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LISTENON 100 mg./5 ml. 5 ampoules

Product Code: LISTENON 100 mg./5 ml. 5 ampoules
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Active substance: 1 ml contains 10 mg Suxamethonium chloride (as Suxamethonium chloride dihydrate).
Excipients: Sodium chloride, water for injections.
1 ampoule of 5 ml contains 50 mg Suxamethonium chloride as Suxamethonium chloride dihydrate in an isotonic aqueous solution.

Manufacturer and Marketing Authorisation Holder:
Nycomed Austria GmbH, Austria.

1. What Listenon 10 mg / ml and what it is used
Listenon 10 mg / ml induces relaxation of skeletal muscle by blocking the transmission of impulses in the final neuromuscular synapses. The action of Listenon 10 mg / ml began almost immediately after its application - from 30 sec to 1 min. The duration of effect is small, about 2 min and 8-10 min after the granting of the muscles cease.
Listenon 10 mg / ml is used for relaxation of skeletal muscle endotracheal intubation during surgery, reduction of fractures and dislocations, relieve muscle spasms during electroshock therapy.

2. How to apply Listenon 10 mg / ml
Route of administration:
Listenon 10 mg / ml is administered by intravenous injection (may also infused), and if necessary, by intramuscular injection.
Ampoules with breaking point. Does not require cutting.

Turn ampoule point upward. Leave the solution to flow down gently shaking the vial. Turn ampoule colored point to himself. Breaking end.

Listenon 10 mg / ml, as well as all other relaxants peripherally acting can only be administered by physicians experienced in artificial respiration and endo-tracheal intubation. The dosage of Listenon 10 mg / ml is determined by the physician and depend on your age and body weight, the desired degree of muscle relaxation, the route of administration and the individual response of the patient.
For further information see "Information for healthcare professionals" at the end of the leaflet.

3. Before taking Listenon 10 mg / ml
Listenon 10 mg / ml, and other relaxants peripherally acting can only be administered by medical specialists with expertise in the application of artificial respiration and endotracheal intubation, which have at their disposal the necessary equipment for ventilation with high pressure oxygen supply and separation of carbon dioxide.

Use in children and adolescents
In children and adolescents in the application of the product have been reported cases of irreversible cardiac events (cardiac arrest) in patients suffering from neuromuscular diseases who have not been diagnosed before. Due to severe adverse reactions is recommended even in apparently healthy children to apply Listenon 10 mg / ml only in urgent cases in need of immediate intubation or maintain a clear airway.

Pregnancy and lactation
Listenon 10 mg / ml must not be used during pregnancy only when absolutely necessary. Pseudo-cholinesterase levels may be decreased to 25% during pregnancy. This can lead to extended effect of Listenon 10 mg / ml, especially in the application of repeated doses. Normal levels of pseudo-cholinesterase activity are achieved 6-8 weeks after birth.
Listenon excretion of 10 mg / ml in breast milk is unknown and the consequences for the infant are unknown. Listenon 10 mg / ml should not be used during breastfeeding.

Effects on ability to drive and use machines
Special attention should be paid when driving or operating machinery until 24 hours after Listenon 10 mg / ml. This is necessary because co-administration of anesthetics

Listenon 10 mg / ml should not apply in the case of:
Hypersensitivity to Listenon 10 mg / ml;
Acute hepatic dysfunction, pulmonary edema, malignant hyperthermia (hyperpyrexia), cholinesterase deficiency, hyperkalemia;
Neuromuscular diseases and neurological disorders, muscle rigidity;
Patients with severe injuries or major burns, penetrating eye injuries;
Be used with caution in patients suffering from heart diseases in children and adolescents;
Not recommended implementing Listenon 10 mg / ml in patients with uremia, especially in the presence of high serum potassium levels.
Interactions of Listenon 10 mg / ml with other drugs
Heart and circulation
Digitalis (Digioxin)
Amplification of digitalis-induced ventricular excitability and effects on conduction and / or exit of potassium from muscle cells digitized myocardium. Increased cardiac excitability, leading to increased risk of cardiac dysrhythmias.

Anti-infective drugs
Aminoglycosides (gentamycin, neomycin, kanamycin, streptomycin)
Additive neuromuscular blocking effect.
Enhancement of neuromuscular blockade and extension of Suxamethonium.

