MARCAIN 0.25/0.5%w %v/v Solution for Injection

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE

から入手可能:

AstraZeneca UK Limited

ATCコード:

N01BB51

INN（国際名）:

BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE

投薬量:

0.25/0.5%w %v/v

医薬品形態:

Solution for Injection

処方タイプ:

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

治療領域:

Amides

認証ステータス:

Authorised

承認日:

1998-05-31

情報リーフレット

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 ADRENALINE is used to 
numb (anaesthetise) parts of t

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Marcain 0.25%
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 2.5 mg per ml (50 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:
Each millilitre (ml) of Marcain with adrenaline contains 3.27 mg of sodium, equivalent to 65.33 mg per 20 ml single
dose vial.
Each ml of Marcain with adrenaline also contains 0.5 mg of sodium metabisulphite (10 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 0.25% w/v with Adrenaline 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.
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 neur