국가: 이스라엘
언어: 영어
출처: Ministry of Health
APRACLONIDINE AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
S01EA03
OPHTHALMIC SOLUTION
APRACLONIDINE AS HYDROCHLORIDE 5 MG/ML
OCULAR
Required
ALCON COUVREUR, BELGIUM
APRACLONIDINE
APRACLONIDINE
Short term adjunctive therapy of chronic glaucoma in patients on maximally tolerated medical therapy who require additional intraocular pressure (IOP) reduction to delay laser treatment or glaucoma surgery.
2020-07-31
KAPVORM 140 x 210 / 140 x 22 mm AANTAL KLEUREN : 1 KT 16-09-2011 IL recto-verso Iopidine 0,5% 44480-5 BELGIUM V4 068 60 28209 00 068 60 28209 00 PMS ZWART à 100% 44480-5 APPROVAL BESOP-00326 The undersigned: Ready for sending: LOCAL GRAPHICS LOCAL GRAPHICS AFFILIATES 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 mentionned, shelflife if mentionned, storage conditions and trademarks. This proof is approved Signature and date: as is. as is. as is, waiting for M.O.H. approval. Customer r equests new proof. Final release: as is. new proof. new proof. (do not order component yet) 전체 문서 읽기
IOP API NOV23 V3 1. NAME OF THE MEDICINAL PRODUCT IOPIDINE 0.5% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains apraclonidine 5 mg (as hydrochloride). Excipients with known effect: 1 ml of solution contains 0.1 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ophthalmic, solution. A colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications IOPIDINE 0.5% is indicated for short‐term adjunctive therapy of chronic glaucoma in patients on maximally tolerated medical therapy who require additional intraocular pressure (IOP) reduction to delay laser treatment or glaucoma surgery. The IOP lowering efficacy of IOPIDINE 0.5% diminishes over time in most patients. Although some patients have received successful treatment with IOPIDINE 0.5% for longer periods, the benefit for most patients is less than one month. The addition of IOPIDINE 0.5% to patients already using two aqueous suppressing drugs (i.e. beta‐blockers plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because IOPIDINE 0.5% is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. 4.2 Posology and method of administration Posology One drop of IOPIDINE 0.5% should be instilled into the affected eye(s) three times per day (t.i.d.). Since IOPIDINE 0.5% will be used with other ocular glaucoma therapies, an approximate five minute interval between instillation of each medication should be observed to prevent washout of the previous dose. Eye ointments should be administered last. If, for any reason, the drop of IOPIDINE 0.5% does not remain in the eye, then the patient should repeat the dose by placing another drop in the eye. The maximum recommended duration of therapy is one month due to loss of effect over time (tachyphylaxis). However, some patients may benefit from treatment with IOPIDINE 0.5% for longer periods. There are 전체 문서 읽기