Marcain Polyamp Steripack 0.5% w/v Solution for Injection

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Bupivacaine hydrochloride

Disponibil de la:

Aspen Pharma Trading Limited

Codul ATC:

N01BB; N01BB01

INN (nume internaţional):

Bupivacaine hydrochloride

Dozare:

0.5 percent weight/volume

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Amides; bupivacaine

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1988-09-19

Prospect

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
MARCAIN POLYAMP STERIPACK 0.25% W/V AND 0.5% W/V SOLUTION FOR
INJECTION
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 Polyam
p
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 before you are given this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before having Marcain Polyamp

Caracteristicilor produsului

Health Products Regulatory Authority
19 April 2023
CRN00DGML
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Marcain Polyamp Steripack 0.5% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bupivacaine hydrochloride equivalent to bupivacaine hydrochloride
anhydrous 5.0mg/ml.
Excipient(s) with known effect: sodium (31.47 mg per 10 ml ampoule and
62.94 mg per 20 ml ampoule).
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

A
cute 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 concentration must be considered.
The dosages in the following table are recommended as a guide for use
in the average adult. Individual variations in onset and
duration occur. For you