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BUPIVACAINE-CLARIS 5MG/ML SOLUTION FOR INJECTION

Active substance(s): BUPIVACAINE HYDROCHLORIDE MONOHYDRATE

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Package Leaflet: Information for the User
Bupivacaine-Claris 2.5mg/ml Solution for Injection
Bupivacaine-Claris 5 mg/ml Solution for Injection
Bupivacaine hydrochloride monohydrate
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 pharmacist.



If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4. .
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Bupivacaine-Claris is and what it is used for
What you need to know before you use Bupivacaine-Claris
How to use Bupivacaine-Claris
Possible side effects
How to store Bupivacaine-Claris
Contents of the pack and other information

1. What Bupivacaine-Claris is and what it is used for
Bupivacaine-Claris is a local anaesthetic. It belongs to a group of medicines called amidetype local anaesthetics. It produces a loss of feeling or sensation that is confined to one
part of the body.
Bupivacaine-Claris is used to numb (anaesthetise) parts of the body. It is used to

stop pain happening or to provide pain relief. It can be used to:
• Numb parts of the body during surgery in adults and children above 12 years
• Relieve pain in adults, infants and children above 1 year of age



surgical operations, including obstetric operations such as caesarean section
relief of acute pain including labour pain or pain after an operation

2. What you need to know before you use Bupivacaine-Claris
Do not use Bupivacaine-Claris :
• If you are allergic (hypersensitive) to bupivacaine hydrochloride monohydrate or
local anaesthetics of the amide type or to any of the other ingredients of this
medicine (listed in section 6). An allergic reaction may be recognised as a rash,
itiching, swollen face or lips, or shortness of breath.
• To produce local anaesthesia by injecting it into a vein of a limb that has been
isolated from the circulation by means of a tourniquet (a technique called
intravenous regional anaesthesia or Bier’s-block)
• if you are having obstetrical paracervical block (a type of anaesthesia given
during labour).

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containing adrenaline for special techniques (e.g. penile block, Oberst block) to
numb parts of the body where areas with end arteries are affected

Warnings and precautions
Your doctor will take special care if you are suffering from:








any liver disorder
a blood infection (septicaemia)
very low or very high blood pressure
dehydration or any recent vomiting, diarrohea or blood loss
heart disease
a tumour or an accumulation of fluid in the abdomen.
pleural effusions (fluid in the lungs) and septicaemia (blood poisoning)

You should talk to your doctor if you think this could apply to you.
Children
In children < 12 years as some injections of Bupivacaine-Claris in order to numb parts of
the body during surgery are not established in younger children Bupivacaine-Claris is not
established in children < 1 year.
Other medicines and Bupivacaine-Claris
Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines, including medicines obtained without a prescription.
Taking some medicines together can be harmful. Remember that the doctor at the
hospital may not have been informed if you have recently begun a course of treatment
for another illness. In particular tell your doctor if you are taking
- other local anaesthetics
- medicines to control your heartbeat (such as lidocaine, mexiletine, or
amiodarone)
- clonidine (used to treat high blood pressure or migraine)
- ketamine (an anaesthetic)

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must not have an obstetrical paracervical block (a type of anaesthesia during
labour) if you are receiving this medicine.
Bupivacaine may get into breast milk. If you are breast-feeding you should discuss
options with your doctor.

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Driving and using machines
Do not drive or use any tools or machines because Bupivacaine may interfere with your
ability to do so safely. Ask your doctor when it would be safe to resume these activities.
Bupivacaine-Claris contains sodium

This medicinal product contains 3.15 mg/ml (0.14 mmol) sodium per dose. This
should be taken into consideration by patients on a controlled sodium diet.

