Eligard 7.5mg

  • Name:

    Eligard 7.5mg

  • Company:
    info
  • Active Ingredients:

    Leuprorelin 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: 25/02/19

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Summary of Product Characteristics last updated on medicines.ie: 25/2/2019

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Astellas Pharma Co. Ltd

Astellas Pharma Co

Company Products

Medicine NameActive Ingredients
Medicine Name Advagraf 0.5mg Prolonged-Release Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Advagraf 1mg Prolonged-Release Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Advagraf 3 mg prolonged-release hard capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Advagraf 5mg Prolonged-Release Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Betmiga 25mg and 50mg prolonged-release tablets Active Ingredients Mirabegron
Medicine Name DIFICLIR 200 mg film-coated tablets Active Ingredients Fidaxomicin
Medicine Name Eligard 22.5mg Active Ingredients Leuprorelin Acetate
Medicine Name Eligard 45mg Active Ingredients Leuprorelin Acetate
Medicine Name Eligard 7.5mg Active Ingredients Leuprorelin Acetate
Medicine Name Modigraf 0.2mg & 1mg granules for oral suspension Active Ingredients Tacrolimus Monohydrate
Medicine Name Mycamine 50 & 100 mg powder for solution for infusion Active Ingredients Micafungin sodium
Medicine Name Omnexel Active Ingredients Tamsulosin Hydrochloride
Medicine Name Prograf 0.5 mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf 1mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf 5mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf Concentrate for Infusion Active Ingredients Tacrolimus
Medicine Name Vesitirim 1 mg/ml oral suspension Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 10mg Film-coated Tablets Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 5mg Film-Coated tablets Active Ingredients Solifenacin succinate
Medicine Name Vesomni 6 mg/0.4 mg modified release tablets Active Ingredients Solifenacin succinate, Tamsulosin Hydrochloride
Medicine Name Xtandi 40 mg soft capsules Active Ingredients enzalutamide
Medicine Name Zepholin SR 100mg Prolonged Release Capsules Active Ingredients Theophylline
Medicine Name Zepholin SR 200mg Prolonged Release Capsules Active Ingredients Theophylline
1 - 0 of 23 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 25 February 2019 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 25 February 2019 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

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

Updated on 9 January 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to information for healthcare professionals

Updated on 9 January 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 not be renewed (A)

Updated on 24 August 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Update of instructions regarding the safety needle that is not to overtighten.

Adding information as mentioned in the SmPC that testosterone levels should be evaluated in case of suspected or known handling errors.

Updated on 17 July 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 17 July 2018 SmPC

Reasons for updating

  • 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

4.8       Undesirable effects

 New side effect:

not know:  interstitial lung disease

10.     DATE OF REVISION OF THE TEXT

Revision date: 16 July 2018

 

 

 

 

Updated on 7 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 December 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 4 December 2017 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container
  • 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

(bold– text added, strikethrough – text deleted)

3.         PHARMACEUTICAL form

 

Solvent (Syringe A):

Pre-filled syringe with a clear, colourless to pale yellow/brown solution

 

 

6.5       Nature and contents of container

 

Two pre-filled cyclic olefin copolymer/polypropylene syringes, one cyclic olefin copolymer syringe containing powder (Syringe B), and one polypropylene syringe containing solvent (Syringe A). Together the two syringes comprise a mixing system.

 

·                A bundle pack containing kits of 2 x 2 pre-filled polypropylene/cyclic olefin copolymer syringes (1 x Syringe A; 1 x Syringe B)

 

 

6.6       Special precautions for disposal and other handling

 

Step 8:

 

When thoroughly mixed, the viscous solution will appear with a colour in the range of colourless to white to pale yellow brown (which could include shades of white to pale yellow).

 

Step 11:

·         Hold Syringe B upright and hold back the white plunger to prevent loss of the product.

·         Open pack of the safety needle by peeling back paper tab and take out safety needle.

·         Secure the safety needle to Syringe B by holding the syringe and twisting gently turning the needle clockwise with approximately a three-quarter turn until the needle is secure to fully seat the needle (Figure 11).

