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Bimanoks 2 mg / ml 5 ml of eye drops




Istruktion on medical use of Bimanoks Torgovoye medicine a name of Bimanoks the International unlicensed name Brimonidin Lekarstvennaya the Drop form eye 2 mg/ml, 5 ml Structure of 1 ml of drug contains active agent – a brimonidin tartrate of 2 mg (1.32 mg of a brimonidin are equivalent), excipients: a benzalkoniya chloride of 50% solution, polyvinyl alcohol (40-88), sodium citrate, citric acid, sodium chloride, sodium hydroxide / chlorohydrogen acid (for correction rn 5.5 – 6.5), the water purified. Description Transparent solution of yellowish-green color. Pharmacotherapeutic group Sympathomimetics for treatment of glaucoma. Brimonidin. SO1EA05 the Pharmacological Pharmacokinetics At properties topical administration of a brimonidin tartrate quickly gets through a cornea. In insignificant quantities gets to a system blood stream by absorption through vessels of a conjunctiva, mucous a nose and a plaintive path. After the 10th day use of eye drops the concentration of a brimonidin of tartrate in blood plasma did not exceed 0.06 ng/ml, in this regard systemic action of drug is very low. After drug use elimination half-life of a brimonidin tartrate makes about 3 hours of blood plasma. The pharmacodynamics Active agent of drug – a brimonidin tartrate is agonist α2-адренорецепторов, shows the greatest selectivity to α2-адренорецепторам, than to α1-адренорецепторам. As a result of selective effect on α2-адренорецепторы drug does not cause a mydriasis and vasoconstriction of the microvessels associated with retina heterografts at people. Topical administration of a brimonidin of tartrate causes decrease in intraocular pressure in people at insignificant influence on a cardiovascular and respiratory system. Information on clinical trials concerning safe use of drug for patients with bronchial asthma are limited. Intraocular pressure begins to decrease quickly after drug use, and its maximum decrease is noted in 2 h Brimonidin reduces intraocular pressure due to reduction of intraocular liquid and insignificant increase in its uveoskleralny outflow. Indications For decrease in the increased intraocular pressure at patients with an open angle glaucoma or intraocular hypertensia: – as monotherapy at patients to whom drugs of beta-blockers in eye drops are contraindicated – as auxiliary therapy at patients at whom adequate decrease in intraocular pressure at monotherapy is not reached by other protivoglaukomny drugs. Route of administration and doses Adult and elderly: on 1 drop in the affected eye two times a day every 12 hours. Elderly people do not need correction of a dosage of drug when assigning. For decrease in possible system absorption it is recommended to press quickly (no more than a minute) a finger-tip in the field of an internal corner of an eye in a dacryocyst projection. At simultaneous use of other local ophthalmologic means the interval between instillations has to be not less than 5 minutes. Side effect is Very frequent (≥ 1/10) – the irritation of mucous membranes of eyes (hyperaemia, burning and pricking, an itching, feeling of a foreign body, a conjunctiva folliculosis), the obscured sight, local allergic reactions from eyes, allergic blepharitis, allergic blefarokonjyunktivit, allergic conjunctivitis, follicular conjunctivitis – a headache, drowsiness – dryness in a mouth – weakness (feeling of fatigue) is frequent (≥ 1/100, & lt, 1/10) – local reactions of irritation (hyperaemia and the century, blepharitis, a chemosis, eye pain, dacryagogue), a photophobia, an erosion and coloring of a cornea, xerophthalmus, a disorder of vision, an asthenia – dizziness, disturbance of taste – bronchitis, cough, short wind – an asthenia Infrequently (≥ 1/1,000, & lt, 1/100) – a depression – system allergic reactions Seldom (≥ 1/10,000, & lt, 1/1,000) – increase of pulse, arrhythmia (including bradycardia and tachycardia), – xeromycteria, dispny – gastrointestinal disorders Very seldom (≤ 1/10,000 swelled) – faints – an iritis, a miosis – arterial hypertension, arterial hypotension – insomnia Frequency is unknown – an iridocyclitis (front uveitis) – an itching of a century – a dot keratopathy and/or a toxic ulcer keratopathy – an erythema, a face edema, an itching, rash and a vazodilatation of the Contraindication – newborns and children up to 18 years – hypersensitivity to a brimonidin to tartrate or any component of drug – simultaneous use with inhibitors of a monoaminooxidase or other antidepressants which have effect through release of noradrenaline (tricyclic antidepressants) Medicinal interactions is possible interaction with the drugs and substances oppressing the central nervous system (alcohol, barbiturates, opiates, sedative drugs and anesthetics). It is necessary to appoint with care to the patients taking medicines which can affect metabolism and the return neuronalny capture of amines (Chlorpromazinum, methylphenidate, reserpine) though there are no data on the level of catecholamines in the blood course after use of eye drops with brimonidiny. It is necessary to be careful at co-administration of eye drops with brimonidiny and antihypertensive drugs, cardiac glycosides. Bromonidin can interact with alpha adrenoblockers. Special instructions It is necessary to use with care Bimanoks at patients with a serious cardiovascular illness, a depression, disturbance of cerebral or coronary circulation, orthostatic hypotension, Reynaud’s syndrome, an obliterating thromboangitis. Use of ophthalmologic solution of a brimonidin of tartrate of 2 mg/ml for patients with a liver or renal failure was not studied therefore it is necessary to show care at treatment of such patients. Delayed-type hypersensitivity reactions can be associated with increase in intraocular pressure. At emergence of serious side reactions or at manifestation of hypersensitivity the use should be stopped. Bimanoks contains preservative a benzalkoniya chloride which can be absorbed by soft contact lenses and have the damaging effect on eye tissues. Therefore the patients carrying soft contact lenses should remove them before use of drops and to establish back not earlier than in 15 min. after burying. Can change color of soft contact lenses. Pediatrics the Clinical trials confirming safety and efficiency of eye drops with brimonidin tartrate at children aged up to 18 years were not carried out. Pregnancy and a lactation Use of drug during pregnancy can be considered only at absolute indications taking into account advantage/risk for the pregnant woman and a fruit. During chest feeding the use of drug is contraindicated. Influence on ability to run transport and other mechanisms It is necessary to be careful in connection with a possibility of development of side effects from the central nervous system (drowsiness, weakness) and disturbance of visual acuity. Overdose of Data on overdose there is no drug. Symptoms at accidental intake: development of systemic side effects. Treatment: symptomatic therapy. The form of release and packing On 5 ml of drug place in a plastic bottle with a stopper dropper and the screwing-up protective cap supplied with a safety ring. On 1 bottle together with the instruction for use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not over 30 ºС. To store out of children’s reach! Period of storage 2 years. The use period after opening of a bottle – within 4 weeks. Not to apply after an expiration date. Prescription status According to the prescription the Name and the country of the JSC YaDRAN manufacturing organization Galenski of Laboratories, Svilno 20, 51000 Rijeka, Croatia the Name and the country of the owner of the registration certificate of JSC Yadran Galenski of Laboratories, Croatia the Name and the country of the JSC Yadran organization packer Galenski of Laboratories, Croatia in Republic of Kazakhstan, Almaty, Zhamakayev St., 126
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Yadran Galenski of Laboratories

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