SPERSADEX 5 ml
Excipients: benzalkonium chloride, macrogol 400, polyoxyl castor oil, edetate disodium, sodium hydroxide, water for injections.
1. WHAT IS SPERSADEX . AND WHAT IT IS USED FOR?
Spresadex Comp. is used in the inflammation of the anterior segment in the patients is shown corticosteroid therapy, and there is a concomitant bacterial infection susceptible to chloramphenicol, or at high risk for such an infection.
2. Before you start using Spersadeks Comp.
Do not use Spersadeks Comp if you have:
• Hypersensitivity to any component.
• Injury and ulcerous processes of corneal herpes simplex and other viral infections, mycoses and other fungal infections.
• Serious diseases of the circulatory system and liver dysfunction.
• Presence of a family determined failure in bone marrow.
• Infants aged from 0 to 27 days.
Inform your doctor before you start using Spersadeks Comp:
Long-term treatment with chloramphenicol, also with topical ocular administration may, in rare cases, lead to bone marrow aplasia.
Long-term use can lead to secondary infections of the eye or to help the growth of non-susceptible bacteria. Corticosteroids may lead to masking, activation or exacerbation of infection of the eye.
Prolonged use of corticosteroids may cause a pathological increase in intraocular pressure. In people with a predisposition and those with known glaucoma, you should regularly monitor the intraocular pressure, especially in the case of prolonged treatment.
Intensive long-term therapy may lead to the formation or worsening of cataracts.
The product should not be used for more than 10 days.
In diseases causing thinning of the cornea or sclera is described perforation in chronic use of topical steroids.
If there is no improvement after 3 days of treatment, consult your doctor.
The use of steroids immediately after cataract surgery may delay healing and increase the incidence of formation of bullae.
Informairayte your doctor if you suffer from diabetes before starting treatment. You may be prone to increases in intraocular pressure and / or the formation of cataracts. Your doctor will discuss with Vad benefits of treatment.
It is not recommended the use of contact lenses for infections of the eye, as they may contribute to the spread of microorganisms. Behzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.
The eye drops are not for injection. They should never be injected!
Pregnancy and lactation
Sperzadeks Comp. should not be administered to pregnant women or newborns. Similarly, nursing mothers should not use Spersadeks Comp.
No dosage adjustment is required in elderly patients
It is cautious behavior in use of corticosteroids in infants (aged from 28 days to 3 months) and children under the age of 2 years.
3. How to use Spersadeks Comp.
Apply 1 drop 3-5 times per day in the conjunctival sac, for not more than 10 days.
Acute cases: 1 drop every hour.
Spersadex Comp. should not be used in infants (aged 0 to 27 days).
After administration of the eye drops is needed to squeeze the inner corner of the eye or the closing of the eyes for 3 minutes.
If you need the application of more than one eye medicine should be observed at least 5 minute interval between application of the different medicinal products.
Driving and using machines
Each patient had blurred vision or a visual impairment should not drive or operate machinery until normal vision.
Taking other medicines
Spersadex Comp. should not be used together with antibacterial substances (penicillin, cephalosporins, gentamicin, tetracyclines, polymyxin B, vancomycin, sulfadiazine).
Bacteriostatic antibiotics may inhibit bactericidal antibiotics should not be used during treatment with drugs that damage haematopoietic with sulphonylureas, coumarin derivatives, hydantoins or methotrexate.
4. Possible side effects
Since Spersadex Comp. a combination of dexamethasone and chloramphenicol, can be expected adverse reactions observed in each of the active substances. There is no evidence from post-marketing studies of added toxicity following co-administration of both compounds.
Blood and lymphatic system
The literature has reported rare cases of sometimes irreversible blood dyscrasias (aplastic anemia, pancytopenia, leukopenia, thrombocytopenia, and agranulocytosis) with fatal outcome after use of ophthalmic solution containing chloramphenicol.
The literature published cases of anaphylactic reactions to topically applied chloramphenicol. Rarely reported allergic reactions in the form of eczema on the corners of the mouth.
In rare cases following administration of chloramphenicol was observed reversible optic neuritis.
The most commonly reported side effects are those that are indicative of irritation or hypersensitivity reactions (itching, redness, swelling, foreign body sensation, or other sign of irritation, spill before initiation of therapy). There are also reports of ocular burning and stinging after instillation and blurred vision.
Adverse reactions associated with local steroid therapy include increased intraocular pressure with possible development of glaucoma (damage to the optic nerve, visual acuity and visual field loss), formation of rear subkapsulana cataracts, secondary infection of the eye after the suppression of the patient's response . Option is delayed wound healing and thinning of the cornea and / or perforation of the olfactory.
Of steroid use for ocular administration are also possible ptosis and mydriasis.
After administration of chloramphenicol patient may have a bitter taste in the mouth (dysgeusia).
Although systemic effects are not common, some few cases of systemic corticosteroid effects after topical applications.
If you use more than the required amount
Overdose with topical application is unusual. If inadvertently drug is taken by mouth, inform your doctor.
5. How to store Spersadeks Comp.
Keep eye drops in a refrigerator (2-8 ° C).
Close the bottle immediately after use. Do not use the product for more than one month after the initial opening of the package. It is advisable to destroy any remaining amount of the drug after treatment.
If the packaging has not been opened, Sperzadeks Comp. can be used until the expiration date marked "EXP" on the package.
CAUTION: Medicines must be kept out of reach of children.
6. Further information
PACKAGING: dropper vial of 5ml, placed in a cardboard box.
Each pack contains one bottle of eye drops.