Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Fentanyl citrate 78.125 µg/mL equivalent to 50 µg/mL fentanyl; Fentanyl citrate 78.125 µg/mL
Pfizer New Zealand Limited
Fentanyl citrate 78.125 µg/mL (equivalent to 50 µg/mL fentanyl)
50 mcg/mL
Solution for injection
Active: Fentanyl citrate 78.125 µg/mL equivalent to 50 µg/mL fentanyl Excipient: Water for injection Active: Fentanyl citrate 78.125 µg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection
Ampoule, glass, 10mL, 5 dose units
Class B3 Controlled Drug
Class B1 Controlled Drug
Macfarlan Smith Ltd
Package - Contents - Shelf Life: Ampoule, glass, 10mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 2mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light
1990-10-17
Version: pfdfenti10721 Supercedes: pfdfenti10820 Page 1 of 22 NEW ZEALAND DATA SHEET WARNINGS _LIMITATIONS OF USE_ Because of the risks associated with the use of opioids, fentanyl should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _HAZARDOUS AND HARMFUL USE_ Fentanyl poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _LIFE-THREATENING RESPIRATORY DEPRESSION_ Serious, life-threatening or fatal respiratory depression may occur with the use of fentanyl. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, _ _INCLUDING ALCOHOL_ Concomitant use of opioids with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics, general anaesthetics, tranquilisers, or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking fentanyl (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 1. PRODUCT NAME DBL Fentanyl Injection 50 micrograms/mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Fentanyl Injection is Baca dokumen lengkapnya