Musrelan

Patient Information Leaflet: Information for the User

Musrelan 10 mg/ml, solution for injection in pre-filled syringe

suxamethonium chloride anhydrous
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Musrelan is and what it is used for

Musrelan belongs to a group of medicines called muscle relaxants.
These medicines work by blocking the connection between nerves and certain muscles, thereby causing these muscles to relax and become temporarily paralysed.
It is used in adults and in the paediatric population above 12 years of age during general anaesthesia or emergency situations.
Musrelan is administered when a tube is inserted into the trachea (endotracheal intubation), in cases where a person needs assistance with breathing. During this procedure, it is necessary for the muscles involved in breathing to be paralysed.

2. What you need to know before using Musrelan

Do not receive Musrelan:

• if you are allergic to suxamethonium or to any of the other ingredients of this medicine (listed in section 6);
• if you are a conscious patient;
• if you or someone in your family has previously had an adverse reaction to an anaesthetic, such as a very high body temperature (malignant hyperthermia);
• if you have a deficiency of an enzyme called pseudocholinesterase, which breaks down suxamethonium in the body;
• if you have high levels of potassium in your blood (hyperkalaemia);
• if you have recently had severe trauma, surgery, or serious burns;
• if you have had a spinal cord injury, nerve injury, or sudden muscle atrophy;
• if you have been unable to move for a prolonged period, such as during recovery from a bone fracture or prolonged bed rest;
• if you have muscle weakness and muscle tissue atrophy (e.g. Duchenne muscular dystrophy);
• if you or someone in your family has a condition causing muscle weakness (congenital myotonia, myotonic dystrophy);
• if you have recently had eye injuries;
• if you have a condition caused by increased pressure in the eye (glaucoma), unless the potential benefit outweighs the possible risk to the eye.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Musrelan:

• if you have had an allergic reaction to any other muscle relaxant administered during a procedure;
• if you have myasthenia gravis, a disease causing severe muscle weakness, or any other nerve or muscle disorder;
• if you are pregnant or have given birth within the last six weeks;
• if you have tetanus, an infection occurring through wound contamination;
• if you have tuberculosis or another severe or long-lasting bacterial infection;
• if you have any chronic illness that has caused muscle weakness;
• if you have a blood disorder known as anaemia;
• if you are malnourished or unable to absorb nutrients from food (malnutrition);
• if you have liver or kidney problems;
• if you have a disease caused by the body attacking itself (autoimmune disease), such as a thyroid gland disorder (myxoedema);
• if you have diseases causing joint problems (collagen diseases);
• if you are undergoing or have undergone blood treatment known as plasmapheresis therapy;
• if you have recently had cardiopulmonary bypass surgery.

Children
This medicine is not recommended for children under 12 years of age, as the graduated scale on the pre-filled syringes does not allow accurate dosing in this population.
Particular care must be taken when this medicine is administered to children over 12 years of age.

Other medicines and Musrelan
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor, pharmacist, or nurse if you are taking / are being treated with any of the following:

• psychiatric medicines (e.g. phenelzine, promazine);
• anticancer medicines (e.g. cyclophosphamide, thiotepa, irinotecan);
• anaesthetic medicines (e.g. ketamine, halothane, enflurane, desflurane, propofol);
• local anaesthetics (e.g. lidocaine, procaine, procainamide);
• a medicine used to treat and prevent nausea or discomfort (metoclopramide);
• medicines used for Alzheimer's disease or myasthenia gravis (anticholinesterases such as donepezil, edrophonium, galantamine, neostigmine, pyridostigmine, rivastigmine, and tacrine);
• medicines used to treat asthma or other respiratory conditions (e.g. bambuterol, terbutaline);
• organic compounds containing phosphorus;
• a medicine used to reduce bleeding (aprotinin);
• oestrogens and oestrogen-containing oral contraceptives;
• a medicine used to contract the uterus (oxytocin);
• medicines used for inflammatory conditions (steroids such as for rheumatism, etc.);
• medicines used to treat heart rhythm disorders (antiarrhythmics such as quinidine, verapamil);
• certain antibiotics used to treat bacterial infections (e.g. lincosamides, polymyxins, and aminoglycosides);
• antiepileptic medicines used to stop seizures (e.g. carbamazepine and phenytoin);
• a beta-blocking medicine used to slow heart rate (esmolol);
• a medicine used to suppress the immune response (azathioprine);
• a medicine used to control overexcitement and/or depression (lithium);
• magnesium salts;
• medicines that increase the contraction of the heart muscle (cardiac glycosides such as digoxin);
• a medicine used to treat high eye pressure, i.e. glaucoma (ecotiopate).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before receiving this medicine.
Musrelan should be used during pregnancy only if your doctor determines that the benefits to you outweigh the potential risks to the fetus.
Particular caution is required after administering suxamethonium to pregnant or postpartum women.
It is not known whether suxamethonium passes into breast milk. However, since suxamethonium is rapidly metabolized into an inactive metabolite, effects on breastfed infants are not expected.

