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PACKAGE LEAFLET DEX-TOBRIN® COMPOSITION Active substances in one ml suspension: Tobramycin 3 mg (as a sulphate) and Dexamethasone 1 mg. Excipients: Benzalkonium Chloride, Hydroxyethyl Cellulose, Edetate Sodium, Sodium Chloride, Potassium Dihydrogen Phosphate, Disodium Phosphate, Polysorbate 80, and Purified Water. PHARMACEUTICAL DOSAGE FORM AND PACKAGING Eye drop suspension in vial of 5 ml. INDICATIONS Dex-Tobrin® is administered for inflammations of conjunctiva, cornea, and anterior chamber of eye in cases when corticoid use is recommendable, and a superficial eye infection or a risk of such infection exists. NECESSARY INFORMATION BEFORE USE CONTRAINDICATIONS Dex-Tobrin® is not administered in hypersensitivity to any of the active substances or excipients. Dex-Tobrin® is not administered in herpes; allergic reaction following smallpox vaccination; and in varicella and other viral corneal and conjunctival diseases. Dex-Tobrin® is not used in eye diseases caused by fungi. SPECIAL PRECAUTIONS Dex-Tobrin® administration should be discontinued should you observe any hypersensitivity reactions or if overdosed. Such reactions resemble the adverse drug reactions: redness, lacrimation, swelling, and itching of eyelid. Cataract may develop, and higher intraocular pressure and visual disturbances may occur upon prolonged use. Intraocular pressure monitoring is recommendable. Prolonged Dex-Tobrin® use may lead to occurrence of resistant microorganisms. Possibility of masked or aggravated infection occurrence exists with Dex-Tobrin® use in acute purulent infections. The vial instillation device should not come into contact with any surfaces due to a danger of vial content contamination. One Dex-Tobrin® excipient – Benzalkonium Chloride – may induce an allergic reaction, as well as soft lens discoloration. Allergic reactions are possible to the disodium salt of Ethylenediaminetetraacetic Acid. SPECIAL WARNINGS FOR SPECIAL CATEGORIES OF PATIENTS No Dex-Tobrin® efficacy and safety studies in children exist. Administration during pregnancy and breast-feeding Please, report to your attending physician if you are pregnant or breast-feeding! Dex-Tobrin® use during pregnancy is prescribed only, if necessary. Dex-Tobrin® should not be used during the breast-feeding period because of threatened passage of the drug to breast milk. Effect on ability to drive or operate machines Dex-Tobrin® has no influence on active attention, and it does not hamper driving and using machines. 2 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER SUBSTANCES No drug interactions are known. ADVERSE DRUG REACTIONS Please, report to your doctor should you feel unwell or have any complaints you do not understand. As any medicine, Dex-Tobrin® may have side effects. Mild eye/s burning, and eyelid itching and swelling, and redness are reported most commonly. Higher intraocular pressure and glaucoma occurrence is possible in some cases upon prolonged use of steroids. Optic nerve damage and delayed eye wound healing may occur very rarely. Eyeball perforation cases have been reported with corticosteroids applied in diseases leading to corneal and scleral thinning. Sometimes, with the use of such medicines, a superimposed additional bacterial or fungal infection may occur. INSTRUCTIONS FOR USE DOSAGE Medicinal product subject to medical prescription. Usually, 1-2 drops DexTobrin® are instilled in each eye/s every 4-6 hours. Treatment may begin with 1-2 drops every 2 hours for the first 24-48 hours, and gradually, upon clinical symptom improvement, the intervals should be extended up to treatment discontinuation. METHOD OF ADMINISTRATION Dex-Tobrin® is instilled in the eye, as follows: - shake vigorously vial before instillation - lean head backwards 3 - place a finger on cheek immediately below eye, and carefully pull lower eyelid downwards - in the “sac” so formed, apply the eye drop quantity prescribed by the physician. Vial instillation device should not touch eye! - look downwards before closing eye. Do not touch vial instillation device tip. Should you feel that Dex-Tobrin® effect is rather strong or weak, discuss this with your attending physician. FREQUENCY OF ADMINISTRATION Usually, 1-2 drops Dex-Tobrin® are instilled in each eye/s every 4-6 hours. TREATMENT DURATION Treatment duration shall be specified by your doctor. PRECAUTIONS Carefully read the instructions before use. Consult your doctor for further information. Use upon doctor's prescription only. STORAGE CONDITIONS At temperature not above 25°C! Do not refrigerate! Keep out of reach of children! Do not use vial content for longer than 1 month following vial opening! Store vial tightly closed. SHELF LIFE Three (3) years. Do not use Dex-Tobrin following expiration of the term indicated on the package. 4 MANUFACTURER Balkanpharma-Razgrad AD 68, Aprilsko vustanie Blvd Phone: (++359) 084/660 999 Facsimile: (++359) 084/24 372 E-mail:[email protected] 5