البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PREDNISOLONE ACETATE
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
S01BA04
OPHTHALMIC SUSPENSION
PREDNISOLONE ACETATE 1 %W/V
OCULAR
Required
ALLERGAN PHARMACEUTICALS IRELAND
PREDNISOLONE
PREDNISOLONE
For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
2020-04-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed w ith a doctor’s prescription only PRED FORTE ® OPHTHALMIC SUSPENSION ACTIVE INGREDIENT AND ITS CONCENTRATION: prednisolone acetate 1% w/v Inactive ingredients and allergens in the medicine: see section 2, under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness/for you. Do not pass it on to others. It may harm them, even if it seems to you that their illness/medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? PRED FORTE is used to treat eye inflammation that responds to steroids and involves the conjunctiva, cornea or the anterior segment of the eyeball. THERAPEUTIC GROUP: corticosteroids PRED FORTE belongs to a group of medicines known as steroidal anti- inflammatory drugs. It reduces the irritation, burning, redness and swelling of eye inflammation caused by chemicals, heat, radiation, allergy, or foreign objects in the eye. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to the substance prednisolone acetate, benzalkonium chloride or any of the other ingredients of this medicine (listed in sect ion 6 ‘Addi tional information ’) . • you suffer from viral, fungal or bacterial eye infections. • you suffer from tuberculosis of the eye. • you have injuries or ulcers on the cornea. • you have previously had herpes simplex. Page 2 of 6 SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE TREATMENT WITH PRED FORTE, TELL YOUR DOCTOR IF: - you suffer from or have ever suffered from eye ulcers, or if you have had a disease or received treatment in the eye that caused the tissue to become thin - you have glauco اقرأ الوثيقة كاملة
PRE API JAN 24 CL Page 1 of 5 1. NAME OF THE MEDICINAL PRODUCT Pred Forte ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1% w/v prednisolone acetate. Excipient(s) with known effect: Benzalkonium chloride 0.006% w/v. Boric acid 1% w/v. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ophthalmic suspension. A dense white sterile microfine eye drops suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosing frequency may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely. No overall differences in safety or effectiveness have been observed between elderly and younger patients. _Paediatric population _ The safety and efficacy in paediatric population have not yet been established. No posology can be recommended. Method of administration Route of administration is by ocular instillation. To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop. Shake well before use. 4.3 CONTRAINDICATIONS Acute untreated purulent ocular infections. Acute superficial herpes simplex (dendritic keratitis); vaccinia, varicella and most other viral diseases of the cornea and conjunctiva. Fungal diseases of the eye. Mycobacterial infection such as tuberculosis of the eye. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. PRE API JAN 24 CL Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Acute purulent infections of the eye may be masked or enhanced by the use of topical steroids. Pred Forte contains no antimicrobial agent. If infection is presen اقرأ الوثيقة كاملة