LEVOBUPIVACAINE 1.25 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOBUPIVACAINE HYDROCHLORIDE

Available from:

Fresenius Kabi Limited

ATC code:

N01BB10

INN (International Name):

LEVOBUPIVACAINE HYDROCHLORIDE

Dosage:

1.25 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Amides

Authorization status:

Authorised

Authorization date:

2014-10-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOBUPIVACAINE  
0.625 MG/ML OR 1.25 MG/ML 
SOLUTION FOR INFUSION
FOR EPIDURAL USE ONLY
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, 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.
THE NAME OF YOUR MEDICINE IS LEVOBUPIVACAINE  0.625 MG/ML OR 1.25
MG/ML SOLUTION FOR 
INFUSION; IN THE REST OF THE LEAFLET IT WILL BE CALLED
“LEVOBUPIVACAINE ”
WHAT IS IN THIS LEAFLET:
1.   What Levobupivacaine  is and what it is used for 
2.   What you need to know before you are given Levobupivacaine 
3.   How you will be given Levobupivacaine 
4.   Possible side effects 
5.   How to store Levobupivacaine 
6.   Contents of the pack and other information 
1. WHAT LEVOBUPIVACAINE  IS AND WHAT IT IS USED FOR
Levobupivacaine  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.
Levobupivacaine  Solution for Infusion is for adult use only.
Levobupivacaine  is used for pain relief:
•
after major surgery
•
during childbirth
2.  WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVOBUPIVACAINE 
DO NOT USE LEVOBUPIVACAINE :
•
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 Levobupivacaine  into a vein 
WARNINGS AND PRECAUTIONS 
Talk to your doctor before you are given Levobupivacaine  if you have
any o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levobupivacaine 1.25 mg/mL solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 1.25 mg of levobupivacaine as levobupivacaine hydrochloride.
Each bag of 100 ml contains 125 mg of levobupivacaine as levobupivacaine hydrochloride.
Excipients with known effect:
1 ml solution contains 3.6 mg of sodium equivalent to 360 mg of sodium per bag of 100 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear colourless solution
pH 4.0-6.0
Osmolarity: 271 – 332 mOsmol/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
_Pain management_
Continuous epidural infusion, for the management of post operative pain and labour analgesia.
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.
Posology
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 levbupivacaine should
be closely monitored (see Section 4.4).
Type of Block
Concentration
mg/ml
Infusion Rate Per Hour
ml
mg
_Continuous Infusion: _Post
operative pain management
Lumbar epidural (analgesia
in labour)
1.25
1.25
10-15
4-10
12.5-18.75
5–12.5
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 05/11/2015_
_CRN 2169594_
_page number: 1_
Maximum dose
The maximum dosage must be determined by evaluating the size and physical status of the patient. The maximum
recommended dose during a 24 hour period is 400 mg.
For post-operative p