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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.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: 29/12/2011
SPC Arixtra 5mg, 7.5mg, 10mg solution for injection, pre-filled syringe

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 29/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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:   15-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.1 - Amendment to wording - use of a needle shield
Section 6.4 - Addition of storage conditions 'store below 25oC'
Section 10 - Updated date of revision of text
Updated on 02/11/2011 and displayed until 29/12/2011
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:   20-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of a warning regarding latex allergy
Secion 10 - date of revision updated
Updated on 10/03/2011 and displayed until 02/11/2011
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
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.2 – cross reference to Section 5.1 and 5.2 regarding use in children below 17 years of age

Section 5.1 – addition of information regarding a pilot dose-finding and pharmacokinetic study of fondaparinux in children with deep vein thrombosis. 

Section 5.2 -  addition of a statement that there is limited data available in the Paediatric patient population with a cross reference to Section 5.1.

Section 10 - date of revision
Updated on 01/10/2010 and displayed until 10/03/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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:   31-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.1 - Minor text changes.

 

Section 4.6 - Updated with information on fertility.

 

Section 4.8 - Updated with new statement regarding most commonly reported adverse reactions.

 

Section 10 - Updated with new date of revision of text.
Updated on 14/01/2009 and displayed until 01/10/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.5 - Minor change to the wording relating to colour of the syringe for the automatic needle protection system
Section 10 - Updated to date of Commission Decision
Updated on 25/09/2008 and displayed until 14/01/2009
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.5 - To change the second, third and fourth paragraphs to read:

"Arixtra 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes. There are two types of syringes:

orange syringe with an automatic safety system

syringe with orange plunger and a manual safety system."

"Arixtra 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes. There are two types of syringes:

magenta syringe with an automatic safety system

syringe with magenta plunger and a manual safety system."

"Arixtra 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes. There are two types of syringes:

violet syringe with an automatic safety system

syringe with violet plunger and a manual safety system."

First and last paragraphs remain unchanged.

Section 6.6 - To change the third paragraph as follows:

 

"The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection."

Other paragraphs remain unchanged.

Section 8 - To change to:

 

"Arixtra 5 mg/0.4 ml EU/1/02/206/009-011, 018 and 027-028, 033

Arixtra 7.5 mg/0.6 ml EU/1/02/206/012-014, 019 and 029-030, 034

Arixtra 10 mg/0.8 ml EU/1/02/206/015-017, 020 and 031-032, 035"

Section 10 - To change the date to:

 

"22 August 2008"
Updated on 16/04/2008 and displayed until 25/09/2008
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   19-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


4.2 Posology and method of administration

Further clarification provided for the dosage instructions for the special patient population group with hepatic impairment, including an additional cross reference to 5.2.

 

4.4 Special warnings and precautions

The precaution for patients with Heparin Induced Thrombocytopenia (HIT) has been updated to add further clarity and to reflect the rare spontaneous safety reports, although a causal association has not been established.

 

4.8 Undesirable Effects

Minor typographical errors have been corrected.

 

5.1 Pharmacodynamic properties

To include safety information obtained from routine pharmacovigilance reporting; prolonged activated partial thromboplastin time (aPTT) has been observed rarely during routine coagulation testing.

 

Additionally, minor typographical errors have been corrected.

 

5.2 Pharmacokinetic properties

Update to include the results of data collected from a study in subjects with moderate hepatic impairment, which supports the dosage adjustment clarification provided in 4.2

 
Updated on 26/09/2007 and displayed until 16/04/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

5.1 Pharmacodynamic Properties

  • Correction of an administrative error that was previously registered, the ATC code is no longer ‘proposed’ and therefore this has been removed.
Updated on 29/05/2007 and displayed until 26/09/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Formating and Punctuation changes made for consistency
References to Arixtra replaced with Fondaparinux for consistency
Section 2: Declaration of Sodium content added
Section 4.8:updated in line with MeDRA system Oran Class and CIOMS frequencies
Minor updates to comply with current QRD template
Updated on 10/03/2006 and displayed until 29/05/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
  • Correction of spelling/typing errors
Updated on 10/03/2006 and displayed until 10/03/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 15/04/2005 and displayed until 10/03/2006
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 13/04/2005 and displayed until 15/04/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
  • Pending awaiting re-submission

Active Ingredients/Generics

 
  fondaparinux sodium