Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
DICLOFENAC SODIUM
NOVARTIS (SINGAPORE) PTE LTD
S01BC03
1 mg/ml
SOLUTION
DICLOFENAC SODIUM 1 mg/ml
OPHTHALMIC
Prescription Only
EXCELVISION
ACTIVE
1997-07-31
VOLTAREN OPHTHA Anti-inflammatory agents, non-steroids. COMPOSITION AND PHARMACEUTICAL FORM Voltaren Ophtha: one mL contains 1 mg of diclofenac sodium. Eye drops, solution. For a full list of excipients, see section EXCIPIENTS. INDICATIONS Post-operative inflammation following cataract surgery and other surgical interventions. Preoperative and postoperative prophylaxis of cystoid macular oedema associated with lens extraction and intraocular lens implantation. Post-traumatic inflammation in patients with non-penetrating wounds Inhibition of miosis during cataract surgery Non-infectious inflammatory conditions affecting the anterior region of the eye DOSAGE AND ADMINISTRATION ADULTS: EYE SURGERY AND ITS COMPLICATIONS Preoperative: Instill up to 5 doses of 1 drop each over the course of the 3 hours preceding surgery. Postoperative: Instill 3 doses of 1 drop each on the day of the operation, followed by 1 drop 3–5 times daily for as long as necessary. TREATMENT OF PAIN AND DISCOMFORT, POST-TRAUMATIC INFLAMMATION One drop 4 to 6 hourly. ELDERLY: There is no indication that dosage needs to be modified for the elderly. 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 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 products must be allowed. Novarti Przeczytaj cały dokument
VOLTAREN OPHTHA Anti-inflammatory agents, non-steroids. COMPOSITION AND PHARMACEUTICAL FORM Voltaren Ophtha: one mL contains 1 mg of diclofenac sodium. Eye drops, solution. For a full list of excipients, see section EXCIPIENTS. INDICATIONS • Post-operative inflammation following cataract surgery and other surgical interventions. • Preoperative and postoperative prophylaxis of cystoid macular oedema associated with lens extraction and intraocular lens implantation. • Post-traumatic inflammation in patients with non-penetrating wounds • Inhibition of miosis during cataract surgery • Non-infectious inflammatory conditions affecting the anterior region of the eye DOSAGE AND ADMINISTRATION ADULTS: EYE SURGERY AND ITS COMPLICATIONS Preoperative: Instill up to 5 doses of 1 drop each over the course of the 3 hours preceding surgery. Postoperative: Instill 3 doses of 1 drop each on the day of the operation, followed by 1 drop 3–5 times daily for as long as necessary. TREATMENT OF PAIN AND DISCOMFORT, POST-TRAUMATIC INFLAMMATION One drop 4 to 6 hourly. ELDERLY: There is no indication that dosage needs to be modified for the elderly. 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 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 products must be allowed. Novartis Country Specific Package Leaflet (Singapore) – Sep 2015 Page 2 Voltaren Ophtha Following instillation of the eye drops, nasolacrimal occlusion or closing the eyes for 5 minutes may reduce systemic absorption. This may result in a decrease in systemic side effects and an increase in local activity. Eye drops are not Przeczytaj cały dokument