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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 1.5 mg/0.3 ml 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
Section 10 - date of revision updated
Updated on 06/06/2011 and displayed until 02/11/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.1 - Replaced the word ‘local’ with ‘standard’

Section 4.4 – Updated with information on Special warnings and precautions for use

Section 5.1 – Updated with additional clinical data

Section 10 - Updated with new date of revision of text
Updated on 08/03/2011 and displayed until 06/06/2011
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:   28-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 5.2 -  addition of a statement that Fondaparinux has not been investigated in Paediatric patients for the prevention of VTE or for the treatment of superficial vein thrombosis.  


Section 10 - date of revision
Updated on 01/10/2010 and displayed until 08/03/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic Properties
  • 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.

Addition of new indication – Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.

 

Section 4.2 - Updated with information for new indication.

Updated with information on treating patients with a low body weight.

 

Section 4.4 - Updated with information for new indication.

 

Section 4.6 - Updated with information on fertility.

 

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

 

Section 5.1 - Updated with information for new indication.

 

Section 10 - Updated with new date of revision of text.
Updated on 08/04/2009 and displayed until 01/10/2010
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:   25-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 6.3 - Shelf life increased to 3 years

Section 10 - Date of revision of the text updated to 25 March 2009

 
Updated on 14/01/2009 and displayed until 08/04/2009
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 24/09/2008 and displayed until 14/01/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
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 paragraph to read:

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

yellow syringe with an automatic safety system

syringe with yellow plunger and a manual safety system.

Not all pack sizes may be marketed."

The first paragraph remains 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.

Not all pack sizes may be marketed."

Other paragraphs remain unchanged.

Section 8 - To change to:

 

"EU/1/02/206/005-008 and 024-026"

 

Section 10 - To change the date to:

 

"22 August 2008"

 
Updated on 16/04/2008 and displayed until 24/09/2008
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 01/11/2007 and displayed until 16/04/2008
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.3 Shelf Life: Type II to reduce the shelf life from 3-years to 2-years, based on data from the stability programme
Updated on 06/09/2007 and displayed until 01/11/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  fondaparinux sodium