Sublimaze 50 micrograms/ml, Solution for Injection

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

FENTANYL CITRATE

Disponible depuis:

Piramal Critical Care Limited

Code ATC:

N01AH; N01AH01

DCI (Dénomination commune internationale):

FENTANYL CITRATE

Dosage:

50 microgram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

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

Domaine thérapeutique:

Opioid anesthetics; fentanyl

Statut de autorisation:

Marketed

Date de l'autorisation:

1997-06-10

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUBLIMAZE
®
50 MICROGRAMS/ML SOLUTION FOR INJECTION
Fentanyl (as citrate)
Sublimaze is a registered trademark
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. 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 Sublimaze is and what it is used for
2 What you need to know before you are given Sublimaze
3 How Sublimaze is given
4 Possible side effects
5 How to store Sublimaze
6 Contents of the pack and other information
1 WHAT SUBLIMAZE IS AND WHAT IT IS USED FOR
Sublimaze contains a medicine called fentanyl citrate. It belongs to a
group of
medicines called ‘opioid analgesics’. Sublimaze is a strong
painkiller that works
for a short period of time.
Sublimaze is used to prevent or relieve pain during different types of
surgery. It
can be:
•
Used alone for short operations, when you go home on the same day
•
Used with other medicines (anaesthetics) to put you to sleep for
longer
operations when you may stay in hospital for a number of days
High doses of Sublimaze are also used to lower your natural breathing
rate
when you are on a ventilator (a machine to help you breathe). During
major
operations, it is used with a sedative known as a neuroleptic to put
you to sleep.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SUBLIMAZE
DO NOT HAVE SUBLIMAZE IF:
•
You are allergic to anything in Sublimaze (listed in section 6 below)
•
You are allergic to other strong medicines for pain called ‘opioid
analgesics’
•
You suffer from breathing difficulties called ‘obstructive airways
disease’ or
‘respiratory depressi

Résumé des caractéristiques du produit

Health Products Regulatory Authority
23 November 2018
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Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sublimaze 50 micrograms/ml, Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 78.5 micrograms fentanyl citrate
equivalent to 50
micrograms fentanyl base.
Ampoule of 2ml contains 100 micrograms of fentanyl.
Ampoule of 10ml contains 500 micrograms of fentanyl.
Excipient(s) with known effect:
Sodium 3.5 mg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection. (Injection)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the maintenance of general anaesthesia and analgesia.
In conjunction with a neuroleptic agent in the technique of
neuroleptanalgesia.
As a respiratory depressant/analgesic in patients requiring prolonged
assisted
ventilation.
As the sole intravenous anaesthetic agent in surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 Special
warnings and
precautions).
The dosage of fentanyl should be individualised according to age, body
weight,
physical status, underlying pathological condition, use of other
drugs, and type of
surgery and anaesthesia.
Techniques that involve analgesia in a spontaneously breathing child
should only be
used as part of an anaesthetic technique, or given as part of a
sedation/ analgesia
technique, with experienced personnel in an environment that can
manage sudden
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23 November 2018
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Page 2 of 14
chest wall rigidity requiring intubation, or apnoea requiring airway
support (see
section 4.4).
It is recommended to wear gloves while opening the ampoule (see
section 6.6
Special precautions for disposal and other handling).
_Method of administration: _
For intravenous administration.
_Posology: _
As an adjunct in the maintenance of general anaes