MOXIVIG

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 2-3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered.

The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. Paediatric patients No dosage adjustment is necessary. Hepatic and renal impairment No dosage adjustment is necessary.

Method of administration For ocular use only. Not for injection. 5%w/v eye drops, solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new- born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops. After cap is removed, if tamper evident snap collar is loose, remove before using the product.

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.

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 safety population that received the medicinal product consisted of 1,389 patients from the United States and Canada, 586 patients from Japan and 277 patients from India.

No serious ophthalmic or systemic undesirable effects related to the medicinal product were reported in any of the clinical studies. The most frequently reported treatment-related undesirable effects with the medicinal product were eye irritation and eye pain, occurring at an overall incidence of 1 to 2%.

These reactions were mild in 96% of those patients who experienced them, with only 1 patient discontinuing therapy as a result. Tabulated summary of adverse reactions The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000) or not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness. System Organ Classification Frequency Adverse reactions Blood and lymphatic system disorders Rare haemoglobin decreased Immune system disorders Not known Hypersensitivity Nervous system disorders Uncommon Rare Not known headache paresthesia dizziness Eye disorders Common Uncommon Rare Not known eye pain, eye irritation punctate keratitis, dry eye, conjunctival haemorrhage, ocular hyperaemia, eye pruritus, eyelid oedema, ocular discomfort, corneal epithelium defect, corneal disorder, conjunctivitis, blepharitis, eye swelling, conjunctival oedema, vision blurred, visual acuity reduced, asthenopia, erythema of eyelid endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, lacrimation increased, eye discharge, foreign body sensation in eyes Cardiac disorders Not known palpitations Respiratory, thoracic and mediastinal disorders Rare Not known nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat) dyspnoea Gastrointestional disorders Uncommon Rare Not known dysgeusia vomiting nausea Hepatobiliary disorders Rare alanine aminotransferase increased, gamma- glutamyltransferase increased Skin and subcutaneous tissue Not known erythema, rash, pruritus, urticaria disorders Description of selected adverse reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following first dose, have been reported in patients receiving systemic quinolone therapy.

In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. 8). If an allergic reaction to MOXIVIG occurs, discontinue use of the medicinal product.

Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated. As with other anti-infectives, prolonged use may result in overgrowth of non- susceptible organisms, including fungi.

If superinfection occurs, discontinue use and institute alternative therapy. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroids.

8). MOXIVIG should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.

Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection. Paediatric population Data are very limited to establish efficacy and safety of VIGAMOX in the treatment of conjunctivitis in neonates.

Therefore use of this medicinal product to treat conjunctivitis in neonates is not recommended. g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria gonorrhooeae The medicinal product is not recommended for the treatment of Chlamydia trachomatis in patients less than uch patients.

Patients older than 2 years of age with eye infections caused by Chlamydia trachomitis should receive appropriate systemic treatment.

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