Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
LOTEPREDNOL ETABONATE
TEVA ISRAEL LTD
S01BA14
OPHTHALMIC GEL
LOTEPREDNOL ETABONATE 5 MG / 1 G
OCULAR
Required
BAUSCH & LOMB INCORPORATED, USA
LOTEPREDNOL
LOTEMAX® is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
2022-08-31
Be sure that the tip of the bottle does not come into contact with any surface, including with the finger or the eye and close the bottle tightly after use. This medicine is not intended for use in children and infants. DO NOT EXCEED THE RECOMMENDED DOSE. If you are using Lotemax for 10 days or more, intraocular pressure should be monitored. Use this medicine at specified times, as determined by the attending doctor. IF YOU ACCIDENTALLY TOOK AN OVERDOSE OF THE MEDICINE, OR IF A CHILD ACCIDENTALLY SWALLOWED THE MEDICINE, immediately refer to a doctor or proceed to a hospital emergency room and bring the package of the medicine with you. IF YOU FORGOT TO TAKE THE MEDICINE If you forgot to take this medicine at the scheduled time, take a dose as soon as you remember; but never take two doses together. ADHERE TO THE TREATMENT AS RECOMMENDED BY THE DOCTOR. EVEN IF THERE IS AN IMPROVEMENT IN YOUR HEALTH, DO NOT STOP TREATMENT BEFORE CONSULTING A DOCTOR. HOW CAN YOU CONTRIBUTE TO THE SUCCESS OF THE TREATMENT? Do not take medicines in the dark! Check the label and dose each time you take medicine. Wear glasses if you need them. IF YOU HAVE FURTHER QUESTIONS REGARDING USE OF THE MEDICINE, CONSULT THE DOCTOR OR PHARMACIST. 4. SIDE EFFECTS As with any medicine, use of this preparation may cause side effects in some users. Do not be alarmed when reading the list of side effects. You may not suffer from any of them. THE MOST COMMON SIDE EFFECTS ∙ Inflammation of the iris ∙ Ocular pain ∙ Sensation of a foreign object in the eye. ADDITIONAL SIDE EFFECTS Upon use of corticosteroids for ocular treatment, the following side effects may occur: ∙ Increased intraocular pressure (glaucoma) ∙ Damage to the optic nerve ∙ Defects in visual acuity and visual fields ∙ Cataract formation ∙ Secondary ocular infections, such as herpes simplex ∙ Perforation of the cornea in areas where the cornea is thinner due to disease. IF A SIDE EFFECT OCCURS, IF ANY OF THE SIDE EFFECTS WORSEN, OR IF YOU ARE SUFFERING FROM A SIDE EFFECT N Pročitajte cijeli dokument
LOTEMAX- GEL SPC Notification N.A. 07.2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT LOTEMAX ® GEL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the gel contains 5 mg of Loteprednol etabonate (0.5%, 5mg/ml). Excipient with known effect :: Each 1 gram of gel contains 0.06 mg of Benzalkonium chloride 0.003% For the full list of excipients, see section 9. Sterile preserved ophthalmic gel, white to off-white 3. INDICATIONS AND USAGE LOTEMAX GEL is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. 4. DOSAGE AND ADMINISTRATION LOTEMAX Gel (loteprednol etabonate ophthalmic gel) is a sterile preserved ophthalmic gel containing 5 mg of loteprednol etabonate per gram of gel. Invert closed bottle and shake once to fill tip before instilling drops. Apply one to two drops of LOTEMAX GEL into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period. 5. CONTRAINDICATIONS Hypersensitivity to active substance or any of the excipient listed in section 9. LOTEMAX GEL, , is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in mycobacterial infection of the eye and fungal diseases of ocular structures. 6. WARNINGS AND PRECAUTIONS 6.1 Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids, including LOTEMAX, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. 6.2 Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. 6.3 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing Pročitajte cijeli dokument