SUBLOCADE buprenorphine 100 mg/0.5 mL modified release solution for injection pre-filled syringe (with needle)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

buprenorphine, Quantity: 100 mg

Available from:

Indivior Pty Ltd

Pharmaceutical form:

Injection, modified release

Composition:

Excipient Ingredients: N-methyl-2-pyrrolidone; polyglactin

Administration route:

Subcutaneous

Units in package:

One pack contains a single (1) pre-filled syringe plus (1) 19G 16 mm sterile needle

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

SUBLOCADE is indicated for maintenance treatment of opioid dependence, within a framework of medical, social and psychological treatment.

Product summary:

Visual Identification: Colourless to amber, clear, viscous solution in a pre-filled syringe; Container Type: Syringe; Container Material: Plastic; Container Life Time: 21 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-07-18

Patient Information leaflet

SUBLOCADE
®
_Buprenorphine_
CONSUMER MEDICINE INFORMATION
WARNINGS:
Risk of serious harm or death with intravenous administration
Serious harm or death could result if administered intravenously.
SUBLOCADE forms a solid mass upon contact with body
fluids and may cause occlusion, local tissue damage, and
thrombo-embolic events, including life threatening pulmonary
emboli, if administered intravenously.
Hazardous and harmful use
Although SUBLOCADE is indicated for the treatment of opioid
dependence, it still poses risks of hazardous and harmful
use which can lead to overdose and death. The doctor will monitor your
ongoing risk during treatment with SUBLOCADE.
Life threatening respiratory depression
Serious, life-threatening respiratory depression may occur with the
use of SUBLOCADE. Talk to your doctor about situa-
tions which may increase the risk of respiratory depression.
Concomitant use of medicines affecting the central nervous system,
including alcohol
Use of SUBLOCADE with anti-anxiety medicines, sedatives,
antihistamines, some antidepressants, antipsychotics, cannabis
and alcohol may result in profound sedation, respiratory depression,
coma and death.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about SUBLOCADE. 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 taking
SUBLOCADE against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
SUBLOCADE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IS SUBLOCADE
USED FOR?
SUBLOCADE is used as part of a
medical, social and psychological
treatment program for patients
dependent on opioids like heroin,
morphine, oxycodone or codeine.
SUBLOCADE is used to help
patients overcome this medical
condition. SUBLOCADE is used
after patients started treatment with a
buprenorphine-containing product.
SUBLOCADE modified release
injection conta

Summary of Product characteristics

Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
SUBLOCADE (BUPRENORPHINE)
1
NAME OF THE MEDICINE
SUBLOCADE 100 mg/0.5 mL buprenorphine modified release solution for
injection.
SUBLOCADE 300 mg/1.5 mL buprenorphine modified release solution for
injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Buprenorphine is dissolved in the ATRIGEL® Delivery System at 18% by
weight.
0.5 mL modified release injection solution in a prefilled syringe
contains 100 mg buprenorphine (as
buprenorphine base).
1.5 mL modified release injection solution in a prefilled syringe
contains 300 mg buprenorphine (as
buprenorphine base).
Buprenorphine is a white to cream, crystalline powder, very slightly
soluble in water (<1 mg/mL).
Chemically, buprenorphine is
(2_S_)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-
6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol.
Buprenorphine has the molecular formula C
29
H
41
NO
4
and the molecular weight is 467.6.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SUBLOCADE is a modified release solution for injection.
WARNINGS:
_RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION_
Serious harm or death could result if administered intravenously.
SUBLOCADE forms a solid mass upon
contact with body fluids and may cause occlusion, local tissue damage
and thrombo‐embolic events,
including life threatening pulmonary emboli, if administered
intravenously. (see section 4.4).
_HAZARDOUS AND HARMFUL USE _
Although SUBLOCADE is indicated for the treatment of opioid dependence
it still poses risks of hazardous
and harmful use which can lead to overdose and death. Monitor the
patient’s ongoing risk of hazardous and
harmful use regularly during opioid substitution therapy with
SUBLOCADE (see section 4.4. Special Warnings
and Precautions for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life‐threatening or fatal respiratory depression may occur
with the use of SUBLOCADE. Be aware of
situations which increase the risk of respirato