Summary of Product Characteristics
last updated on the eMC:
05/01/2012
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 05/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 29-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3:
Deleted "Allergies to any of the components"
Added the statement :
"Hypersensitivity to the active substance or to any of the excipients, including arachis oil. Deca-Durabolin is therefore contraindicated in patients allergic to peanuts or soya (see section 4.4)"
Section 4.4:
Deleted "Arachis oil (peanut oil) and should not be taken / applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Deca Durabolin 50mg/ml"
Added the statement :
"100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause anaphylactoid reactions in infants and children up to 3 years old."
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Updated on 17/05/2011 and displayed until 05/01/2012
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.5, the following has been added:
Anabolic steroids have been reported to increase the activity of oral anticoagulants. Patients receiving oral anticoagulants require close monitoring, especially at the beginning or end of androgen therapy. Increased monitoring of the prothrombin time, and INR determinations, are recommended.
In section 10:
The date of revision has been updated to April 2011.
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Updated on 27/04/2010 and displayed until 17/05/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 20-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The removal of a 1 x 1ml disposable syringe (with a shelf life of 36 months).
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Updated on 24/07/2006 and displayed until 27/04/2010
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 6.1 - List of Excipients
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Change to section 4.3 - Contra-indications
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Change to section 5 - Pharmacological Properties
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 03/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 BP has been removed
Section 4.3 The following contra-indications have been added:
Breast-feeding
Porphyria
Allergies to any of the components
Section 4.4 Addition of text to bullet point for liver dysfunction:
· Liver dysfunction – caution should be used in patients with severe hepatic impairments and Deca Durabolin 50mg/ml should only be used if the benefits outweigh the risks.
Additional bullet point:
· diabetes mellitus
Section 5 Addition of heading as shown below:
Section 5.3 Preclinical Safety Data
Not applicable
Section 6.1 EP has been removed from excipients
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Updated on 14/12/2004 and displayed until 24/07/2006
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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