Bupivacaine 2.5 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bupivacaine hydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N01BB; N01BB01

INN (International Name):

Bupivacaine hydrochloride

Dosage:

2.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Amides; bupivacaine

Authorization status:

Marketed

Authorization date:

2017-05-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPIVACAINE 2.5 MG/ML SOLUTION FOR INJECTION
BUPIVACAINE 5 MG/ML SOLUTION FOR INJECTION
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or pharmacist.
-
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. This
includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:.
1. What Bupivacaine solution for injection is and what it is used
for
2. What you need to know before you use Bupivacaine solution for
injection
3. How to use Bupivacaine solution for injection
4. Possible side
ef
fects
5. How to store Bupivacaine solution for injection
6. Contents of the pack and other information
1. WHAT BUPIVACAINE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Bupivacaine solution for injection contains the active substance
bupivacaine hydrochloride. It belongs
to a group of medicines called
amide-
type local anaesthetics.
Bupivacaine solution for 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 during childbirth.
•
Relieve pain in adults, infants and children above 1 year of age
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUPIVACAINE SOLUTION FOR
INJECTION
DO NOT USE BUPIVACAINE SOLUTION FOR INJECTION:
•
if you are allergic to bupivacaine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)
•
if you are allergic to any other local anaesthetics of the same class
(such as lidocaine or
ropivacaine).
•
if you have a skin infection near to where the

Summary of Product characteristics

Health Products Regulatory Authority
30 October 2019
CRN0099C3
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bupivacaine 2.5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2.5 mg bupivacaine hydrochloride (as monohydrate)
Each 5 ml contains 12.5 mg bupivacaine hydrochloride (as monohydrate)
Each 10 ml contains 25 mg bupivacaine hydrochloride (as monohydrate)
Each 20 ml contains 50 mg bupivacaine hydrochloride (as monohydrate)
Excipient with known effect:
Each ml of Bupivacaine 2.5 mg/ml solution for injection contains 0.15
mmol (3.4 mg) of sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless or almost colourless solution.
The pH of solution is 4.0 to 6.5.
Osmolality of solution is 270 - 320 mOsmol/kg H2O
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bupivacaine is indicated for:
● Surgical anaesthesia in adults and children above 12 years of age
● Acute pain management in adults, infants and children above 1 year
of age
Bupivacaine is used for the production of prolonged local anaesthesia
by percutaneous infiltration, intra-articular block,
peripheral nerve block(s) and central neural block (caudal or
epidural), Bupivacaine is also used for pain relief during labour.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
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.
ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE
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
consult