Reasons for adding or updating:

• Correction of spelling/typing errors

Date of revision of text on the SPC: 03-Feb-2016

Legal Category:POM

Black Triangle (CHM): NO

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 6.5 - Nature and contents of container
• Change to section 6.6 - Special precautions for disposal and other handling
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 03-Feb-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 5.1, 5.2, 6.3, 6.5 and 6.6 of the SmPC in line with Union referral procedure EMEA/H/A-5(3)/1384 Article 31 of Directive 2001/83/EC for medicinal products for human use which contain the active substance colistimethate sodium and colistin and in line with Union referral procedure EMEA/H/A-5(3)/1384 - Article 5(3) of Regulation EC (No) 726/2004 for Polymyxin-based products.

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects
• Change to section 7 - Marketing authorisation holder
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Jun-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Information added to Section 4.8:

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard).

Address of MAH updated in section 7:

Forest Laboratories UK Limited
Whiddon Valley

Barnstaple

North Devon

EX32 8NS

United Kingdom

Date of revision of the text updated in section 10:

June 2015

Reasons for adding or updating:

• Change to section 6. 4 - Special Precautions for Storage
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Aug-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



addtional inforamtion included in section 6.4:

Keep the vials in the outer carton in order to protect from light.

Reasons for adding or updating:

• Change to section 7 - Marketing Authorisation Holder
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Dec-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - Marketing Authorisation Holder needs to be amended to the new address, so that it shoudl read as follows;

Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent DA2 6SL
UK

section 10 Date of revision of the text shoudl be updated to read as follows;

December 2009

Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 3 - Pharmaceutical form
• Change to section 6. 5 - Nature and Contents of Container
• Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
• Change to section 9 - Date of first Authorisation/renewal of the Authorisation
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 24-Jul-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Colomycin Injection 500,000 IU/vial has been discontinued and therefore information regarding this strength has been removed from sections 2, 3, 6.5, 8 and 9.  Section 10 has been updated to show 'July 2009'.

The Colomycin Injection 1 million and 2 million IU/vial strengths remain.

Reasons for adding or updating:

• Change to section 6. 4 - Special Precautions for Storage
• Change to section 6. 5 - Nature and Contents of Container
• Change to section 9 - Date of first Authorisation/renewal of the Authorisation
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 07-Nov-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.4

The sentence 'For storage of solutions following reconstitution refer to 6.3' has been added.

Section 6.5

From:    Type 1 glass vials in outer cartons of 10.

To:        500,000 IU/vial:    Type 1 glass vial with a blue 'flip-off' cap supplied in cartons of ten vials.
            1 million IU/vial:    Type 1 glass vial with a red 'flip-off' cap supplied in cartons of ten vials.
            2 million IU/vial:    Type 1 glass vial with a lilac 'flip-off' cap supplied in cartons of ten vials.

Section 9

The date of renewal of the authorisation has been updated to November 2006.

Section 10

The date of revision of the text has been updated to November 2006.

Reasons for adding or updating:

• Change to section 1 - trade name
• Change to section 3 - pharmaceutical form
• Change to section 10 (date of (partial) revision of the text

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

'For infusion' has been added in the pharmaceutical form in sections 1 and 3.

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 4.8 - Undesirable Effects
• Change to section 5.1 - Pharmacodynamic Properties
• Change to section 5.2 - Pharmacokinetic Properties
• Change to section 5.3 - Preclinical Safety Data
• Change to section 6. 6 - Instruction for Use/Handling

Reasons for adding or updating:

• Addition of new strength

Reasons for adding or updating:

• Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

• Change to section 6. 3 - Shelf Life
• Change to section 6. 4 - Special Precautions for Storage

Reasons for adding or updating:

• Improved Electronic Presentation

Reasons for adding or updating:

• Change to section 4.2 - Posology and Method of Administration

Reasons for adding or updating:

• Addition of Legal Category

Reasons for adding or updating:

• Correction of spelling/typing errors

Reasons for adding or updating:

• No reasons supplied