Login

Tractocile 37.5 mg/5ml concentrate for solution for infusion

*
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):

    Atosiban Acetate

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

Updated on 31 March 2022

File name

Tractocile 5 ml SPC_In line with licence dated 30 03 2022.pdf

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 of marketing authorisation holder address

Updated on 15 February 2016

Reasons for updating

  • New SPC for new product

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

Updated on 15 February 2016

Reasons for updating

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

Section 4.8: reporting of side effects information added
Section 7: Telephone number for MA holder added

Updated on 15 February 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 4.8: reporting of side effects information added
Section 7: Telephone number for MA holder added

Updated on 21 March 2013

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 6.4 - 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 4.2:

Deletion of text:
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution.

Addition of text:

Patients with renal or hepatic impairment

There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution.

 

Paediatric population

The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established.

No data are available.

Method of administration
For instructions on preparation of hte medicinal product before administration, see section 6.6.


Section 4.4:

 

Addition of text:
Multiple pregnancy and tocolytics like calcium channel blockers and betamimetics are known to be associated with increased risk of pulmonary oedema. Therefore, atosiban should be used with caution in case of multiple gestations and/or concomitant administration of other tocolytics.


Section 4.8:
Addition of text:
Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other tocolytics like calcium antagonists and beta-mimetics and/or multiple pregnancy, have been reported post-marketing.

Section 6.4:
Addition of text:

For storage conditions after first opening of the medicinal product, see section 6.3.

Updated on 21 March 2013

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 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Section 4.2:

Deletion of text:
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution.

Addition of text:

Patients with renal or hepatic impairment

There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution.

 

Paediatric population

The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established.

No data are available.

Method of administration
For instructions on preparation of hte medicinal product before administration, see section 6.6.


Section 4.4:

 

Addition of text:
Multiple pregnancy and tocolytics like calcium channel blockers and betamimetics are known to be associated with increased risk of pulmonary oedema. Therefore, atosiban should be used with caution in case of multiple gestations and/or concomitant administration of other tocolytics.


Section 4.8:
Addition of text:
Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other tocolytics like calcium antagonists and beta-mimetics and/or multiple pregnancy, have been reported post-marketing.

Section 6.4:
Addition of text:

For storage conditions after first opening of the medicinal product, see section 6.3.

Updated on 05 September 2011

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 4 years

Updated on 05 September 2011

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 4 years

Updated on 10 June 2010

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Section 1: Name changed to 'Tractocile 37.5 mg/5 ml concentrate for solution for infusion'

Section 2: Updated to 'Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate). Each ml of solution contains 7.5 mg atosiban.'

Section 4.2:  Updated warning on hepatic function.

Section 4.4: Updated information on impaired renal and hepatic function.

Section 4.5:  Updated information indicating that interaction studies were performed with labetalol adn betamethasone and no clinically relevant interaction was found.

Section 4.6: Lactation statement updated 'If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with TRACTOCILE, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.'

Section 4.8: Undesirable effects presented in MedDra format.  Statement included: 'The observed adverse reactions were generally of a mild severity. The most commonly reported adverse reaction in the mother is nausea (14 %).'

Updated on 10 June 2010

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 1: Name changed to 'Tractocile 37.5 mg/5 ml concentrate for solution for infusion'

Section 2: Updated to 'Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate). Each ml of solution contains 7.5 mg atosiban.'

Section 4.2:  Updated warning on hepatic function.

Section 4.4: Updated information on impaired renal and hepatic function.

Section 4.5:  Updated information indicating that interaction studies were performed with labetalol adn betamethasone and no clinically relevant interaction was found.

Section 4.6: Lactation statement updated 'If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with TRACTOCILE, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.'

Section 4.8: Undesirable effects presented in MedDra format.  Statement included: 'The observed adverse reactions were generally of a mild severity. The most commonly reported adverse reaction in the mother is nausea (14 %).'

Updated on 14 November 2008

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

Section 6:  Change in MA holder

Updated on 14 November 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 6:  Change in MA holder

Updated on 27 August 2007

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 27 August 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 05 July 2005

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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)

Updated on 05 July 2005

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of renewal of authorisation
  • 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