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Salvacyl

Last Updated on eMC 25-Apr-2016 View document  | Ipsen Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 25-Apr-2016 and displayed until Current

Reasons for adding or updating:

  • 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 10 - Date of revision of the text
  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 06-Apr-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1: inclusion of prolonged release in product name
Section 2: update to excipient wording in line with QRD template
Section 3: inclusion of prolonged release pharmaceutical form and update to colour of powder
Section 4.4: inclusion of statement relating to risk benefit analysis and sodium free statement
Section 4.8 : inclusion of frequency not known statement before AE table.

Updated on 21-Jan-2016 and displayed until 25-Apr-2016

Reasons for adding or 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 07-Jan-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Addition of an administration device with CE marking:

Addition of a safety system onto the needle used for injection which is packed in the sterile injection kit. As previously approved, the kit also contains a needle without a safety system, used for reconstitution.

Section 4.2:  There is no relevant use of Salvacyl in the paediatric population.
Section 4.4:  Minor changes to terminology: agonist replaced with analogues, Salvacyl replaced with triptorelin.
Section 4.8: Yellowcard address update
Section 6.6:  Changes made to enhance the reconstitution instructions. Guidance provided on how to use the safety needle system.

Updated on 20-Aug-2015 and displayed until 21-Jan-2016

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 07-Aug-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



n section 2 (Qualitative and quantitative composition): The salt has been changed from ‘pamoate’ to ‘embonate’

In section 4.2 (Posology and method of administration) – The following information has been added:

Paediatric population

The safety and efficacy of Salvacyl in children have not been established. Salvacyl is not indicated for use in neonates, infants, children and adolescents.’

In section 4.3 (Contraindications) – the following information in bold has been added:

‘Hypersensitivity to gonadotropin releasing hormone (GnRH), its analogues or any other component of the medicinal product (see section 4.8) or to any of the excipients listed in section 6.1.’

In section 4.4 (Special warnings and precautions for use) – The following information has been added after the 11th paragraph:

‘Androgen deprivation therapy may prolong the QT interval.

In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Salvacyl.’

In section 4.5 (Interaction with other medicinal products and other forms of interaction) – The following information has been added:

‘Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Salvacyl with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).’

In section 4.8 (Undesirable effects) – QT prolongation has been added to the additional post-marketing AEs column under cardiac disorders.

The following information has been added:

‘Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

In section 5.1 (Pharmacodynamic properties) – The heading ‘Clinical efficacy’ has been changed to ‘Clinical efficacy and safety’.

In section 5.2 (Pharmacokinetic properties) – The following information has been added:

Pharmacokinetic/pharmacodynamics relationship

The pharmacokinetics/pharmacodynamics relationship of triptorelin is not straightforward to assess, since it is non-linear and time-dependent. Thus, after acute administration in naive subjects, triptorelin induces a dose-dependent increase of LH and FSH responses.

When administered as a sustained release formulation, triptorelin stimulates LH and FSH secretion during the first days post dosing and, in consequence, testosterone secretion. As shown by the results of the different bioequivalence studies, the maximal increase in testosterone is reached after around 4 days with an equivalent Cmax which is independent from the release rate of triptorelin. This initial response is not maintained despite continuous exposure to triptorelin and is followed by a progressive and equivalent decrease of testosterone levels. In this case too, the extent of triptorelin exposure can vary markedly without affecting the overall effect on testosterone serum levels.’

Updated on 18-Dec-2012 and displayed until 20-Aug-2015

Reasons for adding or updating:

  • 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

Date of revision of text on the SPC: 30-Nov-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 Special warnings and precautions for use: The following information has been added "There is an increased risk of incidentdepression (which may be severe) in patients undergoing treatment with GnRHagonists, such as triptorelin. Patients should be informed accordingly andtreated as appropriate if symptoms occur."$0The following information has been deleted: "Mood changes, including depression have been reported."$0$0$0$0$0In section 4.8 Undesirable effects: In the second sentence "impotence" has been changed to "erectile dysfunction"$0$0In the adverse event table, under System organ class - Psychiatric disorders "Depression" and "Mood swings" have been removed from the Uncommon AEs column and "Depression" and "Mood changes" have been added to the Common AEs column.$0

Updated on 04-Dec-2012 and displayed until 18-Dec-2012

Reasons for adding or updating:

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 10-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.6 Special precautions for disposal and other handling - the following information has been added to beginning of the first sentence "Using one of the injection needles, all of the .." and the following information has been removed from the end of the first sentence "...using the plain injection needle".$0The 4th sentence has been amended to read "The injection needle has to be changed and the produced suspension for injection should be administered immediately."$0$0$0$0$0$0

Updated on 06-Aug-2012 and displayed until 04-Dec-2012

Reasons for adding or updating:

  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 16-Jul-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 9 Date of first authorisation/Renewal of the authorisation - the following has been added: Date of latest renewal: 09 June 2011$0$0

Updated on 01-Jun-2011 and displayed until 06-Aug-2012

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 date of revision of the text

Date of revision of text on the SPC: 13-May-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 2 Qualitative and quantative composition - emobonate has been changed to pamoate

In section 4.3 Contraindications - wording has been amended to read:

Hypersensitivity to gonadotropin releasing hormone (GnRH), its analogues or any other component of the medicinal product (see section 4.8).

In section 4.4 Special Warnings and precautions for use - the following information has been added:

Long term androgen deprivation either by bilateral orchidectomy or administration of GnRH agonists is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture. Preliminary data suggest that the use of a bisphosphonate in combination with a GnRH agonist may reduce bone mineral loss. Particular caution is necessary in patients with additional risk factors for osteoporosis (e.g. chronic alcohol abuse, smokers, long-term therapy with drugs that reduce bone mineral density, e.g. anticonvulsants or corticosteroids, family history of osteoporosis, malnutrition).

Mood changes, including depression have been reported.  Patients with known depression should be monitored closely during therapy.

In addition, from epidemiological data, it has been observed that patients may experience metabolic changes (e.g. glucose intolerance), or an increased risk of cardiovascular disease during androgen deprivation therapy. However, prospective data has not confirmed the link between treatment with GnRH analogues and an increase in cardiovascular mortality. Patients at high risk of metabolic or cardiovascular diseases should be carefully assessed before commencing treatment and adequately monitored during androgen deprivation therapy.

In section 4.5 Interaction with other medicinal products and other forms of interaction - the following information has been added:

When triptorelin is co-administered with drugs affecting pituitary secretion of gonadotropins, caution should be exercised and it is recommended that the patient’s hormonal status be supervised.

In section4.8 Undesirable effects - additional information has been added, please SPC for full information.

 

 

Updated on 21-Dec-2010 and displayed until 01-Jun-2011

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Ipsen Ltd

Company image
Address

190 Bath Road, Slough, Berkshire, SL1 3XE

Fax

+44 (0)1753 627 778

Medical Information e-mail
Telephone

+44 (0)1753 627 777

Medical Information Direct Line

+44 (0)1753 627 777

Customer Care direct line

+44 (0)1753 627 627

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

triptorelin embonate

Legal categories

POM - Prescription Only Medicine

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