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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Earcalm Spray (2012)

Εκδότης

Εκδότης Forest Laboratories UK Limited
Διεύθυνση Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL
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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, ...

Contraindications

The product should not be used in patients with a known sensitivity to any of the ingredients. Not recommended ...

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 ...

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 ...

Overdose

Overdosage by this route is extremely unlikely. If EarCalm should be accidentally swallowed, neutralisation ...

Pharmacodynamic properties

Acetic acid possesses antibacterial activity. It is reported to be active against: Haemophilus and Pseudomonas ...

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 ...

Incompatibilities

None known.

Shelf life

Shelf-life in the product as packaged for sale: 18 months from the date of manufacture. Shelf-life after ...

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 ...

Marketing authorization holder

Forest Laboratories UK Limited Riverbridge House Anchor Boulevard Crossways Business Park Dartford Kent ...

Marketing authorization number(s)

PL 00108/0334

Date of first authorization / renewal of the authorization

8 June 1999

Date of revision of the text

April 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.