Citanest Plain

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

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Preparatomtale Preparatomtale (SPC)
27-06-2019

Aktiv ingrediens:

Prilocaine hydrochloride 2%; Prilocaine hydrochloride 20 mg/mL

Tilgjengelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Prilocaine hydrochloride 2%

Dosering :

2 %

Legemiddelform:

Solution for injection

Sammensetning:

Active: Prilocaine hydrochloride 2% Excipient: Sodium chloride Sodium hydroxide Water for injection Active: Prilocaine hydrochloride 20 mg/mL Excipient: Hydrochloric acid as 2M solution for pH adjustment (pH 5-7) Methyl hydroxybenzoate Sodium chloride Sodium hydroxide as 2M solution for pH adjustment (pH 5-7) Water for injection

Enheter i pakken:

Polyamp, 10x5ml Duofit., 50 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Siegfried Evionnaz SA

Produkt oppsummering:

Package - Contents - Shelf Life: Polyamp, 5ml Duofit. - 10 dose units - 24 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

1969-12-31

Preparatomtale

                                C
ITANEST
Data Sheet
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
C
ITANEST
®
solution for injection
Prilocaine hydrochloride 0.5%, 2.0%
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Citanest contains 5mg or 20mg of prilocaine hydrochloride per 1mL
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Citanest solution for injection is a sterile, isotonic aqueous
solution. The pH of the
solution is 5.0-7.0. The single dose vials and Polyamps® are free
from preservatives
and are intended for single use only.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Citanest solutions are indicated for the production of local or
regional anaesthesia by
the following techniques:
•
local infiltration
•
minor and major nerve blocks
•
epidural block
•
arthroscopy
•
intravenous regional anaesthesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Care should be taken to prevent toxic reactions by avoiding
intravascular injection.
Careful aspiration before and during the injection is recommended.
When a large
dose is to be injected, e.g. in epidural block, a test dose of 3-5 mL
of prilocaine
containing adrenaline is recommended. An accidental intravascular
injection may be
recognised by a temporary increase in heart rate. The main dose should
be injected
slowly, at a rate of 100-200 mg/min, or in incremental doses, while
keeping in
constant verbal contact with the patient. If toxic symptoms occur, the
injection
should be stopped immediately.
In general, surgical anaesthesia (e.g. epidural administration)
requires the use of the
higher concentrations and doses. When a less intense block is
required, the use of
a lower concentration is indicated. The volume of local anaesthetic
used will affect
the extent of spread of anaesthesia.
For
a
more
prolonged
effect,
an
indwelling
catheter,
through
which
the
local
anaesthetic may be injected, can be used. This technique is common in
epidural
anaesthesia and may also be used in brachial plexus anaesthesia and
interpleural
analgesia.
C
ITANEST
Data Sheet
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