Menopur 75IU Powder and Solvent for Solution for Injection. Menotrophin (HMG) *
Pharmacy Only: Prescription

  • Company:

    Ferring Ireland Limited
  • Status:

    No Recent Update
  • Legal 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

Updated on 28 July 2015

Reasons for updating

  • New SPC for new product

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

Updated on 28 July 2015

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf life reduced from 3 years to 2 years.

Updated on 28 July 2015

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf life reduced from 3 years to 2 years.

Updated on 25 May 2015

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

Update to include new HPRA contact information

Updated on 25 May 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Update to include new HPRA contact information

Updated on 24 July 2013

Reasons for updating

  • 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 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 5 - Pharmacological 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

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

Free text change information supplied by the pharmaceutical company

Section 2:
composition statements updated to "Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 75 IU and luteinizing hormone activity LH 75 IU.

 Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in MENOPUR and is the main contributor of the LH activity. "


 Section 4.2:
-
"Method of administration" moved to end of section
- "Paediatric population" secton added
- sentence udpated from "In line with clinical trials with Menopur that involved downregulation with GnRH agonists Menopur therapy should start approximately 2 weeks after the start of agonist treatment"
to 
 "In a protocol using down-regulation with a GnRH agonist MENOPUR therapy should start approximately 2 weeks after the start of agonist treatment.  In a protocol using down-regulation with a GnRH antagonist, MENOPUR therapy should start on day 2 or 3 of the menstrual cycle."

Section 4.4:
sentence added: "In very rare cases, severe OHSS may be life-threatening."

Section 4.6:
Section updated to:

 

"Fertility

MENOPUR is indicated for use in infertility (see section 4.1).

 

Pregnancy

MENOPUR is contraindicated in women who are pregnant (see section 4.3).

There are no or limited amount of data from the use of menotrophins in pregnant women.  No animal studies have been carried out to evaluate the effects of MENOPUR during pregnancy (see section 5.3).

 

Lactation

MENOPUR is contraindicated in women who are lactating (see section 4.3)"


Section 4.7:
section updated to: "No studies on the effects on the ability to drive and use machines have been performed.  However, MENOPUR is unlikely to have influence on the patient’s ability to drive and use machines."

 

Section 4.8:
Full section update

Sections 5.1, 5.2 and 5.3: full updates

Section 6.4:
text reworded and new text included "Do not freeze".








 

 

Updated on 24 July 2013

Reasons for updating

  • 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 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 5 - Pharmacological 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

Free text change information supplied by the pharmaceutical company

Section 2:
composition statements updated to "Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 75 IU and luteinizing hormone activity LH 75 IU.

 Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in MENOPUR and is the main contributor of the LH activity. "


 Section 4.2:
-
"Method of administration" moved to end of section
- "Paediatric population" secton added
- sentence udpated from "In line with clinical trials with Menopur that involved downregulation with GnRH agonists Menopur therapy should start approximately 2 weeks after the start of agonist treatment"
to 
 "In a protocol using down-regulation with a GnRH agonist MENOPUR therapy should start approximately 2 weeks after the start of agonist treatment.  In a protocol using down-regulation with a GnRH antagonist, MENOPUR therapy should start on day 2 or 3 of the menstrual cycle."

Section 4.4:
sentence added: "In very rare cases, severe OHSS may be life-threatening."

Section 4.6:
Section updated to:

 

"Fertility

MENOPUR is indicated for use in infertility (see section 4.1).

 

Pregnancy

MENOPUR is contraindicated in women who are pregnant (see section 4.3).

There are no or limited amount of data from the use of menotrophins in pregnant women.  No animal studies have been carried out to evaluate the effects of MENOPUR during pregnancy (see section 5.3).

 

Lactation

MENOPUR is contraindicated in women who are lactating (see section 4.3)"


Section 4.7:
section updated to: "No studies on the effects on the ability to drive and use machines have been performed.  However, MENOPUR is unlikely to have influence on the patient’s ability to drive and use machines."

 

Section 4.8:
Full section update

Sections 5.1, 5.2 and 5.3: full updates

Section 6.4:
text reworded and new text included "Do not freeze".








 

 

Updated on 16 March 2011

Reasons for updating

  • 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

Update to mixing details

Updated on 16 March 2011

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Update to mixing details

Updated on 19 May 2009

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 2 to 3 years

Updated on 19 May 2009

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 2 to 3 years

Updated on 02 April 2009

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 - change in shelf-life to 3 years

Updated on 02 April 2009

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Section 6.3 - change in shelf-life to 3 years

Updated on 29 July 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4    This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.
 
Section 5.1    ATC code: G03G A02

Updated on 29 July 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Section 4.4    This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.
 
Section 5.1    ATC code: G03G A02

Updated on 17 September 2007

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

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 4.1-Therapeutic Indications-Annovulation
Change to section 4.2 - Posology and method of administration-Dosage regimens for Women with annovulation(including PCOD) and ART Dosages.
Change to section 4.3-Contra-indications updated for men and women to include various cancers(pituitary gland, hypothalmus, ovarian, mammary, uterine, testes, prostate) and hypersensitivity to ingredients,
Change to section 4.4-Special warnings and precautions for use: OHSS, Multiple pregnancy,pregnancy wastage, ectopic pregnancy, reproductive system neoplams, congenital malformation, thromboembolic events.
Change to section 4.5-Interactions with other medications
Change to section 4.8 -Undesirable effects-Distributed by SOC and frequency
Change to section 4.9-Overdose
Change to section 5.2 -Pharmacokinetic properties-maximum serum level and half-life.
                                                                                        

Updated on 17 September 2007

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Change to section 4.1-Therapeutic Indications-Annovulation
Change to section 4.2 - Posology and method of administration-Dosage regimens for Women with annovulation(including PCOD) and ART Dosages.
Change to section 4.3-Contra-indications updated for men and women to include various cancers(pituitary gland, hypothalmus, ovarian, mammary, uterine, testes, prostate) and hypersensitivity to ingredients,
Change to section 4.4-Special warnings and precautions for use: OHSS, Multiple pregnancy,pregnancy wastage, ectopic pregnancy, reproductive system neoplams, congenital malformation, thromboembolic events.
Change to section 4.5-Interactions with other medications
Change to section 4.8 -Undesirable effects-Distributed by SOC and frequency
Change to section 4.9-Overdose
Change to section 5.2 -Pharmacokinetic properties-maximum serum level and half-life.
                                                                                        

Updated on 01 September 2006

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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

All changes due to update to section 4.2 of SPC and recently finalised renewal.

Updated on 01 September 2006

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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

Free text change information supplied by the pharmaceutical company

All changes due to update to section 4.2 of SPC and recently finalised renewal.

Updated on 27 June 2005

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 27 June 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie