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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 2.5mg/0.5ml 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 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 09/03/2011 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 09/03/2011
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 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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 paragraph to read:

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

blue syringe with an automatic safety system

syringe with blue 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."

Other paragraphs remain unchanged.

Section 8 -

 

To change to:

"EU/1/02/206/001-004 and 021-023"

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 26/09/2007 and displayed until 01/11/2007
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
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

4.2 Posology & method of administration

  • Update dosage recommendations for renal impairment:

-  to reduce the dose to 1.5mg daily for VTE prevention in patients with creatine clearance in the range 20 to 50 ml/min.

-  no dosage reduction is required in patients with mild renal impairment (>50 ml/min).

  • The recommendation of do not use in patients with creatine clearance <20ml/min is unchanged by this variation.

 

4.4 Special warnings and precautions

The following sentence has been added:

  • There are limited clinical data available from patients with creatine clearance less than 30 ml/min.
Updated on 04/09/2007 and displayed until 26/09/2007
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 
 
 
 

4.1 Therapeutic indications

Addition of new indications in Acute Coronary Syndromes (ACS), as follows:

Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (<120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).

Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy."

Subsequently the following sections have been updated: -

4.2 Posology & method of administration

Specific guidance for the treatment of UA/STEMI & STEMI.

A new method of administration by intravenous (IV) injection has been added for the first dose used to treat STEMI patients.

4.4 Special warnings and precautions

Addition of information related to the treatment of UA/NSTEMI & STEMI

Guidance related to Percutaneous Coronary Intervention (PCI) and risks of guiding catheter thrombus

Renal impairment guidance specific to patients being treated with UA/STEMI & STEMI

4.8 Undesirable effects

The AE profile for the ACS indications is consistent with those already presented and a brief summary of AEs from the phase III studies has been included.

5.1 Pharmacodynamic properties

Relevant information from the clinical trials OASIS 5 and OASIS 6 for the new additional indications for ACS (UA/NSTEMI and STEMI, respectively) has been added.

 
 
 
Updated on 29/05/2007 and displayed until 04/09/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.9 - Overdose
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
Section 2: Sodium content declaration added
Section 4.9: Amended for consistency with higher strength
Minor updates to comply with current QRD templates
Updated on 11/08/2005 and displayed until 29/05/2007
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 15/04/2005 and displayed until 11/08/2005
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 18/02/2005 and displayed until 15/04/2005
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 23/09/2004 and displayed until 18/02/2005
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 22/09/2004 and displayed until 23/09/2004
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