CITANEST 2% POLYAMP DUOFIT prilocaine hydrochloride 100mg/5mL injection BP ampoule

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

prilocaine hydrochloride, Quantity: 20 mg/mL

Commercializzato da:

Aspen Pharmacare Australia Pty Ltd

Forma farmaceutica:

Injection, solution

Composizione:

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

Via di somministrazione:

Epidural, Intramuscular, Intravenous, Peridural, Subcutaneous

Confezione:

10 x 5mL

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

CITANEST Solutions are indicated for the production of local or regional anaesthesia by infiltration techniques; intravenous regional anesthesia; by peripheral nerve block techniques such as intercostal blocks; major plexus blocks such as brachial plexus blocks and by epidural and subarachnoid blocks.

Dettagli prodotto:

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

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

1996-05-02

Scheda tecnica

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