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Atriance 5 mg/ml solution for infusion

Last Updated on eMC 04-Jul-2017 View document  | Novartis Pharmaceuticals UK Ltd 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 04-Jul-2017 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 - Fertility, 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 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 16-Jun-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



SPC update reflects renewal outcome.

Section 4.2

Removal of phrase in following sentence:

Nelarabine is for intravenous use only and must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.

Removal of following paragraph:

Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practise for the management of hyperuricaemia in patients at risk for tumour lysis syndrome. For patients at risk of hyperuriceamia, the use of allopurinol should be considered (see section 4.4)

Section 4.4

Neurological Adverse Reactions updated

Section 4.6 - Breast-feeding

Removal of: The excretion of nelarabine in milk has not been studied in  animals. However, because of the potential for serious adverse reactions in infants, breastfeeding should be discontinued.

Replaced with: A risk to the newborn/infant cannot be excluded. Breast-feeding should be discontinued during treatment with Atriance

Section 4.7

Removal of: No studies on the effects on the ability to drive and use machines have been performed.

Replaced with: Atriance has major influence on the ability to drive and use machines.

Section 4.8

Reformatting throughout the section.

Section 6.4

Change wording to: For storage conditions after first opening of the medicinal product, see section 6.3.

 

Updated on 20-May-2015 and displayed until 04-Jul-2017

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: 24-Apr-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 7 changed due to change of ownership from GlaxoSmithKline to Novartis.

Updated on 21-Jun-2013 and displayed until 20-May-2015

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC: 20-Jun-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Before 1. Additional monitoring (‘black triangle’) statement
4.8.    ADR reporting statement (per QRD 9).
10.     Date of revision of text

Updated on 11-Mar-2013 and displayed until 21-Jun-2013

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: 11-Mar-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

7.     Change in address of marketing authorisation holder
10.   Updated with new date of revision of text

Updated on 25-Oct-2012 and displayed until 11-Mar-2013

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle

Date of revision of text on the SPC: 19-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

1.

Removal of black triangle

10.

Updated to date of awareness of latest Black Triangle list

Updated on 31-Jul-2012 and displayed until 25-Oct-2012

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • 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: 18-Jun-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

2.

administrative amendment to add ‘solution’

4.2

addition of monitoring complete blood counts under posology and delete this text from ‘method of administration’

 

administrative amendments

4.8

- administrative amendments

- Addition of Rhabdomyolysis as rare adverse event

- addition of descriptive text for Infections and Nervous System disorders

- deletion of demyelination

- deletion of opportunistic infections

5.2

administrative amendments

6.5

deletion of ‘non’ latex’ reference to rubber stopper of vial

6.6

administrative amendments

10.

Updated date

Updated on 25-Apr-2012 and displayed until 31-Jul-2012

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 21-Mar-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

2.

Addition of the words- “with known effect” after “Excipient”

4.3

Addition of “listed in section 6.1” after the sentence

4.8

Addition of Rhabdomyolysis as a rare side effect

6.6

Addition of the word “medicinal” in final sentence

9.

Addition of the words “date of first authorisation” also change date format

10.

Updated date

Updated on 24-Apr-2012 and displayed until 25-Apr-2012

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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: 21-Mar-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

2.

Addition of the words - “with known effect” after “Excipient”

4.3

Addition of “listed in section 6.1” after the sentence

4.8

Addition of Rhabdomyolysis as a rare side effect

6.6

Addition of the word “medicinal” in final sentence

9.

Addition of the words “date of first authorisation” also change date format

10.

Updated date

Updated on 10-Jan-2011 and displayed until 24-Apr-2012

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC: 29-Nov-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Sections changed:

4.2 Revision of information and formatting update
4.6 Revision of information and formatting update
10 Change of revision date of text

Updated on 12-Dec-2008 and displayed until 10-Jan-2011

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC: 19-Nov-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - Nelarabine is not diluted prior to administration. The appropriate dose of nelarabine is transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.

Section 5.1 - The monophosphate metabolite is subsequently converted to the active 5-triphosphate form, ara-GTP.

Section 5.2 - Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.

Updated on 22-Sep-2008 and displayed until 12-Dec-2008

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 05-Aug-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 6.3 - Shelf life: 3 years

Section 10 - Approval date: 5 August 2008

Updated on 11-Sep-2007 and displayed until 22-Sep-2008

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Novartis Pharmaceuticals UK Ltd

Company image
Address

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

E-mail
Medical Information e-mail
Telephone

+44 (0)1276 692 255

Medical Information Direct Line

+44 (0)1276 698 370

Customer Care direct line

+44 (0)845 741 9442

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

nelarabine

Legal categories

POM - Prescription Only Medicine

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