Public Assessment Report Decentralised Procedure ...

1 PAR Dexamethasone mg/ml Solution for Injection or infusion UK/H/5643/001/DC. Public Assessment Report Decentralised Procedure Dexamethasone mg/ml Solution for Injection or infusion (Dexamethasone sodium phosphate). Procedure No: UK/H/5643/001/DC. UK Licence No: PL 14682/0023. Edmond Pharma 1. PAR Dexamethasone mg/ml Solution for Injection or infusion UK/H/5643/001/DC. LAY SUMMARY. Dexamethasone mg/ml Solution for Injection or infusion (dexamethasone sodium phosphate, solution for injection or infusion , mg/ml). This is a summary of the Public Assessment Report (PAR) for Dexamethasone mg/ml Solution for Injection or infusion (PL 14682/0023; UK/H/5643/001/DC).

2 It explains how Dexamethasone mg/ml Solution for Injection or infusion was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Dexamethasone mg/ml Solution for Injection or infusion . For practical information about using Dexamethasone mg/ml Solution for Injection or infusion , patients should read the package leaflet or contact their doctor or pharmacist. What is Dexamethasone mg/ml Solution for Injection or infusion and what is it used for? Dexamethasone mg/ml Solution for Injection or infusion is a generic medicine'.

3 This means that Dexamethasone mg/ml Solution for Injection or infusion is similar to a reference medicine' already authorised in the European Union (EU) called Decadron Injection, mg/ml (Merck Sharp & Dohme Limited, UK). Dexamethasone mg/ml Solution for Injection or infusion contains the active ingredient dexamethasone sodium phosphate which belongs to a group of medicines called corticosteroids. This medicine is used to reduce inflammation and treat a number of different diseases of the immune system. How does Dexamethasone mg/ml Solution for Injection or infusion work?

4 Dexamethasone belongs to a group of medicines called corticosteroids. Corticosteroids are hormones that are found naturally in the body and help to maintain health and well-being. Boosting the patient's body with extra corticosteroid (such as dexamethasone) is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone lowers inflammation, which could otherwise go on making the patient's condition worse. The patient must take this medicine regularly to get maximum benefit from it. How is Dexamethasone mg/ml Solution for Injection or infusion used?

5 The pharmaceutical form of this medicine is a solution for injection or infusion and the route of administration is into the patient's muscle, vein or under the skin. This medicine is normally given by a doctor. It will be given as an injection into a muscle or vein or under the patient's skin. The dose depends on the patient's illness and how bad it is. The dose in adults is normally from to 24mg daily, and in children is normally mg to daily. The patient's doctor will decide the dose. Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment.

6 This medicine can only be obtained with a prescription. What benefits of Dexamethasone mg/ml Solution for Injection or infusion have been shown in studies? 2. PAR Dexamethasone mg/ml Solution for Injection or infusion UK/H/5643/001/DC. No additional studies were needed as Dexamethasone mg/ml Solution for Injection or infusion is a generic medicine that is given as an injection or infusion and contains the same active substance as the reference medicine, Decadron Injection, mg/ml. What are the possible side effects of Dexamethasone mg/ml Solution for Injection or infusion ?

7 Because Dexamethasone mg/ml Solution for Injection or infusion is a generic medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of all side effects reported with Dexamethasone mg/ml Solution for Injection or infusion , see section 4 of the package leaflet available on the MHRA website. Why was Dexamethasone mg/ml Solution for Injection or infusion approved? It was concluded that, in accordance with EU requirements, Dexamethasone mg/ml Solution for Injection or infusion has been shown to have comparable quality and to be comparable to Decadron Injection, mg/ml.

8 Therefore, the MHRA decided that, as for Decadron Injection, mg/ml, the benefits are greater than its risk and recommended that it can be approved for use. What measures are being taken to ensure the safe and effective use of Dexamethasone mg/ml Solution for Injection or infusion ? A risk management plan (RMP) has been developed to ensure that Dexamethasone mg/ml Solution for Injection or infusion is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics and the package leaflet for Dexamethasone mg/ml Solution for Injection or infusion including the appropriate precautions to be followed by healthcare professionals and patients.

9 Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about Dexamethasone mg/ml Solution for Injection or infusion Ireland and the UK agreed to grant a Marketing Authorisation for Dexamethasone mg/ml Solution for Injection or infusion on 12 December 2014. A Marketing Authorisation was granted in the UK on 15. January 2015. The full PAR for Dexamethasone mg/ml Solution for Injection or infusion follows this summary. For more information about treatment with Dexamethasone mg/ml Solution for Injection or infusion , read the package leaflet, or contact your doctor or pharmacist.

10 This summary was last updated in February 2015. 3. PAR Dexamethasone mg/ml Solution for Injection or infusion UK/H/5643/001/DC. TABLE OF CONTENTS. I Introduction Page 5. II Quality aspects Page 6. III Non-clinical aspects Page 14. IV Clinical aspects Page 14. V User consultation Page 19. VI Overall conclusion, benefit/risk Assessment and Page 19. recommendation 4. PAR Dexamethasone mg/ml Solution for Injection or infusion UK/H/5643/001/DC. I INTRODUCTION. Based on the review of the data on quality, safety and efficacy, the Member States considered that the application for Dexamethasone mg/ml Solution for Injection or infusion (PL 14682/0023.)