Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: Azopt eye drops, suspension (2010)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Alcon Laboratories (U.K) Limited
Διεύθυνση :
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Name of the medicinal product

AZOPT 10 mg/ml eye drops, suspension.

Qualitative and quantitative composition

Each ml of suspension contains 10 mg brinzolamide. Excipients: Each ml of suspension contains 0.15 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 any of the excipients. 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 ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of brinzolamide in pregnant women. Studies in animals have shown reproductive toxicity (see also section 5.3). AZOPT is not recommended during ...

Effects on 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 vision occurs at instillation, the patient must wait until the ...

Undesirable effects

In clinical studies involving over 1800 patients treated with AZOPT as monotherapy or adjunctive therapy to timolol maleate 5 mg/ml, the most frequently reported treatment-related adverse reactions were: ...

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 Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. ...

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 with brinzolamide based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Developmental ...

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

Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom

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 last renewal: 9 March 2005

Date of revision of the text

29 January 2010