3. How to use Bupivacaine-Claris
Bupivacaine-Claris will be given to you by your doctor who will have the necessary
knowledge and experience in the technique of epidural anaesthesia.
The medicinal product is for single use only.
Dosage:
Your doctor will decide what dose is right for you. This will normally between 15150mg of Bupivacaine hydrochloride monohydrate. The dose will depend on your size,
your state of health, the part of the body that the medicine is injected into and what the
medicine is being used for. Smaller doses are used for elderly people, young children
and people who are unwell.
You may be given this medicine before minor or major surgery, or during childbirth.
For minor surgery, the injection will usually be given near the part of the body to be
operated on. The medicine will prevent pain and cause numbness which will gradually
wear off once the procedure is over. For major surgery or childbirth, you may be given
an injection in your back which will take a few minutes. This will prevent pain and
cause numbness in the lower half of your body which usually lasts for 3 to 4 hours.
For most procedures, one dose is enough but more doses may be needed if the
procedure takes a long time.
Route and method of administration:
The medicinal product is for epidural use, intraarticular use, subcutaneous use or
intramuscular use only.
Epidural anaesthesia involves an injection into the spine that can cause both a loss of
sensation (an anaesthetic) as well as pain relief (an analgesic) by blocking the
transmissionof pain signals through nerves in or near the spinal cord. It can be used as
an anaesthetic, as a pain reliever (an analgesic) together with general anaesthesia, and
for postoperative pain relief (analgesia) in procedures involving the lower limbs,
perineum, pelvis, abdomen and thorax.
If you use more Bupivacaine-Claris than you should
It is unlikely that you will be given too much Bupivacaine-Claris as it will be
administered by a medical professional. However, if you are concerned, contact your
doctor or nurse immediately.

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If you forget to take Bupivacaine-Claris
If you think you have missed a dose, please tell your doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
Use in children and adolescents
Depending on the type of required analgesia Bupivacaine-Claris is injected slowly
either into the epidural space (part of the spine) or other parts of the body by an
anaesthesiologist experienced in paediatric anaesthetic techniques. Dosage depends
on the age and weight of the patient and will be determined by the anaesthesiologist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face or lips, rash or itching (especially
affecting your whole body).
Serious side effects
If you develop any of the following side effects, contact your doctor immediately:
• Fits
• Heart attack - rare
Side effects can be listed according to how often they occur:

very common: may affect more than 1 in 10 people
common:
may affect up to 1 in 10 people
uncommon:
may affect up to 1 in 100 people
rare:
may affect up to 1 in 1,000 people
very rare:
may affect up to 1 in 10,000 people
not known:
frequency cannot be estimated from the available data
The following side effects have also been reported:
Very Common
Nausea (feeling sick), low blood pressure (your doctor can monitor this).
Common
Slow heartbeat, pins and needles, dizziness, vomiting, not being able to urinate, and
high blood pressure (your doctor can monitor this).
Uncommon
Pins and needles around the mouth, numbness of the tongue, sensitivity to sound,
visual disturbances, loss of consciousness, tremor, light- headedness, ringing in the
ears, and speech disorder.

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Rare
Nerve disorders or injury, loss of movement, paralysis, double vision, and shallow
breathing.
Additional side effects in children and adolescents
Adverse drug reactions in children are similar to those in adults.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report any side effects directly via the national reporting system {insert
link to the relevant ‘national reporting system website’ - details will be defined at
national level}. By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Bupivacaine-Claris
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and the box
after “EXP”. The expiry date refers to the last day of the month.
Store below 30°C. Do not refrigerate or freeze.
Shelf life after dilution:
Chemical and physical in use stability has been demonstrated for 36 hours at 25°C.
From a microbiological point of view the product should be used immediately.
After first opening: to be used immediately
Only clear solutions practically free from particles should be used. Do not use if
container is damaged.
Any unused solution should be discarded.
Do not throw away any medicines via waste-water or with household waste. Ask
your pharmacist how to throw away medicines you no longer use. These measures
will help to protect the environment.
6. Contents of the pack and other information
What Bupivacaine-Claris contains
The active substance is bupivacaine hydrochloride monohydrate.
For 2.5mg/ml
Each ml contains 2.5 mg of Bupivacaine hydrochloride monohydrate
Each 10 ml glass vial contains 25 mg of bupivacaine hydrochloride monohydrate.
Each 20 ml glass vial contains 50 mg of bupivacaine hydrochloride monohydrate.

