Sublimaze

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fentanyl citrate 78.5 µg/mL equivalent to 50 µg/mL fentanyl

Available from:

Seed Pharma Limited

INN (International Name):

Fentanyl citrate 78.5 µg/mL (=50 µg/mL fentanyl)

Dosage:

50 mcg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Fentanyl citrate 78.5 µg/mL equivalent to 50 µg/mL fentanyl Excipient: Sodium chloride Water for injection

Units in package:

Ampoule, glass, 20mL, 20 mL

Class:

Class B3 Controlled Drug

Prescription type:

Class B1 Controlled Drug

Manufactured by:

Janssen Pharmaceutica NV

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, - 20 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, (10 x 2mL) - 20 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, (5 x 10mL) - 50 mL - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1969-12-30

Patient Information leaflet

SUBLIMAZE
®
INJECTION
1
SUBLIMAZE
®
INJECTION
_Fentanyl _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SUBLIMAZE
injection. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving
SUBLIMAZE against the benefits
this medicine is expected to have
for you.
If you have any concerns about
receiving SUBLIMAZE, ask
your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT SUBLIMAZE
IS USED FOR
SUBLIMAZE injection is used to
provide short-term pain relief and to
help anaesthesia when you have an
operation. It is a strong painkiller
for use in hospitals.
SUBLIMAZE injection contains a
medicine called fentanyl. It belongs
to a group of medicines known as
opioid analgesics. Fentanyl relieves
pain by blocking the nerves in the
brain that recognise pain messages
from the body.
Your doctor may have prescribed
SUBLIMAZE for another
reason. Ask your doctor if you
have any questions about why
this medicine has been
prescribed for you.
SUBLIMAZE may be addictive.
Addiction is unlikely in patients
who receive it under medical
supervision.
You may be at more risk of
addiction if:
•
You or someone in your family
have a history of drug and
alcohol abuse or mental illness
•
You require repeated injections of
SUBLIMAZE
•
You need increasingly larger
doses of SUBLIMAZE to control
your pain.
BEFORE YOU ARE GIVEN
SUBLIMAZE
_WHEN YOU MUST NOT BE GIVEN _
_SUBLIMAZE _
SUBLIMAZE should not be used:
•
if you have an allergy or known
intolerance to fentanyl, other
strong pain killers or any of the
ingredients at the end of this
leaflet - see Product Description
for a list of ingredients.
•
if you suffer from asthma
•
if you have taken a type of
medicine known as monoamine
oxidase inhibitors (MAOIs)
within the last 14 days. These
include phenelzine, moclobemide
and tranylcypromine (f

Summary of Product characteristics

1
SUBLIMAZE
®
FENTANYL CITRATE
DAT
A SHEET
1.
PRODUCT NAME
SUBLIMAZE
®
fentanyl 50 micrograms/mL injection
2.
QUALITATIVE AND QUANTITATTIVE COMPOSITION
Each 1 mL of solution contains 78.5 micrograms fentanyl citrate
equivalent to 50 micrograms 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 indicated in adults and children aged above two years
for:
•
analgesic action of short duration during anaesthetic periods,
premedication, induction and
maintenance, and in the immediate post-operative period (recovery
room) as the need arises;
•
use as an opioid analgesic supplement in general and regional
anaesthesia;
•
administration with a neuroleptic such as droperidol injection as an
anaesthetic premedication,
for the induction of anaesthesia, and as an adjunct in the maintenance
of general and regional
anaesthesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Dosage should be individualised. Some of the factors to be considered
in determining the dose are:
age, body weight, physical status, underlying pathological condition,
use of other medicines, type of
anaesthesia to be used, and the surgical procedure involved.
USUAL DOSAGE IN ADULTS
1.
PREMEDICATION (To be appropriately modified in the elderly,
debilitated and those who have
received other depressant medicines)
50 to 100 micrograms (1 to 2 mL) may be administered intramuscularly
30 to 60 minutes prior to
2
surgery.
2.
ADJUNCT TO GENERAL ANAESTHESIA
INDUCTION - 50 to 100 micrograms (1 to 2 mL) may be administered
initially intravenously and
may be repeated at 2 to 3 minute intervals until the desired effect is
achieved. A reduced dose
as low as 25 to 50 micrograms (0.5 to 1 mL) is recommended in elderly
and poor-risk patients.
MAINTENANCE - 25 to 50 micrograms (0.5 to 1 mL) may be administered
intravenously or
intramuscularly when movement and/or changes in vital signs indicate
surgic