Bimoptik Romfarm eye drops 0.3 mg / ml bottle of 3 ml (bimatoprost)

Release form

A solution clear from colorless to light yellow.

Indications

Decreased increased intraocular pressure in open-angle glaucoma and ophthalmic hypertension in adults (as monotherapy or in combination with beta-blockers).

Contraindications

Hypersensitivity to the active substance or to any of the excipients, under the age of 18 years. With caution Caution should be exercised when using BIMOPTIC ROMFARM in the treatment of patients with known risk factors for macular edema (for example, in patients with aphakia, in patients with artifact and rupture of the posterior lens capsule). BIMOPTIC ROMFARM should be used with caution in patients with a history of severe eye infections (for example, caused by the herpes simplex virus) or iritis / uveitis. There is no experience with bimatoprost in patients with concomitant respiratory dysfunction, which requires caution in such patients. When conducting clinical studies in patients with impaired respiratory function, no significant adverse effects on the respiratory system were noted. The effect of bimatoprost on patients with heart block is heavier than the first degree or on patients with uncontrolled congestive heart failure.

Use during pregnancy and lactation

Fertility There is no information on the effect of bimatoprost on fertility. Pregnancy There are no data from clinical studies of the use of bimtoprost in pregnant women. According to animal studies, reproductive toxicity has been demonstrated when used in high doses that are toxic to the mother's body. The use of bimatoprost during pregnancy is not recommended in the absence of strict indications. Breastfeeding Period It is not known whether bimatoprost is excreted in human milk. Animal studies have shown that bimatoprost is excreted in breast milk The decision to continue / stop breastfeeding or to continue / stop treatment with BIMOPTIC ROMFARM should be taken in view of the benefits of breastfeeding for the baby and the benefit of BIMOPTIC ROMFARM therapy for the mother.

Special instructions

Before starting treatment, patients should be informed about the possibility of eyelash growth, darkening of the skin of the eyelids and increased pigmentation of the iris. Some of these changes can be permanent and can lead to differences in appearance between the eyes when only one eye is treated. Changes in pigmentation of the iris occur slowly and can be invisible for several months or years. Most often, the color change of the iris is permanent. A change in the color of the iris is more associated with an increase in the melanin content in melanocytes than with an increase in the number of melanocytes. The long-term effects of increased iris pigmentation are unknown. In typical cases, brown pigment spreads from the area around the pupil to the root of the iris, as a result, the entire iris or parts of it becomes more brown. The use of bimatoprost does not affect the nevi and lentigo of the iris. Pigmentation of periorbital tissue is reversible in some patients. There are reports of the possibility of developing cystoid macular edema during bimatoprost therapy, the frequency of occurrence of this adverse event is infrequent ((> 1/1000 to <1/100), which requires caution when using the drug in the treatment of patients with risk factors for macular edema (patients with aphakia, pseudo-aphakia and rupture of the posterior lens capsule). BIMOPTIC ROMFARM, eye drops, 0.3 mg / ml contains benzalkonium chloride preservative, which can be absorbed by soft contact lenses. Eye irritation and discoloration of soft contact lenses due to the presence of benzalkonium chloride may also occur. Contact lenses must be removed before instillation and put on again 15 minutes after instillation. Benzalkonium chloride, used as a preservative in eye drops, can cause point keratopathy and / or toxic ulcerative keratopathy. Caution should be exercised when using the drug in patients with dry eye syndrome, with damage to the cornea and in the case of the simultaneous use of several types of eye drops containing benzalkonium chloride. Corneal monitoring is required with prolonged use of the drug in this category of patients. There are reports of the possibility of developing bacterial keratitis associated with the use of vials for repeated use of eye drops. Dropper bottles were unintentionally contaminated by patients with concomitant diseases of the organ of vision. The risk of developing bacterial keratitis was higher in patients with a violation of the integrity of the corneal epithelium. It is necessary to warn patients about the need to avoid touching the tip of the dropper bottle with the surface of the eye and other surfaces in order to avoid damage to the organ of vision and bacterial contamination of the drug. The impact on the ability to drive vehicles and control mechanisms BIMOPTIC ROMFARM has a slight effect on the ability to drive a vehicle and work with mechanisms. As with other eye drops, if temporary blurring of vision occurs after instillation, it is necessary to wait until the patient regains visual clarity before driving or operating machinery.

