Lidocaine-Baxter

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Lidocaine hydrochloride monohydrate 10.66 mg/mL equivalent to Lidocaine hydrochloride 10.0 mg/ml

Beszerezhető a:

Baxter Healthcare Ltd

INN (nemzetközi neve):

Lidocaine hydrochloride monohydrate 10.66 mg/mL (= Lidocaine hydrochloride 10.0 mg/ml)

Adagolás:

1% w/v

Gyógyszerészeti forma:

Solution for injection

Összetétel:

Active: Lidocaine hydrochloride monohydrate 10.66 mg/mL equivalent to Lidocaine hydrochloride 10.0 mg/ml Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection

db csomag:

Ampoule, glass, 5ml clear, Ph. Eur. Type 1, in blister sheets of 5 ampoules in carton of 5 sheets, 25 dose units

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

Moehs Catalana SL

Terápiás javallatok:

Lidocaine solutions are indicated for the production of local or regional anaesthesia by the following techniques: local infiltration; minor or major nerve blocks; epidural block; arthroscopy; intravenous regional anaesthesia.

Termék összefoglaló:

Package - Contents - Shelf Life: Ampoule, glass, 5ml clear, Ph. Eur. Type 1, in blister sheet of 5 ampoules packed in carton - 5 dose units - 48 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze - Ampoule, glass, 5ml clear, Ph. Eur. Type 1, in blister sheets of 5 ampoules in carton of 5 sheets - 25 dose units - 48 months from date of manufacture stored at or below 25°C - Ampoule, glass, 2ml clear, Ph. Eur. Type 1, in blister sheets of 5 ampoules in carton of 5 sheets - 25 dose units - 48 months from date of manufacture stored at or below 25°C - Vial, glass, 20 ml clear Ph. Eur Type 1, grey bromobutyl stopper unit packed in carton - 1 dose units - 48 months from date of manufacture stored at or below 25°C - Vial, glass, 20 ml clear Ph. Eur Type 1, grey bromobutyl stopper unit packed in carton - 5 dose units - 48 months from date of manufacture stored at or below 25°C

Engedély dátuma:

2012-01-24

Termékjellemzők

NEW ZEALAND DATA SHEET
LIDOCAINE‐BAXTER Data Sheet 11 March 2020
Page 1 of 13
Baxter Healthcare Ltd
1 LIDOCAINE‐BAXTER (solution for infusion)
Lidocaine‐Baxter 1% w/v solution for injection.
Lidocaine‐Baxter 2% w/v solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient _
Lidocaine‐Baxter 1% w/v: Lidocaine hydrochloride monohydrate
10.66mg/mL (= Lidocaine
hydrochloride 10.0mg/mL).
Lidocaine‐Baxter 2% w/v: Lidocaine hydrochloride monohydrate
21.32mg/mL (= Lidocaine
hydrochloride 20.0mg/mL).
Note: Lidocaine is another name for lignocaine. Lidocaine is mostly
used in this document.For the full
list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
_Appearance _
Lidocaine‐Baxter is a clear, colourless, particle‐free, sterile,
isotonic, pH adjusted solution of Lidocaine
hydrochloride Ph Eur conforming to Lidocaine Injection BP.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Lidocaine solutions are indicated for the production of local or
regional anaesthesia by the following
techniques: local infiltration; minor or major nerve blocks; epidural
block; arthroscopy; intravenous
regional anaesthesia.
4.2
Dose and method of administration
_Adults and children above 12 years _
The following table is a guide to dosage for the more commonly used
techniques in the average adult.
The figures reflect the expected average dose range needed. Standard
textbooks should be consulted
for factors affecting specific block techniques and for individual
patient requirements.
The clinician's experience and knowledge of the patient's physical
status are of importance in
calculating the required dose. The lowest dose required for adequate
anaesthesia should be used
(see section 4.4). Individual variations in onset and duration occur.
Table 1 Dosage recommendations
Type of block
Concentration
(mg/mL)
Dose
Onset (min)
Duration of
effect (h)
(mL)
(mg)
SURGICAL ANAESTHESIA
Lumbar epidural
administration [1]
20
15 to 25
300 to 500
15 to 20
1.5 to 2
Thoracic epidural
admi