WAXSOL Ear drops (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
WAXSOL Ear Drops, Docusate sodium BP 0.5% w/v.
Qualitative and quantitative composition
WAXSOL Ear Drops contain the following active ingredient: Docusate Sodium BP 0.5% w/v.
Pharmaceutical form
Ear drops.
Therapeutic indications
WAXSOL Ear Drops are indicated as an aid in the removal of ear wax.
Posology and method of administration
Recommended dose and dosage schedules Adults (including the elderly) The application of ear drops sufficient to fill the affected ear on not more than two consecutive nights, prior to attending for syringing ...
Contraindications
Perforation of the ear drum or inflammation of the ear.
Special warnings and precautions for use
If pain or inflammation is experienced, treatment should be discontinued.
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
There is no evidence to suggest that Waxsol Ear Drops should not be used during pregnancy and lactation.
Effects on ability to drive and use machines
None known.
Undesirable effects
<u>Immune system disorders:</u> Hypersensitivity/allergic reactions. <u>Skin disorders:</u> Contact dermatitis and allergic skin reactions. <u>General disorders:</u> Application site reactions rarely including ...
Overdose
Excess WAXSOL may seep from the ear and treatment of any resulting adverse events, such as skin irritation should be symptomatic.
Pharmacodynamic properties
The so-called wax which often obstructs the external auditory meatus of the ear contains less than 50% of fatty matter derived from secretions of the sebaceous ceruminous glands. The majority of the wax ...
Pharmacokinetic properties
There are no available data on systemic absorption following instillation into the ear. However, any absorption which may occur is likely to be of an extremely low magnitude.
Preclinical safety data
Although no toxicity studies via application to the ear are available, oral repeated dose toxicity studies with docusate sodium did not identify any clinically relevant information.
List of excipients
Glycerin Phenonip (solution of esters of 4-hydroxybenzoic acid in phenoxetol) Water
Incompatibilities
None known.
Shelf life
18 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Amber glass bottle with a dropper applicator, containing 10 or 11 ml of WAXSOL solution.
Special precautions for disposal and other handling
The dropper applicator must be filled before dripping WAXSOL Ear Drops into the affected ear.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0146
Date of first authorization / renewal of the authorization
27/09/2006
Date of revision of the text
17/04/2019
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