Do not over tighten as this may cause cracking of the needle hub resulting in leakage of the product during injection.

 

Should the needle hub crack, appear to be damaged, or have any leakage, the product should not be used. The damaged needle should not be substituted/replaced and the product should not be injected. The entire product should be disposed of securely

 

In the event of damage to the needle hub, a new replacement product should be used.

 

 

10.       DATE OF REVISION OF THE TEXT

 

24 November 2017

Updated on 4 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 14 February 2017 SmPC

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 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



 4.2    Posology and method of administration (underlined text added)

 

In patients with metastatic castration resistant prostate cancer not surgically castrated receiving a GnRH agonist, such as leuprorelin, and eligible for treatment with androgen biosynthesis inhibitors or androgen receptor inhibitors, treatment with a GnRH agonist may be continued.

 

4.4       Special warnings and special precautions for use (underlined text added, strikethrough text deleted)

 

 

Convulsions: Post marketing reports of convulsions have been observed in patients on leuprorelin acetate therapy with or without a history of predisposing factors. Convulsions are to be managed according to the current clinical practice.

 

A proportion of patients will have tumors which are not sensitive to hormone manipulation. Absence of clinical improvement despite adequate testosterone suppression is diagnostic of this condition, which will not benefit from further therapy with ELIGARD 7.5 mg.

 

4.8       Undesirable effects

The following adverse events have been added to the table of adverse drug reactions:

 

Nervous system disorders:

Vertigo (frequency uncommon)

 

Gastrointestinal disorders:

Gastroenteritis/colitis (frequency common)

 

Musculoskeletal, connective tissue disorders:

Rigors, weakness (frequency common) Moved from General disorders and administration site conditions

 

Reproductive System and breast disorders

Erectile dysfunction, reduced penis size (frequency common)

 

General disorders and administration site conditions

Injection site induration (frequency uncommon)

 

Blood and lymphatic system disorders

Anaemia (frequency common)

 

Other changes to section 4.8 (underlined text added, strikethrough text deleted)

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, an alteration in the skin sensation, chills, peripheral vertigo, rash, amnesia and visual disturbances. Muscular atrophy has been observed with long term use of products in this class. Infarction of pre-existing pituitary apoplexy has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.

 

Convulsions have been reported after GnRH agonist analogue administration (see section 4.4).

 

Local adverse events reported after injection of ELIGARD are similar to the local adverse events associated with similar subcutaneously injected products.

Generally, these localised adverse events following subcutaneous injection are mild and described as being of brief duration.

 

Anaphylactic/anaphylactoid reactions have been reported rarely after GnRH agonist analogue administration.

 

Section 10:

Date of revision changed to January 2017

 

 

 

 

 

Updated on 1 February 2017 PIL

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 25 May 2015 SmPC

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 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

Section 4.2, the following has been added:

As lack of efficacy may result from incorrect preparation, reconstitution, or administration, testosterone levels should be evaluated in cases of suspected or known handling errors (see section 4.4).

 

ELIGARD 7.5 mg should be prepared, reconstituted and administered only by healthcare professionals who are familiar with these procedures.  See section 6.6: Special precautions for disposal and other handling. If the product is not prepared appropriately, it should not be administered.

Section 4.4, the following text has been added:

See section 4.2 and section 6.6 for the instructions for preparation and administration of the product and for evaluation of testosterone levels in cases of suspected or known handling errors.

Section 6.6, the underlined text has been added:

If the product is not prepared using the proper technique, it should not be administered, as lack of clinical efficacy may occur due to incorrect reconstitution of the product.

 

 

 

The date of revision is updated to May 2015

Updated on 18 May 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section

Updated on 27 April 2015 SmPC

Reasons for updating

  • 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 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

Section 4.2 & 4.3:
Administrative updates to comply with QrD template
Section 4.4:
The following text has been added:
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 ELIGARD 7.5 mg.
Section 4.5:
The following text has been added:

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of ELIGARD 7.5 mg 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:
Administrative & wording updates to comply with QrD template and the following added to the tabulated list of adverse events:

Cardiac disorders
not known                   QT prolongation (see sections 4.4 and 4.5)
Section 10:
Date of revision updated to March 2015

Updated on 23 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 3 February 2015 SmPC

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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Section 4.4 Special warnings and special precautions for use, the following warning has been added: 
Lack of clinical efficacy may occur due to incorrect reconstitution of the product (see section 4.2).

