Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Ondansetron 2 mg/ml Solution for Injection or Infusion.
| Pharmaceutical Form |
|---|
|
Solution for Injection or Infusion. Clear colourless solution. |
Each ml of solution for injection or infusion contains 2mg ondansetron (as ondansetron hydrochloride dihydrate).
Each ampoule with 2ml contains 4mg ondansetron (as ondansetron hydrochloride dihydrate).
Each ampoule with 4ml contains 8mg ondansetron (as ondansetron hydrochloride dihydrate).
Excipient with known effect: 1 ml solution for injection or infusion contains 3.62 mg of sodium as sodium citrate, sodium chloride and sodium hydroxide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ondansetron |
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. |
| List of Excipients |
|---|
|
Citric acid monohydrate |
Type I clear glass ampoules/ amber glass ampoules.
2 ml:
Pack sizes: Carton containing 10 ampoules.
Carton containing 5 ampoules.
4 ml:
Pack sizes: Carton containing 10 ampoules.
Carton containing 5 ampoules.
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0082
11/12/2009
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