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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

ACULAR Eye drops, solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Acular.

Qualitative and quantitative composition

Ketorolac trometamol 5 mg/ml. Excipient(s) with known effect: benzalkonium chloride 0.1 mg/ml. For the full list of excipients, see section 6.1.

Pharmaceutical form

Eye drops, solution. Clear, colourless to pale yellow aqueous solution.

Therapeutic indications

ACULAR is indicated for the prophylaxis and reduction of inflammation and associated symptoms following ocular surgery. ACULAR is indicated in adults.

Posology and method of administration

Posology Post-operative inflammation One drop instilled into the eye three times daily starting 24 hours pre-operatively and continuing for up to three weeks post-operatively. Paediatric population There ...

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory ...

Special warnings and precautions for use

It is recommended that ACULAR be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. In common with other anti-inflammatory ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. ACULAR has been safely administered with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of eye drops containing ketorolac trometamol in pregnant women. Studies in animals have shown reproductive toxicity. Inhibition of prostaglandin synthesis ...

Effects on ability to drive and use machines

Transient blurring of vision may occur on instillation of eye drops. Do not drive or use hazardous machinery unless vision is clear.

Undesirable effects

The most frequent adverse events reported with the use of ACULAR are transient stinging and burning on instillation. The frequency of adverse reactions documented during clinical trials of ketorolac trometamol ...

Overdose

No case of overdose has been reported. Overdose is unlikely to occur via the recommended method of administration. If accidentally ingested, drink fluids to dilute.

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory agents, non-steroids ATC code: S01BC05 ACULAR (ketorolac trometamol) is a non-steroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory ...

Pharmacokinetic properties

General characteristics Absorption Rabbit aqueous humor bioavailability: Mean concentration of total radioactivity 0.856 µg-equiv./ml @ 0.5 hr &nbsp; 1.607 µg-equiv./ml @ 2 hr T<sub>max</sub> 3.38 hr ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...

List of excipients

Sodium chloride Benzalkonium chloride Disodium edetate Octoxinol 40 1N Sodium hydroxide or 1N Hydrochloric acid, to adjust pH Purified water

Incompatibilities

Not applicable.

Shelf life

Unopened: 2 years. Use within 28 days of first opening.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Low density polyethylene dropper bottles (with LDPE dropper tips) containing 3 ml, 5 ml or 10 ml of solution. The drop size is 35 microlitres. Each bottle has a medium impact polystyrene (MIPS) screw-cap. ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Allergan Ltd., Marlow International, The Parkway, Marlow, Bucks SL7 1YL, United Kingdom

Marketing authorization number(s)

PL 00426/0082

Date of first authorization / renewal of the authorization

27<sup>th</sup> July 2006

Date of revision of the text

7<sup>th</sup> June 2019

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