Sublimaze 500micrograms/10ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl citrate

Available from:

Piramal Critical Care Ltd

ATC code:

N01AH01

INN (International Name):

Fentanyl citrate

Dosage:

50microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010403; GTIN: 5012674067345

Patient Information leaflet

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUBLIMAZE
®
50 micrograms/ml solution for injection or infusion
Fentanyl 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 for:

Short operations, where you go home on the same day

Longer operations where 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. During major operations, it is used
together with a
sedative known as a neuroleptic to put you to sleep. It can also be
used to
relieve severe pain such as during a heart attack.
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 depr

Summary of Product characteristics

OBJECT 1
SUBLIMAZE
Summary of Product Characteristics Updated 20-Jun-2017 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Sublimaze
2. Qualitative and quantitative composition
Each 1ml of solution contains 78.5 micrograms fentanyl citrate
equivalent to 50 micrograms per ml
fentanyl base.
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.
4. Clinical particulars
4.1 Therapeutic indications
Sublimaze is an opioid analgesic used:
a. In low doses to provide analgesia during short surgical procedures.
b. In high doses as an analgesic/respiratory depressant in patients
requiring assisted ventilation.
c. In combination with a neuroleptic in the technique of
neuroleptanalgesia.
d. In the treatment of severe pain, such as the pain of myocardial
infarction
4.2 Posology and method of administration
_Route of administration_
Intravenous administration either as a bolus or by infusion.
Intramuscular 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).
To avoid bradycardia, it is recommended to administer a small
intravenous dose of an anti-cholinergic
just before anaesthetic induction.
It is recommended to wear gloves while opening the ampoule (see
section 6.6 Special precautions for
disposal and other handling).
_Posology_
Sublimaze, by the intravenous route, can be administered to both
adults and children. The dose of
Sublimaze should be individualised according to age, body weight,
physical status, underlying
pathological condition, use of other drugs and type of surgery and
anaesthesia.
_Adults _
The usual dosage regimen in adults is as follows:
Initial
Supplemental
Spontaneous Respiration
50-200 mcg
50 mcg
Assisted Ventilation
300-3500 mcg
100-200 mcg
Doses in excess of 200 mcg are for use in anaesthesia only. As a
premedicant, 1-2 ml Sublimaze may be
given intramuscularly 45 minutes