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Excipient with known effect:Each 1 ml of solution contains 0.13mmol (3.1mg) of sodium.For the full list of excipients, see section 6.1.
Adults:The usual dose of chlorphenamine injection for adults is 10mg to 20mg, but not more than 40mg should be given within a 24-hour period. The injection may be given by the subcutaneous, intramuscular or intravenous route.When a rapid effect is desired, as in anaphylactic reactions, the intravenous route is recommended in addition to emergency therapy with adrenaline (epinephrine), corticosteroids, oxygen and supportive therapy as required. In this case chlorphenamine injection should be injected slowly over a period of one minute, using the smallest adequate syringe. Any drowsiness, giddiness or hypotension which may follow is usually transitory.In the event of a blood transfusion reaction, a dose of 10mg to 20mg of chlorphenamine injection should be given by the subcutaneous route. This can be repeated to a total of 40mg within a 24-hour period, or oral forms of chlorphenamine may be given until the symptoms subside.Chlorphenamine injection may be helpful in the prevention of delayed reactions to penicillin and other drugs when given separately by intramuscular injection immediately prior to administration of the other drug. The usual dose is 10mg.Chlorphenamine injection cannot, however, be relied on to prevent anaphylactic reactions in patients known to be allergic to a particular drug.
Paediatric population:The dose for children should be calculated, based on either the child's age or their body weight, using the following table:
|1 month to 1 year||0.25mg/kg|
|1 to 5 years||2.5mg to 5mg||OR||0.20mg/kg|
|6 to 12 years||5mg to 10mg||OR||0.20mg/kg|
|12 to 18 years||10mg to 20mg||OR||0.20mg/kg|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
Use in the paediatric populationDue to the small volumes that are required for children under one year of age, chlorphenamine injection may be diluted with sodium chloride 0.9% injection to produce a solution containing chlorphenamine 1mg/ml. For example, 0.2ml chlorphenamine injection may be diluted to 2ml with sodium chloride 0.9% injection immediately prior to administration. See section 4.2 for details of paediatric dosing.The diluted solution should be inspected visually for particulate matter and discoloration prior to administration. In the event of either being observed, discard the medicinal product. Only clear solution should be used. See section 6.3 for details regarding the shelf-life of the diluted solution.This medicinal product is for single use only. If the entire reconstituted content of the ampoule is not required, any unused solution should be discarded in accordance with local requirements.