MARTINDALE PHARMA FENTANYL SOLUTION FOR INJECTION 50MCGML

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

FENTANYL CITRATE 78.5MCG EQV TO FENTANYL BASE

Tilgængelig fra:

ALLIANCE PHARM PTE. LTD.

ATC-kode:

N01AH01

Lægemiddelform:

INJECTION, SOLUTION

Sammensætning:

FENTANYL CITRATE 78.5MCG EQV TO FENTANYL BASE 50MCG

Indgivelsesvej:

INTRAVENOUS, INTRAMUSCULAR

Recept type:

Prescription Only

Fremstillet af:

MACARTHYS LABORATORIES LIMITED T\A MARTINDALE PHARMA

Autorisation status:

ACTIVE

Autorisation dato:

2019-05-16

Produktets egenskaber

PRODUCT INFORMATION
MARTINDALE PHARMA FENTANYL SOLUTION FOR INJECTION 50
MICROGRAMS/ML
1
NAME OF THE MEDICINAL PRODUCT
Fentanyl 50 micrograms/ml Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fentanyl citrate 78.5 micrograms equivalent to 50 micrograms per ml
fentanyl
base. Excipient(s) with known effect:
Sodium 3.5 mg/ml.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Clear, colourless, sterile solution for Injection
4
PHARMACOLOGICAL PROPERTIES
4.1
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Anaesthetic general, opioid anaesthetic.
ATC code: N01AH01
Fentanyl is a synthetic opiate with a clinical potency of 50 to 100
times that of
morphine. Its onset of action is rapid and its duration of action is
short. In
man, a single IV dose of 0.5-1 mg/70 kg body weight immediately
produces a
pronounced state of surgical anaesthesia, respiratory depression,
bradycardia
and other typical morphine-like effects. The duration of action of the
peak
effects about 30 minutes. All potent morphine-like drugs produce
relief from
pain,
ventilatory
depression,
emesis,
constipation,
physical
dependence,
certain vagal effects and varying degrees of sedation. Fentanyl,
however,
differs from morphine not only by its short duration of action but
also by its
lack of emetic effect and minimal hypotensive activity in animals.
4.2
PHARMACOKINETIC PROPERTIES
Some pharmacokinetic parameters for fentanyl are as follows:
Urinary excretion = 8%
Bound in plasma = 80%
Clearance (ml/min/kg) =
13±2
Volume of distribution (litres/kg) = 4.0±0.4
Estimates of terminal half-life range from 141 to 853 minutes.
Renal impairment
Data obtained from a study administering IV fentanyl in patients
undergoing
renal transplantation suggest that the clearance of fentanyl may be
reduced
in this patient population. If patients with renal impairment receive
fentanyl,
they should be observed carefully for signs of fentanyl toxicity and
the dose
reduced if necessary (see section 4.2 Posology and method of
administration)