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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Alphagan (2012)

Εκδότης

Εκδότης Allergan Ltd
Διεύθυνση Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK
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Περιεχόμενα

Name of the medicinal product

Alphagan 0.2% w/v (2 mg/ml) eye drops, solution.

Qualitative and quantitative composition

One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine. Excipient(s): ...

Pharmaceutical form

Eye drops, solution. Clear, greenish-yellow to light greenish-yellow solution.

Therapeutic indications

Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. ...

Posology and method of administration

Recommended dosage in adults (including the elderly) The recommended dose is one drop of Alphagan in ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Neonates and infants (see section ...

Special warnings and precautions for use

Children of 2 years of age and above, especially those in the 2-7 age range and/or weighing ≤ 20 Kg, ...

Interaction with other medicinal products and other forms of interaction

Alphagan is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients ...

Pregnancy and lactation

The safety of use during human pregnancy has not been established. In animal studies, brimonidine tartrate ...

Effects on ability to drive and use machines

Alphagan may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. ...

Undesirable effects

The most commonly reported ADRs are oral dryness, ocular hyperaemia and burning/stinging, all occurring ...

Overdose

Ophthalmic overdose (Adults) In those cases received, the events reported have generally been those already ...

Pharmacodynamic properties

Pharmacotherapeutic group: Sympathomimetics in glaucoma therapy ATC code: S01EA05 Brimonidine is an alpha-2 ...

Pharmacokinetic properties

a) General characteristics After ocular administration of a 0.2% solution twice daily for 10 days, plasma ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

List of excipients

Benzalkonium Chloride Poly(vinyl alcohol) Sodium chloride Sodium citrate Citric acid monohydrate Purified ...

Incompatibilities

Not applicable.

Shelf life

Before first opening: 2 years for the 2.5 ml container 3 years for the 5 ml and 10 ml containers After ...

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

White low density polyethylene dropper bottles with a 35 microlitre tip. The cap is either a conventional ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Allergan Ltd 1st Floor Marlow International The Parkway Marlow Buckinghamshire SL7 1YL UK

Marketing authorization number(s)

PL 00426/0088

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 March 1997 Date of last renewal: 17 September 2006

Date of revision of the text

2 September 2010
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.