Levobupivacaine 1.25 mg/mL solution for infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Levobupivacaine

זמין מ:

Fresenius Kabi Deutschland GmbH

קוד ATC:

N01BB; N01BB10

INN (שם בינלאומי):

Levobupivacaine

כמות:

1.25 milligram(s)/millilitre

טופס פרצבטיות:

Solution for infusion

סוג מרשם:

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

איזור תרפויטי:

Amides; levobupivacaine

מצב אישור:

Marketed

תאריך אישור:

2014-10-24

עלון מידע

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOBUPIVACAINE 0.625 MG/ML SOLUTION FOR INFUSION
LEVOBUPIVACAINE 1.25 MG/ML SOLUTION FOR 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 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.

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).
- 2 -
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given Levobupivacaine if you have
any of the diseases or
conditions below. You may need to be c

מאפייני מוצר

Health Products Regulatory Authority
18 May 2021
CRN00C8Y5
Page 1 of 9
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.
Each bag of 200 ml contains 250 mg of levobupivacaine as
levobupivacaine hydrochloride.
Excipients 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 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
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
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).
Health Products Regulatory Authority
18 May 2021
CRN00C8Y5
Page 2 of 9
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 pain management, the dose should not exceed 18.75
mg/hour, however the accumulated dose for a 24
hour period should not excee