MOXIVIG Eye drops (2021)
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Περιεχόμενα
Name of the medicinal product
MOXIVIG 0.5% w/v eye drops, solution.
Qualitative and quantitative composition
1 ml of solution contains 5.45 mg moxifloxacin hydrochloride (equivalent to 5 mg moxifloxacin). Each eye drop contains 190 micrograms of moxifloxacin. For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Eye drops (solution). Clear, greenish-yellow solution.
Therapeutic indications
Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use ...
Posology and method of administration
Use in adults including the elderly (≥65 years) The dose is one drop in the affected eye(s) 3 times a day. The infection normally improves within 5 days and treatment should then be continued for a further ...
Contraindications
Hypersensitivity to the active substance, to other quinolones, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed with MOXIVIG 0.5% w/v eye drops, solution. Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of MOXIVIG in pregnant women. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. The ...
Effects on ability to drive and use machines
MOXIVIG has no or negligible influence on the ability to drive and use machines, however, as with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or ...
Undesirable effects
Summary of the safety profile In clinical studies involving 2,252 patients, MOXIVIG was administered up to 8 times a day, with over 1,900 of these patients receiving treatment 3 times daily. The overall ...
Overdose
The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of the medicinal product. The total amount of moxifloxacin in a single container is too ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals; anti-infectives, other anti-infectives ATC code: S01AE07 Mechanism of Action Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and ...
Pharmacokinetic properties
Following topical ocular administration of MOXIVIG, moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure following administration to the eye indicating little relevance to clinical ...
List of excipients
Sodium chloride Boric acid Hydrochloric acid and/or sodium hydroxide (to adjust pH) Purified water
Incompatibilities
Not applicable.
Shelf life
3 years. Discard 4 weeks after first opening.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
5 ml bottle with DROP-TAINER dispensing system consisting of a transparent low density polyethylene bottle and dispensing plug and white polypropylene closure. Tamper evidence is provided by a security ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland.
Marketing authorization number(s)
PL 23860/0016
Date of first authorization / renewal of the authorization
Date of first authorisation: 27/07/2009 Date of last renewal: 29/04/2014
Date of revision of the text
31/10/2021
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