Tractocile 37.5 mg/5ml concentrate for solution for infusion
*Company:
Ferring Ireland LimitedStatus:
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
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 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 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
Deletion 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
Deletion 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
Updated on 05 September 2011
Reasons for updating
- Change to section 6.3 - Shelf life
Free text change information supplied by the pharmaceutical company
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 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 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
Updated on 14 November 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
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
Ferring Ireland Limited
Address:
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, , IrelandMedical Information E-mail:
enquiries.ireland@ferring.comTelephone:
+353 1 463 7355Fax:
+353 1 463 7363Medical Information Direct Line:
+353 1 463 7355