Public Assessment Report Decentralised Procedure …

1 1 Public Assessment Report Decentralised Procedure ONDANSETRON 2MG/ML SOLUTION FOR INJECTION UK/H/1240/01/DC UK Licence No: PL 20568/0009 CLARIS LIFESCIENCES UK LIMITED PAR Ondansetron 2mg/ml Solution for Injection UK/H/1240/01/DC 2 LAY SUMMARY On 23rd July 2009, the UK granted Claris Lifesciences UK Limited a Marketing Authorisation (licences) for the medicine Ondansetron 2mg/ml Solution for Injection. Ondansetron injection is a clear solution containing the active ingredient ondansetron, which is an anti-emetic (prevents nausea [feeling sick] and vomiting).

2 Ondansetron Injection is used to prevent and treat nausea and vomiting caused by chemotherapy or radiotherapy and for the prevention and treatment of nausea and vomiting after surgery. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking Ondansetron 2mg/ml Solution for Injection outweigh the risks; hence a Marketing Authorisation has been granted. PAR Ondansetron 2mg/ml Solution for Injection UK/H/1240/01/DC 3 TABLE OF CONTENTS Module 1: Information about initial Procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Product Information Leaflet Page 13 Module 4: Labelling Page 15 Module 5.

3 Scientific Discussion Page 20 1 Introduction 2 Quality aspects 3 Non-clinical aspects 4 Clinical aspects 5 Overall conclusions Module 6: Steps taken after initial Procedure PAR Ondansetron 2mg/ml Solution for Injection UK/H/1240/01/DC 4 Module 1 Product Name Ondansetron 2mg/ml Solution for Injection Type of Application Generic, Article Active Substance Ondansetron hydrochloride dihydrate Form Solution for Injection Strength 2 mg/ml MA Holder Claris Lifesciences UK Ltd Crewe Hall, Golden Gate Lodge Crewe, Cheshire, CW1 6UL Reference Member State (RMS)

4 UK CMS Belgium, Estonia, Germany, Greece, Ireland, Italy, Lithuania, Luxemburg, Latvia, The Netherlands, Poland, Portugal, Slovenia Procedure Number UK/H/1240/01/DC End of Procedure Day 236 1st June 2009 PAR Ondansetron 2mg/ml Solution for Injection UK/H/1240/01/DC 5 Module 2 Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ondansetron 2mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2 mg Ondansetron as Ondansetron hydrochloride dihydrate. Each glass ampoule of 2ml contains 4mg Ondansetron (as hydrochloride dihydrate) Each glass ampoule of 5ml (containing 4 ml of solution) contains 8mg Ondansetron (as hydrochloride dihydrate) Each ml of the solution contains mg of Sodium.

5 For a full list of excipients, see section 3 PHARMACEUTICAL FORM Solution for Injection A clear, colourless solution. 4 CLINICAL PARTICULARS Therapeutic indications Ondansetron 2mg/ml Solution for Injection is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy and for the prevention and treatment of post-operative nausea and vomiting (PONV). Posology and method of administration For intravenous injection, intravenous infusion after dilution or intramuscular administration.

6 For instructions on dilution of the product before administration, see section Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting associated with chemotherapy or radiotherapy in adults, adolescents or children should take into consideration current practice and appropriate guidelines. Chemotherapy and radiotherapy induced nausea and vomiting: Adults: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The dose range of Ondansetron 2mg/ml Solution for Injection or infusion is 8-32mg a day and selected as shown below.

7 Emetogenic chemotherapy and radiotherapy: For patients receiving emetogenic chemotherapy or radiotherapy, 8mg of ondansetron should be administered as a slow intravenous injection, an intravenous infusion over 15 minutes, or intramuscular injection immediately before treatment, followed by 8mg orally twelve hourly. To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8mg twice daily or 16mg rectally once daily.

8 For oral or rectal administration refer to the SPC of ondansetron tablets and suppositories, respectively. Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, high-dose cisplatin, ondansetron can be given by intravenous or other routes of administration, however this product is for intravenous use only. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy: A single dose of 8mg by slow intravenous or intramuscular injection immediately before chemotherapy. A dose of 8mg by slow intravenous or intramuscular injection or as a short-time intravenous infusion over 15 minutes immediately before chemotherapy, followed by two further intravenous or intramuscular doses of 8mg two to four hours apart, or by a constant infusion of 1mg/hour for up to 24 hours.

9 PAR Ondansetron 2mg/ml Solution for Injection UK/H/1240/01/DC 6 A single dose of 32mg diluted in 50-100ml of sodium chloride 9mg/ml ( w/v) solution or other compatible infusion fluid (see compatibility with solutions for infusion under section ) and infused over not less than 15 minutes immediately before chemotherapy. Doses of greater than 8mg and up to 32mg of Ondansetron may only be given by intravenous infusion diluted in 50-100ml of saline or other compatible infusion fluid (see Pharmaceutical Precautions) and infused over not less than 15 minutes. The selection of dose regimen should be determined by the severity of the emetogenic challenge.

10 The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy. To protect against delayed or prolonged emesis after the first 24 hours, ondansetron treatment with dosage forms other than intravenous should be continued after a course of treatment. The recommended dose for oral administration is 8mg twice daily. Children (aged 2 years and above) and adolescents (< 18 years): Experience in paediatric patients is limited. In children older than 2 years, Ondansetron may be administered as a single intravenous dose of 5mg/m2 over 15 minutes immediately before chemotherapy, followed by treatment with dosage forms other than intravenous.