Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
KETOTIFEN
Laboratoires THEA 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
S01GX08
KETOTIFEN 0.25 mg/ml
EYE DROPS, SOLUTION
KETOTIFEN 0.25 mg/ml
POM
OPHTHALMOLOGICALS
Withdrawn
2005-12-12
Zaditen ® Eye Drops, Solution (Ketotifen) Read all of this leaflet carefully before you start using this medicine • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. • The active ingredient is ketotifen 0.25mg/ml. • The other ingredients are benzalkonium chloride, glycerol, sodium hydroxide, water for injections. Marketing Authorisation Holder: Laboratoires THEA 12 rue Louis Blériot 63017 Clermont-Ferrand Cedex 2 France Manufacturer: EXCELVISION, Rue de la Lombardière, 07100 Annonay, France 1. What Zaditen Eye Drops is and what it is used for The name of your eye drops is Zaditen ® . The active ingredient is 0.25mg ketotifen per ml of ophthalmic solution and is packaged in a dropper bottle containing 5ml of eye drops. Ketotifen is an anti-allergic agent. Zaditen ® Eye Drops is used for the treatment and prevention of signs and symptoms of seasonal allergic conjunctivitis (itchy, watery, red or swollen eyes and/or eyelids). Your doctor will explain your condition. 2. Before you use Zaditen ® Eye Drops Zaditen ® Eye Drops can be used by adults, elderly and children of 12 years and older. Efficacy has not been tested in children below 12 years, however limited safety documentation is available for Zaditen ® Eye Drops in children from 3 years of age. Do not use Zaditen ® Eye Drops If you are allergic to ketotifen or to any of the excipients. Pregnancy There is limite Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISITICS 1. NAME OF THE MEDICINAL PRODUCT ZADITEN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL contains 0.345 mg of ketotifen hydrogen fumarate corresponding to 0.25 mg of ketotifen. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Eye drops, Solution in a 5 mL bottle. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prevention of signs and symptoms of seasonal allergic conjunctivits. 4.2 DOSAGE ANDADMINISTRATION Dosage Use in adults One drop of Zaditen eye drops into the conjunctival sac twice a day. The contents and dispenser remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the dropper tip. Safety and effectiveness in paediatric patients below the age of 3 years have not been established. GERIATRICS No dosage adjustment is required in patients above 65 years of age. RENAL IMPAIRMENT No dosage adjustment is required in patients with renal impairment. HEPATIC IMPAIRMENT No dosage adjustment is required in patients with hepatic impairment. METHOD OF ADMINISTRATION _ _ ZADITEN: The contents and dispenser remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the dropper tip. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. If Zaditen eye drops are used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications. 4.3 CONTRAINDICATIONS Known hypersensitivity to ketotifen or any other excipients of the formulation. 4.4 WARNINGS AND PRECAUTIONS The multidose formulation of Zaditen eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore Zaditen eye drops should not be instilled while the patient is wearing these lenses. The lenses should be re Đọc toàn bộ tài liệu