Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
brimonidine tartrate, Quantity: 2 mg/mL; timolol maleate, Quantity: 6.8 mg/mL
Abbvie Pty Ltd
Eye Drops, solution
Excipient Ingredients: benzalkonium chloride; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; purified water; hydrochloric acid
Ophthalmic
5mL
(S4) Prescription Only Medicine
COMBIGAN eye drops are indicated for the reduction of elevated intraocular pressure for treatment of open angle glaucoma and/or ocular hypertension, in patients not adequately responding to monotherapy
Visual Identification: Clear, greenish-yellow sterile isotonic solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-01-07
COMBIGAN ® Eye Drops-CMI Version 2.0 – PIv5.0 1 COMBIGAN ® EYE DROPS (BRIMONIDINE TARTRATE 2.0 MG PER ML AND TIMOLOL (AS MALEATE) 5.0 MG PER ML) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about COMBIGAN ® eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using COMBIGAN ® eye drops 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 THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT COMBIGAN ® EYE DROPS ARE USED FOR COMBIGAN ® eye drops are used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye. There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems, including total blindness. In fact, untreated glaucoma is one of the most common causes of blindness. COMBIGAN ® eye drops lower the pressure in the eye by decreasing the fluid produced and helping the flow of fluid out of the eye chamber. Although COMBI Aqra d-dokument sħiħ
COMBIGAN ® Eye Drops PI v6 – CCDS v3.1 1 AUSTRALIAN PRODUCT INFORMATION – COMBIGAN ® (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) EYE DROPS 1 NAME OF THE MEDICINE Brimonidine tartrate and timolol maleate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of COMBIGAN ® Eye Drops solution contains brimonidine tartrate 2.0 mg (equivalent to 1.32 mg as brimonidine free base) and 6.8 mg of timolol maleate (equivalent to 5.0 mg of timolol). COMBIGAN ® is a combination eye drop containing brimonidine tartrate and timolol maleate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Eye drops, solution. COMBIGAN ® is a sterile ophthalmic solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COMBIGAN ® eye drops are indicated for the reduction of elevated intraocular pressure for treatment of open angle glaucoma and/or ocular hypertension, in patients not adequately responding to monotherapy. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose is one drop of COMBIGAN ® in the affected eye(s) twice daily, approximately 12 hours apart. In order to minimise systemic absorption of COMBIGAN ® 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 drug is to be used, other eye drops should not be used within five to ten minutes of using COMBIGAN ® eye drops. COMBIGAN ® Eye Drops PI v6 – CCDS v3.1 2 4.3 CONTRAINDICATIONS COMBIGAN ® eye drops are contraindicated in patients with hypersensitivity to any component of this medication, in patients receiving monoamine oxidase (MAO) inhibitor therapy, in patients with bronchospasm, bronchial asthma or patients with a history of bronchial asthma, or severe chronic obstructive pulmonary disease, in patients with sinus bradycardia, sick sinus syndrome, sino-atrial nodal block, second or third deg Aqra d-dokument sħiħ