Fentanyl Citrate Injection
1. Name of the medicinal product
Fentanyl 50 microgram/ml Injection
Fentanyl 100 microgram/2ml Injection
Fentanyl 250 microgram/5ml Injection
Fentanyl 500 microgram/10ml Injection
Fentanyl 1000 microgram/20ml Injection
Fentanyl 2500 microgram/50ml Injection
Fentanyl Citrate Injection
2. Qualitative and quantitative composition
Fentanyl citrate 78.5 micrograms equivalent to 50 micrograms per ml fentanyl.
Each 2ml ampoule contains 100 micrograms of fentanyl as fentanyl citrate.
Each 10ml ampoule contains 500 micrograms of fentanyl as fentanyl citrate.
Each 50ml vial contains 2500 micrograms of fentanyl as fentanyl citrate.
Excipient with known effect:
This medicine contains:
• 7.1 mg (or 0.31 mmol) sodium per 2 ml ampoule, that is to say essentially ‘sodium-free’.
• 35.4 mg (or 1.54 mmol) sodium) per 10 ml ampoule, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
• 177 mg (or 7.70 mmol) sodium per 50 ml vial, equivalent to 9% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear, colourless solution
4. Clinical particulars
4.1 Therapeutic indications
Fentanyl is an opioid analgesic used:
– in low doses to provide analgesia during short surgical procedures
– in high doses as an analgesic/respiratory depressant in patients requiring assisted ventilation
– in combination with a neuroleptic drug as part of the technique of neuroleptanalgesia
– in the treatment of severe pain, such as the pain of myocardial infarction
4.2 Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with fentanyl in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).
Route of administration
Intravenous administration either as a bolus or by infusion.
Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway (see section 4.4 Special warnings and precautions for use).
To avoid bradycardia, it is recommended to administer a small intravenous dose of an anti-cholinergic just before anaesthetic induction.
It is recommended to wear gloves while opening the ampoule (see section 6.6).
Fentanyl, by the intravenous route, can be administered to both adults and children. The dose of fentanyl should be individualised according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia.