Posology : מינונים

4.2 Posology and method of administration                                             muscles and/or nerves from injected local anaesthetic.
The extent of this tissue damage depends on the degree of trauma,
Bupivacaine Baxter 5 mg/ml should only be used by clinicians with                concentration of the local anaesthetic and how long the tissue has been experience of regional anaesthesia or under their supervision. The lowest        exposed to the local anaesthetic. For this reason, the lowest effective dose possible dose for adequate anaesthesia should be used.                           should be chosen. Accidental intravascular injections in the head and neck area can cause cerebral symptoms even at low doses.
In order to prevent inadvertent intravascular injections, it is important that   •    Paracervical block can sometimes cause bradycardia/tachycardia in great caution be exercised. Careful aspiration before and during the                  the foetus, and foetal heart rate should be carefully monitored.
injection of the total dose is recommended. The total dose must be injected slowly, 25-50 mg/min or in divided doses with continuous verbal contact          Caution should be exercised in patients with grade II or III AV block since being maintained with the patient and controls of heart rate. In epidural        local anaesthetic agents can decrease the conduction capacity of the injection of high doses, a test dose of 3-5 ml Marcaine adrenaline is            myocardium. The elderly and patients with severe hepatic disease, recommended. An inadvertent intravascular injection can cause e.g. a brief       severely impaired renal function, patients in late stages of pregnancy or increase in heart rate and inadvertent intrathecal injection can produce         whose general condition is impaired also require special attention.
signs of spinal block. If toxic symptoms occur, the injection must be discontinued immediately.                                                        Patients being treated with class III antiarrhythmic agents (e.g.
amiodarone) should be closely monitored and ECG monitoring considered The doses given below are guides, and the dosage should be adjusted              since the cardiac effects of bupivacaine and class III antiarrhythmic agents according to the extent of the block and the patient's general condition.        may be additive.

For infiltration anaesthesia Bupivacaine Baxter 5 mg/ml 5-30 ml (25-150 mg       Epidural anaesthesia may lead to hypotension and bradycardia. The risk of bupivacaine hydrochloride) should be given.                                      such effects can be reduced, e.g., by injecting a vasopressor. Hypotension should be treated promptly with a sympathomimetic intravenously,
For diagnostic and therapeutic blocks Bupivacaine Baxter 5 mg/ml 0.5-20          repeated as necessary.
ml (2.5-100 mg bupivacaine hydrochloride), for example for trigeminal block 0.5-2.5 ml (2.5-12.5 mg) and for stellatum block 5-10 ml (25-50 mg)        There have been post-marketing reports of chondrolysis in patients should be given.                                                                 receiving postoperative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved For intercostal block Bupivacaine Baxter 5 mg/ml 2-3 ml (10-15 mg                the shoulder joint. Due to multiple contributing factors and inconsistency in bupivacaine hydrochloride) per nerve up to a total of 10 nerves should be        the scientific literature regarding mechanism of action, causality has not given.                                                                           been established. Intra-articular continuous infusion is not an approved indication for Bupivacaine Baxter 5 mg/ml.
For larger blocks (for example epidural, sacral and brachial plexus              Paediatric population anaesthesia): Bupivacaine Baxter 5 mg/ml 15-30 ml (75-150 mg bupivacaine hydrochloride).                                                      The safety and efficacy of Bupivacaine Baxter 5 mg/ml in children aged < 1 year has not been established. Only limited data are available.
For obstetric anaesthesia (for example epidural anaesthesia and caudal anaesthesia for vaginal delivery and vacuum extraction) Bupivacaine              Use of bupivacaine for intra-articular block in children aged 1 to 12 years Baxter 5 mg/ml 6-10 ml (30-50 mg bupivacaine hydrochloride). The doses           has not been documented.
are initial doses, which if necessary may be repeated every two to three hours.                                                                           Use of bupivacaine for major nerve block in children aged 1 to 12 years has For epidural block (for caesarean section): Bupivacaine Baxter 5 mg/ml 15-       not been documented.
30 ml (75-150 mg bupivacaine hydrochloride).
