Marcain 0.5% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Adrenaline tartrate; BUPIVACAINE HYDROCHLORIDE

Tersedia dari:

Aspen Pharma Trading Limited

Kode ATC:

N01BB; N01BB51

INN (Nama Internasional):

Adrenaline tartrate; BUPIVACAINE HYDROCHLORIDE

Dosis:

0.5%/0.55% percent volume/volume

Bentuk farmasi:

Solution for injection

Jenis Resep:

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

Area terapi:

Amides; bupivacaine, combinations

Status otorisasi:

Not marketed

Tanggal Otorisasi:

1988-05-31

Selebaran informasi

Page 1 of 18
PACKAGE LEAFLET: INFORMATION FOR THE USER
MARCAIN 0.25% W/V AND 0.5% W/V WITH ADRENALINE
(EPINEPHRINE, 5 MICROGRAMS PER ML) (1:200,000) SOLUTION FOR INJECTION
bupivacaine hydrochloride anhydrous, adrenaline (epinephrine)
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 with adrenaline is and what it is used for
2.
What you need to know before Marcain with adrenaline is given to you
3.
How Marcain with adrenaline is given to you
4.
Possible side effects
5.
How to store Marcain with adrenaline
6.
Contents of the pack and other information
1.
WHAT MARCAIN WITH ADRENALINE IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Marcain 0.25% w/v and 0.5% w/v with
Adrenaline
(Epinephrine, 5 micrograms per ml) (1:200,000) Solution for
Injection’. It is referred to as
‘Marcain with adrenaline’ in the rest of this leaflet.
Marcain with adrenaline contains two different medicines: bupivacaine
hydrochloride and
adrenaline (epinephrine). Each of these works in a different way.

Bupivacaine hydrochloride belongs to a group of medicines called local
anaesthetics.
These medicines numb (anaesthetise) parts of the body.

Adrenaline belongs to a group of medicines called vasoconstrictors.
These medicines
make the blood vessels where the injection is given narrower. This
means you will bleed
less and the effects of the medicine will last longer.
MARCAIN 0.5% W/V WITH ADRENALINE is used in adults and children above
12 years 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.

Relieve pain.
MARCAIN 0.25% W/V WITH ADRENA

Karakteristik produk

Health Products Regulatory Authority
20 July 2022
CRN00CZCW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Marcain 0.5% w/v with Adrenaline (Epinephrine, 5 micrograms per ml)
(1:200,000) Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains bupivacaine hydrochloride equivalent to anhydrous
bupivacaine hydrochloride 5.0 mg per ml (100 mg per
20 ml single dose vial) and Adrenaline Tartrate (epinephrine
bitartrate) equivalent to adrenaline (epinephrine) 5 micrograms
per ml (100 micrograms per 20 ml single dose vial).
Excipient(s) with known effect: sodium metabisulphite (0.5 mg/ml,
equivalent to 10 mg per 20 ml single dose vial), sodium (in
total 3.2 mg/ml , equivalent to 64.1 mg per 20 ml single dose vial),
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, aqueous, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Marcain 0.5% w/v with Adrenaline is indicated for:
- Surgical anaesthesia in adults and children above 12 years of age
- Acute pain management in adults and children above 12 years of age.
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. For young, elderly or debilitated
patients, these doses should be reduced.
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 be used.
Individual variations in onset and du