MARCAIN POLYAMP STERIPACK 0.25 %w/v Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUPIVACAINE HYDROCHLORIDE

Available from:

AstraZeneca UK Limited

ATC code:

N01BB01

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

Dosage:

0.25 %w/v

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Amides

Authorization status:

Transfer Pending

Authorization date:

1998-09-19

Patient Information leaflet

BODY TEXT SIZE
12.0 pt
SMALLEST TEXT SIZE
6.0 pt
469361-A02
13-04-15
PS05209
AZL033/A
6337
RR
Marcain 2.5mg/ml; 5mg/ml 
Leaflet: Patient IE
Black
Technical Info
Profile
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:
•  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.
You must not be given this medicine if any of 
the above apply to you. If you are not sure, talk 
to your doctor or nurse

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Marcain Polyamp Steripack 0.25% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bupivacaine hydrochloride equivalent to bupivacaine hydrochloride anhydrous 0.25%.
Excipient(s) with known effect:
Also contains sodium chloride 8 mg/ml equivalent to sodium 3.2 mg/ml (0.14 mmol)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
A clear, colourless, aqueous, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
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. The lowest dosage needed to
provide effective anaesthesia should be administered. For most indications, the duration of anaesthesia with Marcain
solutions is such that a single dose is sufficient.
The maximum dosage must be determined by evaluating the size and physical status of the patient and considering the
usual rate of systemic absorption from a particular injection site. 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.
When prolonged blocks are used, either by continuous infusion or by repeated bolus administration, the risks of
reaching a toxic plasma concentrat