Fentanyl 500micrograms/10ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl citrate

Available from:

Advanz Pharma

ATC code:

N01AH01

INN (International Name):

Fentanyl citrate

Dosage:

50microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Intravenous

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010403; GTIN: 5099602992436

Patient Information leaflet

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.
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.
The name of your medicine is Fentanyl 50 micrograms/ml Solution for
Injection/Infusion. It will
be referred to as Fentanyl Injection/Infusion for ease hereafter.
WHAT IS IN THIS LEAFLET:
1.
What Fentanyl Injection/Infusion is and what it is used for
2.
What you need to know before you are given Fentanyl Injection/Infusion
3.
How Fentanyl Injection/Infusion is given to you
4.
Possible side effects
5.
How to store Fentanyl Injection/Infusion
6.
Contents of the pack and other information
1. WHAT FENTANYL INJECTION/INFUSION IS AND WHAT IT IS USED FOR
Fentanyl Injection/Infusion 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/Infusion is used to provide pain relief during short
surgical procedures and as a medicine
given before administration of an anaesthetic. In higher doses,
Fentanyl Injection/Infusion 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/INFUSION
YOU SHOULD NOT BE GIVEN THIS MEDICINE IF:
• you are allergic to Fentanyl Injection/Infusion or any of the
other ingredients of this medicine
(listed in section 6)
• you are allergic to other strong pain relievers, such as morphine
• you have any problems that affect your breathing including
obstructive airways disease like
chronic bronchitis or emphysema or respiratory depression (reduced
respiratory rate)
• after surgery on the biliary tract.
Speak to your doctor i

Summary of Product characteristics

OBJECT 1
FENTANYL 50 MICROGRAMS/ML SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 31-Jan-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Fentanyl 50 micrograms/ml Solution for Injection/Infusion
2. Qualitative and quantitative composition
Contains Fentanyl citrate the equivalent of 50 micrograms of Fentanyl
in 1ml.
Each 2ml ampoule contains 100 micrograms of Fentanyl as Fentanyl
citrate.
Each 10ml ampoule contains 500 micrograms of Fentanyl as Fentanyl
citrate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
A clear, colourless, sterile solution.
4. Clinical particulars
4.1 Therapeutic indications
Fentanyl citrate is a narcotic analgesic. In low doses it is used to
provide analgesia during short surgical
procedures and as a premedicant. In higher doses it is employed as an
analgesic/respiratory depressant in
patients who need assisted ventilation. In combination with a
neuroleptic drug, fentanyl is employed as
part of the technique of neuroleptanalgesia. Fentanyl is also used in
the treatment of severe pain, such as
that of myocardial infarction.
4.2 Posology and method of administration
Posology:
Adult:
The usual dosage regimen is as follows:
Initial micrograms
Supplemental micrograms
Spontaneous Respiration
Assisted ventilation
50 – 200
300 - 3500
50
100 - 200
Doses greater than 200 micrograms are solely for use in anaesthesia.
As a premedicant, 1 - 2ml may be administered intramuscularly before
induction of anaesthesia.
Following intravenous administration in the non-premedicated adult
patient, 2ml fentanyl may be
anticipated to provide adequate analgesia for 10 – 20 minutes in
surgical procedures involving low pain
intensity. A bolus of 10ml of fentanyl can be expected to provide
analgesia for about one hour. The
analgesia produced is generally adequate for surgery involving
moderate pain intensity. Administration of
50 microgram/kg will provide intense analgesia for some four to six
hours for surge