BETAGAN Eye drops, solution (2018)
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Περιεχόμενα
Name of the medicinal product
Betagan Unit Dose.
Qualitative and quantitative composition
One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent to 4.4 mg levobunolol. For a full list of excipients, see section 6.1.
Pharmaceutical form
Eye Drops, solution. A clear, colourless to brown solution.
Therapeutic indications
Reduction of intraocular pressure in chronic open-angle glaucoma and ocular hypertension.
Posology and method of administration
Posology Adults (including the elderly) The recommended adult dose is one drop of Betagan once or twice daily in the affected eye(s). Discard product after use. Paediatric Population Betagan is not recommended ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Reactive airway disease including bronchial asthma or a history of bronchial asthma or severe chronic obstructive ...
Special warnings and precautions for use
Like other topically applied ophthalmic agents, levobunolol is absorbed systemically. Due to the beta-adrenergic component of Betagan (levobunolol), the same types of cardiovascular, pulmonary and adverse ...
Interaction with other medicinal products and other forms of interaction
No specific drug interaction studies have been performed with levobunolol. There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blocker solutions ...
Pregnancy and lactation
Pregnancy There are no adequate data for the use of levobunolol in pregnant women. levobunolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see 4.2. ...
Effects on ability to drive and use machines
Betagan has minor influence on the ability to drive and use machines. Betagan may cause transient blurring of vision, fatigue and/or drowsiness which may impair the ability to drive or operate machines. ...
Undesirable effects
Like other topically applied ophthalmic drugs, levobunolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of ...
Overdose
There are no data available on human overdosage with Betagan which is unlikely to occur via the ocular route. Should accidental ocular overdosage occur, flush the eye(s) with water or normal saline. If ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agents ATC code: S01ED03 Levobunolol is a non-cardioselective beta-adrenoceptor blocking agent, equipotent at both beta<sub>1</sub> and beta<sub>2</sub> receptors. ...
Pharmacokinetic properties
The onset of action with one drop of Betagan can be detected within one hour after instillation, with maximum effect seen between two and six hours. A significant decrease can be maintained for up to 24 ...
Preclinical safety data
Not applicable.
List of excipients
Poly(vinyl alcohol) Sodium chloride Disodium edetate Sodium phosphate dibasic, heptahydrate Potassium phosphate monobasic Sodium hydroxide (to adjust pH) or hydrochloric acid (to adjust pH) Purified water ...
Incompatibilities
No major incompatibilities have been reported from topical use of levobunolol.
Shelf life
18 months. The eye drop solution should be used immediately after opening. Any unused solution should be discarded.
Special precautions for storage
Do not store above 25°C. Keep the container in the outer carton in order to protect from light.
Nature and contents of container
Low density polyethylene (LDPE) blow-fill-seal unit dose container (0.9 ml volume) filled with 0.4 ml solution. Unit dose containers are packaged into a foil covered pouch (2 strips of 5 containers per ...
Special precautions for disposal and other handling
Ensure that the single dose container is intact before use. Discard any unused solution (i.e. once opened do not re-use container for subsequent doses).
Marketing authorization holder
Allergan Limited, Marlow International, The Parkway, Marlow, Buckinghamshire, SL7 1YL, United Kingdom
Marketing authorization number(s)
PL 00426/0072
Date of first authorization / renewal of the authorization
20<sup>th</sup> April 1993 / 26<sup>th</sup> July 2003
Date of revision of the text
August 2018
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