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SPC, UK: Bupivacaine Hydrochloride Infusion Solution BP 0.1% w/v (2012)

Αναφορές

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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Δωρεάν εγγραφή

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