Section 4.8:
Details on reporting suspected adverse reactions added

Section 6.3 Shelf life, the following text has been added:

Once the product has been removed from the refrigerator, it may be stored in the original packaging at room temperature (below 25°C) for up to four weeks

Section 6.4 Special precautions for storage, the following text has been added:

This product must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use. Once outside the refrigerator this product may be stored in its original packaging at room temperature (below 25°C) for up to four weeks.

Section 6.6 Special precautions for disposal and other handling, underlined text added: 

Allow the product to come to room temperature by removing from the refrigerator approximately 30 minutes prior to use.

Please prepare the patient for injection first, followed by the preparation of the product, using the instructions below. Lack of clinical efficacy may occur due to incorrect reconstitution of the product.

Section 10:
Date of revision revised to January 2015

Updated on 30 January 2015 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 5 November 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.1     Therapeutic indications (underlined text added)

 

ELIGARD 7.5 mg is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.


4.2     Posology and method of administration (underlined text added)


ELIGARD 7.5 mg may be used as neoadjuvant or adjuvant therapy in combination with radiotherapy in high-risk localised and locally advanced prostate cancer.

 

Administration (underlined text added, strikethrough text deleted)

Children and adolescentsPaediatric population

 

Safety and efficacy in children aged 0 to 18 years have not been established There is no experience in children (under the age of 18 years) (see also section 4.3).


 

 

5.1     Pharmacodynamic properties (underlined text added)

In a phase III randomized clinical trial including 970 patients with locally advanced prostate cancer (mainly T2c-T4 with some T1c to T2b patients with pathological regional nodal disease) of whom 483 were assigned to short-term androgen suppression (6 months) in combination with radiation therapy and 487 to long-term therapy (3 years), a non-inferiority analysis compared the short-term to long-term concomitant and adjuvant hormonal treatment with GnRH agonist (triptorelin or goserelin). The 5-year overall mortality was 19.0% and 15.2%, in the short-term and long-term groups, respectively. The observed Hazard Ratio of 1.42 with an upper one-sided 95.71% CI of 1.79 or two-sided 95.71% CI of 1.09; 1.85 (p = 0.65 for non inferiority), demonstrate that the combination of radiotherapy plus 6 months of androgen deprivation therapy provides inferior survival as compared with radiotherapy plus 3 years of androgen deprivation therapy. Overall survival at 5 years of long-term treatment and short-term treatment shows 84.8% survival and 81.0%, respectively. Overall quality of life using QLQ-C30 did not differ significantly between the two groups (P= 0.37). Results are dominated by the population of patients with locally advanced tumours.

Evidence for the indication of high-risk localized prostate cancer is based on published studies of radiotherapy combined with GnRH analogues, including leuprorelin acetate. Clinical data from five published studies were analyzed (EORTC 22863, RTOG 85-31, RTOG 92-02, RTOG 8610, and D’Amico et al., JAMA, 2004), which all demonstrate a benefit for the combination of GnRH analogue with radiotherapy. Clear differentiation of the respective study populations for the indications locally advanced prostate cancer and high-risk localized prostate cancer was not possible in the published studies.


Clinical data have shown that radiotherapy followed by 3 years of androgen deprivation therapy is preferable to radiotherapy followed by 6 months of androgen deprivation therapy.

The recommended duration of androgen deprivation therapy in medical guidelines for T3-T4 patients receiving radiotherapy is 2-3 years.


10.     DATE OF REVISION OF THE TEXT

August 2014 October 2014

 

Updated on 29 October 2014 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 28 August 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

 

 

 

4.4     Special warnings and precautions for use

 

 

Precautions

 

Changes in glucose tolerance have been reported in some patients receiving GnRH agonist therapy. It is advised that diabetic patients are monitored more frequently during treatment with ELIGARD 45 mg.

 

 

 

Hyperglycemia and diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Hyperglycemia may represent development of diabetes mellitus or worsening of glycemic control in patients with diabetes. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes.

Cardiovascular diseases: Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving GnRH agonists should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.

 

 

6.6     Special precautions for disposal and other handling

 

Allow the product to come to room temperature.

Please prepare the patient for injection first, followed by the preparation of the product, using the instructions below.

 

Step 1: Open both trays (tear off the foil from the corner which can be recognized by a small bubble) and empty the contents onto a clean field (two trays containing Syringe A (Figure 1.1) and Syringe B (Figure 1.2)). Discard the desiccant pouches.

 

 

 

Step 2: Pull out and do not unscrew the blue coloured short plunger rod together with the attached grey stopper from Syringe B and discard (Figure 2). Do not attempt to mix the product with two stoppers in place.

 

 

 

Step 3: Gently screw the Syringe B white plunger rod to the remaining grey stopper in Syringe B (Figure 3).

 

 

 

Step 4: Remove the grey rubber plug from Syringe B and put down the Syringe (Figure 4).

 

 

 

 


 

Step 5: Hold Syringe A in a vertical position to ensure no liquid leaks out and unscrew the clear cap from Syringe A (Figure 5).

 

 

 

Step 6: Join the two syringes together by pushing in and twisting Syringe B onto Syringe A until secure (Figure 6a and 6b). Do not over tighten.

 

 

 


 

Step 7: Flip the connected unit over and continue to hold the syringes vertically with Syringe B on the bottom while injecting the liquid contents of Syringe A into Syringe B containing the powder (leuproreline acetate) (Figure 7).

 

 

 

Step 8: Thoroughly mix the product by gently pushing the contents of both syringes back and forth between syringes (60 times in total, which takes approximately 60 seconds) in a horizontal position to obtain a homogenous, viscous solution (Figure 8). Do not bend the syringe system (please note that this may cause leakage as you may partially unscrew the syringes).

 

When thoroughly mixed, the viscous solution will appear with a colour in the range of colourless to white to pale yellow (which could include shades of white to pale yellow).

 

Important: After mixing proceed with the next step immediately as the product gets more viscous over time. Do not refrigerate the mixed product.

 

Please note: Product must be mixed as described; shaking WILL NOT provide adequate mixing of the product

 

 

 


 

Step 9: Hold the syringes vertically with Syringe B on the bottom. The syringes should remain securely coupled. Draw the entire mixed product into Syringe B (wide syringe) by pushing down the Syringe A plunger and slightly withdrawing the Syringe B plunger (Figure 9).

 

 

 

Step 10: Twist off Syringe A while continuing to push down on the Syringe A plunger (Figure 10). Ensure that no product leaks out as the needle will then not secure properly when attached.

 

Please note: one large or a few small air bubbles may remain in the formulation - this is acceptable. Please do not purge the air bubbles from Syringe B at this stage as product may be lost!

 

 


 

Step 11: Hold Syringe B upright. Open pack of the safety needle by peeling back paper tab and take out safety needle. Secure the safety needle to Syringe B by holding the syringe and twisting the needle clockwise to fully seat the needle (Figure 11). Do not over tighten.

 

 

Step 12: Pull off the protective needle cap prior to administration (Figure 12).

Important: Do not operate the safety needle mechanism before administration.

 

 

 

 

Step 13: Prior to administration, purge any large air bubbles from Syringe B. Administer the product subcutaneously. Please ensure that the full amount of the product in Syringe B is injected.

 


 

Step 14: After injection, lock the safety shield using any of the activation methods listed below.

 

1. Closure on a flat surface

 

Press the safety shield, lever side down, onto a flat surface (Figure 14.1a and b) to cover the needle and lock the shield.

Verify locked position through audible and tactile “click”. Locked position will completely cover needle tip (figure 14.1b).

 

 

 

2. Closure with your thumb

 

Placing your thumb on the lever, slide the safety shield toward the needle tip (Figure 14.2a and b) to cover the needle and lock the shield.

