The instruction for medical use of VIGADEKSA™ medicine the Trade name of Vigadeksa™ the International unlicensed name Is not present the Dosage form of the Drop eye 5 ml Structure of 1 ml contains active agents – a moksifloksatsina of a hydrochloride of 5.45 mg (5.0 mg of a moksifloksatsin are equivalent) and dexamethasone of sodium of phosphate of 1.10 mg (1.0 mg of dexamethasone of phosphate are equivalent) excipients: edetat dinatrium a dihydrate, boric acid, sodium chloride, sorbitol, tiloksapol, sodium hydroxide and/or acid chlorohydrogen (for adjustment rn), water the cleaned q.s. up to 1 ml. The description Transparent or slightly opalescent solution from chartreuse till yellow color. Pharmacotherapeutic group Drugs for treatment of diseases of eyes. Glucocorticosteroids in a combination with antimicrobial drugs. ATX S01CA01 code Pharmacological Pharmacokinetics At properties topical administration of eye drops of Vigadeksa™ perhaps system absorption of a moksifloksatsin. Elimination half-life of a moksifloksatsin makes of plasma 13.1 + 3.3 hours. After topical administration of one drop of solution of dexamethasone at the patients who underwent cataract surgery, the average value of level of dexamethasone in intraocular liquid was 31±3.9 ng/ml, during the period between 90 and 120 minutes after introduction. The pharmacodynamics Moxifloxacin, as well as other hinolona, inhibits DNK-girazu and topoisomerase IV, enzymes necessary for replication, a transcription, reparation and combination of bacterial DNA. The main mechanism of action of hinolon on the majority of gram-positive bacteria is topoisomerase IV inhibition. The main mechanism of action of hinolon on the majority of gram-negative bacteria – inhibition DNK-girazy. Moxifloxacin has bactericidal effect against the majority of strains of the following organisms: Gram-positive bacteria: Types of Corynebacterium Micrococcus luteus Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri Streptococcus pneumoniae Streptococcus viridans Gram-negative bacteria: Acinetobacter lwoffii Haemophilus influenzae Haemophilus parainfluenzae Other microorganisms: Chlamydia trachomatis Anti-inflammatory effect of dexamethasone is shown by decrease in emission of arachidonic acid and also adhesive molecular suppression of vascular endothelial cells, decrease in level of cyclooxygenase and emission of cytokines. This action leads to reduction of emissions of pro-inflammatory mediators and smaller adhesion of the circulating leukocytes to a vascular endothelium, thereby interfering with their passing to the swelled eye tissues. Besides, decrease of the activity of cyclooxygenase leads to decrease in production of inflammatory prostaglandins which, as we know, cause destruction of a blood-ocular barrier and hit of protein of plasma in eye tissue. Indications – topical treatment of the infections of an eye caused by microorganisms, sensitive to drug, – prevention of inflammations and bacterial infections after eye surgery dig in the Route of administration and doses For prevention of postoperative inflammation of an eye or infection po1 to a solution drop 4 times a day in planned to operation of an eye, beginning burying a day before operation and within 15 days after operation. For treatment of the infections of an eye caused by sensitive organisms dig in on 1 drop 4 times a day within 7 days or as it is offered the doctor. It is necessary to adhere to the dosage appointed by the doctor, the scheme and duration of treatment. Do not touch with a pipette tip eyes or any other surface to avoid pollution of contents of a bottle. Side effects Local: – glaucoma with injury of an optical nerve – disturbance of visual acuity – disturbance of a field of vision – development of a cataract – consecutive infection of an eye, vyzyvanny suppression of an immune response – perforation of an eyeball – misting of sight – decrease in visual acuity – conjunctivitis, – passing discomfort and eye pain – an itching – xerophthalmus – a keratitis – eye hyperaemia – subconjunctival hemorrhage – subconjunctival hemorrhages – lachrymation System: At absorption in rare instances can be noted: – vascular collapse, a Quincke’s disease (including a laryngeal edema, throats or faces) – a loss of consciousness, a headache – respiratory insufficiency, dispnoe, strengthening of cough, pharyngitis, rhinitis, otitis – urticaria – anaphylactoid reactions of the Contraindication – hypersensitivity to any of drug components – the epithelial keratitis caused by a herpes simplex, chicken pox, a viral infection of a cornea and conjunctiva, fungal infections of an eye – glaucoma – the states leading to thinning of a cornea Medicinal interactions Simultaneous use of local steroids and local NPVP can increase the probability of emergence of problems with healing of a cornea. Based on researches of system use the corticosteroids can increase activity of barbiturates and tricyclic antidepressants and can lead to decrease of the activity of drugs of anti-cholinesterase, salicylates and anticoagulants. The specificity of these observations concerning ophthalmologic use was not studied. Special instructions At use of the combined drugs containing steroids and antibiotics during the long time the appearance of a fungal infection and/or increase in growth of insensitive organisms is possible. In case of superinfection it is necessary to consult with the attending physician to start the corresponding therapy. In case of existence of allergic reaction to an antibiotic to a similar moksifloksatsin, there is a risk of manifestation of allergic reaction at use of eye drops of Vigadeksa™. In this case it is necessary to stop use of drug and to consult with the doctor for purpose of the corresponding treatment. The risk of increase in intraocular pressure and/or development of a cataract induced by corticosteroids increases at predisposed patients (for example, diabetes). It is also known that use of local NPVP slows down or delays healing process. Simultaneous use of local steroids and local NPVP can increase the probability of emergence of problems with healing. Contact lenses in the presence of symptoms of bacterial conjunctivitis the carrying contact lenses before full treatment is not recommended to the patient. Pregnancy the corresponding strictly controlled researches of eye drops Vigadeksa™ with participation of pregnant women were not conducted. Вигадекса™ eye drops during pregnancy should be applied only in case the potential advantage justifies potential risk. A lactation of Vigadeksa™ eye drops during a lactation should be applied only in case the potential advantage justifies potential risk. Use in pediatrics Use of eye drops of Vigadeksa™ for children is not studied. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms As well as in a case with other eye drops, after burying the temporary ambiguity of sight or other visual concerns is possible that it can negatively affect ability to drive the car or other potentially dangerous mechanisms. In this case it is necessary to wait some time before recovery of sight. Overdose in case of hit in an eye(s) of excessive amount of drug, wash out an eye(s) plentiful amount of warm water. Do not dig in drug repeatedly before the reception following according to the schedule. At accidental administration of drug inside see a doctor. Form of release and packing On 5 ml of drug in the bottles from white opaque polyethylene of low density corked by a dropper doser of Droptainer™ and the white screw-on polypropylene cap. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not above 30 °C. To store in the places inaccessible for children! 2 years not to apply a period of storage after an expiration date. To use drug within 4 weeks after the first opening of a bottle. Prescription status According to the prescription Novartis Biociencias S.A Producer. Av. N.S. da Assunção, 736 05359-001 San Paulo-SP-Brazil the Owner of the registration certificate of Novartis Biociencias S.A., Brazil Is licensed by Bayer Pharma AG for Alkon Adres of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representation “Alkon Pharmasyyutikalc, Ltd.” Ph.: +7 727 374 35 79 / +7 727 374 35 86 Fax: +7 727 374 35 81 E-mail address:
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