Country: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Fexofenadine hydrochloride 6 mg/mL; Fexofenadine hydrochloride 6 mg/mL
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Fexofenadine hydrochloride 6 mg/mL
6 mg/mL
Oral suspension
Active: Fexofenadine hydrochloride 6 mg/mL Excipient: Butyl hydroxybenzoate Dibasic sodium phosphate heptahydrate Disodium edetate Monobasic sodium phosphate monohydrate Poloxamer Propyl hydroxybenzoate Propylene glycol Purified water Raspberry flavour F-9950 PFC Sucrose Titanium dioxide Xanthan gum Xylitol Active: Fexofenadine hydrochloride 6 mg/mL Excipient: Dibasic sodium phosphate heptahydrate Disodium edetate Monobasic sodium phosphate monohydrate Poloxamer Potassium sorbate Propylene glycol Purified water Raspberry flavour F-9950 PFC Sucrose Titanium dioxide Xanthan gum Xylitol
Bottle, plastic, Amber PET bottle, polypropylene child resistant closure (not marketed), 30 mL
Pharmacy only
Pharmacy only
Sanofi-Aventis Deutschland GmbH
Relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.
Package - Contents - Shelf Life: Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 30 mL - 18 months from date of manufacture stored at or below 25°C - Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 60 mL - 24 months from date of manufacture stored at or below 30°C. Product manufactured at Sanofi-aventis Farmaceutica Ltda - Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 150 mL - 24 months from date of manufacture stored at or below 30°C. Product manufactured at Sanofi-aventis Farmaceutica Ltda - Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 300 mL - 24 months from date of manufacture stored at or below 25°C
2009-03-02
TELFAST ® ORAL LIQUID REFORMULATION 1 TELFAST ® _ORAL LIQUID REFORMULATION _ _Fexofenadine hydrochloride _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Telfast. Please read the information carefully before giving your child Telfast. This leaflet provides a summary of the information available; it does not contain all the available information. It does not take the place of talking to your pharmacist or doctor, who have more detailed information. IF YOU HAVE ANY QUESTIONS ABOUT TELFAST, OR IF YOUR CHILD EXPERIENCES ANY PROBLEMS WHILE BEING GIVEN TELFAST, SPEAK TO YOUR PHARMACIST OR DOCTOR. All medicines have benefits and risks, so please discuss these with your pharmacist or doctor to make sure that the benefits of your child taking Telfast outweigh any possible risks. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TELFAST IS USED FOR Telfast contains an active ingredient called fexofenadine hydrochloride. It is one of a group of medicines called antihistamines. Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine, which your body produces when exposed to certain substances. Telfast is a non-sedating antihistamine which means it has been shown to not cause drowsiness. Telfast is used to relieve the symptoms of: • hayfever (seasonal allergic rhinitis) and year-round allergies (perennial allergic rhinitis). Symptoms include runny, itchy, blocked nose, sneezing and itchy, watery, red eyes. • hives or nettle rash (chronic idiopathic urticaria). Symptoms include pink to red, itchy swellings on the skin. Your pharmacist or doctor may have recommended this medicine for another reason. ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN RECOMMENDED FOR YOUR CHILD. BEFORE GIVING IT TO YOUR CHILD _WHEN IT MUST NOT BE GIVEN _ TELFAST MUST NOT BE GIVEN TO YOUR CHILD IF YOUR CHILD HAS HAD AN ALLERGIC REACTION TO FEXOFENADINE, TERFENADINE (TELDANE সম্পূর্ণ নথি পড়ুন
telfast-ccdsv7-dsv19-22feb24 Page 1 Internal NEW ZEALAND DATASHEET 1 PRODUCT NAME Telfast® 6 – 11 years 30mg film coated tablets# Telfast® 60mg film coated tablets Telfast® 120mg film coated tablets Telfast® 180mg film coated tablets Telfast® Oral Liquid, 6mg/mL, suspension Telfast® Oral Liquid, Re-formulation 6mg/mL, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 6 – 11 years 30mg film coated tablets#: Each tablet contains 30mg of fexofenadine hydrochloride equivalent to 28mg of fexofenadine. 60mg film coated tablets: Each tablet contains 60mg of fexofenadine hydrochloride equivalent to 56mg of fexofenadine. 120mg film coated tablets: Each tablet contains 120mg of fexofenadine hydrochloride equivalent to 112mg of fexofenadine. 180mg film coated tablets: Each tablet contains 180mg of fexofenadine hydrochloride equivalent to 168mg of fexofenadine. Oral liquid, 6mg/mL: Each mL of liquid contains 6mg (30mg/5mL) of fexofenadine hydrochloride equivalent to 5.6mg of fexofenadine. Oral liquid re-formulation, 6mg/mL: Each mL of liquid contains 6mg (30mg/5mL) of fexofenadine hydrochloride equivalent to 5.6mg of fexofenadine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 6 – 11 years 30mg film coated tablets#: peach, round, standard convex. 60mg film coated tablets: peach, oval, double convex. telfast-ccdsv7-dsv19-22feb24 Page 2 Internal 120mg film coated tablets: peach, modified capsule shaped (6.1mm x 15.8mm). 180mg film coated tablets: peach, capsule shaped (7.6mm x 17.3mm). Oral liquid: white uniform aqueous suspension, with a raspberry cream flavour. Oral liquid re-formulation: white uniform aqueous suspension, with a raspberry cream flavour 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PHARMACY ONLY MEDICINE Relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age. Relief of symptoms of urticaria in adults and children from 6 months of age. Telfast 6 – 11 years 30mg film coated tablets#: 20 tablet সম্পূর্ণ নথি পড়ুন