LISAMETHYLE 20 mg /2 Ml Порошок И Раствор Для Инъекционного Раствора

Содержание инструкции

1. LISAMETHYLE 20 mg/2 ml powder and solvent for injectable solution, 40 mg/2 ml powder and solvent for injectable solution, 120 mg/2 ml powder and solvent for injectable solution, 500 mg powder for injectable solution
   1. What is LISAMETHYLE and what is it used for
   2. What you need to know before using LISAMETHYLE
   3. How to use LISAMETHYLE
   4. Possible side effects
   5. How to store LISAMETHYLE
   6. Package Contents and Other Information

LISAMETHYLE 20 mg/2 ml powder and solvent for injectable solution, 40 mg/2 ml powder and solvent for injectable solution, 120 mg/2 ml powder and solvent for injectable solution, 500 mg powder for injectable solution

Methylprednisolone sodium succinate
Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the doctor treating the child or your pharmacist.
• This medicine has been prescribed only for you and/or the child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you and/or the child experience any side effects, including those not listed in this leaflet, tell your doctor or the doctor treating the child or your pharmacist. See section 4.

Contents of this leaflet

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

1. What is LISAMETHYLE and what is it used for

LISAMETHYLE contains the active ingredient methylprednisolone sodium succinate. Methylprednisolone sodium
succinate belongs to a category of medicines called corticosteroids. Corticosteroids are substances
produced naturally by the body and are important for many functions of the body.
LISAMETHYLE is used in adultsand childrenover three years of age for the treatment of:

• diseases in which the body is unable to produce a sufficient amount of natural corticosteroids, for example due to problems with the adrenal glandssuch as adrenal insufficiency;
• skin diseases(pemphigus, severe erythema multiforme, exfoliative dermatitis);
• allergic diseases(bronchial asthma, contact dermatitis, serum sickness, drug allergies, angioedema, urticaria, anaphylactic shock);
• intestinal diseases(ulcerative colitis, segmental ileitis);
• blood cancers(e.g. leukemia in adults and children);
• brain diseases(e.g. conditions caused by a tumor or trauma);
• lung diseasesin subjects affected by AIDS;
• cancers affecting the lymph glands(lymphomas in adults);
• diseases characterized by fluid accumulation(edematous states);
• very advanced stage cancers (palliative therapy).

LISAMETHYLE can also be used for exacerbations of the symptoms of multiple sclerosis and systemic lupus erythematosus or for other stressful conditions.
LISAMETHYLE can also be used in the following diseases:

• generalized skin disease (neurodermatitis);
• acute rheumatic fever(acute inflammatory diseaseaffecting the joints, heart, skin and central nervous system);
• esophageal burns;
• prevention of nausea and vomiting associated with chemotherapy for the treatment of tumors;
• severe lung diseases from Pneumocystis jiroveci in subjects affected by AIDS (adjunctive therapy).

Consult your doctor if you are not sure why this medicine has been prescribed to you or your
child.

2. What you need to know before using LISAMETHYLE

Do not use LISAMETHYLE if you and/or the child:

• are allergicto methylprednisolone sodium succinate or to any of the other ingredients of this medicine (listed in section 6);
• have an infectioncaused by fungithat has spread to some organs or throughout the body;
• if the child was born prematurely, is a newborn or a child under three years of age.

LISAMETHYLE will notbe administered to you/the child through injections into the back
(intrathecal/epidural administration).
You and/or the child should not be vaccinated with “live” or “live attenuated” vaccinesduring treatment
with LISAMETHYLE.

