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GONAL-f 450 IU (33 micrograms) *
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):

    Follitropin Alpha

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

Updated on 25 August 2022

File name

630730dd01b65.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

The package Leaflet is updated regarding the use of GONAL-f in combination with a LH preparation, such as lutropin alfa, for severe LH and FSH deficiency.

Internal Reference number: TW3499617

Updated on 25 August 2022

File name

63072e14c659e.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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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
  • Change to section 5.3 - Preclinical safety data
  • 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

Update of sections 4.1, 4.2, 4.3, 4.4, 4.7, 5.1, 5.2, and 6.1 of the SmPC regarding the use of GONAL-f in combination with a LH preparation, such as lutropin alfa, for severe LH and FSH deficiency. 

Internal reference number: TW3499617

Updated on 28 January 2020

File name

Gonal F 450iu powder UK & ROI TW2140571 v4.0 current - Clean_1580213090.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • 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 28 January 2020

File name

Package leaflet 450 IU-0.75 mL (33 micrograms-0.75 mL) pij_1580213044.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 September 2018

File name

Package leaflet 450 IU-0.75 mL (33 micrograms-0.75 mL) pij_1537169397.pdf

Reasons for updating

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

Updated on 17 September 2018

File name

Gonal F 450iu powder UK & ROI TW1735675 v3.0 current_1537169459.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 11 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 11 May 2017

Reasons for updating

  • 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

Section 4.8 - Undesirable effects

Thromboembolism may occur very rarely (see section 4.4).

 

 

Vascular disorders

Very rare:       Thomboembolism (both in association with and separate from OHSS)

Updated on 10 May 2017

File name

PIL_15319_716.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 May 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change of distributor details

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

  • 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 08 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 30 July 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 12 May 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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, including information on the reporting of adverse reactions in section 4.8.

 

Date change in Section 10

Updated on 18 March 2014

Reasons for updating

  • Change of distributor details

Updated on 24 October 2012

Reasons for updating

  • Change of distributor details

Updated on 14 June 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

2. Qualitative and QuantitativeComposition

Each

 

multidose vial contains 44 micrograms of follitropin alfa* (equivalent to 600 IU), in order to deliver 33 micrograms (equivalent to 450 IU) in 0.75 ml. Each ml of the reconstituted solution contains 600 IU.
.........

 

10. Date of Revision of the Text

11/2011

Updated on 10 April 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 June 2011

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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

............

Thromboembolic events

In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for

 

thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events. In these women, the benefits of gonadotropin administration need to be weighed against the risks. It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events


 

9. Date of First Authorisation/Renewal of the Authorisation

Date of first authorisation: 20 October 1995

Date of last renewal: 20 October

 

2010

 

10. Date of revision of the text

May 2011

Updated on 16 November 2010

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

Date of Renewal corrected to:

Date of last renewal: 20 October 2010

Updated on 13 August 2010

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 4.5 - 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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Changes to SPC are widespread throughout document as result of MA Renewal. SPC is in compliance with QRD template.

Updated on 30 October 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

From:

Serono Europe Ltd.

56 Marsh Wall

London E14 9TP

United Kingdom


To:

Merck Serono Europe Ltd.

56 Marsh Wall

London E14 9TP

United Kingdom

Updated on 28 August 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Following changes apply:

4.2     Posology and method of administration



It is advised to adhere to the recommended starting doses indicated below.

Comparative clinical studies have shown that on average patients require a lower cumulative dosage and shorter treatment duration with GONAL-f compared with urinary FSH. Therefore, it is considered appropriate to give a lower total dosage of GONAL-f than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation. See section 5.1.



5.1     Pharmacodynamic properties



In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in assisted reproduction technologies (see table below) and in ovulation induction, GONAL-f was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.

In assisted reproduction technologies, GONAL-f at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH.

 

Table: Results of study GF 8407 (randomised parallel group study comparing  efficacy and safety of Gonal-f with u-FSH in assisted reproduction technologies)



 

GONAL-f
(n = 130)

u-FSH
(n = 116)

No. of oocytes retrieved

11.0 ± 5.9

8.8 ± 4.8

Days of FSH stimulation required

11.7 ± 1.9

14.5 ± 3.3

Total dose of FSH required (no. of FSH 75 IU ampoules)

27.6 ± 10.2

40.7 ± 13.6

Need to increase the dosage (%)

56.2

85.3

Differences between the 2 groups were statistically significant (p<0.05) for all criteria listed.

Updated on 15 August 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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: 30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate.

 

For a full list of excipients, see section 6.1.

 

Section 3 Pharmaceutical Form: pH added.

 

Section 4.2 Posology and method of administration: The phrase: ‘….treatment should be stopped and hCG withheld (see warnings)’ has been amended to ‘…treatment should be stopped and hCG withheld (see section 4.4)’.

 

Section 4.4 Special warnings and precautions for use: The following warnings have been added:

 

‘As GONAL-f multidose is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation.’

 

‘Patients with porphyria or a family history of porphyria should be closely monitored during treatment with GONAL-f. Deterioration or a first appearance of this condition may require cessation of treatment.’

 

‘GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.’

 

‘Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.’

 

The phrase: ‘….the incidence of ovarian hyperstimulation and multiple pregnancy (see Sections 4.2 ‘Posology and method of administration’ and 4.8 ‘Undesirable effects’)’ has been amended to ‘…the incidence of ovarian hyperstimulation and multiple pregnancy (see Sections 4.2 and 4.8)’.

 

Section 4.8 Undesirable Effects: The listing of adverse events reported is updated presented by body systems. Adverse events added include:

 

Treatment in women

Very rare:

Immune system disorders: Urticaria, oedema, difficulty breathing. Serious cases of allergic reactions including anaphylactic reactions have also been reported.

Respiratory, thoracic and mediastinal disorders: exacerbation or worsening of asthma.

Treatment in men

Common:

Reproductive system and breast disorders: Varicocele

Very common:

General disorders and administration site conditions: Mild to severe injection site reaction (pain, redness, bruising, swelling and/or irritation at the site of injection)

 

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 paragraph has been deleted and replaced with ‘Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of the SPC.’

 

Section 6.3 Shelf life: The last sentence ’Do not store above 25°C. Do not freeze.’ has been deleted.

 

Section 6.6 Instructions for use, handling and disposal: The following paragraph has been added:

 

‘Any unused product or waste material should be disposed of in accordance with local requirements.’

 

The sentence ‘The patient should reconstitute the product and inject it immediately.’ has been deleted.

 

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 July 2006.

Updated on 20 August 2003

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 17 July 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 10 July 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)