Verify locked position through audible and tactile “click”. Locked position will completely cover needle tip (figure 14.2b).

 

 

 

Step 15: Once safety shield is locked, immediately dispose of the needle and syringe in an approved sharps container.

Updated on 28 August 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section

Updated on 17 August 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 27 July 2012 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

7     Marketing authorisation holder

Astellas Pharma Co. Ltd.

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

Updated on 27 April 2012 PIL

Reasons for updating

  • Change to packaging
  • Change to side-effects

Updated on 7 December 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

ELIGARD 7.5  &22.5 mg powder and solvent for solution for injection

 

 

4.8     Undesirable effects

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment

include peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, an

alteration in the skin sensation, chills, peripheral vertigo, rash, amnesia and visual disturbances.

 

 

 

6.5     Nature and contents of container

 

Two pre-filled polypropylene syringes, one containing powder (Syringe B), and one containing solvent (Syringe A). Together the two syringes comprise a mixing system.

 

Syringe A has a plunger tip of thermoplastic rubber and is capped with a polyethylene or polypropylene Luer-Lok cover. The syringe tip cap and the two plunger tips of Syringe B are composed of chlorobutyl bromobutyl rubber.

 

The following pack sizes are available:

  • A kit consisting of one large aliminium outer pouch which contains 2 aluminium pouches, a 20-gauge sterile needle and a silicone desiccant pouch. One pouch contain one pre-filled polypropylene syringe A and a plunger.The other pouch contains one pre-filled cyclic olefin copolymer syringe B.
  • A kIt consisting of two thermoformed trays in a cardboard carton. On tray contains one pre-filled polypropylene syringe A, a large plunger, a 20-gauge sterile needle and asilicone dessicant pouch.The other tray contains pre-filled cyclic olefin copolymer syringe B, a 20-gauge sterile needle and a silicone dessicant pouch.
  • A bundle pack containing kits of 3 x 2 pre-filled polypropylene/ cyclic olefin copolymer syringes (1 xSyringe A; 1 x Syringe B).

 

Updated on 17 November 2010 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

6.5       Nature and contents of container

 

The syringe material is being changed from polypropylene to cyclic olefin copolymer

 

The syringe tip cap and plunger tips material is being changed from bromobutyl to chorobutyl.

Updated on 15 December 2009 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 25 June 2009 SmPC

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
  • Change to section 9 - Date of renewal of authorisation
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

 

One prefilled syringe with powder for solution for injection contains 7.5 mg leuprorelin acetate, equivalent to 6.96 mg leuprorelin.

 

Changed to read

 

One pre-filled syringe with powder for solution for injection contains 9.7mg leuprorelin (as acetate).

 

The deliverable amount after reconstitution with the solvent is 7.5 mg leuprorelin acetate.

 

 

3.       PHARMACEUTICAL form

 

Powder and solvent for solution for injection

 

Powder: white to off-white powder

Solvent: clear, light tan to tan solution

 

 

Changed to read

 

Powder and solvent for solution for injection,

 

Powder (Syringe B):

Pre-filled syringe with a white to off-white powder.

 

Solvent (Syringe A):

Pre-filled syringe with a clear, colourless to pale yellow solution

 

 

 

 

4.2     Posology and method of administration

 

Clinical studies have shown that testosterone levels increased during the first 3 days of treatment in the majority of non-orchiectomised patients and then decreased to below medical castration levels within 3-5 weeks

 

Changed to read

 

Clinical studies have shown that testosterone levels increased during the first 3 days of treatment in the majority of non-orchiectomised patients and then decreased to below medical castration levels within 3 - 4 weeks.

 

 

Administration

 

Addition of Children and adolescents

There is no experience in children (under the age of 18 years) (see also section 4.3)

 

4.4     Special warnings and special precautions for use

 

Ommitted:

Pituitary adenomas have been detected in chronic toxicity studies in animals following administration of high doses of leuprorelin acetate in some animal species. This has not been observed in long-term clinical studies with leuprorelin acetate.

