Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
timolol maleate, Quantity: 6.83 mg/mL (Equivalent: timolol, Qty 5 mg/mL); latanoprost, Quantity: 0.05 mg/mL
Aspen Pharmacare Australia Pty Ltd
Latanoprost,Timolol maleate
Eye Drops, solution
Excipient Ingredients: sodium hydroxide; benzalkonium chloride; dibasic sodium phosphate; water for injections; sodium chloride; hydrochloric acid; monobasic sodium phosphate monohydrate
Ophthalmic
1 x 2.5 mL
(S4) Prescription Only Medicine
The reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. LATANOCOM should not be used to initiate therapy.
Visual Identification: clear, colourless liquid; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2012-03-30
LATANOCOM ® _EYE DROPS_ _Latanoprost/Timolol maleate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Latanocom. 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 Latanocom against the benefits it is expected to 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 LATANOCOM IS USED FOR Latanocom is 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. 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. _HOW LATANOCOM WORKS_ Latanocom is made up of 2 active ingredients, latanoprost and timolol maleate. Latanoprost works by allowing more fluid to flow out from within your eye(s). Timolol maleate lowers the pressure in the eye by reducing the production of fluid. Latanoprost belongs to a family of medicines called prostaglandin agonists. Timolol maleate belongs to a family of medicines called beta- blockers. Although Latanocom helps control your g Prečítajte si celý dokument
Version: pfplatae10317 Supersedes: pfplatae10114 Page 1 of 15 PRODUCT INFORMATION LATANOCOM (LATANOPROST AND TIMOLOL) NAME OF THE MEDICINE Latanocom is a combination eye drop containing latanoprost and timolol maleate. The chemical name of latanoprost is isopropyl-(Z)-7[(1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3- hydroxy-5-phenyl-1-pentyl]cyclopentyl]-5-heptenoate, according to IUPAC. Its molecular formula is C 26 H 40 O 5 . The CAS number for latanoprost is 130209-82-4. The chemical structure is as follows: OH OH OH COOCH(CH 3 ) 2 The chemical name of timolol maleate is (S)-1-( _tert-_ butylamino)-3-[(4-morpholino-1,2,5-thiadiazol- 3-yl)oxy]-2-propanol maleate (1:1) (salt). Its molecular formula is C 13 H 24 N 4 O 3 S∙C 4 H 4 O 4 . The CAS number for timolol maleate is 26921-17-5. The chemical structure is as follows: ∙ DESCRIPTION The active ingredients in Latanocom eye drops are latanoprost and timolol maleate. Latanoprost is a prostaglandin F 2 analogue. It has a molecular weight of 432.58. It is a colourless to slightly yellow oil which is practically insoluble in water, freely soluble in ethanol, ethyl acetate, isopropanol, methanol, acetone and octanol, and very soluble in acetonitrile. Sixty four isomers of latanoprost are possible, however, for Latanocom it is purified as a single isomer. Timolol maleate is a beta-adrenergic receptor blocking agent. It has a molecular weight of 432.50. It is a white to off-white crystalline powder which is soluble in water, alcohol and practically insoluble in ether. N S N O N O N H H OH H 3 C CH 3 CH 3 + HO O O OH N S N O N O N H H OH H 3 C CH 3 CH 3 + HO O O OH Version: pfplatae10317 Supersedes: pfplatae10114 Page 2 of 15 Latanocom is a sterile, isotonic solution containing 50 micrograms/mL of latanoprost and 5 mg/mL of timolol (6.83 mg timolol maleate) in an aqueous buffer solution of pH 6.0. The excipients in Latanocom are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, hydrochloric acid, sodium hydroxide, Water for Prečítajte si celý dokument