Citanest 0.5% 250mg/50mL injection vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

prilocaine hydrochloride, Quantity: 5 mg/mL

Boleh didapati daripada:

Aspen Pharmacare Australia Pty Ltd

Borang farmaseutikal:

Injection, solution

Komposisi:

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

Laluan pentadbiran:

Intramuscular, Intravenous, Peridural, Subcutaneous, Epidural

Unit dalam pakej:

50mL x 1, 50mL x 5

Kelas:

Medicine Registered

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

INDICATIONS AS AT 12 MARCH 1996: CITANEST solutions are indicated for the production of local or regional anaesthesia by infiltration techniques; intravenous regional anaesthesia; by peripheral nerve block techniques such as intercostal blocks; major plexus blocks such as brachial plexus blocks and by epidural and subarachnoid blocks.

Ringkasan produk:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

1991-08-13

Risalah maklumat

CITANEST
®
INJECTION
1
CITANEST
®
INJECTION
_Prilocaine hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
CITANEST. It does not contain all
the information that is known about
CITANEST.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of your being given
CITANEST against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CITANEST IS FOR
CITANEST is used to prevent or
relieve pain, before surgery or other
procedures. It will not put you to
sleep.
CITANEST is also used to make
childbirth less painful.
CITANEST belongs to a group of
medicines called local anaesthetics. It
is injected into the body where it
makes the nerves unable to pass
messages to the brain. Depending on
the amount used, CITANEST will
either totally stop pain or will cause a
partial loss of feeling.
CITANEST is sometimes combined
with Adrenaline to make it last
longer. Adrenaline makes the blood
vessels at the site of injection
narrower, which keeps the
CITANEST where it is needed for a
longer time.
Your doctor will have explained why
you are being treated with
CITANEST 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.
CITANEST is not addictive.
BEFORE YOU ARE GIVEN
CITANEST
_WHEN YOU MUST NOT USE IT _
CITANEST SHOULD NOT BE GIVEN TO
YOU WHILE YOU ARE PREGNANT
BECAUSE IT MAY HARM YOUR BABY'S
HEALTH.
IF YOU ARE BREASTFEEDING DO NOT USE
CITANEST UNLESS YOUR DOCTOR
SAYS SO. ASK YOUR DOCTOR ABOUT THE
RISKS AND BENEFITS OF BEING GIVEN
CITANEST WHILE YOU ARE
BREASTFEEDING.
It is not known if CITANEST
appears in breas

Ciri produk

1
AUSTRALIAN PRODUCT INFORMATION
CITANEST
®
(PRILOCAINE HYDROCHLORIDE)
INJECTION SOLUTIONS FOR THE PRODUCTION OF LOCAL OR REGIONAL
ANAESTHESIA
1
NAME OF THE MEDICINE
Prilocaine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in CITANEST is prilocaine hydrochloride.
CITANEST solution for injection contains the following inactive
ingredients: sodium chloride,
water for injection, hydrochloric acid and/or sodium hydroxide for pH
adjustment.
3
PHARMACEUTICAL FORM
All CITANEST solutions are clear and colourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CITANEST
solutions
are
indicated
for
the
production
of
local
or
regional
anaesthesia
by
infiltration techniques; intravenous regional anaesthesia; by
peripheral nerve block techniques
such as intercostal blocks; major plexus blocks such as brachial
plexus blocks and by epidural and
subarachnoid blocks.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The lowest dosage that results in effective anaesthesia should be used
and should be based on the
status of the patient and the type of regional anaesthesia intended.
The product contains no antimicrobial preservative. An ampoule or
single dose vial should be
used on one patient on one occasion only. Solutions showing
discolouration and unused portions
of solutions from single dose vials and ampoules should be discarded.
ADULTS
Table 1. Recommended dosages for CITANEST plain solutions for various
anaesthetic procedures
in the average, healthy, 70 kg adult patient.
PROCEDURE
CONCENTRATION
%
VOLUME ML
PLAIN
INFILTRATION
0.5
80
1.0
40
2.0
20
INTRAVENOUS REGIONAL
Upper Extremities
0.5
40 - 60
Lower Extremities
0.5
60 - 80
PLEXUS NERVE BLOCKS
2
Brachial
2.0
20
PERIPHERAL NERVE BLOCKS
Intercostal
1.0
-
Paravertebral
1.0
3 - 5
Sciatic femoral
2.0
20
PROCEDURE
CONCENTRATION
%
VOLUME ML
PLAIN
EPIDURAL*
THORACIC
1.0
10 - 20
Analgesia
1.0
30
Anaesthesia
2.0
20
CAUDAL
Analgesia
1.0
30
Anaesthesia
2.0
20
* Dose determined by number of segments to be anaesthetised (2-3
mL/segment)
NOTE:
1.
RECOMMENDED DOS