Decapeptyl (triptorelin) SR

  • Name:

    Decapeptyl (triptorelin) SR

  • Company:
    info
  • Active Ingredients:

    triptorelin acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/01/19

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Summary of Product Characteristics last updated on medicines.ie: 18/5/2018
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Ipsen Pharmaceuticals Ltd

Ipsen Pharmaceuticals Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Cabometyx Tablets Active Ingredients Cabozantinib
Medicine Name Decapeptyl (triptorelin) 3-month Active Ingredients triptorelin pamoate
Medicine Name Decapeptyl (triptorelin) SR Active Ingredients triptorelin acetate
Medicine Name Decapeptyl 6 Month 22.5mg Active Ingredients triptorelin pamoate
Medicine Name Dysport Active Ingredients Clostridium botulinum type A toxin-haemagglutinin complex
Medicine Name Hexvix 85 mg powder and solvent for solution for intravesical use Active Ingredients Hexaminolevulinate Hydrochloride
Medicine Name INCRELEX Active Ingredients Mecasermin
Medicine Name Mucodyne 375mg Capsules- Discontinued Active Ingredients Carbocisteine
Medicine Name NutropinAq Active Ingredients Somatropin
Medicine Name Somatuline Autogel 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe Active Ingredients Lanreotide acetate
Medicine Name Somatuline LA 30mg Active Ingredients Lanreotide acetate
Medicine Name Xermelo 250 mg film-coated tablets Active Ingredients Telotristat ethyl
1 - 0 of 12 items.Total: Infinity pages

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 9 January 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 18 May 2018

Updated on 18 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 January 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 21 January 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

In Section 4.2 Posology and Method of Administration

The following (bold) text was added:

Male Adults only: one intramuscular or subcutaneous injection every three months.

 

Endometriosis:

Female adults only: one intramuscular injection every three months.

 

Decapeptyl 3-month 11.25 mg must not be injected intravascularly.

Subcutaneous administration has not been studied in women and children.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.


In Section 4.3 Contraindications -the text has been updated to read:
Hypersensitivity to GnRH (gonadotropin releasing hormone), its analogues or to any of the excipients listed in section 6.1.

In Section 4.8 Undesirable effects: The adverse events tables have been extensively updated. The most common undesirable effects now are:
Prostate cancer: Very common: Libido decreased, erectile dysfunction, asthenia, hyperhidrosis, back pain, paraesthesia in lower limbs and hot flush. Common: Hypersensitivity, hypertension, dry mouth, nausea, injection site reaction (including erythema, inflammation, pain), oedema, weight increased, musculoskeletal pain, pain in extremity, pelvic pain, dizziness, headache, depression, mood change and loss of libido. Endometriosis and uterine fibroids: Very common: Headache, libido decreased, sleep disorder (including insomnia), mood disorder, breast disorder, dyspareunia, genital bleeding (including vaginal bleeding, withdrawal bleed), ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness, asthenia, acne, seborrhoea, hyperhidrosis and hot flush. Common: Hypersensitivity, nausea, abdominal pain, abdominal discomfort, injection site reaction (including erythema, inflammation, swelling, pain), oedema peripheral, weight increased, arthralgia, muscle spasms, pain in extremities, depression, nervousness, dizziness and breast pain. Precocious puberty: Very common: Vaginal bleeding (including discharge, spotting, haemorrhage, withdrawal bleed, uterine haemorrhage). Common: Abdominal pain, acne, injection site reaction (including erythema, inflammation, pain), headache, hot flush, weight increased and hypersensitivity.

Section 5.1 Pharmacodynamic Properties was updated with technical information surmising that:

In men, administration via subcutaneous route or intramuscular route achieved similar results (about 20 days to achieve castration level and castration still maintained 3 months after administration).

 

In Section 5.2 Pharmacokinetic Properties:

 

The following text was added:

 

The pharmacokinetic properties following subcutaneous injection of Decapeptyl

3-month11.25 mg in men are similar to those observed after intramuscular injection: the plasma concentration peak of triptorelin is rapidly achieved after the administration (median Tmax ranged from 2.0 to 4.5 h, whatever the route of administration subcutaneous or intramuscular) and triptorelin is continuously released over the 91-day period. Three months after subcutaneous or intramuscular administration, the residual levels of triptorelin (Cmin) were similar (0.062 ng/ml for subcutaneous route, 0.032-0.063 ng/ml for intramuscular route).

 

In Section  6.6 Special precautions for disposal and other handling: the text has been updated to differentiate between reconstitution needle and administration needle(s) (with safety device): 

The suspension for injection must be reconstituted using an aseptic technique and only using the ampoule of solvent for injection.

The instructions for reconstitution hereafter and in the leaflet must be strictly followed.

