Not applicable.
Not applicable
None.
Administrative dataAs for all parenteral products, ampoules of Buscofen should be visually inspected for particulate matter and the integrity of the container prior to use. Ampoules are intended for single use only, any unused portions must be discarded.
Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Buscofen solution. Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.
When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Buscofen solution, the ampoule must be completely dry before it is opened.
The required volume to be given to the infant should be determined according to body weight, and should be injected intravenously as a short infusion over 15 minutes, preferably undiluted.
Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to adjust injection volume.
The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered. A maximal volume of 80 ml/kg/day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/kg birthweight/day) up to a maximal volume of 180 ml/kg birthweight/day.
Before and after administration of Buscofen, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%), solution for injection.
After first opening of an ampoule, any unused portions must be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
