Xomolix 2.5mg/ml solution for injection

  • Name:

    Xomolix 2.5mg/ml solution for injection

  • Company:
    info
  • Active Ingredients:

    Droperidol

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/01/19

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Summary of Product Characteristics last updated on medicines.ie: 21/1/2019

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Kyowa Kirin International plc

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1 - 0 of 10 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 21 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 21 January 2019

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

Free text change information supplied by the pharmaceutical company

Section 7: Marketing Authorisation Holder changed to: Kyowa Kirin Holdings B.V, Bloemlaan 2, 2132NP Hoofddorp, the Netherlands; +31(0)237200822

Section 8: Marketing Authorisation Number updated to: PA2288/003/002

Section 10: Date of revision of the text updated to January 2019

Updated on 21 January 2019

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

Updated on 27 April 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 21 February 2018 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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

Section 1- ® sign on Xomolix has been removed.$0$0$0Section 2- The sentence 'Excipient: sodium < 23 mg per ml' has been updated to ' Excipient with known effect: sodium  < 23 mg per ml (see section 4.4 for further details) '. $0$0$0$0$0Section 4.1- 'Xomolix is indicated in:' has been added as the opening statement.$0$0$0$0$0Section 4.2- Header for method of administration moved toward the end of the section.$0$0                  - The sentence ' For instructions on dilution of the product before administration, see section 6.6' has been updated to 'For instructions on dilution of the medicinal product                       before administration, see section 6.6.'$0$0$0$0$0Section 4.3- The sentence ' Droperidol is contraindicated in patients with: $0$0                                            ·   Hypersensitivity to droperidol or to any of the excipients;'$0$0                     updated to ' Xomolix is contraindicated in patients with:$0$0         ·   Hypersensitivity to the active substance or to any of the excipients listed in section 6.1'$0$0$0$0$0Section 4.5- Specific examples of medicinal products that interact with Xomolix 2.5mg/ml solution for injection have been removed. $0$0$0$0$0Section 4.6- Fertility section has been moved to bottom of section.$0$0$0$0$0Section 4.7- In the first sentence, the word 'Droperidol' changed to 'Xomolix'$0$0$0$0$0Section 4.8- 'Psychomotor hyperactivity' and 'coma' have been removed.$0$0                  - 'Neonatal drug withdrawal syndrome' has been added.$0$0                  - Under reporting of suspected adverse reactions, HPRA contact details have been updated.$0$0$0$0$0Section 5.1- The sentence 'Droperidol's inhibitory action....and treatment of postoperative nausea and vomiting and/or induced by opioid analgesics' has been updated to$0$0                     'Droperidol's inhibitory action....and treatment of postoperative nausea and vomiting and/or nausea and vomiting induced by opioid analgesics'$0$0$0$0$0Section 5.2- Under section distribution, the sentence ' Following intraveneous administration, plasma concentrations fall rapidly during the first 15 minutes.' has been updated to$0$0                    ' Following intraveneous administration, plasma concentrations fall rapidly during the first 15 minutes; this is metabolism independent, redistribution of the drug.'$0$0                  - Under section Paediatric population, typo error ' 4.66  2.88 ml/kg*min ' has been corrected to ' 4.66 ± 2.88 ml/kg*min ' $0$0$0$0$0Section 6.4- The sentence ' Store in the original package' has been updated to 'Store in the original package in order to protect from light'$0$0$0$0$0Section 6.6- The sentence' Any unused product or waste material should be disposed of in accordance with local requirements' has been updated to                                                                           'Any unused medicinal product or waste material should be disposed of in accordance with local requirements.' $0$0$0$0$0Section 10- Date of revision has been updated from September 2016 to February 2018.$0$0$0$0$0$0$0$0               $0$0$0

Updated on 21 February 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 20 September 2016 SPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects)- contact details for how to report suspected adverse reactions have been added.$0$0$0$0In section 10, the date of revision of the text has been changed from May 2016 to Sep 2016.$0

Updated on 15 July 2016 SPC

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

In section 7: Change name of Marketing Authorisation Holder from ProStrakan Ltd. to Kyowa Kirin Ltd.
In section 10: Change date of revision of the text from March 2014 to May 2016.

Updated on 15 July 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 15 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 February 2016 SPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 21 December 2015 PIL

Reasons for updating

  • New PIL for medicines.ie