Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Diclofenac sodium 1 mg/mL;
Novartis New Zealand Ltd
Diclofenac sodium 1 mg/mL
300 mcg/0.3mL
Eye drops, solution
Active: Diclofenac sodium 1 mg/mL Excipient: Boric acid Polyoxyl 35 castor oil Trometamol Water for injection
Single use dropper, 0.3ml x 5, sample pack, 5 dose units
Pharmacy only
Prescription
Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Ltd)
Voltaren Ophtha eye drops are indicated for: · Post-operative inflammation in cataract surgery and other surgical interventions. · Prevention of cystoid macular oedema after cataract extraction with lens implantation. · Post-traumatic inflammation in non-penetrating wounds. · Inhibition of miosis in cataract surgery. · Relief of pain and photophobia. · Non-infected inflammatory conditions of the anterior segment of the eye.
Package - Contents - Shelf Life: Single use dropper, 0.3ml x 5, sample pack - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Single use dropper, 0.3ml x 30 - 30 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Single use dropper, 0.3ml x 40 - 40 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Single use dropper, 0.3ml x 100 - 100 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1996-06-14
1 Internal Document Code vlo041217cNZ VOLTAREN OPHTHA ™ EYE DROPS 0.1%_ _ _Diclofenac sodium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE VOLTAREN OPHTHA EYE DROPS. This leaflet answers some common questions about Voltaren Ophtha Eye Drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM www.medsafe.govt.nz. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using Voltaren Ophtha against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT VOLTAREN OPHTHA IS USED FOR Voltaren Ophtha contains diclofenac sodium. It belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). NSAIDs relieve pain and reduce inflammation (i.e. swelling, redness and throbbing). This medicine is used to treat inflammation of the eye e.g. inflammation which occurs as a result of surgery. Before prescribing Voltaren Ophtha Eye Drops your doctor will have examined your eye(s) and decided that this is the right medicine for you. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VOLTAREN OPHTHA HAS BEEN PRESCRIBED_ _FOR YOU. _USE IN CHILDREN _ There is not enough information to recommend the use of this medicine for children. BEFORE YOU USE VOLTARE Read the complete document
NEW ZEALAND DATA SHEET 1. PRODUCT NAME VOLTAREN OPHTHA EYE DROPS 0.1% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Voltaren Multi Dose Unit Eye Drops contains diclofenac sodium 1.0mg per 1 mL. Excipient with known effect Benzalkonium chloride 50µg per 1 mL as a preservative. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Slightly opalescent, slightly yellowish sterile aqueous solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Post-operative inflammation in cataract surgery and other surgical interventions. Prevention of cystoid macular oedema after cataract extraction with lens implantation. Post-traumatic inflammation in non-penetrating wounds. Inhibition of miosis in cataract surgery. Relief of pain and photophobia. Non-infected inflammatory conditions of the anterior segment of the eye. 4.2. DOSE AND METHOD OF ADMINISTRATION Adults _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. _Relief of pain and photophobia; post-traumatic inflammation _ One drop 4 to 6 hourly. When pain is due to a surgical procedure (e.g. refractive surgery), 1 to 2 drops in the hour preceding surgery, 1 to 2 drops within the first 15 minutes after intervention and 1 drop 4 to 6 hourly for 3 days thereafter. Elderly There is no indication that the 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. Instructions for use and handling 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. 4.3. CONTRAINDICATIONS Known hypersensitivity to the active substance or to any of the excip Read the complete document