Solu Medrol

Package leaflet: Information for the patient

SOLU MEDROL 125 mg/2 ml powder and solvent for injectable solution, 500 mg/7.8 ml powder and solvent for injectable solution, 1000 mg/15.6 ml powder and solvent for injectable solution

Sodium methylprednisolone succinate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or the doctor treating the child or the pharmacist.
• This medicine has been prescribed for you and/or for the child only. 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, consult your doctor or the doctor treating the child or the pharmacist. See section 4.

Contents of this leaflet:

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

1. What SOLU MEDROL is and what it is used for

SOLU MEDROL contains the active substance methylprednisolone sodium succinate.
Methylprednisolone sodium succinate belongs to a class of medicines called corticosteroids. Corticosteroids are substances naturally produced by the body and are important for many bodily functions.

SOLU MEDROL is used in adults and children over three years of age to treat:

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

SOLU MEDROL may also be used for relapses of symptoms in multiple sclerosis and systemic lupus erythematosus or for other stressful conditions.
SOLU MEDROL may also be used in the following diseases:

• generalized skin disease (neurodermatitis)
• acute rheumatic fever (acute inflammatory disease affecting the joints, heart, skin, and central nervous system)
• esophageal burns
• prevention of nausea and vomiting associated with chemotherapy for cancer treatment
• severe Pneumocystis jiroveci lung disease in patients with A.I.D.S. (adjuvant therapy)

Consult your doctor if you are unsure why this medicine has been prescribed for you or your child.

2. What you should know before using SOLU MEDROL

Do not use SOLU MEDROL if you and/or the child:

• are allergic to sodium methylprednisolone succinate or to any of the other ingredients of this medicine (listed in section 6).
• have a fungal infection that has spread to certain organs or throughout the body;
• the child was born prematurely, is a newborn, or is under three years of age.

SOLU MEDROL will not be administered to you/the child via injections into the back
(intrathecal/epidural administration).
You and/or the child must not be vaccinated with "live" or "live attenuated" vaccines during
treatment with SOLU MEDROL.
Warnings and precautions
Talk to your doctor or pharmacist BEFORE using this medicine if:

• you need to undergo skin sensitivity tests;
• you have or have previously had tuberculosis;
• you are under particular conditions of stress. In such cases, your doctor will prescribe a higher dose of this medicine for you or your child;
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• you have Cushing's syndrome, a disease characterized by excessive production of natural corticosteroids in the body. SOLU MEDROL may worsen your or your child’s condition;
• your thyroid gland is underactive ( hypothyroidism ). In this case, doses of SOLU MEDROL should be reduced;
• you have diabetes;
• you suffer from epileptic seizures;
• you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue, or you are scheduled for surgery with general anaesthesia involving muscle-blocking drugs (e.g. pancuronium). In this case, the risk that SOLU MEDROL causes muscle problems is higher;
• you have an eye infection caused by the Herpes simplex virus;
• you suffer from high blood pressure ( hypertension);
• you have high levels of fat in the blood ( dyslipidaemia);
• you have heart problems ( heart failure);
• you suffer from or are predisposed to developing blood clots in the veins;
• you have a stomach ulcer or other serious stomach or intestinal problems (see section “How to use SOLU MEDROL”);
• you have kidney problems;
• you have scleroderma (also known as systemic sclerosis, an autoimmune disease), since the use of corticosteroids may increase the risk of a serious complication called scleroderma renal crisis;
• you have a brain injury caused 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 SOLU MEDROL”) and have reduced activity of prothrombin, a protein that helps blood to clot;
• you have a type of tumour called phaeochromocytoma;
• you suffer from peritonitis or other gastrointestinal disorders, because glucocorticoid therapy may mask symptoms such as perforation, obstruction, or pancreatitis.
• your thyroid gland is overactive ( hyperthyroidism). If, during treatment with methylprednisolone, you experience muscle weakness, muscle pain, cramps, and stiffness, contact your doctor immediately. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperactive thyroid (hyperthyroidism) treated with methylprednisolone. Additional treatment may be required to relieve this condition.

