Bupivacaine Hydrochloride 0.25% w/v Solution for Injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Bupivacaine hydrochloride

可用日期:

Mercury Pharmaceuticals (Ireland) Ltd

ATC代码:

N01BB; N01BB01

INN（国际名称）:

Bupivacaine hydrochloride

剂量:

0.25 percent weight/volume

药物剂型:

Solution for injection

处方类型:

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

治疗领域:

Amides; bupivacaine

授权状态:

Marketed

授权日期:

1988-01-21

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPIVACAINE HYDROCHLORIDE 0.25% W/V SOLUTION FOR INJECTION AND
BUPIVACAINE HYDROCHLORIDE 0.5% W/V SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or
nurse.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Bupivacaine Hydrochloride 0.25%w/v
solution for Injection and 0.5%
w/v solution for injection. It will be referred to as Bupivacaine
Injection for ease hereafter.
What is in this leaflet:
1.
What Bupivacaine Injection is and what it is used for
2.
What you need to know before you take Bupivacaine Injection
3.
How to take Bupivacaine Injection
4.
Possible side effects
5.
How to store Bupivacaine Injection
6.
Contents of the pack and other information
1. WHAT BUPIVACAINE INJECTION IS AND WHAT IT IS USED FOR
Bupivacaine Hydrochloride is a local anaesthetic; it produces loss of
feeling or sensation that is confined
to one part of the body. Bupivacaine belongs to a group of medicines
called amide type local
anaesthetics.
Bupivacaine Injection is used to numb (anaesthetise) parts of the
body. It is used to stop pain happening
or to provide pain relief. It can be used to:
- numb parts of the body during surgery in adults and children above
12 years -
relieve pain in adults, infants and children above 1 year of age
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPIVACAINE INJECTION
DO NOT TAKE BUPIVACAINE INJECTION IF:
You are allergic (hypersensitive) to bupivacaine hydrochloride or any
of the other ingredients of
Bupivacaine Injection
(see Section 6: Further information).
•
you are allergic to

产品特点

Health Products Regulatory Authority
17 October 2019
CRN0093HL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bupivacaine Hydrochloride 0.25% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of sterile solution for injection contains Bupivacaine
Hydrochloride equivalent to 25 mg of Anhydrous Bupivacaine
Hydrochloride (2.5 mg in 1 ml)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A colourless or almost colourless sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
● Surgical anaesthesia in adults and children above 12 years of age
● Acute pain management in adults, infants and children above 1 year
of age
The suggested dose and strength of solution appropriate for each
indication are provided in Section 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Routes of administration: Infiltration by injection. Epidural. Caudal.
Posology
The dosage varies and depends upon the area to be anaesthetised, the
vascularity of the tissues, the number of neuronal
segments to be blocked, individual tolerance and the technique of
anaesthesia used. The lowest dosage needed to provide
effective anaesthesia should be administered. For most indications,
the duration of anaesthesia with bupivacaine solutions is
such that a single dose is sufficient.
The maximum dosage must be determined by evaluating the size and
physical status of the patient and considering the usual
rate of systemic absorption from a particular injection site.
Experience to date indicates a single dose of up to 150 mg
bupivacaine hydrochloride. Doses of up to 50 mg 2-hourly may
subsequently be used. A maximum dose of 2 mg/kg should
not be exceeded in any four-hour period.
When prolonged blocks are used, either by continuous infusion or by
repeated bolus administration, the risks of reaching a
toxic plasma concentration must be considered.
The dosages in the following table are recommended as a guide for use
in the average adult.