País: Israel
Língua: inglês
Origem: Ministry of Health
FENTANYL AS CITRATE
RAFA LABORATORIES LTD
N01AH01
TABLETS SUBLINGUAL
FENTANYL AS CITRATE 800 MCG
PER OS
Required
ETHYPHARM, FRANCE
FENTANYL
Treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
2016-09-26
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is sold with a doctor's prescription only FENTA SL 67, FENTA SL 133, FENTA SL 267 FENTA SL 400, FENTA SL 533, FENTA SL 800 SUBLINGUAL TABLETS ACTIVE INGREDIENT: FENTA SL 67: each sublingual tablet contains fentanyl citrate equivalent to 67 mcg fentanyl. FENTA SL 133: each sublingual tablet contains fentanyl citrate equivalent to 133 mcg fentanyl. FENTA SL 267: each sublingual tablet contains fentanyl citrate equivalent to 267 mcg fentanyl. FENTA SL 400: each sublingual tablet contains fentanyl citrate equivalent to 400 mcg fentanyl. FENTA SL 533: each sublingual tablet contains fentanyl citrate equivalent to 533 mcg fentanyl. FENTA SL 800: each sublingual tablet contains fentanyl citrate equivalent to 800 mcg fentanyl. For a list of the other ingredients, please see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. 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. This medicine is intended for adults over 18 years old. 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 me Leia o documento completo
Fenta SL-DL-Sep 2016_Jan2019-notif-02 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fenta SL 67, sublingual tablets Fenta SL 133, sublingual tablets Fenta SL 267, sublingual tablets Fenta SL 400, sublingual tablets Fenta SL 533, sublingual tablets Fenta SL 800, sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fenta SL 67 sublingual tablets: Each tablet contains 110 micrograms of fentanyl citrate, equivalent to 67 micrograms of fentanyl. Fenta SL 133 sublingual tablets: Each tablet contains 210 micrograms of fentanyl citrate, equivalent to 133 micrograms of fentanyl. Fenta SL 267 sublingual tablets: Each tablet contains 420 micrograms of fentanyl citrate , equivalent to 267 micrograms of fentanyl. Fenta SL 400 sublingual tablets: Each tablet contains 630 micrograms of fentanyl citrate, equivalent to 400 micrograms of fentanyl. Fenta SL 533 sublingual tablets: Each tablet contains 840 micrograms of fentanyl citrate, equivalent to 533 micrograms of fentanyl. Fenta SL 800 sublingual tablets: Each tablet contains 1260 micrograms of fentanyl citrate, equivalent to 800 micrograms of fentanyl. Excipient with known effect: All doses: Each tablet contains 0.651 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet Fenta SL 67 sublingual tablets: This medicine is presented in the form of a white, convex, triangular tablet, height of 5.6 mm, printed with ‘0’ in black ink on one face. Fenta SL 133 sublingual tablets: This medicine is presented in the form of a white, convex, triangular tablet, height of 5.6 mm, printed with ‘1’ in black ink on one face. Fenta SL 267 sublingual tablets: This medicine is presented in the form of a white, convex, triangular tablet, height of 5.6 mm, printed with ‘2’ in black ink on one face. Fenta SL 400 sublingual tablets: This medicine is presented in the form of a white, convex, triangular tablet, height of 5.6 mm, printed with ‘4’ in black ink on one face. Fenta SL 533 sublingual tablets: This Leia o documento completo