Warnings and precautions
Talk to your doctor or pharmacist BEFOREusing this medicine if:

• you need to undergo skin sensitivity tests;
• you have or have had in the past tuberculosis;
• you are undergoing particular situations of stress. In this case, the doctor will prescribe a higher dose of this medicine to you or your child;
• you have Cushing's syndrome, a disease characterized by excessive production of natural corticosteroids in the body. LISAMETHYLE may worsen your or your child's condition;
• your thyroid gland is functioning less than normal (hypothyroidism). In this case, the doses of LISAMETHYLE must be reduced;
• you have diabetes;
• you suffer from epileptic seizures;
• you suffer from myasthenia gravis, a disease that causes muscle weakness and fatigue or you need to undergo general anesthesiathat involves the use of drugs that block the muscles (e.g. pancuronium). In this case, the risk that LISAMETHYLE causes muscle problems is greater;
• you have an eye infectioncaused by the Herpes simplexvirus;
• you suffer from high blood pressure (hypertension);
• you have high levels of fats in the blood (dyslipidemia);
• you have heart problems (heart failure);
• you suffer from or are predisposed to developing blood clotsin the veins;
• you have a stomach ulceror other serious problems with the stomach or intestines (see "How to use LISAMETHYLE");
• you have kidney problems;
• you have scleroderma(also known as systemic sclerosis, an autoimmune disease), as the use of corticosteroids may increase the risk of a serious complication called scleroderma renal crisis;
• you have a brain injurycaused by trauma;
• you have liver cirrhosis, a liver disease;
• you are being treated with non-steroidal anti-inflammatory drugs(e.g. acetylsalicylic acid) (see section “Other medicines and LISAMETHYLE”) and suffer from reduced activity of prothrombin, a protein that helps the blood to clot;
• you have a type of tumor called pheochromocytoma;
• you suffer from peritonitis or other gastrointestinal diseases because glucocorticoid therapy may mask symptoms such as perforation, obstruction, or pancreatitis.
• If your thyroid is overactive (hyperthyroidism)

If you have cancer, have a high risk of developing tumor lysis syndrome, which can occur when
corticosteroids are used during cancer treatment. Tell your doctor if you have cancer and
present symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion,
irregular heartbeat, loss of vision or visual disturbances, and shortness of breath.
Tell the doctor or the doctor caring for your child if any of the following conditions
occur or worsen DURINGtreatment with this medicine (see also section 4 “Possible
side effects”):

• infections. This medicine may increase susceptibility to infections or worsen ongoing infections. For example, chickenpox and measles may have a more serious course, sometimes fatal;
• Kaposi's sarcoma, a skin tumor. In this case stoptreatment with LISAMETHYLE;
• severe allergic reactions;
• appearance or worsening of mental disorders(e.g. depression). Inform people who live with you about the possible effects of this medicine;
• fat accumulationthat compresses the spinal cord;
• eye problems;
• alterations in the rhythm of the heartbeat (cardiac arrhythmias), reduction in heart rate (bradycardia), circulatory collapsesand cardiac arrest;
• severe inflammation of the pancreasor liver;
• hepatobiliary diseases(reversible after discontinuation);
• osteoporosis(fragile bones);
• swellingin different parts of the body, especially in the legs and ankles, or changes in normal levels of blood mineral salts;
• blurred vision or other visual disturbances.

You or your child should not be vaccinated with “live” or “live attenuated” vaccines during treatment
with LISAMETHYLE (see section “Do not use LISAMETHYLE if you and/or the child”). You can instead
undergo vaccination with killedor inactivatedvaccines, even if the effectiveness of these vaccines may be
reduced.
If you experience muscle weakness, muscle pain, cramps, and stiffness during the use of methylprednisolone, contact your doctor immediately. These may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with an overactive thyroid (hyperthyroidism) treated with
methylprednisolone. Additional treatment may be needed to relieve this condition.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive
anti-doping test.

Children
This medicine should not be given to premature babies, newborns or children under three years of
age.
Treatments with LISAMETHYLE for long periods of time or at high doses can cause delays in
growth, increased pressure inside the skull, inflammation of the pancreas in children.
The use of methylprednisolone in premature newborns may induce the onset of hypertrophic cardiomyopathy
(thickening of the heart walls).

Elderly
If you are elderly, long-term treatment with LISAMETHYLE may increase the risk of
developing osteoporosis, excessive fluid retention in the body, and increased blood pressure.
The doctor will assess your condition and administer this medicine with caution.

