Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
Last Updated on eMC 22-Sep-2016 View document | Beacon Pharmaceuticals Contact details
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 22-Sep-2016 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 4.3 - 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC: 28-May-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
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 5.1 Pharmacodynamic properties
Change to Section 5.2 Pharmacokinetic properties
Change to Section 6.3 Shelf-life – Amend the shelf life from 2 to 3 years
Change to Section 6.6 Special Precautions for disposal
Change the product information (SPC and PIL) following the CHMP recommendations for referral under Article 31 of Directive 2001/83/EC resulting from Commission Implementing Decision (16/12/2004) for products containing active substance colistimethate sodium and colistin. Consequentially changes to SPC fragments 4.1, 4.2, 4.3, 4.4, 4.5, 5.1 and 5.2. Changes to the SPC (6.3 and 6.6) changes recommended by the CHMP pursuant 5(3) of Regulation (EC) No 726/2004 on polymyxin based products
Updated on 12-Dec-2014 and displayed until 22-Sep-2016
Reasons for adding or updating:
- Change to section 6.3 - Shelf life
Date of revision of text on the SPC: 17-Oct-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 6.3 - shelf life has increased from 2 to 3 years.Updated on 31-Mar-2011 and displayed until 12-Dec-2014
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- 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 10 date of revision of the text
Date of revision of text on the SPC: 22-Mar-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2 - section headings changedSection 4.5 - 'curariform muscle relaxants' replaced with 'Neuromuscular blocking drugs and ether'
Section 4.8 - 'curariform agents' replaced with 'Neuromuscular blocking drugs or other'
Section 10 - date of revison changed to 22/03/2011
Updated on 30-Jul-2010 and displayed until 31-Mar-2011
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): NO
Beacon Pharmaceuticals
85 High Street, Tunbridge Wells, TN1 1YG
0845 437 5567
0845 437 5565
+44 (0)1233 506 574
0800 220 280
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?
Active ingredients
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