Prostap 6 DCS
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 08 July 2024
File name
ie-pl-prostap-6-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
File name
ie-hpul-prostap-6-clean.pdf
Reasons for updating
- Replace File
Updated on 08 July 2024
File name
ie-spc-prostap-6-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 July 2024
File name
ie-pl-prostap-6-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
File name
ie-hpul-prostap-6-clean.pdf
Reasons for updating
- Add New Doc
Updated on 12 October 2023
File name
ie-spc-prostap-6-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 June 2022
File name
ie-pl-prostap-6-clean-ccds-19.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 June 2022
File name
ie-spc-prostap-6-clean-03-06-2022.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.4 information on Idiopathic intracranial hypertension has been added.
In section 4.8 Idiopathic intracranial hypertension has been added as frequency unknown to adverse reactions.
Date of revision: 03/06/2022
Updated on 18 September 2020
File name
m1-3-1-leaflet-prostap-6-IRL-24.08.2020-clean Art31.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
In section 3, ‘How to use Prostap 6’, the following wording has been added: PROSTAP 6 should only be administered by your doctor or a nurse who will also take care of the preparation of the product.
Updated on 18 September 2020
File name
m1-3-1-SPC-prostap-6-IRL-24.08.2020-clean-Art31.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.2, ‘Posology and method of administration’ the following text has been added: PROSTAP 6 should be prepared, reconstituted and administered only by healthcare professionals who are familiar with these procedures.
The date of revision is 24/08/2020.
Updated on 06 July 2020
File name
m1-3-1-leaflet-prostap-6-IRL-28.05.2020.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been aligned with the Company Core Data Sheet (CCDS).
Updated on 06 July 2020
File name
m1-3-1-SPC-prostap-6-IRL-28.05.2020.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 6.2 - Incompatibilities
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Following an alignment with the Company Core Data Sheet, the following changes have been made to the SmPC:
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Section |
Change |
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2 QUALITATIVE AND QUANTITATIVE COMPOSITION |
Update/Removal of text: Powder: Each single-dose syringe contains contains 30 mg leuprorelin acetate
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3 PHARMACEUTICAL FORM |
Update: Solvent: A colourless, odourless, slightly viscous, aqueous sterile solvent. |
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4.2 Posology and method of administration |
Update: Prostate Cancer: The
Response to PROSTAP 6 therapy should be monitored by clinical parameters and by measuring prostate-specific antigen (PSA) and testosterone serum levels…Transient increases in PSA levels sometimes occur early in the treatment period but usually return to normal or near normal values by the 4th week of treatment. |
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4.3 Contraindications |
Minor updates: Hypersensitivity to the leuprorelin, any of the excipients (listed in section 6.1) or to other synthetic gonadotrophin releasing hormone (Gn-RH) analogues or Gn-RH derivatives. |
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4.4 Special warnings and precautions for use |
Added: PROSTAP 6 injectable suspension must be prepared at the time of use and, after reconstitution, used immediately.
Updated: ...Patients should be informed and monitored accordingly and treated as appropriate if symptoms occur.
In order to reduce the risk of flare, an anti-androgen may be administered beginning 3 days prior to leuprorelin therapy and continuing for the first two to three weeks of treatment. This has been reported to prevent the sequelae of an initial rise in serum testosterone. If an anti-androgen is used over a prolonged period, due attention should be paid to the contra-indications and precautions associated with its extended use. … Patients at risk of or with ureteric obstruction or spinal cord compression due to metastasis should be considered carefully and closely supervised in the first few weeks of treatment as bone pain, weakness of the lower extremities and paraesthesia (as neurologic symptoms) may occur. … Bone mineral loss: Long-term androgen deprivation either by bilateral orchiectomy or administration of GnRH analogues is associated with increased risk of bone mineral loss which, in patients with additional risk factors, may lead to osteoporosis and an increased risk of bone fracture (see section 4.8).