Other medicines and LISAMETHYLE
Tell your doctor or pharmacist if you and/or the child are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription.
Some medicines can increase the effects of LISAMETHYLE and the doctor may want to keep you under
close observation if you are taking these medicines.
The following medicines can affect the activity of LISAMETHYLE or LISAMETHYLE can
affect the effectiveness and/or toxicity of the following medicines:

• isoniazid, troleandomycin, clarithromycinand erythromycin(antibiotics);
• methotrexate, used for the treatment of tumors and autoimmune diseases;
• rifampicin(antibiotic against tuberculosis);
• phenobarbital, phenytoinand carbamazepine(medicines against seizures);
• aprepitantand fosaprepitant(medicines against vomiting);
• itraconazole, ketoconazoleand amphotericin B(medicines against fungal infections);
• medicines for the treatment of HIVsuch as indinavir, ritonavirand cobicistat(medicines against the HIV virus);
• aminoglutethimide(medicine against the excessive production of natural corticosteroids);
• diltiazem(medicine used for the treatment of heart problems or high blood pressure);
• ethinylestradiol/norethindrone(hormones used in combination as oral contraceptives);
• cyclosporine, cyclophosphamideand tacrolimus, medicines against rejection after organ transplantation and against autoimmune diseases;
• oral anticoagulants, medicines used to thin the blood;
• neuromuscular blockerssuch as pancuroniumand vecuronium(medicines that cause muscle relaxation);
• anticholinesterases, such as pyridostigmineand neostigmine(medicines against muscle diseases, such as myasthenia gravis, and Alzheimer's);
• antidiabetics(medicines against diabetes);
• aspirin(acetylsalicylic acid);
• diuretics(medicines that increase urine production);
• xanthines(e.g. theophylline) and beta-2-agonists(e.g. salbutamol), medicines against asthma;
• antihypertensives, medicines used to lower blood pressure;
• digoxin, used for the treatment of heart failure and/or irregular heartbeat;
• psychotropic drugs(anxiolytics and antipsychotics), medicines used to treat anxiety and mental illness.

LISAMETHYLE with drinks
You and/or the child must notdrink grapefruit juiceduring treatment with LISAMETHYLE, because
the effectiveness and toxicity of this medicine may increase.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using/being given this medicine.
Pregnancy
If you use this medicine during pregnancy, especially at high doses and for a long time,
the baby may experience undesirable effects at birth. Therefore, if you are pregnant, your doctor will prescribe LISAMETHYLE only if strictly necessary.
Breastfeeding
LISAMETHYLE passes into breast milk and this may cause undesirable effects in the baby. If you
are breastfeeding, your doctor will prescribe LISAMETHYLE only if strictly necessary.
Fertility
Based on the information available so far, this medicine may reduce fertility.

Driving and operating machinery
Do not drivevehicles or operate machinery if you experience dizziness,
vertigo, visual disturbances, fatigue, euphoria or mood disturbances during treatment with LISAMETHYLE.

LISAMETHYLE contains sodium

LISAMETHYLE 20 mg/2 ml, 40 mg/2 ml, 120 mg/2 ml: contains less than 1 mmol (23mg) of sodium per
vial, i.e. it is practically “sodium-free”.

3. How to use LISAMETHYLE

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The doctor will establish the dose of LISAMETHYLE that will be administered to you after evaluating the severity of the
clinical condition to be treated and your state of health (yours or your child’s).
During treatment, your response to treatment will be monitored, therefore, the dose may be
modified. The doctor will explain how to reduce the dose before stopping LISAMETHYLE.

Adults
The recommended starting dose ranges from 10 mg to 40 mg, to be administered intravenously (into a vein)
over several minutes.
Subsequent doses may be administered intravenously or intramuscularly (into a muscle).
LISAMETHYLE can be administered at high doses for up to a maximum of 48-72 hours.
In this case, the recommended dose is 30 mg/kg of body weight administered intravenously over a
30-minute interval. The dose may be repeated every 4-6 hours over 48 hours.

Children over 3 years of age
The doctor will establish the dose based on the severity of the child’s condition, their response to
therapy, their age and their body weight.
The recommended dose should not be less than 0.5 mg/kg of body weight per day.

