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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

suxamethonium chloride anhydrous

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 questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Zennux is and what it is used for

Zennux belongs to a group of medicines called muscle relaxants.

Its effect is to block the connection between nerves and certain muscles, thereby temporarily paralyzing and relaxing these muscles.

It is used in adults and in pediatric patients over 12 years of age during general anesthesia or emergency situations.

Zennux is administered during the insertion of a tube into the trachea (endotracheal intubation), when a person requires respiratory assistance. During this procedure, it is necessary for the muscles used for breathing to be paralyzed.

2. What you need to know before Zennux is administered to you

Do not administer Zennux:

• if you are allergic to suxamethonium or any of the other components of this medicine (listed in section 6);
• if you are a conscious patient;
• if you or a family member have previously had a negative 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 the blood (hyperkalaemia);
• if you have recently had a serious injury, surgery, or severe burns;
• if you have suffered a spinal cord injury, nerve injury, or sudden muscle loss;
• if you have been immobilized for a prolonged period, such as during treatment for a bone fracture or prolonged bed rest;
• if you have muscle weakness or loss of muscle tissue (e.g. Duchenne muscular dystrophy);
• if you or a family member have a disease causing muscle weakness (congenital myotonia, myotonic dystrophy);
• if you have recently sustained eye injuries;
• if you suffer from a condition caused by excessive pressure in the eye (glaucoma), unless the potential benefit outweighs the potential risk to the eye.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before Zennux is administered to you:

• if you have ever experienced an allergic reaction to any muscle relaxant administered during surgery;
• 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 resulting from wound contamination;
• if you have tuberculosis or other serious or long-standing bacterial infections;
• if you have a long-term illness that has weakened you;
• 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 in which the body attacks itself (autoimmune disease), such as a thyroid gland disorder (myxoedema);
• if you have diseases causing joint problems (collagen diseases);
• if you have undergone or are undergoing a blood treatment known as therapeutic plasmapheresis;
• if you have recently undergone cardiopulmonary bypass.

Children

This medicine is not recommended for children under 12 years of age, as the graduations on the pre-filled syringe do not allow for accurate dosing in this population.

Particular care must be taken when administering this medicine to children over 12 years of age.

Other medicines and Zennux

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor, pharmacist, or nurse if you are taking or being treated with any of the following:

• medicines used in psychiatry (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 or prevent nausea and vomiting (metoclopramide);
• medicines used for Alzheimer's disease or myasthenia gravis (anticholinesterases such as donepezil, edrophonium, galantamine, neostigmine, pyridostigmine, rivastigmine, and tacrine);
• medicines for asthma or other respiratory problems (e.g. bambuterol, terbutaline);
• organic substances containing phosphorus;
• a medicine used to reduce bleeding (aprotinin);
• oestrogens and oral contraceptives containing oestrogen;
• a medicine used to contract the uterus (oxytocin);
• medicines used for inflammatory conditions (steroids such as those used 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 reduce 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 contractions of the heart muscle (cardiac glycosides such as digoxin);
• a medicine used to treat high pressure in the eyes, i.e. glaucoma (ecothiopate).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before this medicine is administered to you.

Zennux should only be used during pregnancy if your doctor decides that the benefits to you outweigh any risk to the unborn baby.

Caution should be exercised when administering suxamethonium to pregnant or postpartum patients.

It is unknown whether suxamethonium is excreted in breast milk. However, no effect on newborns or breastfed children is expected, as suxamethonium is rapidly metabolized to an inactive metabolite.

Driving and using machines

It may be dangerous to drive or operate machinery too soon after receiving this medicine. Your doctor will advise you how long you should wait before you can drive or use machines.

Zennux contains sodium.

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

3. How Zennux is administered

You will never have to administer this medicine yourself. It will always be given to you by a qualified healthcare professional.

Your doctor will decide the dose you will receive. This depends on your individual needs, body weight, and the degree of muscle relaxation required.

Zennux will be administered as an injection into your vein (intravenous use). The pre-filled syringe is not suitable for use with a syringe pump.

If you are given more Zennux than you should

Since this medicine will always be administered under carefully controlled conditions, it is unlikely that you will be given more than required. In the event of an overdose, muscle relaxation will last longer than necessary.

If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Very common (may affect more than 1 in 10 people):

• visible muscle contractions under the skin
• muscle pain after surgery – your doctor will monitor you for this.

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

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

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

• breathing difficulty
• elevated body temperature
• difficulty opening the mouth

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

• swelling (angioedema)
• cardiac arrest
• high or low blood pressure
• excessive saliva production
• excessive phlegm production
• temporary loss of air
• muscle injuries

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zennux

Keep this medicine out of the sight and reach of children.

Do not administer this medicine after the expiry date stated on the pre-filled syringe label, blister pack, and carton. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the pre-filled syringe in the closed blister pack until use.

The medicine should be used immediately after opening.

This medicine may be stored for a short period of time at temperatures not exceeding 25°C. In any case, once removed from the refrigerator, the medicine must be discarded after 30 days.

Do not use this medicine if visible signs of deterioration are observed.

Any pre-filled syringe, even if partially used, must be appropriately disposed of after use. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zennux

• The active substance is suxamethonium chloride.

Each ml of injectable 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 components are: sodium chloride, succinic acid, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injections.

Appearance of the product and contents of the pack

Zennux is a clear, colourless injectable solution in a 10 ml polypropylene pre-filled syringe, individually packaged in a transparent blister pack. Carton boxes containing 1 or 10 pre-filled syringes.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer

Laboratoire Aguettant
1, rue Alexander Fleming
69007 LYON
France

Laboratoire Aguettant
Lieu Dit Chantecaille
07340 Champagne
France

Local representative:

Aguettant Ibérica S.L.
Parc Científic de Barcelona
Baldiri Reixac, 4-8 (Torre I)
08028 Barcelona

Date of the most recent review of this leaflet: December 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gov.es/)

This information is intended for healthcare professionals only:

Instructions for use:

The pre-filled syringe is not suitable for use with a syringe pump.

Please prepare the syringe carefully as follows:

The pre-filled syringe is intended for use in a single patient only. Dispose of the syringe after use. Do not reuse.

The medicinal product should be inspected visually for particles and discoloration prior to administration. Only a clear, colourless solution free from particles or precipitates should be used.

The medicinal product must not be used if the syringe’s security seal 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 field once removed from the blister.

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

1. Attach the syringe to an access device or needle. Push the plunger slowly to inject the required volume.