For epidural anaesthesia, children should be administered gradually
For continuous epidural anaesthesia in the form of intermittent bolus doses,     increasing doses proportional to their age and weight, since thoracic initially Bupivacaine Baxter 5 mg/ml 10 ml (50 mg bupivacaine                    epidural anaesthesia in particular can result in severe hypotonia and hydrochloride) should be given, thereafter Bupivacaine Baxter 5 mg/ml 3-8        decreased respiratory function.
ml (15-40 mg bupivacaine hydrochloride) every 4-6 hours depending on the desired number of anaesthetised segments and the patient's age.                  4.5 Interaction with other medicinal products and other forms of interaction
For continuous epidural infusion (for example postoperative pain relief):        Bupivacaine should be used with caution with other local anaesthetic Concentration Volume          Dose                   agents or class IB antiarrhythmic agents as the systemic toxic effects are additive.
Lumbar epidural infusion:                                                        Specific interaction studies have not been performed with bupivacaine and Bolus1                       5 mg/ml     2.5-5 ml         12.5-25 mg             class III antiarrhythmic agents (e.g. amiodarone), but caution is Infusion                     5 mg/ml     2.5-3.75 ml/hour 12.5-18.75 mg²         recommended (see also section 4.4 Special warnings and precautions for Thoracic epidural                                                                use).
infusion:                                2.5-5 ml         12.5-25 mg
Bolus1                       5 mg/ml     1.25-2.5 ml/hour 6.25-12.5 mg           4.6 Fertility, pregnancy and lactation Infusion                     5 mg/ml                                             Pregnancy: Epidural infusion for                                                            Paracervical block increases the risk of reactions such as bradycardia/tachycardia in the foetus; therefore foetal heart rate must be vaginal delivery: closely monitored.
Bolus1                       5 mg/ml     3-5 ml              15-25 mg            See also section 5.2 Pharmacokinetic properties.
Infusion                     5 mg/ml     1-2.5 ml/hour       5-12.5 mg Breast-feeding:
1)   If an adequate bolus dose was not given in the previous hour.               Bupivacaine passes into breast milk, but the risk of an effect on the child   2)   The maximum recommended dose per day should not be exceeded                 seems unlikely at therapeutic doses.
(see below).
4.7 Effects on ability to drive and use machines
Account must be taken of the dose given intra-operatively.
Depending on the dose and method of administration, bupivacaine may
In cases of combination with an opioid the dose of bupivacaine may be            have a transient effect on mobility and coordination.
reduced.
•    Throughout the time that the infusion is being given patients must be       4.8 Undesirable effects observed at regular intervals with regard to blood pressure, heart rate     Side effects caused by the medicinal product itself can be difficult to and possible toxic symptoms. If signs of a toxic effect are observed the    distinguish from the physiological effects of the nerve blockade (e.g. fall in infusion must be stopped immediately.                                       blood pressure, bradycardia), events caused directly by the needle puncture (e.g. nerve damage) or caused indirectly by the needle puncture For children under 12 years the following dose is recommended:                   (e.g. epidural abscess).
Caudal block: Bupivacaine Baxter 5 mg/ml 0.25 ml/kg bodyweight up to 10          Neurological damage is a rare but well-known consequence of regional ml.                                                                              anaesthesia, particularly in epidural and spinal anaesthesia.
For information about symptoms and treatment of acute systemic toxicity, Maximum recommended doses                                                        see section 4.9 Overdose The maximum recommended dose on one and the same occasion is calculated on the basis of 2 mg/kg body weight, and for adults is a maximum       Organ system             Frequency                Symptom of 150 mg within a four-hour period.                                              Immune system            Rare (≥1/10,000, <       Allergic reactions, Bupivacaine Baxter 5 mg/ml: 30 ml (150 mg bupivacaine hydrochloride)              disorders                1/1,000)                 anaphylactic shock The maximum recommended dose during a 24-hour period is 400 mg. The               Nervous system           Common (≥ 1/100, <       Paraesthesia, dizziness total dose must be corrected on the basis of the patient's age, constitution      disorders                1/10) and other relevant circumstances.                                                                          Uncommon (≥ 1/1,000,     Symptoms of CNS < 1/100)                 toxicity (convulsions,