Epipen Junior 150 micrograms solution for injection in pre-filled pen

  • Name:

    Epipen Junior 150 micrograms solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Adrenaline

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/12/19

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Summary of Product Characteristics last updated on medicines.ie: 6/12/2019

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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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 6 December 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 6 December 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 19 March 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 March 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 February 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

$0In section4.4: Information added regarding the immobilization of the patient’s leg duringadministration and that the pen is for single use only.$0$0In section4.8: Injection site infection with frequency unknown added to undesirableeffects.$0$0In section5.2: Instruction to gently massage the injection area is advised.$0$0In section6.6: Point number five has changed – hold firmly in place for 5 seconds (waspreviously 10 seconds). Point no 6 has changed -  Instruction to gentlymassage the injection area is advised.$0$0 $0$0In section10: Date of revision changed.$0

Updated on 1 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 February 2018 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Free text change information supplied by the pharmaceutical company

$0In section4.4: Information added regarding the immobilization of the patient’s leg duringadministration and that the pen is for single use only.$0$0In section4.8: Injection site infection with frequency unknown added to undesirableeffects.$0$0In section5.2: Instruction to gently massage the injection area is advised.$0$0In section6.6: Point number five has changed – hold firmly in place for 5 seconds (waspreviously 10 seconds). Point no 6 has changed -  Instruction to gentlymassage the injection area is advised.$0$0 $0$0In section10: Date of revision changed.$0

Updated on 6 September 2016 PIL

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 6.4 - Special precautions for storage
  • 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

Free text change information supplied by the pharmaceutical company

In section 4.2: Slight text amendment. Recommendation to carry two pens added.

In section 4.4: New special a=warning and precaution added with regards to patients to be thoroughly instructed to understand the indications for the use and the correct method of administration. And to advise to educate the patient’s immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the Epipen Junior in case support is needed in the emergency situation.

In section 6.5: information regarding the exposed and protected needle length added

In section 6.6: the text ‘viewing’ to point No 5

In section 10: Date of revision changed.

Updated on 6 September 2016 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 6.4 - Special precautions for storage
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2: Slight text amendment. Recommendation to carry two pens added.

In section 4.4: New special a=warning and precaution added with regards to patients to be thoroughly instructed to understand the indications for the use and the correct method of administration. And to advise to educate the patient’s immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the Epipen Junior in case support is needed in the emergency situation.

In section 6.5: information regarding the exposed and protected needle length added

In section 6.6: the text ‘viewing’ to point No 5

In section 10: Date of revision changed.

Updated on 17 December 2015 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1: The therapeutic indications has changed

In section 4.2: Information regarding the posology and method of administration has changed

In In section 10: The date of revision has been changed.

Updated on 17 December 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.1: The therapeutic indications has changed

In section 4.2: Information regarding the posology and method of administration has changed

In In section 10: The date of revision has been changed.

Updated on 11 November 2014 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 - 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

In section 4.2: Additional instructions has been added outlining what patients should do following the use of Epipen

In section 4.4:  The patient/carer is informed about the possibility of biphasic anaphylaxis, the risk associated with concomitant asthma and warned in relation to related allergens to be investigated.

In section 4.8: the reporting of adverse reports has been reworded

In section 6.6: A reference to 4.2 is added for instructions to be conveyed to patient/carer regarding actions to be taken following use of Epipen

In section 10: the date of revision has changed

Updated on 11 November 2014 PIL

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 - 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

Free text change information supplied by the pharmaceutical company

In section 4.2: Additional instructions has been added outlining what patients should do following the use of Epipen

In section 4.4:  The patient/carer is informed about the possibility of biphasic anaphylaxis, the risk associated with concomitant asthma and warned in relation to related allergens to be investigated.

In section 4.8: the reporting of adverse reports has been reworded

In section 6.6: A reference to 4.2 is added for instructions to be conveyed to patient/carer regarding actions to be taken following use of Epipen

In section 10: the date of revision has changed

Updated on 25 February 2014 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 25 February 2014 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided