Ropivacaine 2 mg/ml solution for injection

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

ROPIVACAINE HYDROCHLORIDE

Disponible desde:

Mercury Pharmaceuticals Ltd

Código ATC:

N01BB; N01BB09

Designación común internacional (DCI):

ROPIVACAINE HYDROCHLORIDE

Dosis:

2 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Amides; ropivacaine

Estado de Autorización:

Not marketed

Fecha de autorización:

2012-02-17

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ropivacaine 2 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution for injection contains 2 mg ropivacaine
hydrochloride.
Each 10 ml ampoule contains 20 mg ropivacaine hydrochloride.
Each 20 ml ampoule contains 40 mg ropivacaine hydrochloride.
Excipient(s) with known effect:
Each 10 ml ampoule contains 1.47 mmol (or 33.9 mg) of sodium.
Each 20 ml ampoule contains 2.95 mmol (or 67.8 mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless, sterile, isotonic, isobaric aqueous solution for
injection with a pH of 4.0 to 6.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ropivacaine 2 mg/ml solution for injection is indicated for acute pain
management :
In adults and children above 12 years of age :
•
Continuous epidural infusion or intermittent bolus administration
during postoperative or labour pain
•
Field blocks
•
Continuous peripheral nerve block via a continuous infusion or
intermittent bolus injections, e.g. postoperative
pain management
•
In infants from 1 year and children up to and including 12 years for :
•
Single and continuous peripheral nerve block
•
In neonates, infants and children up to and including 12 years for
(per-and postoperative)
•
Caudal epidural block
•
Continuous epidural infusion
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ropivacaine should only be used by, or under the supervision, of
clinicians experienced in regional anaesthesia.
POSOLOGY
_ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE_
The following table is a guide to dosage for the more commonly used
blocks. The smallest dose required to produce an
effective block should be used. The clinician's experience and
knowledge of the patient's physical status are of
importance when deciding the dose.
INDICATION
CONCENTRATION
VOLUME
DOSE
ONSET
DURATION
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