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Almirall Limited

4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK
Telephone: +44 (0) 1256 698 037
Fax: +44 (0) 1256 698 237
WWW: http://www.almirall.com
Medical Information Direct Line: +44 (0)1748 828 795
Medical Information e-mail: almirall@professionalinformation.co.uk.
Medical Information Facsimile: +44 (0) 1748 828 801
Summary of Product Characteristics last updated on medicines.ie: 17/03/2011
SPC Meptid 100 mg/ml Solution for Injection

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 17/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.9 - Overdose
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
·         section 2 updated in line with QRD
·         section 3 for the injection updated to align with the description parameter as detailed in the finished product specification

  • section 4.3 updated to strengthen the safety statements already under sections 4.4 and 4.5 namely contraindicating use during an asthma attacks and for patients on MAOIs and for 14 days after stopping MAOIs
·        section 4.4 updated by deleting the cautionary statement regarding MAOIs as this is now under section 4.3
·        section 4.5 updated with minor rewording
·        section 4.8 updated by ranking undesirable events under headings of frequency using the following convention: very common (≥ 1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data).  This was purely a formatting request by the IMB; where within section 4.8, it was written that these were the "most commonly reported adverse reactions", these AEs were slotted under the tabular heading very common and those detailed as uncommon were slotted under the uncommon tabular heading under the relevant system organ class; "occassional reports" were re-classified as very rare reports.  
·        section 4.9 updated with minor rewording
section 7 updated with change of name of MAH from "Laboratorios Almirall SA" to Almirall SA
Updated on 30/06/2009 and displayed until 17/03/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

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

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Active Ingredients

 
  Meptazinol hydrochloride