Oftagel 2.5 mg / g 10g ophthalmic gel.

The instruction for medical use of OFTAGEL medicine ® the Trade name of Oftagel® the International unlicensed name Carbomer Dosage Form Gel of Eye 0.25%, 10 g Structure of 1 g of gel contains active agent - carbomer 974P - 2,5 of mg. excipients: a benzalkoniya chloride, sorbitol, a lysine monohydrate, sodium acetate, polyvinyl alcohol, water for injections. Description Transparent or slightly opalescent viscous gel. Pharmacotherapeutic group Drugs for treatment of diseases of sense bodys. Drugs for treatment of diseases of eyes. Drugs for treatment of diseases of eyes others. Artificial tears and other indifferent drugs. The ATX S01XA20 code the Pharmacological Pharmacokinetics Because of properties of rather big size of a molecule of carbomer penetration through a cornea is improbable. Gel remains on the surface of an eye approximately within 30 minutes. Pharmacodynamics SUBSTITUTE of PLAINTIVE LIQUID (S: a sense body (eye)) - the Liquid eye gel formed by hydrophilic polymer with a high molecular weight (carbomer 974P). - Thanks to the physical properties, gel forms the transparent greasing and moistening film on the surface of an eye, temporarily compensating a lack of plaintive liquid. - On characteristics of pH (7.3) and osmolality gel is similar to a normal plaintive film. - Viscosity of drug (700 MPa·c) are exceeded by viscosity of drugs of an artificial tear that provides a possibility of more rare use. Indications Symptomatic treatment of a syndrome of dry eye. Route of administration and doses Ophthalmologic use. Adults (including elderly): To dig in on one drop of gel in the lower part of a conjunctival sac 1–4 times a day depending on the degree of manifestation of symptoms from eyes. Children up to 8 years and teenagers: Safety and efficiency of eye Oftagel® gel at children and teenagers at the doses recommended to adults are established on the basis of clinical experience. Data of clinical trials are absent. After burying the bottle should be stored vertically, with the tip dropper directed down to accelerate forming of drops at the subsequent use. Avoid contact of an eye with a tip of a dropper. Close a bottle a cap after use. Side effects Right after burying: passing misting of sight short-term burning sensation local irritation of eyes of the Contraindication - hypersensitivity to drug components - children's age up to 8 years Medicinal interaction At simultaneous use of other eye drops it is necessary to observe a 15-minute interval between burying drugs. Офтагель® it has to be applied in the last turn. Special instructions of Benzalkoniya the chloride which is widely used as preservative in ophthalmologic products as it is reported, can cause a dot keratopathy and/or an ulcer keratopathy. Benzalkoniya chloride can be absorbed on contact lenses and decolour them. Before burying drug they should be removed and established in 30 minutes after burying drug again. If symptoms proceed or worsen, the patient has to be examined by the doctor. Pregnancy and the period of a lactation As safety of use of drug at pregnancy and in the period of a lactation is not studied, it is necessary to be careful when assigning to pregnant women or the nursing women. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Eye Oftagel® gel can cause misting of sight for several minutes after burying. Before driving of the car or work with mechanical devices it is necessary to wait until the visual acuity completely is restored. The overdose Any overdose after instillation in eyes or oral introduction which can occur has no clinical importance. Form of release and packing On 10 g in a transparent bottle from polyethylene of low density, with a capacity of 10 ml, corked by the pipette with the screw-on cap and a ring for control of opening of a bottle. On a bottle paste the label from paper self-adhesive. On 1 bottle together with the instruction for medical use on gosudarst wine and Russian languages on disturb in a cardboard pack. To Store storage conditions in the place protected from light, at a temperature from 15 ° to 25 °C. Between burying the bottle should be stored in a cardboard pack in the turned look, for simplification intake of gel. To store in places inaccessible for children! 2.5 years After opening of a bottle to use a period of storage within 1 month. Not to apply after the expiration date specified on packing. Prescription status Without prescription Vladelts of the registration certificate and the releasing quality control of JSC Santen, Niittyukhaankatu 20, 33720 Tampere, Finland. Ursapharm Artsnaymittel GmbH producer, Industriestrasse 35, 66129 Saarbrücken, Germany the Name, the address and a contact information of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Representative office of JSC Canten in Kazakhstan Republic of Kazakhstan, 050000, Almaty, Panfilov St. 98, office 713 Phone number: 8 (727) 250-39-17 E-mail: santen.kaz@santen.com the Name, the address and a contact information responsible in the territory Republic of Kazakhstan for post-registration observation of safety of medicine: Representative office of JSC Canten in Kazakhstan Republic of Kazakhstan, 050000, Almaty, Panfilov St. 98, office 713 Phone number: 8 (727) 250-39-17 E-mail: santen.kaz@santen.com