البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
GLYCERYL TRINITRATE
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
C01DA02
OINTMENT
GLYCERYL TRINITRATE 0.4 %
RECTAL
Required
PHARBIL WALTROP GMBH (A SUBSIDIARY OF NEXT PHARMA)
GLYCERYL TRINITRATE
GLYCERYL TRINITRATE
For relief of pain associated with chronic anal fissure. In the clinical development of the drug a modest effect has shown on improvement in average daily pain intensity.
2014-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only. RECTOGESIC ® RECTAL OINTMENT Each 1 gram contains 0.4% glyceryl trinitrate. Inactive and allergenic ingredients in the medicine - see section 6 in the leaflet. 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. THE MEDICINE IS NOT INTENDED FOR CHILDREN AND ADOLESCENTS UNDER THE AGE OF 18, since studies have not been performed in this population. 1. WHAT IS THE MEDICINE INTENDED FOR? To relieve pain caused by chronic anal fissures. An anal fissure is a tear in the skin lining the anal canal. Topical application of glyceryl trinitrate reduces the anal pressure and increases the blood flow, thereby reducing pain. THERAPEUTIC GROUP: Organic nitrates. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: ∙ you are sensitive (allergic) to the active ingredient or any of the additional ingredients contained in the medicine (see section 6 for the list of inactive ingredients), or to similar medicines. ∙ you are pregnant or breastfeeding. ∙ you suffer from low blood pressure. ∙ you suffer from blood vessel or heart disorders. ∙ you suffer from closed-angle glaucoma – a condition where pressure inside the eye rises rapidly, causing loss of vision. ∙ you suffer from migraines or recurrent headaches. ∙ you suffer from increased intracranial pressure or high pressure within the skull (such as: head injury or cerebral hemorrhage - bleeding from a ruptured blood vessel in the brain that can be fatal without prompt medical treatment, cerebral hemorrhage [a type of stroke] or abnormal cerebral circulation [inadequate amount of blood reaches the brain]). ∙ اقرأ الوثيقة كاملة
PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Rectogesic ® Rectal Ointment. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glyceryl trinitrate: 4 mg/g. One gram of rectal ointment contains 4 mg Glyceryl trinitrate (GTN). The delivered dose from 375 mg of this formulation is approximately 1.5 mg GTN. Excipient(s) with known effect: The ointment also contains 36 mg Propylene Glycol, and 140 mg Lanolin, per gram rectal ointment. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Rectal ointment. Off-white smooth opaque ointment formulation. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rectogesic 4 mg/g Rectal Ointment is indicated for relief of pain associated with chronic anal fissure. In the clinical development of the drug, a modest effect has been shown on improvements in average daily pain intensity (see Section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: rectal use ADULTS: A finger covering, such as cling film or a finger cot, may be placed on the finger to be used to apply the ointment. (Finger cots to be obtained separately from local pharmacy or surgical supplies retailer or cling film from local store.) The finger is placed along side a 2.5cm dosing line which is provided on the outside carton in which Rectogesic is supplied, and a strip of ointment the length of the line is expressed onto the end of the finger by gently squeezing the tube. The amount of ointment expressed is approximately 375 mg (1.5 mg GTN). The covered finger is then gently inserted into the anal canal to the distal interphalangeal joint of the finger and applied circumferentially to the anal canal. The dose delivered from the 4 mg/g ointment is 1.5 mg glyceryl trinitrate. The dose is to be applied intra-anally every twelve hours. Treatment may be continued until the pain abates, up to a maximum of 8 weeks. _ _ Rectogesic should be used following conservative treatment failure for acute symptoms of anal fissure. ELDERLY (OVER 65 YEARS): No specific information concer اقرأ الوثيقة كاملة