Bupivacaine Hydrochloride Infusion Solution BP 0.1% w/v (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Mercury Pharma Group |
|---|---|
| Διεύθυνση | No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK |
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Name of the medicinal product
Bupivacaine Hydrochloride 0.1%w/v Solution for Infusion.
Qualitative and quantitative composition
Each 100ml contains anhydrous bupivacaine hydrochloride 0.10g equivalent to 0.1055g of bupivacaine hydrochloride. For excipients, see 6.1
Pharmaceutical form
Solution for Infusion.
Therapeutic indications
Bupivacaine Hydrochloride Infusion Solution 0.1% w/v may be used: for continuous infusion lumbar epidural analgesia to relieve pain during labour for continuous infusion epidural analgesia to control postoperative ...
Posology and method of administration
Route of Administration: Epidural infusion. Bupivacaine Hydrochloride Infusion Solution should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia. Every precaution ...
Contraindications
Bupivacaine hydrochloride solutions are contra-indicated in patients with a known hypersensitivity to local anaesthetic agents of the amide group or to other components of the infusion formulation. Solutions ...
Special warnings and precautions for use
There have been reports of cardiac arrest during the use of bupivacaine for epidural anaesthesia or peripheral nerve blockade where resuscitative efforts have been difficult, and were required to be prolonged ...
Interaction with other medicinal products and other forms of interaction
Bupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, e.g. certain anti-arrhythmics, such as lidocaine ...
Pregnancy and lactation
There is no evidence of untoward effects in human pregnancy. In large doses there is evidence of decreased pup survival in rats and an embryological effect in rabbits if bupivacaine is administered in ...
Effects on ability to drive and use machines
In general, it is sufficient to allow 2 4 hours post nerve block or until full functions have returned following regional nerve block. In many situations, patients receive a sedative or other CNS (central ...
Undesirable effects
Accidental sub-arachnoid injection can lead to very high spinal anaesthesia possibly with apnoea and severe hypotension. The adverse reaction profile for Bupivacaine hydrochloride is similar to those for ...
Overdose
Accidental intravascular injections of local anaesthetics may cause immediate (within seconds to a few minutes) systemic toxic reactions. In the event of overdose, systemic toxicity appears later (15-60 ...
Pharmacodynamic properties
Pharmacotherapeutic Group (ATC code): N01B B51 Bupivacaine Hydrochloride is a long acting local anaesthetic of the amide type. It prevents the generation and conduction of the nerve impulse by decreasing ...
Pharmacokinetic properties
Like other local anaesthetics, the rate of systemic absorption of bupivacaine is dependent upon the total dose and concentration administered, the route of administration and the vascularity of the tissue ...
Preclinical safety data
No further relevant information other than that which is included in other parts of the Summary of Product Characteristics.
List of excipients
Sodium Chloride Sodium Hydroxide Water for Injections
Incompatibilities
Bupivacaine Hydrochloride Infusion Solution 0.1% w/v should not be mixed with other drugs unless compatibility is known. The pH range is 4.0 to 6.5. The solution must not be stored in contact with metal ...
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
100ml or 250ml polypropylene infusion bags in packs of 10, 20 or 50.
Special precautions for disposal and other handling
The infusion is for single patient use and should be used immediately after opening. Any unused portion should be discarded. Bupivacaine Hydrochloride Infusion Solution has been demonstrated to be compatible ...
Marketing authorization holder
Antigen International Limited Roscrea Co. Tipperary Ireland
Marketing authorization number(s)
PL 02848/0197
Date of first authorization / renewal of the authorization
09/03/2000 / 29/09/2005
Date of revision of the text
25/05/2012