Bupivacain-BP

Clorhidrat de bupivacaină

Each ml of solution for injection contains bupivacaine hydrochloride 5 mg. One ampoule (4 ml) contains 20 mg; one vial (10 ml) contains 50 mg; one vial (20 ml) contains 100 mg. Excipient with known effect: sodium 3.148 mg/ml.

Indication: Surgical anaesthesia in adults and children over 12 years of age; management of acute pain in adults and children over 1 year of age.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1.;
- hypersensitivity to amide-type local anaesthetics
- severe disorders of the cardiac conduction system
- cardiogenic or hypovolaemic shock
- significant coagulation disorders
- increased intracranial pressure
- severe headache caused by intracerebral haemorrhage
- infection of the skin at the injection site
- meningitis, poliomyelitis, spondylitis
- sepsis
- recent spinal trauma, spinal tuberculosis, spinal tumours
- spinal cord disorders caused by pernicious anaemia (Biermer's anaemia)
- obstetrical paracervical block.
This medicinal product is contraindicated for intravenous regional anaesthesia (Bier's block) because entry of bupivacaine into the systemic circulation may cause manifestations of systemic toxicity.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Cases of cardiac arrest or death have been reported during administration of bupivacaine into the epidural space or during peripheral nerve block. In some cases, resuscitation of patients was difficult or practically impossible despite correct and immediate intervention. Like other anaesthetics, bupivacaine can induce acute central and cardiovascular toxicity if the plasma concentration of the anaesthetic happens to increase as a result of a procedure, such as accidental intravascular administration or administration into heavily vascularised areas. In association with increased plasma concentrations of bupivacaine, the following have been reported: ventricular arrhythmia, fibrillation, sudden cardiac arrest and death. Regional anaesthesia procedures should always be carried out in departments equipped with appropriate personnel and equipment […]