If you have cancer, you are at increased risk of developing tumour lysis syndrome, which may
occur when corticosteroids are used during cancer treatment.
Inform your doctor if you have cancer and experience symptoms of tumour lysis syndrome such
as muscle cramps, muscle weakness, confusion, irregular heartbeat, loss of vision or visual
disturbances, and shortness of breath.

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Inform your doctor or the doctor treating your child if any of the following
conditions appear or worsen DURING treatment with this medicine (see also section 4 “Possible side effects”):

• infections. This medicine may reduce resistance to various infections, mask certain infection symptoms, worsen ongoing infections, or cause recurrence or worsening of hidden old infections. New infections may also occur during treatment with Solu-Medrol. Therefore, certain infections may occur more easily during treatment, for example, chickenpox and measles. These infections may be mild, severe, and sometimes fatal. Your doctor will monitor you closely for the development of infections and may consider, if necessary, stopping treatment or reducing the dose.
• Kaposi's sarcoma, a skin tumour. In this case, discontinue treatment with SOLU MEDROL;
• severe allergic reactions;
• onset or worsening of mental disorders (e.g. depression). Inform people living with you about the possible effects of this medicine;
• fat accumulation compressing the spinal cord;
• eye problems;
• changes in heart rhythm ( cardiac arrhythmias), decreased heart rate ( bradycardia), circulatory collapse, and cardiac arrest;
• severe inflammation of the pancreas or liver;
• hepatobiliary disorders (reversible after discontinuation);
• osteoporosis (fragile bones);
• swelling in various parts of the body, especially in the legs and ankles, or changes in normal levels of mineral salts in the blood.
• blurred vision or other visual disturbances.

You or your child must not be vaccinated with "live" or "live attenuated" vaccines during
treatment with SOLU MEDROL (see section “Do not use SOLU MEDROL if you and/or the
child”). However, you may be vaccinated with killed or inactivated vaccines, although
the effectiveness of these vaccines may be reduced.
Oral anticoagulants (medicines taken by mouth to prevent blood clotting) taken together with Solu-Medrol may increase the risk of bleeding. In some cases, the effectiveness of oral anticoagulants may be reduced. Your doctor may need to frequently monitor your bleeding risk by performing additional blood tests during treatment with Solu-Medrol. Your doctor may also need to adjust the dose of Solu-Medrol if necessary.
For athletes
Using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children

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This medicine must not be given to premature infants, newborns, or children under three years of age. Long-term or high-dose treatment with SOLU MEDROL may cause growth retardation, increased intracranial pressure, and pancreatitis in children.
The use of methylprednisolone in premature newborns may induce hypertrophic cardiomyopathy (thickening of the heart walls).
Benzyl alcohol, one of the components of SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml, may cause serious, even fatal, adverse effects in children and newborns, such as a condition called “gasping syndrome”, characterized by agonal breathing (gasping breaths with reduced respiration down to respiratory arrest).
It is recommended to use this medicine only if strictly necessary and if no other alternatives are available.
Elderly
If you are elderly, long-term treatment with SOLU MEDROL may increase the risk of developing osteoporosis, excessive fluid retention in the body, and increased blood pressure. Your doctor will evaluate your condition and administer this medicine with caution.
Other medicines and SOLU MEDROL
Inform your doctor or pharmacist if you and/or the child are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines may increase the effects of SOLU MEDROL, and your doctor may want to monitor you closely if you are taking these medicines.
The following medicines may affect the activity of SOLU MEDROL or SOLU MEDROL may affect the efficacy and/or toxicity of the following medicines:

