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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Betoptic Eye Drops Solution (2012)

Εκδότης

Εκδότης Alcon Laboratories (U.K) Limited
Διεύθυνση Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
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Περιεχόμενα

Name of the medicinal product

Betoptic 0.5% w/v eye drops, solution.

Qualitative and quantitative composition

Betaxolol 0.5% w/v (as hydrochloride).

Pharmaceutical form

Eye Drops, Solution.

Therapeutic indications

Betoptic is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension ...

Posology and method of administration

Adults (including the elderly): The usual dose is one drop to be instilled into the affected eye(s) twice ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Reactive airway disease including ...

Special warnings and precautions for use

Like other topically applied ophthalmic agents, betaxolol is absorbed systemically. Due to the beta-adrenergic ...

Interaction with other medicinal products and other forms of interaction

No specific drug interaction studies have been performed with betaxolol. There is a potential for additive ...

Pregnancy and lactation

Pregnancy There are no adequate data for the use of betaxolol in pregnant women. Betaxolol should not ...

Effects on ability to drive and use machines

No effects on ability to drive and use machines have been reported.

Undesirable effects

Like other topically applied ophthalmic drugs, betaxolol is absorbed into the systemic circulation. This ...

Overdose

A topical overdose of Betoptic may be flushed from the eye(s) with warm tap water.

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals: Antiglaucoma Preparations & Miotics. ATC Code: S01ED02 ...

Pharmacokinetic properties

Betaxolol is highly lipophilic which results in good permeation of the cornea, allowing high intraocular ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included ...

List of excipients

Disodium edetate Sodium chloride Benzalkonium chloride Sodium hydroxide Hydrochloric acid Purified water ...

Incompatibilities

None known.

Shelf life

Unopened 36 months, after opening 28 days.

Special precautions for storage

Do not store above 25°C. Keep in the outer carton in order to protect from light.

Nature and contents of container

5 ml & 10 ml LDPE bottles (10 ml present in 15 ml container) with natural LDPE plug and blue polystyrene ...

Special precautions for disposal and other handling

Do not touch the top of the bottle to any surface as this may contaminate the contents.

Marketing authorization holder

Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way HemelHempstead Herts. HP2 7UD

Marketing authorization number(s)

PL 0649/0097

Date of first authorization / renewal of the authorization

19th August 1986 / 14th November 2001

Date of revision of the text

26th March 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.