ACULAR Eye drops, solution (2022)
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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 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
AbbVie Ltd., Maidenhead, SL6 4UB, UK
Marketing authorization number(s)
PL 41042/0051
Date of first authorization / renewal of the authorization
27<sup>th</sup> July 2006
Date of revision of the text
01/04/2022
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