Bupivacaine Hydrochloride 0.25% w/v Solution for Injection

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

BUPIVACAINE HYDROCHLORIDE

Предлага се от:

Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

АТС код:

N01BB01

INN (Международно Name):

BUPIVACAINE HYDROCHLORIDE 2.5 mg/ml

Лекарствена форма:

SOLUTION FOR INJECTION

Композиция:

BUPIVACAINE HYDROCHLORIDE 2.5 mg/ml

Вид предписание :

POM

Терапевтична област:

ANESTHETICS

Каталог на резюме:

Licence number in the source country: NOT APPLICAPABLE

Статус Оторизация:

Authorised

Дата Оторизация:

2021-09-17

Листовка

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

Данни за продукта

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 10ml of sterile solution for injection contains Bupivacaine
Hydrochloride Equivalent to
25mg of Anhydrous Bupivacaine Hydrochloride (2.5 mg in 1ml)
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.
Individual variations in onset and duration occur. For young, elderly