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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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: 02/06/2010
SPC Rapifen Intensive Care

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 02/06/2010 and displayed until Current
Reasons for adding or updating:
  • 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:   01-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Addition of propofol interaction information.

Change to section 4.8 - Undesirable Effects

Update of ADR table- additional ADR’s in “not known” category

Change to section 10 - Date of revision of the text

26.05.10
Updated on 17/07/2009 and displayed until 02/06/2010
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 5.2 - Pharmacokinetic properties

Addition of information regarding special populations.

Change to section 10 – Date of revision of the text

Changed to 10.07.09
Updated on 21/04/2009 and displayed until 17/07/2009
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 6.6 –  Instructions for use, handling and disposal

Addition of statement regarding Single Use only, and discarding any unused contents.

Change to section 10 – Date of revision of the text

09.04.09
Updated on 09/02/2009 and displayed until 21/04/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 – Special Warnings and Precautions for Use

Replacement of term “asystole” with “cardiac arrest” throughout this section, for consistency with MedRA term levels (use of preferred terms).

Change to section 10 – Date of revision of the text

29.01.09
Updated on 26/01/2009 and displayed until 09/02/2009
Reasons for adding or updating:
  • 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:   20-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.8 – Undesirable effects

Replacement of existing text with a single consolidated ADR table in System, Organ, Class format

Change to section 10 – Date of revision of the text

20.01.09
Updated on 11/07/2008 and displayed until 26/01/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   02-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder

Change in address of MAH
Updated on 15/05/2008 and displayed until 11/07/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   07-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 – Special Warnings and Precautions for Use

Addition of warning re loss of consciousness and mandatory statement re sodium content
Updated on 03/03/2006 and displayed until 15/05/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/11/2004 and displayed until 03/03/2006
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/09/2004 and displayed until 29/11/2004
Reasons for adding or updating:
  • 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 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/08/2001 and displayed until 30/09/2004
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 17/10/2000 and displayed until 23/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 09/08/2000 and displayed until 17/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 09/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  alfentanil hydrochloride