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Mercury Pharma Group
No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK
Telephone: +44 (0)208 588 9100
Fax: +44 (0)208 686 0807
WWW: http://www.mercurypharma.com
Medical Information Direct Line: 08700 70 30 33
Medical Information e-mail: medicalinformation@mercurypharma.com
Customer Care direct line: +44 (0)208 588 9273
Medical Information Fax: +44 (0)208 686 0807

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 18/04/2012
SPC Bupivacaine Hydrochloride Injection BP 0.5% w/v, 10ml & 20ml

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 18/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   31-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section4.4: Warnings about use in the folliwing patients has been added:
-The elderly and patients in poor general condition.
- Patients with partial or complete heart block., patients in later stages of Pregnancy.

Warning about the use of certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used, especially relateed to the procedure has been added.
Updated on 01/12/2010 and displayed until 18/04/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   20-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4: clinicians should be trained appropriately has been added.
Administrsation of large volume of local anaesthetic may be required has been added.
New warnings on the use of this injectables has been added. Warnings on its use as a retrobulbar injection have been added.

Section 4.5: Interaction between Bupivacaine and anti-arrhythmic drugs has been added.

Section 4.6: A ststement on bupivacaine entering mother's milk has been added.

Section 4.7: A warning about bupivicaine impairing alertness and mental function and co-ordination has been added.

Section 4.8: Symptoms have been arranged according to SOc and frequency has been added.
New symptoms have been added.
Acute systemic toxicity, central nervous system toxicity and cardiovascular system toxicity has been added.

Section 4.9: Some data from overdosage has been removed from this section and has been added in section 4.8.

Section 5.1: ATC COde and some more properties have been added.

Section5.2: Statement on diminished clearance in neonates and volume of distribution , placental transfer has been added.

Section 5.3: Bupivacaine is a well established ingredients has been added.
Updated on 06/08/2009 and displayed until 01/12/2010
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  bupivacaine hydrochloride