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TRUSOPT Eye drops, solution (2020)

Αναφορές

Βιβλιογραφική αναφορά

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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 equivalent to 20 mg of dorzolamide. For the full list of excipients, see section 6.1.

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 to beta-blockers or in whom beta-blockers are contraindicated, in the treatment of elevated intra-ocular ...

Posology and method of administration

Posology When used as monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s), three times daily. When used as adjunctive therapy with an ophthalmic beta-blocker, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Dorzolamide has not been studied in patients with severe renal impairment (CrCl <30 ml/min) or with hyperchloraemic ...

Special warnings and precautions for use

Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients. The management of patients with acute angle-closure glaucoma requires therapeutic ...

Interaction with other medicinal products and other forms of interaction

Specific drug interaction studies have not been performed with dorzolamide. In clinical studies, dorzolamide was used concomitantly with the following medications without evidence of adverse interactions: ...

Fertility, pregnancy and lactation

Pregnancy Dorzolamide should not be used during pregnancy. There are no or limited amount of data from the use of dorzolamide in pregnant women. In rabbits, dorzolamide produced teratogenic effects at ...

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 effects such as dizziness and visual disturbances may affect the ability to drive and use machines. ...

Undesirable effects

TRUSOPT was evaluated in more than 1400 individuals in controlled and uncontrolled clinical studies. In long-term studies of 1108 patients treated with TRUSOPT as monotherapy or as adjunctive therapy with ...

Overdose

Only limited information is available with regard to human overdose by accidental or deliberate ingestion of dorzolamide hydrochloride. Symptoms The following have been reported with oral ingestion: somnolence; ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiglaucoma preparations and miotics, Carbonic Anhydrase Inhibitors, dorzolamide ATC code: S01EC03 Mechanism of Action Carbonic anhydrase (CA) is an enzyme found in many tissues ...

Pharmacokinetic properties

Unlike oral carbonic anhydrase inhibitors, topical administration of dorzolamide hydrochloride allows for the active substance to exert its effects directly in the eye at substantially lower doses and ...

Preclinical safety data

The main findings in animal studies with dorzolamide hydrochloride administered orally were related to the pharmacological effects of systemic carbonic anhydrase inhibition. Some of these findings were ...

List of excipients

Benzalkonium chloride Hydroxyethylcellulose Mannitol (E421) Sodium citrate (E331) Sodium hydroxide (E524) for pH adjustment Water for injections

Incompatibilities

Not Applicable.

Shelf life

Shelf life: 2 years. After first opening the container, TRUSOPT should be used no longer than 28 days.

Special precautions for storage

Store container in original carton in order to protect from light. This medicinal product does not require any special temperature storage conditions. For storage conditions after first opening of the ...

Nature and contents of container

TRUSOPT container contains 5 ml of solution. Two alternate containers may be marketed. White translucent low-density polyethylene (LDPE) container with a transparent linear LDPE dropper tip and a white ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland

Marketing authorization number(s)

PL 16058/0014

Date of first authorization / renewal of the authorization

11/11/2009

Date of revision of the text

January 2020

Πηγαίο έγγραφο

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