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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

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Summary of Product Characteristics last updated on the eMC: 17/01/2012
SPC Pregnyl 5000IU

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 17/01/2012 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   04-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1, 2, 3, 4.7 and 6 - Update to comply with the EU SmPC guideline and the QRD template. 

Section 4.1 - Use in conjunction with HMG has been updated to use in combination with FSH or HMG.

Section 4.2 - Use in conjunction with HMG has been updated to use in combination with FSH or HMG.  The dose for luteal phase support from has been changed from up to 3 repeat injections of 5000 units to 2-3 repeat injections of 1000-3000 IU. 

Duration of treatment and suspension of testosterone replacement therapy has been added for sterility in selected cases of deficient spermatogenesis.

Section 4.3 - Two contraindications have been added.

Section 4.4 - Clinical symptoms of mild ovarian hyperstimulation have been added; an additional symptom of severe OHSS and a statement that Pregnyl should not be used for body weight reduction have also been included.

Section 4.5 - May lead to false pregnancy has been added.

Section 4.8 - SOC categories have been added, under which each undesirable effect is categorised.  Unwanted ovarian hyperstimulation text has been reworded and the description expanded. 

Section 5 - ATC code added and section 5.2 updated to reflect available data.
Updated on 07/06/2005 and displayed until 17/01/2012
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 21/07/2003 and displayed until 07/06/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  human chorionic gonadotrophin