EARCALM Spray (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
EarCalm Spray.
Qualitative and quantitative composition
Acetic Acid (Glacial) Ph. Eur., 2.0% w/w.
Pharmaceutical form
Ear spray for auricular use.
Therapeutic indications
EarCalm Spray is indicated for the treatment of superficial infections of the external auditory canal.
Posology and method of administration
Route of administration Topical. For external aural use to the external auditory canal only. Adults, children, aged 12 years and above, and the elderly For treatment of superficial infections of the outer ...
Contraindications
The product should not be used in patients with a known sensitivity to any of the ingredients. Not recommended for children under 12 years of age without medical advice.
Special warnings and precautions for use
Do not use for more than 7 days. Avoid spraying near the eyes. If pain occurs during use, or if symptoms worsen or do not improve within 48 hours, or if your hearing becomes impaired, stop treatment and ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
There are no known restrictions to the use of the product in pregnancy and lactation.
Effects on ability to drive and use machines
Unresolved ear problems could themselves effect driving ability.
Undesirable effects
Some patients may experience a transient stinging or burning sensation after dosing for the first few days of treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions after ...
Overdose
Overdosage by this route is extremely unlikely. If EarCalm should be accidentally swallowed, neutralisation with milk or water may be required.
Pharmacodynamic properties
Acetic acid possesses antibacterial activity. It is reported to be active against: Haemophilus and Pseudomonas species, Candida and Trichomonas.
Pharmacokinetic properties
EarCalm Spray is applied topically to the external auditory meatus and acts locally.
Preclinical safety data
Acetic acid is widely available and toxicity problems at this concentration are unlikely.
List of excipients
Macrogol (2) stearyl ether Macrogol (20) stearyl ether Stearyl alcohol Methyl parahydroxybenzoate Propyl parahydroxybenzoate Purified water
Incompatibilities
None known.
Shelf life
Shelf life of the product as packaged for sale: 24 months from the date of manufacture. Shelf life after first opening of the container: Use within one month of first use.
Special precautions for storage
Do not store above 25°C. Keep container upright in the outer carton.
Nature and contents of container
5 ml of the product is supplied in a 8.5ml capacity amber glass bottle fitted with a spray device.
Special precautions for disposal and other handling
Shake the bottle well before use. Before first use, press actuator down several times to obtain a fine spray. Each press then delivers one metered dose. Do not inhale the spray. Administer spray directly ...
Marketing authorization holder
Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Marketing authorization number(s)
PL 00289/2300
Date of first authorization / renewal of the authorization
21/05/2008
Date of revision of the text
27/10/2021
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