DBL PETHIDINE HYDROCHLORIDE 50mg/1mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pethidine hydrochloride, Quantity: 50 mg

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Pethidine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium hydroxide

Administration route:

Subcutaneous, Intravenous, Intramuscular

Units in package:

5x50mg/1mL(E), 50x50mg/1mL(E), 5x50mg/1mL, 50x50mg/1mL

Prescription type:

Not scheduled. Not considered by committee, (S8) Controlled Drug

Therapeutic indications:

DBL Pethidine Hydrochloride Injection is indicated for the short-term (24 to 36 hours) management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. It can be given via the following routes of administration: intramuscular, subcutaneous, slow intravenous bolus injection, intravenous infusion and patient controlled analgesia (PCA).,DBL Pethidine Hydrochloride Injection is also indicated for administration as an anaesthetic adjunct and for obstetric analgesia.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-12-15

Patient Information leaflet

DBL™ PETHIDINE HYDROCHLORIDE INJECTION
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING TREATED WITH DBL PETHIDINE HYDROCHLORIDE INJECTION?
DBL Pethidine Hydrochloride Injection contains the active ingredient
pethidine hydrochloride. DBL Pethidine Hydrochloride Injection
is a pain killer that belongs to a group of medicines called opioid
analgesics. It is most commonly used to relieve severe pain. It may
also be used just before, or during, an operation, to help the
anaesthetic work better.
For more information, see Section 1. Why am I being treated with DBL
Pethidine Hydrochloride Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL PETHIDINE HYDROCHLORIDE
INJECTION?
Do not use if you have ever had an allergic reaction to pethidine or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before
treatment with DBL Pethidine Hydrochloride Injection? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Pethidine Hydrochloride
Injection and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DBL PETHIDINE HYDROCHLORIDE INJECTION GIVEN?
Your doctor will decide what dose of pethidine you will receive. This
depends on your condition and other factors, such as your age
and weight.
More instructions can be found in Section 4. How is DBL Pethidine
Hydrochloride Injection given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH DBL PETHIDIN

Summary of Product characteristics

Version: pfppethi10722
Supersedes: pfppethi10520
Page 1 of 24
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
PETHIDINE
HYDROCHLORIDE
INJECTION (PETHIDINE HYDROCHLORIDE)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, DBL Pethidine
Hydrochloride
Injection should only be used in patients for whom other treatment
options, including non-
opioid
analgesics,
are
ineffective,
not
tolerated
or
otherwise
inadequate
to
provide
appropriate management of pain (see Section 4.4 Special warnings and
precautions for use).
_HAZARDOUS AND HARMFUL USE _
DBL Pethidine Hydrochloride Injection poses risks of hazardous and
harmful use which can
lead to overdose and death. Assess the patient’s risk of hazardous
and harmful use before
prescribing and monitor the patient regularly during treatment (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 DBL
Pethidine Hydrochloride Injection . Be aware of situations which
increase the risk of
respiratory depression, modify dosing in patients at risk and monitor
patients closely,
especially on initiation or following a dose increase (see Section 4.4
Special warnings and
precautions for use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, _
_INCLUDING ALCOHOL _
Concomitant
use
of
opioids
with
CNS
depressants
medicines,
such
as
other
opioid
analgesics,
benzodiazepines,
gabapentinoids,
cannabis,
sedatives,
hypnotics,
tricyclic
antidepressants,
antipsychotics,
antihistamines,
centrally-active
anti-emetics,
general
anaesthetics, tranquilisers, or other central nervous system (CNS)
depressants, including
alcohol, may result in profound sedation, respiratory depression,
coma, and death. Limit
dosages and durations to the minimum required; and monitor patients
for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
using DBL Pethidine Hydrochlo