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Abbott Laboratories Limited
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK
Telephone: +44 (0)1628 773 355
Fax: +44 (0)1628 644 185
WWW: http://www.abbottuk.com
Medical Information e-mail: ukmedinfo@abbott.com
Out of Hours Telephone: +44 (0)1628 774 920

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: 03/01/2012
SPC Synagis

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 03/01/2012 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   19-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration; Clarification of the dose calculation was added to the text
Section 4.4 Special warnings and precautions for use; Addition of anaphylactic shock and wording added stating that in some cases fatalities have been reported.
Section 4.8 Undesirable effects: Addition of anaphylactic shock and wording added stating that in some cases fatalities have been reported, to the post marketing experience section.
Section 5.1 Pharmacodynamic properties: Addition of CHD post-marketing study data from M03-681
Section 6.6 Special precautions for disposal and other handling: Wording added to clarify that vials contain overfill and that vials are for Single-use.
Updated on 22/09/2011 and displayed until 03/01/2012
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   13-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


6.5 Nature and contents of container

50 mg of powder in a 4 ml vial (Type I glass) with a stopper (

 

bromo butyl rubber) and a flip-off seal (aluminium).

 

 

100 mg of powder in a 10 ml vial (Type I glass) with a stopper (bromo butyl rubber) and a flip-off seal (aluminium).

1ml of water for injections in an ampoule (type I glass).
Updated on 12/01/2010 and displayed until 22/09/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   23-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7 - Update to MAH address
Updated on 09/12/2009 and displayed until 12/01/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   24-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) - in the post marketing experience paragraph, thrombocytopenia and convulsion have been added and the wording regarding the frequency of post marketing adverse events has been updated.

In section 4.9 (overdose) - from post marketing experience, overdoses as high as 60mg/kg have been observed without any untowards medical events.
Updated on 07/08/2009 and displayed until 09/12/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   27-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Correction of spelling/typographical errors.
The SmPC has been re-formatted per the QRD template as part the European Renewal procedure, this has included updating the adverse event table into MedDRA SOC order and minor text amendments throughout.

2.      QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains 50 mg or 100mg palivizumab*, providing 100 mg/ml of palivizumab when reconstituted as recommended.

 

*recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells.

 

For a full list of excipients, see section 6.1.


6.3    Shelf-life

3 years.

After reconstitution according to instructions: 3 hours After reconstitution, the product should be used immediately. However in-use stability has been demonstrated for 3 hours at 20 - 24oC.


6.6    Special precautions for disposal and other handling

SLOWLY add 0.6 ml of water for injections for the 50 mg vial or 1.0 ml of water for injections for the 100 mg vial along the inside wall of the vial to minimise foaming.  After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds. DO NOT SHAKE THE VIAL.  Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.  Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation. 

 

When reconstituted as recommended, the final concentration is 100 mg/ml.

The appearance of the reconstituted solution is clear to slightly opalescent.

 

Any unused product or waste material should be disposed of in accordance with local requirements.

 

 

 

 

 
Updated on 31/07/2007 and displayed until 07/08/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 7 - Marketing Authorisation Holder
  • 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:   06/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 3 - pharmaceutical form, Change to section 4.1 - Therapeutic Indications, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, 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 5.2 - Pharmacokinetic Properties, Change to section 6.1 - List of Excipients, Change to section 6.2 - Incompatibilities, Change to section 6. 4 - Special Precautions for Storage, Change to section 6. 5 - Nature and Contents of Container, Change to section 6. 6 - Instruction for Use/Handling, Change to section 7 - Marketing Authorisation Holder, Change to section 9 - Date of Renewal of Authorisation, Change to section 10 (date of (partial) revision of the text
Updated on 07/09/2006 and displayed until 31/07/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 
Section 4.8: Correct 2 transposition errors - Table 1 -injection site reaction should have been common. Table 2 -fever should have been common.
 
Section 9: Date of renewal added
 
Section 10:  Date of revision updated
Updated on 01/10/2004 and displayed until 07/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 3 - Shelf Life
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 30/09/2004 and displayed until 01/10/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 3 - Shelf Life
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Pending awaiting re-submission
Updated on 10/11/2003 and displayed until 30/09/2004
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 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/09/2003 and displayed until 10/11/2003
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 30/07/2002 and displayed until 24/09/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/08/2001 and displayed until 30/07/2002
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 31/07/2001 and displayed until 20/08/2001
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 23/07/2001 and displayed until 31/07/2001
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects

Active Ingredients/Generics

 
  palivizumab