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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.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: 27/01/2011
SPC Testosterone Implant 200 mg

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 27/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   17-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


·         Information for use in females has been deleted as more convenient alternatives are available.

·         Section 4.1:  Indications have been replaced by more general terminology.

·         Section 4.3:  Hypersensitivity to active or excipients has been added as contraindication

·         Section 4.4:  Monitoring frequency has been added for DRE and hematocrit and hemoglobin; warnings for with patients with cardiac failure, renal or hepatic dysfunction, or hypertension have been modified; warning for patients with epilepsy or migraine have been added.  Additional warnings on glucose tolerance, anticoagulants and sleep apnea have been added for safety reasons and are in line with the known effects of androgens in general. 

·         Section 4.5: Effect of enzyme inhibiting drugs has been added.  The decrease in the need for anti-diabetic medication and adaptation of the dose of anticoagulants has been added based on ISSAM recommendations.

·         Section 4.8:  Side effects have been revised and undesirable effects are included based on class labeling and valid scientific information. 

·         Section 4.9:  Overdose information has been revised based on recommendations as given by the ISSAM.

·         Section 5:  Pharmacological properties have been revised

 

There have also been editorial changes, including those to update in accordance with the EU Guideline on the SPC and the QRD throughout the SmPC.
Updated on 10/09/2009 and displayed until 27/01/2011
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   04-Oct-2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 6.4 Special precautions for storage 'Protected from light' has been removed and 'Store in the original package' has been added.
Updated on 18/04/2002 and displayed until 10/09/2009
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  testosterone