Method of administration
LISAMETHYLE is administered intravenously (through injection into a vein), intramuscularly (into a muscle), by
infusion (infusion into a vein) or through an infusion pump (infusion
into a vein with an electronic device).
In case of emergency, prefer the intravenous route of administration.
Administration into a vein will be performed by specialized healthcare personnel.

If you use/are given more LISAMETHYLE than you should
If you use/are given a dose of this medicine much higher than the prescribed one, you may experience, although rarely, acute toxicity and death.
Seek immediate medical attention or go to the nearest hospital if you and/or the child have accidentally used
excessive doses of LISAMETHYLE.

If you forget to use LISAMETHYLE
Do not use a double dose to make up for a missed dose.
If you realize you have forgotten a dose, consult your doctor.

If you stop treatment with LISAMETHYLE
You or your child must not suddenly stop taking LISAMETHYLE.
LISAMETHYLE can cause a reduction in the function of the adrenal glands that produce the
natural corticosteroids and abrupt discontinuation can lead to death.
Furthermore, in case of abrupt discontinuation of treatment with LISAMETHYLE, you or the child may
develop withdrawal symptomssuch as: anorexia, nausea, vomiting, excessive drowsiness, headache,
fever, muscle and joint pain, skin flaking, weight loss, low
blood pressure and mental disorders.
In case of discontinuation, the doses must be reduced gradually. The doctor will advise you on how to do it correctly (see “How to use LISAMETHYLE”).
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:

Frequency not known(frequency cannot be estimated from the available data):

• infections, including infections that occur when the body's immune defenses are very low
• increased number of white blood cells in the blood
• hypersensitivity to the medicine
• severe allergic reaction, e.g. swelling of the face, tongue and throat with difficulty swallowing and breathing (angioedema)
• urticaria
• round or moon-shaped face (Cushingoid appearance)
• reduced hormone secretion from the pituitary gland (a gland located at the base of the brain)
• withdrawal syndrome (see section 3 “If you stop taking LISAMETHYLE”)
• metabolic acidosis
• glucose metabolism abnormality and worsening of existing diabetes
• increased or loss of acidic substances from the body
• high levels of fat in the blood
• retention of fluids and sodium in the body
• increased levels of urea in the blood
• increased appetite and body weight
• accumulation of adipose tissue in localized parts of the body
• increased body fat
• mental disorders such as: depression, euphoria, manic behavior, delirium, hallucinations, schizophrenia, altered perception of reality and thought disorders, disorders in experiencing emotions (e.g. mood swings, emotional dependence, suicidal ideation), personality changes, confusion, anxiety, abnormal behavior, insomnia, irritability
• increased pressure of fluid in the skull
• convulsions
• difficulty remembering
• disorders of thought that allow awareness of reality
• dizziness
• headache
• accumulation of fat compressing the spinal cord
• cataract
• increased internal pressure of the eye
• protruding eyes
• reduced vision in the central part of the visual field
• retinal and choroidal membrane disease
• heart problems (heart failure), in sensitive patients
• irregular heartbeat
• formation of blood clots in the veins and lungs
• increased blood coagulation
• increase or decrease in blood pressure
• heat and redness of the skin (flushing)
• hiccups
• ulcer of the stomach and intestines with possible bleeding and perforation
• inflammation of the pancreas
• inflammation of the abdomen (peritonitis)
• inflammation of the esophagus with or without ulcers
• distension and pain in the abdomen
• difficulty digesting
• nausea, vomiting and diarrhea
• inflammation of the liver
• delayed wound healing
• thinning and fragility of the skin
• discolored patches on the skin
• atrophy of the skin and appendages (hair, nails)
• pus formation
• swelling
• bruising
• appearance of small red spots or fine purple lines on the skin
• increased hair growth
• redness of the skin, skin rashes
• itching
• acne
• excessive sweating
• fragile bones (osteoporosis), death and loss of bone tissue
• muscle and joint pain, muscle diseases, reduction of muscle mass
• muscle weakness
• joint rupture (especially of the foot) causing pain and/or swelling
• irregular menstruation
• reaction at the injection site
• fatigue, malaise
• alteration of laboratory tests to evaluate liver function
• possible liver damage, hepatitis, increased liver enzymes
• decreased levels of potassium in the blood
• increased levels of calcium in the urine
• reduced response to skin tests
• fractures of the vertebrae (from trauma or spontaneous), rupture of tendons, in particular the Achilles tendon
• blurred vision

