Bupivacaine 2.5 mg / mL Solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bupivacaine hydrochloride, anhydrous

Available from:

Noridem Enterprises Limited

ATC code:

N01BB01

INN (International Name):

Bupivacaine hydrochloride, anhydrous

Dosage:

2.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

bupivacaine

Authorization status:

Not marketed

Authorization date:

2021-05-14

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
THIS MEDICINE IS GIVEN TO YOU 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 or nurse.
-
If you get any side effects, talk to
your doctor or nurse. This includes
any possible side effects not listed
in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Bupivacaine is and what it is
used for
2.
What you need to know before
Bupivacaine is given to you
3.
How Bupivacaine is given
4.
Possible side effects
5.
How to store Bupivacaine
6.
Contents of the pack and other
information
1.
WHAT BUPIVACAINE IS AND WHAT IT
IS USED FOR
Bupivacaine contains the active
substance bupivacaine hydrochloride. It
belongs to a group of medicines called
amide-type local anaesthetics.
This medicine 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
BUPIVACAINE IS GIVEN TO YOU
YOU MUST NOT BE GIVEN BUPIVACAINE
•
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 injection will be given.
•
if you have something called
cardiogenic shock (a condition
where the heart is unable to supply
enough blood to the body).
•
if you have something called
hypovolaemic shock (very low blood
pressure leading to collapse).
•
if you have problems with clotting of
your blood (coagulation disorder) or
ongoing anticoagulation treatment.
•
if you have diseases of the brain or
spine such as meningitis, polio or
spondylitis.
•
if you have a severe headache
caused by bleeding in

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2022
CRN00CPQR
Page 1 of 12
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 anhydrous.
Each 5-mL ampoule contains bupivacaine hydrochloride monohydrate
equivalent to 12.5 mg bupivacaine hydrochloride
anhydrous.
Each 10-mL ampoule contains bupivacaine hydrochloride monohydrate
equivalent to 25 mg bupivacaine hydrochloride
anhydrous.
Each 20-mL ampoule contains bupivacaine hydrochloride monohydrate
equivalent to 50 mg bupivacaine hydrochloride
anhydrous.
Excipient with known effect:
Each mL of Bupivacaine 2.5 mg / mL Solution contains 0.144 mmol (3.31
mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
pH: 4.0-6.5
Osmolality: 270 – 320 mOsm/kg
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