Bupivacaine Accord Solution for Injection 2.5mg/ml (10ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUPIVACAINE HYDROCHLORIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

N01BB01

INN (International Name):

BUPIVACAINE HYDROCHLORIDE 2.5 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BUPIVACAINE HYDROCHLORIDE 2.5 mg/ml

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Withdrawn

Authorization date:

2015-12-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPIVACAINE ACCORD 2.5 MG/ML SOLUTION FOR INJECTION
BUPIVACAINE ACCORD 5 MG/ML SOLUTION FOR INJECTION
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
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 Accord is and what it is used
for
2. What you need to know before Bupivacaine Accord is given to you
3. How to use Bupivacaine Accord
4. Possible side
ef
fects
5. How to store Bupivacaine Accord
6. Contents of the pack and other information
1. WHAT BUPIVACAINE ACCORD IS AND WHAT IT IS USED FOR
Bupivacaine Accord contains the active substance bupivacaine
hydrochloride. It belongs to a group
of medicines called amide-type local anaesthetics.
Bupivacaine Accord 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 ACCORD IS GIVEN TO YOU
YOU MUST NOT BE GIVEN BUPIVACAINE ACCORD:
•
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 hav

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Bupivacaine Accord 2.5 mg/ml solution for injection
Bupivacaine Accord 5 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mg/ml:
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)
5 mg/ml:
Each ml contains 5 mg bupivacaine hydrochloride (as monohydrate)
Each 2 ml contains 10 mg bupivacaine hydrochloride (as monohydrate)
Each 4 ml contains 20 mg bupivacaine hydrochloride (as monohydrate)
Each 5 ml contains 25 mg bupivacaine hydrochloride (as monohydrate)
Each 10 ml contains 50 mg bupivacaine hydrochloride (as monohydrate)
Each 20 ml contains 100 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.
Each ml of Bupivacaine 5 mg/ml solution for injection contains 0.14
mmol (3.2 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 an