Bupivacaine-Baxter

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Bupivacaine hydrochloride monohydrate 2.5 mg/mL

Saatavilla:

Baxter Healthcare Ltd

INN (Kansainvälinen yleisnimi):

Bupivacaine hydrochloride monohydrate 2.5 mg/mL

Annos:

0.25 %

Lääkemuoto:

Solution for injection

Koostumus:

Active: Bupivacaine hydrochloride monohydrate 2.5 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Kpl paketissa:

Vial, glass, single dose, clear Type I, 20 mL, with synthetic bromobutyl rubber stopper; 1 vial in a carton, 20 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Moehs Catalana SL

Käyttöaiheet:

Surgical anaesthesia - Epidural block for surgery

Tuoteyhteenveto:

Package - Contents - Shelf Life: Vial, glass, single dose, clear Type I, 20 mL, with synthetic bromobutyl rubber stopper; 1 vial in a carton - 20 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Clarion 1 site 30 months from date of manufacture stored at or below 30°C protect from light. Clarion 2 site - Vial, glass, single dose, clear Type I, 10 mL, with synthetic bromobutyl rubber stopper; 5 vials in a blister tray and carton - 50 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Clarion 1 site 30 months from date of manufacture stored at or below 30°C protect from light. Clarion 2 site - Vial, glass, single dose, clear Type I, 20 mL, with synthetic bromobutyl rubber stopper; 5 vials in a carton - 100 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Clarion 1 site 30 months from date of manufacture stored at or below 30°C protect from light. Clarion 2 site

Valtuutus päivämäärä:

2012-01-09

Valmisteyhteenveto

NEW ZEALAND DATA SHEET
BUPIVACAINE‐BAXTER Data Sheet 9 April 2019
Page 1 of 12
Baxter Healthcare Ltd
1 BUPIVACAINE‐BAXTER (solution for injection)
Bupivacaine‐Baxter 0.25% (2.5mg/mL) solution for injection.
Bupivacaine‐Baxter 0.5% (5mg/mL) solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
There are four presentations in two concentrations and two vial sizes:
-
2.5mg/mL (0.25%)
Bupivacaine Hydrochloride Ph Eur 25mg in 10mL and 50mg in 20mL
-
5mg/mL (0.5%)
Bupivacaine Hydrochloride Ph Eur 50mg in 10mL and 100mg in 20mL.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Bupivacaine‐Baxter is a clear, colourless, particle‐free, sterile,
isotonic, pH adjusted solution of
Bupivacaine Hydrochloride Ph Eur conforming to Bupivacaine Injection
BP.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Production of local or regional anaesthesia and analgesia in
individuals as follows:
-
Surgical anaesthesia: epidural block for surgery; field block (minor
and major nerve blocks and
infiltration).
-
Analgesia: continuous epidural infusion or intermittent bolus epidural
administration for analgesia
in postoperative pain or labour pain; field block (minor nerve block
and infiltration).
The choice of four presentations i.e. 25mg in 10mL, 50mg in 20mL, 50mg
in 10mL and 100mg in 20mL
makes it possible to vary the degree of motor blockade.
4.2
Dose and method of administration
As with all local anaesthetics, the dosage varies and depends upon the
area to be anaesthetised, the
vascularity of the tissues, the number of neuronal segments to be
blocked, the depth of anaesthesia
and degree of muscle relaxation required, individual tolerance, the
technique of anaesthesia and the
physical condition of the patient.
The lowest dosage that results in effective anaesthesia should be
used. In general, surgical
anaesthesia requires the use of higher concentrations and doses than
those required for analgesia.
The volume of medicine used will affect the extent of spread of
anaesthesia.
Bupivacaine‐