The solvent should be drawn into the syringe provided using the reconstitution needle (20 G, without safety device) and transferred to the vial containing the powder. The suspension should be reconstituted by swirling the vial gently from side to side for long enough until a homogeneous, milky suspension is formed. Do not invert the vial.

It is important to check there is no unsuspended powder in the vial. The suspension obtained should then be drawn back into the syringe, without inverting the vial. The reconstitution needle should then be changed and the suspension should be injected immediately using the specific injection needle:

  • The 38 mm length needle (20 G) with safety device for intramuscular injection in the gluteal muscle (patients treated for prostate cancer, endometriosis or central precocious puberty)
  • The 25 mm length needle (20 G) with safety device for subcutaneous injection in abdomen or thigh (only patients treated for prostate cancer).

As the product is a suspension, the injection should be administered immediately after reconstitution to prevent precipitation.

For single use only.

Used needles, any unused suspension or other waste materials should be disposed of in accordance with local requirements.

 

Updated on 21 January 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 20 February 2015 SmPC

Reasons for updating

  • 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

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 Addition of:

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 Decapeptyl 6 month

Section 4.5 Addition of:

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Decapeptyl 6 Month 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).

Section 4.8 Addition of QT prolongation in AE table as an Adverse Event - SOC Cardiac Disorders - Frequency unknown as below:

 

System Organ Class

 Very Common AEs

Common AEs

Uncommon AEs

Rare AEs

Additional post-marketing AEs

≥10%

≥1% -<10%

≥0.1% -<1%

≥0.01% -<0.1%

Frequency Unknown

 

 

 

 

Cardiac Disorders

 

 

 

 

QT prolongation (see sections 4.4 and 4.5)

Updated on 17 February 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 24 October 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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

$0$0Insection 4.2 posology the following has been added - In patients withmetastatic castration resistant prostate cancer not surgically castratedreceiving triptorelin and eligible for treatment with androgen biosynthesisinhibitors, treatment with triptorelin needs to be continued.$0$0 $0$0In section 4.8 - undesirable effect  The AEreporting statement has been updated as follows: $0$0 $0$0Reporting ofsuspected adverse reactions$0$0Reporting ofsuspected adverse reactions after authorisation of the medicinal product isimportant.  It allows continued monitoring of the benefit/riskbalance of the medicinal product. Healthcare professionals are asked to reportany suspected adverse reactions via the national reporting system,$0$0Pharmacovigilance Section$0$0Irish Medicines Board$0$0Kevin O’Malley House$0$0Earlsfort Centre$0$0Earlsfort Terrace$0$0IRL-Dublin 2$0$0Tel: +353 1 6764971$0$0Fax: +353 1 6767836$0$0Website: www.imb.ie$0$0e-mail: imbpharmacovigilance@imb.ie$0$0 $0$0Insection 5.1  Pharmacodynamic Properties of the SmPC to reflectcurrent medical practice have been updated to include: $0$0Inpatients with metastatic castration-resistant prostate cancer, clinical studieshave shown the benefit from the addition of androgen $0$0biosynthesisinhibitors, such as abiraterone acetate to GnRH analogues, such as triptorelin.$0$0$0$0 $0$0

Updated on 17 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to MA holder contact details
  • Change due to user-testing of patient information

Updated on 7 May 2013 SmPC

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

$0Change in MAH address (7 Upper Leeson Street, Dublin 4, Ireland to Blanchardstown$0$0Industrial Park, Blanchardstown, Dublin 15, Ireland) and telephone (01 668 1377 to 01$0$0809 8200).$0

Updated on 25 January 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Minor changes are required to section 3, 4.6 (title), 5.1.

Updated on 27 June 2011 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

User Tested

Updated on 21 June 2011 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 26 April 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

2            Qualitative and quantitative composition


Excipients:

Sodium < 1mmol (23mg)




4.4            Special warnings and special precautions for use

This medicinal product contains less than 1mmol sodium (23mg) per dose and is considered essentially ‘sodium-free’.

Updated on 5 April 2011 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 27 May 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 May 2010 PIL

Reasons for updating

  • Change to appearance of the medicine
  • Change to dosage and administration
  • PIL retired pending re-submission

Updated on 23 July 2009 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 16 July 2009 SmPC

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

6.3 Shelf Life

The shelf life expiry date of the powder for injection shall not exceed three years from the date of its manufacture.

The shelf life expiry date of the solvent shall not exceed five years from the date of its manufacture.

The product should be used immediately after reconstitution.

Updated on 27 August 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 27 August 2008 SmPC

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

Section 6.6 : Instructions for use of safety needle have been added.

Updated on 25 January 2007 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

New indication in Precocious Puberty

Updated on 25 August 2006 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 23 August 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 May 2005 SmPC

Reasons for updating

  • 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 16 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 30 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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