AZOPT Eye drops, suspension (2021)
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Περιεχόμενα
Name of the medicinal product
AZOPT 10 mg/ml eye drops, suspension.
Qualitative and quantitative composition
Each ml of suspension contains 10 mg brinzolamide. Excipient with known effect: Each ml of suspension contains 0.1 mg benzalkonium chloride. For a full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, suspension. White to off-white suspension.
Therapeutic indications
AZOPT is indicated to decrease elevated intraocular pressure in: ocular hypertension open-angle glaucoma as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers ...
Posology and method of administration
Posology When used as monotherapy or adjunctive therapy, the dose is one drop of AZOPT in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known hypersensitivity to sulphonamides (see also section 4.4). Severe renal impairment. Hyperchloraemic acidosis. ...
Special warnings and precautions for use
Systemic effects AZOPT is a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically. The same types of adverse reactions that are attributable to sulphonamides ...
Interaction with other medicinal products and other forms of interaction
Specific interaction studies with other medicinal products have not been performed with AZOPT. In clinical studies, AZOPT was used concomitantly with prostaglandin analogues and timolol ophthalmic preparations ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of ophthalmic brinzolamide in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see also ...
Effects on ability to drive and use machines
AZOPT has a minor influence on the ability to drive and use machines. Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines (see also section 4.8). If blurred ...
Undesirable effects
Summary of the safety profile In clinical studies involving 2732 patients treated with AZOPT as monotherapy or adjunctive therapy to timolol maleate 5 mg/ml, the most frequently reported treatment-related ...
Overdose
No case of overdose has been reported. Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur. Serum electrolyte ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiglaucoma preparations and miotics, carbonic anhydrase inhibitors ATC code: S01EC04 Mechanism of action Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, ...
Pharmacokinetic properties
Following topical ocular administration, brinzolamide is absorbed into the systemic circulation. Due to its high affinity for CA-II, brinzolamide distributes extensively into the red blood cells (RBCs) ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Developmental toxicity studies ...
List of excipients
Benzalkonium chloride Mannitol (E421) Carbomer 974P Tyloxapol Edetate disodium Sodium chloride Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water
Incompatibilities
Not applicable.
Shelf life
2 years. 4 weeks after first opening.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
5 and 10 ml opaque low density polyethylene bottles with polypropylene screw caps (droptainer). The following pack sizes are available: outer cartons containing 1 5 ml, 3 5 ml and 1 10 ml bottles. Not ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/00/129/001-3
Date of first authorization / renewal of the authorization
Date of first authorisation: 9 March 2000 Date of latest renewal: 29 January 2010
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