Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
FENTANYL
RAFA LABORATORIES LTD
N02AB03
PATCHES
FENTANYL 25 MCG/HOUR
TRANSDERMAL
Required
TESA LABTEC GMBH, GERMANY
FENTANYL
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.
2022-02-28
Patient Leaflet According to the Pharmacists' Regulations (Preparations) - 1986 1 This medicine requires a doctor's prescription 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 releases 12.5 mcg/hr. Each patch of Fenta 25 contains 4.125 mg Fentanyl and releases 25 mcg/hr. Each patch of Fenta 50 contains 8.25 mg Fentanyl and releases 50 mcg/hr. Each patch of Fenta 75 contains 12.375 mg Fentanyl and releases 75 mcg/hr. Each patch of Fenta 100 contains 16.5 mg Fentanyl and releases 100 mcg/hr. For the list of the additional ingredients, see section 6. • The patches contain a strong painkiller (opioid). • Ensure that the old patch is removed before applying a new patch. • Do not cut the patches. • Do not expose the patches to a heat source (such as hot water bottles). • If you develop a fever tell your doctor immediately. • Follow the dosage usage instructions carefully and change the patch every 3 days (72 hours). • If your breathing becomes shallow and weak remove the patch and seek medical attention immediately. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat 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/Dru Đọc toàn bộ tài liệu
Fenta-DL-Dec 2022-04 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 the full list of excipients, see section 6.1. *The lowest dose is stated as “Fenta12”,however, the actual dose is 12.5 µg/hour, in order to distinguish it from a dose of 125 µg/hour that could be prescribed by using multiple patches. 3. PHARMACEUTICAL FORM Transdermal patch (TDP). 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 sections _4.4, 4.5]_. • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and du Đọc toàn bộ tài liệu