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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 08/05/2012
SPC Nebido 1000mg/4ml, solution for injection

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 08/05/2012 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 10 date of revision of the text
Date of revision of text on the SPC:   20-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes are:

 

·        Section 4.2: Additional detail that the injections must be administered very slowly over two minutes was added.

·        Section 4.4: Medical examination - reference to local guidelines added

Application – again the injection to be administered slowly over two minutes was added. Additional advice to observe the patient during and immediately after each injection for early recognition of possible signs/symptoms of pulmonary oily microembolism.

·        Section 4.8: Additional details on pulmonary oily microembolism.

Statement that androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.

 
Updated on 05/12/2011 and displayed until 08/05/2012
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   23-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The key changes are:
  • Removal of the black triangle. 
Updated on 07/10/2011 and displayed until 05/12/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The key changes are:

 

  • To remove the trading style statement in section 7 of the SmPC.

Updated on 01/09/2011 and displayed until 07/10/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 (Special warnings) Additional text concerning anaphylactic shock
Section 4.8 (Side effects) anaphylactic shock has been added
Section 10 - Revision date is now August 2011
Updated on 22/02/2011 and displayed until 01/09/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

1. Name of the medicinal product: Editorial change to correct spacing

4.2 Posology and method of administration: Section 4.2 now divided clearly under the headings "Posology" and "Method of administration".Inclusion of information on special populations (geriatric patients, patients with hepatic impairment, patients with renal impairment) in order to reflect current requirements. Order of subsections rearragned in line with QRD template.

 Section 4.2 now divided clearly under the headings "Posology" and "Method of administration".Inclusion of information on special populations (geriatric patients, patients with hepatic impairment, patients with renal impairment) in order to reflect current requirements. Order of subsections rearragned in line with QRD template.

4.3 Contraindications. Inclusion of contraindication in women in line with SmPC guideline

Inclusion of contraindication in women in line with SmPC guideline

4.4 Special warnings and precautions for use: Elimination of frequencies in the statement regarding benign and malignant liver tumours and replacement of the term "testosterone" compounds by "androgen" compounds. Statement regarding liver tumor diagnosis added. Inclusion of an explanatory statement regarding oedema predisposition and a cross-reference to section 4.8

 Elimination of frequencies in the statement regarding benign and malignant liver tumours and replacement of the term "testosterone" compounds by "androgen" compounds. Statement regarding liver tumor diagnosis added. Inclusion of an explanatory statement regarding oedema predisposition and a cross-reference to section 4.8

4.6 Pregnancy and lactation: Inclusion of information regarding fertility and cross-references to section 4.8 and 5.3

: Inclusion of information regarding fertility and cross-references to section 4.8 and 5.3

4.8 Undesirable effects: Editorial change to move position of frequency definitions

: Editorial change to move position of frequency definitions

5.2 Pharmacokinetic properties: Typographical corrections

: Typographical corrections

6.6 Instructions for use/handling: Inclusion of information regarding the handling of the OPC ampoule and a graphic demonstration

 Inclusion of information regarding the handling of the OPC ampoule and a graphic demonstration
Updated on 14/05/2009 and displayed until 22/02/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   25-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The key SmPC changes are as follows:

Section 4.4, "Application "

: this has been revised to reflect recent clinical study and post-marketing experience, which report rare, short-lasting reactions to Nebido injection, believed to be due to the "pulmonary oily microembolism" (POME) phenomenon, causing symptoms such as the urge to cough and respiratory distress. The previous version of the SmPC provided no explanation for these side effects, with the consequence that they were occasionally misinterpreted as allergic reactions. This new version of the SmPC describes these reactions more specifically and references POME as a potential cause.

Section 4.8

: Table 1 has been revised to reflect most recent clinical data and recoded in line with MedDRA. As a result, several AEs have been added and pre-existing AEs regraded according to the most recent data on frequency. A paragraph on POME has also been added to this section to reflect recent clinical and post-marketing data.
Updated on 07/07/2008 and displayed until 14/05/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 7 - Marketing Authorisation Holder
  • 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:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections 7, 8, 9 and 10 have been updated to reflect the change of ownership from Schering Health Care Limited (PL 00053/0350) to Bayer plc (PL 00010/0549). 
Updated on 30/11/2006 and displayed until 07/07/2008
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.3 change in shelf - life from 3 to 5 years
Updated on 12/01/2005 and displayed until 30/11/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  testosterone undecanoate