Composition

1 ml of the preparation: active substance: bimatoprost - 0.30 mg excipients: citric acid monohydrate - 0.14 mg, sodium phosphate disubstituted heptahydrate - 2.68 mg, sodium chloride - 8.30 mg, benzalkonium chloride - 0.05 mg, 1 M sodium hydroxide solution or 1 M hydrochloric acid solution - up to pH 7.3+ 0.1, purified water - up to 1.0 ml.

Dosage and Administration

Recommended dose is one drop in the affected eye (s) once daily in the evening. You can not instill the drug more than once a day, since more frequent use can reduce the effect of reducing intraocular pressure. When using more than one ophthalmic preparation for local use, it is necessary to observe an interval of 5 minutes between the introduction of each of them. Application in the pediatric population BIMOPTIC ROMFARM is not recommended for children under 18 years of age due to the lack of data on the safety and effectiveness of the drug. Application for hepatic and renal failure BIMOPTIC ROMFARM has not been studied in patients with moderate or severe renal or hepatic insufficiency, therefore, it should be used with caution in such patients. In patients with anamnestic information about mild liver dysfunction or an increase in the level of alanine aminotransferase (ALT), a history of aspartate aminotransferase (ACT) and / or bilirubin, the drug BIMOPTIC ROMFARM, eye drops, 0.3 mg / ml did not adversely affect the functional state of the liver for 24 months.

Side effects of

The following adverse events were observed during clinical trials and in the post-registration period. The frequency of occurrence is given in accordance with the following classification: very often (> 1/10) often (> 1/100 to <1/10) infrequently (> 1/1000 to <1/100) rarely (> 1/10000 to <1/1000) is very rare (<1/10000) and with an unknown frequency (cannot be estimated based on available data). In each group, unwanted effects are presented in decreasing order of severity. Disorders of the nervous system: Often: headache Infrequently: dizziness Disorders of the organs of vision: Very often: conjunctival injection, itching in the eyes, eyelash growth Often: superficial punctate keratitis, erosion of the cornea, burning eyes, eye irritation, allergic conjunctivitis, blepharitis, decreased visual acuity, asthenopia, conjunctival edema, sensation of a foreign body in the eye, dry eyes, eye pain, photophobia, lacrimation, discharge from the eyes, blurred vision, increased pigmentation of the iris, is dark eyelashes infrequently: hemorrhagic disorders of the retina, uveitis, cystoid macular edema, iritis, blepharospasm, eyelid retraction, periorbital erythema With unknown frequency: enophthalmos. Vascular disorders: Often: hypertension. Disorders from the skin and subcutaneous tissue: Infrequently: hirsutism. General disorders and disorders at the injection site: Infrequently: asthenia. Data from laboratory and instrumental studies Often: a deviation from the norm of biochemical indicators of liver function. In very rare cases, calcification of the cornea was observed with the use of phosphate-containing eye drops in patients with concomitant significant corneal damage.

Drug Interactions

Special studies regarding the interaction of BIMOPTIC ROMFARM with other drugs have not been conducted. Interactions in the human body are not expected, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng / ml) after instillation of the drug BIMOPTIC ROMFARM, eye drops, 0.3 mg / ml. In clinical studies, bimatoprost was used simultaneously with several different ophthalmic beta-blockers, but no interactions were observed. The simultaneous use of bimatoprost and other anti-glaucoma drugs, in addition to ophthalmic beta-blockers, has not been studied in studies of the effectiveness and safety of combination therapy. There was a decrease in the hypotensive effect of bimatoprost when used together with other analogues of prostaglandins in the treatment of ophthalmic hypertension and glaucoma.

Overdose

There have been no cases of overdose with topical application. In case of an overdose, treatment should be symptomatic and supportive.

Storage Conditions

Do not store above 25 ° C in original packaging. Keep out of reach of children!

The Expiration of

is 3 years. After opening the vial, the drops should be used for 4 weeks. Do not use after the expiry date!

active substance

Bimatoprost

conditions granted through pharmacies

By prescription

lekarstvennaja form

Drops hlazn e

Prescribing

For adults as prescribed by a doctor

Indications

Indications

Glaucoma



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