 

Inserted:

During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of GnRH-agonists, with a majority occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy was presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention is required.

 

 

4.8     Undesirable effects

 

hot flushes, reworded as hot flashes

 

Mild hot flushes occur in approximately 55% of patients. Updated to Mild or moderate hot flashes occur in approximately 58% of patients.

 

Undesirable effects in clinical studies with Eligard updated

 

Infections and infestations

Nasopharyngitis added as a common side effect

 

Nervous system disorders

Hypoaesthesia reclassified as an uncommon side effect (previously listed as common)

 

Respiratory, thoracic and mediastinal disorders

Dyspnoea added as an uncommon side effect

 

Gastrointestinal disorders

 

Diarrhoea removed as a common side effect

Dyspepsia reclassified form common to an uncommon side effect

Vomiting added as an uncommon side effect

Gas pain removed as a rare side effect

 

Skin and subcutaneous tissue disorders

night sweats reclassified as from an uncommon to a common side effect

 

 

 

 

 

 

 

 

Musculoskeletal, connective tissues and bone disorders

Addition of limb pain and myalgia as common side effects.

 

General Disorders and Administration Site Reaction

Changed from

 

          very common

injection site burning, injection site paraesthesia

          common

fatigue, injection site pain, injection site bruising, rigors, weakness

          uncommon

injection site pruritus, lethargy, pain, pyrexia

 

To

 

 

very common

fatigue, injection site burning, injection site paraesthesia

common

Malaise, injection site pain, injection site bruising, injection site stinging , rigors, weakness

uncommon

injection site pruritus, lethargy, pain, pyrexia

rare

injection site ulceration

very rare

injection site necrosis

 

 

Paragraph updated from

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include impotence, decrease in libido (both pharmacological consequences of testosterone deprivation), peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, chills, dyspnoea, peripheral vertigo, rash, amnesia, visual disturbances and skin sensation. Infarction of pre-existing pituitary adenoma has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.

 

To

 

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, chills, peripheral vertigo, rash, amnesia and visual disturbances. Infarction of pre-existing pituitary apoplexy has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.

 

 

 

 

 

 

 

 

 

 

 

Below paragraph and table removed:

 

Mild transient burning/stinging following injection is very common. Pain, erythema, bruising and pruritus following injection are common. Induration and ulceration are rare.

 

Table 2: Incidence of local adverse events by number of injections

Burning

29%

Pain

4.6%

Erythema

2.5%

Ecchymosis

2.5%

Pruritus

1.8%

Induration

0.4%

Ulceration

0.1%

 

 

 

4.9     Overdose

 

Paragraph updated from

 

There is no clinical experience with the effects of an acute overdose with ELIGARD 7.5 mg. In the event of an overdose the patient should be monitored and supportive treatment given, if considered necessary.

 

To read

 

ELIGARD 7.5 mg does not have the potential for abuse, and deliberate overdose is unlikely. There are no reports of abuse or overdose having occurred in clinical practice with leuprorelin acetate, but in the event that excessive exposure becomes a reality, observation and symptomatic supportive treatment are recommended.

 

5.1       Pharmacodynamic properties

The agonist possesses greater potency than the natural hormone. Updated to read

 

However, the agonist possesses greater potency than the natural hormone and the time to recovery of testosterone levels may vary between patients.

 

 

5.2     Pharmacokinetic properties

 

Inserted: No drug metabolism study was conducted with ELIGARD.

 

 

5.3     Preclinical safety data

 

Paragraph Updated from

 

Preclinical studies with leuprorelin acetate, revealed effects on the reproductive system, which were expected from the known pharmacological properties. Leuprorelin acetate did not show teratogenicity. Embryotoxicity/lethality was observed in rabbits.

 

Carcinogenicity studies

 

Carcinogenicity studies were performed in rats and mice. In rats, a dose-related increase in pituitary adenomas was observed after subcutaneous administration at doses of 0.6 to 4 mg/kg/day. No such effect was observed in mice.

 

Mutagenicity studies

 

Leuprorelin acetate and ELIGARD 7.5 mg were not mutagenic in a set of in vitro and in vivo assays.

