NAROPIN 0.5% ropivacaine hydrochloride 100mg/20mL injection ampoule

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

ropivacaine hydrochloride, Quantity: 5 mg/mL

Verfügbar ab:

Aspen Pharmacare Australia Pty Ltd

Darreichungsform:

Injection, solution

Zusammensetzung:

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

Verabreichungsweg:

Epidural, Infiltration, Intracutaneous, Intradermal, Intramuscular, Intraneural, Subcutaneous, Mucosal

Einheiten im Paket:

5 x 20mL

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Surgical anaesthesia (Adults and children over 12 years of age) Epidural block for surgery including caesarean section. Intrathecal anaesthesia. Field block (minor nerve block and infiltration). Major nerve block. Analgesia (Adults and children over 12 years of age) Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. Field block (minor nerve block and infiltration). Continuous peripheral nerve block infusion or intermittent injections for post operative pain management. Analgesia (Children aged 0-12 years). Caudal epidural block in neonates (>37 weeks gestation and over 2500g weight), infants and children up to and including 12 years. Continuous epidural infusion in infants (>30 days and over 2500g weight) and children up to and including 12 years. Peripheral nerve block in children aged 1 up to and including 12 years. For peri- and postoperative pain management. There are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).

Produktbesonderheiten:

Visual Identification: A clear, colourless solution.; Container Type: Ampoule; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Berechtigungsstatus:

Registered

Berechtigungsdatum:

1996-01-30

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
(INJECTION SOLUTIONS FOR THE PRODUCTION OF LOCAL OR REGIONAL
ANAESTHESIA)
1
NAME OF THE MEDICINE
Ropivacaine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in NAROPIN
®
is ropivacaine hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Injection, solution
A clear colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SURGICAL ANAESTHESIA (ADULTS AND CHILDREN OVER 12 YEARS OF AGE)
−
epidural block for surgery including caesarean section
−
intrathecal anaesthesia
−
field block (minor nerve block and infiltration)
−
major nerve block
ANALGESIA (ADULTS AND CHILDREN OVER 12 YEARS OF AGE)
−
continuous epidural infusion or intermittent bolus epidural
administration for
analgesia in postoperative pain or labour pain
−
field block (minor nerve block and infiltration)
−
continuous peripheral nerve block infusion or intermittent injections
for post-
operative pain management
−
continuous wound infusion for postoperative pain management (adults
only)
ANALGESIA (CHILDREN AGED 0 - 12 YEARS)
−
Caudal epidural block in neonates (> 37 weeks gestation and over 2500
g weight),
infants and children up to and including 12 years
−
Continuous epidural infusion in infants (> 30 days and over 2500 g
weight) and
children up to and including 12 years
−
Peripheral nerve block in children aged 1 up to and including 12 years
For peri- and postoperative pain management.
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
2
There are no safety or efficacy data to support the use of NAROPIN for
analgesia for longer than
72 hours. (Data for peripheral nerve block administered as a
continuous peripheral infusion or
intermittent injections and for continuous wound infusion support the
use for up to 48 hours
only).
4.2
D
OSE AND METHOD OF ADMINISTRATION
NAROPIN should only be used by or under the supervision of clinicians
experienced in regional
anae