Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Ventolin Injection is indicated in adults and adolescents.
Ventolin Injection provides short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. It is indicated for the relief of severe bronchospasm.
Ventolin Injection may be administered by the subcutaneous, intramuscular or intravenous route, under the direction of a physician.
Subcutaneous route: 500 micrograms (8 micrograms/kg body weight) and repeated every four hours as required.
Intramuscular route: 500 micrograms (8 micrograms/kg body weight) and repeated every four hours as required.
Slow intravenous injection: 250 micrograms (4 micrograms/kg bodyweight) injected slowly. If necessary the dose may be repeated.
The use of Ventolin Injection 500 micrograms in 1ml (500 micrograms/ml, for intravenenous administration may be facilitated by dilution to 10ml with Water for Injection BP (final concentration of 50 micrograms/ml) and 5mls of the diluted preparation (250 micrograms/5ml) administered by slow intravenous injection.
The safety and efficacy of Ventolin Injection in children under the age of 12 has not been established. From the available data no recommendation on posology can be made.
Children aged 12 years and over: Dose as per adult population.
Ampoules are equipped with the OPC (One Point Cut) opening system and must be opened using the following instructions:
Hold with one hand the bottom part of the ampoule as indicated in Picture 1 put the other hand on the top of the ampoule positioning the thumb above the coloured point and press as indicated in Picture 2.
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia and lactic acidosis (see sections 4.4 and 4.8).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
36 months.
24 hours shelf life of admixtures with infusion fluids.
Store below 30°C and keep the ampoule in the outer container in order to protect from light.
Clear, neutral glass ampoules, packed in plastic trays with a cardboard sleeve over the trays.
Pack size: 1ml ampoules in plastic trays of 5.
The only recommended diluents for Ventolin Injection are water for injections BP, sodium chloride injection BP, sodium chloride and dextrose injection BP or dextrose injection BP.
All unused admixtures of Ventolin Injection should be discarded 24 hours after preparation.
Ventolin Injection should not be administered in the same syringe as any other medication.
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