Epidemiological data have shown that
… 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 risks and benefits
PROSTAP 6 contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say it is essentially ‘sodium free’. |
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4.5 Interaction with other medicinal products and other forms of interaction |
Update: No interaction studies have been performed |
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4.8 Undesirable effects |
The following table lists adverse reactions with leuprorelin based on experience from clinical trials as well as from post-marketing experience. Adverse reactions are grouped by MedDRA System Organ Classes and frequency classification. Frequencies are defined as follows: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (>1/1,000 to <1/100), rare (> 1/10,000 to < 1/1.000), very rare (< 1/10,000), not known (cannot be estimated from the available data)). … In cases where a "tumour flare" occurs after PROSTAP 6 therapy, an exacerbation may occur in any symptoms or signs due to disease. Adverse events, which may occur particularly at the beginning of treatment include urinary tract obstruction (as urinary symptoms). In patients with spinal cord compression, bone pain, weakness of lower extremities and paresthesia (as neurologic symptoms) may also occur (see section 4.4). These symptoms subside on continuation of therapy.
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6.2 Incompatibilities |
Added: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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6.6 Special precautions for disposal and other handling |
Added: Prepare the injectable suspension at the time of use and, after reconstituting, use immediately.
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10 Date of revision of the text |
28th May 2020 |
Updated on 29 May 2020
File name
m1-3-1-leaflet-prostap-6-ire-proposed-clean-12.05.2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The MAH (Takeda Products Ireland Limited) address has been changed to:
6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland.
This is the legally registered office.
Also, the local representative/’trading as’ address has been added to the PIL:
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
The date of revision of the SmPC is February 2020.
Updated on 29 May 2020
File name
m1-3-1-spc-prostap-6-ire-proposed-clean-12.05.2020.pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 11, the MAH (Takeda Products Ireland Limited) address has been changed to:
6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland.
This is the legally registered office.
In section 10, the date of revision of the SmPC is 12th May 2020.
Updated on 22 August 2019
File name
m1-3-1-SPC-prostap-6-09.06.2018.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 July 2019
File name
m1-3-1-leaflet-prostap-6-09.06.2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 June 2018
File name
m1-3-1-SPC-prostap-6-09.06.2018.docx
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The updated Prostap DCS SmPCs contain additional information in the following section(s):
- In section 4.8 (undesirable effects), interstitial lung disease has been added as a side effect with unknown frequency.
- The date of revision is 09/06/2018.
Updated on 24 May 2018
File name
m1-3-1-SPC-prostap-6-27.04.2018.docx
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The HPRA has renewed the licence for Prostap DCS.
Updated on 02 November 2016
File name
PIL_15203_266.pdf
Reasons for updating
- New PIL for new product
Updated on 02 November 2016
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 March 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 March 2016
Reasons for 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section |
Details of change |
|
4.4 Special warnings and precautions for use |
Text in red added: … Postmarketing reports of seizures have been observed in patients treated with leuprorelin acetate and these events have been reported in both children and adults, and in those with or without a history of epilepsy, seizure disorders or risk disorders for seizures.
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4.8 Undesirable effects |
Text in red added … Nervous system disorders: Common: headache (occasionally severe) Rare: dizziness Very rare: pituitary apoplexy has been reported after administration of both short-and long acting GnRH agonists Not known: paralysis, seizure
… Nervous system disorders: Common: headache Not known: seizure
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10. Date of revision of the text |
Updated text in red:
23 February 2016 |
Updated on 03 March 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 03 July 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of castrate-resistant prostate cancer. Reference should be made to relevant guidelines.
5.1 Pharmacodynamic properties
Leuprorelin acetate is inactive when given orally.
In patients with metastatic castration resistant prostate cancer, clinical studies have shown benefit from the addition of secondary agents to treatment with LHRH agonists such as leuprorelin. Androgen deprivation therapy (ADT) is generally continued in conjunction with secondary therapies after progression on the initial ADT regimen.
10 DATE OF REVISION OF THE TEXT
23 June 2015
Updated on 17 November 2014
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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section |
Details of change |
4.4 Special warnings and precautions for use |
Addition of text:
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 PROSTAP 6. |
4.5 Interaction with other medicinal products and other forms of interaction |
Addition of text:
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of PROSTAP 6 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).