Muscles, joints and bones
Local anesthetics (procaine, lidocaine)
Local anesthetics are hydrolyzed by plasma cholinesterase. Competitive amplification of the action, leading to a sustained release of Suxamethonium. Neostigmine, physostigmine, tacrine and other cholinesterase inhibitors block the plasma cholinesterase and acetylcholinesterase.
Prolonged action if acetylcholinesterase inhibitors are applied in the application of Suxamethonium.

central nervous system
General anesthetics
Enflurance, desfhirance, isoflurance.
Neuromuscular blockade is potentiated dose dependent upon inhalation anesthetic desflurance.

Metoclopramid (antiemetic)
Reduced plasma cholinesterase activity, leading to a prolongation of the action of Suxamethonium.

Magnesium sulfate
Inhibit release of acetylcholine and reduces the sensitivity of the postsynaptic membrane. Extension of Suxamethonium. The application of magnesium should be discontinued 20-30 min prior to administration of muscle relaxant.

respiratory organs
Terbutaline, bambuterol (product of terbutaline)
Reversibly inhibits plasma cholinesterase activity. Prolongation of the action of Suxamethonium.

Irreversibly inhibits cholinesterase activity, possibly by alkalized of the enzyme, resulting in a slow metabolism Suxamethonium. Sustained release of Suxamethonium.

Parathion and malathion (fosfoorganichni insecticides containing ethiopate)
Ethiopate inhibits the activity of acetylcholinesterase and pseudo-cholinesterase. A sustained release of Suxamethonium because of the reduced free cholinesterase levels.
Previous administration of Suxamethonium enhances the action of non-depolarizing relaxants. Previous administration of nondepolarizing relieve or prevent the side effects of Suxamethonium.
Adverse reactions of the heart and circulation are enhanced by halogenated drugs (halothane), and weakening of thiopental and atropine.
Blocking neuromuscular action Suxamethonium is amplified by polypeptide antibiotics, aniphotericin B, cyclopropane, propanidid, quinidine, thiotepa, parasimpanikomimetitsi, including cholinesterase inhibitors, ajmaline, beta-blockers, calcium channel blockers, phenelzine, thiophosphamide, oxytocin, cimetidine, perphenazine , phenothiazine, lithium, and oral contraceptives.
Under the influence of alcohol and drugs inhibiting the activity of the central nervous system, symptoms of overdose are amplified.
Concomitant administration of volatile anesthetics should be avoided due to an increased risk of occurrence of malignant hyperthermia and increased muscle damage caused by Suxamethonium.
Joint infusion of blood or plasma weakens the effect of Suxamethonium.

Listenon 10 mg / ml is compatible with isotonic sodium chloride solution, Ringer's solution, 5% fructose solution, 5% dextrose, and 6% dextran solution.

Mixing Listenon 10 mg / ml with an alkali (eg. Barbiturates) can neutralize the action of the product

4. Possible side effects
Like any other medicine Listenon 10 mg / ml can cause side effects. Listenon 10 mg / ml have serious and potentially dangerous side effects:
The most frequent non-hazardous side effects include: muscle pain (60%) and muscle fibrillation (90%), non-fatal acute increases in serum potassium (100%), mild bradycardia (50% of children, adults rarely) and myoglobinaemia (20% of children) are very common.
Common are increased intraocular pressure and intrastomashno and hypersensitivity reactions such as ecchymosis.
The following adverse reactions are the most dangerous and rarely seen, but must be taken into account when applying Listenon 10 mg / ml.
Fatal increases in serum potassium with the development of arrhythmias and cardiac arrest, malignant hyperthermia, anaphylactic shock, rhabdomyolysis and myoglobinaemia with renal failure and prolonged paralysis.

Blood and lymphatic system
Very common: Non-fatal increases in serum potassium in 100% of cases (a slight increase of 0,5 mmol / l most common). Myoglobinaemia (20% of children received Listenon 10 mg / ml intravenous develop myoglobinaemia, adults rarely). The reaction was not dose-dependent and can be monitored with or without fibrillation.
Very rare: Ventricular fibrillation and cardiac arrest caused by hyperkalemia.

Immune System Disorders
Common: hypersensitivity reactions (ecchymosis, urticaria).
Rare: bronchospasm.
Very rare: Anaphylactic shock with ecchymosis, with or without bronchospasm and hypotension flowing in complete shock.

Endocrine disorders
Very rare: Malignant hyperthermia (in 0.002% of adults and 0.006% of the children, or once every 15000-150000 anesthesia) with or without muscle hypertonia (stubborn spasm of the jaw muscles), cardiovascular complications (hyperventilation, unstable blood pressure) and fever, severe acidosis, hyperkalemia, hemoglobinuria and myoglobinuria.

