Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Bimatoprost 0.3 mg/mL;
AbbVie Limited
Bimatoprost 0.3 mg/mL
0.3 mg/mL
Eye drops, solution
Active: Bimatoprost 0.3 mg/mL Excipient: Benzalkonium chloride Citric acid monohydrate Dibasic sodium phosphate heptahydrate Hydrochloric acid Purified water Sodium chloride Sodium hydroxide
Bottle, dropper, LDPE, 3ml, 1 dose unit
Prescription
Prescription
Kyowa Pharma Chemical Co. Ltd.
Monotherapy for the reduction of elevated intraocular pressure (IOP) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents.
Package - Contents - Shelf Life: Bottle, dropper, LDPE - 3 mL - 24 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C
2001-03-30
LUMIGAN® eye drops bimatoprost 0.3 mg per mL CMI v9 PI v8 30aug23 1 LUMIGAN® 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 LUMIGAN® EYE DROPS? LUMIGAN® eye drops contains the active ingredient bimatoprost. LUMIGAN® eye drops is used to lower raised pressure in the eye and to treat glaucoma. For more information, see Section 1. Why am I using LUMIGAN® eye drops? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LUMIGAN® EYE DROPS? Check the list of ingredients at the end of the CMI. Do not use LUMIGAN® 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 LUMIGAN® eye drops? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LUMIGAN® eye drops and affect how it works, or LUMIGAN® 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 LUMIGAN® EYE DROPS? • Use one drop in your affected eye(s), according to your doctor's instructions • Use the drops each evening. More instructions can be found in Section 4. How do I use LUMIGAN® eye drops? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LUMIGAN® EYE DROPS? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using LUMIGAN® eye drops • Continue to use LUMIGAN® eye drops every evening unless your doctor tells you to stop • Keep all your appointments so your condition can be checked. THINGS YOU SHOULD NOT DO • Do not touch the dropper tip against your eye, eye lid or any surface • Do Preberite celoten dokument
LUMIGAN ® DS v9 CCDS v13 3 May 23 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME LUMIGAN ® (bimatoprost) 0.3 mg/mL eye drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LUMIGAN ® eye drops contains bimatoprost 0.3 mg/mL For full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM LUMIGAN ® (bimatoprost) eye drops are a clear, isotonic, colourless, sterile ophthalmic solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LUMIGAN ® eye drops is indicated as monotherapy for the reduction of elevated intraocular pressure (IOP) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents. 4.2 DOSE AND METHOD OF ADMINISTRATION MONOTHERAPY: The recommended dose is one drop of LUMIGAN ® eye drops in the affected eye(s) once daily, administered in the evening. ADJUNCTIVE THERAPY: The recommended dose is one drop of LUMIGAN ® eye drops in the affected eye(s) once daily, administered in the evening. More frequent administration has not been shown to provide increased efficacy. If more than one topical ophthalmic medication is to be used, the other medication should not be used within 5 minutes of using LUMIGAN ® eye drops. In order to minimise systemic absorption of LUMIGAN ® eye drops, patients should be instructed to apply pressure to the tear duct immediately following administration of the drug. PAEDIATRIC USE Safety and effectiveness in patients below 18 years of age have not been established. USE IN ELDERLY No dosage adjustment in elderly patients is necessary. 4.3 CONTRAINDICATIONS LUMIGAN ® eye drops are contraindicated in patients with hypersensitivity to bimatoprost or to any component of the medication. LUMIGAN ® DS v9 CCDS v13 3 May 23 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE GENERAL: LUMIGAN ® eye drops has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of bradycardi Preberite celoten dokument