Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Bimatoprost 0.3 mg/mL; ; Timolol maleate 6.8 mg/mL equivalent to 5 mg/mL timolol;
AbbVie Limited
Bimatoprost 0.3 mg/mL
Eye drops, solution
Active: Bimatoprost 0.3 mg/mL Timolol maleate 6.8 mg/mL equivalent to 5 mg/mL timolol Excipient: Benzalkonium chloride Citric acid monohydrate Dibasic sodium phosphate heptahydrate Hydrochloric acid Purified water Sodium chloride Sodium hydroxide
Bottle, plastic, 1, 3 mL
Prescription
Prescription
Kyowa Pharma Chemical Co. Ltd.
Package - Contents - Shelf Life: Bottle, plastic, 1 - 3 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C
2005-11-02
GANFORT® 0.3/5 bimatoprost 0.3 mg per mL & timolol (as maleate) 5.0 mg per mL Eye Drops CMI v8-PIv7 30aug23 1 GANFORT® 0.3/5 EYE DROPS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING GANFORT® 0.3/5 EYE DROPS? GANFORT® 0.3/5 eye drops contains the active ingredients bimatoprost and timolol (as maleate). GANFORT® 0.3/5 eye drops are used to lower raised pressure in the eye and to treat glaucoma. For more information, see Section 1. Why am I using GANFORT® 0.3/5 eye drops? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GANFORT® 0.3/5 EYE DROPS? Check the list of ingredients at the end of the CMI. Do not use GANFORT® 0.3/5 eye drops if you have ever had an allergic reaction to any of them. TALK TO YOUR DOCTOR BEFORE YOU USE THIS MEDICINE IF HE/SHE IS NOT AWARE THAT YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use GANFORT® 0.3/5 eye drops? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with GANFORT® 0.3/5 eye drops and affect how it works, or GANFORT® 0.3/5 eye drops may interfere with other medicines and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE GANFORT® 0.3/5 EYE DROPS? • Use one drop in your affected eye(s), according to your doctor's instructions. • Use the drops each morning. • Please refer to the full instructions which can be found in Section 4. How do I use GANFORT® 0.3/5 eye drops? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GANFORT® 0.3/5 EYE DROPS? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using GANFORT® 0.3/5 eye drops. • Continue to use GANFORT® 0.3/5 eye drops every day unless your doctor te Prečítajte si celý dokument
GANFORT DSv8 CCDSv4 24 April 2023 NEW ZEALAND DATA SHEET GANFORT ® - EYE DROPS 1 PRODUCT NAME GANFORT ® 0.3/5 - Eye drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL For a full list of excipients, see section 6.1 List of excipients 3 PHARMACEUTICAL FORM Eye drops 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GANFORT ® 0.3/5 eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose is one drop of GANFORT ® 0.3/5 in the affected eye(s) once daily, administered in the morning. In order to minimise systemic absorption of GANFORT ® 0.3/5 eye drops, apply pressure to the tear duct immediately following administration of the drug. As with all eye drops containing benzalkonium chloride as a preservative, there is potential for incompatibility with other topical ophthalmic medications. If more than one topical ophthalmic medicinal product is to be used, other eye drops should not be used within five to ten minutes of using GANFORT ® 0.3/5 eye drops. INFORMATION FOR PATIENTS - USE WITH CONTACT LENSES The preservative in GANFORT ® 0.3/5 eye drops, benzalkonium chloride, may be absorbed by and cause discolouration of soft contact lenses. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove them prior to administration and wait at least 15 minutes after instilling GANFORT ® 0.3/5 eye drops before reinserting soft contact lenses. SPECIAL POPULATIONS _Paediatric Use: _ Safety and effectiveness in paediatric patients have not been established. GANFORT DSv8 CCDSv4 24 April 2023 4.3 CONTRAINDICATIONS GANFORT ® 0.3/5 eye drops are contraindicated in patients with hypersensitivity to any component of this medication, in patients with bronchospasm, bronchial asthma or patients with a history of bronchial asthma, or severe chronic obstructive pulmona Prečítajte si celý dokument