GONAL-f 450 IU (33 mcg) pen
*Company:
MerckStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
IENI IFU - Gonal-F 450IU pen - TW3864471 TW 4079830.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Correction of nominal volume and editorial changes
Our reference: TW 4079830
Updated on 24 October 2023
File name
IENI PIL - Gonal-F 450IU pen - TW3864471 TW 4079830.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update of section 3 to align with current clinical practice.
Correction of nominal volume and amendment of storage conditions (see section 5 and 6)
Our reference: TW3864471 / 4079830
Updated on 24 October 2023
File name
IENI SPC - Gonal-F 450IU pen - TW3864471 TW 4079830.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 6.6 - Special precautions for disposal and other handling
- 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
Correction of nominal volume and amendment of storage conditions (see section 1, 2, 6.3, 6.4 ,6.5 ,6.6)
Update to align text with current clinical practice (se sections 4.2 and 4.4)
Our reference: TW3864471 / 4079830
File name
IENI IFU - Gonal-F 450IU pen - TW3499617 - clean.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of Instructions for use (IFU) - change to layout, the addition of a sentence to clarify how the injection button must be pressed & implementation of MDR
Internal Reference number: TW3499617
Updated on 25 August 2022
File name
IENI PIL - Gonal-F 450IU pen - TW3499617 - clean.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
IENI SPC - Gonal-F 450IU pen - TW3499617 - v5 clean.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
Package leaflet 450IU pen.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 28 January 2020
File name
Gonal F 450iu prefilled pen UK & ROI TW2140571 v4.0 current - Clean.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 18 September 2018
File name
Package leaflet 450IU pen.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 prefilled pen UK & ROI TW1735675 v3.0 current.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 17 September 2018
File name
Gonal F 450iu powder UK & ROI TW1735675 v3.0 current.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)
File name
Gonal-f 450IU (33 mcg) pen - Instructions for use.pdf
Reasons for updating
- Add New Doc
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
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_15320_338.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 14 April 2014
Reasons for updating
- Change of distributor details
Updated on 24 October 2012
Reasons for updating
- Change of distributor details
Updated on 30 July 2012
Reasons for updating
- Change of distributor details
Updated on 10 April 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 08 September 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 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
3. PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
....
4. CLINICAL PARTICULARS
.....
4.2 Posology and method of administration
Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Patients must be provided with the correct number of pens for their treatment course and educated to use the proper injection techniques.
Posology
The dose recommendations given....
Method of administration
.......
For instructions on the administration with the pre-filled pen, see section 6.6 and the
“Instructions for Use”.
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.
......
4.8 Undesirable effects
.....
Mild or moderate ovarian hyperstimulation syndrome (OHSS)
has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4).
....
6.5 Nature and contents of container
GONAL-f 300 IU/0.5ml PEN
.....
Pack of one pre-filled pen and
8 needles to be used with the pen for administration
GONAL-f 450 IU/0.5ml PEN
.....
Pack of one pre-filled pen and
12 needles to be used with the pen for administration
GONAL-f 900 IU/0.5ml PEN
.....
Pack of one pre-filled pen and
20 needles to be used with the pen for administration
6.6 Special precautions for disposal and other handling
See the
“Instructions for Use”.
.....
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 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
Updated on 28 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
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 04 September 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
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 |
u-FSH |
|
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 23 May 2008
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Store in a refrigerator (2°C - 8°C). Do not freeze.
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months. Store in the original package in order to protect from light.
For in-use storage conditions, see section 6.3.
Updated on 16 August 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- 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: 45 mg sucrose, 0.8325 mg disodium phosphate dihydrate, 0.3375 mg sodium dihydrogen phosphate monohydrate, 0.075 mg methionine, 2.25 mg m-cresol, 0.075 mg poloxamer 188.
‘For a full list of excipients, see section 6.1.’
Section 3 Pharmaceutical Form: pH added.
Section 4.4 Special warnings and precautions for use: The following warnings have been added:
‘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.’
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 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 ‘After first use: 28 days (within the 2 year shelf-life) has been amended to ‘After first use: 28 days (within the shelf-life)’.
Section 6.5 Nature and contents of container: The first sentence has been amended as follows: 1.5 ml of solution for injection in 3 ml cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
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 01 November 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 06 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 May 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)