Floksal eye ointment 3mg/g in tubes 3g in pack №1

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Floksal eye ointment.3mg/g in tubes 3g in pack No. 1
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In tubes of 3g Main active ingredientOfloxacin Release formOintment Dosage1 g of ointment contains 3.0 mg ofloxacin action. Control points: The primary classification of bacteria according to their susceptibility or resistance was based on the recommendations set out in document 1 DIN 58940-4 (2004): ofloxacin (susceptibility < 1 mg/l, resistance > 2 mg/l). Antibacterial Spectrum: Ofloxacin’s spectrum of activity includes obligate anaerobes, facultative anaerobes, aerobes, and other pathogens such as Chlamydia. With topical application of ofloxacin, partial adsorption is possible, but this does not lead to any clinical or pathological changes. The distribution of acquired resistance in individual species may change geographically and over time. Therefore, case-by-case information on resistance is very important in order to respond to serious infections in a timely manner. If, due to local resistance, the use of ofloxacin is called into question, at least for some types of infections, appropriate studies should be carried out. Microbiological examination, including identification of the pathogen and its susceptibility to ofloxacin, is desirable, especially in the presence of serious infections or therapeutic error. The information below is from 35 German centers and is based on resistance studies including 1470 individual cases. The aerobic bacteria mentioned here provide a clear picture of the pathogens that can and should be considered as a source of eye infections in Germany. It can be assumed that the number of bacterial species that cause ophthalmic infections in other countries is, if not identical, then similar. Therefore, the pathogens mentioned below are the most common causative agents of bacterial infections of the external eye in these countries as well. Resistance data are based on the above breakpoints, which are related to systemic use. When applied topically to the eye, a much higher concentration of the antibiotic is achieved. Therefore, clinical efficacy is noticeable even in relation to those pathogens that are considered resistant in the laboratory. Species with normal susceptibility (resistance < 10%) Gram-positive aerobes Staphylococcus aureus (MS SA) Bacillus spp Gram-negative aerobes Acinetobacter baumannii Acinetobacter Iwoffii Enterobacter cloacae Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae Moraxella catarrhalis Proteus marabilis problematic for use (resistance > 10%) Gram-positive aerobes Corynebacterium spp. Enterococcus faecalis Staphylococcus aureus (MRSA) Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative aerobes Pseudomonas aeruginosa Stenotrophomonas maltophilia Species resistant to Enterococcus spp ciliary body and anterior chamber of the eye. Repeated application also induces therapeutic concentrations in the vitreous. After a single application of a 1 cm strip of ophthalmic ointment Floxal (equivalent to 0.12 mg ofloxacin), the maximum concentration of ofloxacin in the conjunctiva (9.72 µg/g) and sclera (1.61 µg/g) was reached after 5 minutes. Subsequently, these values decreased slowly. The concentration of the active substance in the aqueous humor and cornea reached its maximum after 1 hour (0.69 µg/g and 4.87 µg/g, respectively). Preclinical safety data No toxicological effects have been observed with topical application of ofloxacin. Floxal ophthalmic ointment has been characterized as being well tolerated when used topically. The use of 16 doses within 8 hours may cause vascular injection and conjunctival chemosis. Numerous in vitro and in vivo tests conducted to induce gene and chromosome mutations have shown negative results. Long-term animal studies to evaluate carcinogenic potential have not been conducted. There was no evidence of a cataractogenic or cocataractogenic effect. Ofloxacin does not reduce fertility, does not affect perinatal and postpartum development, and is not teratogenic. After the systemic use of ofloxacin, degenerative changes in the articular cartilage were found in laboratory animals. Articular cartilage damage was dose and age dependent. (The younger the animals were, the more obvious the damage was.) Excipients Liquid paraffin, wool fat, white petrolatum Indications for use Anterior eye infections caused by microorganisms sensitive to ofloxacin: chronic conjunctivitis, keratitis, corneal ulcer and chlamydia. Method of administration and doses If there are no other indications, then 1.0 cm strips of ointment are placed behind the lower eyelid of the diseased eye 2-3 times a day, in the case of chlamydial infection – 5 times a day. For ophthalmic use. It is not recommended to use the drug for more than 2 weeks. Please note: When using Floxal simultaneously with other eye drops / eye ointments, a 15-minute interval must be observed, and the ointment should be used last. Use during pregnancy and lactation There is no evidence of the harmful effects of ofloxacin on the fetus, but it is not recommended to use the drug during pregnancy and lactation. Precautions It is not recommended to wear contact lenses during the entire period of treatment with Floxal eye ointment. Wool fat can cause a local skin reaction (contact dermatitis). Interaction with other drugs. Other forms of interaction Drug interaction of the drug is not described. Interaction with other drugs Not described Contraindications Hypersensitivity to ofloxacin or any of the components of the drug. Composition 1 g of ointment contains 3.0 mg ofloxacin A single dose (a strip of ointment 1.0 cm long) contains 0.12 mg of ofloxacin Excipients: wool fat Overdose Cases of overdose are not known. Side effect Hypersensitivity reactions; hyperemia of the conjunctiva, burning sensation, discomfort in the eyes, itching and dryness of the conjunctiva, photophobia, lacrimation. In most cases, these symptoms are short-lived. In isolated cases, systemic hypersensitivity reactions have been recorded. Rare: Corneal deposits may form under appropriate conditions. Storage conditions Store in a place protected from light, at a temperature not exceeding 25 ° C eye ointment 3mg/g in tubes 3g in pack №1