The instruction for medical use
the Trade name
Mezhdunarodnoye the unlicensed
name Bromfenak Lekarstvennaya
the Drop form eye 0.09% 1.7 ml
of 1 ml contains
active agent – sodium of a bromfenak hydrate of 1.035 mg,
(it is equivalent to a bromfenak) 0.9 mg,
excipients: a benzalkoniya chloride, boric acid, dinatrium edetat, polysorbate 80, K-30 povidone, sodium borate, sodium sulfite, sodium hydroxide, water for injections.
Transparent solution of chartreuse color.
Non-steroidal anti-inflammatory drugs. Bromfenak.
The ATX S01BC11 code
Pharmacokinetics Concentration properties of drug in blood plasma is much lower than a limit of measurement and has no clinical importance.
Broksinak the non-steroidal anti-inflammatory drug (NPVP) possessing anti-inflammatory and analgeziruyushchy action blocks synthesis of prostaglandins from arachidonic acid, by inhibition of cyclooxygenase 1 and 2 that leads to reduction of inflammation and decrease in pain reaction.
The researches in Vivo showed that prostaglandins are mediators of some types of inflammation of an eye. In researches on animals prostaglandins promoted disturbance of a blood-ocular barrier, increased permeability of vessels, caused a vazodilatation, a leukocytosis, increased intraocular pressure.
– treatment of postoperative inflammation and reduction of pain at patients after extraction of a cataract.
A route of administration and the mode of dosing
On one drop in a conjunctival sac of an eye once a day. Treatment is begun in 1 day prior to surgical intervention and continued during the first 14 days of the postoperative period (including day of operation).
Use for patients is more senior than 65 years
the Mode of administration of drug does not differ from that at younger patients.
It is not necessary to touch with a bottle dropper tip eyes or any other surface to avoid pollution of a tip of a dropper and contents of a bottle.
After use it is recommended to close densely a bottle a cover.
Duration of a course of treatment is defined by the attending physician.
Often (2-7% of patients)
– feeling of discomfort and unusual feelings in eyes
– irritation, pain, an itching and burning of eyes
– reddening of eyes
– conjunctiva hyperaemia
– a headache
– inflammation of an iris of the eye of eyes
Is rare (˂2% of patients)
– an erosion, perforation, thinning of a cornea
– destruction of an epithelium
of the Contraindication
– hypersensitivity to drug components and also to other non-steroidal anti-inflammatory drugs
– patients who have attacks of bronchial asthma, urticarias and symptomatology of acute rhinitis, amplify at intake of acetylsalicylic acid and other NPVP
– the children’s and teenage age up to 18 years
Drug can be used along with other ophthalmologic drugs: – adrenomimetikam, – adrenoblockers, inhibitors of a karboangidraza, midriatikama. At the same time drugs have to be used with a break not less than five minutes.
In 24 hours prior to surgery in the face of and within 14 days after ophthalmologic operation, the risk of emergence and severity of side reactions from a cornea can increase the special instructions Use of Local NPVP.
Use of local NPVP can lead ment of a keratitis. Prolonged use of local NPVP can cause a rupture of an epithelium, thinning of a cornea, a cornea erosion, ulceration on a cornea in some susceptible patients or perforation of a cornea. These by-effects can create risk of loss of sight. Patients with signs of a rupture of an epithelium of a cornea have to stop immediately use of drug and be under observation of the doctor before normalization of a condition of a cornea.
Use of NPVP can slow down healing process, especially at combined use with local corticosteroids.
Patients have to be warned that there can be a delay of healing during NPVP usage time.
At drug Broksinak use, patients should not use contact lenses.
Patsiyentov it is necessary to warn that they did not touch a tip of a dropper and did not concern them any surface, it can lead to pollution of contents of a bottle.
the sodium sulfite which is Contained in drug can cause allergic reaction, including an acute anaphylaxis, asthma attacks in susceptible people. The sensitivity to sulfites is increased at persons with bronchial asthma and allergic reactions in the anamnesis.
At use of the drug Broksinak there is a possibility of development of cross sensitivity to acetylsalicylic acid, derivatives of fenilatsetilovy acid and also other NPVP. It is necessary to be careful at treatment of persons at whom the sensitivity to these drugs came to light earlier.
NPVP can increase a bleeding time as a result of disturbance of aggregation of thrombocytes. Use of local NPVP in combination with ophthalmologic operations can increase bleeding of tissues of eye (including in an anterior chamber of an eye). Broksinak has to be used with care at patients in whose anamnesis the tendency to bleeding is recorded or if patients receive other medicines which can raise blood clotting time.
Experience of use of local NPVP shows that patients with complications after surgical ophthalmologic interventions, cornea denervation, defects of an epithelium of a cornea, diabetes, superficial diseases of eyes (for example, a syndrome of a dry eye), the pseudorheumatism or repeated surgical interventions which are carried out during a short period can have the increased risk of development of side reactions from a cornea.
Pregnancy and feeding by a breast
Safety of use of drops of eye 0.09% of a bromfenak during pregnancy was not studied. Use of drug is possible if the expected effect for mother exceeds potential risk for a fruit.
It is necessary to avoid prescribing of drug in the late stages of pregnancy.
It is necessary to be careful at use for women in the period of a lactation.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug slightly affects ability to driving of motor transport and control of mechanisms. Perhaps short-term turbidity of sight after administration of drug therefore it is recommended to wait before complete recovery of sight before starting driving of motor transport and control of mechanisms.
of Cases of overdose it is not established.
At the accidental use of drug inside, it is necessary to drink immediately a large amount of liquid for decrease in concentration of drug in a stomach
the Form of release and packing
On 1.7 ml in a plastic bottle with the screwing-up cap of gray color with control of the first opening.
On 1 bottle with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature of 15 – 25 of C.
To store out of children’s reach!
A period of storage
the use Period after opening of a bottle of 16 days.
Not to use after an expiration date.
According to the prescription
of Proizvoditel SENTISS FARM PVT. LTD.
212/D-1, Greene Park, New Delhi, India
At the plant: Villidzh Khera Nikhla, Tekhsil Nalagarkh, Region of Solan, Himachal Pradesh 174,101, India
Owner of the registration certificate
of SENTISS FARMA of PVT. LTD., India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Republic of Kazakhstan, 050000, Almaty, Bogenbay St. of the Batyr 132, office 309
Ph./fax: +7 (7272) 96-45-99