BUPIVACAINE AGUETTANT 5 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BUPIVACAINE AS HYDROCHLORIDE ANHYDROUS

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

N01BB01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BUPIVACAINE AS HYDROCHLORIDE ANHYDROUS 5 MG / 1 ML

Administration route:

PARACERVICAL, INTERCOSTAL, SACRAL, PUDENTAL, CAUDAL, EPIDURAL

Prescription type:

Required

Manufactured by:

DELPHARM TOURS, FRANCE

Therapeutic area:

BUPIVACAINE

Therapeutic indications:

Long acting local anaesthetic

Authorization date:

2022-05-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE
MEDICINAL
PRODUCT
Bupivacaine Aguettant 5 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains
Bupivacaine hydrochloride
monohydrate......................................................................
5.28 mg
Quantity equivalent to anhydrous bupivacaine
hydrochloride....................................... 5.00 mg
Each 20 ml vial contains 100 mg of bupivacaine (as hydrochloride
anhydrous).
Excipient(s) with known effect: Sodium
For the full list of excipients, see section 6.1.
Each ml of solution for injection contains 3.15 mg equivalent to 0.14
mmol of sodium. Each 20
ml vial contains 63 mg equivalent to 2.7 mmol of sodium.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Long acting local anaesthetic.
4.2 Posology and method of administration
Bupivacaine Aguettant should only be used by physicians with
experience of regional
anaesthesia or under the supervision of such a physician. The lowest
possible dose for
adequate anaesthesia should be sought.
It is important to observe particular caution in order to prevent
inadvertent intravascular
injections. Thorough aspiration before and during injection of the
main dose is
recommended. The main dose should be injected slowly at 25-50
mg/minute or in divided
doses, while keeping continuous verbal contact with the patient and
monitoring the heart
rate. In epidural injection, the administration of high doses, a test
dose of 3-5 ml
bupivacaine with adrenaline is recommended. An inadvertent
intravascular injection can
cause symptoms such as a transient increase in heart rate and an
inadvertent intrathecal
injection can cause signs of spinal block. The injection should be
discontinued immediately
if there are any toxic symptoms.
The following doses are
guidelines; the dosage should be adjusted according to the scope
of the block and the patient's overall health status.
In _infiltration_ _anaesthesia_, administer Bupivacai