Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Triamcinolone acetonide
Lexon (UK) Ltd
R01AD11
Triamcinolone acetonide
55 microgram(s)/dose
Nasal spray, suspension
triamcinolone
2019-08-30
ADDITIONAL SIDE EFFECTS IN CHILDREN If your child has been using this medicine, it can affect how fast your child grows. This means that your doctor will need to regularly check your child’s height and therefore your doctor may lower the dose. In addition, your doctor may consider referring your child to a paediatric specialist. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE NASACORT • Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”. The expiry date refers to the last day of that month. • Do not store above 25°C. • Following the first opening Nasacort should be used with 2 months. • Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT NASACORT CONTAINS The active substance is triamcinolone acetonide. One delivered dose contains 55 micrograms of triamcinolone acetonide. The other ingredients are: - disodium edetate - anhydrous glucose - microcrystalline cellulose and carmellose sodium (AVICEL CL 611) - polysorbate 80 - benzalkonium chloride - dilute hydrochloric acid - sodium hydroxide - purified water 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NASACORT DO NOT USE NASACORT: • If you are allergic to triamcinolone acetonide or any of the other ingredients of this medicine (listed in section 6) Signs of an allergic reaction to Nasacort include: a rash (hives), itching, swallowing or breath Đọc toàn bộ tài liệu
Health Products Regulatory Authority 30 August 2019 CRN008LKF Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NASACORT 55 micrograms/dose nasal spray, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One delivered dose contains 55 micrograms of triamcinolone acetonide. Excipient with known effect Benzalkonium chloride For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, suspension _Product imported from France _ Off-white, nasal spray suspension. 4 CLINICAL PARTICULARS As per PA0540/011/001 5 PHARMACOLOGICAL PROPERTIES As per PA0540/011/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Disodium edetate Microcrystalline cellulose and carmellose sodium (AVICEL CL 611) Polysorbate 80 Benzalkonium chloride Anhydrous glucose Dilute hydrochloric acid Sodium hydroxide Purified water 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the bottle and outer package of the product on the market in the country of origin. After first opening: 2 months 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. Health Products Regulatory Authority 30 August 2019 CRN008LKF Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER NASACORT is contained in a bottle fitted with a metered-dose spray pump unit, providing 120 actuations. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon (UK) Limited Unit 18, Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1097/032/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 th August 2019 10 DATE OF REVISION OF THE TEXT Đọc toàn bộ tài liệu