ALCAINE Eye drops, solution (2018)
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Περιεχόμενα
Name of the medicinal product
ALCAINE TM proxymetacaine hydrochloride Eye Drops 0.5%.
Qualitative and quantitative composition
Alcaine Eye Drops contain the active ingredient proxymetacaine hydrochloride 0.5% (5 mg/mL). Excipient with known effect: Benzalkonium chloride 0.1 mg in 1 mL as a preservative. For the full list of excipients, ...
Pharmaceutical form
Sterile preserved eye drops, solution.
Therapeutic indications
Alcaine Eye Drops are indicated for procedures in which a rapid and short-acting topical ophthalmic anaesthetic is indicated such as in cataract surgery and suture removal from the cornea, and in tonometry, ...
Posology and method of administration
For ocular use only. Single patient use only. After the cap is removed, if tamper evident snap collar is loose, remove before using product. If more than one topical ophthalmic product is being used, the ...
Contraindications
Alcaine is contraindicated in patients with known hypersensitivity to proxymetacaine hydrochloride or any of the excipients listed under section 6.1.
Special warnings and precautions for use
NOT FOR INJECTION INTO THE EYE. Prolonged use of a topical ocular anaesthetic may produce a diminished duration of the effect, thus more and more of the medication is required to produce the desired anaesthetic ...
Interaction with other medicinal products and other forms of interaction
The metabolism of local anaesthetics derived from esters may be inhibited by anticholinesterases thus increasing the risk of systemic toxicity.
Fertility, pregnancy and lactation
Pregnancy Category B2. Animal reproduction studies have not been conducted with Alcaine Eye Drops. It is not known whether proxymetacaine hydrochloride can cause fetal harm when administered to a pregnant ...
Effects on ability to drive and use machines
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after administration, the patient must wait until the vision clears before ...
Undesirable effects
Pupillary dilatation or cycloplegic effect have rarely been observed with proxymetacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anaesthetics, but local ...
Overdose
In the event of overdose or accidental ingestion, systemic effects may manifest as central nervous system (CNS) stimulation and may include nervousness, tremors or convulsions; followed by depression in ...
Pharmacodynamic properties
Pharmacotherapeutic group: Sensory organ; ophthalmologicals; local anaesthetic ATC Code: SO1HA04 Mechanism of action Proxymetacaine hydrochloride is a potent topical anaesthetic of the ester type. The ...
Pharmacokinetic properties
After topical administration, proxymetacaine hydrochloride is absorbed into the system and generally decomposes quickly in the plasma; however, high doses can cause undesirable systemic effects.
Preclinical safety data
Carcinogenicity The carcinogenic potential of proxymetacaine hydrochloride has not been investigated in long-term animal studies. Mutagenicity No study has been conducted to determine the potential proxymetacaine ...
List of excipients
Benzalkonium chloride 0.1 mg in 1 mL as a preservative Glycerol Hydrochloric acid and/or sodium hydroxide to adjust pH Purified water
Incompatibilities
Unknown.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store at 2°C to 8°C. Refrigerate do not freeze. Protect from light. Discard container 4 weeks after opening.
Nature and contents of container
Alcaine Eye Drops come in a 15 mL, dropper bottle consisting of a low density polyethylene.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mount Wellington, Auckland 1060, New Zealand. PO Box 4079, Auckland 1140, New Zealand. Free Phone: 0800 804 079.
Date of first authorization / renewal of the authorization
12 July 2018
Date of revision of the text
17 July 2018
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