 

 

To

 

Preclinical studies with leuprorelin acetate, revealed in both sexes effects on the reproductive system, which were expected from the known pharmacological properties. These effects were shown to be reversible after discontinuation of the treatment and an appropriate period of regeneration. Leuprorelin acetate did not show teratogenicity. Embryotoxicity/lethality was observed in rabbits, in line with the pharmacological effects of leuprorelin acetate on the reproductive system.

 

Carcinogenicity studies were performed in rats and mice over 24 months. In rats, a dose-related increase in pituitary apoplexy was observed after subcutaneous administration at doses of 0.6 to 4 mg/kg/day. No such effect was observed in mice.

 

Leuprorelin acetate and related one-month product ELIGARD 7.5 mg were not mutagenic in a set of in vitro and in vivo assays.

 

 

6.1     List of excipients

 

Insertion of 50:50

 

 

6.3     Shelf life

 

Paragraph  updated from

 

After first opening of one of the trays (tray pack) or the large outer aluminium pouch (pouch pack) the powder and solvent for solution for injection are to be immediately reconstituted and administered to the patient. Chemical and physical in-use stability has been demonstrated for 30 minutes at 25°C. From a microbiological point of view, once reconstituted with sterile vehicle, the product should be administered immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

 

To

 

After first opening of the tray or the large outer aluminium pouch, the powder and solvent for solution for injection are to be immediately reconstituted and administered to the patient.

 

 

 

 

 

 

6.4     Special precautions for storage

 

Store in a refrigerator (2°C – 8°C) in the original package. Updated to read: Store in a refrigerator (2°C – 8°C); in the original package in order to protect from moisture.

 

 

6.5     Nature and contents of container

 

Updated from

 

A kit consisting of one large aluminium outer pouch which contains 2 aluminium pouches, a 20-gauge 12.5 mm sterile cannula and a silicone dessicant pouch. One pouch contains one pre-filled polypropylene syringe B and a plunger. The other pouch contains one pre-filled polypropylene syringe A.

 

To

A kit consisting of one large aluminium outer pouch which contains 2 aluminium pouches, a 20-gauge sterile needle and a silicone desiccant pouch. One pouch contains one pre-filled polypropylene syringe A and a plunger. The other pouch contains one pre-filled polypropylene syringe B.

 

a sterile 20-gauge 12.5 mm sterile cannula updated to read 20-gauge sterile needle

 

Inserted:

 

Not all pack sizes may be marketed

 

6.6     Instructions for use and handling and disposal

 

Inserted:

 

Allow the product to come to room temperature

 

Please prepare the patient for injection first, followed by the preparation of the product, using the instructions below:

 

Mixing instruction and diagrams updated for clarification.

 

 

9.                  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Changed from: Date of first authorisation: 26th August 2005 to 13th October 2005

 

 

10.     DATE OF REVISION OF THE TEXT

Updated from December 2006 to May 2009

 

 

 

 

 

 

Updated on 15 August 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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

Changes Document

 

Eligard 7.5mg and 22.5mg SPCs

 

Version October 2005 v December 2006

 

Main change is that reference is now made to the new tray packs.

 

Section 4.8

Table 1: Vascular disorders:

Hot flushes changed to hot flashes

 

Section 6.3 Shelf life

Added in reference to the new tray pack.

 

Section 6.5 Nature and contents of container

New text inserted describing the new tray pack which may be available:

·         “A kit consisting of two thermoformed trays in a cardboard carton. One tray contains one pre-filled polypropylene syringe A, a large plunger rod and a desiccant pouch. The other tray contains pre-filled polypropylene syringe B, a sterile 20-gauge 12.5 mm sterile cannula and a silicone desiccant pouch.”

 

 

Section 6.6 Instructions for use and handling and disposal

Points 1 and 2 now include reference to the tray pack.

 

Section 10. DATE OF REVISION OF THE TEXT

Updated to December 2006

Updated on 6 July 2006 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 23 June 2006 PIL

Reasons for updating

  • New PIL for new product