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Luveris 75 IU

*
Pharmacy Only: Prescription

  • Company:

    Merck

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Lutropin Alfa

    *Additional information is available within the SPC or upon request to the company

Updated on 23 July 2024

File name

IENI SPC - Luveris - Ampoules removal - TW4573763 - 2024.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Type IA variation for the withdrawal of the presentations containing water for Injection (WFI) in ampoules. 

SmPC sections impacted: 3. PHARMACEUTICAL FORM, 6.5 Nature and contents of container, 8. MARKETING AUTHORISATION NUMBER(S)


Our reference: TW 4573763


Updated on 26 July 2022

File name

IENI SPC - Luveris - Label update TW3538830 - June 2022.pdf

Reasons for updating

  • 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 4.8 - 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 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Internal reference number: TW3538830

Updated on 26 July 2022

File name

IENI PIL - Luveris - Label update TW3538830 - June 2022.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Internal Reference number: TW3538830

Updated on 28 July 2021

File name

PIL_IE_NI_012021.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Amendment of "United Kingdom" with "United Kingdom (Northern Ireland)".
TW1735675

Updated on 28 July 2021

File name

Luveris 75 UK ROI TW2762251_012021.pdf

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

Amendment of "United Kingdom" with "United Kingdom (Northern Ireland)".
TW1735675.

Updated on 26 January 2021

File name

Luveris 75 UK ROI TW2762251 Clean v11.0.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Minor formatting changes throught the SPC. 

Addition of 'traceability' and 'sodium content' sections in 4.4

 

Updated on 26 January 2021

File name

Luveris 75 UK ROI TW2762251 PIL Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Minor formatting changes throughout the leaflet.

Updated on 14 September 2018

File name

Package leaflet.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 14 September 2018

File name

Luveris 75 UK ROI TW1735675Clean v10.0.pdf

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 01 August 2017

File name

PIL_15337_539.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 August 2017

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 20 February 2017

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

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 December 2016

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 02 August 2016

Reasons for updating

  • Change to further information section

Updated on 07 July 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 29 May 2015

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

4.8 Undesirable effects

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

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

Revision date changed from March 2014 to November 2014.

Updated on 14 May 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 26 March 2014

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

Minor editorial changes in these sections.

Updated on 18 March 2014

Reasons for updating

  • Change of distributor details

Updated on 03 April 2013

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

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

Minor editorial updates to Sections 4.2, 4.3, 4.4, 4.6, 4.8, 5.2 and 6.1 - according to QRD template version 8.

Updated on 13 April 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 December 2011

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

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 Revision of the Text - this now read: October 2011

Updated on 21 June 2011

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

The following 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 28 March 2011

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

change to SPC as company core safety data has been added. Changes are widespread throughout document.

Updated on 27 October 2009

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

In section 4.2 the following changed from:

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

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

Change to Section 7 - MA Holder

From

Serono Europe Limited

To

Merck Serono Europe Limited

Updated on 01 July 2009

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

Changes are widespread throughout document

Updated on 09 August 2006

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

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

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)