FENTANYL-HAMELN Solution for Injection 50 Microgr Microgram/ML

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fentanyl-Hameln 50 microgram/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains
Fentanyl citrate
0.0785 mg
Equivalent to Fentanyl 0.050 mg
I ampoule with 2 ml solution for injection contains
Fentanyl citrate
0.157 mg
Equivalent to Fentanyl 0.10 mg
I ampoule with 10ml solution for injection contains
Fentanyl citrate
0.785 mg
Equivalent to Fentanyl 0.50 mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
The product is a clear, colourless solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Fentanyl is a short acting opioid used
-
for neurolept analgesia and neurolept anaesthesia
-
as an analgesic component in general anaesthesia with intubation
and ventilation of the patient
-
for analgesic treatment in the intensive care unit in
patients under the condition of assisted ventilation
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The dose of fentanyl is adjusted individually according to age,
body weight, physical status, pathological condition 
and co-medication as well as type of surgical procedure and
type of anaesthesia.
For guidance, the following dosage schedules are proposed.
For other, special dosage recommendations please 
refer to the literature.
Neurolept analgesia and neurolept anaesthesia
For neurolept analgesia adults normally will require an
initial dose of 50 to 100 microgram (0.7-1.4 microgram/kg) 
fentanyl slowly injected intravenously in a combination with
a neuroleptic (preferably Droperidol). If necessary a 
second dosage of 50 to 100 microgram (0.7-1.4
microgram/kg) fentanyl can be given 30 to 45 minutes after the 
initial dose.
For neurolept anaesthesia under the condition of assisted
ventilation adults in general will require an initial dose of 
IRISH MEDICINES BOARD
_____________________
                                
                                Read the complete document