MAXIDEX Eye drops, suspension (2020)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Novartis Pharmaceuticals UK Limited |
---|---|
Διεύθυνση | 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom |
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
MAXIDEX 0.1% w/v, eye drops, suspension.
Qualitative and quantitative composition
Dexamethasone 0.1% w/v. <u>Excipient with known effect in suspension:</u> Benzalkonium Chloride 0.01% w/v. For the full list excipients, see section 6.1.
Pharmaceutical form
Eye drops, suspension.
Therapeutic indications
Indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye, such as, anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, ...
Posology and method of administration
Adults, adolescents, and children (2 years of age and above) The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the ...
Contraindications
Vaccinia, varicella, or other viral diseases of cornea and conjunctiva (except herpes zoster keratitis). Herpes simplex keratitis. Fungal diseases of ocular structures or untreated parasitic eye infections. ...
Special warnings and precautions for use
Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity, visual field defects and posterior subcapsular ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems. CYP3A4 inhibitors (including ritonavir and cobicistat): ...
Pregnancy and lactation
Fertility Studies have not been performed to evaluate the effect of topical ocular administration of dexamethasone on fertility. There is limited clinical data to evaluate the effect of dexamethasone on ...
Effects on ability to drive and use machines
MAXIDEX has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability ...
Undesirable effects
Summary of the safety profile In clinical trials, the most common adverse reaction was ocular discomfort. Tabulated list of adverse reactions The following adverse reactions are classified according to ...
Overdose
Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 mls) is unlikely to lead to any serious adverse effects. An ocular overdose of Maxidex ...
Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Ophthalmologicals: Anti-inflammatory Agents <b>ATC Code:</b> S01BA01 Dexamethasone has been demonstrated by animal and human studies based on oral application to possess ...
Pharmacokinetic properties
Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. ...
Preclinical safety data
Repeat dose topical ocular safety studies with dexamethasone in rabbits have shown systemic corticosteroid effects. Such effects are considered to be unlikely when MAXIDEX is used as recommended. Dexamethasone ...
List of excipients
Sodium phosphate Polysorbate 80 Disodium edetate Sodium chloride Benzalkonium chloride Hypromellose Citric acid Purified water
Incompatibilities
None known.
Shelf life
20 months (unopened), 1 month (after first opening).
Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Keep container tightly closed. Discard 1 month after first opening. Store in the original package.
Nature and contents of container
Drop-Tainer 5ml and 10ml Natural Low Density Polyethylene Bottles and Plugs. Polystyrene or Polypropylene cap.
Special precautions for disposal and other handling
Do not touch dropper tip to any surface as this may contaminate the contents. If the drop of medication is not retained in the eye upon dosing for any reason then instill another drop.
Marketing authorization holder
Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
Marketing authorization number(s)
PL 00101/0999
Date of first authorization / renewal of the authorization
28/09/1990 / 17/09/2003
Date of revision of the text
03 September 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: