Levobupivacaine 2.5 mg/mL solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levobupivacaine

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

N01BB; N01BB10

INN (International Name):

Levobupivacaine

Dosage:

2.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

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

Therapeutic area:

Amides; levobupivacaine

Authorization status:

Marketed

Authorization date:

2014-10-24

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOBUPIVACAINE 2.5 MG/ML SOLUTION FOR INJECTION/INFUSION
LEVOBUPIVACAINE 5 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 and adolescents (12 years of age and older):
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 (such as on the
eye and mouth).
It is also used for
PAIN RELIEF

after major surgery

during childbirth
In children (below the age of 12):
Levobupivacaine 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.
Levobupivacaine has not been tested in children less than 6 months of
age.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVOBUPIVACAINE
- 2 -
DO NOT USE LEVOBUPIVACAINE:

if you are allergic (hypersensitive) to
levobupivacaine, to any similar local anaesthetics
or
to any o

Summary of Product characteristics

Health Products Regulatory Authority
18 May 2021
CRN00C8Y5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levobupivacaine 2.5 mg/mL solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 2.5 mg of levobupivacaine as levobupivacaine
hydrochloride.
Each ampoule of 10 ml contains 25 mg of levobupivacaine as
levobupivacaine hydrochloride.
Excipient with known effect:
This medicinal product contains 3.6 mg sodium per ml, equivalent to
0.18% of the WHO recommended maximum daily intake
of 2 g sodium for an adult.
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 and adolescents (≥ 12 years)
_Surgical anaesthesia_
- Major, e.g. epidural (including for caesarean section), intrathecal,
perineural (peripheral nerve block).
- Minor, e.g. infiltration (including 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.
Children (< 12 years)
Analgesia: perineural (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.
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 or peribulbar block), the higher
concentrations may be used. Careful aspiration before
and during injection is recommended to prevent intravascular
injection.
Health Products Regulatory Authorit