Additional side effects in children
Frequency not known(frequency cannot be estimated from the available data):

• growth retardation

Reporting of side effects
If you/your child experience any side effect, including those not listed in this leaflet,
please tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://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 LISAMETHYLE

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 package and vial after
“Exp.”. The expiry date refers to the last day of that month. The expiry date indicated refers to the
product in intact packaging, correctly stored.
Store this medicine at a temperature below 25 °C. Shelf life after

reconstitution: use within 4 hours.
Do not dispose of any medicine in 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 LISAMETHYLE contains
The active ingredient is methylprednisolone (as methylprednisolone sodium succinate).

LISAMETHYLE 20 mg/2ml powder and solvent for injectable solution
Each vial of powder contains 20 mg of methylprednisolone (equivalent to 26.5 mg of methylprednisolone
sodium succinate).
The other component is: water for injections.

LISAMETHYLE 40 mg/2ml powder and solvent for injectable solution
Each vial of powder contains 40 mg of methylprednisolone (equivalent to 53.0 mg of methylprednisolone
sodium succinate).
The other component is: water for injections.

LISAMETHYLE 120 mg/2ml powder and solvent for injectable solution
Each vial of powder contains 120 mg of methylprednisolone (equivalent to 159.0 mg of
methylprednisolone sodium succinate).
The other component is: water for injections.

LISAMETHYLE 500 mg powder for injectable solution
Each vial of powder contains 500 mg of methylprednisolone (equivalent to 663.0 mg of
methylprednisolone sodium succinate).

Description of the appearance of LISAMETHYLE and package contents
LISAMETHYLE 20 mg/2 ml powder and solvent for injectable solution is available in packs
containing 1 vial containing the powder + 1 vial of solvent 2 ml.
LISAMETHYLE 40 mg/2 ml powder and solvent for injectable solution is available in packs
containing 1 vial containing the powder + 1 vial of solvent 2 ml.
LISAMETHYLE 120 mg/2 ml powder and solvent for injectable solution is available in packs
containing 1 vial containing the powder + 1 vial of solvent 2 ml.
LISAMETHYLE 500 mg powder for injectable solution is available in packs containing 1
vial.

Marketing Authorisation Holder and Manufacturer
Lab. It. Biochim. Farm.co LISAPHARMA S.p.A. - Via Licinio 11 - 22036 Erba (CO)
February 2025

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The following information is intended exclusively for doctors and healthcare professionals:
INCOMPATIBILITIES
To avoid compatibility and stability issues, it is recommended to administer methylprednisolone sodium
succinate separately from other substances that are administered intravenously. Drugs that
are physically incompatible in solution with methylprednisolone sodium succinate include, but are not
limited to: sodium allopurinol, doxapram hydrochloride, tigecycline, diltiazem hydrochloride, but also include calcium gluconate, vecuronium bromide, rocuronium bromide, cisatracurium besilate,
glycopyrrolate, propofol.

DOSAGE
The dose should be established considering the clinical condition to be treated and its severity.
It is recommended to use the minimum effective dose and for the shortest possible time.
Treatment should be adjusted to the observed response and maintenance should be established with a
gradual titration that allows for an adequate clinical response.
In case of long-term treatment, the medicine should be discontinued gradually (see “Warnings and
Precautions”).
After emergency treatment, consider the use of an injectable formulation with a longer action
or an oral formulation.
In case of treatment with high doses, the recommended dose of LISAMETHYLE is 30 mg/kg administered
intravenously over an interval of at least 30 minutes. The dose may be repeated every 4-6 hours
within 48 hours. Treatment with high doses should be continued until clinical conditions stabilize; however, it should not be prolonged beyond 48-72 hours. The use of high doses in the short term can lead to the onset of peptic ulcer; therefore, prophylactic treatment is recommended (see “Warnings and Precautions” and “Undesirable Effects”).

