البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DICLOFENAC SODIUM
NOVARTIS ISRAEL LTD
S01BC03
EYE DROPS
DICLOFENAC SODIUM 1 MG/ML
OCULAR
Required
NOVARTIS PHARMA AG.,SWITZERLAND
DICLOFENAC
DICLOFENAC
Post-operative inflammation following cataract extraction. Control of ocular pain and discomfort associated with corneal epithelial defects after laser excimer PRK or accidental trauma.
2013-10-31
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED BY IT PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only. VOLTAREN OPHTHA EYE DROPS COMPOSITION: Diclofenac sodium 1 mg/ml READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? THERAPEUTIC GROUP: Non-steroidal anti- inflammatories. THERAPEUTIC ACTIVITY: For treatment of post- operative eye inflammation after cataract surgery. For relief of ocular pain and discomfort associated with corneal epithelial defects after laser surgery or accidental trauma to the eye. 2. BEFORE USING THE MEDICINE: X DO NOT USE THIS MEDICINE: ∙ if you have a known sensitivity to the active ingredient or to any ingredient in the preparation (see section 6). ∙ in patients in whom asthma attacks, urticaria, or acute rhinitis are caused by use of acetylsalicylic acid or by other medicines which inhibit prostaglandin synthesis. ∙ if you are sensitive to acetylsalicylic acid, to phenylacetic acid derivatives or to other non-steroidal anti-inflammatories, there is a chance of sensitivity to this preparation, and vice versa. ∙ if you are in the third trimester of pregnancy. BEFORE TREATMENT WITH VOLTAREN OPHTHA, TELL THE DOCTOR IF: • you are pregnant or breastfeeding. • you are suffering from impaired blood clotting. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: • The anti-inflammatory activity of VOLTAREN OPHTHA may mask the onset and/or progression of ophthalmic infections. In case of infection or risk of infection, appropriate therapy should be given concurrently with VOLTAREN OPHTHA. اقرأ الوثيقة كاملة
Alcon MAT VOL API MAY13 CL V1 COR MAT CL 1 ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ יאמב 2013 PRESCRIBING INFORMATION VOLTAREN ® OPHTHA EYE DROPS 1 NAME OF THE MEDICINAL PRODUCT Voltaren Ophtha Eye Drops. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of Voltaren ® Ophtha Eye Drops contains 1 mg of diclofenac sodium. For a full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Post-operative inflammation following cataract extraction. • Control of ocular pain and discomfort associated with corneal epithelial defects after laser excimer PRK surgery or accidental trauma. 4.2 POSOLOGY, DOSAGE AND METHOD OF ADMINISTRATION ADULTS A) OCULAR SURGERY AND ITS COMPLICATIONS Preoperatively, up to 1 drop 5 times during the 3 hours before surgery. Postoperatively, 1 drop 3 times on the day of surgery, followed by 1 drop 3 to 5 times daily for as long as required. B) TREATMENT OF PAIN AND DISCOMFORT One drop 4 to 6 hourly. When pain is due to a surgical procedure (e.g. refractive surgery(. instill 1 drop, 30-60 minutes prior to surgery, into the eye to be operated on. During the first 10 minutes following surgery, instill 1-2 doses of 1 drop each, followed by 1 drop 4 times daily for 2 days. ELDERLY: There is no indication that dosage needs to be modified for the elderly. Alcon MAT VOL API MAY13 CL V1 COR MAT CL 2 PAEDIATRIC USE: Voltaren Ophtha is not indicated for use in children. Paediatric experience is limited to a few published clinical studies in strabismus surgery. The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to to contact the eye or surrounding structures as this may contaminate the solution. If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes between application of the different medicinal pr اقرأ الوثيقة كاملة