As fever is a normal and generally beneficial response to infection, no elaboration to the words “reduces will be accepted except in the context of duration of treatment, relief of discomfort associated with fever” fever or examples of conditions where fever may occur. Dose Adult dosage dosage recommendations (adults and children 12 years and over): 200 mg to 400 mg every four to six hours as necessary. Dosage should not exceed 1200 mg (expressed on the label as the number of units, for example tablets) in 24 hours. Paediatric dosage Paediatric dosage recommendations (3 months to 12 years): The recommended paediatric dose is 5-10 mg/kg/dose. Doses should be given every 6-8 hours as necessary with no more than four doses in 24 hours. dosage instructions for children under 12 months of age are included on the labelling, the dosage instructions (see Table 7.2) must include statements advising that the product should not be given to infants under 3 months, and that it should only be given to infants aged 3-12 months following the advice of a doctor. Labels could include appropriate discrete doses (consistent with the table below), instead of dosage ranges. E.g. for children aged 1-3 years, the label could include a dose equivalent to 100 mg (rather than a dosage range, such as 80-120 mg). Wider age ranges (e.g. 1-3 years) could be used on product labelling where appropriate. Table 1. Ibuprofen dosage for children aged 3 months to 12 years. Age Average body weight (kg) Dose (mg) 3 6 months 6 8 kg 40 60 mg – – – 6 12 months 8 10 kg 60 80 mg – – – 1 2 years 10 12 kg 80 100 mg – – – 2 3 years 12 14 kg 100 120 mg – – – 3 4 years 14 16 kg 120 140 mg – – – 4 5 16 18 kg 140 mg – – 5 6 years 18 20 kg 140 160 mg – – – 6 7 years 20 22 kg 160 180 mg – – – 7 8 years 22 25 kg 180 200 mg – – – 8 9 25 28 kg 200 220 mg – – – 9 10 years 28 32 kg 220 240 mg – – – 10 11 years 32 36 kg 240 280 mg – – –
As fever is a normal and generally beneficial response to infection, no elaboration to the words “reduces fever” will be accepted except in the context of duration of treatment, relief of discomfort associated with fever or examples of conditions where fever may occur. Dose Adult dosage dosage recommendations (adults and children 12 years and over): 200 mg to 400 mg every four to six hours as necessary. Dosage should not exceed 1200 mg (expressed on the label as the number of units, for example tablets) in 24 hours. Paediatric dosage Paediatric dosage recommendations (3 months to 12 years): The recommended paediatric dose is 5-10 mg/kg/dose. Doses should be given every 6-8 hours as necessary with no more than four doses in 24 hours. dosage instructions for children under 12 months of age are included on the labelling, the dosage instructions (see Table 7.2) must include statements advising that the product should not be given to infants under 3 months, and that it should only be given to infants aged 3-12 months following the advice of a doctor. Labels could include appropriate discrete doses (consistent with the table below), instead of dosage ranges. E.g. for children aged 1-3 years, the label could include a dose equivalent to 100 mg (rather than a dosage range, such as 80-120 mg). Wider age ranges (e.g. 1-3 years) could be used on product labelling where appropriate. Table 1. Ibuprofen dosage for children aged 3 months to 12 years. Age Average body weight (kg) Dose (mg) 3 – 6 months 6 – 8 kg 40 – 60 mg 6 – 12 months 8 – 10 kg 60 – 80 mg 1 – 2 years 10 – 12 kg 80 – 100 mg 2 – 3 years 12 – 14 kg 100 – 120 mg 3 – 4 years 14 – 16 kg 120 – 140 mg 4 – 5 16 – 18 kg 140 mg 5 – 6 years 18 – 20 kg 140 – 160 mg 6 – 7 years 20 – 22 kg 160 – 180 mg 7 – 8 years 22 – 25 kg 180 – 200 mg 8 – 9 25 – 28 kg 200 – 220 mg 9 – 10 years 28 – 32 kg 220 – 240 mg 10 – 11 years 32 – 36 kg 240 – 280 mg
consult-otc-argom-111128-app5-product-specific.docx