Driving and using machines
It may be dangerous to drive or operate machinery immediately after receiving this medicine. Your doctor will advise you how long you should wait before driving or using machinery.

Musrelan contains sodium.
This medicine contains 27.9 mg of sodium (a main component of table salt). This corresponds to 1.4% of the maximum daily recommended dietary intake for an adult.

3. How Musrelan is administered

You must never administer this medicine to yourself. It will always be given to you by a qualified healthcare professional.
Your doctor will decide the dose you will receive. This will depend on your individual needs, body weight, and the amount and duration of muscle relaxation required.
Musrelan will be administered to you as a single intravenous injection (intravenous use). The pre-filled syringe is not suitable for use in a syringe pump.
If you are given more Musrelan than you should
Since this medicine will be administered under strictly controlled conditions, it is unlikely that you will receive more than the required amount. In case of overdose, muscle relaxation will last longer than intended.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. 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):

• visible contraction of the muscle under the skin
• muscle pain after the procedure; your doctor will monitor you for this.

Common (may affect up to 1 in 10 people):

• allergic reactions: itching, hives, collapse
• increased fluid pressure in the eye which may cause headache or blurred vision
• increased gastric pressure
• increased or decreased heart rate
• low blood pressure
• presence of proteins in blood or urine due to muscle damage
• high level of potassium in the blood
• skin redness
• skin rash

Rare (may affect up to 1 in 1,000 people):

• breathing difficulties
• high body temperature
• difficulty opening the mouth

Not known (frequency cannot be estimated from available data):

• swelling (angioedema or Quincke's edema)
• cardiac arrest
• high or low blood pressure
• excessive saliva production
• excessive mucus production
• temporary cessation of breathing
• muscle damage

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Musrelan

Keep this medicine out of the sight and reach of children.
This medicine must not be used after the expiry date stated on the pre-filled syringe, the blister and the outer carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in its original blister until use.
After opening, the medicine should be used immediately.
This medicine may be stored for a short period of time at temperatures not exceeding 25°C.
However, once removed from initial refrigerated storage, the medicine must be discarded after 30 days.
Do not use this medicine if you notice any visible signs of deterioration.
Any pre-filled syringe, even if partially used, must be properly disposed of after use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Musrelan contains

• The active substance is suxamethonium chloride. Each ml of injection solution contains 10 mg of anhydrous suxamethonium chloride (as 11 mg of suxamethonium chloride dihydrate). Each 10 ml pre-filled syringe contains 100 mg of anhydrous suxamethonium chloride (as 110 mg of suxamethonium chloride dihydrate).
• The other ingredients are: sodium chloride, succinic acid, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Musrelan and contents of the pack
Musrelan injectable solution is a clear, colourless solution in a 10 ml pre-filled syringe made of
polypropylene, individually packed in a transparent blister.
Carton boxes containing 1 or 10 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:

The following information is intended for healthcare professionals only:

Instructions for use:
The pre-filled syringe is not suitable for use in a syringe driver.
Please prepare the syringe carefully as follows:
The pre-filled syringe is intended for single patient use only. Dispose of the syringe after use. Do not reuse.
Visually inspect the medicinal product for particulate matter or discoloration prior to administration. Use the solution only if it is clear, colorless, and free of particles or precipitates.
Do not use the medicinal product if the tamper-evident seal on the syringe is broken.
The outer surface of the syringe is sterile until the blister is opened. Do not open the blister until the time of use.
When handled using an aseptic technique, this medicinal product may be placed on a sterile surface after removal from the blister.

1. Remove the sterile pre-filled syringe from the blister.

2. Push the plunger to remove the cap. The sterilization process may have caused the cap to adhere to the syringe barrel.

3. Rotate the terminal cap to break the seal. To avoid contamination, do not touch the exposed Luer connector.

4. Check that the syringe seal has been completely removed. If not, reattach the cap and rotate again.

5. Expel air by gently pressing the plunger.
6. Attach the syringe to an access device or needle. Slowly depress the plunger to inject the required volume.