| In section 4.1 the following indication has been added to the SPC:
Children (6 months to 18 years)
- Short term treatment of peptic ulcer
- Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.
In section 4.2 the following posology information has been added to the SPC:
Adults (including elderly) / Adolescents (12 years and over)
Ranitidine Injection may be given at a dose of 50mg either as slow intravenous injection, intermittent intravenous infusion or intramuscularly.
In section 5.1 the following pharmacodynamic properties have been added to the SPC:
The clinical data available mentions the use of ranitidine in children to prevent stress ulcers. No
direct evidence for prevention of stress ulcers is available. Treatment for these patients is based
on the observation that pH is above 4 after administration of ranitidine. The value of this surrogate
parameter in children with stress ulcers remains to be established
In section 5.2 the following pharmacokinetic properties have been added to the SPC:
Special Patient Populations
Children/infants (6 months and above)
Limited pharmacokinetic data show that there were no significant differences in half-life (range for children 3 years and above: 1.7 - 2.2 h) and plasma clearance (range for children 3 years and above: 9 - 22 ml/min/kg) between children and healthy adults receiving intravenous ranitidine when correction is made for body weight. Pharmacokinetic data in infants is extremely limited but appears to be in line with that for older children.
Neonates (under 1 month)
Limited pharmacokinetic data from term babies undergoing treatment with Extracorporeal Membrane Oxygenation (EMCO) suggests that plasma clearance following iv administration may be reduced (1.5-8.2 ml/min/kg) and the half-life increased in the new-born. Clearance of ranitidine appeared to be related to the estimated glomerular filtration rate in the neonates.
In section 10 the date of revision of the text has been changed to October 2009
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