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Merck Serono
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Telephone: +44 (0)208 818 7200
Fax: +44 (0)208 818 7267
Medical Information Direct Line: +44 (0)208 818 7373
Medical Information e-mail: medinfo.uk@merckserono.net
Medical Information Fax: +44 (0)208 818 7274

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: 09/12/2011
SPC Luveris 75 IU

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 09/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 3. Pharmaceutical Form the below sentance has been added:
 "Presentations other than ampoules should be considered for self administration by patients.

In Section 10. Date of the Revision of the Text -  now reads: October 2011
Updated on 20/06/2011 and displayed until 09/12/2011
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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The follwoing sections updated:

4. CLINICAL PARTICULARS

4.4 Special warnings and precautions for use

.....

Congenital

malformations

 

The prevalence of ......

4.8 Undesirable effects

General description

.....

Ovarian Hyper-Stimulation Syndrome (OHSS) was observed in less than 6% of patients treated with Luveris. No severe

 

OHSS was reported (section 4.4).

 

......

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

.......

Lutropin alfa is a recombinant human

 

Luteinising Hormone (r-hLH), a glycoprotein composed of non-covalently bound α- and β-subunits. Luteinising Hormone (LH) binds on the ovarian theca (and granulosa) cells .......

 

5.2 Pharmacokinetic properties

.......

The pharmacokinetic profile of lutropin alfa is similar to that of urinary-derived hLH. Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour and eliminated from the body with a terminal half-life of about 10-12 hours. The steady state volume of distribution is around 10-14 l. Lutropin alfa shows linear pharmacokinetics, as assessed by

 

area under curve (AUC) which is directly proportional to the dose administered. Total clearance is around 2 l/h, and less than 5% of the dose is excreted in the urine. The mean residence time is approximately 5 hours.

 

........

　

10. DATE OF REVISION OF THE TEXT

May 2011
Updated on 29/03/2011 and displayed until 20/06/2011
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 4.6 - 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 6.2 - Incompatibilities
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
update to SPC to incorporate company core safety data. Changes are widespread throughout document.
Updated on 26/10/2009 and displayed until 29/03/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
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
None provided
Updated on 27/07/2009 and displayed until 26/10/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
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
Change to Section 7 - MA Holder

From

Serono Europe Limited

To

Merck Serono Europe Limited
Updated on 07/07/2009 and displayed until 27/07/2009
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes are widespread throughout document.
Updated on 09/08/2006 and displayed until 07/07/2009
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   01/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2: Qualitative and Quantitative Composition: Text amended to include: Excipients: 47.75 mg sucrose, 0.1 mg L-methionine, 0.05 mg polysorbate 20.

For a full list of excipients, see section 6.1.

 

Section 3: Pharmaceutical Form: pH added.

 

Section 4.8 Undesirable Effects: The listing of adverse events reported is updated presented by revised body systems. No new adverse events added. The following paragraph has been added ‘Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.’

 

Section 4.9 Overdose: The phrase: ‘….which is further described in ‘Special warnings and special precautions for use’ has been amended to ‘…which is further described in ‘section 4.4’.

 

Section 5.3 Preclinical safety data: The first 3 sentences have been deleted and replaced with ‘Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.’

 

Section 6.2 Incompatibilities: ‘6.6’ has been amended to ‘section 6.6’.

 

Section 6.3 Shelf life: ’36 months’ has been amended to ‘3 years’.

 

Section 6.4 Special precautions for storage: ‘Store in the original package’ has been

amended to ‘Store in the original package in order to protect from light’.

 

Section 6.5 Nature and contents of container: The phrase ‘ The solvent is packaged either in 2 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper’ has been amended to ‘The solvent is packaged either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper.’

 

Section 9 Date of First Authorisation / Renewal of Authorisation: Date of renewal has been added.

 

Section 10 Date of Revision of the Text: Amended to January 2006.

 

 
Updated on 27/05/2004 and displayed until 09/08/2006
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 22/01/2004 and displayed until 27/05/2004
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 22/08/2002 and displayed until 22/01/2004
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 19/02/2002 and displayed until 22/08/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 04/02/2002 and displayed until 19/02/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  lutropin alfa