Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
OFLOXACIN
FISCHER PHARMA RX LTD
S01AX11
OPHTHALMIC OINTMENT
OFLOXACIN 3 MG / 1 G
OCULAR
Required
DR.GERHARD MANN,CHEM.-PHARM. FABRIC GmbH
OFLOXACIN
Infections of the anterior eye sections with ofloxacin- sensitive pathogens: chronic conjunctivitis, keratitis and corneal ulcers, and chlamydia infections.
2020-09-21
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Floxal ® Eye ointment Active ingredient 1 g contains 3 mg ofloxacin Inactive ingredients and allergens, see section 2 'Important information about some of this medicine’s ingredients' and section 6 'Additional information'. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. What is this medicine intended for? To treat infections of the anterior eye sections caused by ofloxacin-sensitive pathogens (bacteria): chronic conjunctivitis keratitis and corneal ulcers chlamydia infections Therapeutic group: Gyrase inhibitor antibiotics, fluoroquinolones. 2. Before using this medicine Do not use this medicine if: You are sensitive (allergic) to the active ingredient (ofloxacin), to other quinolones or to any of the other ingredients in this medicine (see section 6 'Additional information'). You are breastfeeding. Special warnings about using this medicine Talk to your doctor before treatment with Floxal ® . During treatment with Floxal ® , remember the following: Tendon swelling and rupture have occurred in patients taking oral or intravenous fluoroquinolones, particularly in older patients and in those treated concurrently with corticosteroids. Stop using Floxal ® and consult your doctor if you develop pain or swelling of the tendons (tendinitis). It is not recommended to use contact lenses during eye infection. Extensive sunbathing or use of UV light (e.g. sunbathing lamps, solarium) should be avoided if possible. Floxal ® should be used with caution in patients with corneal defects or corneal ulcers. As with othe Pročitajte cijeli dokument
Page 2 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FLOXAL ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: ofloxacin 1 g eye ointment contains 3 mg of ofloxacin. One single dose (a strip of the eye ointment with length of 1 cm) contains 0.12 mg of ofloxacin. Excipients with known effect: wool fat (lanolin) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye ointment Light yellowish ointment with soft consistency 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Infections of the anterior eye section with ofloxacin-sensitive pathogens: chronic conjunctivitis, keratitis and corneal ulcers, and chlamydia infections. 4.2 Posology and method of administration Posology Unless otherwise prescribed, insert a strip with length of 1 cm (equivalent to 0.12 mg of ofloxacin) three times daily (in chlamydia infections five times daily). The length of treatment should not exceed 14 days. Notice: If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between applications. Floxal ® should always be applied last. Method of administration For topical ocular use Page 3 of 10 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or any other quinolones. 4.4 Special warnings and precautions for use Ofloxacin is not intended for injection. Safety and effectiveness in infants below the age of one year have not been established. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching. If an allergic reaction to ofloxacin occurs, discontinue the drug. Use Floxal ® with caution in patients who have exhibited sensitivitie Pročitajte cijeli dokument