Puregon Cartridge 300 IU, 600 IU, 900 IU

  • Name:

    Puregon Cartridge 300 IU, 600 IU, 900 IU

  • Company:
    info
  • Active Ingredients:

    Follitropin beta

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/08/18

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Summary of Product Characteristics last updated on medicines.ie: 3/8/2018

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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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 3 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 3 August 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)

Free text change information supplied by the pharmaceutical company

Update to Marketing Authorisation Holder name and address in section 7 of the SPC

Updated on 2 June 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 2 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 June 2016 SmPC

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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • 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

Detailed SPC change information: Change to combined the SPCs for Puregon 300IU, 600IU and 900IU vials and to update to QRD v9.1

Updated on 2 June 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of joint PIL covering all presentations
  • Change to product name

Updated on 13 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 9 May 2014 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 4.8 - Undesirable effects
  • 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

Change to separate SPCs covering individual presentations and 4.2 Posology and method of administration, 4.4 – Special warnings and precautions for use, 4.6 – Fertility, pregnancy and lactation, 4.8 – Undesirable effects, 5.2 Pharmacokinetic properties and section 10 date of revision due to approval of EMEA/H/C/0001042/WS/465

Updated on 9 December 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 4 November 2013 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

sections 5.1 (Pharmacodynamic properties), 7 (Marketing authorisation holder), 8 (MA Number), 9 (Date of renewal of authorisation) and 10 (Date of revision of the text)

Change of MA Holder from Organon to Merck Sharpe & Dohme

Updated on 30 October 2013 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 26 January 2012 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)

Free text change information supplied by the pharmaceutical company

The following changes have been made to section 7. Marketing Authorisation Holder of the SmPC as follows:

 N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BHBH NL-5349 AB Oss, The Netherlands

Updated on 25 January 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 20 July 2011 SmPC

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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

Section 4.1 Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.

Section 4.2 Based on the results of comparative clinical studies, it is considered appropriate to give a lower total dosage of Puregon over a shorter treatment period 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).

The first injection with Puregon should be performed under direct medical supervision

Section 4.3 Addition of the following sub-headings, "For males and females", "Additionally for females", and an extra bullet point for "Primary gonadal failure".
Update to two bullet points to include, "syndrome (PCOS)" and "reproductive"

Section 4.4 Addition of new bullet point, "Puregon may contain traces of streptomycin and/or neomycin. These antibiotics may cause hypersensitivity reactions in susceptible persons".

Two subheadings, "In females" and "In males".

 New bullet point under "In females" subheading,

"Ovarian torsion has been reported after treatment with follitropin beta and after intervention with other gonadotropins. This may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.

" Section 4.6 Addition of three subheadings, "Fertility", "Pregnancy" and "Lactation"
Following statement under Fertility, "Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes. In males Puregon is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism. For posology and method of administration, see section 4.2."
 
Following statement under Lactation, "There is no information available from clinical or animal studies on the excretion of follitropin beta in milk. It is unlikely that follitropin beta is excreted in human milk due to its high molecular weight. If follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of the child. Follitropin beta may affect milk production.

" Section 4.8 Update to include formatting of adverse reactions into two tables (female and male) listed in line with system organ class and frequency.
Following statement under the female table of adverse events, "In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are considered to be related to the ART procedure or subsequent pregnancy."

Section 5.1 In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian stimulation in women participating in an assisted reproduction technology (ART) program and for ovulation induction (see tables 1 and 2 below), Puregon was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.

For controlled ovarian stimulation, Puregon resulted in a higher number of oocytes retrieved at a lower total dose and with a shorter treatment period, when compared to urinary FSH.

Updated on 19 July 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 19 March 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 1 March 2010 SmPC

Reasons for updating

  • 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 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

Reasons for adding or updating:

Change to section 3 - Pharmaceutical form
the word injection is added in brackets

Change to section 4.2 - Posology and method of administration

Section 4.2 - Second paragraph under "posology" changed from:

In comparative clinical studies with Puregon and urinary FSH it was shown that Puregon is more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions. Therefore, it is considered appropriate to give a lower dosage of Puregon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.

 

to:

Based on the results of comparative clinical studies it is considered appropriate to give a lower dosage of Puregon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.



4.4          Special warnings and precautions for use

 

The text in bold has been added:

 

·                Unwanted ovarian hyperstimulation: in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment. Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values. The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of Puregon should be discontinued. In that case pregnancy should be avoided and hCG must be withheld, because it may induce, in addition to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS). Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts.  Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with ovarian hyperstimulation syndrome.  In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening. This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS.

Change to section 4.8 - Undesirable Effects

4.8     Undesirable effects

 

The text in bold has been added – the text with strikethrough has been removed:

 

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection:such as bruising, pain, redness, swelling and itching are commonly reported (3% of all patients treated). The majority of these local reactions  which are mild and transient in nature. Very rarely Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Puregon).

 

Treatment of women:

In 3% approximately 4% of the women treated with Puregon in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).  Other undesirable effects related to this syndrome were observed in clinical studies.  These include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints (breast tenderness, pain and/or engorgement), ovarian enlargement, and spontaneous abortion.  They were all reported at an incidence of approximately 1% (pelvic pain and abdominal distension) or less.

A slightly increased risk of ectopic pregnancy and multiple gestations has been seen.

Other more general symptoms that have been reported include headache and nausea (in up to 1% of the women treated with Puregon).

In rare instances, thromboembolism has been associated with Puregon/hCG therapy as with other gonadotrophins.

 

 

 

 Change to section 10 date of revision of the text

Date of Revision of Text is now 23 November 2009

Updated on 24 February 2010 PIL

Reasons for updating

  • Change of manufacturer
  • Change to side-effects

Updated on 25 October 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 August 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

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