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For 5 mg/ml
Each ml contains 5 mg of bupivacaine hydrochloride monohydrate
Each vial with 10 ml contains 50 mg of bupivacaine hydrochloride monohydrate.
Each vial with 20 ml contains 100 mg of bupivacaine hydrochloride monohydrate.
Other ingredients – Sodium Chloride, 0.4% Sodium hydroxide, 0.85% hydrochloric
acid and Water for injections.

What Bupivacaine-Claris looks like and content of the pack:
Bupivacaine-Claris is a clear, colourless, aqueous, sterile solution for injection
supplied in 10ml and 20 ml glass vial.
Pack sizes:
5 or 10 X 10ml solution for injection
1 X 20ml solution for injection
Not all packs sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Claris Lifesciences (UK) Ltd.,
Golden Gate Lodge, Crewe Hall, Crewe, Cheshire,
CW1 6UL, United Kingdom.

Manufacturer:
Peckforton Pharmaceutical Limited
Crewe Hall, Crewe, Cheshire,
CW1 6UL, United Kingdom.
This medicinal product is authorized in the Member States of EEA under the following
names:
Germany
Estonia
Ireland
Italy
Latvia
Lithuania
Poland

Bupivacain-Claris 2,5 mg/ml Injektionslösung
Bupivacain-Claris 5 mg/ml Injektionslösung
Bupivacaine Claris 2.5mg/ml
Bupivacaine Claris 5.0mg/ml
Bupivacaine Claris 2.5mg/ml Solution for Injection
Bupivacaine Claris 5.0mg/ml Solution for Injection
Bupivan 2.5mg/ml Solution for Injection
Bupivan 5.0mg/ml Solution for Injection
Bupivacaine Claris 2.5mg/ml Solution for Injection
Bupivacaine Claris 5.0mg/ml Solution for Injection
Bupivacaine Claris 2.5mg/ml injekcinis tirpalas
Bupivacaine Claris 5.0mg/ml injekcinis tirpalas
Bupivacaine Claris
Bupivacaine Claris

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Netherlands
United Kingdom

Bupivacaine Claris 2.5mg/ml Solution for Injection
Bupivacaine Claris 5.0mg/ml Solution for Injection
Bupivacaine Claris, 2.5mg/ml Solution for Injection
Bupivacaine Claris, 5.0mg/ml Solution for Injection

This leaflet was last revised in 05/2015
---------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Any unused solution should be adequately disposed of, in accordance with local
requirements.
1. Administration
Solution for injection.
The medicinal product is for epidural use, intraarticular use, subcutaneous use or
intramuscular use only.
The maximum dosage must be determined by evaluating the size and physical status
of the patient and considering the usual rate of systemic absorption from a particular
injection site. A single dose of up to 150 mg bupivacaine hydrochloride monohydrate
can be used. Doses of up to 50 mg 2-hourly may subsequently be used. A total dose
of up to 500 mg bupivacaine hydrochloride monohydrate over 24 hours, which does
not include the initial bolus dose, can be used routinely. For young, elderly or
debilitated patients, the doses should be reduced.
2. Handling Instructions
For single use only.
Only clear solutions practically free from particles should be used. Any unused
solution should be discarded.
Do not use Bupivacaine Injection after the expiry date as indicated on the box after
“EXP”. The expiry date refers to the last day of the month.
Bupivacaine is compatible when admixed with 0.9% w/v sodium chloride injection,
Ringer Lactate Solution and Sufentanil Citrate 50 µg/ml. However, this medicinal
product must not be mixed with other medicinal products.
3. Storage information
Store below 30°C. Do not refrigerate or freeze.
After first opening: to be used immediately.
Shelf life after dilution:
Chemical and physical in use stability has been demonstrated for 36 hours at 25°C.
From a microbiological point of view the product should be used immediately.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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