Episodes of exacerbation of systemic lupus erythematosus and edematous states caused by glomerulonephritis
or lupus nephritis:
pulsed intravenous administration of 250 – 1000 mg per day for 1-3 days is recommended.
In case of exacerbation of pathological states or in the absence of response to standard therapies, the
following intravenous boluses are recommended:

Multiple sclerosis
1 g per day intravenously for 3 - 5 days

Acute spinal cord injuries
Treatment should be started within 8 hours of trauma with a bolus of 30 mg/kg to be administered
over 15 minutes, followed by an interval of 45 minutes and a maintenance infusion of 5.4 mg/kg
per hour during the following 23 hours.
The choice of treatment must be made on a case-by-case basis, with a careful risk/benefit assessment, and
referring to official Guidelines.
Rigorous monitoring of the traumatized patient is also necessary, given the high risk of toxicity related to
the high dose of methylprednisolone administered.

Palliative therapy in very advanced stage cancer
The recommended dose is 120 mg per day; careful evaluation is necessary on a case-by-case basis regarding
short-term treatment.

In the prevention of nausea and vomiting associated with mildly or moderately emetogenic chemotherapy:
120-240 mg of LISAMETHYLE, also in association with a phenothiazine, one hour before
chemotherapy.
Followed by a second dose of LISAMETHYLE at the time of chemotherapy and a final one to be
administered before discharge.

Prophylaxis of nausea and vomiting associated with highly emetogenic chemotherapy:
240 mg of LISAMETHYLE associated with 1-2.5 mg of droperidol or 1.5-2 mg/kg of metoclopramide one hour
before chemotherapy.
Followed by a second dose of LISAMETHYLE at the time of chemotherapy and a final one to be
administered before discharge.
In any case, the brevity of the treatment is recommended.

Adjuvant therapy for severe Pneumocystis jiroveci pneumonia in patients with AIDS.
0.5 mg/kg every 6 hours for 10 days.
Administration must occur within 72 hours of starting antimicrobial therapy.
For other indications, the initial dose may vary from 10 to 40 mg of methylprednisolone depending on
the clinical condition to be treated.
In acute and severe conditions, higher doses may be necessary. In such cases, a short duration of treatment is strongly
recommended.
The initial dose should be administered intravenously over several minutes.
Subsequent doses can be administered intravenously or intramuscularly; the choice of the route of
administration should take into account the condition to be treated and the response obtained.
Corticosteroid therapy is an adjuvant and not a substitute for conventional therapy.
If, during the treatment of a chronic disease, remission is noted, the medicine should be
discontinued (see “Warnings and Precautions”).

Paediatric population
In children over 3 years of age, the dose should be guided, rather than by age and weight, by
the severity of the condition to be treated and the response obtained.
The dose should not be less than 0.5 mg/kg per day.
The dosage should be gradually reduced if the treatment has been prolonged for more than a few days.

ROUTE OF ADMINISTRATION
Remove the protective cap of the vial and proceed in the usual manner.
LISAMETHYLE can be administered by intravenous injection, intramuscularly, by fleboclisis and
through an infusion pump.
In case of emergency, prefer the intravenous route of administration.
In case of intramuscular and intravenous injections, no further dilution is necessary. For fleboclisis
dilute LISAMETHYLE in a volume of 100 to 1000 ml of 5% glucose solution or saline solution.
After dilution or reconstitution of the solution, LISAMETHYLE must be used within 4 hours.

UNDESIRABLE EFFECTS
The following adverse reactions have been reported with the contraindicated intrathecal/epidural routes of administration: arachnoiditis, gastrointestinal/vesical dysfunction, headache, meningitis, paraparesis/paraplegia,
seizures, sensory disturbances. The frequency of these adverse reactions is unknown.

For further information, consult the SmPC (Summary of Product Characteristics).