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Taflotan® 15 ug / ml 2.5 ml of eye drops .

$30.50

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Description

The instruction for medical use of TAFLOTANâ medicine the Trade name Taflotan Mezhdunarodnoye the unlicensed name Tafluprost Lekarstvennaya the Drop form eye 15 mkg/ml, 2.5 ml Structure of 1 ml of solution contains active agent – tafluprost 15 mkg, excipients: a benzalkoniya chloride, glitserol, dihydrophosphate sodium a dihydrate, dinatrium edetat, polysorbate 80, acid chlorohydrogen or sodium hydroxide for PH value correction, water for injections the Description Transparent, colourless solution Pharmacotherapeutic group Protivoglaukomny drugs and miotik. Prostaglandin analogs. Tafluprost. The ATX S01EE05 code the Pharmacological Pharmacokinetics Absorption Later properties of burying the tafluprost, 0.0015% once a day on one drop in both eyes within 8 days, its concentration in plasma were low, and had a similar profile in days 1 and 8. Concentration in plasma reached a maximum in 10 minutes after burying, and decreased to level, lower, than the lower limit of detection (10 pg/ml) before the expiration of one hour after administration of drug. The average sizes Cmax (24.4 and 31.4 pg/ml) and AUCo-last (405.9 and 581.1 pg/min/ml) were similar in days 1 and 8, it demonstrates that within the first week of treatment, stable concentration of drug was reached. Between dosage forms with preservative and without preservative no significant differences in system bioavailability were revealed. Absorption of the tafluprost in watery moisture, after single burying ophthalmologic solution of the tafluprost, 0.0015% with preservative and without preservative, was comparable. Distribution was Not noted specific distribution of the tafluprost with a radioactive label in an iridescent ciliary body or in an eye choroid, including a retinal pigmentary epithelium that demonstrates low affinity of drug to a melaninovy pigment. The Autoradiografichesky research, showed that the highest concentration of radioactivity was observed in a cornea then in centuries, a sclera and an iris of the eye. Out of eyes the radioactivity extended to the plaintive device, the sky, a gullet, digestive tract, kidneys, a liver, bilious and a bladder. Tafluprost acid linking with in vitro human serum albumin makes 99% for 500 ng/ml of tafluprostovy acid. Biotransformation the Main way of metabolism of the tafluprost in a human body – hydrolysis with formation of tafluprost-acid and then beta oxidation with formation pharmacological of inactive 1.2 diholes and 1,2,3,4 tetraholes tafluprost acids which can be glyukuronirovana or are hydroxylated. The enzymatic system P450 (CYP) cytochrome does not participate in metabolism tafluprost acids. In the research conducted on cornea fabrics with the refined enzymes it was revealed that the main esterase of the tafluprostovy acid which is responsible for radio hydrolysis is the karboksilesteraza. Butyrylcholinesterase, but not acetylcholinesterase, can also promote hydrolysis. Removal After single instillation of the 3H-tafluprost (0.005% of ophthalmologic solution, 5 mkl / an eye) in both eyes within 21 days, about 87% of the general radioactive dose was revealed in excrement. With urine about 27-38% of the general dose, and about 44-58%, with a stake were removed. A pharmacodynamics the Mechanism of action Tafluprost – the fluorinated F2α prostaglandin analog. Tafluprost-kislota, biologically active metabolite of the tafluprost, highly active and selection agonist of a human prostanoid receptor of FP. The affinity of tafluprost-acid to FP to a receptor is 12 times higher, than affinity of the latanoprost. Pharmakodinamichesky researches showed what tafluprost reduces intraocular pressure by means of strengthening of uveoskleralny outflow of watery moisture. Pharmakodinamichesky effects Use of drug for patients with the normal and increased intraocular pressure (VGD) showed that Tafluprost is effective medicine for decrease in VGD. In a research on studying VGD-ponizhayushchego effect of metabolites of the tafluprost, it was revealed that only tafluprost acid considerably reduces VGD. Researches after use of drug within 4 weeks once a day, showed that the blood stream in an optic disk considerably (for 15%) amplified in comparison with initial level, at measurement for 14 and 28 day with use laser a flougrafiya speckle. Indications – raised intraocular pressure at patients with an open angle glaucoma and an oftalmogipertenziya – as monotherapy at patients: with insufficient reaction to drugs of the first line of therapy with intolerance of drugs of the first line of therapy or having contraindications to these drugs – as additional therapy to beta-blockers the Route of administration and doses the Recommended dose – one drop of eye drops of Taflotan in a conjunctival sac of the affected eye (eyes) once a day, in the evening. The dose should be entered strictly once a day as more frequent use can reduce effect of lowering of intraocular pressure. Use for elderly patients At treatment of elderly patients is not present need for change of a dose. Use in pediatric population Safety and efficiency of the tafluprost at children aged up to 18 years is not established. There are no available data. Use at disturbance of functions of kidneys/liver of Researches on influence of the tafluprost for patients with renal/hepatic disorders was not carried out therefore it is necessary to be careful at treatment of this category of patients. A use method For prevention of possible pollution of solution the patients should not allow touches of a tip of the applicator of a bottle by centuries, to skin around eyes and to any other surfaces. To reduce risk of darkening of an eyelid skin, patients should remove excess of solution from skin. As well as at use of other eye drops the lacrimonasal occlusion – soft closing after burying drug is recommended a century. It can reduce system absorption of the medications administered through eyes. At use of several ophthalmologic drugs of local action, intervals between their use have to be not less than 5 minutes. Side effects Very often (& gt, 1/10) – hyperaemia of conjunctivas/a eyes Often (from & gt, 1/100 to & lt, 1/10) – an itching of eyes, irritation of eyes, eye pain, changes of eyelashes (increase in length, thickness and number of eyelashes) – xerophthalmus, discoloration of eyelashes, feeling of a foreign body in eyes, an erythema a century – misting of sight, the increased lachrymation, pigmentation the century, discharges from eyes, lowering of visual acuity, – photophobia, swelled a century, the increased pigmentation of irises of the eye – a headache not often (from & gt, 1/1000 to & lt, 1/100) – a superficial dot keratitis, an asthenopia, a chemosis, blepharitis, sensation of discomfort in eyes, inflammation of an anterior chamber, conjunctival follicles – allergic conjunctivitis, inflammatory reaction of a cell of an anterior chamber, pigmentation of a conjunctiva and abnormal feeling in eyes – a hypertrichosis a century it is not known (it cannot be estimated on the basis of the available data) – an iritis/uveitis – exacerbation of asthma, dispnoe was Occasionally reported about cases of calcification of a cornea associated with use of the phosphate which is contained in eye drops at some patients with considerable damages of a cornea. Contraindications – hypersensitivity to active ingredient – a tafluprost or any of exicipients – children’s and teenage age up to 18 years Medicinal interactions Medicinal interactions with other drugs are improbable as after instillation drug in eyes the system concentration of the tafluprost are extremely low. Special researches on studying specific cross interactions of the tafluprost with other medical products were not conducted. In clinical trials tafluprost it was applied along with Timololum, and at the same time no signs of cross interactions were noted. Special instructions Prior to treatment patients have to be warned about a possibility of overgrowth of eyelashes, darkenings of an eyelid skin and the increased pigmentation of irises of the eye. Some of these changes can be permanent, and it can result in differences in outward of eyes if only one eye was treated. Change of pigmentation of an iris of the eye happens slowly, and within several months can remain imperceptible. Discoloration of eyes is observed mainly at patients with irises of the eye of the mixed flowers, for example, if eyes brown-blue, gray-brown, yellowy-brown or green-brown. The risk of lifelong heterochromia is probable if only one eye is exposed to treatment. There is no experience of use of the tafluprost in cases of neovascular, closed-angle, narrow or congenital angle glaucoma. There is only a limited experience of treatment tafluprosty patients with an aphakia, pigmentary or pseudo-exfoliative glaucoma. It is recommended to be careful at treatment tafluprosty patients with an aphakia, the artifakiya damaged by the back capsule of a crystalline lens or lenses of an anterior chamber or patients with the established risk factors of developing kistoidny hypostasis of a makula or an iritis/uveitis. There is no experience of use of drug for patients with heavy asthma. In this regard patients of this group should be treated with care. It was reported that the benzalkoniya chloride which is usually applied as preservative in ophthalmologic drugs, causes a dot keratopathy and/or a toxic ulcer keratopathy. As Taflotan bottles contain a benzalkoniya chloride, careful monitoring in cases of frequent or long use of drug for patients with xerophthalmus is necessary and also in cases when the cornea is damaged. Benzalkoniya the chloride which is contained in eye drops of Taflotan can also cause irritation of eyes and decolouration of soft contact lenses. It is necessary to avoid contact of drug with soft contact lenses. Remove contact lenses before use of drug and insert them again not earlier than in 15 minutes after instillation. Pregnancy and the period of a lactation of the Woman with a genital potential / contraception of Taflotan should not apply the woman of childbearing age and the woman with a genital potential if they do not use adequate contraceptives. Pregnancy Is not present adequate data on use of the tafluprost for pregnant women. Tafluprost can make harmful pharmacological effects on pregnancy and/or on a fruit and/or on the newborn child. Researches on animals showed toxic impact on a reproductive system. In this regard Taflotan should not be applied during pregnancy, except for cases when it is absolutely necessary (in situations, when there is no other options of treatment). Breastfeeding Is unknown whether it is excreted tafluprost or its metabolites in breast milk of the person. In a research on rats the excretion of the tafluprost and/or its metabolites in breast milk after topical administration was established. Therefore tafluprost it is not necessary to apply during breastfeeding. Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of Tafluprost has no impact on ability to drive the car and to work with potentially dangerous mechanisms. As well as at use of any other ophthalmologic means, when burying drug there can be short-term misting of sight and in this case the patient has to wait, so far the sight completely is restored before driving the car or to work with mechanisms. Overdose Symptoms: There were no messages about overdose cases. After instillation of drug in an eye the overdose is improbable. Treatment: In case of overdose, treatment has to be symptomatic. The form of release and packing On 2.5 ml of drug place in a transparent polypropylene bottle with a polyethylene stopper dropper with the screwing-up cover. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in original packing at a temperature not above +25ºС. To store out of children’s reach! A period of storage 3 years After the first opening of a bottle 4 weeks. Not to use drug after the expiry date specified on packing Prescription status According to the prescription the Producer Sangteng AO, Niittyukhaankatu 20, 33720 Tampere, Finland the Owner of the registration certificate Sangteng AO, Niittyukhaankatu 20, 33720 Tampere, Finland the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Representative office of JSC Santen in Kazakhstan Almaty, Zheltoksan St. 115, office 338 Phone number – 250-39-17 Fax – 250-39-17
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