THERAPEUTIC INDICATIONS:
-
inhibition of miosis during cataract surgery;
-
treatment and prevention of inflammatory processes after surgical interventions on the eyeball;
-
prevention of cystic macular edema after cataract surgery;
-
treatment of non-infectious conjunctivitis;
-
treatment and prevention of posttraumatic inflammatory process (as an adjunct to local antibacterial therapy).
Download instructions for use
Composition
1 ml of the solution contains
- active substance - diclofenac sodium 1 mg,
- excipients: propylene glycol, edetate disodium, sodium chloride, sodium dihydrophosphate dihydrate, sodium hydrophosphate dodecahydrate, sodium hydroxide solution 1 M, water for injection.
Pharmaceutical form
Eye drops 0.1%, 5 ml
Pharmacotherapeutic group
Sense organs. Ophthalmologicals. Anti-inflammatory drugs. Nonsteroidal anti-inflammatory drugs. Diclofenac.
ATC code S01ВС03
Indications
- inhibition of miosis during cataract surgery;
- treatment and prevention of inflammatory processes after surgical interventions on the eyeball;
- prevention of cystic macular edema after cataract surgery;
- treatment of non-infectious conjunctivitis;
- treatment and prevention of posttraumatic inflammatory process (as an adjunct to local antibacterial therapy).
Contraindications
- hypersensitivity to the product components;
- hematopoiesis disorders of unclear genesis;
- history of allergic reactions to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
- pregnancy, lactation period;
Posology and method of administration
Topically. To inhibit intraoperative miosis, instill the product into the conjunctival sac for 2 hours at 30-minute intervals (4 times) before surgery.
To prevent cystic edema of the macula, instill the product 1 drop 3 times a day for 2-3 weeks after surgery.
For therapeutic purposes, 1 drop 3-4 times a day depending on the severity of the condition. The course of treatment is 1 to 2 weeks.
Adverse reactions
Common (>10 %):
- a transient moderate burning sensation in the eyes.
Uncommon (> 1-10 %):
- blurred visual perception (immediately after instillation);
- corneal opacity (spot).
Rare (> 0.001-1 %):
- iritis;
- itchy eyes, hyperemia, fever, chills, photosensitization, skin rash (mostly erythematous, urticaria), erythema multiforme exudative;
- pitting keratitis and corneal epithelium damage after frequent instillations;
- corneal ulceration or thinning or melting (in patients with risk factors for corneal ulceration and thinning, such as during corticosteroid use or for comorbidities such as infectious disease or rheumatoid arthritis; most patients have been treated for a long time)
- dizziness;
- dyspnea;
- exacerbation of asthma;
- nausea, vomiting.
Very rare (< 0.001 %):
- angioedema.
Overdose
When using Diclofenac eye drops overdose is unlikely.
Use during pregnancy or breastfeeding
Drops are contraindicated in pregnancy and lactation.
Pediatric population
In children under 18 years of age, use only if the expected therapeutic effect exceeds the risk of possible side effects.
Special warnings
With caution: bronchial asthma caused by acetylsalicylic acid; epithelial herpetic keratitis (including history); diseases causing blood clotting disorders (including hemophilia, prolonged bleeding time, susceptibility to bleeding); elderly.
Contact lenses should be removed prior to instillation and reinserted no earlier than 30 minutes after instillation.
Effects on ability to drive and use machines
In case of blurred vision after instillation, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require high concentration and speed of psychomotor reactions until its recovery.
Presentation and package
5 ml of the product in plastic dropper bottles, sealed with tamper-proof caps. Each bottle has a label made of label or writing paper.
One bottle is with instruction for use in the state and Russian language are placed in a carton pack.
Storage conditions
Store in a place protected from light at a temperature of 15°С to 25°С.
Do not freeze.
Keep out of the reach of children.
Shelf life
2 years
After opening the bottle, use within 28 days.
Manufacturer
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.
Marketing authorization holder
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.
Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,
Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: Адрес электронной почты защищен от спам-ботов. Для просмотра адреса в вашем браузере должен быть включен Javascript.