Fentanyl 100 micrograms in 2 ml Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FENTANYL

Available from:

Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATC code:

N01AH01

INN (International Name):

FENTANYL 50 µg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FENTANYL 50 µg/ml

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Authorised

Authorization date:

2006-08-31

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

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:
Use in children:
Analgesia during operation, enhancement of anaesthesia with
spontaneous respiration.
Techniques that involve analgesia in a spontaneous breathing child
should only