• isoniazid, troleandomycin, clarithromycin, and erythromycin (antibiotics);
• methotrexate, used for the treatment of tumours and autoimmune diseases;
• rifampicin (antibiotic for tuberculosis);
• phenobarbital, phenytoin, and carbamazepine (medicines for seizures);
• aprepitant and fosaprepitant (medicines for vomiting);
• itraconazole, ketoconazole, and amphotericin B (medicines for fungal infections);
• HIV medicines such as indinavir, ritonavir, and cobicistat (medicines against HIV virus);
• aminoglutethimide (medicine for excessive production of natural corticosteroids);
• diltiazem (medicine used for heart problems or high blood pressure);
• ethinylestradiol/norethindrone (hormones used in combination as oral contraceptives);
• cyclosporine, cyclophosphamide, and tacrolimus, medicines to prevent organ transplant rejection and for autoimmune diseases;
• oral anticoagulants (medicines taken by mouth to prevent blood clotting);
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• neuromuscular blockers such as pancuronium and vecuronium (medicines causing muscle relaxation);
• anticholinesterases such as pyridostigmine and neostigmine (medicines for muscle diseases like myasthenia gravis and Alzheimer's);
• antidiabetics (medicines for diabetes);
• aspirin (acetylsalicylic acid);
• diuretics (medicines that increase urine production);
• xanthines (e.g. theophylline) and beta-2 agonists (e.g. salbutamol), medicines for asthma;
• antihypertensives, medicines used to lower blood pressure;
• digoxin, used for treatment of heart failure and/or irregular heartbeat;
• psychotropic medicines (anxiolytics and antipsychotics), medicines used to treat anxiety and mental disorders.

SOLU MEDROL with beverages
You and/or the child must not drink grapefruit juice during treatment with SOLU
MEDROL, as the efficacy and toxicity of this medicine may increase.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using/being administered this medicine.
Pregnancy
If you use this medicine during pregnancy, especially at high doses and for a prolonged period, the baby may experience adverse effects at birth.
Therefore, if you are pregnant, your doctor will prescribe SOLU MEDROL only if strictly necessary.
SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml contain benzyl alcohol (see section “SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml contain benzyl alcohol”)
Breastfeeding
SOLU MEDROL passes into breast milk and may cause adverse effects in the infant. If you are breastfeeding, your doctor will prescribe SOLU MEDROL only if strictly necessary.
SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml contain benzyl alcohol (see section “SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml contain benzyl alcohol”)
Fertility
Based on currently available information, this medicine may reduce fertility.
Driving and using machines
Do not drive or operate machinery if during treatment with SOLU MEDROL you experience dizziness, vertigo, visual disturbances, fatigue, euphoria, or mood disturbances.

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SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml contain benzyl alcohol
SOLU MEDROL contains 9 mg of benzyl alcohol in 1 ml of solution, equivalent to 9 mg/ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems (so-called "gasping syndrome") in newborns and young children. Do not use medicines containing benzyl alcohol in newborns (up to 4 weeks of age) and do not use these medicines for more than one week in young children (under 3 years of age), unless otherwise recommended by a doctor. Consult your doctor or pharmacist if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects such as increased acid levels in the blood (called "metabolic acidosis").
SOLU MEDROL contains sodium
SOLU MEDROL 125 mg/2 ml contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.
SOLU MEDROL 500 mg/7.8 ml contains 58.3 mg of sodium (main component of table salt) per vial. This corresponds to 2.92% of the maximum recommended daily dietary intake for an adult.
SOLU MEDROL 1000 mg/15.6 ml contains 116.8 mg of sodium (main component of table salt) per vial. This corresponds to 5.84% of the maximum recommended daily dietary intake for an adult.

3. How to use SOLU MEDROL

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose of SOLU MEDROL based on the severity of the condition being treated and your health status (either yours or your child's).
During treatment, your response to therapy will be monitored, and therefore the dose may be adjusted. Your doctor will explain how to taper the dose before stopping SOLU MEDROL.

Adults
The initial dose is 10 mg – 40 mg, administered intravenously (into a vein) over several minutes. Subsequent doses may be given either intravenously or intramuscularly (into a muscle).
SOLU MEDROL may be administered at high doses for up to a maximum of 48–72 hours. In such cases, the recommended dose is 30 mg/kg body weight administered intravenously over a 30-minute period. This dose may be repeated every 4–6 hours within 48 hours.

