País: Israel
Língua: inglês
Origem: Ministry of Health
FENTANYL
RAFA LABORATORIES LTD
N02AB03
PATCHES
FENTANYL 50 MCG/HOUR
TRANSDERMAL
Required
TESA LABTEC GMBH, GERMANY
FENTANYL
Management of chronic pain and intractable pain requiring opioid analgesia.Fenta should only be used in patients who are already receiving opioid therapy who have demonstrated opioid tolerance.
2014-12-16
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is sold with a doctor's prescription only FENTA 12, FENTA 25, FENTA 50, FENTA 75, FENTA 100 TRANSDERMAL PATCHES ACTIVE INGREDIENT: Each patch of Fenta 12 contains 2.063 mg Fentanyl and delivers 12.5 mcg/hr. Each patch of Fenta 25 contains 4.125 mg Fentanyl and delivers 25 mcg/hr. Each patch of Fenta 50 contains 8.25 mg Fentanyl and delivers 50 mcg/hr. Each patch of Fenta 75 contains 12.375 mg Fentanyl and delivers 75 mcg/hr. Each patch of Fenta 100 contains 16.5 mg Fentanyl and delivers 100 mcg/hr. For a list of inactive ingredients, please see section 6. PLEASE READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICATION. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed for treating your condition. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. Medicines of the opioids group may cause addiction, especially with prolonged use and they have a potential for misuse and overdose. A reaction to an overdose, may be manifested by slow breathing and may even cause death. Make sure you know the name of the medicine, the dosage that you take, how often you take it, the duration of treatment, potential side effects and risks. Additional information regarding the risk of dependence and addiction can be found at the following link: https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf Taking this medicine along with medicines from the benzodiazepines group, other medicines which depress the central nervous system (including drugs) or alcohol may cause a feeling of profound drowsiness, breathing difficulties (respiratory depression), coma and death. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for relief of strong chronic pain requiring opioid analgesia. Fenta is indicated for patients who are already Leia o documento completo
Fenta-DL-Jan 2015-May 2019_box_02 1. NAME OF THE MEDICINAL PRODUCT Fenta 12, Fenta 25, Fenta 50, Fenta 75, Fenta 100 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FENTA 12: Each patch releases 12.5 micrograms fentanyl per hour. Each patch of 3.75 cm 2 contains 2.063 mg fentanyl. FENTA 25: Each patch releases 25 micrograms fentanyl per hour. Each patch of 7.5 cm 2 contains 4.125 mg fentanyl. FENTA 50: Each patch releases 50 micrograms fentanyl per hour. Each patch of 15 cm 2 contains 8.25 mg fentanyl. FENTA 75: Each patch releases 75 micrograms fentanyl per hour. Each patch of 22.5 cm 2 contains 12.375 mg fentanyl. FENTA 100: Each patch releases 100 micrograms fentanyl per hour. Each patch of 30 cm 2 contains 16.5 mg fentanyl. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal matrix patch. Each patch is marked: FENTA 12:Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 12 µg/h“. FENTA 25:Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 25 µg/h“. FENTA 50:Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 50 µg/h“. FENTA 75:Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 75 µg/h“. FENTA 100:Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 100 µg/h“. 4. CLINICAL PARTICULARS WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death _[_see section _4.5]_. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. _ _ 4.1 THERAPEUTIC INDICATIONS Management of chronic pain and intractabl Leia o documento completo