MAXITROL Eye drops, suspension (2020)
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Περιεχόμενα
1. Name of the medicinal product
MAXITROL EYE DROPS.
2. Qualitative and quantitative composition
1 ml suspension contains 1 mg dexamethasone, 6000 IU polymyxin B sulphate, 3500 IU neomycin sulphate (as base). <u>Excipient(s) with known effect:</u> 1 ml suspension contains 0.04 mg benzalkonium chloride. ...
3. Pharmaceutical form
Eye drops, suspension. White sterile suspension for topical ocular administration.
4.1. Therapeutic indications
MAXITROL eye drops, suspension is indicated for the short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence ...
4.2. Posology and method of administration
Children and Adults (including the Elderly) Apply one or two drops to each affected eye up to six times daily or, more frequently if required. Hepatic and renal impairment Maxitrol Eye Drops has not been ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients. Herpes simplex keratitis. Vaccinia, varicella, and other viral infection of cornea or conjunctiva. Fungal diseases of ocular structures ...
4.4. Special warnings and precautions for use
As with all antibacterial preparation prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated. Sensitivity ...
4.5. 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): ...
4.6. Fertility, pregnancy and lactation
Fertility There are no available data on the use of this medicine affecting male or female fertility. There is limited clinical data to evaluate the effect of dexamethasone on male or female fertility. ...
4.7. Effects on ability to drive and use machines
MAXITROL eye drops, suspension has no or negligible influence on the ability to drive and use machines. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ...
4.8. Undesirable effects
Summary of the safety profile In clinical trials with MAXITROL eye drops and MAXITROL eye ointment the most common adverse reactions were ocular discomfort, keratitis, and eye irritation, occurring in ...
4.9. Overdose
No case of overdose has been reported. Signs and symptoms of an overdosage of MAXITROL eye drops, suspension may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> ophthalmologicals; anti-infectives <b>ATC code:</b> S01CA01 Mechanism of Action MAXITROL eye drops, suspension has a dual effect: suppression of inflammation symptoms ...
5.2. Pharmacokinetic properties
Dexamethasone, like other corticosteroids, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application to ...
5.3. Preclinical safety data
Mutagenicity and Carcinogenicity Genotoxicity studies performed with neomycin and polymyxin B, with and without metabolic activation, were negative in bacterial (Ames test) or mammalian cells (chromosomal ...
6.1. List of excipients
Sodium chloride Polysorbate 20 Benzalkonium chloride Hydroxypropyl methylcellulose Hydrochloric acid/sodium hydroxide Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
Unopened 24 months. Discard 28 days after first opening.
6.4. Special precautions for storage
Do not store above 25°C. Keep away from direct sunlight. Do not refrigerate. Keep the container tightly closed.
6.5. Nature and contents of container
5 ml & 10 ml DROP-TANIER, natural LDPE bottles and plugs with polystyrene or polypropylene caps.
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
8. Marketing authorization number(s)
PL 00101/1000
9. Date of first authorization / renewal of the authorization
24 January 1991
10. Date of revision of the text
30 December 2020
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