Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Betaxolol HCl 0.56% w/v eqv Betaxolol
NOVARTIS (SINGAPORE) PTE LTD
S01ED02
5.6 mg/ml
SOLUTION
Betaxolol HCl 0.56% w/v eqv Betaxolol 0.5% w/v
OPHTHALMIC
Prescription Only
ALCON-COUVREUR NV
ACTIVE
1990-06-13
KAPVORM PMS ZWART À 100 % B E S O P -0 0 3 2 6 A P P ROV AL LOCAL Ready for sending: as is. new proof. GRAPHICS The undersigned: confirms that this proof contains an accurate translation of the English Corporate Standard text, and is in compliance with the registered information and the legal rules. Please also carefully check : local barcodes if any, formula, components if AFFILIATES mentionned, shelflife if mentionned, storage conditions and trademarks. This proof is approved Signature and date : as is. as is, waiting for M.O.H. approval. (do not order component yet) Customer requests new proof. LOCAL Final release: as is. new proof. GRAPHICS 64585-0 1. NAME OF THE MEDICINAL PRODUCT BETOPTIC ® 0.5 % STERILE OPHTHALMIC SOLUTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of BETOPTIC ® Ophthalmic Solution contains 5 mg betaxolol base (equivalent to 5.6 mg betaxolol hydrochloride) Preservative : 1 ml solution contains 0.1 mg benzalkonium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM BETOPTIC ® 0.5 % Sterile Ophthalmic Solution is formulated as a sterile, multiple-dose solution for topical ophthalmic use. It is a clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BETOPTIC ® Ophthalmic Solution contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent. BETOPTIC ® Ophthalmic Solution has been shown to be effective in lowering intraocular pres Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT BETOPTIC® 0.5 % STERILE OPHTHALMIC SOLUTION (BETAXOLOL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Solution contains 5 mg betaxolol base ( equivalent to 5.6 mg betaxolol hydrochloride ) Preservative: 1 ml solution contains 0.1 mg benzalkonium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sterile Ophthalmic Solution Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BETOPTIC ® Ophthalmic Solution contains betaxolol, a cardioselective beta-adrenergic receptor blocking agent (beta-blocker). BETOPTIC ® Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of: • Patients with chronic open-angle glaucoma. • Patients with elevated intraocular pressure ( ocular hypertensive patients). • Patients with glaucoma or ocular hypertension who have reactive airway disease. • Patients with glaucoma or ocular hypertension who are currently on multiple-anti-glaucoma therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Use in adults ( including the elderly ) The usual dose is 1 drop of BETOPTIC Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering response to BETOPTIC Ophthalmic Solution may require a few weeks to stabilise. Clinical follow up should include a determination of the intraocular pressure during the first month of treatment with BETOPTIC Ophthalmic Solution. Thereafter, intraocular pressures should be determined on an individual basis at the judgement of the physician. When a patient is transferred from a single anti-glaucoma agent, continue the agent already used and add 1 drop of BETOPTIC Ophthalmic Solution in the affected eye(s) twice a day. On the following day, discontinue the previous anti-glaucoma agent completely and continue with BETOPTIC Ophthalmic Solution. If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with Les hele dokumentet