Fentanyl Citrate 500 micrograms in 10 ml Solution for Injection

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

FENTANYL

Dostupno od:

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

ATC koda:

N01AH01

INN (International ime):

FENTANYL 50 µg/ml

Farmaceutski oblik:

SOLUTION FOR INJECTION

Sastav:

FENTANYL 50 µg/ml

Tip recepta:

POM

Područje terapije:

ANESTHETICS

Status autorizacije:

Withdrawn

Datum autorizacije:

2006-08-31

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENTANYL 100 MICROGRAMS IN 2ML SOLUTION FOR
INJECTION
FENTANYL 500 MICROGRAMS IN 10ML 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.
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 THIS MEDICINE IF:
• you are allergic to Fentanyl citrate or any of the other
ingredients of this medicine (listed in section 6).
• you are allergic to strong pain relievers such as morphine
• you have any problems that affect your breathing such as asthma,
chronic bronchitis or
emphysema
• you are taking monoami

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fentanyl 500 micrograms in 10 ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml ampoule contains 500 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
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