Bupivacaine 100mg/100ml (0.1%) infusion bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bupivacaine hydrochloride

Available from:

0.1%) infusion bags (Advanz Pharma

ATC code:

N01BB01

INN (International Name):

Bupivacaine hydrochloride

Dosage:

1mg/1ml

Pharmaceutical form:

Infusion

Administration route:

Epidural

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5099602902541

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Bupivacaine Hydrochloride 0.1% w/v
Solution for Infusion, Bupivacaine
Hydrochloride 0.125% w/v Solution for Infusion. It will be referred to
as Bupivacaine Hydrochloride
Infusion Solution for ease hereafter.
In this leaflet:
1. What Bupivacaine Hydrochloride Infusion Solution is and what it is
used for
2. Before you are given Bupivacaine Hydrochloride Infusion Solution
3. How Bupivacaine Hydrochloride Infusion Solution is given to you
4. Possible side effects
5. How to store Bupivacaine Hydrochloride Infusion Solution
6. Further information
1. WHAT BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION IS AND
WHAT IT IS USED FOR
Bupivacaine belongs to a group of medicines called amide-type
anaesthetics.
Bupivacaine Hydrochloride solution for infusion 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.
Bupivacaine Hydrochloride Infusion Solution may be used to prevent or
give prolonged relief of pain
when it is injected around the spinal cord, e.g. as an epidural in
labour or after a surgical operation.
2. BEFORE YOU ARE GIVEN BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION
YOU SHOULD NOT BE GIVEN THIS MEDICINE IF:
• you know you are allergic to bupivacaine or to any other
amide-type of local anaesthetic, or to any
of the other ingredients (see Section 6 of this leaflet)
• you are to be injected in a vein of the

Summary of Product characteristics

OBJECT 1
BUPIVACAINE HYDROCHLORIDE 0.1%W/V SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 28-Nov-2012 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Bupivacaine Hydrochloride 0.1%w/v Solution for Infusion
2. Qualitative and quantitative composition
Each 100ml contains anhydrous bupivacaine hydrochloride 0.10g
equivalent to 0.1055g of bupivacaine
hydrochloride.
For excipients, see 6.1
3. Pharmaceutical form
Solution for Infusion
4. Clinical particulars
4.1 Therapeutic indications
Bupivacaine Hydrochloride Infusion Solution 0.1% w/v may be used:
1) for continuous infusion lumbar epidural analgesia to relieve pain
during labour
2) for continuous infusion epidural analgesia to control postoperative
pain
4.2 Posology and method of administration
Route of Administration: Epidural infusion.
Bupivacaine Hydrochloride Infusion Solution should only be used by, or
under the supervision of,
clinicians experienced in regional anaesthesia.
Every precaution should be taken to avoid accidental intravascular
administration; careful aspiration is
essential. Prior to commencing a continuous epidural infusion,
satisfactory epidural block should be
established with test and loading doses of local anaesthetic. A test
dose containing adrenaline is
recommended, since an intravascular injection of an
adrenaline-containing solution may be recognised by
an increase in heart rate. A test dose of 7.5mg of bupivacaine 0.25%
(3ml) or 10mg of bupivacaine 0.5%
(2ml) containing adrenaline may be used. Verbal contact with the
patient and repeated measurements of
heart rate (ECG) should be maintained following the test dose.
Aspiration should be repeated prior to
administration of the loading dose and before starting the infusion.
Epidural block can usually be
established with test and loading doses (total volume 8 – 12ml of
bupivacaine 0.25%) and sufficient time
should be allowed to confirm that a satisfactory block has been
established before commencing the
infusion. If symptoms of toxicity or signs