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Mivacron Injection 2 mg/ml

Last Updated on eMC 16-Oct-2017 View changes  | Aspen Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL39699/0094, PL39699/0094.



Mivacron Injection 2 mg/ml

Package Leaflet: Information for the Patient

Mivacron Injection 2 mg/ml

mivacurium

Read all of this leaflet carefully before you are given 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 about your illness or your medicine, ask your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

What is in this leaflet:

1. What Mivacron is and what it is used for
2. What you need to know before you are given Mivacron
3. How Mivacron is given
4. Possible side effects
5. How to store Mivacron
6. Contents of the pack and other information

1. What Mivacron is and what it is used for

Mivacron contains a medicine called mivacurium. This belongs to a group of medicines called muscle relaxants.

Mivacron is used:

  • to relax muscles during operations on adults and children 2 months of age and over.
  • to help insert a tube into the windpipe (tracheal intubation), if a person needs help to breathe

Ask your doctor if you would like more explanation about this medicine.

2. What you need to know before you are given Mivacron

Do not have Mivacron if:

  • you are allergic to mivacurium, any other muscle relaxant or any of the other ingredients in Mivacron (listed in Section 6)
  • you or your family have reacted badly to an anaesthetic before.

Do not have Mivacron if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you have Mivacron.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before having this medicine if:

  • you have muscle weakness, tiredness or difficulty in co-ordinating your movements (myasthenia gravis)
  • you have a neuromuscular disease, such as a muscle wasting disease, paralysis, motor neurone disease or cerebral palsy
  • you have a burn which requires medical treatment
  • you have ever had an allergic reaction to any muscle relaxant that was given as part of an operation.

Talk to your doctor before having this medicine, if you have or have ever had any of the following:

  • Tetanus
  • A severe or long-standing infection such as tuberculosis (TB)
  • Any long-standing illness which has left you weak
  • Cancer
  • Anaemia
  • Malnutrition
  • An under-active thyroid gland
  • Heart disease
  • Stomach ulcers
  • Burns
  • Liver or kidney disease

Tell your doctor if:

  • You are pregnant or have been pregnant recently or you have given birth in the last 6 weeks.
  • You have been diagnosed as having a genetically determined abnormal cholinesterase.
  • You are particularly sensitive to histamine or if you have asthma.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before you are given Mivacron.

Other medicines and Mivacron

Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because these medicines can affect how well Mivacron works or can cause side effects.

In particular tell your doctor, nurse or pharmacist if you are taking any of the following:

  • anaesthetics (used to reduce sensation and pain during surgical procedures)
  • antibiotics (used to treat infections)
  • medicines for uneven heart beats (anti-arrhythmics)
  • medicines for high blood pressure
  • water tablets (diuretics), such as furosemide (previously known as frusemide)
  • medicines for inflammation of the joints, such as chloroquine or d-penicillamine
  • steroids
  • medicines for mental illness, such as lithium, monoamine oxidase inhibitors (MAOIs) or chlorpromazine (which can also be used for sickness)
  • medicines containing magnesium.
  • medicines used to treat depression and/or anxiety SSRIs (selective serotonin reuptake inhibitors) including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram

Pregnancy and breast-feeding

If you are pregnant, or are breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.

Driving and using machines

It can be dangerous to drive or operate machinery too soon after having had an operation. Your doctor will tell you how long to wait before you can drive and use machinery.

3. How Mivacron is given

How your injection is given

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

Mivacron can be given:

  • as a single injection into your vein (intravenous bolus injection)
  • as a continuous infusion into your vein. This is where the drug is slowly given to you over a long period of time.

Your doctor will decide the way you are given the drug and the dose you will receive. It will depend on:

  • your body weight
  • the amount and duration of muscle relaxation required
  • your expected response to the medicine.

Children under 2 months old should not have this medicine.

If you receive more Mivacron than you should

Mivacron will always be given under carefully controlled conditions. However, if you think that you have been given more than you should tell your doctor or nurse immediately.

4. Possible side effects

Like all medicines, Mivacron can cause side effects, although not everybody gets them.

Allergic reactions (may affect up to 1 in 10,000 people)

If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include:

  • sudden wheeziness, chest pain or chest tightness
  • swelling of your eyelids, face, lips, mouth or tongue
  • a lumpy skin rash or ‘hives’ anywhere on your body
  • a collapse

Very Common (may affect more than 1 in 10 people)

  • reddening of the skin

Uncommon (may affect up to 1 in 100 people)

  • increase in heart rate
  • decrease in blood pressure
  • wheezing or coughing
  • rash or urticaria (lumpy skin rash) or ‘hives’ anywhere on your body

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mivacron

  • Keep out of the sight and reach of children.
  • Do not use Mivacron after the expiry date which is stated on the pack after ‘Exp’.
  • Store below 25°C. Do not freeze.
  • Store in the original package to protect from light.
  • When Mivacron is made up it should be used straight away. Do not throw away any medicines via wastewater or household waste. Your doctor, nurse or pharmacist will throw away any medicine that is no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mivacron contains

  • The active substance is mivacurium chloride.
  • The other ingredients are hydrochloric acid and Water for Injections.

What Mivacron looks like and contents of the pack

  • Mivacron solution for injection comes in ampoules containing 5 ml or 10 ml of the product.

Marketing authorisation holder and manufacturer

Marketing Authorisation holder:

Aspen Pharma Trading Limited
3016 Lake Drive
City West Business Campus
Dublin 24
Ireland
Service-Tel: 0800 008 7392 (+ 44 1748 828 391)

Manufacturer:

GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana 90
43056 San Polo di Torrile
Parma
Italy

Aspen Pharma Ireland Limited
One George’s Quay Plaza
Dublin 2
Ireland

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only).

Please be ready to give the following information:

Product name Mivacron Injection 2 mg/ml

Reference number PL 39699/0094

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in August 2017

Mivacron is a trade mark of the Aspen group. © 2017 Aspen group of companies. All rights reserved.

Company contact details

Aspen

Company image
Address

3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Medical Information Direct Line

0800 0087 392

Telephone

+ 44 1748 828 391

Medical Information e-mail

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

mivacurium chloride

Legal categories

POM - Prescription Only Medicine

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