Marcain Heavy Steripack 0.5% w/v Solution for Injection

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

BUPIVACAINE HYDROCHLORIDE

Tillgänglig från:

Aspen Pharma Trading Limited

ATC-kod:

N01BB; N01BB01

INN (International namn):

BUPIVACAINE HYDROCHLORIDE

Dos:

0.5 percent weight/volume

Läkemedelsform:

Solution for injection

Receptbelagda typ:

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

Terapiområde:

Amides; bupivacaine

Bemyndigande status:

Marketed

Tillstånd datum:

1987-04-02

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MARCAIN HEAVY STERIPACK 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 Heavy is and what it is used for
2. What you need to know before Marcain Heavy is given to you
3. How Marcain Heavy is given to you
4. Possible side effects
5. How to store Marcain Heavy
6. Contents of the pack and other information
1.
WHAT MARCAIN HEAVY IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Marcain Heavy Steripack 0.5% w/v
Solution for Injection’. It is referred to as
Marcain Heavy in the rest of this leaflet. Marcain Heavy contains the
active substance called bupivacaine
hydrochloride. It belongs to a group of medicines called local
anaesthetics.
Marcain Heavy is used to numb (anaesthetise) parts of the body during
surgery in adults and children of all
ages. It stops pain happening during surgery (operations).
2.
WHAT YOU NEED TO KNOW BEFORE MARCAIN HEAVY IS GIVEN TO YOU
YOU MUST NOT BE GIVEN MARCAIN HEAVY:
•
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 at or near to where the injection will be
given.
•
If you have blood poisoning (septicaemia).
•
If you have something called cardiogenic shock (a serious 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 clotting of your bloo

Produktens egenskaper

Health Products Regulatory Authority
08 August 2022
CRN00CZCS
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Marcain Heavy Steripack 0.5% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains Bupivacaine Hydrochloride equivalent to 5.0 mg of
anhydrous bupivacaine hydrochloride (20 mg per 4 ml
ampoule).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (Injection)
Clear, colourless, sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intrathecal spinal anaesthesia in adults and children of all ages.
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.
The clinician's experience and knowledge of the patient's physical
status are of importance in calculating the required dose.
The lowest dose required for adequate anaesthesia should be used.
Individual variations in onset and duration occur, and the
extent of the spread of anaesthesia may be difficult to predict, but
will be affected by the volume of the drug used.
DOSAGE RECOMMENDATIONS
CONC. MG/ML
DOSE
ONSET (MIN)
DURATION (H)
ML
MG
Urological
5
1.5–3
7.5–15
5–8
2–3
Lower abdominal surgery (incl. caesarean section), lower limb,
including hip surgery
5
2–4
10–20
5–8
1.5–3
Pregnant women: 2–2.5 ml (10–12.5 mg bupivacaine hydrochloride).
The dose should be reduced in the older people and in patients in the
late stages of pregnancy.
NEONATES, INFANTS AND CHILDREN UP TO 40KG
Marcain Heavy may be used in children.
One of the differences between small children and adults is a
relatively high CSF volume in infants and neonates, requiring a
relatively larger dose/kg to produce the same level of bloc