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BUPIVACAINE-CLARIS 2.5MG/ML SOLUTION FOR INJECTION

Active substance(s): BUPIVACAINE HYDROCHLORIDE MONOHYDRATE / BUPIVACAINE HYDROCHLORIDE MONOHYDRATE

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Claris Injectables Limited
Artwork Code : 1400005594

Artwork Req. No: 16035

Quality of Paper/Board : Super Sun Shine

Size of Artwork (In mm) : 400x175

Quality of Gum :

GSM of Paper/Board : 60 GSM

Colour Code :

BLACK

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Barcode Information:

Barcode Scan Report:
Packing: 10ml Tub. Vial

Plant Location : Injectable

Country: United Kingdom, Ireland

Language : English

Ref. Code Creation/Blockage Note:

Artwork Control Key No.:

“Controlled Copy” Holder (1)

(2)

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Package Leaflet: Information for the User
Bupivacaine 2.5mg/ml Solution for Injection
Bupivacaine 5 mg/ml Solution for Injection
Bupivacaine hydrochloride monohydrate
Read all of this leaflet carefully before you are given this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this Leaflet
1.What Bupivacaine is and what it is used for
2.Before you are given Bupivacaine
3.How to use Bupivacaine
4.Possible side effects
5.How to store Bupivacaine
6.Further information
1.What Bupivacaine is and what it is used for
Bupivacaine is a local anaesthetic. It belongs to a group of medicines called amide-type local anaesthetics. It produces a loss of
feeling or sensation that is confined to one part of the body.
Bupivacaine is used for
- surgical operations, including obstetric operations such as caesarean section
- relief of acute pain including labour pain or pain after an operation
2.Before you are given Bupivacaine
Do not use Bupivacaine :
• If you are allergic (hypersensitive) to bupivacaine hydrochloride monohydrate or local anaesthetics of the amide type or to
any of the other ingredients in this medicine. An allergic reaction may be recognised as a rash, itching, 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).
Take special care with Bupivacaine :
and tell your doctor if you suffer 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 you think you may be pregnant, you should inform your doctor who will decide whether or not you should be
given Bupivacaine.
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. Ask your doctor or
pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Bupivacaine.
Bupivacaine 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
Bupivacaine 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 15-150mg 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:
Bupivacaine 2.5mg/ml Solution for Injection is for epidural administration, major nerve block, field block and intra-articular block
only.
Bupivacaine 5mg/ml Solution for Injection is for epidural administration, major nerve block and field block 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 transmission of 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 have been given more Bupivacaine than you should
It is unlikely that you will be given too much Bupivacaine as it will be administered by a medical professional. However, if you are
concerned, contact your doctor or nurse immediately.
If you forget to take Bupivacaine
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 product, ask your doctor or pharmacist.

The following information is intended for medical or 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.
Use only particle free solutions. Any unused solution should be discarded.

Claris Injectables Limited
Artwork Code : 1400005594

Artwork Req. No: 16035

Quality of Paper/Board : Super Sun Shine

Size of Artwork (In mm) : 400x175

Quality of Gum :

GSM of Paper/Board : 60 GSM

Colour Code :

BLACK

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Barcode Information:

Barcode Scan Report:
Packing: 10ml Tub. Vial

Plant Location : Injectable

Country: United Kingdom, Ireland

Language : English

Ref. Code Creation/Blockage Note:

Artwork Control Key No.:

“Controlled Copy” Holder (1)

(2)

(3)

(4)

(5)

4.Possible side effects
Like all medicines, Bupivacaine 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
The following side effects have also been reported:
Very Common
(affects more than 1 user in 10)
Nausea (feeling sick), low blood pressure (your doctor can monitor this).
Common
(affects 1 to 10 users in 100)
Slow heartbeat, pins and needles, dizziness, vomiting, not being able to urinate, and high blood pressure (your doctor can
monitor this).
Uncommon
(affects 1 to 10 users in 1,000)
Pins and needles around the mouth, numbness of the tongue, sensitivity to sound, visual disturbances, loss of consciousness,
tremor, light- headedness, ringing ion the ears, and speech disorder.
Affects more than 1 user in 10
Rare
(affects 1 to 10 users in 10,000)
Nerve disorders or injury, loss of movement, paralysis, double vision, and shallow breathing.
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 (see details below). By reporting side effects you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland
HPRA Pharmacovigilance
IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website:www.hpra.ie, e-mail: medsafety@hpra.ie

5.How to store Bupivacaine
Keep out of the sight and reach of children.
Do not use Bupivacaine 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.
Medicine should not be disposed of via waste-water or with household waste. Ask your pharmacist how to dispose of medicines
no longer required. These measures will help to protect the environment.

What Bupivacaine 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.

1400005594

6.Further information

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 looks like and the content of the pack:
Bupivacaine is a clear, colourless, aqueous, sterile solution for injection supplied in 10ml and 20 ml glass vial.
Pack sizes:
5 X 10ml solution for injection
10 X 10ml solution for injection
1 X 20ml solution for injection
Not all packs sizes may be marketed.
Marketing Authorization Holder:
Claris Lifesciences (UK) Ltd,
Golden Gate Lodge, Crewe Hall, Crewe, Cheshire,
CW 1 6UL, United Kingdom
Manufacturer:
Peckforton Pharmaceutical Limited
Golden Gate Lodge, Crewe Hall, Crewe, Cheshire,
CW 1 6UL, United Kingdom
This medicinal product is authorized in the Member States of EEA under the following names:
This leaflet was last revised in October 2016

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 mg/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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