Download PACKAGE LEAFLET DEX-TOBRIN COMPOSITION Active

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.
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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:
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shake vigorously vial before instillation
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lean head backwards
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place a finger on cheek immediately below eye, and carefully pull lower eyelid
downwards
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in the “sac” so formed, apply the eye drop quantity prescribed by the
physician. Vial instillation device should not touch eye!
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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.
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MANUFACTURER
Balkanpharma-Razgrad AD
68, Aprilsko vustanie Blvd
Phone: (++359) 084/660 999
Facsimile: (++359) 084/24 372
E-mail:[email protected]
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