Children over 3 years of age

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

Method of administration
SOLU MEDROL is administered intravenously (by injection into a vein), intramuscularly (into a muscle), by intravenous infusion (drip into a vein), or via an infusion pump (intravenous infusion using an electronic device).
In an emergency, the intravenous route is preferred.
Intravenous administration must be performed by a qualified healthcare professional.

If you use/administer more SOLU MEDROL than you should
If a dose much higher than prescribed is used or administered, acute toxicity and even death may occur, although this is rare.
Seek immediate medical advice or go to the nearest hospital if you or your child have accidentally taken an excessive dose of SOLU MEDROL.

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

If you stop using SOLU MEDROL
You or your child must not stop taking SOLU MEDROL suddenly. SOLU MEDROL can cause reduced function of the adrenal glands, which produce natural corticosteroids, and abrupt discontinuation may lead to death.
Additionally, sudden interruption of SOLU MEDROL treatment may lead to withdrawal symptoms such as: anorexia, nausea, vomiting, excessive drowsiness, headache, fever, muscle and joint pain, skin peeling, weight loss, low blood pressure, and mental disturbances.
When stopping treatment, doses must be gradually reduced. Your doctor will advise you on the correct way to do this (see "How to use SOLU MEDROL").
If you have any doubts about using this medicine, consult 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 occurring when the body's immune defences are very low
• increased number of white blood cells in the blood
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• 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 secretion of hormones from the pituitary gland (a gland located at the base of the brain)
• withdrawal syndrome (see section 3 “If you stop treatment with SOLU MEDROL”)
• metabolic acidosis
• disturbance in glucose metabolism and worsening of pre-existing diabetes
• increased loss or retention of acidic substances from the body
• elevated levels of fats in the blood
• fluid and sodium retention in the body
• increased levels of urea in the blood
• increased appetite and body weight
• accumulation of fatty tissue in specific body areas
• increased body fat
• psychiatric disorders such as: depression, euphoria, manic behaviour, delirium, hallucinations, schizophrenia, altered perception of reality and thought disorders, emotional disturbances (e.g. mood swings, emotional dependence, suicidal ideation), personality changes, confusion, anxiety, abnormal behaviour, insomnia, irritability
• increased pressure of the fluid within the skull
• seizures
• memory difficulties
• thought disturbances affecting awareness of reality
• dizziness
• headache
• fat accumulation compressing the spinal cord
• cataract
• increased internal pressure of the eye
• protruding eyes
• reduced vision in the central part of the visual field
• disease of the retina and choroid membrane
• heart problems (heart failure) in susceptible patients
• irregular heartbeat
• formation of blood clots in veins and lungs
• increased blood coagulation
• increased or decreased blood pressure
• warmth and redness of the skin (flushing)
• hiccups
• stomach and intestinal ulcers with possible bleeding and perforation
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• inflammation of the pancreas
• inflammation of the abdomen (peritonitis)
• inflammation of the esophagus with or without ulcers
• abdominal distension and pain
• difficulty digesting
• nausea, vomiting and diarrhoea
• inflammation of the liver
• delayed wound healing
• thinning and fragility of the skin
• skin patches of unusual colour
• atrophy of the skin and its appendages (hair, nails)
• pus formation
• swelling
• bruising
• appearance of small red spots or thin purple streaks on the skin
• increased hair growth
• redness of the skin, skin rashes
• itching
• acne
• excessive sweating
• bone fragility (osteoporosis), bone tissue death and loss
• muscle and joint pain, muscle diseases, reduced muscle mass
• muscle weakness
• joint rupture (especially in the foot) causing pain and/or swelling
• irregular menstruation
• reaction at the injection site
• fatigue, malaise
• abnormal laboratory tests assessing liver function
• possible liver damage, hepatitis, increased liver enzymes
• decreased potassium levels in the blood
• increased calcium levels in the urine
• reduced response to skin tests
• vertebral fractures (traumatic or spontaneous), tendon rupture, particularly of 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, talk to your doctor or pharmacist. 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.

