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Winthrop Pharmaceuticals UK Ltd
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

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: 09/11/2010
SPC Gentamicin Paediatric 20mg/2ml Solution for Injection

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 09/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1, following wording added: Consideration should be given to official local guidance on the appropriate use of antibacterial agents.

 

Section 4.2: text changed to

 

The daily dose recommended in children (aged 1 year and above) and adolescents with normal renal function, is 3-6 mg/kg body weight per day as 1 (preferred) up to 2 single doses.

 

The daily dose in infants after the first month of life is 4.5-7.5 mg/kg body weight per day as 1 (preferred) up to 2 single doses.

 

The daily dose in newborns is 4-7 mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily dose in 1 single dose.

 

Section 4.4- re-formatted


section 10: revision date changed to 01/11/2010
Updated on 22/04/2010 and displayed until 09/11/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   10-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of ownership to Winthrop Pharmaceuticals
Updated on 24/09/2008 and displayed until 22/04/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   14-Nov-2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Completely updated version of SmPC including changes to sections 4.4, 4.5 and 4.8.
Updated on 30/08/2005 and displayed until 24/09/2008
Reasons for adding or updating:
  • Change from BAN to rINN
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 30/08/2005
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Updated on 29/09/2004 and displayed until 29/09/2004
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 03/06/2004 and displayed until 29/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/05/2004 and displayed until 03/06/2004
Reasons for adding or updating:
  • New SPC for new product
  • Pending awaiting re-submission

Active Ingredients/Generics

 
  gentamicin sulphate