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

Προτάσεις

SPC, UK: Trusopt 20 mg/ml Eye drops, solution (2010)

Εκδότης

Εκδότης Merck Sharp & Dohme Limited
Διεύθυνση Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Περιεχόμενα

Name of the medicinal product

TRUSOPT® 20 mg/ml Eye drops, solution.

Qualitative and quantitative composition

Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg of dorzolamide. For a full ...

Pharmaceutical form

Eye drops, solution. Clear, colourless to nearly colourless, slightly viscous, solution.

Therapeutic indications

TRUSOPT is indicated: as adjunctive therapy to beta-blockers, as monotherapy in patients unresponsive ...

Posology and method of administration

When used as monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected ...

Contraindications

Dorzolamide is contraindicated in patients who are hypersensitive to the active substance or to any of ...

Special warnings and precautions for use

Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with ...

Interaction with other medicinal products and other forms of interaction

Specific drug interaction studies have not been performed with dorzolamide. In clinical studies, dorzolamide ...

Pregnancy and lactation

Use During Pregnancy Dorzolamide should not be used during pregnancy. No adequate clinical data in exposed ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Possible side ...

Undesirable effects

TRUSOPT was evaluated in more than 1400 individuals in controlled and uncontrolled clinical studies. ...

Overdose

Only limited information is available with regard to human overdose by accidental or deliberate ingestion ...

Pharmacodynamic properties

Pharmacotherapuetic group: Antiglaucoma preparations and miotics, Carbonic Anhydrase Inhibitors, dorzolamide ...

Pharmacokinetic properties

Unlike oral carbonic anhydrase inhibitors, topical administration of dorzolamide hydrochloride allows ...

Preclinical safety data

The main findings in animal studies with dorzolamide hydrochloride administered orally were related to ...

List of excipients

Benzalkonium chloride Hydroxyethyl cellulose Mannitol (E421) Sodium citrate (E331) Sodium hydroxide (E524) ...

Incompatibilities

Not Applicable.

Shelf life

2 years. TRUSOPT should be used no longer than 28 days after first opening the container.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store bottle in original ...

Nature and contents of container

The OCUMETER Plus Ophthalmic Dispenser consists of a translucent, high-density polyethylene container ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

Marketing authorization number(s)

PL 0025/0323.

Date of first authorization / renewal of the authorization

9 January 1995/ 11 November 2009

Date of revision of the text

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.