LEVOBUPIVACAINE 5 Mg/Ml Solution for Inj/Inf

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:

5 Mg/Ml

Pharmaceutical form:

Solution for Inj/Inf

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 2.5 MG/ML
AND 5.0 MG/ML
SOLUTION FOR INJECTION/INFUSION
LEVOBUPIVACAINE HYDROCHLORIDE
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 2.5 MG/ML
AND 5.0 MG/ML SOLUTION FOR INJECTION/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.
IN ADULTS:
Levobupivacaine 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.
It is also 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
•
to numb an area by injecting Levobupivacaine into a vein
•
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)
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given Levobupivacaine if

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levobupivacaine 5.0 mg/mL solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 5 mg of levobupivacaine as levobupivacaine
hydrochloride.
Each ampoule of 10 ml contains 50 mg of levobupivacaine as
levobupivacaine hydrochloride.
Excipient with known effect:
1 ml solution contains 3.6 mg of sodium, equivalent to 36 mg of sodium
per ampoule of 10 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
Clear colourless solution
pH 4.0-6.0
Osmolarity: 271 – 372 mOsmol/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
_Surgical anaesthesia_
- Major, e.g. epidural (including for caesarean section), intrathecal,
perineural (peripheral nerve block).
- Minor, e.g.
infiltration
_Pain management_
- Continuous epidural infusion, single or multiple bolus epidural
administration for the management of pain
especially post - operative pain or 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
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), the higher
concentrations may be used.
Careful aspiration before
and during injection is recommended to prevent intravascular
injection.
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