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Wockhardt UK Ltd
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

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: 16/09/2008
SPC Diazepam 5mg/ml Solution for Injection (Wockhardt UK Ltd)

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 16/09/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change of Marketing Authorisation Holder
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   23-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - name amended to include full pharamceutical form

Section 4.4 - % ethanol stipulated

Section 7 - 'CP Pharmaceuticals Ltd' amended to 'Wockhardt UK Ltd'

Section 8 - PL 04543/0179 amended to PL 29831/0065

Section 9 & 10 amended
Updated on 20/09/2006 and displayed until 16/09/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   13/04/04
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Addition of text "The dose can be repeated if necessary after 30 to 60 minutes" unders sub-headings 'In status epilepticus or epileptic convulsions' (adults & children)
 
Section 4.3 - Minor text amendments. Addition of  'severe hepatic insufficiency'. 'Myasthenia gravis' transferred to section 4.4.
 
Section 4.4 - Addition of text regarding the following - CNS effects of benzodiasepines on elderly and debilitated patients, amnesia and benzyl alcohol poisoning in infants and children.  Addition of sodium and ethanol warnings as per guidelines. 'Myasthenia gravis' transferred from section 4.3.
 
Section 4.5 - Section re-structured into sub-headings. Addition of text  under sub-headings 'Anaesthetics', 'Antidepressants', 'Antiepileptics', 'Antipsychotics' and 'Antivirals'.  Addition of 'Digoxin'.
 
Section 4.8 - Section re-structured into sub-headings. Removal of 'double vision', 'increased apetite', 'laryngeal spasm' and 'menstrual disturbances' (no longer substantiated/justified). Additon of text under sub-heading 'CNS', 'Neurological', 'Psychiatric' and 'Withdrawal Symptoms'. Addition of 'gynaecomastia'. 
 
Section 4.9 - Addition of text unders sub-heading 'Symptoms' regarding impairment of consciousness, respiratory depression and cardiac rate and rhythm (mild overdose), deep coma (severe overdose) and insomnia and major convulsions (as drug levels fall).  Addition of text under sub-heading 'Treatment' regarding the use of activated charcoal.
 
Updated on 15/01/2004 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/05/2003 and displayed until 15/01/2004
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 28/08/2001 and displayed until 20/05/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  diazepam