Fentanyl 100 micrograms in 2 ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FENTANYL CITRATE

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

N01AH; N01AH01

INN (International Name):

FENTANYL CITRATE

Dosage:

100/2ml microgram(s)

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Opioid anesthetics; fentanyl

Authorization status:

Marketed

Authorization date:

1990-07-04

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
FENTANYL 100 MICROGRAMS IN 2ML SOLUTION FOR
INJECTION
FENTANYL 500 MICROGRAMS IN 10ML SOLUTION FOR
INJECTION
fentanyl citrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any of the side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
This leaflet describes two strengths of the Injection. For simplicity
they will both be referred to as Fentanyl
injection.
WHAT IS IN THIS LEAFLET:
1. What Fentanyl Injection is and what it is used for
2. What you need to know before you are given Fentanyl Injection
3. How Fentanyl Injection is given to you
4. Possible side effects
5. How to store Fentanyl Injection
6. Contents of the pack and other information
1. WHAT FENTANYL INJECTION IS AND WHAT IT IS USED FOR
Fentanyl injection is a type of medicine called an opioid analgesic.
The word opioid means a substance
similar to opium, for instance strong pain relievers such as morphine
or codeine.
An analgesic is a medicine that can be used to relieve pain. In low
doses, Fentanyl injection is used to
provide pain relief during short surgical procedures and as a medicine
given before administration of an
anaesthetic. It may also be used in combination with antipsychotic
drugs to provide pain relief. In higher
doses, Fentanyl injection is used to provide pain relief in patients
whose breathing needs to be assisted
during surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FENTANYL INJECTION
YOU SHOULD NOT BE GIVEN FENTANYL INJECTION :
• if you are allergic to fentanyl citrate or any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic to strong pain relievers such as morphine
• if you have any problems that affect your breathing such as
asthma, chronic bronchitis or emphysema
• if y

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2023
CRN00DHWF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fentanyl 100 micrograms in 2 ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml ampoule contains 100 micrograms of fentanyl as Fentanyl
Citrate (50 micrograms of fentanyl per ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
As the sole intravenous analgesic agent in surgical procedures.
2.
As an adjunct in the maintenance of general anaesthesia and analgesia.
3.
In conjunction with a neuroleptic agent in the technique of
neuroleptanalgesia.
4.
As a respiratory depressant/analgesic in patients requiring prolonged
assisted ventilation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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).
Recommended Dosage:
1.
AS SOLE I.V. ANALGESIC AGENT IN SURGICAL PROCEDURES_Adults: _The usual
dose is 100 to 800 micrograms (0.1 to 0.8mg)
initially, depending on response, with maintenance doses of 50
micrograms (0.05mg) as necessary, in conjunction
with controlled ventilation.
2.
AS AN ADJUNCT IN THE MAINTENANCE OF GENERAL ANAESTHESIA AND ANALGESIA
_Adults: _50 micrograms (0.05mg)
supplements as necessary.
3.
IN CONJUNCTION WITH A NEUROLEPTIC AGENT IN THE TECHNIQUE OF
NEUROLEPTANALGESIA_Adults: _The usual dose is 100
micrograms (0.1mg) initially, with maintenance doses of 50 micrograms
(0.05mg) as necessary.
4.
IN PATIENTS REQUIRING PROLONGED ASSISTED VENTILATION_Adults: _Up to
600 micrograms (0.6mg) initially, with
supplemental doses of 50 to 200 micrograms (0.05mg to 0.2mg).
PAEDIATRIC POPULATION
Children aged 12 to 17 years old- Follow adult dosage
Children aged 2 to 11 years old:
the usual dosageregimen in children is as follows:
Age
Initial
Supplemental
Spontaneous
Respiration
2-1