PETHIDINE JUNO pethidine injection BP 100mg/2mL ampoule

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

pethidine hydrochloride, Quantity: 50 mg/mL

Dostopno od:

Juno Pharmaceuticals Pty Ltd

Farmacevtska oblika:

Injection, solution

Sestava:

Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid

Pot uporabe:

Subcutaneous, Intramuscular, Intravenous

Enote v paketu:

2mL x 10, 2mL x 5, 2mL x 50

Tip zastaranja:

(S8) Controlled Drug

Terapevtske indikacije:

INDICATIONS AS AT 18 MAY 2020: 1. The short-term 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. 2. Pre-operative medication. 3. Analgesic adjunct in general anaesthesia. 4. Obstetric analgesia.

Povzetek izdelek:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Registered

Datum dovoljenje:

2020-09-28

Navodilo za uporabo

PETHIDINEJUNO
Page: 1
PETHIDINE JUNO INJECTION
_Pethidine hydrochloride _
_ _
CONSUMER MEDICINE INFORMATION
WARNINGS
_ _
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, pethidine
should only be used when your doctor
decides that other treatment options are not able to effectively
manage your pain or you cannot tolerate them.
_ _
_HAZARDOUS AND HARMFUL USE _
Pethidine poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will
monitor you regularly during treatment.
_ _
_LIFE THREATENING RESPIRATORY DEPRESSION _
Pethidine can cause life-threatening or fatal breathing problems
(slow, shallow, unusual or no breathing),
even when used as recommended. These problems can occur at any time
during use, but the risk is higher
when first starting pethidine, after a dose increase, if you are
older, or have an existing problem with your
lungs. Your doctor will monitor you and change the dose as
appropriate.
_ _
_USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS)
DEPRESSANTS, INCLUDING ALCOHOL _
Using pethidine with other medicines that can make you feel drowsy
such as sleeping tablets (e.g.
benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentinoids (e.g.
gabapentin and pregabalin), cannabis and alcohol may result in severe
drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will minimize the dose
and duration of use; and monitor
you for signs and symptoms of breathing difficulties and sedation. You
must not drink alcohol while using
pethidine.
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about Pethidine Juno. It does not
contain all the information that is
known about pethidine.
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 being
given
pethidine
against
the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEIN

Lastnosti izdelka

Australian Product Information
Product Information v2.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_ _
_PETHIDINE JUNO (PETHIDINE HYDROCHLORIDE) _
WARNINGS
_ _
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, pethidine
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 _
Pethidine 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 pethidine.
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 benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis 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 taking pethidine.
1 NAME OF THE MEDICINE
Pethidine hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mL sterile solution of pH 3.5 – 6.0 containing 100 mg of pethidine
hydrochloride (50 mg/mL).
Excipients with known effect: none.
For the full list of excipie