Lidokain Aguettant 20 mg/ml Injektions-/infusionsvätska, lösning

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

lidokainhydrokloridmonohydrat

Available from:

Laboratoire Aguettant

ATC code:

N01BB02

INN (International Name):

lidokainhydrokloridmonohydrat

Dosage:

20 mg/ml

Pharmaceutical form:

Injektions-/infusionsvätska, lösning

Composition:

lidokainhydrokloridmonohydrat 21,33 mg Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Injektionsflaska, 1 x 50 ml; Injektionsflaska, 10 x 50 ml

Authorization status:

Godkänd

Authorization date:

2020-11-02

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lidokain Aguettant 20 mg/ml, solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection/infusion contains 20 mg of lidocaine
hydrochloride (equivalent to
21.33 mg of lidocaine hydrochloride monohydrate).
Each 50 ml vial of solution for injection/infusion contains 1000 mg of
lidocaine hydrochloride
(equivalent to 1066.5 mg of lidocaine hydrochloride monohydrate).
Excipients with known effect:
This medicinal product contains sodium.
Each ml of solution for injection contains 2.0 mg of sodium equivalent
to 0.09 mmol of sodium.
Each 50-ml vial contains 101 mg of sodium equivalent to 4.4 mmol of
sodium.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear colourless solution
pH: 5.0 to 7.0
Osmolality: 270-320 mOsm/Kg
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
is indicated in adult patients for use in infiltration
anaesthesia, intravenous regional
anaesthesia, nerve blocks and epidural anaesthesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
should only be used by, or under the supervision of,
doctors with experience of
regional anaesthesia and resuscitative skills. Facilities for
resuscitation should be available when
administering local anaesthetics.
Posology
The lowest possible dose producing the required effect should be
given.
The table may serve as a guide for adults having a body weight of
about 70 kilograms. The dose
should be adjusted according to age, weight and condition of the
patient.
2
Recommended doses of Lidocaine hydrochloride
Route of administration or
procedure
Concentration
(mg/ml)
Volume (ml)
Total dose (mg)
Infiltration anaesthesia:
Large procedures
20 mg/ml
5-10 ml
100-200 mg
Intravenous regional anaesthesia:
Arm
20 mg/ml
5-10 ml
100-200 mg
Leg
20 mg/ml
10 ml
200 mg
Nerve blocks
20 mg/ml
1-10 ml
20-200 mg
Epidural anaesthesia:
Lumbar analgesia
20 mg/ml
12.5-20 ml
250-400 mg
Thoracic ana