Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Olopatadine hydrochloride 0.111%{relative} equivalent to 0.1% w/v olopatadine;
Novartis New Zealand Ltd
Olopatadine hydrochloride 0.111% w/v (equivalent to 0.1% w/v olopatadine)
0.1% w/v
Eye drops, solution
Active: Olopatadine hydrochloride 0.111%{relative} equivalent to 0.1% w/v olopatadine Excipient: Benzalkonium chloride Dibasic sodium phosphate Hydrochloric acid Sodium chloride Sodium hydroxide
Bottle, dropper, 1mL LDPE Sample pack, 1 mL
Prescription
Prescription
Kyowa Hakko Bio Co., Ltd
Package - Contents - Shelf Life: Bottle, dropper, 5mL LDPE - 5 mL - 24 months from date of manufacture stored at or below 25°C. for finished product manufactured at Alcon Cusi SA only 36 months from date of manufacture stored at or below 25°C. for finished product manufactured at other sites 28 days opened stored at or below 25°C
2001-03-09
Internal document code pat090623cNZ is based on PI pat090623iNZ 1 PATANOL ® _Olopatadine hydrochloride 0.1% _ Eye Drops CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE PATANOL EYE DROPS. This leaflet answers some common questions about Patanol eye drops. It does not contain all 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.medsafe.govt.nz. 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 risks of you using Patanol against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT PATANOL IS USED FOR Patanol eye drops belong to the group of medicines called antihistamines. Patanol eye drops are used to treat seasonal, allergic conjunctivitis, which is an inflammation of the eye due to pollens that cause an allergic response to give watery, itchy and/or red eyes. Before prescribing Patanol eye drops for you, your doctor will have examined your eye(s) and decided that Patanol eye drops is the right medicine for you. Your doctor may have prescribed Patanol eye drops for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PATANOL EYE DROPS HAVE BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor’s prescription. Patanol eye drops are not addictive. _USE IN CHILDREN _ Pantanol eye drops are not recommended for use in children under 3 years of age. The safety and effectiveness of Patanol eye dro Prečítajte si celý dokument
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME PATANOL EYE DROPS, SOLUTION 0.1% W/V 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Patanol Eye Drops contains 1.11 mg olopatadine hydrochloride which is equivalent to 1.0 mg olopatadine (0.1%). Excipient with known effect Benzalkonium chloride 0.1 mg per 1 mL as a preservative. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. The solution is clear and colourless to pale yellow. The solution is buffered to a pH of approximately 7. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Patanol Eye Drops are indicated for the treatment of the signs and symptoms of allergic conjunctivitis. 4.2. DOSE AND METHOD OF ADMINISTRATION The recommended therapy is one to two drops of Patanol Eye Drops in the affected eye(s) twice daily. 4.3. CONTRAINDICATIONS Patanol Eye Drops are contraindicated in patients hypersensitive to olopatadine hydrochloride or any other component of the preparation listed under Section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE NOT FOR INJECTION OR ORAL INGESTION. Paediatric use Safety and effectiveness have not been established in children below 3 years of age. Instructions to patients Patanol contains the preservative benzalkonium chloride, which may cause eye irritation and be deposited in or discolour soft (hydrophilic) contact lenses. Avoid contact with soft contact lenses. Patients who wear soft contact lenses should remove their lenses prior to instilling Patanol Eye Drops and should not reinsert their lenses until at least 15 minutes after instillation of the eye drops. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. The bottle should be tightly closed when not in use. Each bottle of Patanol Eye Drops should be discarded within 28 days of opening 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Interactions with other medications have not been investigate Prečítajte si celý dokument