Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Levobupivacaine hydrochloride

Διαθέσιμο από:

AbbVie Limited

Φαρμακολογική κατηγορία (ATC):

N01BB; N01BB10

INN (Διεθνής Όνομα):

Levobupivacaine hydrochloride

Δοσολογία:

5.0 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection/infusion

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Amides; levobupivacaine

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2007-06-08

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHIROCAINE 2.5 MG/ML AND 5.0 MG/ML SOLUTION FOR INJECTION/CONCENTRATE
FOR SOLUTION FOR INFUSION
LEVOBUPIVACAINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, please 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 Chirocaine is and what it is used for
2.
What you need to know before you are given Chirocaine
3.
How you will be given Chirocaine
4.
Possible side effects
5.
How to store Chirocaine
6.
Contents of the pack and other information
1. WHAT CHIROCAINE IS AND WHAT IT IS USED FOR
Chirocaine belongs to a group of medicines called local anaesthetics.
This type of medicine is used to
make an area of the body numb or free from pain.
ADULTS:
Chirocaine is used as a local anaesthetic to numb parts of the body
before major surgery (for example
as an epidural for caesarean section) and minor surgery (such as on
the eye and mouth).
IT IS ALSO USED FOR PAIN RELIEF:

after major surgery

during childbirth
CHILDREN:
Chirocaine can also be used with children to numb parts of the body
before surgery and for pain relief
after minor surgery, such as the repair of a groin hernia.
Chirocaine has not been tested in children less than 6 months of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CHIROCAINE_ _
DO NOT TAKE CHIROCAINE:

if you are allergic (hypersensitive) to levobupivacaine, to any
similar local anaesthetics or to
any of the other ingredients of this medicine (listed in section 6)

if you have very low blood pressure

as a type of pain relief given by injection into the area around the
neck of the womb (the
cervix) during the early stage of labour (paracervical block)

to numb an area by injecting Chirocaine into a vein
WARNINGS AND PR

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
13 January 2021
CRN009ZMX
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chirocaine 5 mg/ml solution for injection/concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 5 mg levobupivacaine as levobupivacaine hydrochloride.
Each ampoule contains 50 mg in 10 ml.
Excipients with known effect: 3.5 mg/ml of sodium per ampoule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/concentrate for solution for infusion.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
_Surgical anaesthesia_
• Major, e.g. epidural (including for caesarean section),
intrathecal, peripheral nerve block.
• Minor, e.g. local infiltration, peribulbar block in ophthalmic
surgery.
_Pain management_
• Continuous epidural infusion, single or multiple bolus epidural
administration for the management of pain especially
post-operative pain or labour analgesia.
Paediatric population
Analgesia (ilioinguinal/iliohypogastric blocks).
No data are available in paediatric population < 6 months of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Levobupivacaine should be administered only by, or under the
supervision of, a clinician having the necessary training and
experience.
The table below is a guide to dosage for the more commonly used
blocks. For analgesia (e.g. epidural administration for pain
management), the lower concentrations and doses are recommended. Where
profound or prolonged anaesthesia is required
with dense motor block (e.g. epidural or peribulbar block), the higher
concentrations may be used. Careful aspiration before
and during injection is recommended to prevent intravascular
injection.
There is limited safety experience with levobupivacaine therapy for
periods exceeding 24 hours. In order to minimise the risk
for severe neurological complications, the patient and the duration of
administration of levobupivacaine should be closely
monitored (se