Cetrimide Adverse reactions have been reported following repeated application of creams containing more than 1% cetrimide. Topical products containing more than 1% cetrimide will not be approved for registration unless appropriate supporting clinical efficacy and safety data are provided. Chest rubs The use of chest rubs will not be accepted for the treatment of bronchial conditions. The only indications that will be accepted for chest rubs containing ingredients such as eucalyptus oil, menthol, camphor and other aromatics are: May relieve the nasal congestion of colds and make breathing easier (or similar wording). The directions for use of rubs should include the following statement: Do not apply to infants under 12 months of age unless on the advice of a doctor or pharmacist. Rub on the chest and/or the throat. Do not use on the face or anywhere near or in the eyes or nostrils. See also , and . Chlorhexidine Adverse allergic reactions have been reported for products containing chlorhexidine for use on oral mucosal surfaces. Therefore the labels of products containing chlorhexidine for application to mucous membranes should include a prominent statement consistent with the following: *Warning – This product contains chlorhexidine. Severe allergic reactions can Stop use if this occurs.
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
Mebendazole See Metered dose inhalers Spacer devices A statement consistent with the following should be included in the Product Information of metered dose inhaler products used in the treatment of respiratory disorders such as asthma and chronic obstructive airways disease: Children and many people will benefit from the consistent use of a spacer device with their metered dose inhaler (MDI or ‘puffer’), particularly those with poor inhaler technique. Use of a spacer will also decrease the amount of medicine deposited in the mouth and back of the throat, and therefore reduce the incidence of local side effects such as mouth and throat irritation. In those people using a spacer, a change in formulation of the medicine used, or a change in the make of spacer may be associated with alterations in the amount of medicine delivered to the lungs. The clinical significance of these alterations is uncertain. However, in these situations, the person should be monitored for any loss of asthma control. If using a spacer, the patient should be instructed to breathe in and out several times after each release into the spacer. Any delay should be kept to a minimum. Because of electrostatic charge, leading to adherence of medicine particles to the walls of the spacer, spacers should be washed in warm water with kitchen detergent and left to drain dry (without rinsing) before initial use and at least monthly thereafter. A cloth should not be used to dry the spacer, as this can produce more static electricity. The Product Information should include information on compatible spacers, and should recommend that patients are directed to read the instructions that come with the spacer. Consistent advice should also be included on the label and/or in the CMI (or other package insert). Mouth ulcers, relief Product labels should include a statement such as: If symptoms persist, seek medical or dental advice.