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5. How to store SOLU MEDROL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "Exp.". The expiry date refers to the last day of that month.
SOLU MEDROL 125 mg/2 ml, 500 mg/7.8 ml, and 1000 mg/15.6 ml: Do not store above 25°C.
Period of validity after reconstitution: The reconstituted solution must be used immediately.
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 SOLU MEDROL contains
The active substance is methylprednisolone (as methylprednisolone sodium succinate).
SOLU MEDROL 125 mg/2 ml powder and solvent for injectable solution
Each 2 ml dual-chamber vial contains 125 mg of methylprednisolone (equivalent to 165.72 mg of methylprednisolone sodium succinate).
Other components are:
The powder vial contains: disodium hydrogen phosphate, sodium phosphate (see section 2 “SOLU MEDROL contains sodium”).
The solvent vial contains: water for injections.

SOLU MEDROL 500 mg/7.8 ml powder and solvent for injectable solution
Each 7.8 ml vial contains 500 mg of methylprednisolone (equivalent to 662.88 mg of methylprednisolone sodium succinate).
Other components are:
The powder vial contains: disodium hydrogen phosphate, sodium phosphate (see section 2 “SOLU MEDROL contains sodium”).
The solvent vial contains: benzyl alcohol (E1519) (see section 2 “SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml contain benzyl alcohol”), water for injections.

SOLU MEDROL 1000 mg/15.6 ml powder and solvent for injectable solution
Each 15.6 ml vial contains 1000 mg of methylprednisolone (equivalent to 1325.77 mg of methylprednisolone sodium succinate).
Other components are:
The powder vial contains: disodium hydrogen phosphate, sodium phosphate (see section 2 “SOLU MEDROL contains sodium”).
The solvent vial contains: benzyl alcohol (E1519) (see section 2 “SOLU MEDROL 500 mg/7.8 ml and 1000 mg/15.6 ml contain benzyl alcohol”), water for injections.

Description of the appearance of SOLU MEDROL and contents of the pack
SOLU MEDROL 125 mg/2 ml powder and solvent for injectable solution is available in packs containing 1 dual-chamber vial.
SOLU MEDROL 500 mg/7.8 ml powder and solvent for injectable solution is available in packs containing 1 glass vial with rubber stopper containing the powder + 1 solvent vial of 7.8 ml.
SOLU MEDROL 1000 mg/15.6 ml powder and solvent for injectable solution is available in packs containing 1 glass vial with rubber stopper containing the powder + 1 solvent vial of 15.6 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Pfizer Italia S.r.l.
via Isonzo, 71
04100 Latina
Italy

Manufacturer
PFIZER MANUFACTURING BELGIUM NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

The following information is intended exclusively for physicians and healthcare professionals.
INCOMPATIBILITIES
To avoid compatibility and stability problems, methylprednisolone sodium succinate should be administered separately from other substances administered intravenously. Drugs that are physically incompatible in solution with methylprednisolone sodium succinate include, but are not limited to: allopurinol sodium, doxapram hydrochloride, tigecycline, diltiazem hydrochloride, as well as calcium gluconate, vecuronium bromide, rocuronium bromide, cisatracurium besylate, glycopyrronium, propofol.

DOSAGE AND ADMINISTRATION
The dose must be determined according to the clinical condition being treated and its severity.
It is recommended to use the lowest effective dose for the shortest possible duration.
Treatment should be adjusted according to the observed response, and maintenance therapy should be established through gradual titration to achieve an adequate clinical response.
In case of long-term treatment, the drug should be withdrawn gradually (see “Warnings and Precautions”).
After completion of emergency treatment, consider using a longer-acting injectable formulation or an oral formulation.

For high-dose treatment, the recommended dose of SOLU MEDROL is 30 mg/kg administered intravenously over a period of at least 30 minutes. The dose may be repeated every 4–6 hours within 48 hours. High-dose treatment should be continued until clinical stabilization; however, it should not be prolonged beyond 48–72 hours. Short-term use of high doses may lead to peptic ulcer development; therefore, concomitant prophylactic treatment is recommended (see “Warnings and Precautions” and “Undesirable Effects”).

