Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzydamine hydrochloride
Advanz Pharma
A01AD02
Benzydamine hydrochloride
1.5mg/1ml
Spray
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12030100; GTIN: 5060064791219
OBJECT 1 BENZYDAMINE 0.15%W/V OROMUCOSAL SPRAY Summary of Product Characteristics Updated 21-Feb-2017 | Concordia International- formerly Focus Pharmaceuticals Ltd 1. Name of the medicinal product Oroeze Spray 0.15% w/v Oromucosal Spray Benzydamine 0.15% w/v Oromucosal Spray 2. Qualitative and quantitative composition Benzydamine hydrochloride 0.15% w/v. Each spray contains 262.5 micrograms of benzydamine hydrochloride. Excipients with known effect Ethanol (96%) 8.1 %w/v Methyl parahydroxybenzoate 0.1 %w/v It also contains propylene glycol. For the full list of excipients, see Section 6.1 3. Pharmaceutical form Oromucosal spray. A clear solution with an odour of peppermint in a multidose spray container fitted with a metering pump and nozzle. 4. Clinical particulars 4.1 Therapeutic indications Oroeze Spray is a locally acting analgesic and anti-inflammatory treatment for the throat and mouth. It is especially useful for the relief of pain in traumatic conditions such as following tonsillectomy or the use of a naso-gastric tube; dental surgery. 4.2 Posology and method of administration Posology ADULTS AND ELDERLY: 4 to 8 sprays, 1½ - 3 hourly. Paediatric population CHILDREN (6-12): 4 sprays, 1½ - 3 hourly. CHILDREN UNDER 6: One spray to be administered per 4 kg body weight, up to a maximum of 4 sprays, 1½ - 3 hourly. Because of the small amount of drug applied, elderly patients can receive the same dose as adults. Method of administration Oromucosal administration. 4.3 Contraindications Hypersensitivity to active substance or to any of the excipients, listed in section 6.1 4.4 Special warnings and precautions for use Avoid contact with the eyes. Oroeze Spray/Benzydamine 0.15% w/v Oromucosal Spray contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains propylene glycol which may cause skin irritation. 4.5 Interaction with other medicinal products and other forms of interaction None known. 4.6 Fertility, pregnancy and lactation Pregnancy Oroeze Spray/Benzydamine Прочетете целия документ