In all
cases the lowest concentration and
smallest dose that will produce the desired result should be given.
The onset of anesthesia, the duration of anesthesia and the degree of
muscular relaxation are proportional to
the volume and concentration (i.e., total dose) of local anesthetic
used. Thus, an increase in volume and
concentration of Lidocaine H

Produktets egenskaber

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lidocaine B.Braun 2%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the solution for injection contains 20mg Lidocaine
Hydrochloride Monohydrate (2% w/v)
Accordingly, the contents per ampoule are as follows:
•
One ampoule of 5ml contains 100mg of Lidocaine Hydrochloride
Monohydrate
•
One ampoule of 10ml contains 200mg of Lidocaine Hydrochloride
Monohydrate
•
One ampoule of 20ml contains 400mg of Lidocaine Hydrochloride
Monohydrate
Excipients with known effect:
Sodium (as sodium chloride and sodium hydroxide) 95 micromol/ml
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless aqueous solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local and regional anaesthesia
Severe symptomatic ventricular tachycardia or tachy-arrhythmia, if
assessed to be life-threatening.
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.
_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
40
0.5
50-100
0.25
*1.5 ml per segment in average
For prolongation of anaesthesia lidocaine may be combined with a
vasoconstricto