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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com

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: 31/08/2011
SPC Beromun 1 mg

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 31/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • 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:   27-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 has been revised to include information relating to administration (previously given in section 6.6). Additionally the statement relating to paediatric patients has been updated

Section 4.4 has been updated to include a warning relating to latex

Section 4.6 includes a statement on fertility

Section 4.8 The side effect section has been updated and revised

Section 10 – has been revised to 27.7.2011
Updated on 21/04/2009 and displayed until 31/08/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • 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 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 7 - Marketing Authorisation Holder
  • 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:   25-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Several sections and headings of the SPC have been updated following renewal of the product, main changes include the following:

 

Section 1

Heading updated

 

Section 2

Heading updated and information reworded


Section 4.2

Additional information included

 

Section 4.3

Minor changes to the content

 

Section 4.4

Additional information included

 

Section 4.5

Section reworded

 

Section 4.6

Updated information

 

Section 4.8

Change to expression of frequency

 

Section 4.9

Minor changes to content

 

Section 5.1

Minor changes to content

 

Section 5.2

Minor changes to content

 

Section 5.3

Minor changes to content

 

Section 6.2

Minor changes to content

 

Section 6.4

Additional statement included

 

Section 6.5

Updated information

 

Section 6.6

Updated information

 

Section 9

Section reworded

 

Section 10

Date revised to 25/3/2009
Updated on 07/01/2009 and displayed until 21/04/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • 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:   17-Jun-2004
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1

Black triangle removed and 5 ml inserted into name

 

Section 2

Two sentences inserted:

“One ampoule solvent contains 5 ml 0.9% sodium chloride solution.”

“Tasonermin is produced by recombinant DNA technology in E. coli.”

 

Section 3

The following text deleted:

 

“containing a nominal quantity of 1 mg tasonermin.

The reconstituted solution is solely for single use in the isolated limb perfusion (ILP) setting.”

 

Section 4.2

information on reference in paragraph headed “Melphalan” extended

 

Section 4.4

Information on references in paragraph beginning 'In order to minimise the risk of leakage' extended.

 

Section 4.8

This section has been revised to make it clear of the frequencies of Undesirable effects.

 

Section 6.1

This section has been revised to present the excipients in a list instead of a paragraph format.

 

Section 6.4

Order of wording amended

 

Section 9

Updated to included date of last renewal

 

Section 10

Date of revision amended.
Updated on 29/04/2002 and displayed until 07/01/2009
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/07/2001 and displayed until 29/04/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
  • Removal of Black Triangle
Updated on 07/02/2000 and displayed until 18/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  tasonermin