Bupivacaine Accord Solution for Injection 5mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUPIVACAINE HYDROCHLORIDE

Available from:

Accord Healthcare Limited

ATC code:

N01BB01

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BUPIVACAINE HYDROCHLORIDE 5 mg/ml

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Authorised

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 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 Accord is and what it is used
for
2. What you need to know before you use Bupivacaine Accord
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
You must talk to a doctor if you do not feel better or if you feel
worse after {number of} days
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUPIVACAINE ACCORD
DO NOT USE 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

Summary of Product characteristics

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.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 fi