Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
ketotifen fumarate, Quantity: 0.345 mg/mL (Equivalent: ketotifen fumarate, Qty 0.25 mg/mL; Equivalent: ketotifen, Qty 0.25 mg/mL)
Care Pharmaceuticals Pty Ltd
Eye Drops, solution
Excipient Ingredients: water for injections; glycerol; sodium hydroxide; benzalkonium chloride
Ophthalmic
1 x 5mL, 1 x 2.5mL
(S2) Pharmacy Medicine
The symptomatic short term treatment of seasonal allergic conjuctivitis in adults and children 3 years or older.
Visual Identification: Clear, colourless to faintly yellow solution.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-07-19
ZADITEN ® EYE DROPS 1.0% _Ketotifen_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use Zaditen Eye Drops. This leaflet answers some common questions about Zaditen Eye Drops. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using Zaditen Eye Drops against the risks this medicine could have for you. The information in this leaflet applies to Zaditen only. This information does not apply to similar products, even if they contain the same ingredients. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZADITEN IS USED FOR Zaditen contains the active ingredient, ketotifen, which is an anti-inflammatory medicine. It works by blocking the allergic response and reducing inflammation. This medicine is used for short term treatment of the symptoms of seasonal allergic conjunctivitis (itchy, watery or swollen eyes and/or eyelids). ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN GIVEN TO YOU. Your pharmacist or doctor may have given it for another reason. This medicine is not addictive. It is available from your pharmacy. _USE IN CHILDREN_ Zaditen is not recommended for use in children under 3 years. The safety and effectiveness of Zaditen in this age group has not been established. BEFORE YOU USE ZADITEN DO NOT USE ZADITEN EY Leggi il documento completo
1 AUSTRALIAN PRODUCT INFORMATION – ZADITEN (KETOTIFEN) EYE DROPS SOLUTION 1 NAME OF THE MEDICINE ketotifen as ketotifen fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zaditen is a sterile ophthalmic solution containing ketotifen for topical administration to the eye. Each 1.0 mL contains 345 µg ketotifen fumarate corresponding to 250 µg ketotifen. Excipients with known effect: Benzalkonium chloride (multidose bottle only). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye Drops - clear, colourless to faintly yellow, sterile ophthalmic solution for administration to the eye. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Symptomatic short term treatment of seasonal allergic conjunctivitis in adults and children 3 years or older. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults, elderly and children (age 3 and older): One drop of Zaditen into the conjunctival sac twice daily. INSTRUCTIONS FOR USE AND HANDLING MULTIDOSE BOTTLE: 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 tip of the container should also not come into contact with the eye as this may cause injury to the eye. The multidose formulation of Zaditen eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses and may possibly discolor soft contact lenses (see Section 4.4 Special Warnings and Precautions for Use). After opening, Zaditen should not be used for more than 4 weeks and any remaining contents should be discarded. After cap is removed, if tamper evident snap collar is loose, remove before using the product. 2 SINGLE DOSE UNITS: The contents remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the tip of the container. The tip of the container should also not come into contact with the eye as this may cause injury to the eye. After opening, single dose units must be used immediately. Con Leggi il documento completo