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Hospira UK Ltd
Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
Telephone: +44 (0)1926 820 820
Fax: +44 (0) 1926 834446
WWW: http://www.hospira.com
Medical Information Direct Line: +44 (0) 1926 834400
Medical Information e-mail: medinfouk@hospira.com
Customer Care direct line: +44 (0)1926 821 022

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: 04/02/2009
SPC Nipent 10 mg powder for solution for injection, powder for solution for infusion

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 04/02/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • 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:   30-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



3.       PHARMACEUTICAL form

 

            pH information added:

The pH of reconstituted solution is 7.0 – 8.2.

6.1     List of excipients

 

Mannitol

Sodium hydroxide or Hydrochloric acid pH wording added:(for pH adjustment)

 

6.4     Special precautions for storage

 

Wording changed to:Store in a refrigerator (2°C – 8°C)


10.     DATE OF REVISION OF THE TEXT

 

          30th January 2009
Updated on 14/01/2009 and displayed until 04/02/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   03-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


  • Update to section 4.2 and 5.2 with regards to creatinine clearance levels for treatment with pentostatin in patients with impaired renal function.
  • To bring the SPC in line with the current QRD format.

 

  • wording of Section 4.7 (Effects of ability to drive and use machines) has been updated for clarity
  • section 4.8 has been updated following full review of the safety database.
Updated on 11/02/2008 and displayed until 14/01/2009
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  pentostatin