Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Prednisolone sodium phosphate 0.5%{relative} (3.6% overage );
Bausch & Lomb (NZ) Ltd
Prednisolone sodium phosphate 0.5% w/v (3.6% overage )
0.5% w/v
Eye drops, solution
Active: Prednisolone sodium phosphate 0.5%{relative} (3.6% overage ) Excipient: Disodium edetate dihydrate Monobasic sodium phosphate dihydrate Purified water Sodium chloride Sodium hydroxide
Single use dropper, 0.5ml, 20 dose units
Prescription
Prescription
Sanofi Chimie
Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1982-03-18
MINIMS ® PREDNISOLONE EYE DROPS 1 MINIMS ® PREDNISOLONE EYE DROPS _Prednisolone Sodium Phosphate Eye Drops _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minims Prednisolone Eye Drops, including how to use the eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using Minims Prednisolone Eye Drops 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 THE MEDICINE. You may need to read it again. WHAT MINIMS PREDNISOLONE EYE DROPS IS USED FOR Minims Prednisolone Eye Drops belongs to a class of medicines called corticosteroids. It is used to treat inflammation of the eye(s) that is not caused by an infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED TO YOU. Your doctor may have prescribed it for another reason. BEFORE YOU USE MINIMS PREDNISOLONE EYE DROPS _WHEN YOU MUST NOT USE IT _ DO NOT USE MINIMS PREDNISOLONE EYE DROPS IF YOU HAVE AN ALLERGY TO: * Any medicine containing Prednisolone or Prednisone * Any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: * Shortness of breath * Wheezing or difficulty breathing * Swelling of the face, lips, tongue or other parts of the body * Rash, itching or hives on the skin DO NOT USE MINIMS PREDNISOLONE EYE DROPS IF YOU HAVE AN EYE INFECTION. Your doctor will want to treat the eye infection first. DO NOT USE MINIMS PREDNISOLONE EYE DROPS IF YOU HAVE GLAUCOMA (HIGH PRESSURE IN THE EYE). Your doctor will discuss with you how to use this medicine and the risks and benefits involved. DO NOT USE THIS MEDICINE IN CHILDREN FOR CONTINUOUS, LONG PERIODS OF TIME. Your doctor will discuss with you how long to use this medicine in children and the risks and benefits Baca dokumen lengkap
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME MINIMS PREDNISOLONE SODIUM PHOSPHATE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clear, colourless, sterile eye drops containing prednisolone sodium phosphate BP 0.5% w/v. 3. PHARMACEUTICAL FORM Single-use, sterile eye drops. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-infected inflammatory conditions of the eye. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults and the elderly: One or two drops applied topically to the eye as required. Children: At the discretion of the physician. 4.3 CONTRAINDICATIONS Use is contraindicated in viral, fungal, tuberculous and other bacterial infections. Prolonged application to the eye of preparations containing corticosteroids has caused increased intraocular pressure and therefore the drops should not be used in patients with glaucoma. In children, long-term, continuous topical corticosteroid therapy should be avoided due to possible adrenal suppression. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care should be taken to ensure that the eye is not infected before Minims Prednisolone is used. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the 2 passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.) Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Corticosteroids are known to increase the effects of barbiturates, sedative hypnotic Baca dokumen lengkap