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Gerard Laboratories

Gerard Laboratories
Unit 36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13,
Telephone: +353 1 832 2250
Fax: +353 1 466 1912
Medical Information Direct Line: +353 1800 272 272
Medical Information e-mail: sales@gerard-laboratories.ie
Summary of Product Characteristics last updated on medicines.ie: 21/07/2011
SPC Germentin 500/125mg Film-Coated Tablets

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

Updated on 21/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

4.2             Posology and Method of Administration

Children may be treated with Amoxicillin/Clavulanic Acid tablets, suspensions. Children aged 6 years and below should preferably be treated with Amoxicillin/Clavulanic Acid suspension.

No clinical data are available on doses of Amoxicillin/Clavulanic Acid 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.



Children < 40 kg

CrCl: 10-30 ml/min

15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily).

CrCl < 10 ml /min

15 mg/3.75 mg/kg as a single daily dose (maximum 500 mg/125 mg).

Haemodialysis

15 mg/3.75 mg/kg per day once daily. Prior to haemodialysis 15 mg/3.75 mg/kg. In order to restore circulating drug levels, 15 mg/3.75 mg per kg should be administered after haemodialysis.

Updated on 10/04/2008 and displayed until 21/07/2011
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 4.3 - Contraindications
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 Following approval of variation (MR 023) sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1 & 5.3 are updated
Updated on 28/08/2007 and displayed until 10/04/2008
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Improved electronic presentation
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 To submit am improved electronic presentation and include revised storage conditions from renewal
Updated on 20/09/2006 and displayed until 28/08/2007
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   04/2004
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 
 
The SPC has been updated to incorporate the change of shelf life from 2years to 3 years.  
Updated on 19/08/2003 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Updated on 18/08/2003 and displayed until 19/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Amoxicillin trihydrate
   Potassium clavulanate

Versions

 
21/07/2011 to Current
10/04/2008 to 21/07/2011
28/08/2007 to 10/04/2008
20/09/2006 to 28/08/2007
19/08/2003 to 20/09/2006
18/08/2003 to 19/08/2003
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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