Chirocaine 125mg/200ml infusion bags

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Levobupivacaine hydrochloride

Beschikbaar vanaf:

AbbVie Ltd

ATC-code:

N01BB10

INN (Algemene Internationale Benaming):

Levobupivacaine hydrochloride

Dosering:

.625mg/1ml

farmaceutische vorm:

Infusion

Toedieningsweg:

Epidural

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 15020000; GTIN: 5013158774162

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHIROCAINE 0.625 MG/ML OR 1.25 MG/ML SOLUTION FOR INFUSION
FOR EPIDURAL USE ONLY
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.
Chirocaine solution for infusion is for adult use only.
Chirocaine is used for pain relief:
•
after major surgery
•
during childbirth
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 PRECAUTIONS
Talk to your doctor or nurse before you are given Chirocaine if you
have any of the diseases
or conditions below. You may need to be checked more closely or given
a smaller dose.
•
if you suffer from diseases of the nervous system
•
if you are weak or ill
•
if you are elderly
•
if you have liver disease.
OTHER MEDICINES AND CHIROCAINE
Tell your doctor or nurse if you are tak

Productkenmerken

OBJECT 1
CHIROCAINE 1.25MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 07-Aug-2015 | AbbVie
Limited
1. Name of the medicinal product
Chirocaine 1.25 mg/ml solution for infusion
2. Qualitative and quantitative composition
Levobupivacaine hydrochloride corresponding to 1.25 mg/ml
levobupivacaine.
Excipients with known effect: 3.6 mg/ml of sodium per bag.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion
Clear solution
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.
Chirocaine Solution for Infusion is for epidural use only. It must not
be used for intravenous
administration.
Type of block
Concentration
mg/ml
Infusion Rate Per Hour
ml
mg
_Continuous Infusion: _Post operative pain
management
1.25
10-15
12.5-18.75
Lumbar epidural (analgesia in labour)
1.25
4-10
5-12.5
Careful aspiration before infusion is recommended to prevent
intravascular injection. If toxic symptoms
occur, the injection should be stopped immediately.
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 (see Section 4.4).
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 exceed 400 mg. For
labour analgesia by epidural
infusion, the dose should not exceed 12.5 mg/ hour.
Paediatric population
The safety and efficacy of levobupiva