ALBALON Eye drops, solution (2021)
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Περιεχόμενα
1. Name of the medicinal product
ALBALON. Naphazoline hydrochloride.
2. Qualitative and quantitative composition
Each mL of ALBALON eye drops contains 1 mg naphazoline hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. Physicochemical properties Naphazoline hydrochloride is a white, ...
3. Pharmaceutical form
Eye drops, solution.
4.1. Therapeutic indications
For use as a topical ocular vasoconstrictor.
4.2. Posology and method of administration
1 or 2 drops every three to four hours. In order to minimise systemic absorption of ALBALON eye drops, apply pressure to the tear duct immediately following administration of the drug. To prevent contaminating ...
4.3. Contraindications
Hypersensitivity to any component of these medications; narrow angle glaucoma or anatomically narrow angle.
4.4. Special warnings and precautions for use
Identified precautions This preparation should not be used in patients who have glaucoma or other serious eye conditions. Potential systemic effects A severe hypertensive crisis may ensue in patients under ...
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent use of methyldopa, maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAOI medication may experience a severe ...
4.6. Fertillity, pregnancy and lactation
Effects on fertility No data available. Use in pregnancy Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause foetal harm when administered ...
4.7. Effects on ability to drive and use machines
As with other ocular medication, if transient blurred vision occurs at instillation, the patient should wait until their vision clears before driving or using machinery.
4.8. Undesirable effects
Pupillary dilation with increased intraocular pressure, systemic effects due to absorption (hypertension, cardiac irregularities, hyperglycaemia). Drowsiness may be experienced in some patients. Postmarketing ...
4.9. Overdose
ALBALON eye drops can cause peripheral vasoconstriction and severe central nervous depression including hypertension followed by reflex braddycardia and hypotension, marked reduction in body temperature, ...
5.1. Pharmacodynamic properties
Mechanism of action Naphazoline constricts the vascular system of the conjunctiva. It is presumed this effect is due to direct action of the drug upon the α-(excitory) receptors of the vascular smooth ...
5.2. Pharmacokinetic properties
No data available.
5.3. Preclinical safety data
Genotoxicity Genotoxicity was either not assessed or not identified as part of the registration of this medicine. Carcinogenicity Carcinogenicity was either not assessed or not identified as part of the ...
6.1. List of excipients
Polyvinyl alcohol 14 mg/mL, with benzalkonium chloride, disodium edetate, citric acid, sodium citrate, sodium chloride, sodium hydroxide and purified water.
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light. Do not use if solution changes colour or becomes cloudy. To avoid contamination of the solution, keep container tightly closed. Do not touch dropper tip to any surface. ...
6.5. Nature and contents of container
ALBALON eye drops solution is supplied in dropper bottles. Each bottle has a fill volume of 15 mL.
6.6. Special precautions for disposal and other handling
Discard unused contents 4 weeks after opening the bottle.
7. Marketing authorization holder
Allergan Australia Pty Ltd, 810 Pacific Highway, Gordon NSW 2072, ABN: 85 000 612 831
8. Marketing authorization number(s)
AUST R 23197
9. Date of first authorization / renewal of the authorization
Date of first approval: 14 November 1995
10. Date of revision of the text
11 February 2021
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