Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
FLURBIPROFEN
RECKITT BENCKISER (NEAR EAST) LTD
S01BC04
LOZENGES
FLURBIPROFEN 8.75 MG
PER OS
Not required
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD, UK
FLURBIPROFEN
FLURBIPROFEN
For the short term relief of symptoms of sore throat such as throat pain and soreness in adults and children over the age of 12 years
2017-02-28
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strefen Honey and Lemon Strefen Orange flavour Sugar Free 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient; Flurbiprofen 8.75mg Excipient(s) with known effect: STREFEN HONEY AND LEMON Glucose Sucrose Wheat Starch* Sulphites – sulphur Dioxide (E220)* d-Limonene** Linalool** Citral** Citronellol** Farnesol** Geraniol** Butylate Hydroxyanisole (E220)** *present in liquid glucose **present in Lemon Flavour STREFEN ORANGE FLAVOUR SUGAR FREE Maltitol Liquid 0.5 09 g/lozenge. Total maximum daily dose (MDD) is 2.55 g. Isomalt 2.03 3 g/lozenge. Total maximum daily dose (MDD) is 10.195 g. Citral** Citronellol** d-Limonene** Geraniol** Linalool** **present in Orange flavour 2 For excipients, see 6.1. 3 PHARMACEUTICAL FORM Lozenges. STREFEN HONEY AND LEMON: A round, pale yellow to brown lozenge with an icon intagliated on both sides of the lozenge. STREFEN ORANGE FLAVOUR SUGAR FREE. A white to pale yellow circular lozenge, with a characteristic orange taste with an icon intagliated on both. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strefen Honey and Lemon & Strefen Orange flavour Sugar Free are indicated for the short term relief of symptoms of sore throat such as throat pain and soreness in adults and children over the age of 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, the elderly and children over the age of 12 years: One lozenge sucked/dissolved slowly in the mouth every 3 - 6 hours as required. Maximum 5 lozenges in a 24 hour period. It is recommended that this product should be used for a maximum of three days. Children: Not indicated for children under 12 years. Elderly: A general dose recommendation cannot be given, since to date clinical experience is limited. The elderly are at increased risk of the serious consequences of adverse reactions. Impaired hepatic: In patients with mild to moderate impairment of hepatic function no dose reduction is required. In patients with severe hepatic insufficiency fl Prečítajte si celý dokument