Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorhexidine gluconate; Lidocaine hydrochloride
Thornton & Ross Ltd
N01BB52
Chlorhexidine gluconate; Lidocaine hydrochloride
2mg/1ml ; 500microgram/1ml
Spray
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12030300; GTIN: 5011309016116
PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes C gill.kennedy 538655 11349 Change to dimensions to accomodate new bottle. Addition of reporting of side effects statement. MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 30ml 23659206 297 x 148mm 12 20.10.2014 Process Black Keylines (non-printing) Covonia Throat Spray Helvetica Neue LT PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes C gill.kennedy 538655 11349 Change to dimensions to accomodate new bottle. Addition of reporting of side effects statement. MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 30ml 23659206 297 x 148mm 12 20.10.2014 Process Black Keylines (non-printing) Covonia Throat Spray Helvetica Neue LT COVONIA THROAT SPRAY (chlorhexidine gluconate, lidocaine hydrochloride) IMPORTANT INFORMATION ABOUT COVONIA THROAT SPRAY • This medicine relieves the symptoms of painful, irritated sore throats in adults, the elderly and children over 12 years. • It is a sugar-free medicine which can be used by diabetics. DO NOT USE…. • On children under 12 years. TALK TO YOUR DOCTOR…. • If your sore throat has lasted for more than 2 days. • If you also have high temperature. You may need another medicine in these cases. NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT INCLUDES OTHER INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need any more information or advice. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. WHAT THE MEDICINE IS FOR Covonia Throat Spray contains chlorhexidine, an antiseptic and lidocaine which is a local pain killer. It reliev Прочитайте повний документ
OBJECT 1 COVONIA THROAT SPRAY Summary of Product Characteristics Updated 07-Nov-2016 | Thornton & Ross Ltd 1. Name of the medicinal product Covonia Throat Spray 2. Qualitative and quantitative composition Chlorhexidine gluconate 0.2% w/v Lidocaine hydrochloride 0.05% w/v For excipients, see 6.1. 3. Pharmaceutical form Oromucosal spray 4. Clinical particulars 4.1 Therapeutic indications Covonia Throat Spray is indicated for the symptomatic relief of painful, irritated sore throats. It is a sugar free preparation and can be used by diabetics. Additional therapy is required in the event of bacterial infection accompanied by fever. 4.2 Posology and method of administration Adults and children over 12 years The dose is 3 to 5 sprays (0.3 - 0.5 ml). This can be repeated 6 to 10 times per day. Children under 12 years Not recommended. 4.3 Contraindications Use in children under 12 years. Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8). 4.4 Special warnings and precautions for use Treatment with Covonia Throat Spray should be limited to the relief of existing pain and irritation when strictly necessary. It is not intended for prolonged use, either continuously or repeatedly. This medicine contains 42.5 vol % ethanol (alcohol), i.e. up to 168mg per application (5 sprays), equivalent to 0.85ml beer or 0.35ml wine per dose. Each 10 ml of the throat spray contains 3.5 g of ethanol. Covonia Throat Spray contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be rare. Covonia Throat Spray should not be administered to anyone with a potential history of allergic reaction to chlorhexidine- containing compound (see sections 4.3 and 4.8). Do not use and consult your doctor if you have difficulty in swallowin Прочитайте повний документ