BUPRELIEVE INJECTION

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv ingrediens:

BUPRENORPHINE PRESENT AS BUPRENORPHINE HYDROCHLORIDE

Tilgjengelig fra:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

buprenorphine as HCl(0.3mg/mL)

Legemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensetning:

BUPRENORPHINE PRESENT AS BUPRENORPHINE HYDROCHLORIDE ACTIVE Active 0.3 mg/ml

Enheter i pakken:

10mL

Klasse:

VM - Veterinary Medicine

Terapeutisk område:

ANAESTHETICS/ANALGESICS

Produkt oppsummering:

Poison schedule: 8; Withholding period: ; Host/pest details: CAT: [POST SURGICAL PAIN]; DOG: [POST SURGICAL PAIN]; HORSES: [ANALGESIC INJECTION (IN CONJUNCTION WITH SEDATIVE AGENT), POST SURGICAL PAIN]; Poison schedule: 8; Withholding period: WHP: N/A; Host/pest details: CAT: [POST SURGICAL PAIN]; DOG: [POST SURGICAL PAIN]; An analgesic injection for dogs & catsShould not be administered by the intrathecal or peridural route. CONTROLLED DRUG - POSSESSION WITHOUT AUTHORITY ILLEGAL. Should not be used pre-operatively for caesarian section. See Precautions on label also.

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

Product Name:
APVMA Approval
No:
BUPRELIEVE INJECTION
69057
/139310
Label Name:
BUPRELIEVE INJECTION
Signal Headings:
CONTROLLED DRUG
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
POSSESSION WITHOUT AUTHORITY ILLEGAL
READ SAFETY DIRECTIONS
Constituent
Statements:
0.3 mg/mL BUPRENORPHINE (AS HYDROCHLORIDE)
Claims:
An analgesic injection for dogs, cats and horses.
For the control of postoperative pain associated with surgical
procedures in dogs and
cats. It is intended that the first dose of buprenorphine is given as
part of a premedication
regimen prior to general anaesthesia and surgery.
For the relief of post-operative pain in the horse only in conjunction
with a sedative agent.
When used in horses, an intravenous sedative should be administered
within five minutes
prior to injection of buprenorphine.
Net Contents:
10 mL
Directions for Use:
Restraints:
DO NOT USE in horses that may be used for human consumption.
Contraindications:
This product should not be administered by the intrathecal or
peridural route.
This product should not be used pre-operatively for caesarean section.
Precautions:
Buprenorphine may cause respiratory depression, however this is
generally not clinically
significant. As with other opioid drugs, care should be taken when
treating animals with
impaired respiratory function or animals that are receiving drugs that
can cause respiratory
depression. RLP APPROVED
A margin of safety in dogs younger than 5 months and cats younger than
4 months has not
been established.
The effects of an opioid on head injury are dependent on the type and
severity of the injury
and the respiratory support supplied. Opioids generally should be used
with considerable
caution in patients with head injuries and instances of intra-cranial
pressure. The
product should be used in accordance with the risk-benefit assessment
of the attending
veterinarian.
Buprenophine should be used with caution in animals with impaired
liver function or bile
tract disease, as the substance is metabolised by the liver and its
int

Preparatomtale

BUPRELIEVE INJECTION
Page 1 of 6
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
27 NOVEMBER 2018
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
BUPRELIEVE INJECTION (CURRENTLY REGISTERED AND PREVIOUSLY
MARKETED AS BUPREDYNE INJECTION)
PRODUCT IDENTIFIER:
0.3 mg/mL Buprenorphine (as hydrochloride), an analgesic
injection for dogs and cats
PRODUCT CODE:
504410 (10 mL) – Bupredyne Injection
504411 (10 mL) – Buprelieve Injection
RECOMMENDED USE:
An analgesic injection for dogs and cats.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street,
Rutherford, NSW 2320
Australia
EMAIL:
[e-mail]
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (24 hrs)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS: This product has been assessed according
to GHS and is classified as non-
hazardous. However, buprenorphine hydrochloride is a potent narcotic
drug and is a Schedule 8 controlled
substance. Buprenorphine hydrochloride may cause physical and/or
psychological dependence, can harm the
developing foetus, and affects the central nervous system and
digestive system.
GHS LABEL ELEMENTS:
Signal word: None.
GHS Pictograms: None.
Precautionary statements: None.
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Buprenorphine hydrochloride
53152-21-9
0.032%
Ingredients not contributing to the
hazards
-
> 90%
BUPRELIEVE INJECTION
Page 2 of 6
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 4: FIRST AID MEASURES
GENERAL INFORMATION: Consult the National Poisons Centre on 13 1126 or
a doctor immediately in every case
of suspected chemical poisoning. Never give fluids or induce vomiting
if a patient is unconscious or
convulsing regardles

Sikkerhetsdatablad

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
BUPRELIEVE
®
Injection
ACTIVE CONSTITUENT
Buprenorphine 0.3 mg/mL
DESCRIPTION
A clear, colourless solution for injection containing 0.3 mg
buprenorphine per mL and presented in a multi-use amber injection
vial.
PHARMACOLOGY
Buprenorphine is a potent, long-acting analgesic acting at opiate
receptors in the central nervous system. Buprenorphine can
potentiate the effects of other centrally-acting agents, but unlike
most opiates, buprenorphine has, at clinical doses, only a limited
sedative effect of its own.
Buprenorphine exerts its analgesic effect via high affinity to various
subclasses of opiate receptors, particularly µ, in the central
nervous system. At clinical dose levels for analgesia, it binds to
opiate receptors with high affinity and high receptor avidity, such
that
its dissociation from the receptor site is slow, as demonstrated in
_in vitro_ studies. This unique property of buprenorphine could
account
for its longer duration of activity when compared to morphine. In
circumstances where excessive opiate agonist is already bound
to opiate receptors, buprenorphine can exert a narcotic antagonistic
activity as a consequence of its high-affinity opiate receptor
binding, such that an antagonistic effect on morphine equivalent to
naloxone has been demonstrated.
Buprenorphine has little effect on gastrointestinal motility.
PHARMACOKINETICS
When given parenterally, the product may be administered by
intramuscular or intravenous injection. Buprenorphine is rapidly
absorbed after intramuscular injection in various animal species and
man. The substance is highly lipophilic and the volume of
distribution in body compartments is large. Pharmacological effects
(e.g. miosis in dogs or mydriasis in cats) may occur within minutes
of administration and signs of sedation normally appear by 15 minutes.
Analgesic effects appear around 30 minutes with peak effects
usually being observed at about 1 – 1.5 hours. Dura