Exacerbations of systemic lupus erythematosus and edematous states caused by glomerulonephritis or lupus nephritis:
Pulsed intravenous administration of 250–1000 mg daily for 1–3 days is recommended.

In case of exacerbation of pathological conditions or lack of response to standard therapies, the following intravenous boluses are recommended:

Multiple sclerosis:
1 g daily by intravenous infusion for 3–5 days.

Acute spinal cord injury:
Treatment should be initiated within 8 hours of trauma with a bolus dose of 30 mg/kg administered over 15 minutes, followed by a 45-minute interval and then a maintenance infusion of 5.4 mg/kg/hour for the next 23 hours.

Treatment choice must be made on a case-by-case basis, carefully weighing risks and benefits, and referring to official guidelines.

Close monitoring of the injured patient is also required due to the high risk of toxicity associated with the high dose of methylprednisolone administered.

Palliative therapy in advanced-stage cancer:
The recommended dose is 125 mg daily; short-term treatment should be carefully evaluated on a case-by-case basis.

Prophylaxis of nausea and vomiting associated with mildly or moderately emetogenic chemotherapy:
125–250 mg of SOLU MEDROL, alone or in combination with a phenothiazine, one hour before chemotherapy.
This is followed by a second dose of SOLU MEDROL at the time of chemotherapy and a final dose before discharge.

Prophylaxis of nausea and vomiting associated with highly emetogenic chemotherapy:
250 mg of SOLU MEDROL combined with 1–2.5 mg droperidol or 1.5–2 mg/kg metoclopramide, one hour before chemotherapy.
This is followed by a second dose of SOLU MEDROL at the time of chemotherapy and a final dose before discharge.
In all cases, short duration of treatment is recommended.

Adjuvant therapy in severe Pneumocystis jirovecii pneumonia in AIDS patients:
0.5 mg/kg every 6 hours for 10 days.
Administration must begin within 72 hours of starting antimicrobial therapy.

For other indications, the initial dose is 10–40 mg of methylprednisolone, depending on the severity of the clinical condition.
Higher doses may be required in acute and severe conditions. In such cases, short duration of treatment is strongly recommended.

The initial dose should be administered intravenously over several minutes.
Subsequent doses may be administered intravenously or intramuscularly; the choice of route should depend on the condition being treated and the response achieved.

Corticosteroid therapy is an adjuvant and not a substitute for conventional therapy.

If remission occurs during treatment of a chronic disease, the drug should be discontinued (see “Warnings and Precautions”).

Paediatric population
In children over 3 years of age, dosage should be based not on age or weight, but on the severity of the condition and the response achieved.
The dose should not be less than 0.5 mg/kg per day.
Dosage should be gradually reduced if treatment has been prolonged for several days.

Method of administration
SOLU MEDROL may be administered by intravenous or intramuscular injection, by infusion, or via infusion pump.
In emergencies, the intravenous route is preferred.
For instructions on reconstitution and dilution of the medicinal product prior to administration, see “Instructions for Use”.

INSTRUCTIONS FOR USE

DUAL-CHAMBER VIAL

1. Press the cap firmly to release the solvent into the lower compartment of the vial containing the powder.
2. Shake the vial until the powder is completely dissolved.
3. Remove the plastic cap protecting the center of the rubber stopper and disinfect the area.
4. Insert the needle into the center of the stopper until the tip is visible inside the vial. Invert the vial and withdraw the solution.

VIALS WITH POWDER AND SOLVENT
Remove the protective cap from the powder vial and dissolve the powder with the solvent drawn up.
For intramuscular and intravenous injections, no further dilution is necessary. For infusions, dilute in 100 to 1000 ml of 5% glucose solution or physiological saline.
The reconstituted solution must be used immediately.

UNDESIRABLE EFFECTS
When administered by contraindicated routes (intrathecal/epidural), the following adverse reactions have been reported: arachnoiditis, gastrointestinal/vesical dysfunction, headache, meningitis, paraparesis/paraplegia, seizures, sensory disturbances. The frequency of these adverse reactions is unknown.
For further information, please consult the SmPC (Summary of Product Characteristics).