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 particularly those with poor inhaler technique. Use of a ‘puffer’), 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.
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.
consult-otc-argom-111128-app5-product-specific.docx