SUBLIMAZE 50 Microgram/ML Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FENTANYL CITRATE

Available from:

Janssen-Cilag Ltd

ATC code:

N01AH01

INN (International Name):

FENTANYL CITRATE

Dosage:

50 Microgram/ML

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Opioid anesthetics

Authorization status:

Authorised

Authorization date:

1997-06-10

Patient Information leaflet

1
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 depres

Summary of Product characteristics

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 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.
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