CITANEST 1% POLYAMP DUOFIT prilocaine hydrochloride 50mg/5mL injection BP ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prilocaine hydrochloride, Quantity: 10 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Intravenous, Peridural, Subcutaneous, Epidural

Units in package:

10 x 5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: A clear colourless, particle free solution.; Container Type: Ampoule; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1996-05-02

Summary of Product characteristics

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