Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
FENTANYL AS CITRATE
MEDISON PHARMA LTD
N01AH01
NASAL SPRAY, SOLUTION
FENTANYL AS CITRATE 4 MG / 1 ML
NASAL
Required
KYOWA KIRIN HOLDINGS B.V., THE NETHERLANDS
FENTANYL
PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
2019-07-31
This is an information document that should be referred to in conjunction with important information contained within the PecFent Physician's Prescribing Information (PPI). This educational material is essential to ensure the safe and effective use of the product and appropriate management of the important risks and it is advised therefore that it be read carefully before prescribing/ dispensing/administering the product. Please consult the PPI for full prescribing information. PRESCRIBER GUIDE CONTENTS This guide contains specific information on the safe prescribing and use of PecFent (fentanyl citrate). This guide contains the following information: 1 THERAPEUTIC INDICATIONS 2 IMPORTANT INFORMATION 3 DOSING 4 OVERDOSE 5 OPIOID USE DISORDER (ABUSE AND DEPENDENCE) 6 DISCUSS 7 PRESCRIBER'S CHECKLIST THERAPEUTIC INDICATIONS IMPORTANT INFORMATION • PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. • Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. • Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. 1. Treatment with PecFent should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients, in particularly regarding transition from hospital to home. 2. Physicians should keep in mind the potential for abuse of fentanyl. 3. PecFent should not be prescribed to or used by children and adolescents aged below 18 years as the safety and efficacy of such use have not yet been established. The indication stated in the PPI must be adhered to. 4. Abuse or intentional misuse of PecFent may result in overdose and/or death. Lesen Sie das vollständige Dokument
1 _ _ PHYSICIAN'S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT PECFENT 100 PECFENT 400 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PecFent 100 Each ml of solution contains 1,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate) Each Bottle contains: 1.55 ml (1,550 micrograms fentanyl PecFent 400E ach ml of solution contains 4,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate) Each bottle contains 1.55 ml (6,200 micrograms fentanyl) Excipients with known effect: _ _ Each spray contains 0.02 mg propylparahydroxybenzoate (E216). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution (nasal spray). A clear to practically clear colourless aqueous solution. 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 Special warnings and precautions for use (4.4)] 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 2 PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. 4. Lesen Sie das vollständige Dokument