Luveris 75 IU
- Name:
Luveris 75 IU
- Company:
Merck
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/09/18
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Merck
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 14 September 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 September 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 1 August 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 1 August 2017 PIL
Reasons for updating
- Change to section 3 - how to take/use
Updated on 20 February 2017 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 16 December 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 December 2016 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects - how to report a side effect - was updated with the addition of Malta. Internal Ref: TW1230178.
Updated on 2 August 2016 PIL
Reasons for updating
- Change to further information section
Updated on 7 July 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 29 May 2015 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Updated on 25 November 2014 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 May 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 26 March 2014 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 18 March 2014 PIL
Reasons for updating
- Change of distributor details
Updated on 3 April 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
Updated on 31 January 2013 SmPC
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 13 April 2012 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 12 December 2011 SmPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
"Presentations other than ampoules should be considered for self administration by patients."
In Section 10. Date of Revision of the Text - this now read: October 2011
Updated on 21 June 2011 SmPC
Reasons for 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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 28 March 2011 SmPC
Reasons for 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 October 2009 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
When an optimal response is obtained, a single injection of 250 microgram of
r-hCH or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last lutropin alfa and FSH injections.
To:
When an optimal response is obtained, a single injection of 250 microgram of r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last lutropin alfa and FSH injections.
Updated on 27 July 2009 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
From
Serono Europe Limited
To
Merck Serono Europe Limited
Updated on 1 July 2009 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 9 August 2006 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
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 22 January 2004 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 August 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2003 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)