Marcain 0.25% solution for injection 10ml Polyamp Steripack ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bupivacaine hydrochloride

Available from:

Aspen Pharma Trading Ltd

ATC code:

N01BB01

INN (International Name):

Bupivacaine hydrochloride

Dosage:

2.5mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous; Epidural

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5014162002937 5000455019805

Patient Information leaflet

Page 1 of 7
Package leaflet: Information for the user
Marcain
®
Polyamp Steripack 0.25% and 0.5%
bupivacaine hydrochloride
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 Marcain Polyamp Steripack is and what it is used for
2. What you need to know before Marcain Polyamp Steripack is given to
you
3. How Marcain Polyamp Steripack is given to you
4. Possible side effects
5. How to store Marcain Polyamp Steripack
6. Contents of the pack and other information
1.
What Marcain Polyamp Steripack is and what it is used for
Marcain Polyamp Steripack contains a medicine called bupivacaine
hydrochloride. It belongs to a
group of medicines called local anaesthetics.
Marcain Polyamp Steripack 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.
2.
What you need to know before Marcain Polyamp Steripack is given to
you
You must not be given Marcain Polyamp Steripack:
Page 2 of 7

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 cl

Summary of Product characteristics

OBJECT 1
MARCAIN POLYAMP STERIPACK 0.25%
Summary of Product Characteristics Updated 07-Feb-2017 | Aspen
1. Name of the medicinal product
Marcain Polyamp Steripack 0.25%.
2. Qualitative and quantitative composition
Bupivacaine Hydrochloride BP 2.64 mg/ml equivalent to bupivacaine
hydrochloride anhydrous 2.5
mg/ml.
Excipient(s) with known effect:
Each millilitre (ml) of Marcain Polyamp Steripack contains 3.15 mg of
sodium, equivalent to 31.4 mg per
10 ml ampoule.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Injection.
4. Clinical particulars
4.1 Therapeutic indications
Marcain 0.25% and 0.5% solutions are used for the production of local
anaesthesia by percutaneous
infiltration, peripheral nerve block(s) and central neural block
(caudal or epidural), that is, for specialist
use in situations where prolonged anaesthesia is required. Because
sensory nerve block is more marked
than motor block, Marcain is especially useful in the relief of pain,
e.g. during labour.
Marcain 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.
The suggested dose and strength of solution appropriate for each
indication are provided in Section 4.2.
4.2 Posology and method of administration
POSOLOGY
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 consulted for
factors affecting specific block techniques and for individual patient
requirements.
N.B. When prolonged blocks are used, either by continuous infusion or
by repeated bolus administration,
the risks of reaching a toxic plasma concentration or inducing a local
neural injury must be considered.
The clinician's experience and knowledge of the patient's physical
status is important in calculating the
required dose. The lowest dose required for adequate anaesthesia
should