Pethidine Injection BP 100mg/2mL ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pethidine hydrochloride

Available from:

Juno Pharmaceuticals Pty Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

PETHIDINE INJECTION BP
Page: 1
PETHIDINE INJECTION
BP
_Pethidine Hydrochloride _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
of
the
common questions people ask about
Pethidine. 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
taking
Pethidine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PETHIDINE IS FOR
Pethidine is a powerful drug used to
relieve pain and produce sleepiness.
It
can
be
used
for
the
short-term
management of severe pain or it can
be used before painful operations to
reduce the pain that you feel. It can
also be used during childbirth to ease
the pain of contractions.
Pethidine
belongs
to
a
group
of
medicines
called
opioid
(narcotic)
analgesics.
Pethidine
works
by
changing
the
pain messages that are sent to the
brain.
Your
doctor
will
have
explained
why
you
are
being
treated
with
pethidine
and
told you
what
dose
you will be given.
_ _
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They
may
differ
from
the
information contained in this leaflet.
Your
doctor
may
prescribe
this
medicine for another use.
ASK YOUR DOCTOR IF YOU WANT MORE
INFORMATION.
Pethidine can be addictive. The risk
of addiction is increased in people
with a history of substance abuse or
mental
illness.
The
risk
also
increases the longer the drug is used
and with higher doses. However, it
is also important to keep your pain
under
control.
Your
doctor
can
advise you on how to best manage
this.
This medicine is only available with
a doctor’s prescription.
BEFORE
YOU
ARE
GIVEN
PETHIDINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
THIS MEDICINE MUST NOT BE GIVEN TO
YOU
IF
YOU
HAVE
AN
ALLERGY
TO
PETHIDINE OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an

Summary of Product characteristics

1 of 11
AUSTRALIAN PRODUCT INFORMATION
PETHIDINE INJECTION BP
(PETHIDINE HYDROCHLORIDE)
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 excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Injection solution. Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of moderate to severe pain not responsive to non-opioid
analgesics.
Pre-operative medication.
Analgesic adjunct in general anaesthesia.
Obstetrical analgesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Pethidine hydrochloride may be administered by subcutaneous,
intramuscular or slow intravenous
injection. Pethidine Injection BP contains no antimicrobial agent. It
should be used only once and
any residue discarded.
For intravenous administration the dosage should be decreased and the
injection administered very
slowly as a dilute solution. When pethidine is given parenterally,
especially by the intravenous
route, the patient should be lying down. While the subcutaneous route
is suitable for occasional
use, intramuscular administration is preferred for repeated doses.
When administered intravenously, an opioid antagonist and facilities
for assisted or controlled
respiration should be immediately available during and following the
injection.
ADULT
Analgesia: 25 to 100 mg by SC or IM injection or 25 to 50 mg by slow
IV injection every 3 to 4
hours (see Section 4.4 Special warnings and precautions for use).
2 of 11
The dose should be adjusted according to the severity of pain and the
response of the patient.
Dosage reduction may be necessary in the elderly.
PREMEDICATION
50 to 100 mg by SC or IM injection or 25 to 50 mg by slow IV injection
(see Section 4.4 Special
warnings and precautions for use).
OBSTETRIC ANALGESIA
50 to 100 mg by SC or IM injection at intervals of 1 to 3 hours if
necessary. Up to 3 doses may be
given in 24 hours.
RENAL

Summary of Product characteristics

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PRODUCT INFORMATION
LEUCOVORIN CALCIUM INJECTION
Calcium folinate as equivalent to folinic acid 50 mg/5 mL, 100 mg/10
mL
NAME OF THE MEDICINE
Non-proprietary name: calcium folinate
Chemical name: calcium 5-formyl-tetrahydropteroylglutamate
CAS Number: 1492-18-8
The empirical formula is C
20
H
21
CaN
7
O
7
, xH
2
O and the molecular weight 511.5 (anhydrous)
The structural formula is:
Ca
2+
, xH
2
O
H
C
COO
-
CH
2
CH
2
COO
-
N
N
N
N
H
2
N
OH
C
H
CH
2
NH
C
NH
H
O
O
DESCRIPTION
Leucovorin Calcium Injection is a sterile, isotonic, clear, yellowish,
preservative-free solution
containing calcium folinate 54 mg in 5 mL (equivalent to 50 mg folinic
acid) and 108 mg in
10 mL (equivalent to 100 mg folinic acid), with sodium chloride in
water for injections.
Calcium folinate potency is usually expressed in terms of equivalent
units of folinic acid.
Calcium folinate is a white or light yellow, amorphous or crystalline
powder, sparingly
soluble in water and practically insoluble in acetone and ethanol.
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PHARMACOLOGY
MECHANISM OF ACTION
CLASS: Antidote for folic acid antagonists.
MECHANISM OF ACTION: Folinic acid (leucovorin) is the 5-formyl
derivative of tetrahydrofolic
acid (THF), the active form of folic acid. Folinic acid as a co-factor
participates in many
metabolic
reactions
including
purine
synthesis,
pyrimidine
synthesis
and
amino
acid
conversion. Calcium
folinate is used in
cytotoxic therapy
as
an antidote to folic acid
antagonists (such as methotrexate), which block conversion of folic
acid to tetrahydrofolate
by binding the enzyme dihydrofolate reductase.
PHARMACOKINETICS
_DISTRIBUTION _
Following administration, calcium folinate enters the general body
pool of reduced folates. It
has been reported that, following intravenous and intramuscular
administration, peak serum
levels of total reduced folates are achieved within a mean time of 10
minutes and 52 minutes
respectively. Peak levels of 5-formyl T