País: Israel
Idioma: anglès
Font: Ministry of Health
BUPIVACAINE AS HYDROCHLORIDE ANHYDROUS
MBI PHARMA LTD., ISRAEL
N01BB01
SOLUTION FOR INJECTION
BUPIVACAINE AS HYDROCHLORIDE ANHYDROUS 5 MG / 1 ML
PARACERVICAL, INTERCOSTAL, SACRAL, PUDENTAL, CAUDAL, EPIDURAL
Required
DELPHARM TOURS, FRANCE
BUPIVACAINE
Long acting local anaesthetic
2022-05-25
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 Llegiu el document complet