Fentanyl 50 micrograms/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fentanyl

Available from:

AS Kalceks

ATC code:

N01AH01

INN (International Name):

Fentanyl

Dosage:

50 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

fentanyl

Authorization status:

Marketed

Authorization date:

2020-08-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENTANYL 50 MICROGRAMS/ML SOLUTION FOR INJECTION
fentanyl
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Fentanyl is and what it is used for
2. What you need to know before you are given Fentanyl
3. How Fentanyl is given
4. Possible side effects
5. How to store Fentanyl
6. Contents of the pack and other information
1. WHAT FENTANYL IS AND WHAT IT IS USED FOR
Fentanyl 50 micrograms/ml solution for injection is a fluid that is
injected. Fentanyl is a substance that
reduces pain and is responsible for the action of this medicine.
Fentanyl belongs to a group of strong,
narcotic painkillers, which are also called opioid painkillers.
You will be given this medicine during surgery to ensure that you feel
no pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FENTANYL
YOU SHOULD NOT BE GIVEN FENTANYL
-
If you are allergic to fentanyl or any of the other ingredients of
this medicine (listed in section 6).
Also, if you are hypersensitive to other strong (narcotic)
painkillers, you must not be given this
medicine.
-
Your lungs are not working properly (without mechanical ventilation of
the lungs).
WARNINGS AND PRECAUTIONS
After administration of this medicine, your breathing may become
abnormally slow or weak. It is
important that you tell your doctor about this immediately. As this
may also occur some time after
surgery, you will be observed for some time after the operation.
Talk to your doctor or nurse before Fentanyl is given:
-
if you have poor liver, kidney or

Summary of Product characteristics

Health Products Regulatory Authority
19 June 2023
CRN00DJC5
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fentanyl 50 micrograms/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms of fentanyl (as fentanyl
citrate).
Each ampoule of 2 ml contains 100 micrograms of fentanyl (as fentanyl
citrate).
Each ampoule of 10 ml contains 500 micrograms of fentanyl (as fentanyl
citrate).
Excipient with known effect
Each ampoule of 2 ml contains 7.08 mg (0.31 mmol) sodium.
Each ampoule of 10 ml contains 35.41 mg (1.54 mmol) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution for injection, free from visible particles.
The pH of the solution is 4.0 to 7.0.
Osmolality is approximately 285 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fentanyl 50 micrograms/ml is an anaesthesia analgesic:
-for use as an opioid analgesic supplement in general or local
anaesthesia;
-for administration with a neuroleptic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fentanyl 50 micrograms/ml may only be administered in an environment
where the airways can be monitored and by
personnel able to monitor the airways (see section 4.4).
Posology
The dosage of Fentanyl 50 micrograms/ml must be determined
individually based on age, body weight, physical status,
underlying pathological condition, medication use and type of surgery
and anaesthesia.
_Adults_
At induction, 200 to 600 micrograms (2.8 to 8.5 micrograms/kg)
corresponding to 4‑12 ml is usually injected intravenously.
Doses above 200 micrograms should only be administered together with
ventilation. For maintenance of analgesia, additional
intravenous doses of 50 to 200 micrograms (0.7 to 2.8 micrograms/kg)
corresponding to 1‑4 ml can be administered after 30
to 45 minutes.
_Paediatric population_
_Adolescents 12 to 17 years of age_
Follow adult dosage.
_Children 2 to 11 years of age_
A dose of 1.25‑2.