Metabolism and nutrition
Very rare: Life threatening hyperkalemia in patients with increased risk of fatal increase in serum potassium after administration of Listenon 10 mg / ml.

Eye disorders
Common: Increased intraocularly pressure (probably due to the contraction of extra-ocular muscles and increase blood volume choroid).

cardiac disorders
Very common: Arrhythmias (mild bradycardia, nodal rhythm, ectopic) were observed in 50% of children and 20% of adults after the first intravenous injection. Most often incidents were observed in infants and young children. Incidents rise regardless of age; if administered a second dose within 15 min of the initial dose. Incidents of bradycardia may be reduced in premedication with atropine.
Uncommon: Transient hypertension, tachycardia.
Very rare: Ventricular arrhythmia, ventricular fibrillation due to hyperkalemia, hypercalcemia (see section 4.8. Blood and lymphatic system). Cardiac arrest induced by Listenon 10 mg / ml induced hyperkalemia, particularly in children with undiagnosed skeletal muscle myopathies (muscular dystrophy Duchenne). Severe hypotension due to anaphylactic reactions (see section 4.8. Immune system).

Respiratory, thoracic and mediastinal disorders
Rare: Prolonged apnea in patients with a defect in plasma pseudo-cholinesterase, see section 4.4.

Very rare: Late respiratory failure in muscular dystrophy Duchenne. Secondary bronchospasm as anaphylactoid reactions (see section 4.8. Immune system). Laryngeal edema and pulmonary edema.

Disorders of the digestive system
Common: Increased intrastomashno pressure (risk of regurgitation in pregnant women, patients with hiatal hernia, gastric or intestinal dilatation, ascites and intra-abdominal tumors, see section. 4.4).
Uncommon: Increased salivary secretion.

Skin and subcutaneous tissue disorders
Common: Redness of the skin due to histamine release.
Very rare: anaphylactoid reactions.

Disorders of the musculoskeletal system and connective tissue
Very common: Muscle pain after muscle fibrillation observed in 60% of patients. Most often in the neck, chest, shoulders and back, the most common in women between 20 and 50 years of age. Muscle fibrillation (90%).
Uncommon: A slight increase in pressure jaw (60 seconds), after application of Listenon 10 mg / ml. May be decreased by administration of propofol and a small dose of non-depolarising muscle relaxant.
Rare: Muscle contractions instead of the usual relaxation (most often associated with dystrophic myotonia congenital myotonia). Prolonged paralysis due to development of dual block can be seen in neuromuscular diseases or develop in ideosinkreziya (see paragraph 5.2. Inherited variations in plasma cholinesterase), an overdose or reduced levels of plasma cholinesterase.
Very rare: Acute rhabdomyolysis in patients with diagnosed or undiagnosed neuromuscular diseases.

Renal and urinary
Rare: Myoglobinuria or elevated CPK (creatine kinase) levels, most often seen in children treated with Listenon 10 mg / ml and halothane.
Very rare: Myoglobinuria causing kidney failure. The most commonly in patients with (latent) muscular dystrophy.
Longer relaxation, with possible apnea may be due to: "Atypical" serum cholinesterase, congenital deficiency of serum cholinesterase or temporary reduction of serum cholinesterase, liver diseases, severe anemia after prolonged starvation, cachexia, dehydration, febrile conditions after acute poisoning, chronic exposure or ingestion of blocking holinesterata insecticides or drugs (phospholine, demecarium, neostigmine, physostigmine, distigmine) and concomitant use of drugs competing with enzyme breaks down succinylcholine (eg. procaine iv).
Increased duration of the relaxation of muscles at risk of respiratory arrest can be caused by:
"Atypical" serum cholinesterase, congenital deficiency of serum cholinesterase;
Temporary reduction in serum cholinesterase: acute liver disease, acute anemia after prolonged fasting, weight loss, dehydration, fever;
After acute poisoning, acceptance or permanent exposure to cholinesterase inhibitors - insecticides or drugs (fosfolin, demekarium, neostigmine, physostigmine, distigmin) and concomitant use of drugs in competition with Listenoi 10 mg / ml of the enzyme (such as procaine ), which is decomposed by plasma cholinesterase.
Ampoules Listenon 10 mg / ml of 5 ml. Pack of 5 and 25 ampoules.

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