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4.8 Undesirable effects |
Addition of text:
Cardiac disorders: Not known, palpitations, QT prolongation (see sections 4.4 and 4.5)
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10 DATE OF REVISION OF THE TEXT |
31/10/2014 |
Updated on 17 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 02 October 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SECTION 7. MARKETING AUTHORISATION HOLDER
Change of address of Marketing Authorisation Holder to:
Takeda UK Limited
Building 3, Glory Park,
Glory Park Avenue,
Wooburn Green,
BUCKS,
HP10 0DF
SECTION 10. DATE OF REVISION OF THE TEXT
26/09/2014
Updated on 02 October 2014
Reasons for updating
- Change to MA holder contact details
Updated on 04 June 2014
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 4.8 – Undesirable effects - how to report a side effect
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The following highlighted text has been added
Change to Section 2 an additional word "the" has been added: "For the full list of excipients, see section 6.1"
Change to Section 4.2 Additional highlighted text has been added: the word "posology" and the words "Method of"
4.2 Posology and method of administration
Posology
and
Method of Administration
Change to section 4.3 Contraindications Addition of text “”listed in section 6.1)”
Hypersensitivity to the active substance, any of the excipients (listed in section 6.1) or to synthetic gonadotrophin releasing homone (Gn-RH) or Gn-RH derivatives.
Change to Section 4.4 additional paragraphs have been added to 4.4 Special warnings and precautions for use
Epidemiological data have shown that during androgen deprivation therapy changes in the metabolic condition (e.g. reduction in glucose tolerance or aggravation of pre-existing diabetes) as well as an increased risk for cardiovascular diseases may occur. However, prospective data did not confirm the link between treatment with GnRH analogues and an increase in cardiovascular mortality. Patients at high risk for metabolic or cardiovascular diseases should be appropriately monitored.
Change to section 4.6 There is an insertion of an additional word, "Fertility": 4.6 Fertility, pregnancy and lactation
Change to section 4.8 insertion of an additional paragraph at the end of section 4.8
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 to Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2. Tel: +353 1 6764971, Fax: +353 1 676 2517, Website: www.imb.ie. e-mail:imbpharmacovigilance@imb.ie.
Change to section 6.6 insertion of the additional words as highlighted: 6.6 Special precautions for disposal and handling
Change to section 10 – date of revision of text is : 26/05/2014
Updated on 04 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 07 May 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
6.5 Nature and contents of container
One dual chamber pre-filled syringe containing 11.25 mg leuprorelin acetate in the front chamber and 1 ml of aqueous sterile solvent in the rear chamber.
1 x 23 gauge syringe needle fitted with safety device
1 x syringe plunger
6.6 Special precautions for disposal
Always ensure the safety device to prevent needle-stick injury is deployed after injection. For single use only. Discard any unused content. Any unused product or waste material should be disposed of in accordance with local requirements.
Updated on 04 March 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as leuprorelin. Patients should be informed accordingly and treated as appropriate if symptoms occur.
section 10: date of revision of text has been updated to 08/02/2013
Updated on 21 February 2013
Reasons for updating
- Change of manufacturer
- Change to warnings or special precautions for use
Updated on 19 June 2012
Reasons for 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The IMB has approved new versions of the Prostap DCS SmPCs. The updates are as follows:
1. warning around injection site reactions in section 4.4 (Special warnings and precautions) : “In the rare event of an abscess occurring at the injection site, testosterone level should be monitored as there may be inadequate absorption of leuprorelin from the depot formulation.”
2. Section 4.8- Undesirable effects have been updated to include the following adverse events:
Uncommon: as with other medicinal products of this class, anaemia has been reported
Rare: reactions at the injection site, e.g., induration, erythema, pain, abscesses, swelling, nodules, ulcers and necrosis have been reported rarely
Updated on 19 June 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 29 November 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 November 2011
Reasons for updating
- New PIL for new product