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Genus Pharmaceuticals
Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN
Telephone: +44 (0)1635 568 400
Fax: +44 (0)1635 568 401
Medical Information Direct Line: +44 (0)870 851 0207
Medical Information e-mail: genus@medinformation.co.uk
Customer Care direct line: +44 (0)1635 568 445
Medical Information Fax: +44 (0)1793 710 387

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: 18/08/2010
SPC APO-go PFS 5mg/ml Solution for Infusion in 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 18/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to SmPC following renewal
Updated on 10/03/2010 and displayed until 18/08/2010
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Additional wording for QT interval prolongation.
Updated on 05/02/2010 and displayed until 10/03/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of Genus as MAH, new MA #
Updated on 25/09/2009 and displayed until 05/02/2010
Reasons for adding or updating:
  • 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.4 the following statement has been added:

Apomorphine is associated with local subcutaneous effects.  These can sometimes be reduced by the rotation of injection sites or possibly by the use of ultrasound (if available) to areas of nodularity and induration.


Section 4.6 has been re-written in line with the renewal.

Section 4.8 has been updated.

The following paragraph has been added to section 5.3:

The effect of apomorphine on reproduction has been investigated in rats. Apomorphine was not teratogenic in this species, but it was noted that doses which are toxic to the mother can cause loss of maternal care and failure to breathe in the newborn.

Updated on 27/06/2008 and displayed until 25/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes to Section 4.4 Special warnings and precautions for use

 

We have provided clarification of the association between Coombs’ positivity and haemolytic anaemia. The old wording has been removed:

 

“Coombs’ positive haemolytic anaemia has been reported rarely in patients treated with levodopa and the incidence in patients taking levodopa and apomorphine is unaltered. Coombs’ positive anaemia has not been reported in patients taking apomorphine in association with other therapy.”

 

and replaced with:

 

“Haemolytic anaemia has been reported in patients treated with levodopa and apomorphine. Haematology tests should be undertaken at regular intervals as with levodopa when given concomitantly with apomorphine.”

 

The following has also been added:

 

“Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’s disease, including apomorphine.”

 

Changes to Section 4.8 Undesirable effects

 

This section has been rearranged in to system order class.  We have also changed the following:

 

Psychiatric disorders

 

We have amended the first paragraph of this section to read as follows:

 

“Neuropsychiatric disturbances are common in Parkinsonian patients. APO-go should be used with special caution in these patients.  Neuropsychiatric disturbances (including transient mild confusion and visual hallucinations) have occurred during apomorphine HCl therapy.”

 

We have added the following paragraph:

 

“Patients treated with dopamine agonists for treatment of Parkinson's disease, including apomorphine, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.”

 

Blood and lymphatic system disorders

 

As above, the following text regarding Coomb’s positive haemolytic anaemia has been changed:

 

“Coombs’ positive haemolytic anaemia has rarely been reported in patients treated with levodopa and apomorphine.”

 

to:

 

“Haemolytic anaemia has been reported in patients treated with levodopa and apomorphine.”

 

Skin and subcutaneous tissue disorders

 

The following has been added:

 

“Local and generalised rashes have been reported.”

 

Investigations

 

The following has been added:

 

“Positive Coombs’ tests have been reported for patients receiving apomorphine and levodopa.”
Updated on 02/02/2007 and displayed until 27/06/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/01/2007 and displayed until 02/02/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 31/07/2006 and displayed until 29/01/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/07/2006 and displayed until 31/07/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/05/2006 and displayed until 26/07/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 11/05/2006 and displayed until 19/05/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   21/10/05
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 (List of excipients) - an excipient has been removed from the formulation
Updated on 04/05/2005 and displayed until 11/05/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/04/2005 and displayed until 04/05/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 29/04/2005 and displayed until 29/04/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  apomorphine hydrochloride