Buprenorphine Naloxone BNM

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Buprenorphine hydrochloride 8.64mg (equiv 8 mg buprenorphine);  ;  ; Naloxone hydrochloride dihydrate 2.44mg (equiv 2 mg naloxone);  

から入手可能:

Boucher & Muir (New Zealand) Limited t/a BNM Group

医薬品形態:

Sublingual tablet

構図:

Active: Buprenorphine hydrochloride 8.64mg (equiv 8 mg buprenorphine)     Naloxone hydrochloride dihydrate 2.44mg (equiv 2 mg naloxone)   Excipient: Acesulfame potassium Citric acid monohydrate Lactose monohydrate Lemon flavour SD01600158 Lime flavour SD01620018 Magnesium stearate Maize starch Mannitol Povidone Sodium citrate

処方タイプ:

Class C4 Controlled Drug

適応症:

Treatment of opiate dependence, within a framework of medical, social and psychological treatment. Naloxone is included to deter intravenous misuse of the product.

製品概要:

Package - Contents - Shelf Life: Blister pack, Polyamide/aluminium/PVC and aluminium foil, in cardboard carton - 28 tablets - 24 months from date of manufacture stored at or below 30°C

承認日:

2017-07-17

情報リーフレット

BUPRENORPHINE NALOXONE BNM
1
BUPRENORPHINE
NALOXONE BNM
SUBLINGUAL TABLETS
_Buprenorphine Hydrochloride - Naloxone Hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before
you
are
given
BUPRENORPHINE
NALOXONE
BNM.
This
leaflet
answers
some
common
questions
about
BUPRENORPHINE
NALOXONE
BNM.
It
does
not
contain
all
the
available information. The most up-
to-date
Consumer
Medicine
Information can be downloaded from
www.medsafe.govt.nz.
Reading this
leaflet
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
BUPRENORPHINE
NALOXONE
BNM
against
the
benefits
you
may
gain
and
he/she
believes it will help in your treatment.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT
BUPRENORPHINE
NALOXONE BNM IS
USED FOR
BUPRENORPHINE
NALOXONE
BNM is used as part of a medical,
social
and
psychological
treatment
program for patients’ dependent on
opioids like heroin, morphine,
oxycodone or codeine.
BUPRENORPHINE
NALOXONE
BNM is used to help such patients to
regain control over their lives.
BUPRENORPHINE
NALOXONE
BNM
tablets
contain
the
active
ingredients
buprenorphine
hydrochloride
and
naloxone
hydrochloride. Buprenorphine acts as
a substitute for opioids like heroin and
it helps withdrawal from opioids over
a
period
of
time.
When
taken
sublingually
(under
the
tongue)
as
prescribed, naloxone has no effect, as
it is very poorly absorbed.
However,
if
BUPRENORPHINE
NALOXONE
BNM
is
injected,
naloxone will act to block the effects
of
other
opioids
like
heroin,
methadone or morphine, leading to
bad withdrawal symptoms. Therefore,
naloxone
is
included
in
BUPRENORPHINE
NALOXONE
BNM
to
discourage
misuse
by
injection, as it can cause very bad
withdrawal symptoms.
BUPRENORPHINE
NALOXONE
BNM
should
be
used
exactly
as
prescribed by your doctor.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS

製品の特徴

1
BUPRENORPHINE NALOXONE BNM
BUPRENORPHINE NALOXONE 2MG/0.5MG AND 8MG/2MG SUBLINGUAL TABLETS
Page
1
of
24
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
BUPRENORPHINE NALOXONE BNM
2mg/0.5mg and 8mg/2mg sublingual tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BUPRENORPHINE NALOXONE BNM 2mg/0.5mg
Each sublingual tablet contains buprenorphine hydrochloride 2.16mg
(equivalent to 2mg
buprenorphine)
naloxone
hydrochloride
dihydrate
0.61mg
(equivalent
to
0.5mg
naloxone).
Excipient 42mg of lactose monohydrate per tablet
BUPRENORPHINE NALOXONE BNM 8mg/2mg
Each sublingual tablet contains buprenorphine hydrochloride 8.64mg
(equivalent to 8mg
buprenorphine) naloxone hydrochloride dihydrate 2.44mg (equivalent to
2mg naloxone).
Excipient 168mg of lactose monohydrate per tablet
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
BUPRENORPHINE NALOXONE BNM 2mg/0.5mg -
White to off-white, round and
biconvex tablets, with embossing “L” on one side and a diameter of
about 6.5mm.
BUPRENORPHINE NALOXONE BNM 8mg/2mg - White to off-white, round and
biconvex tablets, with embossing “H” on one side and a diameter of
about 11.5mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of opioid dependence, within a framework of medical, social
and psychological
treatment. Naloxone is included in BUPRENORPHINE NALOXONE BNM to deter
intravenous misuse of the product.
2
BUPRENORPHINE NALOXONE BNM
BUPRENORPHINE NALOXONE 2MG/0.5MG AND 8MG/2MG SUBLINGUAL TABLETS
Page
2
of
24
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment with BUPRENORPHINE NALOXONE BNM sublingual tablets is
intended
for adults and children aged 16 years or over who have agreed to be
treated for opioid
dependence. When initiating BUPRENORPHINE NALOXONE BNM treatment, the
physician should be aware of the partial agonist profile of the
molecule to the μ opioid
receptors, which can precipitate withdrawal in opioid-dependent
patients if given too soon
after the administration of heroin, methadone or another opioid. To
avoid precipi