2 mg / ml solution for injection
Mivacurium
What Mivacron is and what it is used for
Mivacron contains a medicine called mivacurium.
Mivacron belongs to a group of medicines called muscle relaxants. Mivacron is used in conjunction with anesthesia during surgery to provide skeletal muscle relaxation.
When undergoing certain types of surgeries, the muscles must be completely relaxed. This makes it easier for the surgeon to operate. Mivacron blocks the nerve impulses to the muscles, which gives the muscle a relaxing effect. When Mivacron is used, the respiratory muscles are also relaxed and you then get help with breathing in the form of artificial (mechanical) breathing during and after the operation. When you are anesthetized, a tube is inserted into the trachea and this is facilitated by the fact that you have received Mivacron.
What you need to know before you get Mivacron
You can not get Mivacron:
- if you are allergic to mivacurium or any of the other ingredients of this medicine (listed in section 6).
- if you or someone in your family has previously reacted negatively to an anesthetic.
- If you are not sure if any of these apply to you, talk to your doctor, nurse or pharmacist before taking Mivacron.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving this medicine if you:
- suffers from muscle weakness, fatigue or difficulty coordinating your movements ( myasthenia gravis )
- have a burn that requires medical treatment
- have had an allergic reaction to any muscle relaxant given as part of an operation.
- have or have had tetanus
- have or have had a serious or long-term infection such as tuberculosis (TB)
- have or have had a serious illness that has made you weak such as anemia or malnutrition
- have or have had cancer
- has or has had an underactive thyroid gland
- have or have had heart disease
- have or have had stomach ulcers
- have or have had liver or kidney disease.
- have an increased risk of falling blood pressure
- is pregnant or has recently been pregnant or if you have given birth in the last 6 months
- have a diagnosed genetic abnormality in cholinesterase .
If you are not sure if any of the above applies to you, talk to your doctor, nurse, or pharmacist before taking Mivacron.
Children and young people
The use of Mivacron in newborns and infants under 2 months of age is not recommended.
Other medicines and Mivacron
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or over-the-counter medicines.
You must tell your doctor or pharmacist if you are taking any of the following medicines:
- drugs used for anesthesia in connection with surgery ( anesthetics )
- medicines used to treat infections ( antibiotics )
- drugs used to treat irregular heartbeats ( antiarrhythmics )
- medicines for high blood pressure called beta- blockers
- diuretics ( diuretics ), such as furosemide
- drugs used in inflammation of the joints (rheumatism), such as chloroquine or d-penicillamine
- corticosteroids ( cortisone ) given for inflammation
- anticonvulsants ( epilepsy ), such as phenytoin
- drugs used in mental illness, such as lithium, monoamine oxidase inhibitors ( MAOIs ) or chlorpromazine
- medicines containing magnesium .
- muscle relaxants, such as suxamethasone
- antidepressant drugs, so-called SSRIs (selective serotonin reuptake inhibitors)
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It can be dangerous to drive a car or use machines too soon after an operation.
Your doctor will tell you how long to wait before driving or using machines.
How Mivacron is given
You are never expected to give this medicine to yourself. It is always given by a person who has the training to do so.
Mivacron can be given:
- as a single injection into a friend
- as a continuous infusion into a friend. This is when the medicine is given to you slowly over a long period of time.
Your doctor will decide how you will receive the medicine and in what dose. This is because:
- your body weight
- how long the muscle relaxing effect is needed
- how you are expected to react to the medicine.
Use for children
Children under 2 months of age should not be given this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
- reddening of the skin
Uncommon (may affect up to 1 in 100 people):
- transient increase in heart rate
- lowering of blood pressure et
- wheezing or coughing
- rash
- veninflammation
- hypoxia ( hypoxemia )
- dizziness
Rare (may affect up to 1 in 1,000 people)
- local reaction at the injection site
- prolongation of the muscle relaxing effect.
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions
If you get an allergic reaction , talk to a doctor or nurse immediately. Characters can be:- sudden wheezing, chest pain or pressure over the chest
- swelling of eyelids, lips, mouth, tongue or face
- lumpy skin rash or “hives” somewhere on the body
- collapse.
How to store Mivacron
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 label and the carton after “EXP”.
The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store in the outer carton. Sensitive to light.
A reconstituted solution should be used immediately. Any remaining medicine should be discarded immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is mivacurium
- The other ingredients are hydrochloric acid (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Glass ampoule 5×5 ml
Glass ampoule 5×10 ml
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland.
Tel: +46 856 642 572
Manufacturer
Aspen Bad Oldesloe GmbH
32-36 Industriestrasse,
23843 Bad Oldesloe
Germany
or
GlaxoSmithKline Manufacturing SpA
Strada Provinciale Asolana 90, 43056
San Polo di Torrile (Parma)
Italy
or
Aspen Pharma Ireland Limited,
One George’s Quay Plaza, Dublin 2,
Ireland